December 10, 2015
By Alex Keown, BioSpace.com Breaking News Staff
RALEIGH, N.C. – Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals, the company that developed the first female sex drive drug, is stepping down from the company she founded, the Triangle Business Journal reported this morning.
Following regulatory approval of its female sex drive drug Addyi in August, Raleigh-based Sprout was acquired by Canadian-based Valeant Pharmaceuticals International Inc. , which has since faced its own battles over its accounting practices and its relationship with a specialty pharmacy company, Philidor Rx Services. Sprout, which has about 35 employees, was acquired for $1 billion plus a share of future profits based upon the achievement of certain milestones in August. Valeant still owes approximately $530 million to Sprout, Seeking Alpha reported.
But since Addyi has become available, the drug has seen dismal sales. The drug became available Oct. 17 and within the first few weeks, only 227 prescriptions had been written. Although the female sex drug is not truly comparable to Pfizer Inc. ‘s sexual enhancement blockbuster drug Viagra, that medication was prescribed more than 500,000 times in its first week. After Addyi was approved, Sprout said the medication will only be able to be prescribed by pharmacies certified by Sprout and will require training on counseling patients on the risks and side effects, especially the interaction with alcohol. So far the company has been able to train 5,600 physicians, about 1 percent of obstetricians and general practitioners who might be able to prescribe the drug, Bloomberg reported in November.
With poor sales and Valeant’s other issues, as well as some pressure on Valeant CEO J. Michael Pearson to correct plunging stock value, it is not known whether or not that had anything to do with Whitehead’s decision to step down from the company she founded. Valeant’s is trading at $94.40 per share this morning. Since a high of $259.98 per share price on Aug. 4, Valeant’s stock has plummeted to a year-low of $69.33 per share.
In an interview with Chicago-based BizWoman, Whitehead said she had accomplished what she wanted. In a note she sent to her staff at Sprout, Whitehead said it was “time to turn the seat over” to her Sprout colleagues in order to move its lead product Addyi forward.
“While bittersweet, the truth is phase I was mine to shepherd. Phase II is yours. What you have already accomplished despite the distractions is a testament to the potential of Addyi and who you are as advocates. You will not compromise in getting this right for women - that’s why you’re here,” Whitehead wrote in her note, according to the Business Journal report.
Addyi was approved by the U.S. Food and Drug Administration (FDA) for a low sex drive, called hypoactive sexual desire disorder (HSDD) in premenopausal women, after being rejected twice by the regulatory agency in 2010 and 2013. Unlike the drug’s oft-compared male counterpart Viagra, Addyi addresses desire, not performance. Another difference between male erectile dysfunction drugs, Addyi is a once-daily dose that takes some time before the patient begins to see a difference in sexual desire. In clinical trials, patients began to show desire after about four weeks.
HSDD is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance.
Whitehead is expected to stay on as a consultant to Sprout, Laurie Little, a Valeant spokesperson said, the Business Journal reported. Tracy Valorie and Ray Larwood, both of Valeant, will take over Sprout operations, Little said.
