Pharmaceutical

AMAG Pharmaceuticals (NASDAQ:AMAG) closed a licensing agreement with Endoceutics for the US commercial rights to Intrarosa, (prasterone).

AMAG Pharmaceuticals (NASDAQ:AMAG) closed a licensing agreement with Endoceutics for the US commercial rights to Intrarosa, (prasterone).
As quoted in the press release:

Intrarosa is the only FDA-approved, locally administered, non-estrogen steroid hormone for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA), due to menopause. Unlike all other FDA-approved medications for the treatment of VVA symptoms, Intrarosa does not carry a boxed safety warning in its label. The agreement was announced on February 14, 2017, and its closing broadens AMAG’s presence in women’s health.
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 will address an important unmet need as a novel treatment for moderate-to-severe dyspareunia due to menopause and it represents a significant commercial opportunity,” said William Heiden, chief executive officer of AMAG. “We believe Intrarosa will offer an attractive alternative for the approximately 20 million post-menopausal women who suffer from dyspareunia, including those who are currently on estrogen-based therapy for this common symptom of vulvar and vaginal atrophy and those women who are not being treated due to the safety concerns of existing treatment options.”
Intrarosa contains prasterone, an inactive steroid hormone that is converted locally inside the vaginal cells into androgens and estrogens. This intracellular production does not result in clinically meaningful increases in blood concentrations. The Intrarosa label 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. The most common adverse reactions are vaginal discharge and abnormal Pap smears, predominantly composed of atypical cells of undetermined significance (ASCUS). Intrarosa has not been studied in women with a history of breast cancer.
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.
About IntrarosaTM (Prasterone)
Intrarosa is the only 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. 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.
In two primary 12-week placebo-controlled efficacy trials, women taking Intrarosa experienced a significant reduction in symptoms of 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 smears, predominantly composed of atypical cells of undetermined significance (ASCUS). 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 and maternal 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.

Click here to read the full press release.

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