Amylin trims losses in Q4, full-year results
SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.
The company reported revenues of $174.2 million for the quarter and $668.8 million for the year. This compared with $185.5 million in fourth quarter 2009 and $758.4 million for 2009 as a whole. This translated into $11.9 million in losses for fourth quarter 2010 and $135.5 million for 2010, compared with $44.7 million in losses for fourth quarter 2009 and $169.3 million for 2009 as a whole.
Better news came for the company’s individual products. Amylin received a $10 million milestone payment from Eli Lilly in connection with the launch in Japan of the diabetes drug Byetta (exenatide), which the two market under a collaborative agreement.
Lilly also received approval of Byetta in Canada, while a retrospective clinical study found that the drug outperformed most other treatments in patients with Type 2 diabetes. The Food and Drug Administration also approved the design of a clinical trial of Bydureon, a long-acting version of Byetta.
In addition, the company plans to complete its submission of a regulatory approval application for the biotech drug metreleptin in patients with diabetes and hypertriglyceridemia by the end of the year.
GSK receives complete response letter for Avodart
LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.
GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.
The FDA issues a complete response letter when it has finished reviewing an approval application, but issues remain that preclude final approval. GSK did not specify what issues the FDA had cited.
FDA reaccepts approval application for Remoxy
CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.
Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.
King resubmitted the application in late December 2010. The FDA issued a complete response letter when approval originally was sought in December 2008. The FDA issues a complete response letter when it has completed review of an approval application, but questions remain that preclude final approval.