GlaxoSmithKline has entered into a new drug formulation agreement with Flamel Technologies of France that could see the latter firm receive up to $45 million (€41.3m) in licensing fees and milestone payments.
The collaboration will see Flamel apply its controlled-release Micropump technology to develop a new formulation of one of GSK's existing products; the identity of the active compound is not being divulged at present. Flamel will receive $2 million in an upfront payment under the terms of the deal, which could see the French company receive up to $45 million at the end of the product's first year on the market. In addition, Flamel will receive royalties on any eventual sales, and may also participate in the manufacture of the product.
This is not the first time that GSK and Flamel have worked together. Last year, the French firm started to develop a sachet formulation of GSK's blockbuster antibiotic Augmentin (amoxicillin/clavulanate) which made use of the micopump technology to create a product that is easier to swallow.
Flamel has also signed Micropump-related deals with Servier and Merck and is applying the technology to an in-house product, the antiviral Genvir (acyclovir). Genvir is currently at the registration stage in France, having been held back in 2001 by a request from the regulatory authorities for another clinical trial after questions were raised about the active control drug used in the study. Flamel is currently seeking partners to take this product further.
The Micropump technology takes the form of microparticles coated in a polymer that controls the diffusion of active drug out of a central reservoir. It is designed to retain small molecule drugs for longer in the small intestine, and is particularly suitable for delivery compounds with a narrow window of absorption.
Gerard Soula chief executive of Flamel said: "This additional agreement further demonstrates the interest of major worldwide pharmaceutical companies in our versatile technology platforms. Moreover, this is our second licence agreement with GSK within the past nine months based on Micropump technology."
The existing collaborations with Servier and GSK helped Flamel post revenues and other income of $21.0 million in 2002, up from $13.1 million in 2001. License and research revenues totalled $14.6 million, compared to $9.9 million in the prior year. 2002 was also Flamel's first full year of profitability with net income of $3.0 million, compared to a loss of $2.9 million in 2001.