Date: 2017-04-04
Type of information: Licensing agreement
Compound: Intrarosa™ (prasterone)
Company: Amag Pharmaceuticals (USA - MA) Endoceutics (Canada)
Therapeutic area: Women health
Type agreement: licensing
Action mechanism: hormone. Intrarosa™ (prasterone) is a locally administered, daily non-estrogen steroid hormone approved by the FDA for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Prasterone, also known as dehydroepiandrosterone (DHEA), is an inactive endogenous steroid, which is converted locally in the vagina into androgens and estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, pH and pain with intercourse. The mechanism of action is not fully established.
Disease: moderate-to-severe dyspareunia
Details:
- • On April 4, 2017, Amag Pharmaceuticals announced the closing of the licensing agreement with Endoceutics, for the U.S. commercial rights to Intrarosa™ (prasterone). Intrarosa™ was approved in November 2016 and Amag expects to launch Intrarosa™ in the U.S. in mid-2017. Endoceutics and AMAG have also agreed to co-develop the product as a potential treatment for female sexual dysfunction (FSD) in post-menopausal women.
- • On February 14, 2017, Amag Pharmaceuticals and Endoceutics, announced that they have entered into an exclusive license agreement that provides Amag with U.S. commercial rights to Intrarosa™ (prasterone). Intrarosa™ is the only FDA-approved, locally administered, daily, non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA), due to menopause. Unlike conventional pharmacological estrogen-containing medications, Intrarosa™ does not carry a boxed safety warning in its label.
- This transaction represents a further expansion into women’s health and is an important step in continuing to execute Amags growth strategy. Recently, AMAG announced the closing of a license agreement with Palatin Technologies, for the exclusive North American rights to develop and commercialize Rekynda™ (bremelanotide), a potential novel treatment for hypoactive sexual desire disorder.
- The addition of these two products will allow Amag to address key needs across the continuum of women’s healthcare, with three potential new product launches over the next two years, starting with Intrarosa in 2017, followed by the Makena subcutaneous auto-injector and Rekynda, if approved.
- Amag will be expanding its women’s health sales force beyond the current 100-person Makena- and CBR-focused team with approximately 150 additional sales representatives dedicated to the commercialization of Intrarosa. This expanded sales force will allow Amag to call on a larger number of OB/GYNs, as well as provide Amag with future sales force deployment flexibility in women’s health, such as the potential launch of Rekynda in early 2019. AmagG expects to launch Intrarosa in the U.S. in mid-2017.
Financial terms:
- Under the terms of the license agreement, Amag will receive the right to commercialize and develop Intrarosa in the U.S. for the treatment of vaginal atrophy and female sexual dysfunction. At closing, Amag will pay Endoceutics $50 million of total upfront consideration and issue Endoceutics 600,000 unregistered shares of Amag common stock.
- In addition, Amag will pay Endoceutics up to $10 million upon delivery of adequate launch quantities of Intrarosa™ and $10 million upon the first anniversary of the effective date of the agreement. Endoceutics will be entitled to certain sales milestone payments, including a first sales milestone payment of $15 million, which would be triggered when Intrarosa™ annual net U.S. sales exceed $150 million, and a second milestone payment of $30 million, which would be triggered when annual net U.S. sales exceed $300 million. Should annual net U.S. sales exceed $500 million, there are additional sales milestone payments of up to $850 million, which would be triggered at various sales thresholds.
- Amag will also pay Endoceutics tiered royalties as a percent of Intrarosa™ net sales ranging from the mid-teens (for calendar year net sales up to $150 million) to the mid-twenties (for any calendar year net sales that exceed $1 billion).
- At closing, Amag and Endoceutics will also enter into a supply agreement, under which Endoceutics will supply Intrarosa™ to Amag.
- Amag has also committed to co-fund a Phase 3 clinical program, which would be conducted by Endoceutics to support regulatory approval of Intrarosa™ for the treatment of certain types of FSD in post-menopausal women. The direct costs of the potential FSD label expansion study will be shared equally by the parties and capped at up to $20 million for Amag. The transaction does not include the transfer of any Endoceutics employees or facilities.
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