February 16, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WALTHAM, Mass. –After securing exclusive U.S. marketing rights for Intrarosa, a drug that treats moderate-to-severe dyspareunia from Canadian pharmaceutical company Endoceutics, AMAG Pharmaceuticals said it intends to hire 150 sales representatives to support marketing efforts.
AMAG made the announcement on Feb. 14 during a conference call with investors, shortly after releasing a statement it had acquired the U.S. right to the drug. Intrarosa is a non-estrogen treatment for dyspareunia patients, which is a common symptom of vulvar and vaginal atrophy due to menopause. One of the advantages Intrarosa has over rival products, AMAG said, is it does not carry a boxed warning from the U.S. Food and Drug Administration (FDA). 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, according to information provided by the company.
The expanded sales force will increase the number of calls AMAG can make on women’s healthcare providers and also provide a strong sales force for other products, including the newly acquired Rekynda, which the company anticipates being commercially available in 2019.
Bill Heiden, AMAG’s chief executive officer, said Intrarosa “adds a large near-term commercial opportunity” to the company’s portfolio that is expected to generate a “durable revenue stream” since the drug’s patents extend to 2031. According to transcripts of the call posted on Seeking Alpha, Heiden said AMAG anticipates launching its Intrarosa efforts in mid-2017. During the call, Heiden said there are approximately 64 million women in the United States who are postmenopausal. About half of those women suffer from vulvar and vaginal atrophy. Of those approximately 32 million women, 10 percent are treated with a prescription drug and about 60 percent do not receive any treatment. He said the reason so many women do not seek treatment is due to the safety concerns about estrogen therapy.”
“Postmenopausal VVA is the common and under-treated—under-reported condition that’s caused by decreased sex steroid levels,” Julie Krop, AMAG’s chief medical officer, said according to the transcripts of the call.
Krop said despite many over-the-counter treatment, many women do not want to talk to their doctors about the issue, or are afraid of the safety concerns associated with estrogen therapy.
Nik Grund, AMAG’s chief commercial officer, said the market for treating dyspareunia is largely untapped, according to the transcripts. AMAG plans to initially target patients already receiving estrogen therapy for vulvar and vaginal atrophy, which the company estimates could generate about $1 billion. Following that initial market target, Grund said the company will begin attempting to appeal to women using over-the-counter products and those women afraid of safety warnings on current products used to treat postmenopausal VVA.
Under terms of the deal with Endoceutics, AMAG provided $50 million in upfront payments and 600,000 unregistered shares of AMAG common stock. Factoring in milestone payments and other payments, the Canadian company could earn about $1 billion off the deal.
Shares of AMAG closed at $23.35 on Wednesday, one day after the deal with Endoceutics was announced.
In addition to the new revenue stream Intrarosa is expected to provide, earlier this month AMAG completed securing the U.S. rights to develop and commercialize Rekynda from Palatin Technologies, Inc. Rekynda is used to treat hypoactive sexual desire disorder in pre-menopausal women. Rekynda has currently undergone two Phase III trials and the company anticipates filing a New Drug Application in 2018.
