Trimeris' Fuzeon Unpopular Due to Painful Delivery System, Analysts Say
Analysts are skeptical on whether a less painful, needle-free device to administer Trimeris Inc.'s HIV-fusion inhibitor drug will help boost sales, if it is ultimately approved.
The biopharmaceutical company on Wednesday reduced its full-year sales guidance for the drug, Fuzeon, and also said the Food and Drug Administration wants more safety information on an application for a needle-free delivery system of the drug - a device that forces the drug through the skin without using a syringe. As a result, the application might not proceed until the first half of 2007, the company said.
Fuzeon prevents HIV from entering and fusing with the human immune cell and is sometimes used in patients who have become immune to other HIV treatments, said Trimeris.
ThinkEquity Partners analyst Vinny Jindal maintained a "Sell" rating on Trimeris and said Fuzeon's unpopularity is due to "the pain and inconvenience of twice daily" injections. Meanwhile, a smaller gauge needle or needle-less delivery system might not help the drug take off, since competition is heating up in the form of less inconvenient drugs that are in development, noted Jindal.
Goldman Sachs analyst Meg Malloy reiterated a "Neutral" rating on the company in a client note, and said the possible delay in expanding the drug to include the new delivery system is a "modest setback." Instead, the bigger challenge, is getting hard to treat patients to use the drug itself. "Fuzeon growth has long been hindered by administration and injection site reactions," she wrote.
Morgan Stanley Steven Harr likewise noted that the needle-free delivery platform was expected to be a growth driver and reiterated an "Underweight" rating.
"We still see little evidence of acceleration in Fuzeon end-user demand to drive long-term profitability, giving us little reason to own the stock at these levels," Harr wrote.
Trimeris cut 2006 sales forecasts for Fuzeon in the U.S. and Canada to a range of $126 million to $134 million compared with a prior range of $140 million to $150 million.
The needle-free delivery platform, which is being developed in partnership with the Swiss pharmaceutical company Roche, was associated with nerve pain and hematoma in some patients, said Trimeris.
The company also said it expects to post yearly profit for the first time since beginning operations 13 years ago.
Shares of Trimeris closed at $9.06 Wednesday.
Analysts are skeptical on whether a less painful, needle-free device to administer Trimeris Inc.'s HIV-fusion inhibitor drug will help boost sales, if it is ultimately approved.
The biopharmaceutical company on Wednesday reduced its full-year sales guidance for the drug, Fuzeon, and also said the Food and Drug Administration wants more safety information on an application for a needle-free delivery system of the drug - a device that forces the drug through the skin without using a syringe. As a result, the application might not proceed until the first half of 2007, the company said.
Fuzeon prevents HIV from entering and fusing with the human immune cell and is sometimes used in patients who have become immune to other HIV treatments, said Trimeris.
ThinkEquity Partners analyst Vinny Jindal maintained a "Sell" rating on Trimeris and said Fuzeon's unpopularity is due to "the pain and inconvenience of twice daily" injections. Meanwhile, a smaller gauge needle or needle-less delivery system might not help the drug take off, since competition is heating up in the form of less inconvenient drugs that are in development, noted Jindal.
Goldman Sachs analyst Meg Malloy reiterated a "Neutral" rating on the company in a client note, and said the possible delay in expanding the drug to include the new delivery system is a "modest setback." Instead, the bigger challenge, is getting hard to treat patients to use the drug itself. "Fuzeon growth has long been hindered by administration and injection site reactions," she wrote.
Morgan Stanley Steven Harr likewise noted that the needle-free delivery platform was expected to be a growth driver and reiterated an "Underweight" rating.
"We still see little evidence of acceleration in Fuzeon end-user demand to drive long-term profitability, giving us little reason to own the stock at these levels," Harr wrote.
Trimeris cut 2006 sales forecasts for Fuzeon in the U.S. and Canada to a range of $126 million to $134 million compared with a prior range of $140 million to $150 million.
The needle-free delivery platform, which is being developed in partnership with the Swiss pharmaceutical company Roche, was associated with nerve pain and hematoma in some patients, said Trimeris.
The company also said it expects to post yearly profit for the first time since beginning operations 13 years ago.
Shares of Trimeris closed at $9.06 Wednesday.
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