The deal adds to the regenerative medicine portfolio Shire started with its May 2011 buyout of Advanced BioHealing. Shire, based in Dublin and Lexington, Mass., shelled out $750 million for the company and its DermaGraft skin substitute for diabetic foot ulcers, becoming one of the first large biopharms to get into the regenerative medicine game.
But the much-ballyhooed transformative value of the Advanced BioHealing buyout took a hit when Shire abandoned its pursuit of a leg ulcer indication for DermaGraft shortly after closing the acquisition. That decision was prompted by the failure of a Phase III clinical trial examining DermaGraft in treating venous leg ulcers failed to meet its primary endpoint of complete healing after 16 weeks.
Shire said it plans to focus on a Phase II trial of Pervasive’s Vascugel for arteriovenous access for hemodialysis patients.
"There are currently no approved therapies that directly target the underlying physiological processes associated with the creation of AV access sites in hemodialysis patients, including inflammation, thrombosis, and restenosis. As a result, there remains a significant unmet need for technologies that improve hemodialysis access for patients with ESRD," Kevin Rakin, president of Shire’s regenerative medicine division, said in prepared remarks. We believe Vascugel has the potential to enhance the rate of blood vessel repair while also providing for increased maintenance of the access site for a prolonged period of time as compared to current treatments. This acquisition marks a very important step for Shire in building a Regenerative Medicine business focused on tissue repair and regeneration."
Orthopedic bellwether Biomet’s Q3 results signal sector growth
Orthopedic device maker Biomet Inc.‘s 3rd-quarter results could be a bellwether of better things to come for the larger orthopedics sector, according to Leerink Swann analysts Richard Newitter and Rick Wise.
"All else equal, we’re inclined to think ortho stocks (Zimmer (NYSE:ZMH), Stryker (NYSE:SYK), NuVasive Inc.(NSDQ:NUVA), Wright Medical (NSDQ:WMGI)) will react positively to the y/y growth acceleration Biomet posted in its U.S. recon division. We note that Biomet (and the rest of the hip/knee industry) is up against easier y/y U.S. recon growth comparisons this quarter, especially in knees, which likely contributed – at least to some extent – to the growth pick-up this quarter," the analysts wrote in a note to investors earlier this week. "Overall, Biomet’s hip performance seems to suggest basically stable hip market growth trends this quarter. U.S. spine growth accelerated for the 3rd quarter in a row, which may suggest key industry pressures (e.g., insurer pushback and ASP declines) are at least not getting worse, which could have positive implications for NUVA. Biomet’s extremities division continues to chug along at a double-digit clip and points to a still strong growth environment for this ortho category. Read more
McKesson beats out rivals for $32B VA deal
McKesson (NYSE:MCK) won out over rivals Cardinal Health (NYSE:CAH) and Amerisource Bergen (NYSE:ABC) for a U.S. Dept. of Veterans Affairs drug distribution contract worth $32 billion over 8 years. Read more
Insulet expands OUS distribution deal
Insulet (NSDQ:PODD) enlarged its 5-year, $100 million distribution deal with Ypsomed (FRA:OWX), making the Swiss firm its exclusive distributor in 22 countries in Europe, the Middle East, and Asia and adding at least a year to the agreement. Read more
Revolutions Medical inks Korean distribution deal
Revolutions Medical (PINK:RMCP) inked a marketing and distribution agreement with Sungwon Medical Co. Ltd. to distribute its RevVac auto-retractable vacuum safety syringe. Read more