Elan's plans for its post-Tysabri existence are up in the air. Privately held Royalty Pharma, which typically buys intellectual property rights, such as those for Amgen's Neupogen and Boehringer Ingelheim's Tradjenta, is looking to enter the manufacturing side of the business with its $6.5 billion proposal to buy up Élan. The announcement follows weeks of rejiggering at Ireland-based Élan, which announced February 6 that it sold off its 50% ownership in the MS drug Tysabri for $3.25 billion to Biogen Idec. This was preceded by its fourth-quarter announcement that it was walking away from biopharma Alkermes. Élan has not said if it will accept Royalty's offer, but said in a statement Monday that “any credible proposal which may be made . . . will of course be considered by the Company,” along with its previously announced plans for the $3.25 billion payout, which included share buybacks and investments, among other moves. The transaction would give Royalty Pharma ownership of a pipeline focus that includes Alzheimer's, Parkinson's, MS and Crohn's disease treatments, adding greater depth and breadth to its current portfolio. Although Royalty is known for its pursuit of royalty streams, this is not the first time that it's looked for ownership rights. The company purchased biotech Cypress for $255 million three years ago.
Omontys, the anemia drug the Independent Dialysis Foundation told the New York Times
was going to end the Amgen monopoly, has hit a wall. Takeda and Affymax are recalling the drug after several patient deaths and severe allergic reactions, almost a year after landing regulatory approval. The recall comes just over a month after a distribution deal with DSI renal, which FiercePharma reported
serves almost 7,000 patients a year. Kidney disease is a common side effect of anemia. The DSI deal was in addition to the July agreement with Fresenius. In addition to having significant implications for Affymax, which has 130 employees as of December 2011 and went public just six years ago, former FDA deputy commissioner Scott Gottlieb noted in Forbes
that the fallout could affect the FDA's approach to biosimilars vetting. Gottlieb wrote that the problem surfaced with an agent the FDA is familiar with and yet the “inability to ferret out the risks with Omontys is likely to underscore how hard this science remains.” He added that FDA has already been cautious about biosimilars and the latest events will likely increase concern and cause the agency to “take a harder view that the safety of biosimilars needs to be even more firmly established before approval.” The FDA's 2012 approval letter required the post-marketing analysis and REMS that covered a combination of cardiovascular, stroke and mortality risks. Neither DSI or Fresenius could comment in time on the recall's impact on their businesses. ISI analyst Mark Schoenebaum pointed out in his Monday research note that Omontys was not a biosimliar, but a unique branded product, which means its regulatory review cannot be compared to that of a biosimilar. However, he, like other analysts MM&M
spoke to about lookalike drugs, noted that it will take time for biosimilars to gain traction, and the built-in hesitation about the category could mean Big Pharma producers could end up dominating the lookalike market.