Shire Turning to Regenerative Med
On May 18, 2011, Shire shelled out $750 million for Advanced BioHealing, which agreed to sell itself one day after it planned to go public. That acquisition bought Shire Dermagraft, approved to help heal diabetic foot ulcers. It is an artificial skin product consisting of foreskin-derived human fibroblasts grown on a mesh scaffold.
Advanced Tissue Sciences (ATS), Dermagraft’s developer, went out of business in 2002, filing for bankruptcy. Canaan, among other investors, obtained rights to the project and started Advanced BioHealing to commercialize it.
This April 11, Shire made a second acquisition moving it further into the regenerative medicine space. The company reported an agreement to acquire substantially all the assets of Pervasis Therapeutics for its Vascugel product. This endothelial cell-based therapy is being developed to improve the function of arteriovenous (AV) access sites, dialysis access points that connect veins and arteries with tubing. Vascugel has received orphan drug designation from the FDA and EMA.
“About 50 percent of those grafts don’t last the first year,” Xconomy quoted Kevin Raking, former CEO and chairman of Advanced BioHealing and now head of Shire’s Regenerative Medicine, as saying. “But when Pervasis’ cells are wrapped around those access points, it improves healing.”
Advanced BioHealing was a leader in the field of regenerative medicine with its living cell product Dermagraft, Jeff Jonas, M.D., Shire’s svp of R&D, specialty pharmaceuticals and regenerative medicine, pointed out to GEN. The acquisition brought in biomaterials, experience in cell-based manufacturing, and an understanding of the complications of diabetes, he added.
“Shire already had an internal familiarity with the complications of the disease, and we thought we might have some competitive advantage because of our work with Renovo, even though we decided not to move forward with Juvista, so this was a natural fit.
“Pervasis provides a natural evolution of a product line that leverages both our experience with Dermagraft and our manufacturing skill. We already know how to develop a matrix and put cells on it, and now we have another cell-based technology platform that we can leverage to develop additional regenerative medicine therapies.
“Pervasis gives us an opportunity to conduct a clear Phase II clinical trial that will give us a clear go/no-go outcome. This is in line with Shire’s desire to make decisions early on in the clinical development process regarding whether or not to move forward with a technology. These products are also in line with our focus on specialist physicians because each of them will be delivered to patients by physicians in specialty practices.
Shire, however, has experienced some bad luck in moving from pills to proteins, following its other acquisitions of biologics companies. In 2005, Shire acquired Transkaryotic Therapies (TKT), now Shire Human Genetic Therapies, in an all-cash transaction valued at $1.6 billion. At the time, Shire said the acquisition was consistent with its strategy and highly complementary to its business model to develop and market products for specialty pharmaceutical markets.
The deal brought Shire two approved recombinant protein products, an enzyme replacement therapy for Fabry disease called Replagal, and Dynepo, a treatment for anemia in patients with chronic kidney disease.
Shire decided to stop marketing Dynepo, citing “changes in the external environment,” including the launch of several biosimilars at lower prices. And while Replagal was approved in Europe in 2001 and is avalaible in 46 countries, this March Shire decided to pull its BLA in the U.S. Shire commented that “recent interactions with the FDA have led the company to believe that the agency will require additional controlled trials for approval.”