Wyeth backs Flamel drug delivery tech

Wyeth Pharmaceuticals is the fifth pharma firm this year to sign up to Flamel's controlled release delivery technology Medusa, designed to provide controlled release of therapeutic proteins, peptides and other large molecules. The deal, financial details of which were not disclosed, is further validation of the Flamel delivery system, and will help to dispel any ideas that the firm is a one-trick pony according to company representatives. Micropump, Flamel's other delivery system providing controlled release and taste-masking for oral administration of small molecule drugs, is the company's most recognised technology due to its use in GlaxoSmithKline's heart medication Coreg (carvedilol). However, the Medusa technology is seen as just as important and capable of offering significant advantages to companies looking to add improved release profiles to their biologic drug candidates. The delivery technology itself is based on a new uniform polymer that the company has spent the last few years perfecting. The Medusa polymeric nanoparticles are formed of naturally occurring amino acids (Leu hydrophobic and Glu hydrophilic), and are 20-50nm in diameter. Once the Medusa formulated drugs are subcutaneously injected, a nano-depot is formed under the skin from which the treatment is released in a controlled manner. One of the key features of the Medusa system is the fact that proteins and peptides delivered through this technique are not denatured in any way, with the structural integrity (and thus biological activity) of the drug maintained through a delivery mechanism based purely on hydrophobic reactions. The system doesn't transform the formulated protein at all (as opposed to alternative methods of extending drug duration such as pegylation), and can also be modified to provide a variety of release profiles stretching from a 24 hour release schedule to drug delivery over the course of several weeks. Another key advantage according to the company is that using the Medusa system reduces the occurrence of side effects, which can be a distinct problem with biologic medications. The Wyeth deal is a another feather in Flamel's cap, and further confirmation that the extra effort put towards perfecting the polymeric nano-carrier was time well spent. "We redeveloped and improved the basic polymer,"​ Flamel CFO and deputy CEO Michel Finance told in-PharmTechnologist.com. ​"It was fundamental to create a single polymer that worked for everything."​ The revamped delivery system has been attracting real attention since the improvements were completed at the beginning of the year. Not only has Flamel established a total of five agreements with pharma firms keen to investigate the suitability of the Medusa technology for their products, but the areas in which it is being applied are also a real mix. "The agreements show a diversification of fields of application for Medusa,​" said Finance. "Between them they cover oncology, ophthalmology, vaccines and currently marketed proteins." ​ With the boom in interest in biopharmaceuticals and large molecule therapeutics, companies are increasingly looking at ways to give their product an edge in the market. The side effects that can be associated with biologic treatments and unpleasant repeated injections that patients have to endure make extended release options particularly attractive, even more so if they can reduce the severity of side effects as well. Flamel's polymeric nanoparticles therefore look particularly promising, and the company expects more Medusa agreements to be added to the current list over the course of the year. In addition, the company has also applied the improved Medusa system to its own long-lasting basal insulin product, Basulin. After former development partner Bristol-Myers Squibb pulled out in 2004 following a refocusing drive at the company, Flamel continued development of the product alone, repeating Phase I trials with the new Medusa polymer. Results from the trial are due later this month, expected to demonstrate the long-acting insulin product's promising potential. Flamel plans to start seeking out a new partner for its Basulin product over the next quarter.