Embattled AMAG braces for October FDA Makena adcom, but it need not worry — analyst
When the FDA approved AMAG Pharmaceuticals’ female libido drug, Vyleesi, months ago sans an advisory committee despite weak data — controversy ensued. But the Massachusetts-based drugmaker must now contend with the regulatory fallout of another one of its women’s health drugs: Makena.
Makena — which has been on the market for years as a therapy designed to cut the risk of preterm birth in pregnant women — earlier this year failed a post-confirmatory study. Now, the FDA has set up a meeting of independent advisors in October to figure out whether or not to take it off the shelves.
For long the therapy, a man-made version of the hormone progesterone, was used off-label sourced from unregulated concoctions prepared by compounding pharmacies. Eventually, the FDA granted the product accelerated approval in 2011, despite limited clinical data. The manufacturer was acquired by AMAG in 2014. Last year, a prefilled auto-injector version with a thinner, almost invisible, needle (versus the original bulky intramuscular Makena injection) was endorsed by the US regulator.
In March, AMAG $AMAG revealed the therapy had fizzled in the 1,700-patient post-approval PROLONG study — blaming the failure on the fact that 75% of the patients enrolled were not from the United States, suggesting that the difference in demographics had played a role in the setback.
Back when the FDA originally approved Makena, the agency was “presented with a very difficult choice: accept fairly limited clinical data (albeit via sponsorship from the NIH) or continue to allow pregnant women to receive an injection from unregulated sources. The Agency clearly accepted the limited clinical data and granted approval for Makena as we believe (and speculate) that the true goal was to bring the manufacturing under FDA compliance,” Cowen’s Ken Cacciatore wrote in a note.
“For these reasons, we do not believe that the Agency would now relegate clinicians and patients to once again sourcing this critical care product from unapproved manufacturing sources.”
As part of its second-quarter results unveiled in August, AMAG said that generic competition for Makena was eating into sales, that it had faced supply constraints relating to the product, that it had decided to exit the intramuscular Makena market, and that it had terminated an arrangement with Prasco, its authorized generic partner.
Meanwhile, AMAG is battling on other fronts. On Monday, the company put out a statement admonishing the activist hedge fund Caligan Partners, which has been accumulating its shares.
“(L)ast month Caligan initiated what appears to be a rushed, aggressive and misleading scheme to seize near control of your AMAG Board. Now you are essentially being asked by Caligan — as part of a rarely used corporate action called a consent solicitation — to remove and replace four members of the recently-reelected Board as a precursor to risky and ill-informed changes that Caligan wants to make at AMAG,” the company wrote in a letter to shareholders, urging them to disregard Caligan’s campaign.
Last month, the company lowered its full-year financial guidance after exiting the Makena intramuscular market and revising its expectations of ciraparantag development milestone revenue. Now, the drugmaker expects $325 – $355 million in revenue, versus its previous range of $365 – $415 million.
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