Under the terms of their deal, Valeant would pay cash for Sprout’s product through a $500 million installment upfront and a second next year.
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The cost for the daily bedtime drug is expected to be similar to Viagra – up to about US$400 per month – assuming it can win the same insurance coverage.
An analysis commissioned by Forbes found that so far this year the FDA has rejected only three new molecular entities, which are drugs that have never been marketed before, and approved 25 new drugs-giving the agency an approval rate of 89%.
Sprout did promise to avoid marketing the drug for 18 months, but in recent days it’s been handed a free blockbuster media campaign, with reporters and editors around the world often incorrectly calling it a “female Viagra”.
Following the closing of the acquisition, Sprout will remain headquartered in Raleigh, N.C. and become a division of Valeant.
Valeant said in a press release that it expects to launch Addyi in the U.S.by the fourth quarter of this year and that it will also seek regulatory approvals internationally.
Midsize companies like Valeant have driven the field, exploiting modest premium rates and lower, seaward duty rates, while trying to adapt to a rapidly changing health-care market.
The “female Viagra”, which will be commercially known as Addyi, was approved by the FDA and will be available on the market on October. Addyi is taken everyday and works on the chemicals in the brain like an antidepressant.
“We applaud the efforts of the Sprout team to address this important area of unmet need and look forward to working with them”, Valeant CEO Pearson said.
The pink-colored pill developed by Sprout Pharmaceuticals will be sold under the brand name Addyi. The FDA slapped a black box, its strictest warning, on Addyi because it can cause severe low blood pressure and fainting.
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Sprout’s drug is intended to treat women who report emotional stress due to a lack of libido. In the 1990s, Rosen worked with Pfizer to develop a five-question form to diagnose erectile dysfunction in men. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment“. At the time, Valeant said that it would concentrate on “delivering strong organic results and evaluating acquisition opportunities as we always have: prudently, in a disciplined manner, and in the best interests of our shareholders”. The regulator also requires that both doctors and pharmacists be trained and certified before they administer it. That’s to ensure patients know to avoid alcohol and certain medicines like birth-control tablets that raise the risk of side effects.
