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AMAG and Endoceutics Enter Into an Exclusive U.S. License Agreement for Intrarosa  (Prasterone)

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AMAG Pharmaceuticals, Inc. and Endoceutics, Inc. 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.

“AMAG is pleased to add another product to its expanding women’s health portfolio and to work with Endoceutics founder Dr. Fernand Labrie, a world-renowned endocrinologist who led the development of this innovative treatment approach,” said William Heiden, chief executive officer of AMAG. “Intrarosa will address a compelling unmet medical need for post-menopausal women suffering today from moderate-to-severe dyspareunia who are interested in alternatives to their current treatment or most of whom choose to go untreated due to safety concerns about conventional synthetic estrogen-containing therapies. We look forward to introducing this new, differentiated therapy to women and their healthcare providers.”

The transaction represents a further expansion into women’s health and is an important step in continuing to execute AMAG’s growth strategy. Earlier this month, AMAG announced the closing of a license agreement with Palatin Technologies, Inc., for the exclusive North American rights to develop and commercialize Rekynda™ (bremelanotide), a potential novel treatment for hypoactive sexual desire disorder, the most common form of female sexual dysfunction (FSD). 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.

Intrarosa enters an existing billion dollar-plus market for intravaginal prescription therapies that treat VVA symptoms. There are an estimated 64 million post-menopausal women in the U.S., and as many as 32 million women suffer from VVA symptoms.1 Studies suggest that between 44 percent and 78 percent of women with VVA suffer from dyspareunia.2,3 According to patient survey data, more than half of women who report symptoms of dyspareunia are not currently being treated with a prescription therapy or seeking treatment.4

Intrarosa contains prasterone, a precursor of hormones that is converted locally inside the vaginal cells into androgens and estrogens with no meaningful increases detected in the blood. Intrarosa does not carry the boxed warnings currently included in the labels of conventional estrogen-containing medications which highlight the increased risk of certain types of cancers, such as endometrial cancer, as well as cardiovascular disorders and probable dementia. While Intrarosa is currently approved for the treatment of moderate-to-severe dyspareunia, Endoceutics and AMAG have agreed to co-develop the product as a potential treatment for FSD in post-menopausal women.

“As a non-estrogen containing treatment, Intrarosa is a novel vaginal prescription therapy that provides an important alternative for patients with moderate-to-severe dyspareunia, a common symptom of post-menopausal VVA,” said Dr. Fernand Labrie, founder and chief executive officer of Endoceutics. “Intrarosa stimulates the body’s natural ability to produce hormones locally and thus significantly reduces pain during intercourse. Because Intrarosa does not contain estrogen, patients may feel more comfortable seeking treatment than with synthetic traditional estrogen-containing hormone therapies.”

“Endoceutics is committed to ensuring that Intrarosa becomes the standard of care for the treatment of VVA. In addition to AMAG’s investments in the success of Intrarosa, Endoceutics plans to put an additional $20 million toward supporting educational programs in 2017,” Dr. Labrie continued.

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. AMAG expects to launch Intrarosa in the U.S. in mid-2017.

“Three Orange Book-listed patents with terms out to 2031, a sizeable untapped market and overlap with our current physician call points make Intrarosa an excellent strategic opportunity for AMAG that will help drive growth and sustained shareholder value,” said Frank Thomas, president and chief operating officer of AMAG. “The additions of FDA-approved Intrarosa and recently licensed Rekynda will meaningfully add to our expanding women’s health portfolio. AMAG’s strong cash position, combined with the cash-generating potential of our current businesses, puts us in an excellent position to continue to pursue additional acquisition and licensing opportunities.”

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.

The license transaction is expected to close in the first half of 2017 and is subject to customary closing conditions, including U.S. antitrust approval.

About Intrarosa™ (Prasterone)
Intrarosa is the only FDA-approved, locally administered, daily non-estrogen steroid for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa contains prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone is an inactive endogenous steroid, which is converted locally into androgens and estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, and pH. The mechanism of action is not fully established.

In two primary 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in dyspareunia, as well as significant improvements in the percentage of vaginal superficial cells and parabasal cells, as well as vaginal pH. In clinical trials, the most common adverse reactions were vaginal discharge and abnormal pap smear. Intrarosa has not been studied in women with a history of breast cancer.

About AMAG
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com

About Endoceutics
Endoceutics is a private pharmaceutical company operating in the field of women’s health and hormone-sensitive cancer prevention and treatment. Endoceutics research focuses on developing non estrogen-based therapies for vulvar and vaginal atrophy, sexual dysfunction and the other symptoms of menopause, including hot flashes, osteoporosis, muscle loss and type 2 diabetes. Hormonal therapies for breast, uterine and prostate cancer, male hypogonadism as well as endometriosis are also under development.

Endoceutics has five Phase 3 product candidates addressing large market opportunities and two Phase 1/2 product candidates. Endoceutics has exclusive worldwide rights to patents, patent applications, technology and know-how related to all its products.

1 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30.
2 Ibid.
3 F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study.
4 Multiple publications based on patient surveys.

CONTACT:

Investors:
Linda Lennox
Vice President, Investor Relations
908-627-3424

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Katie Payne
Vice President, External Affairs
202-669-6786

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