Thursday, November 30, 2006
The company lost $7.8 million, or $6.01 per share, compared with a loss of $2.4 million, or $2.04 per share, a year ago. Cadence did not record revenue during the quarter.
Operating costs jumped to $8 million from $2.5 million, mainly attributable to costs associated with a late-stage clinical trial of the company's Omigard treatment, aimed at preventing local catheter site infections. Also, costs of additional personnel to support development efforts increased overall operating expenses.
As of Sept. 30, the company had cash and cash equivalents of $38.2 million. The company completed its IPO during the fourth quarter.
Shares of Cadence fell 30 cents, or 2.4 percent, to close earlier at $12 on the Nasdaq, having reached a new 52-week high of $12.50 earlier in the day.
Wednesday, November 29, 2006
The Australian company's facility in Darra will make the first step of the process and a "large," U.S.-based manufacturer will produce the final ingredient, according to Progen. Up to 150,000 doses will be produced ahead of the study, which is expected to begin in mid-2007.
Shares of Progen rose 45 cents, or 15.3 percent, to $3.38 on the Nasdaq in morning trading after hitting a 52-week high of $3.93 shortly after the market opened.
Tuesday, November 28, 2006
Bonelli was previously CEO of Optigenex Inc., a New York life sciences company. Prior to that he was president of Anthony Bonelli Associates Inc., a health-care consulting firm; and president and COO of Neuman Health Services, a pharmaceutical wholesaler of Ridgefield, N.J.
Dr. William A. Carter, chairman and CEO of Hemispherx (AMEX HEB), believes Bonelli's "experience and expertise" will help the company develop strategies to expand revenue for its natural human interferon Alferon N injection, which has received Food and Drug Administration approval as a treatment for genital warts, and its experimental therapeutic Ampligen.
Carter said Hemispherx is getting ready to file a new drug application seeking approval for Ampligen as a treatment for chronic fatigue syndrome.
Bonelli is replacing Doug Hulse, who has been serving part-time as president and COO under a contract arrangement with health-care consultant The Sage Group of Branchburg, N.J., where he is executive director.
Monday, November 27, 2006
The company announced in June that it was taking responsibility for further development of SB-743921 from its partner GlaxoSmithKline.
The revised agreement also assigns responsibility for development of ispinesib, or SB-715992, to Cytokinetics.
Glaxo has the option to resume responsibility for some or all of the development and marketing activities associated with the two drugs.
The companies have been collaborating in developing cancer treatments for five years and have extended the relationship for an additional year in June. The collaboration has already moved two drug candidates into clinical trials.
Cytokinetics said it is considering plans to conduct in 2007 a focused development program to supplement a broad series of Phase I and Phase II clinical trials on ispinesib. The trials, previously sponsored by GlaxoSmithKline, focused on lung and breast cancer patients. Cytokinetics' clinical trials would focus on breast cancer patients.
Shares of Cytokinetics fell 33 cents, or 4.3 percent, to close at $7.29 on the Nasdaq. The stock has traded between $5.20 and $9.35 over the last 52 weeks.
Shares of GlaxoSmithKline finished 17 cents lower at $51.48 on the New York Stock Exchange.
The stock gained $1.22, or 7.6 percent, to reach $17.21 on the Nasdaq in morning trading, having earlier set a new 52-week high of $17.38 shortly after the market opened. Previously, the stock has traded between $12.70 and $16.24 over the last year.
The boost came after Morgan Stanley, Bank of America and Lazard Capital Markets initiated coverage with "Buy" and "Overweight" ratings, saying there is a low clinical risk associated with the arthritis treatment candidate. Analysts also believe TRU-015 would enter the market as a solid competitor to Genentech Inc.'s Rituxan.
The market itself for rheumatoid arthritis is expanding, analysts said, and with Wyeth as a partner in the drug's development, Trubion will have a reliable path into that field.
Seattle-based Trubion, which went public Oct. 18, is currently conducting mid-stage clinical trials of the treatment. Another drug candidate, TRU-016, is undergoing development for use as a cancer treatment.
"We have argued that until the next innovation in biotech, Trubion and other fast-follower players may offer the best risk-adjusted returns," said Morgan Stanley analyst Steven Harr, who rates the stock at "Overweight" with a $24 price target.
"Fast-follower" refers to a company that moves a product to market soon after the entrance of an initial, sometimes blockbuster, treatment. Harr expects to see data from the current TRU-015 trial during the second half of 2007, and late-stage clinical trials by early 2008. He forecasts the product will launch in late 2010.
Lazard analyst Joel Sendek initiated coverage with a "Buy" rating and a $22 price target, citing a similar outlook for TRU-015. The drug has a lower clinical risk than most biotech drugs, he said, because it is already directed against a validated target, uses a similar mechanism to Genentech's Rituxan and has so far shown positive results in clinical trials.
The rheumatoid arthritis market for biologic therapies is forecast to grow to $6.4 billion by 2009, Sendek said.
However, while Sendek said a survey of physicians showed 91 percent would switch to the drug from Rituxan, it faces not only an increasingly competitive market, but patent issues as well. Genentech and Trubion are currently disputing patents involved in the drug's use. That litigation, which has the potential to thwart TRU-015's release in both the United States and Europe, is on of the biggest risks facing the company.
Bank of America analyst David Witzke also started Trubion at "Buy" with a $23 price target, citing a similar positive outlook as well as lingering patent litigation concerns. He cited the collaboration with Wyeth on the drug as a strong point for the company, that validates the drug's market potential.
Friday, November 24, 2006
But J&J, of New Brunswick, N.J., Wednesday said it still plans to pursue a full trial in the case. J&J argues Amgen's discounts have hurt sales of Procrit, which treats chemotherapy-related anemia in cancer patients.
J&J has licensed Procrit from Amgen since the 1980s. Amgen sells the same drug under the brand Epogen, but under an agreement with J&J, Amgen only sells Epogen to treat anemia in kidney-dialysis patients, while J&J sells it in non-dialysis settings.
Amgen, Thousand Oaks, Calif., also sells a newer drug, Aranesp, to treat anemia in both dialysis and chemotherapy patients, thus competing directly with J&J's Procrit in chemotherapy settings.
To spur sales, Amgen offers cancer clinics discounts if they purchase certain amounts of Aranesp and two other Amgen chemotherapy-related drugs, Neupogen and Neulasta, which are designed to boost white blood cell counts and ward off infections. Partly as a result, Aranesp sales have taken off and gained market share from Procrit, rising 27 percent to $1.1 billion for the third quarter.
J&J sales of Procrit and Eprex _ the brand name it's sold under in Europe _ fell 5.3 percent to $2.4 billion for the third quarter.
J&J's Ortho Biotech unit sued Amgen in October 2005 in federal court in New Jersey alleging violations of antitrust law. J&J alleges the discounts constitute "unlawful tying" and an unlawful attempt to gain a monopoly. J&J also sought a preliminary injunction stopping Amgen from offering the discounts to oncology clinics.
Tuesday's ruling in Newark, N.J., by U.S. District Court Judge Stanley Chesler denies the preliminary injunction. He wrote that J&J's allegations, if true, can be remedied by monetary damages, so a preliminary injunction wasn't necessary.
"We believe that Amgen does not engage in anticompetitive practices in the sale of Aranesp," said David Scott, Amgen's senior vice president and general counsel.
Ortho Biotech also is seeking a permanent injunction against Amgen, which Chesler's ruling doesn't address. "The ruling does not resolve our underlying challenge to Amgen's anticompetitive contracting strategy," said Ortho Biotech.
J&J shares rose 17 cents to close at $66.77 on the New York Stock Exchange. Amgen shares fell 30 cents to $72.68 on the Nasdaq Stock Market.
Wednesday, November 22, 2006
But J&J, of New Brunswick, N.J., Wednesday said it still plans to pursue a full trial in the case. J&J argues Amgen's discounts have hurt sales of Procrit, which treats chemotherapy-related anemia in cancer patients.
J&J has licensed Procrit from Amgen since the 1980s. Amgen sells the same drug under the brand Epogen, but under an agreement with J&J, Amgen only sells Epogen to treat anemia in kidney-dialysis patients, while J&J sells it in non-dialysis settings.
Amgen, Thousand Oaks, Calif., also sells a newer drug, Aranesp, to treat anemia in both dialysis and chemotherapy patients, thus competing directly with J&J's Procrit in chemotherapy settings.
To spur sales, Amgen offers cancer clinics discounts if they purchase certain amounts of Aranesp and two other Amgen chemotherapy-related drugs, Neupogen and Neulasta, which are designed to boost white blood cell counts and ward off infections. Partly as a result, Aranesp sales have taken off and gained market share from Procrit, rising 27 percent to $1.1 billion for the third quarter.
J&J sales of Procrit and Eprex -- the brand name it's sold under in Europe -- fell 5.3 percent to $2.4 billion for the third quarter.
J&J's Ortho Biotech unit sued Amgen in October 2005 in federal court in New Jersey alleging violations of antitrust law. J&J alleges the discounts constitute "unlawful tying" and an unlawful attempt to gain a monopoly. J&J also sought a preliminary injunction stopping Amgen from offering the discounts to oncology clinics.
Tuesday's ruling in Newark, N.J., by U.S. District Court Judge Stanley Chesler denies the preliminary injunction. He wrote that J&J's allegations, if true, can be remedied by monetary damages, so a preliminary injunction wasn't necessary.
"We believe that Amgen does not engage in anticompetitive practices in the sale of Aranesp," said David Scott, Amgen's senior vice president and general counsel.
Ortho Biotech also is seeking a permanent injunction against Amgen, which Chesler's ruling doesn't address. "The ruling does not resolve our underlying challenge to Amgen's anticompetitive contracting strategy," said Ortho Biotech.
In afternoon trading J&J shares rose 17 cents to $66.77 on the New York Stock Exchange. Amgen shares fell 37 cents to $72.61 on the Nasdaq Stock Market.
Drug developer PDL BioPharma Inc. said Tuesday Swiss drug maker Roche Holding AG pulled out of their partnership on to develop daclizumab as an organ transplant therapy.
The co-development agreement on the organ transplant program will formally end in May 2007. The move gives PDL exclusive rights for daclizumab's use in transplant maintenance.
"Roche made this decision subsequent to a periodic internal review of its development programs," PDL said in a statement.
Earlier this year, Roche pulled out of another partnership with PDL to develop the drug to treat asthma.
PDL said it will provide an update on the expected financial impact of the move with its 2006 financial results, expected to be released in February.
Shares of PDL rose 17 cents to close at $22.67 on the Nasdaq, but lost $1, or 4.4 percent, to $21.67 in aftermarket activity. The shares have ranged between $16.39 and $33.30 over the past year.
Tuesday, November 21, 2006
The companies plan to launch the drug in Europe in 2007. Byetta was given a positive recommendation by a panel advising European regulators in September. The drug, which is derived from the saliva of the Gila monster, was launched in the U.S. in June 2005.
Lilly and Amylin ran into difficulties in April when the companies asked doctors to limit the number of patients started on the drug because cartridges had fallen into short supply. In August, the companies lifted the restriction when supplies caught up with demand again.
Monday, November 20, 2006
The biotech stock gained 49 cents to $29.35 in afternoon trading on the Nasdaq, after setting a fresh 52-week high of $30.49 earlier in the session. The stock's previous year high of $29 was set on Friday.
The biotech company's lead products include Evicel and Crosseal, both of which are used to stem bleeding, or for homeostasis, during liver surgery. The products, called fibrin sealants, promote clot formation. Evecel is also undergoing two additional clinical trials as part of a move by the company to get it approved for use in general surgery.
Analyst Jonathan Aschoff initiated coverage with a "Buy" rating and a $35 price target. He cited the company's marketing partnership on Evicel and Crosseal with Johnson & Johnson as a key reason for the rating, saying Omrix could be a possible buyout target.
"Since we view Omrix's business as relatively low-risk and on the brink of such robust revenue growth, it therefore makes for a very rational acquisition by J&J," he wrote.
Johnson & Johnson already made an offer for the company before it went public in April.
Evicel is superior to products currently on the market, he wrote, and it is poised to gain more market share with additional FDA approvals.
The company's immunotherapy business, which included developing treatments for West Nile virus, smallpox and hepatitis B-related liver transplants, is another positive, the analyst wrote.
The company placed 2.79 million common shares at $4.68 per share and warrants to purchase up to 557,400 shares with an exercise price of $6.33 each.
Dyadic said it will use proceeds to expand its development program, strengthen its product pipeline and accelerate the commercial launch of new products.
Cowen and Co. LLC acted as the exclusive placement agent for the offering. The closing of the private placement is subject to the approval of the listing of the shares and the shares underlying the warrants by the American Stock Exchange and other customary closing conditions.
Dyadic shares added 7 cents to $5.31 in morning trading. The stock has traded between $1.50 and $9.06 over the past 52 weeks.
Oragenics issued just over 185,000 shares for iviGene, which holds two patents for identifying gene and protein biomarkers that can be used for a better diagnosis and treatment of a wide range of infectious diseases and cancers. Oragenics has about 21 million shares outstanding.
Oragenics had an exclusive license to specific applications of iviGene's patented IVIAT technology since February 2004. With this transaction Oragenics now has all of iviGene's assets, including issued and pending patents to two broad-based platform technologies.
The transaction was approved by the boards of both companies. Oragenics is required to file a resale registration statement for its newly issued shares within 90 days.
Shares of Oragenics rose 2 cents at $1.27 in morning trading on the American Stock Exchange.
Sunday, November 19, 2006
The AMEX BIOTECHNOLOGY INDEX recently broke through technical resistance and now trades at a 5 year high. This one year chart of the Index shows that the biotech sector has made a very impressive move off of the July lows. Both the biotech index and sector are in a very bullish pattern. Many analysts expect biotech to continue to rally well into 2007.
Friday, November 17, 2006
The drug was originally approved in 1998 to treat metastatic breast cancer.
Studies showed that adding the drug to chemotherapy early in breast cancer treatment reduced the relative risk of recurrence by half.
Shares of the biotecg giant rose 41 cents to $81.43 on the New York Stock Exchange.
Thursday, November 16, 2006
The total proceeds imply a per-share offering price of about $4.54, representing a 15 percent discount to the stock's Wednesday closing price of $5.35.
Credit Suisse Securities (USA) LLC and Lazard Capital Markets LLC acted as joint lead placement agents for the offering, which is expected to close on Nov. 21, subject to customary closing conditions.
The company currently has about 71.9 million shares outstanding.
Shares tumbled 69 cents, or 12.9 percent, to $4.68 in morning trading on the Nasdaq, where the stock has ranged between $3.68 and $6.22 over the past year.
The Cambridge, Mass. company (Nasdaq MLNM) raised the amount by selling convertible senior notes due Nov. 15, 2011. Morgan Stanley & Co. Inc. and J.P. Morgan Securities Inc. acted as joint book-running managers.
It's not as if Millennium needs the cash. The company reported more than $635 million in cash and equivalents on hand as of Sept. 30. But the move to raise more funds comes after Millennium lost a bid to buy cancer drug developer AnorMed Inc. earlier this fall.
After a fierce bidding war, biotech giant Genzyme Corp. in Cambridge won out, agreeing to pay $580 million for the Canadian company. Millennium had bid $515 million, which trumped an earlier Genzyme bid.
Millennium announced in late October that it would lay-off 150 employees, outsource some drug discovery functions and consolidate space in Cambridge.
Wednesday, November 15, 2006
The NASDAQ Biotechnology Index was launched in 1993 and includes contains securities of NASDAQ-listed companies that meet minimum requirements, including market value, average daily share volume, and seasoning as a public company, among other criteria. The index is ranked on a semi-annual basis in May and November and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Amex IBB).
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
The disorder, called Batten Disease, affects infants and young children and is brought on by inherited genetic mutations. That mutation causes the lack of a lysosomal enzyme, which leads to loss of motor skills, seizures and other symptoms. Eventually, the patient becomes blind, bedridden and unable to communicate, the company said.
The disease is fatal.
The company's human neural stem cell is transplanted into the brain of the patient, with the goal of producing the missing enzyme. The intention is for the enzyme to increase and continuing increasing over time, providing long-term delivery.
The Phase I clinical trial is designed to primarily study the safety of the treatment, but will also look at effectiveness. In all, six patients are expected to undergo the treatment over the next 12 months.
The beginning of human studies for the treatment gave biotech company StemCells a boost in premarket trading, raising shares 36 cents, or 11.3 percent, to $3.53 on the INET electronic exchange.
Tuesday, November 14, 2006
Gilead said preliminary results show about 40.1 million shares, or more than 91.3 percent of outstanding stock, were validly tendered and not withdrawn prior to the expiration of the tender offer on Monday.
All shares have been accepted for payment.
In October, Gilead said it planned to buy Westminster, Colo.-based drug company Myogen for $52.50 cash per share, or about $2.5 billion.
Shares of Gilead rose 23 cents to $67.30 during premarket electronic trading on the INET.
The company lost $5 million, or 8 cents per share, compared with a loss of $2.7 million, or 6 cents per share, a year ago. Analysts polled by Thomson Financial expected a loss of 11 cents per share.
Revenue dipped to $1.2 million from $1.9 million a year ago, while analysts expected revenue of $700,000.
Costs rose to $6.9 million from $4.1 million. The increase came as the company ramped up development of its VLP, or virus-like particle-based, flu vaccines. In July, the company received positive news from researchers that the developing vaccine could protect from influenza after only one dose. The results were part of preclinical trials.
The company is working with the Food and Drug Administration to design studies to test the vaccine in humans.
Shares of Novavax rose 7 cents to $5.02 in premarket trading on the INET electronic exchange.
Monday, November 13, 2006
The drug, being developed with Swiss-based biotechnology company Serono, was tolerated across all dose levels in the Phase Ib study. Seattle-based ZymoGenetics said the companies hope to start a Phase II clinical trial before the end of the year.
The study involved 49 patients with systemic lupus erythematosus, the most common form of the immune system disorder. The key goal of the study was to test the drug for safety. Secondary goals measured biologic activity, or impact of the drug on disease symptoms. Results varied based on the dose.
The results were released at the American College of Rheumatology's annual meeting.
Shares of ZymoGenetics rose 57 cents, or 3.7 percent, to $16.06 on the Nasdaq in midday trading. The stock has traded between $15.02 and $25 over the last 52 weeks. American depositary shares of Serono fell 12 cents to $21.79 on the New York Stock Exchange.
Samaritan said it did not comply with Amex rules requiring companies to have shareholder equity of not less than $4 million and losses from continuing operations, or net losses, in three out of four of its most recent fiscal years -- as well as a rule requiring shareholder equity of not less than $6 million and net losses in the five most recent fiscal years.
If it wants to stay listed, Samaritan Pharmaceuticals must submit a plan by Dec. 6 describing how it will be back in compliance within 18 months. The company said it will come up with a plan.
"If we fail to timely submit this plan, AMEX does not accept the plan, or we fail to perform in accordance with the plan, we will be subject to delisting procedures," the company said.
Shares of Samaritan Pharmaceuticals dipped 2 cents to 28 cents in midday trading on the AMEX.
The drug was approved by the Food and Drug Administration in 2003 to treat ankylosing spondylitis, a chronic inflammation of the spine and joints at either side of the spine. The ongoing open study showed that after a period between 148 and 160 weeks, patients maintained improvement in spinal mobility. The condition is known for impeding movement and flexibility.
In all, 59 patients received the drug in the ongoing study, and 78 percent of them improved based on a clinical scale measuring back pain, physical function and inflammation. The drug appeared to be safe and tolerable in the long-term study.
The results from the ongoing study reflect those seen in late-stage clinical trials, in which patients improved over a 24-week period.
The drug was approved in 1998 to treat inflammation associated with rheumatoid arthritis.
Shares of Amgen fell 46 cents to $73 on the Nasdaq in morning trading.
Friday, November 10, 2006
The findings were released at a New York symposium by Dr. Daniel Petrylak, an associate professor of medicine with Columbia University Medical Center, Dendreon said in a press release.
The study examined the effects of Provenge, a drug that is designed to stimulate a patient's immune system. Seattle-based Dendreon (NASDAQ DNDN) is developing Provenge as an initial treatment for men with prostate cancer who later receive docetaxel chemotherapy for their illness.
Petrylak tracked 82 prostate cancer patients who were administered either Provenge or a placebo before undergoing chemotherapy.
The median survival period for patients treated with Provenge was 34.5 months, while the median survival period for patients treated with a placebo was 25.4 months, the company said.
Provenge is in late-stage clinical development.
The offering, announced on Nov. 3, generated roughly $40 million in gross proceeds, and $37.3 million in net proceeds. All shares were sold by the company.
Shares of Adventrx were unchanged in premarket trading from Thursday's closing price of $2.69 on the American Stock Exchange.
Thursday, November 09, 2006
The Lexington, Mass., biotech company (Nasdaq EPIX) lost $133.1 million during the quarter ending Sept. 30, compared to a $5.7 million loss in its fiscal 2005 third quarter. The number jumped because of a one-time charge of $123.5 million recorded for ongoing research and development connected to Epix's merger with Predix Pharmaceutical Holdings Inc. in August.
Company revenue reached $1.3 million during the third quarter, down from $2.3 million in the same quarter last year.
Epix pursued its $125 million merger with Predix in an effort to diversify its product line after repeated delays in U.S. regulatory approval for its Vasovist imaging agent, which has received approval in Australia, Canada, the European Union, Norway, Iceland and Switzerland.
The merger transaction includes a $35 million milestone payment based on Predix's strategic collaboration with Amgen Inc., for which the merger triggered the extra money.
The combined company focuses on imaging agents and treatments for hypertension, anxiety and depression, and pulmonary disease.
MedImmune has filed an investigational new drug application with the Food and Drug Administration to start human studies of its cell culture-based flu vaccine as part of a five-year, $170 million contract with the U.S. Department of Health and Human Services.
This flu vaccine would be produced through cell culture manufacturing techniques, replacing the decades-old method of using chicken eggs. Cell culture-based production would allow the Gaithersburg company to scale up its manufacturing without worrying about chickens getting infected.
With the new manufacturing technology, MedImmune estimates that by 2012 it will be able to produce 300 million bulk doses of a pandemic flu vaccine each year, beefing up the national stockpile of vaccines fighting that disease.
In July, MedImmune (NASDAQ MEDI) got FDA approval to turn to reverse genetics technology to develop seasonal and pandemic flu vaccines -- another method that the company says will speed up the manufacturing process.
On the other side of the Potomac River, Innocoll has filed an investigational new drug application to further test an antibiotic for diabetic foot ulcers.
The Ashburn company is developing a topical treatment version of CollaRx Gentamicin, already approved and being sold outside of the United States as a surgical implant.
Innocoll had purchased the rights to the drug from Essex Chemis, an affiliate of Schering-Plough, and has since won approval to sell the surgical-implant product in Central and South America. In August, the company joined its sales and marketing arm with BurnsAdler Pharmaceuticals to market the treatment in Mexico, Argentina, Chile, Colombia and parts of the Caribbean.
EntreMed shares rose 8 cents, or 3.9 percent, to $2.15 in morning trading on the Nasdaq. Shares have traded between $1.43 and $2.99 over the past 52 weeks.
The company said preclinical results for its cell cycle inhibitor MKC-1 showed that the compound interfered with tumor cells in models of lung cancer and pancreatic cancer when used by itself and with the cancer drug Tarceva.
Data showed that MKC-1 binded to tumor cells and destabilized structural components within the cells.
Wednesday, November 08, 2006
The stock gained $1.92, or 24.2 percent, to reach $9.86 in afternoon trading as volume surged to more than 15 times its average level. Shares have traded between $7.21 and $14.92 over the last 52 weeks.
The Morrisville, N.C.-based company reported a third-quarter profit late Tuesday on a doubling of revenue from royalty and collaborations. The boost came mainly from global Fuzeon sales of $63 million and its partnership with Swiss drug maker Roche Holding AG.
Analysts took a cool view of the results, predicting a likely slowing in growth of Fuzeon sales. Citing side effect issues and competition, several analysts forecast a tougher market for the drug. The big boost in profit was partly due to lighter operating expenses.
"While the focus on spending control and profitability is encouraging in the near term, absent visibility on growth drivers from Fuzeon or the pipeline, we doubt that over the long-term the earnings story is sustainable," said Morgan Stanley analyst Dr. Steven Harr.
Harr reaffirmed an "Underweight" rating for the company.
Goldman Sachs analyst Meg Malloy reaffirmed a "Neutral" rating with an $11.50 price target, saying Fuzeon growth will continue to be gradual.
"Growth has been hindered by administration and injection site reactions, despite solid efficacy and favorable guideline positioning," she said.
The company is working on developing a next-generation version of the drug and that would represent a longer term driver. Trimeris is also awaiting a Food and Drug Administration decision for Fuzeon administered through its needle-less Biojector 2000 system. The FDA has requested more safety data.
"The level of profitability should depend not only on Fuzeon growth but also on research & development spending, the latter we expect to pick up as the pipeline advances," she wrote.
ThinkEquity Partners analyst Vinny Jindal reaffirmed a "Sell" rating with a $8 price target, citing similar issues and an increasingly competitive field.
The state constitutional amendment drew national attention after actor Michael J. Fox, who has Parkinson's disease, appeared in a television ad endorsing the bill.
Shares of Palo Alto, Calif.-based StemCells Inc. rose 21 cents, or 6.8 percent to $3.28 in morning trading on the Nasdaq as volume surged. The company is focusing its research on treating major organ systems using stem cells.
Geron Corp., based in Menlo Park, Calif., rose 17 cents, or 2 percent, to $8.55 on the Nasdaq as volume doubled. Geron is developing possible treatments for a variety of diseases based on stem-cell technology.
Cambridge, Mass.-based ViaCell Inc. caught a slight boost from the news, rising 5 cents to $5.56 in morning trading. The company develops umbilical cord and adult-derived stem-cell treatment candidates for cancer, cardiac disease and diabetes.
The Missouri legislation allows any federally allowed stem-cell research and treatment to occur in the state. Bank of America analyst Frank H. Pinkerton considered the vote a much needed candidate for Invitrogen Corp., which makes kits used by researchers and companies to speed up gene cloning. In June the company licensed patents related to human embryonic stem cells from Geron.
"There are still questions regarding intellectual property ownership, economic returns, and funding has also slowed the research process; however, we view this as a step toward loosening funds that could accelerate Invitrogen's sales," he said in a note to investors.
Shares of Carlsbad, Calif.-based Invitrogen rose 37 cents to $57.74 in the morning Nasdaq session.
The company's quarterly loss totaled $20.7 million, or 29 cents per share, compared with $19.7 million, or 33 cents per share, a year ago. Revenue jumped 45 percent to $84,000 form $58,000 last year.
Analysts polled by Thomson Financial forecast a loss of 29 cents per share on sales of $100,000.
Total operating expenses rose to $21.7 million from $21 million a year ago.
Tuesday, November 07, 2006
Shares of biotech company Trimeris Inc. soared 26 percent in late trading after the biopharmaceutical company swung to a profit sales more than doubled to top Wall Street expectations.
The Morrisville, N.C.-based biotech and pharma company said the increase came mainly from royalties from the HIV drug Fuzeon. Trimeris' partner on the drug, Roche Holding, posted a 29 percent rise in global sales to $63 million for the drug during the quarter.
Shares of Trimeris surged in after-hours electronic trading, rising $2.07, or 26 percent, to $10. Shares closed up 2.7 percent, at $7.93 on the Nasdaq.
Cambridge, Mass.-based Genzyme (Nasdaq GENZ) announced in October that it had inked an agreement to acquire AnorMed (Nasdaq ANOR) for $580 million in cash, worth about $13.50 per share.
The agreement will give Genzyme access to AnorMed's Mozobil, a treatment in late-stage clinical trials for the blood cancer multiple myeloma and non-Hodgkin's lymphoma.
Tuesday the companies said the expiration of the waiting period under the Hart-Scott- Rodino Antitrust Improvements Act of 1976.
Neurocrine's stock plunged on Friday after the company said it planned to conduct more studies on Indiplon. The Food and Drug Administration rejected a high-dose version of the drug and also requested more information on two lower dose versions.
But analyst Lawrence H. Neibor upgraded his rating on the stock to "Neutral" from "Underperform," expecting the company to see gains from other products, including its Gonadotropin-Releasing Hormone, or GnRH, antagonist in endometriosis -- a condition where endometrial tissue grows outside the uterus and forms painful cysts on the ovaries, fallopian tubes and abdominal cavity.
"With investor expectations currently running at a seven-year low, we believe the potential for future Indiplon disappointment is balanced by the potential for positive updates on earlier-stage products in the pipeline such as the GnRH antagonist in endometriosis," Neibor said.
In a Phase 1 dosing trial, data showed that its endometriosis treatment lowered levels of a female hormone, estradiol, associated with the disease.
Neibor also said his upgrade was based on a stock price that is approaching his $7 price target, as well as Indiplon gains -- once the drug is finally launched.
"The launch of Indiplon would quickly transition the company from the development stage to an operating entity and could make the company profitable shortly thereafter," Neibor wrote in a client note.
The stock rose 12 cents to $7.96 in the premarket electronic session, after closing at $7.73 on the Nasdaq.
The company, which makes products used in surgery and immunotherapy, earned $8.1 million, or 53 cents per share, compared with a loss of $321,000, or 3 cents per share, a year ago. Analysts polled by Thomson Financial expected a profit of 33 cents per share.
Revenue surged 137 percent to $18.3 million from $7.7 million. Analysts expected revenue of $16.4 million.
The bulk of the increase came from $13.8 million in antibody products, which include intravenous treatments, and $3.5 million from biosurgery products.
During the remainder of the year, the company said it expects to complete enrollment in a late-stage clinical trial of its fibrin sealant Evicel and to complete enrollment of its early-to-midstage study on a West Nile fever treatment.
Omrix said it expects full-year earnings to range from $1.40 to $1.45 a share on product sales revenue of between $54 million and $55 million. The figures mark an increase from previous guidance calling for profit of between $1.15 and $1.20 per share on revenue of between $50 million and $51.5 million.
Analysts previously forecast profit of $1.20 per share on revenue of $59.7 million
Shares of Omrix rose $1.84, or 9.3 percent, to $21.50 in premarket trading on the INET electronic exchange. The stock had closed at $19.66 Monday.
Chairman Irwin Lerner was appointed interim president and CEO, and the board launched a search for a new CEO. Lerner was unanimously elected by the board. Drakeman also gave up his seat on the board, along with Michael A. Appelbaum, who also agreed to step down from the board.
An internal probe into the company's stock option accounting practices found that before Sarbanes-Oxley legislation in 2002, it was commonplace for the company to date its stock option grants when shares were trading at relatively low prices, a practice known as "backdating." The company said the probe found no fraud or willful misconduct on the part of management.
Nearly 100 companies are under federal scrutiny, and another 60 have launched internal probes without government prompting.
In June, Medarex said it received a federal grand jury subpoena over the timing of its stock options grants, and had earlier received a letter of informal inquiry from the Securities and Exchange Commission.
At least 41 senior executives or directors, including 11 CEOs, nine finance chiefs and eight general counsels have left at 20 companies following stock option probes.
Senior executives at Medarex involved with the practice have agreed to repay the company any gains from such practices.
Under his employment agreement, Drakeman will remain with the company as an employee until Jan. 4 and as a consultant until March 25 to ensure an orderly transition.
The company is still in the process of restating its financial results from 2000 through 2005 and for the quarter ended March 31, 2006.
Shares of Medarex rose 61 cents, or 5 percent, to $12.80 in afternoon trading on the Nasdaq at above-average volume.
Monday, November 06, 2006
Abbott plans to buy Kos for $78 per share, a 56 percent premium on its closing price Friday at $50.09 on the Nasdaq Stock Market.
Kos, based in Cranbury, N.J., is a specialty drugmaker whose main product is Niaspan, which raises levels of "good" cholesterol. Kos booked 2005 revenue of $751.7 million.
Abbott, based in North Chicago, Ill., expects the transaction to depress earnings by 2 cents to 3 cents per share in 2007, have a neutral impact on profit in 2008 and add to earnings thereafter.
Abbott shares dipped to $46.85 in electronic premarket trading from their close Friday at $47.64 on the New York Stock Exchange.
The agency sent the companies an approvable letter on the drug, requesting 12-month safety data that includes analysis of serious cardiovascular events from an ongoing study and a risk management plan. The ongoing study is expected to be complete by the first quarter of 2007, with data available during the second quarter.
Adolor shares plummeted $4.24, or 30.4 percent, to $9.70 in premarket trading on the INET electronic exchange, indicating that stock may open at a new 52-week low. Shares, which closed Friday at $13.94 on the Nasdaq, have ranged between $11.28 and $27.80 over the past year.
Chairman Irwin Lerner was appointed interim president and CEO, and the board launched a search for a new CEO. Lerner was unanimously elected by the board. Drakeman also gave up his seat on the board, along with Michael A. Appelbaum, who also agreed to step down from the board.
An internal probe into the company's stock option accounting practices found that before Sarbanes-Oxley legislation in 2002, it was commonplace for the company to date its stock option grants when shares were trading at relatively low prices, a practice known as "backdating." The company said the probe found no fraud or willful misconduct on the part of management.
Senior executives involved with the practice have agreed to repay the company any gains from such practices.
Under his employment agreement, Drakeman will remain with the company as an employee until Jan. 4 and as a consultant until March 25 to ensure an orderly transition.
The company is still in the process of restating its financial results from 2000 through 2005 and for the quarter ended March 31, 2006.
Shares of Medarex rose 23 cents to $12.42 in early trading on the Nasdaq.
Sunday, November 05, 2006
Biotech company Spectrum Pharmaceuticals reported a net loss of $7.4 million, or 30 cents a share, in its third quarter, down from a net loss of $5.2 million, or 32 cents a share, in the year-ago period, the company said Friday.
Spectrum reported $92,000 in revenue in the quarter, down from $184,000 in the year-ago period. Research and development expenses were $5.8 million, up from $3.3 million in the year-ago period, due to the expanded scope of Spectrum's research and development activities.
The company reported positive results in a Phase 3 trial of satraplatin as a second line treatment for hormone refractory prostate cancer, and began a Phase 2 trial of satraplatin in combination with Tarceva in patients suffering from inoperable, advanced non-small cell lung cancer by its partner GPC Biotech AG, among other trials.
For the first nine months of the fiscal year, Spectrum reported $92,000 in revenue, down from $424,000 in the year-ago period. Net loss was $22.3 million, or 93 cents a share in the nine-month period, down from a loss of $15 million, or 96 cents a share, in the first nine months of fiscal 2005.
Irvin, California based Spectrum (NASDAQ: SPPI) develops anti-cancer drugs, funding the research through the sale of generic versions of common prescription drugsSaturday, November 04, 2006
Biotech company Cell Therapeutics said late Friday it has halted enrollment in its most important clinical trial because of premature deaths among patients taking its experimental cancer drug.
James Bianco, chief executive of the Seattle company, said the deaths do not appear related to any safety problems with its drug, Xyotax.
In an interview, Bianco would not say how many patients enrolled have died among the 200 women with lung cancer. But he acknowledged there were more deaths in the group receiving Xyotax than another receiving a standard chemotherapy drug. Further analysis is needed to sort out the reasons, he said.
Bianco said most of the deaths have been attributed to disease progression — meaning the advancement of the patient's cancer. The study's patients have advanced lung cancer, with a life expectancy of 8 to 10 weeks.
The company said it expects results from the study to be delayed by at least six months while the data is studied. That could have a financial impact on the company, which has regularly run low on cash.
Cell Therapeutics said it made the decision to halt enrollment voluntarily after getting advice from doctors on the study and an independent safety-monitoring committee.
The study, known as Pioneer, has the unusual feature of being limited exclusively to women with lung cancer. It began enrollment at 170 medical centers around the world in April, and is designed for up to 600 patients.
The company is testing whether Xyotax can prolong patients' lives. Xyotax uses a common chemotherapy agent and modifies it with a polymer intended to make it more tolerable.
Last year, the drug failed to show a survival benefit in three major lung-cancer trials, but the company thought it saw some positive signs in women.
Women who have already enrolled in the study will be able to continue receiving treatment, the company said.
Bianco said the company expects to revise the study when it resumes, to focus on women with normal estrogen levels. He said earlier that Xyotax studies had found a better effect in such women.
Also, said Bianco, "Some of the women in the trial are entering when they are sicker than they probably should be."
The halted trial isn't the first in the company's history. In October 2003, it halted a Xyotax trial in lung cancer and reduced the dose, after "a handful" of patients suffered premature deaths when their infection-fighting white blood cells were wiped out.
This time, Bianco said, his company is using a lower dose from the start, and it thinks the premature deaths are not related to drug toxicity.
Bianco said the delay will not affect the company's newly signed partnership with Swiss drug giant Novartis.
The news was released after markets had closed. Cell Therapeutics shares ended trading unchanged at $1.66.
Friday, November 03, 2006
Gilead intends to utilize this Edmonton, Alberta-based site for process research and scale-up of clinical development candidates, for manufacturing of active pharmaceutical ingredients (API) for both investigational and commercial products and for chemical development activities to improve existing commercial manufacturing processes.
Gilead and Degussa announced the planned acquisition on June 6, 2006.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.The company expects to raise gross proceeds of $40 million. Adventrx has about 73.6 million shares outstanding.
ThinkEquity Partners is the lead placement agent with Fortis Securities as the co-placement agent.
The company expects to close the offering by Nov. 8.
Adventrx shares fell 24 cents, or 7.8 percent, to $2.83 in morning trading on the American Stock Exchange. Shares have traded between $2.35 and $5.38 over the past 52 weeks.
The company said late Thursday it is in the lead in a bid for a Department of Health and Human Services contract to make its Neumune drug part of the national stockpile for the treatment of acute radiation syndrome.
The HHS said Hollis-Eden "is within the competitive range for discussion and further evaluation" for the contract. Hollis-Eden said it is not aware of another competitor within range of getting the contract.
The agency set a tentative award date of Jan. 31.
Thursday, November 02, 2006
The company said 12 patients, or nearly 10 percent of those enrolled, experienced "serious adverse cardiovascular events."
Through the end of September, 117 patients had been dosed with the compound. Also, the company said 4 of 14 patients enrolled in October experienced similar adverse events, "which raised a concern with the company's internal safety monitoring committee."
Shares tumbled $1.04, or 11.1 percent, to $8.30 in premarket trading on the Nasdaq, having closed Wednesday at $9.34 on the Nasdaq.
But, Exelixis said, because 115 of the 131 people enrolled in the study have received repeated doses with no reported events, those already enrolled patients may continue on with the Phase II clinical trial.
"Since all but one of the events occurred on first administration of XL999, we are continuing to treat those patients presently enrolled in the trial," said President and Chief Executive George A. Scangos, in a statement.
The enrollment delay is expected to last between two weeks and three months.
Valeant posted net income of $11.5 million, 12 cents per share, for the quarter, compared with a loss of $3.7 million, or 4 cents per share, last year. Excluding one-time charges, earnings from continuing operations were $13.6 million, or 14 cents per share.
Quarterly sales rose slightly to $219.4 million compared with $205 million last year.
Analysts polled by Thomson Financial, on average, expected earnings of 13 cents per share on sales of $225.7 million.
"The preliminary financial information could be significantly impacted by the effects of the pending restatement associated with the stock option review and by information that may subsequently become available that could alter the estimates and assumptions used in its preparation," Valeant said in a press release.
Also because of the restatements, Valeant said it will not declare a dividend for the third quarter, which "will limit the company's ability to declare or pay dividends in the future."
The company recorded a gain of $17.6 million in the third quarter from a settlement agreement with its former chairman and chief executive, and recorded restructuring charges of $15 million mostly from an impairment charge for assets held for sale. Restructuring charges in 2006 are expected to be between $90 million and $115 million.
Valeant has said it should have used different measurement dates for computing stock option grants going back to 1997 and that its financial statements for and after that year should no longer be relied upon. The Securities and Exchange Commission also is informally investigating Valeant's stock option granting practices dating from Jan. 1, 2000, and the company continues to cooperate with that inquiry.
There are about 98 companies currently under SEC or Justice Department stock-options grant scrutiny, plus at least 58 other companies that have launched or completed internal reviews into their stock options practices, according to an Associated Press review.
At least 41 senior executives or directors, including 11 CEOs, nine finance chiefs and eight general counsels have been fired or have stepped down at 20 companies.
Shares of Valeant dipped 49 cents, or 2.7 percent, to $18.01 on the New York Stock Exchange.
The company lost $15.2 million, or 25 cents per share, compared with a loss of $14.6 million, also 25 cents per share. The most recent quarter included about 4.4 million additional shares.
Analysts polled by Thomson Financial expected a loss of 28 cents per share.
Revenue fell slightly to $229,000 from $321,000 a year ago. Analysts expected revenue of $480,000.
The company said the loss was primarily due to higher expenses associated with a patent dispute. In May, a federal jury found in favor of Ariad in a case against Eli Lilly. Specifically, it found that Lilly's Evista and Xigiris infringed on a 2002 patent that covers any medical treatment targeting the body's molecular pathway, called NF-kappa B. Ariad is involved in another patent lawsuit involving Amgen Inc.'s arthritis treatments Enbrel and Kineret. Stock option expenses also added to the loss.
Those added costs were offset by lower research and development costs as the company moves toward the end of development on its lead product AP23573, for cancer treatment.
The company ended the quarter with $39.2 million in cash and cash equivalents.
Shares of Ariad rose 2 cents to $4.35 on the Nasdaq in midday trading.
The collaboration is intended to capitalize on Berkeley-based Xoma's (Nasdaq XOMA) expertise in monoclonal antibodies.
Under the agreement announced Thursday, Takeda will make up-front and milestone payments to Xoma, fund Xoma's R&D activities including manufacturing of the antibodies for preclinical and early clinical supplies, and pay royalties to Xoma on sales of products resulting from the collaboration.
Xoma will discover therapeutic antibodies against multiple targets selected by Takeda and perform preclinical studies to support regulatory filings, cell line and process development, and production of antibodies for initial clinical trials. Takeda will be responsible for clinical trials and commercialization of drugs and is granted the right to manufacture once the product enters into mid-stage clinical trials.
The compound, recombinant human Mannose-Binding Lectin, is under review for a clinical trial to test safety and effectiveness in treating severe infections in patients with low levels of MBL undergoing liver transplant treatment. MBL is a human plasma protein with anti-microbial properties which helps fight infections.
The FDA has already approved the company's application for another study of the compound, one aimed at studying the prevention of severe infections in patients with multiple myeloma with low levels of MBL undergoing chemotherapy and hematopoietic stem cell transplants.
Enrollment in the liver transplant and multiple myeloma studies is expected to begin later this year.
The company reported a loss of $25.5 million, or 44 cents per share, compared with a loss of $18.8 million, or 32 cents per share, a year ago.
Revenue more than doubled to $6.3 million from $3 million last year from higher royalties on sales of the blood thinner Argatroban by GlaxoSmithKline PLC.
Analysts surveyed by Thomson Financial expected a larger loss per share of 48 cents on revenue of $3.9 million.
Total costs jumped 43 percent to $31.7 million, driven by a near tripling of sales and marketing expenses, and general and administrative expenses that more than doubled, as the company prepares for the launch of its pulmonary hypertension treatment Thelin.
Thelin, which is intended to treat chronic high blood pressure in the blood vessel carrying oxygen-poor blood to the lungs, was approved in Europe in August and is still awaiting final approval by the Food and Drug Administration.
Shares fell 8 cents to $4.55 in pre-market activity on the INET electronic exchange, after closing Wednesday at $4.63 on the Nasdaq.
The company reported a quarterly net loss of $61 million, or $1.23 per share, versus a loss of $31.7 million, or 73 cents per share, for the same quarter in 2005. The company recorded no revenue in either quarter.
Analysts polled by Thomson Financial had expected a loss of $1.17 per share.
Total operating expenses increased to $61.1 million from $32.9 million in the third quarter of 2005.
Research and development expenses more than doubled to $50.8 million, primarily due to the expansion of clinical trials for the company's Technosphere insulin program, MannKind said.
General and administrative expenses increased by $2 million to $10.3 million, mainly as a result of stock-compensation expenses and increased consulting costs.
Wednesday, November 01, 2006
The company said the purpose of the offering is to partially meet anticipated demand from index funds when the company is added to the S&P 500 Index on Nov. 3.
Proceeds from the offering will be used for general corporate purposes, including working capital, capital expenditures, possible future licenses, strategic investments and acquisitions, Celgene said.
The company lost $2.8 million, or 10 cents per share, compared with $6.2 million, or 26 cents per share, a year ago. Revenue jumped 118 percent to $18.4 million from $8.4 million.
Analysts polled by Thomson Financial expected a loss of 32 cents per share on revenue of $18.2 million.
The company's inhaled pulmonary arterial hypertension treatment Vantavis, launched in March, brought in all the revenue for quarter.
The company said it expects sales of Vantavis to bring in between $100 million and $105 million in sales during 2007. Analysts expect the company to report $107 million in sales for the year.
Shares of CoTherix gained 83 cents, or 11.3 percent, to $8.16 in aftermarket electronic trading, from their close at $7.33 on the Nasdaq Wednesday.
"Biotech is riding a wave of heightened investor enthusiasm driven by an increase in M&A activity, significant clinical data reported broadly and excellent third quarter financial reports," says Steven Burrill, CEO of Burrill & Co. "Historically, the fourth quarter has always been a good one for biotech and so there is every reason to believe that it is on target to make up for the beating suffered during the first two quarters of 2006.”
The biotech industry's aggregate market cap at the end of October was just over $488 billion and by the end of the year it could reach a new record high, Mr. Burrill says.
Merger and acquisition activity picked up in October, the company says.
Eli Lilly said it was acquiring Icos Corp. for $2.1 billion, a move that gains full ownership of the erectile-dysfunction drug Cialis.
Merck & Co., Inc. enhanced its interest in RNA interference technologies with its $1.1 billion acquisition of Sirna Therapeutics, Inc. Sirna has been at the forefront of efforts to create RNAi-based therapeutics.
The improved environment for biotechs opened the way for three IPOs getting done, although all had to modify their original filing prices ranges, Burrill says in its report.
Achillion Pharmaceuticals Inc. priced its initial public offering of 4.5 million shares of its common stock at $11.50 per share (down from its $14- $16 filing range). Net proceeds from the offering are expected to be approximately $46.2 million, or $53.4 million if the underwriters exercise their over-allotment option in full. The infectious disease company's shares closed October at $14.00 up 21 percent.
Cadence Pharmaceuticals priced six million shares at $9 each (also below its $11-$13 filing range) in its initial public offering. The company's shares closed October at $9.60 up 6 percent.
Trubion Pharmaceuticals Inc. priced its offering of four million shares at $13 per share. At the close of the month its shares were valued at $14.00, up 7 percent.
On the other side of the ledger, BioVex and Asthmatx withdrew their planned IPOs.
"Investors are obviously wondering whether the fourth quarter will be a robust one for the IPO market," says Mr. Burrill. He says investors are "still selectively looking at individual company portfolios and still skittish on the market's performance in October. While those that did get out benefited from the positive environment, valuation of offerings remains soft."
The company also cut its outlook for the full year. Shares sank 75 cents, or 7.9 percent, to $8.75 in premarket electronic trading on the results.
Quarterly net income dropped to $6.9 million, or 9 cents per share, from $15.9 million, or 19 cents per share during the same period last year.
Excluding certain litigation expenses and other charges, earnings from continuing operations totaled $16.4 million, or 19 cents per share, in the latest quarter.
Analysts polled by Thomson Financial forecast a profit of 20 cents per share.
Revenue rose 80 percent to $86.2 million, from $47.9 million in the year-ago quarter. Wall Street was expecting revenue of $94.9 million for the quarter.
The company said the royalty revenue from its pharmaceutical technologies segment and sales from its Medical Products division drove the upswing.
Angiotech Pharmaceuticals lowered its expectations for full-year revenue to $302 million to $306 million, from $325 million to $335 million, due to lower-than-expected sales of drug-coated stents and other devices, and discontinued operations.
For the year, the company expects to earn 70 cents to 72 cents per share, down from prior guidance for 79 cents to 81 cents due to the sales shortfalls and a rise in other expenses in the fourth quarter.
Analysts are currently expecting the company to post a profit of 74 cents on million in revenue.
On July 25, 2006, the jury had determined that Invitrogen's 4,981,797 patent is valid and that Stratagene infringed that patent by making and selling its competent E. coli cell products, the company said in a statement.
The judge ruled that Stratagene must pay Invitrogen's attorney's fees, in an amount to be determined by the court and awarded Invitrogen $16.2 million in damages plus pre-judgment interest, Stratagene added.
CV Therapeutics posted a loss of $1.23 per share, but still topped analysts' forecasts for a loss of $1.44 per share. The company sold $8.2 million worth of its angina treatment Ranexa, but sold only $3.2 million worth of the drug during the quarter. The remaining $5 million was deferred revenue from the first quarter, when the drug was launched.
The company said 250 new doctors prescribed Ranexa per week during the quarter, which is theoretically good news because new patients are buying the drug. However, some analysts said the figures suggest these doctors are only prescribing the drug to one or two patients.
The modest usage of the drug "indicates that adoption is very slow as physicians are not re-prescribing the drug, or are not prescribing Ranexa in general," said Citigroup analyst Yaron Werber, who rates the stock "Hold."
"Ranexa continues to show a slow start, mainly due to the drug's high price, modest benefit and low awareness," he said.
Piper Jaffray analyst Thomas Wei said the trend could reflect a number of factors. Fewer patients than expected could be eligible for the drug, doctors may question the Ranexa's effectiveness or doctors may be awaiting results from the Merlin trial, Wei said. He rates CV Therapeutics stock "Market Perform."
Analysts agree the results of the Merlin trial, a 6,500-patient Ranexa study whose results will be presented at the American College of Cardiology in March, will be a watershed event for the company and determine how readily physicians prescribe the drug.




