After the 2013 rejection, they i just suspected that there were higher barriers for something to treat women, a lot higher than were set up for the male drugs, said sally greenberg, executive director of the national consumers league, which campaigned for the drug. On wednesday, in a call with pershing square investors, mr. The researchers analyzed eight studies of about 5,900 women, using a method that involved pooling the data.
Before the valeant buyout, sprout had lined up cardinal health, one of the nations largest drug distributors. And a vocal investment research firm that had bet against valeants shares published a report criticizing the companys accounting. The drug was approved last june, after twice being rejected by the agency over several years.
That is the average benefit a woman gets when she takes the new female libido drug, sometimes called the female , flibanserin, making it the first drug available to treat low sexual desire in women. . He left the room a few minutes later, in spite of having promised to stay for the day.
The valeant spokeswoman said the company intended to fulfill its obligations under the deal. Cindy whitehead, sprouts chief executive, told fortune magazine at the time. Schiller, who represents the sprout shareholders, said in a statement that valeant was not meeting the obligations it agreed to with sprout, to the detriment of sprout shareholders, valeants own shareholders, its debt holders and the millions of women who would benefit from addyi.
His fund, pershing square capital management, became a top shareholder of valeant when its shares were flying high. Washington half of one satisfying sexual encounter a month. Still, the dismal results have come as a surprise and underscore valeants troubles.
The drugs effects were modest, they said, and not worth side effects such as sleepiness, , fatigue and nausea. But when valeant took over, it ended this arrangement, former employees said, handing over that crucial job to philidor, which was out of business. Valeant also halted a planned speakers program, in which doctors explained the drug to their colleagues. Now sprout shareholders, in their letter to valeant, say that relying on philidor to distribute addyi was a crucial mistake. Last august, sprout pharmaceuticals had a new pill on its hands that quickly captured the nations imagination.
He said the way the analysis was done, combining data from a number of different studies, carried less statistical weight than the randomized trials. In clinical trials, women taking the pink pill reported having about one more sexually satisfying experience per month than those taking a placebo. Ackman, who runs pershing square capital management, became a top shareholder of valeant when its shares were flying high. In their letter to valeant, angry sprout shareholders asked the company to explain its actions. And the risk of some side effects increased with alcohol consumption.
In addition, sprout prepared pamphlets and other marketing materials and enlisted doctors as expert speakers for addyi. But when valeant took over, it ended this arrangement, former employees said, handing over that crucial job to philidor, which was out of business. Addyi would have to carry a black box warning, the most serious kind, stating that taking the drug with alcohol can cause dangerous drops in blood pressure or fainting. Ackman also bought a personal stake in sprout in june 2015, two months before its drug was approved by the f. Ackman has spoken publicly about valeant, but he declined to discuss his investment in sprout on the record.
They also say they did not have access to many of their standard sales tools, including basic promotional materials like wall posters and brochures. Cindy whitehead, who was sprouts chief executive, left valeant pharmaceuticals when distribution of addyi lagged. Tage ramakrishna, the chief medical officer at valeant, the company that now owns the drug, said that the new analysis confirmed the findings of the clinical trials and provided little additional context. That result lifted the benefits above the bar of being scientifically meaningful, but barely. It was promoted by a group of womens rights activists who argued it was unfair that men had numerous drugs to boost sexual function while women had nothing. The company is dismissing the rest of the sales force this month. The former employees would speak only on the condition of anonymity either because they had signed nondisclosure agreements or because they feared that being identified would jeopardize their future in the industry. Ackman suggested the company needed management changes, valeant said it would replace mr. And a vocal investment research firm that had bet against valeants shares published a report criticizing the companys accounting. Insurance companies, she said, would most likely receive discounts to make the drug cost less than 800.Jun 17, 2015 ... 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.