AMAG Pharmaceuticals has signed a licence agreement for US commercial rights to Intrarosa (prasterone).
The locally administered, daily non-oestrogen product Intrarosa is used to treat moderate-to-severe dyspareunia (pain during intercourse), a common symptom of vulvar and vaginal atrophy (VVA) that occurs due to menopause.
Under the agreement, AMAG will receive the right to commercialise and develop Intrarosa in the US to treat VVA and female sexual dysfunction (FSD) and pay $50m to Endoceutics at closing.
AMAG Pharmaceuticals CEO William Heiden said: “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 oestrogen-containing therapies.
“We look forward to introducing this new, differentiated therapy to women and their healthcare providers.”
The transaction represents an expansion into women’s health and serves as a vital step in continuing to execute Amag’s growth strategy.
Earlier this month, AMAG concluded a licence agreement with Palatin Technologies for the exclusive North American rights to develop and commercialise Rekynda (bremelanotide), a potential treatment for hypoactive sexual desire disorder.
With the addition of these two products, AMAG will be in a position to address key needs across the continuum of women’s healthcare.
The company is planning three potential new product launches over the next two years, starting with Intrarosa this year, followed by the Makena subcutaneous auto-injector and Rekynda upon approval.
Intrarosa contains prasterone and does not carry the boxed warnings that are currently included in the labels of conventional oestrogen-containing medications highlighting the risk of certain types of cancers, such as endometrial cancer, as well as cardiovascular disorders and probable dementia.
The product will be co-developed by Endoceutics and AMAG as a potential treatment for FSD in post-menopausal women.
The transaction is subject to customary closing conditions, including US anti-trust approval, and is slated for completion in the first half of this year.