|Valeant CEO J. Michael Pearson|
Valeant Pharmaceuticals ($VRX) is famous for its aversion to pharmaceutical R&D, but the serial acquirer makes an exception when it sees blockbuster promise in a late-stage asset. And that's the case for the glaucoma treatment Vesneo, which met its goals in pivotal trials and, according to the company, has blockbuster potential.
The drug, formerly known as latanoprostene bunod, is a once-a-day treatment designed to relieve in-eye pressure for patients with glaucoma or ocular hypertension. In two Phase III studies on 840 patients, it did just that, proving itself noninferior to the commonly used timolol, which is dosed twice a day, and meeting its co-primary endpoint of significantly reducing pressure at three months.
Now Valeant, which picked up the drug in its $8.7 billion deal for Bausch + Lomb last year, plans to submit Vesneo for FDA approval in the second quarter of 2015, expecting to launch it in the first half of 2016. And the Canadian conglomerate believes its new glaucoma treatment can top out at more than $1 billion in sales a year, with half of that coming from the U.S.
The company is touting its commitment to the program, in-licensed from France's Nicox, as evidence that it's not afraid to spend money on research.
"Valeant is committed to innovation in healthcare and continues to fund important R&D programs that will bring benefits to physicians and the patients they serve," CEO J. Michael Pearson said in a statement. "... We are proud of our R&D team who have worked diligently over the past four years to bring this program to successful completion. We are pursuing development plans and programs for other priority markets around the world."
Pearson's words--and Valeant's uncommon move of throwing around sales figures before approval--take on particular significance as the company works to convince Allergan ($AGN) shareholders to surrender to its $53 billion advance.
In its protracted battle with Allergan management, Valeant has faced withering criticisms that its unwillingness to develop drugs handicap it from creating real value, and that its penchant for acquisitions is a smoke screen to conceal an ailing balance sheet.
Meanwhile, Valeant and co-agitator Pershing Square Capital Management have secured a Dec. 18 meeting in which Allergan shareholders will get a chance to vote out many of that company's directors, which could finally clear the way for serious negotiations between the parties.
As for Nicox, the Vesneo news sent the company's shares up more than 25%. Last month, the company exercised its option to co-promote the drug in the U.S. and is now in the process of negotiating a split. Under its initial deal with B+L, signed in 2010, Nicox is due another $162.5 million in potential milestone payments, plus double-digit royalties on global Vesneo sales.
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