Advitech, Cothera announce Dermylex deal
as the Canadian biotech enters into its first marketing agreements:
Cothera is to market and distribute Dermylex in France, and further
announcements for the US and Canadian markets are expected soon.
The French deal is subject to the companies entering into a definitive marketing and distribution contract before June 30 2006, but Cothera will go ahead and file its dossier with the regulatory authorities in the next three months.
If the necessary approvals are granted, Dermylex, derived from sweet whey, could be launched before 2006 is out. Sales and marketing efforts will then be stepped up in 2007.
Advitech vice president and CFO Michel Lamontagne told NutraIngredients-USA.com that Advitech hopes the deal is the "first of many".
"We are continuing discussions for the US and Canadian markets and hope to announce these early next year." He said that France is a particularly interesting market as more than two percent of the population suffers from psoriasis, compared with less than two percent in the UK. A potentially large market has also been identified in other European countries, such as Germany, Italy and the UK.
Cothera's model for France involves educating physicians about Dermylex and selling the tablets direct to consumers. In the US a different model is foreseen, with the partner distributing to dermatology clinics. According to Lamontagne, 40 percent of dermatologists sell OTC products.
Tablets intended for all markets are to be manufactured for Advitech by a contract manufacturer in Canada.
Lamontagne said that it would be premature to give a sales forecast at this stage, but that the company has "high expectations".
However Cothera's exclusivity in France is dependent on minimum sales over the three-year term. Other terms and conditions were not disclosed.
Throughout research and development Dermylex has been known as XP-828L. Advitech acquired the rights to develop the nutraceutical though an agreement with French firm Pierre Jouan Biotechnologie in 2003.
It originally hoped to roll out the product by the end of 2004, but decided to delay whilst it carries out a program of placebo-controlled clinical trials, the results of which are expected to give the product weight with dermatologists, as well as just with natural products suppliers.
Its patience paid off in July when the results of a 112-day phase II, multi-center, placebo-controlled, double-blind study involving 84 patients were announced, confirming its safety and efficacy for sufferers of mild to moderate psoriasis.
More than 6 million adults in North America suffer from psoriasis, an immune system disorder, but until now those with mild to medium forms of the condition have had to resort to topical therapies or aggressive drug treatments with significant side effects.
Advitech has said that Dermylex could complement existing drug therapies. Moreover the company believes it could benefit sufferers of other immune-related conditions.
Positive results of a pre-clinical study into the nutraceutical's use for inflammatory bowel diseases like Crohn's disease and autoimmune colitis, were announced in October. Conducted in collaboration with Patrice Poubelle at the Centre de Recherche du Centre Hospitalier de l'Université Laval, the in vivo studies using two animal models indicated statistically-significant improvements of several clinical parameters and showed a dose-dependent effect, said the company.
