The National Institute for Health and Clinical Excellence, the U.K.’s health-cost agency, says the cost of Bristol-Myers Squibb’s (BMY) melanoma drug, Yervoy, is too high. Though it cast no doubts on the drug’s efficacy, it found that at $125,000 for a full round of treatment, which helps extend the lives of about 30% of patients treated with the drug, it didn’t meet NICE’s standards for cost-effectiveness. The agency’s decision is preliminary and NICE plans to review comments from the company, health providers, and the public before issuing another draft decision. BMS, meanwhile, has the option of altering the cost. A spokeswoman for BMS says the company “remains committed to demonstrating that Yervoy represents real value for the money, and is working to overturn this decision.”
Insmed (INSM) said Monday that the FDA is maintaining a clinical hold on its late-stage testing of Arikace, an experimental treatment for cystic fibrosis patients with lung infections. The company said that the FDA informed it that it had insufficient information to assess patient risks and asked that Insmed conduct a nine-month toxicity study in dogs. Insmed’s shares fell 32 percent, to $1.40 on Monday morning after the announcement. The company has stated that it will provide another update once it better understands the FDA’s request.
Two Las Vegas juries ordered Teva Pharmaceuticals (TEVA) to pay punitive damages tied to an outbreak of hepatitis C linked to the reuse of vials of Teva’s anesthetic propofol. Teva and its co-defendants, Baxter (BAX) and McKesson, were ordered to pay damages of $162 million in one case and $90 million in another, but because Teva has accepted liability for the incident it says it will pay all of the damages on its own.
Bayer patched up a dispute with its longtime partner Onyx Pharmaceuticals (ONXX) over who owns the rights to a late-stage cancer drug spin-off, regorafenib. The dispute stemmed from Onyx’s accusation in 2009 that Bayer was secretly developing analogs of the blockbuster cancer drug, Nexavar, and filing patents for them without alerting Onyx. The deal struck between the two companies allows Onyx to retain profit sharing and co-promotion of Nexavar if it is bought out and calls for Bayer to pay $160 million for Nexavar royalties in Japan. The deal also resolves the dispute over regorafenib, giving Onyx a fifth of future sales.
Pfizer (PFE) is suing Merck (MRK) to block Merck’s new Lipitor/Zetia combination pill. Merck is attempting to sell a drug that’s complementary to its cholesterol drug Vytorin with the Lipitor/Zetia combination, which has the potential to treat cholesterol via a different pathway. Though Pfizer faces generics competition after licensing Ranbaxy Laboratories (RBXZF.PK) to sell its generic version of Lipitor and agreeing to supply an authorized generic to Watson Laboratories starting November 30, 2011, they still have some patents on Lipitor that don’t expire for a few more years. Pfizer is using its Lipitor crystalline structure patent, which doesn’t expire until 2017, in its lawsuit against Merck. Though Merck maintains that the combination pill will not infringe on that patent, the lawsuit will trigger a 30-month regulatory delay on the new drug.
Roche (OTC:RHHBY) is expecting the Swiss franc to shave 14 percent off its full-year earnings, blaming the red-hot currency for its poor third-quarter sales numbers, Reuters reported. Top Roche cancer drugs, Avastin, Rituxan, and Herceptin all saw diminished sales, with Avastin sales falling 24 percent, Rituxan dipping 10 percent, and Herceptin slipping 12 percent. Helvea’s Karl Heinz Koch told Bloomberg, “[Roche’s] key drugs really underperformed. These are not encouraging numbers.” Deutsche Bank analysts said that the poor numbers will have operational consequences, with Roche needing to cut costs to achieve guidance. Bernstein analysts have a slightly more optimistic take, stating that the sales miss is “real” but may have more to do with depressed sales in Japan as they still recover from this year’s earthquake and tsunami.
Amgen (AMGN) told its research and development staff that it is evaluating changes in its R&D programs as a means of improving its focus and reallocating resources to key pipeline assets and activities. Further details on the restructuring plans will be announced on October 24 when Amgen announces its third-quarter financial results.
Capstone Therapeutics executive chairman, Jock Holliman, announced that the company would be going into “hibernation mode.” Capstone is cutting 14 of its 18 employees in an attempt to save cash after a mid-stage study on its leading drug against skin scarring failed to meet a primary efficacy endpoint of improving a measurement of scarring 12 months after surgeries. The company plans to operate as a four-person team while it pursues potential partners for the program. Dow Jones Newswire reports that Capstone’s shares have fallen 62% this year and closed Thursday’s trading at 22 cents a share.
A late-stage trial of Depomed’s (DEPO) Serada met three of its four primary goals but missed its secondary endpoints. The drug’s effects appeared to taper off about halfway through the study. Depomed has not given up on gaining approval from the FDA and plans to meet with the FDA about possible pathways to filing an application that would move the program forward. Investors soured on the stock after results of the study were released, dropping Depomed’s shares 29 percent to their lowest point in a year.