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AMAG Pharmaceuticals Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Frank E. Thomas, president and CEO of AMAG, commented on the upcoming FDA decision regarding Makena. He stated, "Right. So, I really don’t see a scenario where it doesn’t get approved. There is always -- this is the FDA, so it’s supposed there is always potential for delay, but I feel pretty good about where we are. We answered all of the FDA’s questions very completely, confirmed that the data they received was the data they were looking for. So, I feel I think as good as one can feel. But, so, I just don’t envision the scenario where it’s not approved.

In terms of the timing and launch, I think those are swing factors and our guidance tries to capture a range of potential scenarios that are going in assumption right now is that the product will be approved next month, or before and that we’ll be launching in Q2. Our sales force, our newly expanded sales force of over 100 reps is selling what they have today. And so, our sales reps today are focused on encouraging new physicians who are currently not prescribing Makena or who potentially utilizing compounded product, to move to Makena. We are working with insurers to encourage them to discourage the use of compounded product where Makena is appropriate. And so, our sales reps are continuing today to sell the products that they have and grow the products, not the product that we have in hand which is the multi-dose vial. And so, we will continue to sell that until we have approval and launch the single-dose preservative-free."
Source: Q4 2015 earnings conference call, 2/17/16

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AMAG Pharmaceuticals Responds to Recent Complete Response Letter From the FDA for the Single-Dose, Preservative-Free Vial of Makena(R)
WALTHAM, Mass., Nov. 23, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that it responded to the U.S. Food and Drug Administration (FDA), providing the information and data requested in the Complete Response Letter (CRL) received by the company on November 18, 2015. The CRL relates to the company's application seeking approval for a new single-dose, preservative-free vial of Makena (hydroxyprogesterone caproate injection).

"We are pleased that we were able to quickly provide a response to the FDA that we believe addresses the requests for additional information and data outlined in the CRL," stated Julie Krop, M.D., chief medical officer and senior vice president of clinical development and regulatory affairs at AMAG. "Based on interaction with the FDA since receiving the CRL, we believe that the review may be completed more expeditiously than the standard four-month review target as outlined in the most recent FDA PDUFA Performance Goals document. We look forward to working with the FDA to gain approval and bring the single-dose, preservative-free vial of Makena to market."

Makena, the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past, is currently marketed in a multi-dose vial, containing five weekly injections. The multi-dose Makena vial remains available for prescribing and is not affected by the letter from the FDA regarding the single-dose application.
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Source: press release, 11/23/15. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=211...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Makena (hydroxyprogesterone caproate injection)Obstetrics and GynecologyPregnancy (Preterm risk)HormoneUnknown

Mechanism of action: Makena (hydroxyprogesterone caproate injection) is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-03-23

Results:

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AMAG Pharmaceuticals Announces FDA Approval of New Single-Dose, Preservative-Free Makena® (hydroxyprogesterone caproate injection)
Company Plans for Full Commercial Launch of Makena Line Extension in Second Quarter of 2016
WALTHAM, Mass., Feb. 23, 2016 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s single-dose, preservative-free formulation of Makena® (hydroxyprogesterone caproate injection). Makena is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past.

The single-dose formulation is an expansion of the Makena product line. Packaged in trays of four (a month’s supply), the single-dose formulation provides an alternative package size to the current multi-dose vial, which contains five weekly injections. AMAG currently expects to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of 2016.

“We are pleased to receive FDA approval of single-dose, preservative-free Makena. This new prescribing option underscores our company’s commitment to listening and responding to requests from healthcare providers and patients,” said William Heiden, chief executive officer of AMAG. “We believe the single-dose formulation is an important first step in our next generation development program for Makena and further demonstrates the company’s dedication to improving the quality of care for women at risk of preterm birth.”

The new single-dose formulation:

Provides the convenience of a single-use vial for once-weekly dosing, without the need for storage of a multi-dose vial;
Allows pharmacists to dispense a month’s supply of single-dose Makena vials or to dispense individual single-dose vials for women who are nearing the end of their course of therapy; and
Offers an FDA-approved, preservative-free version of Makena for patients and healthcare providers who prefer this option.
“We are pleased FDA approved the single-dose, preservative-free formulation of Makena, as it offers a convenient option for healthcare providers to treat women who are at high risk of recurrent preterm birth in accordance with clinical guidelines,” stated Dan O’Keeffe, M.D., executive vice president, Society for Maternal-Fetal Medicine.
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Source: press release, 2/23/16. http://ir.amagpharma.com/phoenix.zhtml?c=61596&p=irol-newsArticle&ID=214...

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