Major deal for TransForm

Formulation specialist TransForm Pharmaceuticals has licensed a
novel salt form of the antiepileptic drug topiramate to Johnson
& Johnson in a development that provides the first real
validation of its business model.

This is a major step for TransForm as the licence is for the company's first issued patent and topiramate is the first of its internally-developed projects to be licensed out. It was granted a US patent on the salt (No 6,559,293​) in May.

J&J's Ortho McNeil subsidiary markets topiramate under the Topamax brand name as a treatment for epilepsy but is also developing it for new applications, including migraine, obesity and neuropathic pain. Sales of the drug are tipped to be around $400 million in 2003.

Under the terms of the deal, J&J acquires the rights to TransForm's patent claiming a novel salt form of topiramate, thought to be topiramate sodium trihydrate, in return for undisclosed upfront payments, milestones and royalties. Furthermore, J&J will fund TransForm​ to conduct further crystallisation studies on topiramate, and is also to make an equity investment in the firm.

The benefit for J&J will come from an increase in its patent estate and the potential for the new salt - which has an improved profile - to extend the lifecycle of topiramate before generic competition kicks in.

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.

Related topics Ingredients

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