Cipla Limited announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) designation. Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL.

AMAG Pharmaceuticals, Inc announced it has completed the sale of its rights to Intrarosa (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in womens health and menopause-related conditions, for up to USD 125 million, including upfront fixed consideration of USD 20 million and contingent, sales-based milestone payments of up to USD105 million.

"As mentioned in our first quarter earnings release, the sale of Intrarosa is an important step in our strategic evolution,” said Scott Myers AMAG’s president and chief executive officer. “We were impressed with Millicent’s commercial capabilities and dedication to women’s healthcare and we are pleased to transition this important therapy into their portfolio. We remain focused on maximizing Feraheme’s value, maintaining patient access to Makena and developing innovative therapies, while managing expenses to help further our goal of achieving profitability in 2020.”

In addition to the upfront consideration of USD 20 million, AMAG will be entitled to certain sales milestone payments, which include USD 25 million the first time Intrarosa net sales exceed USD 65 million during any consecutive 12-month period, a second sales milestone payment of USD 35 million the first time Intrarosa net sales exceed USD 115 million during any consecutive 12-month period, and a third milestone payment of USD 45 million the first time Intrarosa net sales exceed SUD 175 million during any consecutive 12-month period.

The sale of Intrarosa is consistent with AMAG’s previously announced strategic decision to divest its women’s health assets. AMAG has agreed to provide certain transitional services to Millicent Pharma for a limited period of time while Intrarosa is operationally separated from AMAG. AMAG remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.


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