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Expert Financial Analysis and Reporting

AMAG Pharmaceuticals: AdCom Votes 9 to 7 to Remove Makena from the Market, but I Don’t Think It Will Happen:  AMAG (AMAG, $9.80), Antares Pharma (ATRS, $3.40, Buy)

The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs on the panel voted to keep Makenna on the market and to do additional studies to properly define its role in the management of women with singleton pregnancies who previously have had a preterm birth. I wrote on October 29 that I thought there was only a 5% chance of Makena being removed from the market. This vote was a bit surprising to me as Makena (active ingredient 17-P) has demonstrated a very positive effect in the MEIS trial. On the endpoint of preventing preterm birth in women with singleton pregnancies the p value was very positive at p=0.0003. The PROLONG trial was done in a population at much less risk than MEIS and I think this was why it failed to confirm MEIS.

Opinion leaders believe that 17-P is an effective drug as it is included in the treatment guidelines for high risk patients by both the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. Their recommendations are driven by clinical experience as well as results from the MEIS trial. Importantly, there is no safety issue with the drug.

There is no alternative to 17-P in this condition and the product is safe. I think that as in the AdCom meeting, the great majority of OB/GYNs believe that the drug is effective. Practicing OB/GYNS have known about the PROLONG results for nearly nine months and it does not seem to have much effected usage of the drug. I doubt that the AdCom meeting in which members who do not actively practice medicine believed the drug should be removed from the market while those who practiced medicine believed that it should not be removed will alter the consensus professional opinion.

The FDA is not required to follow the advice of the AdCom meeting and I believe that key opinion leaders will likely advise FDA that Makena (17-HP) should remain on the market. I think that the FDA in the end will keep Makena on the market. If so, the FDA will have to decide on how to put the results of the PROLONG trial in the label and whether and how to conduct further studies. Bottom line, in spite of the AdCom vote, I believe that Makena will remain on the market and that usage will not be that much affected.

Of course, this decision will probably cause many (most) investors to disagree with me and act on the belief that Makena will be removed from the market. It may take a few weeks or months for the FDA to formally speak and to determine who is right.






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