|Healthcare Review: MiMedx Group, Sarepta Therapeutics, Boston Scientific, Prothena, GenVec|
|By Staff and Wire Reports|
|Thursday, 12 December 2013 14:53|
MiMedx Group ($MDXG) charges ahead after its wound care allograft EpiFix receives coverage from Medicare contractor CGS. The move brings coverage from Medicare Administrative Contractors to six of eight, and 86% of Medicare beneficiaries will now be eligible for coverage for EpiFix products.
Sarepta Therapeutics ($SRPT) is sharply higher amid today's Duchenne Policy Forum from Parent Project Muscular Dystrophy (live stream here) where the FDA's Janet Woodcock may have made some comments supportive of eteplirsen's regulatory timelines.
Boston Scientific ($BSX) +3.7% after its Watchman device won the backing of an FDA advisory panel yesterday for use as a treatment to prevent strokes in people with irregular heartbeats. Watchman failed to prevent stokes as well as the standard treatment using the blood-thinner warfarin, but the panel said the similar results between the two didn’t carry as much weight as total long-term data; the panel also heard from patients who praised its convenience compared with the bleeding risks of blood thinners. The market for devices to close the left atrial appendage may total $400M, and Watchman may generate $162M in worldwide sales in 2017, Wells Fargo says.
Prothena ($PRTA) shares jump 5.3% after the company enters a worldwide collaboration deal with Roche to develop and commercialize antibodies targeting alpha-synuclein, including PRX002, Prothena's Parkinson's treatment (expected to enter Phase I trials in 2014).In the U.S., the companies will share all development and commercialization costs, as well as profits, on a 70%-30% basis in favor of Roche. Outside America, Roche will have sole development responsibility and pay Prothena "up to double-digit royalties." Under the agreement, Prothena will receive an upfront payment of $45M, with the company eligible for additional payments of up to $380M contingent on development/sales milestones and up to $175M in ex-U.S. commercial milestone payments.
GenVec ($GNVC) shares spike 23.6% AH after the company discloses the National Institutes of Health's Recombinant DNA Advisory Committee unanimously approved the initiation of a Phase I study of CGF166, an adenoviral vector engineered to express the atonal gene in patients with severe hearing loss. (8-K)CGF166 uses GenVec's adenovectors tech and is being developed by the Novartis Institute for Biomedical Institute under a research collaboration and license agreement with GenVec.