AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) and Palatin Technologies, Inc. (NYSEMKT:PTN) have signed an agreement which will see the two firms share rights for the development and commercialization of Rekynda in North America. Rekynda is a product made with the purpose of treating a sexual disorder in pre-menopausal women known as hypoactive sexual desire disorder. Two Phase III trials of the drug have already been completed and by next year, it will be in the hands of the Food and Drug Administration.
The deal will see AMAG fork out $60 million to Palatin in advance. AMAG will also pay an extra $380 million if particular milestones on the regulatory and sales sides are met. Also, Palatin will be reimbursed about $25 million by AMAG pharmaceuticals to cater for development expenses.
If all goes according to plan, Rekynda’s new drug application filing will be filed in 2018. It is also anticipated that the drug could be approved and launched a year after the filing.
“AMAG is excited to expand its women’s health portfolio with a product that could address a compelling medical problem that currently is under-addressed,” said AMAG Pharmaceutical’s chief executive officer, William Heiden.
Hypoactive Sexual Desire Disorder
The disorder that the drug aims to treat, HSDD, is one of the most common of sexual dysfunctions in females globally. It is marked by low sexual desire which leads to interpersonal difficulties and personal distress. In the United States, the disorder affects about 15 million women of which about a third of these are yet to hit menopause.
Currently, there is already a product in the market to treat this condition but there exists low patient awareness and understanding with just a scant number of women seeking treatment for the disorder. A study conducted indicated that approximately 95% of the HSDD sufferers were unaware that the condition was treatable. A majority showed a willingness to try a drug like Rekynda if their doctor so recommended.
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) fell by 35.57% to close the day at $23.00 a share on Monday.