Valeant Gets $125M Up Front from GSK in Epilepsy Deal
BioWorld Today Staff Writer
Valeant Pharmaceuticals International and GlaxoSmithKline plc said they are collaborating on the investigational drug retigabine for epilepsy, a deal that gives Valeant a $125 million up-front payment.
The companies plan to file a new drug application in the U.S. and a marketing authorization application in Europe by early 2009. If approved, retigabine could be launched 10-12 months from approval, toward the end of 2009 or into 2010, Valeant spokeswoman Laurie Little said.
Much of the up-front money from the deal could be offset by expenses that Valeant expects to incur as a result of regulatory filings and the anticipated product launch, Little said.
Valeant also could get up to $545 million for certain regulatory, development and commercialization milestones and the development of additional indications for retigabine.
The Aliso Viejo, Calif.-based company will share up to 50 percent of net profits within the U.S., Canada, Australia, New Zealand and Puerto Rico, and will receive up to a 20 percent royalty on net sales of retigabine outside those regions.
In addition, Valeant could receive up to an additional $150 million based on the achievement of certain regulatory, development and commercial milestones for VRX698 and the backup compounds and double-digit royalties on worldwide sales
GSK is the maker of its own epilepsy treatment, Lamictal. But the London-based drugmaker sees retigabine as a possible add-on epilepsy therapy to help control seizures in refractory patients, spokeswoman Nancy Pekarek told BioWorld Today.
However, Michael Tong, analyst at Wachovia Capital Markets, predicted in a research note that retigabine could get second-class treatment by GSK sales reps. He wrote, "With Lamictal XR potentially entering the market six months ahead of retigabine, and GSK likely realizing better economics off of Lamictal XR than retigabine, we believe retigabine could be a second-class citizen in the GSK sales reps' bags."
But Lamictal and other epilepsy drugs are nearing the end of patent life, Valeant's Little pointed out. And since many epilepsy treatments are used side by side, retigabine would not be in outright competition with GSK's Lamictal, she said.
GSK was a good partner for Valeant, Little said, because it already had a worldwide presence in the epilepsy space and a sales force with established relationships with neurologists. Plus, GSK brought additional scientific expertise to the table, she said.
Retigabine is a potential first-in-class drug aimed at the 30 percent of epilepsy patients who are considered refractory, as they continue to experience seizures even with treatment.
Retigabine is the first potassium channel opener to reach late-stage clinical development. Numerous ion-channel mutations have been linked to epilepsy, and many antiepileptic medications modulate sodium or calcium channels.
Retigabine is expected to be used as a second- or third-line treatment for those patients with partial seizures. But Valeant's little said that ultimately neurologists would make the choice as to whether retigabine would "move to front line."
In Phase III testing of the drug, patients were taking other epilepsy drugs, such as Keppra (UCB SA) and GSK's Lamictal, in addition to the experimental medication retigabine.
Keppra is primarily an epilepsy drug while others like Lamictal have broader uses or off-label use in indications such as neuropathic pain and bipolar disorder.
In November 2007, Valeant initiated a Phase II trial of retigabine for the treatment of pain associated with PHN, a painful and common complication of shingles.
Valeant also is currently developing a modified-release formulation to provide a more convenient dosing schedule, as well as evaluating the potential use of retigabine in treating other conditions.
In addition, Taribavirin nucleoside is in Phase IIb for the treatment of patients with chronic hepatitis C, after not meeting its Phase III endpoint.
The company sells Diastat rectal gel primarily for seizures, but it also is considering a nasal spray formulation.
Shares in Valeant (NYSE:VRX) fell $1.28 or 6.4 percent, closing at $18.82.
Published: August 29, 2008
Suite: 1100 | Atlanta, Georgia 30346, USA
In the U.S. and Canada: 1-800-477-6307
Outside the U.S.: 1-770-810-3144
In the U.S. and Canada: 1-800-336-4474
Outside the U.S.: 1-215-386-0100
Hours: Monday - Thursday, 8:30 am - 6:00 pm EST
Friday, 8:30am - 4:30 pm EST
Sign up for Perspectives FREE e-mail newsletter