Thursday, August 31, 2006

BRT Laboratories, Inc. Has Been Contracted By OncoMethylome Sciences, To Perform MGMT Methylation Assays for a Multi-Site, International Clinical Trial

BRT Laboratories, Inc. announced today that the laboratory has been approved by the clinical trial supporter and OncoMethylome Science's collaborator, Schering-Plough Corporation, to provide MGMT methylation testing for OncoMethylome Sciences. Starting immediately, the laboratory will be evaluating the methylation status of the MGMT gene in DNA extracted from brain tumor cells using OncoMethylome Sciences' patent-protected assay.

This is an important first step in the ongoing collaboration between BRT Laboratories, Inc. and OncoMethylome Sciences that was announced on March 29, 2006. Making this testing service available is a key milestone in OncoMethylome Sciences' collaboration with Schering-Plough, which was announced on November 11, 2005. The tumor samples will originate from the multi-center brain cancer clinical trial conducted by the U.S.-based Radiation Therapy Oncology Group (RTOG), the European Organization for Research and Treatment of Cancer (EORTC), and supported by Schering-Plough.

ABOUT BRT LABORATORIES, INC.

BRT Laboratories, Inc., a Baltimore based biotech company, is a multi-faceted laboratory offering a full range of genetic services that includes relationship analysis, identity testing, and clinical assay development. BRT has been serving the community for over 60 years in the areas of paternity, immigration, forensics, and blood donor services.

Wednesday, August 30, 2006

Clinical data on Adeza Biomedical Corp.'s Gestiva drug to prevent premature births are adequate for it to win U.S. approval, an advisory panel said on Tuesday, adding that future information on possible risks was needed.

Gestiva is a long-acting, injectable form of the hormone progesterone. Its maker, which specializes in women's health products, is seeking approval from the U.S. Food and Drug Administration to allow the shots for women who have previously given birth prematurely.

Adeza stock rose in afterhours trade to $16.60 a share in after closing at $15.91 on Nasdaq.

There is no FDA-approved drug to prevent premature birth, but injectable progesterone was available in the United States for 50 years for other conditions until Bristol-Myers Squibb Co. stopped selling it in 2000.

Since then pharmacists have been making their own version of the drug, and some doctors have used other drugs known to stop contractions, but not approved to prevent early birth.

The drug, Adeza officials said, could also help curb the growing number of American women who are giving birth before a full pregnancy term of 37 weeks, the company said.

About 12 percent of all babies are born too early, according to the March of Dimes health organization, which said it supported approval as long as Gestiva was closely monitored once on the market.

The FDA panelists said more study should be done to evaluate a possible link between the drug and miscarriages and stillbirths. Most said that could be done after the drug's approval, but eight of the 21 panelists urged the data be collected before.

They also recommended the company establish a patient registry to monitor side-effects as well as consider follow-up studies on possible long-term problems.

The FDA, which usually follows the advice of its panels, is expected make its final decision by Oct. 20.

"FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid," the U.S. insurance program for the poor, added March of Dimes' medical director Dr. Nancy Green. She said her group has accepted funds from Adeza but did not collaborate on its Gestiva proposal.

Preemies are often underweight and can experience a host of other problems, including breathing problems and infections.

FDA staff reviewers said they were concerned the drugmaker submitted only one study on how well the drug worked. It had a widely different account of women who did not take the drug compared with another earlier study, they said, which could raise questions about the trial as a whole.

Adeza's data showed 55 percent of women who took a placebo gave birth early compared with 37 percent in the other study. Both were government-funded.

Some panelists agreed it was not entirely clear how well Gestiva worked, although the panel overall said another trial was not needed.

"Even though I voted for it, I'm still skeptical," said panelist James Scott, a professor of obstetrics and gynecology at the University of Utah School of Medicine.



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Hana Biosciences (HNAB) was up 2% after the Food and Drug Administration accepted its new drug application for Zensana oral spray for review. Hana wants to get Zensana cleared for preventing the nausea and vomiting that can follow chemotherapy, radiation and operations. Hana was up 14 cents at $7.29.


Canadian biotechnology company Biomira Inc. said Wednesday it named Robert L. Kirkman as president and chief executive, effective Sept. 5.


Kirkman, 57, was formerly acting president and chief executive of biopharmaceutical company Xcyte Therapies Inc. Prior to that appointment, he served as chief business officer and vice president at Xcyte.

Edward A. Taylor, who remains chief financial officer, had been interim president and chief executive since Alex McPherson resigned in May.

Kirkman also becomes a director. In addition, Biomira named Christopher Henney as chairman, effective Sept. 5. Henney joined the board in 2005 and has co-founded three U.S. biotech companies: Immunex, ICOS and Dendreon.

Biomira (BIOM) edged higher .......Biomira was up 1% to $1.12.


PDL BioPharma (PDLI) said Roche has discontinued its involvement in the development of daclizumab in asthma, which both companies had been co-developing since 2004. The decision has no effect on the companies' collaboration to develop daclizumab in transplant maintenance. They plan to proceed with Phase II studies for the transplant indication during 2007. PDL tacked on 1% to $19.68.

Abbott (ABT) completed the enrollment in a study designed to increase the clinical understanding of "vulnerable" plaque -- a lipid-rich coronary plaque that ruptures and is believed to be the cause of most heart attacks. The study enrolled 700 acute coronary syndrome patients receiving stents in the U.S. and Europe. Patients will be followed for at least two, and up to five, years. Shares of Abbott slipped 1.3% to $48.32.
India announces launch of Asia Biotech Meeting

Noting that the biotechnology industry in Asia is still at a nascent stage, India has announced the launch of an annual 'Asia Biotech' meet, bringing together scientists and biotechnology experts who will focus mostly on the needs of the people of the region.

"Most of Asia is largely an agricultural community so agricultural biotechnology is necessary for food security," Minister of Science and Technology Kapil Sibal said adding that the experts would also focus on health security.

The launching of the annual meeting was announced by Sibal at the fourth Asean informal ministerial meeting on Science and Technology, held at Kuatan in Pahang state.

The annual meet is modelled on the lines of the 'Biotechnology Conference' held annually in the United States. Next year's meeting will be held at Boston.

The Asia Biotech conference will be held in rotation across Asean plus six nations viz China, Japan, South Korea, India, Australia and New Zealand. The first conference will be held at New Delhi in November 2007.

"The meeting will be held in the Asean plus six countries but participation is welcome from other Asian and Western nations, though the focus will be on Asia," Sibal said.

"We also need to set up regulatory mechanisms, something like Asian DA based on the lines of the FDA," the minister said here on his arrival after the informal meet at Kuantan.

Tuesday, August 29, 2006

Analyst Reiterates 'Buy' Rating on ViroPharma After Company Says HCV Promising

Shares of biotech company ViroPharma Inc. climbed in afternoon trading on Tuesday after the drug development company reported positive data from an early-stage clinical study of an experimental drug.

The stock rose $1.37, or 12 percent, to $12.54 in afternoon trading on the Nasdaq. Over the past 52 weeks, the shares have traded in a range of $7.07 and $24.36.

Lazard Capital Markets analyst Joel Sendek maintained a "Buy" rating, and said he was encouraged by the new data.

In the early trial, doses of the drug candidate, HCV-796, were combined with another HCV treatment, pegylated interferon alfa-2b. After 14 days, the combined drugs produced an average viral reduction of nearly 100 percent.

"The data from this Phase I combination trial confirms our previous view that in terms of efficacy, HCV-796 is in mid-range of the drugs in development for HCV," Sendek wrote in a client note.

But Sendek noted that the best way to evaluate HCV-796 is through larger, longer trials with patients who have never received treatment for the disease and patients who haven't yet responded to treatment.

Sendek's price target is $21.

The analyst also expects complete results of the trial to be presented later this year and a mid-stage trial to begin in the fourth quarter.

StemCells (STEM) advanced on word it signed a licensing agreement with Stem Cell Therapeutics, a Canadian biotechnology company engaged in treating central nervous system disorders. Under the agreement, Stem Cell Therapeutics will pay StemCells up-front and license maintenance fees, as well as milestone and royalty payments.

The agreement also provides StemCells with access to the Canadian company's intellectual property portfolio for use in drug discovery, screening and testing. StemCells will pay Stem Cell Therapeutics "a commercially reasonable royalty" that will be negotiated on products developed under the license. Shares of StemCells were up 7.1% to $2.41.

Teva Pharmaceutical Industries (TEVA) was lower after it reached an agreement with Purdue Frederick and its affiliates to settle a patent infringement lawsuit over a generic version of the painkiller OxyContin. Teva expects to eventually stop selling the generic. Its shares slipped 1% to $34.35.

Endo Pharmaceuticals (ENDP) , which also settled a lawsuit regarding generic OxyContin, rose 1.9% to $33.06. Endo will sell its drug until the end of the year.

Monday, August 28, 2006

Chinese biopharmaceutical company Sinovac Biotech (SVA) jumped 17.3% to $2.37 after it said the preliminary results of a Phase I clinical trial showed that its vaccine against the H5N1 strain of avian flu had a high safety and immunogenicity profile.


The result proves that the vaccine with different dosages can induce an immune response, of which the vaccine contained 10ug antigen has been proved to have the best immunogenicity with the sero positive rate of 78.3%, which exceeds the EU CHMP criteria for seasonal influenza vaccines (greater or equals to 70%). There is no serious adverse event reported on the 120 volunteers and it is proved that the vaccine is well tolerated and immunogenic.

Epix Pharmaceuticals (EPIXD) dropped after it received a letter from the Food and Drug Administration denying its formal appeal to approve its novel blood-pool imaging agent Vasovist and turning down the company's request for an advisory committee review. Shares of Epix were lower by 12.9% to $6.28.

Shares of Corcept Therapeutics (CORT) were weaker for a second day, falling 10.4% to $1.38. The stock plunged Friday after the company announced negative results from a clinical trial on its experimental psychotic depression drug Corlux.
Epix Evaluating Options After FDA Turns Down Appeal to Approve Vasovist Blood Imaging Agent

Biotech drug maker Epix Pharmaceuticals Inc. said Monday that the Food and Drug Administration turned down its appeal to get an approval for its blood imaging agent Vasovist, placing pressure on shares.

Shares of Epix fell 91 cents, or 13 percent, to $6.30 in early Nasdaq trading.

Epix said the FDA turned down its request for an advisory committee meeting to review data. The agency also suggested that the company conduct two clinical trials as a safer course of action to get the product approved.

In June, the company appealed the agency's decision requiring another clinical trial for Vasovist. That decision came in an "approvable letter" in November, following another earlier letter that had requested more data from the company.

The product is an injectable agent that when used with imaging technology can show blood flow throughout the vascular system. Vasovist is aimed at detecting blood clots.

"We are evaluating several options available to us as next steps with Vasovist in the United States, including the option to appeal this decision to the next level at the FDA, and will update the market accordingly," said Andrew Uprichard, Epix' president, in a statement.

Vasovist is already approved in Europe and was recently recommended for approval in Australia.

Friday, August 25, 2006

Novogen Ltd. on Friday said it won clearance from the U.S. Food and Drug Administration to go ahead with the final phase of human clinical testing on its lead anti-cancer drug, phenoxodiol.

Separately, the company said its revenue for the year ended June 30, 2006, was $13.9 million, up 3.2 percent over the previous year.

Cash reserves at year-end were $25.4 million, down $10.5 million from a year before.

Research and development spending rose $1.4 million to $9.1 million, from $7.7 million in the previous period. The increase mostly reflects costs associated with its pre-clinical and clinical drug development program and the scale-up and drug manufacturing process development costs for human clinical testing of phenoxodiol.

Dyax (DYAX) rose after the company said it signed a deal for a licensing and research program. The company entered an agreement with Paul Capital Partners' Paul Royalty Fund II for a $30 million upfront cash payment. Dyax also has an option to receive an additional $5 million payment if it achieves certain revenue goals within the next two years. Shares were up 10.9% to $3.15.

Vertex Pharmaceuticals (VRTX) jumped on an upgrade from UBS. According to analyst Annabel Samimy, who raised the stock's rating to buy from neutral, the biotech should report strong efficacy results on trials of its antiviral drug VX-950. She kept her price target of $42. The stock was up 7.9% to $34.80.

Mylan Laboratories (MYL) sank on a downgrade by an analyst at Banc of America Securities. Analyst David Maris downgraded the stock to sell from neutral. The stock fell 1.3% to $20.89. Maris maintained his 12-month price target of $19.

Among other health stocks taking a hit were CoTherix (CTRX) , falling 2.3% to $6.47, Coley Pharmaceutical (COLY) , down 1.7% to $10.70, Cell Therapeutics (CTIC) , sinking 5.6% to $1.52, Avalon Pharmaceuticals (AVRX) , losing 6.8% to $2.89 and Acorda Therapeutics (ACOR) , off 7.5% to $3.08.

Health stocks moving higher included SuperGen (SUPG) , whose shares jumped 13.4% to $3.80, Elan (ELN) , up 4.8% to $16.25, Vertex Pharmaceuticals (VRTX) , gaining 7.9% to $34.80, Teva Pharmaceutical (TEVA) , 1.8% higher to $35.54, Boston Life Sciences (BLSI) , up 8.3% to $3.92, Zila (ZILA) , up 2.1% to $2.95, Tiens Biotech Group (TBV) , whose shares gained 2.7% to $3.07, Introgen Therapeutics (INGN) , up 2.1% to $3.95 and Immunomedics (IMMU) , up 4% to $2.04.

Thursday, August 24, 2006

Drug developer Dendreon Corp. said Thursday it submitted two out of three sections of its rolling Food and Drug Administration application for cancer treatment Provenge.


The company said it turned in the clinical and non-clinical sections of its fast-track application, and plans to submit the chemistry, manufacturing and controls section for Provenge to complete the application later this year.

Companies given FDA fast-track status for a drug can submit data to the agency as it becomes available, and get agency feedback on a rolling basis, rather than having to wait and submit it all at once.

Dendreon seeks to get Provenge approved to treat advanced prostate cancer patients whose disease has spread.

Prostate cancer, the most common non-skin cancer in the United States and the third most common worldwide, affects about 1 million men in the U.S. alone with about 232,000 new cases of diagnosed each year.

Shares of Johnson & Johnson (JNJ) were up after UBS increased its target price on the stock to $80 from $73. Shares were up 1.6% to $64.94.

Goldman Sachs upgraded Taro Pharmaceutical (TARO) to neutral from sell, lifting its shares 6.5% to $14.11. Goldman also raised its price target to $14 from $11.

Among other stocks moving were Genzyme (GENZ) , down 1.5% to $65.13, Adams Respiratory Therapeutics (ARXT) , falling 1% to $39.84, and OraLabs Holding (OLAB) , whose shares lost 9.6% to $6.15.

Moving higher were Celgene (CELG) , up 2% to $42.03, Elan (ELN) , adding 2.6% to $15.11, Boston Scientific (BSX) , up 2.3% to $17.16, and Medtronic (MDT) , gaining 2.1% to $46.28.

As a group, stem-cell stocks were up, with Geron (GERN) gaining 5.4% to $6.70, StemCells (STEM) up 2.7% to $2.31, and Viacell (VIAC) higher by 5.3% to $4.01.

Wednesday, August 23, 2006

Drug-discovery company Critical Therapeutics Inc. on Wednesday reported positive results from an early- to mid-stage clinical trial of its Zyflo zileuton IV asthma drug.

The study found that patients who received the drug showed greater improvement in lung function than patients who received a placebo. The drug was well tolerated at all doses, with no serious adverse events reported in the trial, the company said.

Critical Therapeutics is developing the drug initially for use in emergency room or urgent care centers for patients who have acute flair ups of asthma.

Shares rose to $3.88 19.2% to $1.55.

Device maker Medtronic's (MDT) shares were all over the map. While the company met its lowered guidance for the fiscal first quarter, it reduced its full-year forecast. Lately, the stock was up 4 cents, or 0.1%, to $45.40.

Shares of drug developer SuperGen (SUPG) fell after the company announced the closing of a deal with Mayne Pharma. Mayne will pay around $34 million for SuperGen's Nipent injection and SurfaceSafe cleaner. However, payments will depend on product performance and key events, according to SuperGen. Shares dipped 0.9% to $3.40.

Bristol-Myers Squibb (BMY) slipped after Cell Therapeutics (CTIC) announced positive data on its cancer drug Xyotax, a potential competitor to Taxol. Bristol's shares fell 1.2% to $21.58.

Other movers included Celgene (CELG) , whose shares fell 2.4% to $40.98, Avalon Pharmaceuticals (AVRX) , down 3.5% to $3.07, Meridian Bioscience (VIVO) , falling 3% to $22.70, GeoPharma (GORX) , down 5.5% to $3.08, Hollis-Eden Pharmaceuticals (HEPH) , off 2.2% to $6.97, and Medicines Co. (MDCO) , down 1.7% to $21.99.

Onyx Pharmaceuticals (ONXX) gained 6% to $14.11, Novavax (NVAX) was up 6.8% to $3.94, EpiCept (EPCT) was rising 6.2% to $2.39, GenVec (GNVC) was up 6% to $1.23, and Hemispherx Biopharma (HEB) got a 3.8% boost to $2.19.

Tuesday, August 22, 2006

The National Institute of Allergy and Infectious Diseases is using technology developed by GenVec in human trials of a vaccine that treats HIV.

The agency's Vaccine Research Center plans to dose 15 HIV-infected patients with a combination of a DNA prime vaccine and a booster vaccine that uses GenVec's adenovector technology, which the company says better identifies agents that the immune system uses to fight diseases.

The clinical trial will last for 48 weeks.

The Vaccine Research Center has already conducted Phase I and Phase II trials with more than 600 healthy participants to study the vaccine's preventative strength. This will be the first to treat people who have the disease.

In addition to assisting the allergy and infectious diseases institute with HIV and flu vaccines, the Gaithersburg company is working with other agencies to use the adenovector technology. The Naval Medical Research Center is using it for a malaria vaccine and the U.S. Department of Agriculture for anti-viral drugs and a foot and mouth disease vaccine.

GenVec (NASDAQ: GNVC) is developing other drugs to treat cancer, heart disease and ophthalmic disorders, including one in its second and third phases of clinical trials that battles pancreatic cancer.

Medical-technology company Bruker BioSciences (BRKR) sank following a downgrade by investment firm UBS. Biotech analyst Derik De Bruin downgraded the stock from a buy rating to neutral, saying the company is facing limited upside and increased competition from larger vendors of mass spectrometry technologies. De Bruin maintained his price target of $7. Shares fell 1.3% to $6.06.

Shares of Omnicare (OCR) dropped after a downgrade from investment research firm Stifel Nicolaus. According to health care analyst Jerry Doctrow, who downgraded the stock from a buy to hold, despite an attractive valuation, "we are no longer comfortable recommending OCR because we believe lower pricing and legal settlements could erode some or all of the expected synergy we have been assuming in 2006 and 2007." Omnicare slumped 2.5% to $42.54.

Device maker St. Jude Medical's (STJ) shares fell 2.5% to $36.04 despite the company's announcement that the Food and Drug Administration approved a new feature for its heart devices. The new feature, to be used in patients with a cardiac rhythm device or defibrillator implant, shows vital health data equivalent to what's provided in an echocardiogram within two minutes, compared with a test that usually takes between two hours and 30 minutes to conduct.

Among other health stocks on the move were Neurobiological Technologies (NTII) , 3.3% lower to $2.63, Nymox Pharmaceutical (NYMX) , whose shares lost 3% to $2.55, Bioprogress (BPRG) , down 13.7% to $7.76 and Novacea (NOVC) , off 5.2% to $5.87.

SkyePharma (SKYE) was up 2.6% to $4.74, Praecis Pharmaceuticals (PRCS) gained 9.8% to $2.02, AVI Biopharma (AVII) jumped 19.3% to $4.27 and AMN Healthcare Services (AHS) was up 4.6% to $23.03.

Monday, August 21, 2006

Generic drug company Teva Pharmaceutical Industries Ltd. said Monday regulators approved Azilect, the company's treatment for Parkinson's disease, for sale and marketing in Canada.

Health Canada gave the green light to the drug for initial monotherapy in early Parkinson's disease and as adjunct therapy to levodopa in moderate to advanced disease, the company said. The company expects to begin selling the drug in Canada in September.

The company said the approval was based on three studies on more than 1,500 patients.

Shares of Teva fell 13 cents to $34.21 on the Nasdaq.




Dynavax (DVAX) shares rose after the vaccine maker released early test data indicating that its experimental flu shot could be a universal preventative measure to ward off both seasonal flu and a pandemic. Shares were up 7.8% to $4.29.

Oscient Pharmaceuticals (OSCI) jumped after the company said it acquired the rights to market Reliant Pharmaceuticals' cholesterol drug Antara. The Waltham, Mass., biopharmaceutical company paid Reliant $78 million and purchased about $4 million in existing inventory. Oscient will begin marketing the drug later this week. Shares rose 6.4% to $1.33.

Merck's (MRK) shares edged higher following an upgrade from Lehman Brothers to overweight from equal-weight. "We believe that there will be stock price volatility around Vioxx litigation," wrote pharmaceuticals analyst C. Anthony Butler, who raised his target price on the stock to $46 from $35. However, "our decision to upgrade is predicated on MRK's demonstration of a considerable upside for both earnings growth and product introductions." Shares added 20 cents, or 0.5%, to $39.72.


MGI Pharma's (MOGN) shares fell 11 cents to $15.59 after the stock was downgraded by analysts at research firm Matrix USA to hold. Matrix cited competitive threats to its Aloxi injection for post-operative nausea and vomiting. Last month, Matrix initiated coverage of MGI with a strong buy.

Among other health care stocks on the move were Onyx Pharmaceuticals (ONXX) , whose shares sank 4% to $13.31, Tanox (TNOX) , down 2.8% to $14.36, Genta (GNTA) , whose shares dipped 1.4% to $1.39, Cytokinetics (CYTK) , down 2.3% to $5.92 and Medarex (MEDX) , off 1.5% to $9.82.

Moving higher were Cytori Therapeutics (CYTX) , up 1.4% to $4.41, Threshold Pharmaceuticals (THLD) , gaining 8.9% to $2.09, Accentia Biopharmaceuticals (ABPI) , rising 1.7% to $2.95 and Lipid Sciences (LIPD) , up 3.8% to $1.49.

Sunday, August 20, 2006

U.S. biotech stocks surged last week as investors, perhaps emboldened by tame inflation data and a recent slowdown in Fed rate hikes, showed an appetite for riskier names. The Nasdaq Biotechnology Index pulled back from yearly lows with a weekly gain of 4.3%. Meanwhile, several big pharma companies made negative headlines, but the Amex Pharmaceutical Index still managed to end the week with a 2% gain.

Shares of Eli Lilly ended four straight sessions of stock gains last Friday after U.S. health regulators delayed a decision on Arxxant, an experimental treatment for diabetic retinopathy. The U.S. Food and Drug Administration issued an "approvable letter" and requested additional data from the Indianapolis-based drugmaker. Street analysts expressed concern about whether the request would require a new clinical trial. Bearn Sterns said the FDA letter was "worse than it looks" and cut the 2010 sales forecast for Arxxant to $200 million from $785 million. Arxxant is an inhibitor of an enzyme called protein kinase C-beta, or PKC-beta.

Earlier in the week, shares of Lilly and Amylin Pharmaceuticals got a lift after the companies said diminished inventory levels for diabetes treatment Byetta were no longer a concern. The companies had asked physicians two months ago to stop putting new patients on the drug as rising demand outpaced manufacturing capability. Amylin shares ended the week with a gain of 13.6%; Lilly rose 1.2%.

Bristol-Myers Squibb and Sanofi-Aventis pleaded their case in front of a judge on Friday as the companies hoped to stop sales of generic Plavix. Canadian drugmaker Apotex recently launched a copycat version of the blood-thinning treatment earlier than expected, after U.S. antitrust officials rejected a proposed settlement with Bristol and its marketing partner Sanofi. On Thursday, Bristol announced that it had hired former U.S. Attorney Mary Jo White to take a second look at the company's rejected settlement with Apotex. White, a partner at law firm Debevoise & Plimpton and a former federal prosecutor for the Southern District of New York, was hired by Bristol in late July.

Another Canadian drug outfit grabbing the spotlight last week was Neurochem, whose shares surged more than 40% after the FDA issued an "approvable letter" for experimental drug Kiacta after the close of trading Aug. 11. Kiacta is a medication for a rare but deadly disease known as AA Amyloidosis, a precursor to kidney failure. Neurochem CEO Francesco Bellini said in an interview with Forbes.com that the FDA letter was "very, very good news" and said it expects a final decision from the FDA as early as Christmas. "The FDA will decide, but I think the odds of approval are higher, much higher." Neurochem is developing the drug with health care giant Johnson & Johnson.

Friday, August 18, 2006

UBS on Friday raised its rating on Iomai Corp. shares to "buy" from "neutral," expecting positive news in the next six months.

The brokerage said in its research note the upgrade is based on both valuation and anticipation of the next six months, which could be relatively active on both the clinical and business development fronts.

UBS sees a partnership for the needle free flu vaccine forthcoming within the next several months, which would drive further development of the program beyond phase I/II.

The brokerage maintained its price target of $5.00 on the stock, which closed at $3.47 Thursday on the Nasdaq. Shares were trading up 28.2% to $4.45 on Friday.

Allscripts Healthcare Solutions (MDRX) sank following a downgrade of the stock by UBS analyst Donald Hooker to reduce from neutral. UBS maintained its price target of $18. Shares were down 6% to $20.22. Separately, Allscripts said California's Riverside Physician Network has decided to use the company's TouchWorks Electronic Health Record technology to connect its network of 200 doctors.

Cancer drugmaker Celgene saw its shares move lower after investment firm Goldman Sachs initiated coverage of the stock with a neutral rating and a $50 price target. While the company has strong sales momentum and improving margins, according to biotech analyst May-Kin Ho, Celgene faces reimbursement pressures as off-label use of its drugs are under increasing scrutiny. The company's blood cancer drugs Revlimid and Thalomid also face competitive pressure from Millennium Pharmaceuticals' (MLNM) Velcade. Shares fell 2.6% to $43.46.

Idenix Pharmaceuticals (IDIX) shares sank 6.7% to $8.81 on a downgrade by investment firm Goldman Sachs. While May-Kin Ho deems the hepatitis B drugmaker's research pipeline "above average," she says the hepatitis B market is limited and the company has plenty of competition from companies like Gilead (GILD) and Bristol-Myers Squibb (BMY) . Ho downgraded the stock to neutral from buy and set a 12-month price target of $11.

Adams Respiratory Therapeutics' (ARXT) shares fell 7.2% to $41.84 after the company said an unnamed competitor submitted an application to the Food and Drug Administration to sell a drug that could be pitted against its over-the-counter expectorant Mucinex. Also on Friday, Adams filed a registration statement covering more than 10 million shares held by institutional investors as part of a contractual obligation.

Other health stocks falling were Affymetrix (AFFX) , whose shares sank 4% to $21.24; generic drugmaker Teva Pharmaceutical (TEVA) , down 1.3% to $34.17; nervous-system drug developer Vanda Pharmaceuticals (VNDA) , 5.7% lower to $9.27; IDM Pharma (IDMI) , whose shares fell 6.7% to $2.33; and Cyclacel Pharmaceuticals (CYCC) , down 4.6% to $5.16.

Moving higher were medical-device maker Medtronic (MDT) , up 2.2% to $45.49; Allied Healthcare International (AHCI) , up 12% to $1.68; Dynacq Healthcare (DYII) , up 8.7% to $2; SGX Pharmaceuticals (SGXP) , up 5% to $4.95; and Natural Health Trends (BHIP) up 6.3% to $2.55.
Euronext Paris will make its first listing of a Chinese company when Watson Biotech floats by the end of the year, Watson's consultants announced.

Based in Xi'an, capital of China's northwestern Shaanxi province, the group specializes in extracting active ingredients from trees that are used in the generic anti-cancer drug paclitaxel.

'It will be a first in continental Europe,' said Louis Thannberger, chairman of Europe Finance and industry (Efi), which is advising Watson on the initial public offering.

Euronext, which operates the Paris, Amsterdam, Brussels and Lisbon markets, confirmed that the listing was a first for a Chinese company on its exchanges.

About 40 Chinese groups have been floated in London, mainly on the AIM (Alternative Investment Market) for small companies, and others are quoted in the US.

Watson Biotech reported sales of 7.6 mln eur in 2005 and a net profit of 1.46 mln eur.

Thannberger said that the group will most likely list on the Alternext market for small and medium-sized companies 'before the end of the year' and would have a capitalisation of 60 mln eur.

'It's quicker (on Alternext). There is a real frenzy in China for companies to get listed quickly,' he said.

The listing would involve a rights issue aimed at raising 8 mln eur, Thannberger said.

Thursday, August 17, 2006

Genitope's (GTOP) shares sank 4.3% to $2.46 after the company discussed interim data on its MyVax personalized immunotherapy for previously untreated follicular lymphoma. According to a regulatory filing and a conference call, as of June 15, more than half of the patients in a late-phase MyVax clinical trial, or 158 of 287 patients, got worse.


Shares of Cephalon (CEPH) were up 1.5% to $57.93 after investment bank Morgan Stanley initiated coverage of the stock.

Novavax (NVAX) rose after the company named Jeffrey Church its new chief financial officer. Church was most recently CFO at GenVec. Novavax shares were up 4.8% to $3.27.


Micromet (MITI) , down 6.3% to $2.53, Illumina (ILMN) , falling 2.9% to $31.95, Valera Pharmaceuticals (VLRX) , 6.7% lower to $5.99, Tapestry Pharmaceuticals (TPPH) , down 3.2% to $2.73, and GlaxoSmithKline (GSK) , whose shares fell 1.1% to $55.02.

ImClone Systems (IMCL) gained 2.9% to $29.83, Affymetrix (AFFX) was up 5.1% to $22.06, Amgen (AMGN) rose 0.8% to $67.12, Dendreon (DNDN) advanced 2.6% to $4.38 and Pharmion (PHRM) was up 7.9% to $18.09.
-EPIX Pharmaceuticals, Inc. (NASDAQ EPIX) announced today the completion of its previously announced merger with Predix Pharmaceuticals Holdings, Inc. Pursuant to the merger agreement, Predix merged with and into EPIX Delaware, Inc. and became a wholly-owned subsidiary of EPIX. The combined company will continue to operate as EPIX.

"We are pleased that the shareholders of both EPIX and Predix approved the combining of the two companies and that the merger is now complete," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX Pharmaceuticals. "This merger creates a biopharmaceutical company with a novel MRI angiographic agent, Vasovist(TM), approved in Europe, five internally-discovered clinical-stage product candidates and a deep pipeline of preclinical compounds. We believe these assets provide us with significant opportunities for near-term value creation similar to our collaborations with Amgen and Schering AG."

Andrew Uprichard, M.D., president of EPIX added, "I am excited about the breadth of talent and resources we have assembled that will enhance our ability to improve patients' lives by developing products that meet significant, unmet clinical needs and thereby drive significant shareholder value."

The combined company has a broad pipeline of product candidates, an experienced management team and approximately $114 million in cash and marketable securities as of June 30, 2006. Vasovist(TM), EPIX's novel blood pool imaging agent, which is marketed in Europe by Schering AG, has been recommended for approval in Australia, and is the subject of an appeal following two approvable letters from the U.S. Food and Drug Administration. In addition, the combined company has five drug candidates in clinical trials:

* PRX-00023 in Phase 3 for anxiety, with the results of this trial expected later this year;
* EP-2104R in Phase 2 for MRI imaging of arterial and venous blood clots;
* PRX-08066 in Phase 2 development for pulmonary hypertension associated with chronic obstructive pulmonary disease (CODP);
* PRX-03140, which has completed Phase 1b trials, is expected to enter Phase 2 in combination with Aricept® for Alzheimer's disease later this year; and
* PRX-07034 in Phase 1 and expected to be developed for the treatment of obesity and also for cognitive impairment (associated with Alzheimer's disease or schizophrenia).

The combined company also has a portfolio of several pre-clinical product candidates, including a partnership with Amgen around preclinical compounds targeting S1P1 for the treatment of autoimmune diseases. EPIX has begun to initiate discussions to selectively license its later-stage products to larger pharmaceutical or biotechnology companies at a point where it can maximize the value of these products.

Dr. Kauffman added, "With several milestones on the horizon, including the FDA's response to our appeal regarding Vasovist and the results from our Phase 3 clinical trial of PRX-00023 in patients with generalized anxiety disorder, we believe we will have continued momentum and significant growth opportunities going forward."

Reverse Stock Split and Merger Consideration

In connection with the merger, EPIX effected a 1-for-1.5 reverse stock split of its outstanding common stock. Accordingly, each Predix share (on an as-converted to common stock basis) was converted in the merger into the right to receive .826698 shares of EPIX common stock. In addition, all outstanding Predix options and warrants were assumed by EPIX in the merger. The Predix stockholders, option holders and warrant holders are also entitled to receive their pro rata portion of an additional milestone payment of $35 million. Pursuant to the terms of the merger agreement, the board of directors has determined to pay $20 million of the milestone payment in cash on October 29, 2006. The remaining $15 million of the milestone will be paid in shares of EPIX common stock on October 29, 2007 except to the extent that such shares would exceed 49.99% of EPIX's outstanding shares immediately after such milestone payment when combined with all shares of EPIX issued in the merger and issuable upon exercise of all Predix options and warrants assumed in the merger.

The post reverse-split common stock of EPIX is anticipated to start trading on the NASDAQ Global Market on August 17, 2006 under the symbol "EPIX." As a result of the merger and reverse stock split, a "D" will be appended to EPIX's NASDAQ trading symbol for the next 20 days.

Wednesday, August 16, 2006

Ariad Pharmaceuticals (ARIA) jumped a day after saying it was granted a patent covering cancer and heart drugs called mTOR inhibitors, a class that includes the company's lead product candidate. Shares were up 3.8% to $3.79.

Shares of CV Therapeutics (CVTX) got a lift after the company announced a public offering of 9 million shares for $9.50 a piece. The stock was up 1.5% to $9.90.

Other gainers included Genentech (DNA) , up 0.8% to $80.96, Crucell (CRXL) , up 6.9% to $21.91, Incyte (INCY) , which gained 3.3% to $4.40, MedImmune (MEDI) whose shares were boosted 4.6% to $27.27, Barr Pharmaceuticals (BRL) , up 4.2% to $58.22, Sirna Therapeutics (RNAI) , better by 3.5% to $4.39, Gilead (GILD) , whose shares rose 2% to $63.44, and Endo Pharmaceuticals (ENDP) , up 1% to $33.70.

Among the losers were Shire (SHPGY) , down 1% to $50.20, Novogen (NVGN) , off 4.1% to $9.80, and Biosante Pharmaceuticals (BPA) , lower by 3.5% to $1.95.

Novartis (NVS) climbed after the Swiss drugmaker said it began shipments of its Fluvirin flu vaccine to the U.S. The company said 1 million doses were shipped within the past week. The company expects to continue shipping the vaccine through the end of the year. Novartis' shares were up 0.9% to $57.14.

Pfizer's (PFE) shares rose a day after the company's new CEO, Jeffrey Kindler, announced a management reorganization. Among the changes, Vice Chairman Karen Katen, who was passed over for the position of CEO, is leaving the company. David Shedlarz, another CEO candidate, is staying with the company and will take on additional responsibilities. Pfizer gained 1.3% to $26.73.

Bioenvision (BIVN) soared 12.6% to $4.93 after Prudential initiated coverage of the stock with an overweight rating. According to biotech analyst Ron Ellis, the stock has limited downside and will likely be driven by European regulatory milestones and an expected approval of its drug clofarabine to treat acute myeloid leukemia in 2007. He issued a price target of $11, significantly above the stock's 52-week high of $9.18.

Tuesday, August 15, 2006

Biotech drug maker Genzyme Corp. said Tuesday a medical journal published results of a mid-stage clinical study showing its non-antibiotic treatment of bacteria-caused diarrhea performed as well as a commonly prescribed antibiotic.

The company said the Aug. 15 issue of Clinical Infectious Diseases carried results of a Phase II study that followed about 300 patients with Clostridium difficile-associated diarrhea. Patients were given either tolevamer, Genzyme's experimental treatment, or a standard prescribed dose of the antibiotic vancomycin.

Tolevamer is non-antibiotic treatment designed to bind and remove toxins released by bacteria that damage the large intestine.

Results showed that tolevamer produces similar treatment outcomes to vancomycin. The company said tolevamer has an advantage because over-prescription of antibiotics can produce resistant strains of bacteria.

Tolevamer is currently being studied in two late-stage clinical trials. The company expects the trials to be complete in 2007, with a possible product launch in 2008 pending a favorable regulatory approval.

Genzyme shares rose 84 cents to $67.35 in morning trading on the Nasdaq.



Acadia Pharmaceuticals' (ACAD) shares were up more than 15% after an analyst said the recent drop in the company's stock presents an opportunity to buy.

"We believe that Acadia has an emerging pipeline with five promising clinical programs targeting large [central nervous system] markets such as schizophrenia and Parkinson's disease," wrote Banc of America Securities biotech analyst David Witzke in a research report. He pointed out that the stock is down about 64% since its equity offering in April. He initiated coverage of the stock with a buy rating and set a price target of $10. Shares advanced 83 cents to $6.32.

Genzyme (GENZ) published results of a clinical trial involving its drug Tolevamer for diarrhea caused by the bacteria Clostridium difficile, sending the shares 1.3% higher to $67.37.

According to data from the trial, in which 300 patients received either Genzyme's Tolevamer or the antibiotic vancomycin, patients saw similar results, with the results indicating a possible reduction in the recurrence rate with the Genzyme drug. Vancomycin is currently the only FDA-approved drug to treat the infection.

Biopharmaceutical company Novavax (NVAX) shares were up 13% to $3.21 after an upgrade from RBC Capital Markets. While analyst Ken Trbovich notes that the company's quarterly results were weaker than expected, "with the stock trading near $3 per share, it no longer carries the significant downside risk that lead us to rate NVAX shares underperform," Trbovich wrote. The analyst raised his rating on the stock to sector-perform.

Among other health stocks on the move were Hospira (HSP) , down 1.9% to $34.80, Tenet Healthcare (THC) , whose shares sank 3.4% to $7.29, and Novogen (NVGN) , whose stock was 2.2% lower at $10.22.

Elsewhere, Osteotech (OSTE) gained 7.1% to $3.92, Cytokinetics (CYTK) was up 5.9% to $5.59, CAS Medical Systems (CASM) rose 4.8% to $6.07, New River Pharmaceuticals (NRPH) soared 13.8% to $26.20, Rotech Healthcare (ROHI) climbed 3.3% to $1.25, and AMN Healthcare Services (AHS) was up 1.5% to $22.24.

Monday, August 14, 2006

ANDS 2.80
Change: Down 0.05 (1.75%)

MLNM 9.83
Change: Up 0.07 (0.72%)


Lipid Sciences' (LIPD) stock rose after the company said it entered into an agreement with shareholders for a private placement. The drugmaker received $6.3 million in proceeds, with the potential to raise an additional $2.3 million upon the exercise of warrants. Shares were up 12.5% to $1.44.

Tapestry Pharmaceuticals (TPPH) jumped after research firm Vista Partners initiated coverage of the company. According to biotech analyst Ross Silver, Tapestry has a "strong and experienced executive management team and scientific advisory board with a proven track record of bringing drugs through [Food and Drug Administration] approval and into the marketplace."

The company recently closed a $25.5 million financing deal to bring its top experimental cancer drug into phase II clinical trials. Still, Tapestry might not have adequate funding to take the drug through the trials and onto the market, Silver said. That and potential competition and intellectual property risks could hinder the company's success, Silver said. Shares fell 2.7% to $2.64.

Tenet Healthcare (THC) climbed on upgrades by analysts at investment research firms Jefferies and Raymond James. Jefferies upgraded the stock to a hold rating from underperform, with a price target of $7 following the company's earnings report Thursday. Raymond James upgraded the stock to market-perform from underperform. Shares were up 4.8% to $6.93.

Other health stocks on the move included Oscient Pharmaceuticals (OSCI) , whose shares rose 5% to $1.25, Repligen (RGEN) , up 7% to $2.89, Cardiodynamics International (CDIC) , down 7.9% to 93 cents, and Insite Vision (ISV) , lower by 1.9% to $1.54.

YM BioSciences (YMI) fell 8.4% to $2.61. Geron (GERN) dropped 2.2% to $5.91, and StemCells (STEM) lost 4.4% to $1.95.
ING reiterates neutral weighting on the European pharmaceutical sector, with GlaxoSmithKline (GSK) and Roche (RHHBY) as top picks given their strong earnings momentum and lower risk profiles. Says there is attractive value in Sanofi-Aventis (SNY), which is rated buy, although with heightened risk/reward benefits ahead of the FDA decision on Acomplia. Reiterates hold stance on Novartis (NVS) and AstraZeneca (AZN).

Sunday, August 13, 2006

ImClone Systems Inc., maker of the Erbitux cancer drug, said it will remain independent and invited billionaire U.S. investor Carl Icahn to join its board. The shares dropped.

ImClone decided not sell or merge with another company after its board finished a six-month review of strategic alternatives, the New York-based company said in a statement today. Interim Chief Executive Officer Joseph Fischer will stay in that role until a replacement is found, the company said.

Imclone made its decision in light of ``significant improvements'' in performance, the statement said. Erbitux, approved in 2004 to treat colon cancer, got a boost in March when it was cleared as the first treatment for head and neck malignancies in 45 years. Yet a similar drug by Amgen Inc. awaits approval, clouding the outlook, an analyst said.

``The company is in a lot of trouble going forward,'' said Cowen & Co. analyst Eric Schmidt, who has an ``underperform'' rating on the stock and doesn't own any shares, in a telephone interview today. ``They're not making any money today owning the monopoly they had. And with a superior, competitive drug coming, their financials will only get worse.''

Shares of ImClone fell $3.42, or 11 percent, to $28.95 as of 8:17 a.m. New York time in Nasdaq Stock Market composite trading, after closing at $32.37 yesterday. ImClone shares fell 12.99 euros, or 12 percent, to 22.60 euros in Frankfurt.

Amgen

Amgen, the world's biggest biotechnology company, is seeking U.S. approval of a cancer drug called panitumumab. Like Erbitux, it is designed to block the protein EGFR involved in the growth of cancer cells.

In January, Imclone said it hired investment banker Lazard Ltd. to explore a sale or merger to help it raise money to develop more new medicines. Today, Imclone said it concluded ``that the alternatives available, including bids received for the acquisition of the company, did not match the value potential of ImClone Systems as an independent company.''

ImClone in July said second-quarter earnings rose more than expected as sales of Erbitux gained 77 percent. Net income increased 43 percent to $37.2 million, or 42 cents a share, from $26 million, or 30 cents, a year earlier. U.S. sales of Erbitux, the company's only marketed product, rose to $172.8 million.

``The company has a very strong cash position,'' said ImClone spokesman David Pitts in a telephone interview today. ``Through better Erbitux sales and improvements in our top and bottom lines, we certainly expect to be able to fund our ongoing operations and certainly our strong cash position keeps our options open in terms of business development opportunities.''

$964 Million in Cash

ImClone had $964 million in cash at the end of second quarter, Pitts said.

In May, ImClone agreed to Icahn's request to expand the board and add Alex Denner, then a portfolio manager at Viking Global Investors. Today, the company said it will keep Denner, now an Icahn employee, on the board's slate for its September 20 annual meeting and add an independent director to be suggested by Icahn.

The company also agreed in May to change a rule to allow Icahn to almost double his stake in ImClone to 19.9 percent. Icahn currently holds about 10 percent of the company's shares, ImClone said today.

Bristol-Myers Squibb Co., a partner in selling Erbitux, already has a 17 percent stake in ImClone. Bristol-Myers said in February it had no current plans to acquire the biotech company.

Friday, August 11, 2006

Vista Partners announced today that it has initiated coverage on Tapestry Pharmaceuticals (Nasdaq TTPH). Vista Partners provides independent, equity research for institutional and individual investors, with a focus on publicly traded small capitalization companies. Ross Silver and Jeremy Thum of Vista Partners issued the report.

Tapestry Pharmaceuticals, Inc., together with its subsidiaries, develops therapies for the treatment of cancer. Its development stages therapeutic candidate products include TPI 287 IV, a Phase I product for prostate, nonsmall cell lung, and breast cancers; and TPI 287 oral formulation, a preclinical development stage product for prostate, nonsmall cell lung, ovarian, breast, and colon cancers. Tapestry Pharmaceuticals was founded in 1991 and is based in Boulder, Colorado.

Lipid Sciences' (LIPD) stock rose after the company said it entered an agreement with shareholders for a private placement. The drugmaker received $6.3 million in proceeds with the potential to raise an additional $2.3 million upon the exercise of warrants. Shares were up 12.5% to $1.44.

Tapestry Pharmaceuticals
(TPPH) jumped after research firm Vista Partners initiated coverage of the company. According to biotech analyst Ross Silver, Tapestry has a "strong and experienced executive management team and scientific advisory board with a proven track record of bringing drugs through [Food and Drug Administration] approval and into the marketplace." The company recently closed a $25.5 million financing deal to bring its top experimental cancer drug into phase II clinical trials. Still, Tapestry might not have adequate funding to take the drug through the trials and onto the market, Silver said. That and potential competition and intellectual property risks could hinder the company's success, Silver said. Shares fell 2.7% to $2.64.

Tenet Healthcare
(THC) climbed on upgrades by analysts at investment research firms Jefferies and Raymond James. Jefferies upgraded the stock to a hold rating from underperform, with a price target of $7 following the company's earnings report Thursday. Raymond James upgraded the stock to market-perform from underperform. Shares were up 4.8% to $6.93.

Other health stocks on the move included Oscient Pharmaceuticals (OSCI) , whose shares rose 5% to $1.25, Repligen (RGEN) , up 7% to $2.89, Cardiodynamics International (CDIC) down 7.9% to 93 cents, and Insite Vision (ISV) , lower by 1.9% to $1.54. YM BioSciences (YMI) fell 8.4% to $2.61. Geron (GERN) dropped 2.2% to $5.91, and StemCells (STEM) lost 4.4% to $1.95.

Thursday, August 10, 2006

After a fruitless six-month search for a buyer, ImClone Systems Inc. (NASDAQ:IMCL ) said on Thursday it will remain independent, sending its shares down 13 percent.

The New York-based biotechnology company said it is searching for a new chief executive, and it invited billionaire Carl Icahn -- who in May raised his stake in ImClone to more than 10 percent -- to join its board.

Shares of ImClone, which makes the cancer drug Erbitux, climbed as high as $43 in May from $34 in January as investors bet the company would be acquired. Some hoped ImClone's partner, Bristol-Myers Squibb Co. (NYSE:BMY ), would be the acquirer. Others bet on an outsider.

But cooler heads have been warning for some time that the list of potential suitors for ImClone, whose founder Samuel Waksal was sentenced in 2003 for securities fraud, would likely be small. Bristol-Myers owns roughly 20 percent of ImClone and receives the lion's share of Erbitux sales.

Moreover, there are several potential competitors to Erbitux, particularly a drug that is being developed by Amgen Inc. (NASDAQ:AMGN), and there are concerns that some patents protecting Erbitux could be in jeopardy.

"This was always going to be a tough sell," said Cory Kasimov, an analyst at Oppenheimer & Co. "What the company is back to now is trying to generate maximum value from Erbitux."

That won't necessarily be easy. Erbitux is approved to treat colorectal cancer and head and neck cancer, and the company is hoping to win approval for the drug in lung cancer and pancreatic cancer.

AMGEN COMPETITION

But some analysts believe Amgen's drug, panitumumab, will eventually become the treatment of choice for colorectal cancer in patients who have failed at least two other treatments, the market currently served by Erbitux.

Both drugs work in a similar fashion, but panitumumab has certain safety and convenience advantages, said Keith Haan, an analyst at Summer Street Research Partners who estimates panitumumab will ultimately gain more than 50 percent of the market currently held by Erbitux.

"Now investors are going to focus on ImClone's core business, which is Erbitux, and I think there are a lot of pitfalls going forward," he said.

ImClone, which hired investment bank Lazard Ltd. (NYSE:LAZ) in January to explore the potential sale or merger of the company, said it has restarted its search for a permanent chief executive officer to replace Joseph Fischer, who was named interim CEO in January.

Now, after a period of management turnover following the Waksal scandal -- which later drew in lifestyle guru Martha Stewart, who went to jail for conspiring to lie about selling ImClone stock -- it appears the company is turning to Icahn to help provide stability, analysts said.

However, his ability to help may be limited, they said.

"While he may be able to provide value creating ideas for the company we don't see how he could alleviate the competitive and litigation concerns currently facing ImClone," said Kasimov.

If Icahn were to be elected to the board it would be in addition to Alexander Denner, who joined the board in May 2006 following discussions with Icahn. ImClone said Denner also now works for Icahn.

The company said it plans to bring in another board member and has asked Icahn to recommend someone. Icahn was not immediately available for comment.

ImClone's shares fell $4.24, or 13 percent, to $28.12 in midday trading on Nasdaq.
Biogen Idec files NT 10-Q to explain late filing of 10-Q 41.54 -0.31 : From today's NT 10-Q: "The registrant was not able to timely file its quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2006 because it had not completed the preparation of its financial statements for the period. On August 10, 2006, the registrant filed its quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2006..."

GeoPharma (GORX) sank 12.5% to $3.08 following its earnings report Thursday. The company earned $195,000, or 2 cents a share, in the quarter compared with $515,000, or 5 cents a share, a year ago. Excluding stock options expenses, the company earned 6 cents a share. Revenue reached $14.4 million, up 22.3% from a year ago.

Oscient Pharmaceuticals
(OSCI) got a boost after the company agreed to allow Abbott (ABT) to market its Factive bronchitis drug in Canada. Specific financial terms were not disclosed. Shares were up 2.2% to $1.20.

Advancis Pharmaceutical (AVNC) rose after the company reported positive trial results on its anti-infective drug amoxicillin Pulsys. The stock was higher by 43.9% to $4.49.

Tenet Healthcare's
(THC) shares jumped following its quarterly report after the close of trading Wednesday. While the company reported a wider loss of $398 million, or 85 cents a share, in the second quarter, compared with a loss of $33 million, or 7 cents a share, a year earlier, excluding hefty one-time charges, earnings beat analysts' estimates. Tenet had adjusted earnings of 4 cents a share, compared with 3 cents analysts were expecting. Shares were up 12.5% to $6.56.

Among other health stocks on the move were Dynavax Technologies (DVAX) , up 9.1% to $4.33, Xenoport (XNPT) , up 8.2% to $18.15, Cytokinetics (CYTK) , gaining 7.6% to $5.81, and Medicure (MCU) , higher by 6.6% to $1.62. Celgene (CELG) was down 3.4% to $41.37, EP Medsystems (EPMD) fell 8.7% to $1.37, and Allied Healthcare International (AHCI) lost 13% to $2.

Wednesday, August 09, 2006

Shares of Onyx Pharmaceuticals Inc. fell Wednesday, a day after the company said it widened its second-quarter loss .

The stock lost $1.84, or 11.8 percent, to close at $13.70 on the Nasdaq at nearly triple their average volume. Shares fell as low as $13.60 earlier in the day, breaking an previous 52-week low of $14.52 set in June.

On Tuesday, the company said it lost $31.5 million, or 76 cents per share, in the quarter compared with a loss of $18.1 million, or 51 cents per share, a year ago. That fell far below Wall Street estimates, with analysts polled by Thomson Financial expecting a loss of 57 cents per share. Results for the recent quarter include a charge of $3.7 million, or 9 cents per share, for stock option expensing.

Revenue for the quarter totaled $150,000, up from zero last year.

Analysts were looking more toward sales of kidney cancer treatment Nexavar as a progress indicator. Onyx's partner on Nexavar, Bayer AG recorded quarterly sales of $32.2 million for Nexavar, beating several analyst predictions. Prudential analyst Jason Zhang forecast revenue of $31.9 million from Nexavar, while HSBC analyst Gene Mack predicted $28.6 million.

The companies are currently testing Nexavar for other applications as a possible treatment for melanoma, liver cancer and lung cancer.

Expenses for the quarter surged as Onyx spent more on developing its sales force for Nexavar and for research and development. Also, the company recorded $12.5 million in payments due to Bayer as part of the collaborative agreement on Nexavar.
Tanox (TNOX) lost $2.3 million, or 5 cents a share, in the second quarter, much narrower than the loss of 10 cents that had been expected. Revenue reached $12.7 million compared with $7.4 million a year ago. Shares were up 2.5% to $13.84.

Allion Healthcare (ALLI) plummeted after it posted lower-than-expected earnings and received an analyst's downgrade.

The company also withdrew its guidance for the full year and its outlook for 2007. Shares of Allion sank 41.5% to $3.50.

Hospira (HSP) shares plunged after the company announced that its profit sank on an increase in expenses. The injectable-drug maker earned $54.2 million, or 34 cents a share, in the second quarter, compared with $72 million and 44 cents a share a year earlier. Excluding charges, Hospira earned 43 cents a share, about 13 cents short of estimates.

Net sales were $671.1 million, 1.4% higher than the year-ago quarter but below the $688.1 million Wall Street expectation. Shares fell $7.55, or 17.6%, to $35.25.

Onyx Pharmaceuticals (ONXX) dropped following a wider-than-expected loss in the second quarter. The company reported a loss of $31.5 million, or 76 cents a share, compared with a loss of $18.1 million, or 51 cents a share, last year. Analysts were expecting a loss of 57 cents a share. Onyx fell 11.8% to $13.70.

Millennium Pharmaceuticals (MLNM) edged lower despite the Food and Drug Administration granting priority review to its drug Velcade for the treatment of the blood cancer mantle cell lymphoma.

Velcade is already approved to treat multiple myeloma patients in which at least one prior drug therapy failed to work. Shares slipped 3 cents to $9.75.

Tuesday, August 08, 2006

InVentiv Health 2nd-Quarter Earnings Double, Helped by Tax Benefit

InVentiv Health Inc., which provides services for the pharmaceutical and life sciences industries, said Tuesday its second-quarter earnings doubled, boosted by a $9.1 million tax gain and increased sales in its communications segment.

The company earned $21 million, or 69 cents per share, compared with $10.5 million, or 38 cents per share, a year ago.

Excluding the tax benefit from the sale of divested entities, including three overseas contract sales organizations and two U.S.-based medical communication companies, inVentive said it earned 37 cents per share. That tops Wall Street estimates, as analysts polled by Thomson Financial expected per-share earnings of 32 cents.

Revenue jumped 38.8 percent to $183 million from $131.8 million, boosted by communications segment contracts which added or expanded business with 14 clients during the quarter. Analysts expected revenue of $181.3 million.

The communications segment saw revenue increase 19 percent to $64.5 million, while the clinical trial segment's revenue increased 38 percent to $38.4 million. Meanwhile, the commercial segment saw its revenue fall 23 percent to $80 million, as a result of the anticipated wind-down of some sales teams.

Also Tuesday, InVentiv said it signed a sales team contract with Novartis Pharmaceuticals Corp. Details of the multiyear deal were not disclosed.

Shares of inVentiv jumped $3.19, or 11.8 percent, to $30.18 on the Nasdaq in afternoon trading. The stock has traded between $21.75 and $33.87 over the past year.
Salix Pharmaceuticals' (SLXP) shares rose 9% on a positive earnings report.

The gastrointestinal drug developer earned $6.9 million, or 14 cents a share, during the second quarter. Excluding certain charges, earnings were $7.8 million, or 16 cents a share. Analysts were expecting earnings of 15 cents a share.

Revenue rose 51% from a year ago to $52.9 million, thanks partly to Xifaxan prescription growth of 122% over the prior year. Xifaxan is indicated for the treatment of travelers' diarrhea associated with the bacteria Escherichia coli. Analysts were expecting revenue of $51 million. Shares gained 95 cents to $11.34.

Kos Pharmaceuticals (KOSP) shares rose 5% on an earnings beat.

Kos earned $13.9 million, or 28 cents a share, down from $28.9 million, or 61 cents a share. However, excluding certain one-time charges, the company earned 59 cents a share. Analysts surveyed by Thomson First Call were expecting earnings of 42 cents a share.

Revenue also exceeded expectations, reaching $223.7 million, compared with estimates of $215.3 million.

Barrier Therapeutics (BTRX) shares fell 13% after losses widened.

The drug developer lost $13.9 million, or 58 cents a share, for the second quarter, compared with a year-ago loss of $10.8 million, or 45 cents a share. Analysts were expecting a loss of 53 cents a share.

Revenue more than doubled to $1.08 million from $472,000 a year ago. Shares fell 86 cents to $5.55.

Investors in Inspire Pharmaceuticals (ISPH) fell 8% on a second-quarter loss.

Inspire's net loss widened to $5.4 million, or 13 cents a share, from the year-ago $4.7 million, or 11 cents a share. Analysts were expecting a loss of 18 cents a share. Revenue in the second quarter was $13.4 million, compared with $9.6 million a year ago.

Among other health stocks sinking Tuesday were Celgene (CELG) , down 2.5% to $44; Medtronic (MDT) , off 1.2% to $43.26; Northfield Laboratories (NFLD) , down 2.3% to $11.35; and Momenta Pharmaceuticals (MNTA) , down 9.8% to $14.80.

Among health stocks rising were Genetic Technologies (GENE) , up 9.6% to $8.25; AMN Healthcare Services (AHS) , up 6.8% to $22.54; InterMune (ITMN) , up 3.8% to $15.98; and Valeant Pharmaceuticals (VRX) , up 2.8% to $18.59.

Monday, August 07, 2006

MicroIslet, Inc. (Amex MII), a biotechnology company engaged in the research, development and commercialization of patented technologies in transplantation therapy for people with insulin-dependent diabetes, today announced that primate subjects in ongoing studies have continued to exhibit improved glycemic control over a six-month period by means of MicroIslet's proprietary microencapsulated porcine islet transplantation treatment approach.

In reporting this crucial milestone, an industry first in the effort to establish a more effective treatment for diabetes, MicroIslet's primate subjects showed substantial reduction in the need for insulin to control blood glucose levels. Additionally, this breakthrough was achieved without the need for chronic immunosuppressive therapy to prevent rejection of the transplanted insulin-producing islets.

Marks breakthrough in improved treatment for diabetes

As the American Diabetes Association (ADA) has recently reported, "Scientists are studying ways to microencapsulate islet cells to prevent rejection and reverse the progression of diabetes. If successful, this method may lead to islet cell transplantation without the need for immunosuppressive medicines." MicroIslet management hailed attainment of the six-month milestone in its primate studies as a significant advance toward that goal.

"We believe that with this positive data, we are setting the cornerstone for a new and vastly improved treatment for diabetes, which has reached an epidemic stage, afflicting an estimated 21 million Americans, including over 6 million who are undiagnosed," commented James R. Gavin III, M.D., Ph.D., President and Chief Executive Officer of MicroIslet, former President of the ADA and an internationally recognized diabetes expert.

"There are five key elements supporting our belief," Dr. Gavin continued. "First, we have achieved long-term survival of transplanted insulin-producing islets in our primate subjects. Second, these islets have substantially reduced the need for injected insulin to control blood glucose levels and prevent the progressive damage to the heart, kidneys and other vital organs that make diabetes so devastating. The primate subjects have experienced improved glycemic control for six months in our ongoing studies. Third, our method for islet microencapsulation has eliminated the need for chronic immunosuppression to prevent rejection of the transplanted tissues. Fourth, the transplantation site in the peritoneum allows a minimally invasive procedure, substantially decreasing the risks inherent in major surgery. Finally, unique among the companies investigating islet transplantation, we have secured access to a sufficient supply of islet tissues for human clinical trials and eventual commercialization of our diabetes treatment approach, through our exclusive, long-term islet supply agreement with the Mayo Foundation for Medical Education and Research."

The Company plans to submit abstracts documenting its findings to major transplantation symposia this fall and at the American Society of Cell Biology Conference Annual Meeting in San Diego, December 9-13.

About MicroIslet

MicroIslet is a biotechnology company engaged in the research, development, and commercialization of patented technologies in the field of transplantation therapy for people with insulin-dependent diabetes. MicroIslet's patented islet transplantation technology, exclusively licensed from Duke University, includes methods for isolating, culturing, cryopreservation, and immuno-protection (microencapsulation) of islet cells. MicroIslet is working to develop and commercialize a first product, called MicroIslet-P(TM), a microencapsulated porcine islet cell suspension that will be used for transplantation in patients with insulin-dependent diabetes.
Shares of medical-aesthetics company Syneron (ELOS) were jumping 15.6% to $21.39 after the company reported earnings and reiterated its guidance. Syneron's quarterly revenue reached $27.5 million, up 37% from a year ago and was a record high. Overall, the company earned $8.9 million, or 32 cents a share, including stock-based compensation expenses.

Excluding charges, the company earned $11.3 million, or 41 cents a share, in the quarter, up 22% from last year. Analysts were expecting the company to earn 39 cents a share. The company said it was on track to meet its previously announced guidance, which in February called for revenue of between $113 million and $120 million for the full year.

Among other health care stocks on the move were pharmaceutical company NitroMed (NTMD) , which was gaining 14.1% to $2.91, drug developer Taro Pharmaceutical Industries (TARO) , up 7.7% to $12.81, biotech ICAgen (ICGN) , higher by 7.1% to $1.20, and Spectrum Pharmaceuticals (SPPI) , up 3.4% to $3.68.

Accentia Biopharmaceuticals (ABPI) was down 1.6% to $3.03, Ivax Diagnostics (IVD) fell 8.2% to $1.56, Oscient Pharmaceuticals (OSCI) was down 6% to $1.25, Nyer Medical Group (NYER) lost 9.7% to $2.80, Alpharma (ALO) was down 6.6% to $21.65, and Rigel Pharmaceuticals (RIGL) was losing 3.8% to $9.20.
Teva Pharmaceutical Industries Receives FDA Approval for Generic Version of Wyeth's Effexor

Generic drug maker Teva Pharmaceutical Industries Ltd. said the U.S. Food and Drug Administration approved its version of Wyeth's depression drug, Effexor.

Israel-based Teva said shipment of the generic version of Venlafaxine Hydrochloride tablets, in several dose ranges, will begin immediately. The ranges include 25-milligram tablets, 37.5-milligram tablets, 75-milligram-tablets and 100-milligram tablets.

Effexor has annual sales of about $152 million, Teva said.

Shares of Teva rose 9 cents to $34.40 on the Nasdaq in Monday morning trading.

Sunday, August 06, 2006

Shares of Invitrogen Corp. dropped Friday after the company reported second-quarter profit and revenue below Wall Street expectations.


The stock dropped $4.38, or 7 percent, to $57.95 on the Nasdaq in midday trading. Shares reached a new 52-week low of $56.60 before regaining some ground as trading volume surged to more than five times its average three-month volume.

Late Thursday, the advanced lab research equipment and services company said it earned $19.7 million, marking a 32 percent increase in profit. The company's earnings per share excluding items but including a 15 cent charge on stock option expenses totaled 75 cents, but analysts expected those results to reach 85 cents per share. Revenue of $314 million, a slight increase, also missed the mark, with analysts expecting $319.7 million.

The move sparked reaction from analysts Friday, with many reaffirming positive positions for the company, but reducing price targets considering the results. The reason for the missed revenue targets, several said, was a drop in the company's bioproduction segment on falling prices and flat sales. The segment includes products used for testing in clinical trials and biologic products for use in clinical trials.

UBS Investment Research analyst Derik De Bruin reaffirmed a "Buy" rating for the company, but reduced his price target to $75 from $82.

"Despite the lumps, end-markets are solid, and we remain buyers of Invitrogen shares, especially on weakness," he wrote in a note to investors.

Aside from the drop in one segment, results were generally on target, he said, and the company's core business is intact.

Also, the company reduced its sales and revenue guidance for 2006, citing the flat sales in its Bioproduction segment, which are expected to drop another 50 percent in 2007. But a $500 million share buyback program, De Bruin said, could provide near-term support to boost the company's earnings per share.

Baird U.S. Equity Research analyst Quintin J. Lai reaffirmed his "Outperform" rating, but also lowered his price target to $75 from $80. He said the company will most likely spend the remainder of the year focusing on the core growth of its cell culture systems, complete the integration of recent acquisitions and realign its operating costs structure to match lower expectations.

Also, he wrote in a note to investors, the company will most likely back off of large acquisitions in the near-term.

"We expect the stock to be under pressure today as it enters the realm of value investors," he wrote.

ThinkEquity Partners analyst David Lo lowered his rating to "Accumulate" from "Buy" and his price target from $77 to $72, citing near-term concerns.

"We continue to view Invitrogen as one of the premier life science research and development tools companies," he wrote.

But near-term "growing pains" include ordering and shipment problems within the Biodiscovery segment that will likely be worked out when the company opens a facility in Europe in early 2007.

Saturday, August 05, 2006

Adeza Biomedical Rises As Company Reports Inline 2Q Revenue, Backs Outlook; Analyst Upgrades


Shares of Adeza Biomedical Corp. jumped Friday after the maker of reproductive health care products reported second-quarter revenue that was inline with expectations, backed its sales outlook for the year, and one analyst upgraded the company.

Adeza shares gained $1.48, or 9.9 percent, to $16.43 in afternoon trading on the Nasdaq at nearly double their average volume. Earlier in the session the stock, which has traded between $12.61 and $23.35 over the past 52 weeks, climbed as much as 14.6 percent to $17.13.

Net income fell to $537,000, or 3 cents per share, from $1.8 million, or 10 cents per share, a year ago. Analysts surveyed by Thomson Financial expected higher earnings per share of 5 cents.

Revenue rose 23 percent to $13 million -- in line with analysts' estimates -- from $10.6 million last year.

The Sunnyvale, Calif.-based company reiterated its revenue guidance for the year of $54 million to $57 million, above the Street's projection of $53 million.

Rodman & Renshaw analyst Suraj Kalia upgraded the stock to "Market Outperform" from "Market Perform" and assigned a price target of $22, based on the company's revenue results and the reaffirmation of its outlook. Kalia said the Street had been expecting a soft quarter, and that revenue is the more important metric for the company because many regard it as a takeover candidate.

"Earnings is a crapshoot right now," Kalia said in an interview. "I take it with a grain of salt."

Kalia raised his revenue estimates to $14.3 million from $13.7 million for the third quarter, and to $15.9 million from $15.2 million for fourth quarter.

The analyst said that possible revenue for the premature birth prevention drug Gestiva was not factored into estimates. The Food and Drug Administration is due to respond to the company's drug application by Oct. 20.

Analysts estimate revenue of $13.9 million and $15 million for the third and fourth quarter, respectively.

Friday, August 04, 2006

The Generic Pharmaceutical Association (GPhA) today
applauded Governors Kathleen Sebelius (D-Kan.),
Tim Pawlenty (R-Minn.), James H. Douglas (R-Vt.)
and Jim Doyle (D-Wis.) for
filing a citizen petition with the U.S. Food and Drug Administration (FDA)
seeking immediate release of agency guidance that would pave the way for
introduction of more affordable, generic versions of Insulin and Human
Growth Hormone (HGH). The citizen petition was filed earlier today.

"The Governors have correctly noted that biopharmaceutical products
place an extreme burden on state healthcare budgets, one that could
significantly be lowered if an efficient and effective mechanism existed
for the development and approval of generic biopharmaceutical products,"
said Kathleen Jaeger, President and CEO of GPhA. "Both of these products
are older, simpler, well-understood and characterized biopharmaceuticals.
Yet, for more than seven years, the FDA has been unable to provide the
generic industry with regulatory guidance that would permit the
introduction of generic versions of these products. The time has come to
open the floodgates for generic competition on these and other products."
"While many citizen petitions are frivolous, and often used to
unnecessarily block generic competition, the Governors' petition represents
the way that this system should work. It creates a mechanism that will
require appropriate FDA consideration and response to an urgent consumer
need," Jaeger added. "FDA's paralysis is in stark contrast to the European
Medicines Agency (EMEA), which has taken enormous strides toward the
approval of generic biopharmaceuticals. The EMEA has published a series of
guidances that provide a roadmap for the approval of several different
types of generic biopharmaceuticals. U.S. consumers, as these Governors
outlined in the citizen petition filed today, should not be left behind."
The largest obstacle to enhanced consumer savings through timely
generic market entry is the lack of an efficient and effective approval
pathway for generic biopharmaceuticals, sometimes referred to as
biogenerics. According to IMS Health, biologic drug product sales jumped
17.2% in 2005, to $32.8 billion. An efficient and effective approval
pathway would allow generic companies to develop and market less-expensive
versions of these drugs. In turn, patients and taxpayers would save
billions of dollars on biologic products alone.
According to the citizen petition, American patients spend
approximately $1.5 billion on insulin products to treat diabetes and
approximately $433 million on HGH, which is used to treat a variety of
conditions, including growth deficiencies in children and adults, chronic
renal insufficiency, and AIDS wasting syndrome. Market competition for
insulin and increased market competition for HGH products could save the
American health care system hundreds of millions of dollars annually.
"It is our position that the 505(b)2 FDCA approval process, in
conjunction with FDA's authority under the Public Health Act (PHS), already
serves as a foundation for the approval of safe and effective generic
biopharmaceuticals," Jaeger concluded. "We will continue to call on
Congress to codify FDA's authority to approve generic biopharmaceuticals
under section 351 of PHS."
GPhA represents the manufacturers and distributors of finished generic
pharmaceuticals, manufacturers and distributors of bulk active
pharmaceutical chemicals, and suppliers of other goods and services to the
generic drug industry. Generics represent 56% of the total prescriptions
dispensed in the United States, but less than 13.1% of all dollars spent on
prescription drugs.
Icagen Inc. (ICGN.) lost about three-fourth of its market value on Friday after the biopharmaceutical company said it will cut by half the number of patients enrolled for a key late-stage study after recommendation from a data monitoring committee.

Icagen said the independent panel, which analyzed data for safety, efficacy and futility of the drug candidate to treat sickle cell disease, requested additional information on the study but did not raise any specific safety concerns.

The committee recommended to continue enrollment for patients on concurrent hydroxyurea therapy, it added.

The patients taken off the study were not on concurrent hydroxyurea therapy and they will now enter an eight-week follow-up phase, the company said in a statement.

The committee will be given additional data and "we expect the second meeting to be completed in the third quarter," a company official said during a conference call with analysts.

"We have no additional information to share about the recommendations and will be reluctant to speculate on the DMC's rationale for any other decisions," Kay Wagoner, Icagen's chief executive, told analysts.

Icagen shares were down $3.05 at $1.19 in afternoon trade on the Nasdaq after crashing to 86 cents earlier in the day. More than 40 percent of the company's shares changed hands.

FDA INFORMED

The company said it has notified the U.S. Food and Drug Administration about the recommendations of the committee.

Sickle cell disease is a chronic and debilitating genetic blood disorder, primarily affecting individuals of African descent. It will lead to a variety of complications and significantly shorten lifespan in the majority of patients.

The company said it had received both fast track designation and orphan drug status from the FDA for the oral drug candidate, codenamed ICA-17043.

In January, the company had said the data monitoring panel had recommended to continue with the study after a first protocol interim safety review. At that time, the company had enrolled about 300 patients for the study.
Shares of Cell Genesys (CEGE) lost 8.3% following its earnings report after the close of trading on Thursday. The company reported quarterly revenue of $1.05 million compared with $2.78 million a year ago. Cell Genesys lost $27.9 million, or 60 cents a share, in the second quarter, compared with a loss of $27.4 million, or 60 cents a share, a year earlier. Analysts were expecting the company to lose 62 cents a share. The stock was recently trading at $4.54. Amgen (AMGN) fell a day after the company said a federal appeals court reversed a decision on two patent disputes with Transkaryotic Therapies. The federal court did affirm a lower court's decision that Transkaryotic and Aventis Pharmaceuticals infringed Amgen's patent on its anemia drug Epogen. Shares were down 3.1% to $68.73. Shares of Osteotech (OSTE) rose after the company said it swung to a profit for the second quarter. Osteotech earned $800,000, or 4 cents a share, compared with a loss of $1.9 million, or 11 cents a share, a year earlier. Revenue remained flat at $25.3 million. Shares were up 10.1% to $4.15. Adeza Biomedical (ADZA) , a maker of women's health products, gained 11.3% to $16.64 following its earnings report after the close of trading Thursday. For the second quarter, the company reported record sales of $13 million, up 23% from a year ago. Net income in the quarter reached $537,000, or 3 cents a share, including stock-based compensation expenses. Other health stocks on the move included Acorda Therapeutics (ACOR) , up 8.8% to $3.34, Immtech Pharmaceuticals (IMM) , gaining 7.4% to $5.78, Genentech (DNA) , rising 1.1% to $81.26, ViaCell (VIAC) , up 3.5% to $3.84, CuraGen (CRGN) , adding 3.9% to $3.17, and Oscient Pharmaceuticals (OSCI) , up 16.8% to $1.25. Novacea (NOVC) , shares took a 10.2% hit to $7.35, Orthologic's (OLGC) , shares fell 6.1% to $1.54, and CoTherix (CTRX) , was down 2.6% to $7.22.

Invitrogen (IVGN) , a provider of products and services used in genetic research and drug production, said Thursday its second-quarter earnings rose 32.2% from the year-ago period, helped by lower expenses and gain on business divestitures.

The Carlsbad, Calif.-based company earned $19.7 million, or 36 cents, a share, in the quarter, compared with $14.9 million, or 27 cents a share, a year ago. Adjusted for items, earnings were $49 million, or 90 cents a share in the most recent quarter. Analysts were expecting earnings of $49.5 million, or 85 cents a share.

Second-quarter revenue rose 2.3% from a year ago to $313.6 million against analysts' estimation of $319.7 million.

''We will have approximately $1 billion of funds available by year end, which gives us the ability to do a buyback in the near term, as well as continue to evaluate potential acquisitions," the company said.

Second-quarter gross profit rose 7.1% from a year ago to $190.6 million and gross margin increased 270 basis points to 60.8%. Operating income for the quarter rose 12.7% to $25.8 million and operating margin increased 75.6 basis points to 8.2%.

By segment, second-quarter revenue from BioDiscovery segment rose 10.5% from a year ago to $204.8 million, however revenue from BioProduction segment fell 10% to $108.9 million.

Invitrogen also announced a $500 million share repurchase program, over the next three years, to repurchase shares on the open market or in privately negotiated transactions.

Invitrogen fell $4.21 early Friday to $58.12.

Thursday, August 03, 2006

Pozen More Than Doubles Its 2Q Loss on Lower Revenue and Higher Costs
-- Pain drug developer Pozen Inc. said Thursday its second-quarter loss more than doubled as revenue dropped sharply and research costs jumped.

The company lost $8.4 million, or 29 cents per share, compared with a loss of $4.1 million, or 14 cents per share, a year ago. The loss included a $1.3 million charge for stock compensation expenses. The results missed Wall Street expectations, with analysts polled by Thomson Financial expecting a narrower loss of 26 cents per share.

Revenue dropped to $886,800 from $2 million, due to an extension on the amortization period for recognition of Trexima upfront payments. Pozen is partnering on development of the drug with GlaxoSmithKline. Analysts expected revenue of $2 million.

Operating expenses jumped to $9.7 million from $6.3 million as the company invested more in research and development for its drug pipeline.

Pozen said it expects third-quarter revenue to range from $2 million to $3 million. The company also cut its full-year revenue outlook to a range of $12 million to $14 million, from a prior forecast of $26 million to $30 million. The estimate includes an expected $4 million to $6 million payment for work under its pact with AstraZeneca.

Analysts expect more modest revenue of $1.8 million in the third quarter and $9.6 million for the year.

Shares of the company fell 43 cents, or 4.1 percent, to $10.01 in morning trading on the Nasdaq. Over the past year, the stock has ranged between $5.26 and $18.62.


Pfizer Inc. said on Wednesday it was disappointed a federal appeals court had found that a secondary patent on its Lipitor cholesterol drug is invalid, but said it hoped to correct a "technical defect" in the patent.

The New York-based drugmaker said it hopes to correct the defect through a process at the U.S. Patent and Trademark Office. The patent is on a calcium salt form of the active ingredient of Lipitor, the world's biggest selling drug. It would have protected Lipitor from generic competitors until June 2011.

Earlier on Wednesday, the U.S. Court of Appeals for the Federal Circuit reversed a lower court decision which had accepted the validity of the patent. But the appeals court agreed with the lower court that another patent, covering the basic chemical structure of Lipitor, which extends to March 2010, is valid.

Wednesday, August 02, 2006

Pozen Inc. announced Wednesday a research and licensing deal with pharmaceutical giant AstraZeneca worth as much as $375 million to develop an arthritis pain reliever, sending Chapel Hill drug maker's shares soaring for the second time this week.

Pozen shares rocketed upward more than 38 percent to $10.39 in mid-afternoon trading Wednesday.

The news follows Pozen's announcement Monday that it expects to respond by the end of the fourth quarter to safety questions regarding a migraine treatment it is developing with GlaxoSmithKline. Shares of Pozen (NYSE POZN) jumped more than 25 percent on that news.

Under the terms of the agreement with AstraZeneca, Pozen will receive $40 million up front for the development of the arthritis treatment and the filing of its New Drug Application with the Food and Drug Administration.

Pozen will also receive development and regulatory milestone payments that could total as much as $160 million, and potential sales performance milestones of $175 million.

Pozen will be responsible for the development work and regulatory filings associated with the drug in the United States, while AstraZeneca will have development and regulatory-filing responsibilities outside the U.S. AstraZeneca will also handle all aspects of manufacturing, marketing, sales and distribution on a worldwide basis.

The drug is targeted to begin phase III human trials in 2007, with Pozen expected to file the NDA for U.S. regulatory approval in 2008, AstraZeneca said.

The companies said their agreement is not yet final, pending regulatory clearances.

The new drug would be marketed as a pain reliever for patients suffering from pain and inflammation associated with osteoarthritis and rheumatoid arthritis. The treatment combines Pozen's anti-inflammatory drug naproxen with an ingredient in AstraZeneca's heartburn treatment Nexium.

Fran Barsky, director of investor relations, said the deal would not lead to significant hiring at Pozen because the 35-employee company outsources its manufacturing and clinical trials work.

Viropharma Posts Record Sales of Vancocin, Driving 2Q Profit Surge to Top Street View
-- Drug developer Viropharma Inc. said Wednesday its second-quarter profit surged as sales of its colitis drug Vancocin surged.

The company earned $17.2 million, or 25 cents per share, compared with $5 million, or 11 cents per share, in the year-ago quarter.

The per-share earnings reflect an increase in the number of shares outstanding to about 69.8 million from 57.6 million.

The results beat Wall Street estimates. Analysts polled by Thomson Financial, on average, forecast earnings of 23 cents per share.

Revenue jumped 52 percent to $44 million from $29 million, with the bulk of the quarter's revenue coming from $43.8 million in Vancocin sales. Analysts expected revenue of $42.5 million.

The strong sales of Vancocin, which treats pseudomembranous colitis, an inflammatory disease of the colon, prompted Viropharma to reaffirm its full-year sales guidance between $160 million and $170 million.

Analysts are expecting $163.8 million in sales for the year.


Tuesday, August 01, 2006

Elan Reports Narrowing 2nd-Quarter Loss, Predicts Profit on Resumed Sales of MS Drug

-- Drug maker Elan Corp. PLC reported a smaller second-quarter loss Tuesday and predicted it would return to profit soon because of the burgeoning sales of multiple sclerosis drug Tysabri.

Elan, which pins its hopes for a rebound principally on Tysabri, said its net loss in the quarter ending June 30 fell 37 percent to $90.5 million from $142.6 million in the second quarter of 2005. Sales rose 15 percent to $136.4 million from $118.6 million.

Analysts said the decision by regulators in the United States and Europe to permit some MS sufferers to use Tysabri should enable Elan to return to profit, possibly next year, for the first time since 2002.

Shane Cooke, Elan's executive vice president and chief financial officer, said Tysabri was already on sale in Germany, Ireland, Sweden, the United Kingdom and the United States, but would take between six and 12 months to reach the market throughout the 25-nation European Union.

Elan CEO Kelly Martin told a news conference that the company was "very pleased with what we have seen in the first few weeks" of Tysabri sales. But he said Elan wouldn't announce any sales figures until the third-quarter results.

Elan jointly developed Tysabri with Biogen Idec Inc., of Cambridge, Mass., to prevent relapses in sufferers of MS, an incurable neurological disorder that can cause sudden, partial paralysis. Clinical trials indicated that the drug was far more effective in suppressing MS symptoms than traditional interferon treatments. Elan and Biogen Idec say the annual cost of Tysabri -- which is administrated every four weeks by intravenous infusion -- exceeds $28,000.

"With the approval of Tysabri and the improvements we have made to the business, we are now entering into a new and exciting phase in the development of Elan. We are confident that revenues from Tysabri will drive our return to profitability," Cooke said.

Investors appeared to disagree, driving Elan shares 0.3 percent lower, to close at 11.69 euros ($14.92) on the Irish Stock Exchange.

Goodbody Stockbrokers in Dublin said it remained confident that Tysabri would achieve $2.2 billion in worldwide annual sales by 2009.

The U.S. Food and Drug Administration initially approved Tysabri in November 2004, but Elan and Biogen Idec pulled the drug from the U.S. market three months later, after three people taking it in clinical trials contracted a rare brain disease called PML; two died from the usually fatal condition.

In June, the FDA approved resumed sales after no new PML cases were detected among more than 5,000 other clinical trial patients. European regulators gave their approval this month.

More than 400,000 people suffer from MS in the European Union, about 350,000 in the United States.

But regulators on both continents said MS patients shouldn't be permitted to use Tysabri unless their condition was not improving using longer-established drugs, or were suffering exceptionally life-threatening effects.

Elan's president of research and development, Lars Ekman, said the company also expected to gain approval next year to provide Tysabri to sufferers of Crohn's disease, an intestinal disorder, initially in the European Union.

The Dublin-based company was once an investor's favorite because of its headline-making efforts to cure Alzheimer's disease. But Elan suffered a near-fatal fall in 2002 on bad news.

First, trials of its Alzheimer's drug were abandoned after patients developed potentially fatal brain inflammations. Then, after a two-year U.S. Securities and Exchange Commission investigation into accounting malpractice, the company drastically restated its books -- falling deep into the red for the first time and shocking investors. Elan since has undergone substantial restructuring to cope with more than $2 billion in debt.

Medical-device maker Cyberonics (CYBX) saw its shares plunge 29% to $15.26 after the company offered weak first-quarter estimates and lowered its full-year guidance. First-quarter sales are expected to be about $33.5 million, compared with $27 million in the year-ago quarter, but analysts were calling for $38 million. The company also said it doesn't expect to reach profitability until coverage for its device for treatment-resistant depression improves and investigations into its stock-option grants end. Legal and accounting fees related to the probes will likely exceed $3 million. Additionally, Cyberonics received a Nasdaq Letter on July 31 indicating that it was failing to comply with the filing requirement for continued listing and that its securities are subject to delisting. The company will request a hearing before a Nasdaq Listing Qualifications Panel.

Health care benefits provider Centene (CNC) fell following a downgrade from Goldman Sachs. Analyst Matthew Borsch said he sees "a less favorable risk/reward combination relative to our other buy-rated names." He cut the stock to neutral from his previous buy rating and lowered his price target by $2 to $18. Shares were 1.9% lower, at $15.94.

Bio-Reference Laboratories
(BRLI) was hit with a downgrade from Jefferies & Co. analyst Arthur Henderson, who lowered his rating on the stock to hold from buy. Given the company's size and the level of competition in the lab service space, "BRLI's valuation seemed full to us, and we think a hold rating is more appropriate at this time," Henderson wrote in a report. From a business perspective, however, he remains bullish on the company. Shares fell 10.7% to $21.03.

Biogen Idec (BIIB) shares fell despite an announcement from it's multiple sclerosis drug partner Elan (ELN) that sales of MS drug Tysabri will be a significant contributor to its future profitability. Tysabri was pulled from the market last year after being linked to a potentially fatal brain disease, but it was reapproved for certain uses in June. Biogen Idec shares fell 1.7% to $41.32. Elan lost 2.9% to $14.90 following the company's earnings report Tuesday.