|Healthcare Review: Biogen, Isis Pharmaceuticals, Amarin, Ariad, Threshold Pharmaceuticals|
|By Staff and Wire Reports|
|Friday, 22 November 2013 14:16|
Deutsche's Robyn Karnauskas is out with new numbers for Biogen ($BIIB) on the heels of the CHMP's decision to grant a NSA designation for Tecfidera."Given the solid uptake ... in the U.S., we are raising peak market share ... to 30% vs. 25% previous and now model 2020 worldwide sales at $6B vs. $5B previous," Karnauskas says.U.S. Tecifdera estimates: $1.86B versus consensus of $1.57B.Karnauskas is also upbeat on a hemophilia launch in 2014 (see here).Price target raised to $340 from $270.
Isis Pharmaceuticals ($ISIS) trades higher after the company says it is adding a 12 mg cohort to a Phase 1b/2a ISIS-SMNRx SMA study. The company says the infant 12 mg cohort has been initiated. Patient additions will "not change [the company's] plan to report data on the first three cohorts by early next year," ISIS says.
Under the FDA's special protocol assessment (SPA) for the Anchor indication of Amarin's ($AMRN) Vascepa treatment, the agency had said that the design of the associated Phase III trial was adequate to support a marketing application to broaden the use of the drug, which lowers triglyceride fat in blood. The study was testing Vascepa in people who take statins to cut cholesterol and have a high risk of coronary heart disease. Vascepa is already used to reduce triglycerides in patients who don't take statins. The FDA is due to decide by December 20 whether to widen the authorization of Vascepa. However, given the latest developments and that an FDA advisory committee overwhelmingly voted against such approval, things are not looking promising.
The CHMP renders a positive opinion on the continued availability of Ariad's ($ARIA) Iclusig for "authorized indications" (various phases of dasatinib or nilotinib-resistant CML, dasatinib-resistant Ph+ ALL, etc.)The EMA has also made a few recommendations regarding how to cut down on the risk of occlusive vascular events. Suggestions include: The drug should not be used by patients with a history of heart attack or stroke, patients' cardiovascular status should be assessed prior to treatment, hypertension should be controlled over the course of Iclusig treatment, and monitoring should be in place to detect vascular occlusion or thromboembolism.
Threshold Pharmaceuticals ($THLD) is out with some early data from a Phase 1/2 study of a TH-302/Avastin combo in recurrent glioblastoma (after failed Avastin). Summary: Thus far, there's been no dose-limiting toxicity; median time to progression, 2.8 months; two PRs; one CR.46% of 14 evaluable patients were still alive without progression after three months.