Valeant Pharmaceuticals and GlaxoSmithKline have entered into an exclusive worldwide collaboration for the investigational drug retigabine, a neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown efficacy and safety in two Phase III trials in patients with refractory epilepsy receiving treatment with as many as three antiepileptic drugs (AEDs). The two companies plan to file a NDA in the U.S. and a MAA in Europe by early 2009. The drug is also being studied in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.
   
Under the terms of the agreement, Valeant will grant GSK worldwide development and commercialization rights to retigabine, VRX698 and the other compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million. Valeant is eligible to receive as much as $545 million based on certain regulatory, development and commercialization milestones, as well as the development of additional indications for retigabine. Valeant will co-commercialize and share as much as half of the profits in the U.S., Canada, Australia, New Zealand and PR, and will receive as much as a 20% royalty on sales outside those regions. The two companies will share global R&D expenses for retigabine, and GSK will fund the development of VRX698 and the other back-up compounds from the program. Valeant could receive an additional $150 million based on the achievement of certain milestones for VRX698 and the back-up compounds, and double-digit royalties on worldwide sales.
   
“We were pleased with the significant interest shown in retigabine and we have selected GSK as a collaborator because we believe they are ideally suited and strongly committed to the continued development of this important compound,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “GSK’s development expertise and strong commercial infrastructure will be critical to maximizing the worldwide potential of retigabine. We believe this collaboration will strengthen our ability to bring this medicine to patients suffering from epilepsy and a variety of other conditions.”
   
“GSK is looking forward to working with Valeant to provide important medicines like retigabine to the medical community and to the patients we serve,” commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. “There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications. We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK’s portfolio.”

Genentech, Inc. will initiate a Phase II trial of GDC-0449, an orally administered small molecule Hedgehog antagonist, as a maintenance therapy for ovarian cancer patients in second or third complete remission. Genentech is developing the drug in collaboration with Curis, Inc. and will be the sponsor of this study.
   
GDC-0449 will be evaluated in approximately 100 patients in a randomized, placebo-controlled, double-blind, multi-center Phase II trial. Patients will be randomized to receive either GDC-0449 or a placebo comparator and will be separated based on whether their cancer is in a second or third complete remission. The primary endpoint of the trial is progression-free survival, and secondary outcome measures include overall survival, the amount of Hedgehog protein expression in archival tissue and tracking of adverse events.    
   
“We believe that the dysregulation of developmental pathways such as Hedgehog may play a role in the formation or recurrence of cancer. Therefore, we are hopeful that a Hedgehog inhibitor, such as GDC-0449, may be a useful therapeutic tool in preventing cancer from returning in these ovarian cancer patients and may prove useful as a maintenance therapy,” said Curis president and chief executive officer Dan Passeri. “GDC-0449 is currently in Phase II testing in first-line metastatic colorectal cancer and Genentech has indicated that it expects to initiate an additional Phase II clinical trial in advanced basal cell carcinoma in the second half of 2008.”

David Blumberg has joined KPMG LLP as a principal and advisory sector leader for the Pharmaceutical Industry practice, based in the firm’s Philadelphia office.
   
In his new role, Mr. Blumberg provides a full array of advisory services to pharmaceutical and life sciences clients. He has significant experience working in the global pharmaceutical space, including market evaluations, launch/entry strategy, product strategy, business transformation, performance improvement, strategic planning and merger integration.
   
Prior to joining the company, Mr. Blumberg served as executive vice president at I-Many, a provider of advanced Enterprise Contract Management (ECM) solutions, where he was responsible for all professional services, customer support, sustaining engineering functions, as well as formulating and directing marketing strategies in the Life Sciences and Healthcare business line.
   
He also served as global pharmaceutical and medical products industry leader for Accenture, where he serviced client accounts and led the industry team in developing strategy, positioning, awareness, thought capital, alliances and media/marketing programs.   

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