Schwarz Pharma today received FDA approval for Neupro, its transdermal patch for treatment of early-stage Parkinson’s disease. Neupro has been on the market in Europe since March 2006 and was approved there for all stages of Parkinson’s in January 2007. In the U.S., Schwarz will submit a supplemental New Drug Application for the treatment of advanced Parkinson’s by the end of 2007.
Approval for advanced-stage use would put Schwarz out in front of Altea Therapeutics, a privately held company in Tucker, GA, that’s currently testing an apomorphine hydrochloride patch for management of advanced Parkinson’s disease. The company’s PassPort transdermal patch system is designed to deliver sustained therapeutic levels of highly water-soluble drugs, carbohydrates, nucleic acids, peptides and proteins into the body without the need for needles or pumps. In addition to Parkinson’s, the company is testing its patches for treatment of types 1 and 2 diabetes as well as moderate to severe pain.
In February 2006, Altea entered an exclusive licensing agreement for Japan with pharma company Teikoku Seiyaku Co. to develop and commercialize a PassPort patch for Parkinson’s. Under the terms of the agreement, Altea will receive payments from Teikoku Seiyaku upon completion of certain development milestones. The Japanese company will pay undisclosed royalties on net sales and/or net revenues and also fund the cost of Japanese product development. The agreement gives Teikoku Seiyaku the option to negotiate terms for exclusive Japanese market rights for certain additional products based on the PassPort system.
Altea seems to have decided that partnering with pharma companies is a viable way to get its PassPort products to market.
In January 2007, the company announced another deal, this time with two undisclosed pharmaceutical companies to examine the feasibility of developing novel transdermal patch products for two protein drugs. Under the terms of these agreements, Altea will use its PassPort technology to assess the feasibility of delivering certain proprietary protein drugs from a transdermal skin patch.
And just last week, Altea announced that it has entered into another research agreement with an undisclosed major pharmaceutical company to examine the feasibility of developing a transdermal patch for the treatment of coagulation disorders.