In 2003, J&J was the first company to sign a major deal with TransForm in which the latter agreed to develop a new crystalline form of the drug major's epilepsy treatment topiramate. TransForm also has research agreements in place with AstraZeneca, Eli Lilly and Abbott Laboratories.
The ability of salts to exist in different crystalline forms (polymorphisms) has been behind a number of high-profile patent challenges in the drug industry, perhaps most notably that relating to the histamine H2 antagonist Zantac (ranitidine) originated by Glaxo (now GlaxoSmithKline). In this case, generics companies were able to overturn the originator's exclusivity by developing forms of the drug that got around Glaxo's patent estates.
But pharmaceutical companies are increasingly looking at how refinement of the crystal form of a drug can have a positive effect on its characteristics. For example, with the topiramate project, which has identified a new salt form of the drug, the benefit for J&J could come not only from an extension in its patent estate but also the potential to develop improved dosage forms of the drug.
The new salt is more soluble in water than the commercial form of topiramate, which opens up the possibility of developing formulations - such as an oral, fast-melt version - that are impossible at present.
The transaction is expected to close in the second quarter of 2005, upon which J&J will incur an estimated one-time after-tax charge of approximately $50 million reflecting the expensing of in-process research and development (IPR&D) charges.
Harlan Weisman, chairman for R&D, pharmaceuticals, at J&J, said: "The scientific expertise and intellectual property estate at TransForm provide value-creating opportunities … and immediately expand our ability to create new therapies."
Formed in 1999, TransForm currently has approximately 80 employees. J&J said it expects TransForm to remain in its headquarters in Lexington, Massachusetts, where TransForm has created a new facility housing its suite of technologies for the formulation and crystallization of pharmaceutical products.