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AMAG (AMAG) Launches Intrarosa (Prasterone) In The U.S. – A Novel Product To Treat Moderate To Severe Dyspareunia Due To Menopause



7/24/2017 10:17:14 AM

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Intrarosa addresses an unmet need for women with moderate to severe dyspareunia, a common symptom of vulvar and vaginal atrophy, due to menopause

Launch includes best-in-class copay savings program to help ensure swift and affordable access to Intrarosa for millions of women

WALTHAM, Mass., July 24, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced the commercial availability of Intrarosa™ (prasterone) at pharmacies nationwide, supported by a newly created 137-person women’s health sales force. Intrarosa is the first and only FDA-approved, local non-estrogen product 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, an inactive precursor that is converted locally into estrogens and androgens with minimal systemic exposure.1,2 Intrarosa does not carry a boxed warning in its label and has no restrictions on duration of use.

Nearly 32 million women (approximately half of all post-menopausal women in the United States) suffer from symptoms of VVA.3 Of those women, between 44 percent and 78 percent report symptoms of dyspareunia (pain during intercourse).4,5 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.6,7

“Intrarosa addresses an important unmet medical need for the millions of women suffering from moderate to severe dyspareunia, many of whom are dissatisfied with their current treatment or are untreated due either to lack of awareness of the condition or safety concerns with current treatment options,”8 said Nik Grund, executive vice president and chief commercial officer at AMAG. “Ensuring the immediate accessibility and affordability of Intrarosa for patients who have been prescribed the therapy is a top priority for us at AMAG. Today we are also launching a comprehensive commercial copay savings program to help ensure that patients can gain immediate access to this novel therapy.”

Through the Intrarosa Copay Savings Program, qualified commercially insured patients will receive their first prescription with a $0 copay and will pay no more than a $25 copay for each refill for the duration of the program.

“The launch of Intrarosa demonstrates the rapid progress we are making in executing our corporate strategy to expand AMAG’s product portfolio with the development and commercialization of products with significant, long-term growth potential. Intrarosa extends our commitment to innovation in women’s healthcare and provides us with a unique opportunity to impact the lives of millions of women,” said William Heiden, president and chief executive officer at AMAG.

About IntrarosaTM (prasterone)
Intrarosa is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa contains prasterone, also known as dehydroepiandrosterone (DHEA). Prasterone 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.

Intrarosa is contraindicated in women with undiagnosed abnormal genital bleeding. Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. Intrarosa has not been studied in women with a history of breast cancer.

In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence = 2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence = 2 percent were vaginal discharge and abnormal Pap smear.

Please see full Prescribing Information available at INTRAROSA.com

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 maternal and 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.

Forward-Looking Statements

This press release contains forward-looking information about AMAG Pharmaceuticals, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, the belief that our copay savings program is best-in-class; the belief the prasterone is converted to androgens and estrogens locally with minimal systemic exposure; beliefs regarding Intrarosa’s market opportunity and the ability of Intrarosa to address an important unmet medical need, including for women who are dissatisfied with their current treatment or are untreated due to lack of awareness of the condition or safety concerns; AMAG’s ability to ensure immediate accessibility and affordability of Intrarosa for patients who have been prescribed the therapy; the ability of AMAG’s commercial copay savings program to ensure that patients can gain immediate access to Intrarosa; beliefs that Intrarosa is a novel therapy; AMAG’s ability to expand its product portfolio with the development and commercialization of products with significant, long-term growth potential; the ability of Intrarosa to impact the lives of millions of women; and beliefs that newborn stem cells have the potential to play a valuable role in the development of regenerative medicine are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Such risks and uncertainties include, among others, those risks identified in AMAG’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2016, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and subsequent filings with the SEC. Any such risks and uncertainties could materially and adversely affect AMAG’s results of operations, its profitability and its cash flows, which would, in turn, have a significant and adverse impact on AMAG’s stock price. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

AMAG Pharmaceuticals® is a registered trademark of AMAG Pharmaceuticals, Inc. CBR® is a registered trademark of Cbr Systems, Inc. IntrarosaTM is a trademark of Endoceutics, Inc.

___________________________________
1 Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2017.
2 The mechanism of action is not fully established.
3 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 23–30.
4 Ibid.
5 F. Palma et al: Vaginal atrophy of women in postmenopause. Results from a multicentric observational study: The AGATA study.
6 Wysocki et al. Management of Vaginal Atrophy: Implications from the REVIVE Survey. Clinical Medicine Insights: Reproductive Health 2014:8 25.
7 Multiple publications based on patient surveys.
8 Kingsberg et al. Vulvar and Vaginal Atrophy in Postmenopausal Women: Findings from the REVIVE (REal Women's Views of Treatment Options for Menopausal Vaginal ChangEs) Survey. J Sex Med 2013; 10: 1795.

CONTACT: Investors: Linda Lennox Vice President, Investor Relations O: 617-498-2846 M: 908-627-3424 Media: Rushmie Nofsinger Executive Director, External Affairs rnofsinger@amagpharma.com

Read at BioSpace.com


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