Tracy Staton reporting for FiercePharma.com writes as follows.
The company plans to tout Intrarosa’s safety profile to set it apart from established estrogen-based treatments such as Pfizer’s Premarin cream and Estring vaginal ring. The AMAG drug, which contains the hormone precursor prasterone, has a “similar efficacy profile,” CMO Julie Krop said this week. “[F]rom an efficacy standpoint, I don’t see that there is particularly differentiating advantage,” Krop said. “It’s really on the safety side”.
The company clearly sees big potential for Intrarosa. AMAG will pay Endoceutics $50 million up front, plus 600,000 shares of newly issued common stock, which closed Tuesday at $22.65. Follow-up sales milestones add up to $45 million if Intrarosa surpasses $300 million in sales over time.
AMAG says it’s adding those 150 reps to its current team of 100, who now focus on its preterm labor drug Makena and cord blood registry (CBR). For now, the new salespeople will exclusively handle Intrarosa, a non-estrogen treatment for vaginal pain during intercourse, which often affects post-menopausal women”.
NASDAQ, in its press release on the licensing and introduction of Intrarosa states:
Unlike conventional pharmacological estrogen-containing medications, Intrarosa does not carry a boxed safety warning in its label.
Intrarosa enters an existing billion dollar-plus market for intravaginal prescription therapies that treat VVA symptoms. There are an estimated 64 million post-menopausal women in the U.S., and as many as 32 million women suffer from VVA symptoms.
VVA, or vulvar and vaginal atrophy, causes pain during intercourse (dyspareunia), a common symptom of menopause”.
Jane Allin, horse advocate and expert on drugs made with pregnant mare’s urine such as Premarin® cream which is also prescribed for dyspareunia, states:
“This drug is a steroid — prasterone — of which estrogen is a metabolite so carries with it the same risks as other estrogen substitutes for Premarin® (i.e. the use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer).
“So basically it’s just another form of estrogen that isn’t derived from horse pee. Safer but still has risks associated with estrogen.
“It would be nice if the pharmaceutical companies could come up with something that isn’t a steroid/estrogen. But that’s all they seem to know — and because it’s easy”.
Is this good news for the mares and foals used and cast off by the Premarin® industry?
“Intrarosa may cut into Pfizer’s Premarin® vaginal cream profits some but I doubt it will ever be enough that Pfizer would discontinue its sale”, states Vivian Farrell of The Horse Fund, “which is the only way the success of this new drug could help the horses used by the Premarin® industry in N. America.
“The popularity of Intrarosa may spare a few mares and foals along the way but it doesn’t appear it will spare women from the potential risk of breast cancer”.
“Where the largest threat to horses used and cast off by the PMU drug industry in terms of numbers is of course China where the copycat Premarin® cream they are manufacturing themselves is being marketed to untold millions of women”.
• “AMAG to hire 150 new sales reps to tout newly licensed women’s health med Intrarosa”, by Tracy Staton, FiercePharma.com, Feb 15, 2017.
• “FDA approves Intrarosa for postmenopausal women experiencing pain during sex”, FDA News Release, Nov 17, 2016.
• FDA.gov Intrarosa label (pdf, 1p).
• Premarin Horses Year in Review 2016, The Horse Fund, Tuesday’s Horse »