AMAG Pharmaceuticals has big ambitions for its women’s health business, so it’s snapped up the rights to a new med, Intrarosa, to beef up that portfolio. And it’s bringing on 150 new reps to detail the med.
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.
Initially, the company's payer-focused marketers and Makena reps will start prepping the ground for launch. Meanwhile, AMAG is working with a recruiting firm to bring on the new reps. "We're actively working with them to make sure that we're getting sales reps in place prior to launch," said Nik Grund, the company's chief commercial officer, during the company's earnings call this week.
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.
And if sales grow past $500 million—a big target in a market now worth about $1 billion—additional milestones could add up to a whopping $850 million. The deal also includes tiered royalties and a supply arrangement, and Endoceutics will net up to $10 million for up-front launch supplies.
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 on the company’s fourth-quarter earnings call 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.”
Competing with those heavily marketed products is one reason AMAG needs to more than double the size of its sales team, Grund said during the call. "This is a competitive marketplace," he said. "There are other folks out there who have sales forces, and making sure that we're getting the appropriate share of voice across all the targets is going to be important."
As AMAG pointed out in a statement about the licensing deal, Intrarosa lacks the black-box warnings of cancer and cardiovascular risks that estrogen-based drugs carry. The company plans to detail OB/GYNs as well as some "hybrid" primary care doctors.
Intrarosa joins AMAG’s biggest earning drug, Makena, which brought in $334 million in 2016 sales. The drug has a storied history; it became notorious in 2011 when its then-owner, KV Pharmaceuticals, nabbed brand exclusivity for the long-available hormonal injection through an FDA program that encourages study of old drugs that had never gone through the agency’s approval process. KV slapped a $1,500-per-injection price on the product, which had been available for about $15 each. After some wrangling, the company agreed to cut its price to $595, and then ended up in bankruptcy after allegedly mismanaging the launch.
AMAG bought the company out of bankruptcy and since has worked on developing follow-up products, including one in its current pipeline, a subcutaneous auto-injector version that it hopes to launch in the fourth quarter of this year. The company also inked a deal to co-develop Rekynda, a Palatin Technologies product for hypoactive sexual desire.
The newly enlarged sales force will give AMAG “flexibility” as its portfolio expands, Grund said during the call, including preparing for the potential launch of Rekynda.
(Photo by Alachua County via Flickr: Link)