Sex and drugs: Something doesn’t ‘Addyi’ up

November 4, 2016 – 9:35 pm | By Randy Osborne | No comments yet

female viagraThe day before news broke of the lawsuit against Valeant Pharmaceuticals International Inc. – lodged by former shareholders of Sprout Pharmaceuticals Inc. over Valeant’s non-promotion of Addyi (flibanserin) for female sexual dysfunction – officials of Palatin Technologies Inc. groused to me about that very topic. “It’s just there, doing nothing,” he said of Addyi, a non-hormone agonist at the 5-HT1A receptor and an antagonist at the 5-HT2A receptor.

Palatin hoped that Valeant’s $1 billion buyout last year of Sprout in order to get its hands on then just-approved Addyi  would mean a big push for greater awareness of the drug as well as its long-neglected condition, specifically known as hypoactive sexual desire disorder (HSDD).This would pave the way for Palatin’s therapy, bremelanotide, or BMT, a melanocortin 4 receptor agonist and synthetic peptide analogue of naturally occurring alpha-melanocyte-stimulating hormone.

The would-be scenario held promise for Palatin. Although Addyi has the advantage over subcutaneously administered BMT in that it’s orally taken as a tablet, it must – unlike BMT – be used chronically. What’s more, Addyi interacts with alcohol (hence a black-box warning on the label), and causes dizziness as a side effect.

Palatin (and former Sprout shareholders) expected Valeant to promote Addyi in ob-gyn office visits, urging doctors to talk with their patients about sexual dissatisfaction and make them aware that a treatment is available. Then BMT, which just completed favorable phase III trials, could step in when approved and tout an even better one. Valeant dropped the ball. To be sure, the company has had plenty else to keep busy on, given the controversies over its drug pricing and business practices, and investigations by U.S. regulators and Congress.

But even before all that, the buyout of Sprout at such a premium stunned me.

Any drug will have a problem selling if it must be used chronically in order to address a situation (sexual activity) that, for many people, doesn’t manifest regularly. Healthy people don’t want to put chemicals in their bodies every day, unless doing so is necessary to remedy pains or problems that also recur on a daily basis. Nor do they don’t want to be dizzy as a result of ingesting those chemicals, if they get no practical benefit in the near term. And, not to put too fine a point on it, a lot of people don’t want to take a drug that purports to ensure their sexual satisfaction by boosting libido and blocks them from enjoying alcohol at the same time.

Wrongly dubbed “the female Viagra,” Addyi differs greatly in its mechanism of action from the sildenafil product marked by Pfizer Inc. for men. The label differs as well: There’s no black-box warning on Viagra’s label with regard to alcohol use. (Since Viagra’s approval, the male-dominated industry has won approval for more erectile-dysfunction therapies, but – until Addyi – nothing to address libido in women: a separate issue. Or maybe not.)  

Even if Valeant had stuck to its Addyi knitting after the Sprout purchase, instead of firing everybody and doing practically nothing, the company would have faced a big hurdle in getting the drug widely accepted, especially with BMT in the wings. Spana, of Palatin, called Addyi “a product that can be used by women and should be used by women” for whom it’s appropriate. At least, you can almost hear him saying, for now.

The scenario reminded me of what Nitromed Inc.’s Bidil for heart failure in African Americans faced after the FDA granted approval in June 2005. Bidil is made up of two generic ingredients, isosorbide dinitrate and hydralazine, available separately at a much cheaper price than the combined pill. It seemed obvious to me that doctors would prescribe the two components separately as a way of keeping the out-of-pocket cost lower for patients – that “convenience” wouldn’t carry the day.

In May 2006, shares of Nitromed took a 30 percent hit when investors got a gander at the low sales numbers. Liana Moussatos, analyst with Pacific Growth Equities (now at Wedbush), told me that “Bidil sales would have been fantastic, had the separate components not been available.” Nitromed later sold the rights to Bidil to Arbor Pharmaceuticals LLC.

With Bidil, Nitromed targeted a different, more serious indication and a different populace than those to be served by Valeant with Addyi, but they may be overlooking in a similar way how the real world will work – in terms of doctors prescribing two pills vs. one, or an HSDD therapy self-administered subcutaneously as needed instead of taken by mouth daily.

Palatin plans to file the NDA in the second half of next year and could get a decision by the second half of 2018, chief financial officer and chief operating officer Stephen Wills told me. With only 22 employees, the company will need to sign a marketing collaborator that has a presence in women’s health. Roth Capital Partners views Pfizer or Allergan plc as likely bidders. Wills said, “I think the most important thing is, we’re going to have a focused partner that’s going to do what needs to be done in the marketplace.” In BMT, Palatin has something that deserves the effort.

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