BioWorld International Correspondent

PARIS - Novagali Pharma SA and Topigen Pharmaceuticals Inc. signed a cross-licensing agreement, with Novagali obtaining an exclusive license to develop and commercialize a multitarget compound developed by Topigen as a potential therapeutic and preventive treatment for eye allergies.

At the same time, Topigen was granted an exclusive license for the use of Novasorb, a technology platform developed by Novagali that is based on cationic emulsions and enables products that are not soluble in the emulsion to circulate in the organism. Topigen, of Montreal, will use it to formulate and develop compounds targeting RNA for the treatment of respiratory diseases, including allergic rhinitis.

The agreement thus gives Novagali the right to develop a product for eye allergies based on Topigen's technology platform, and Topigen the right to develop an allergic rhinitis product based on Novasorb.

In addition, the two companies will collaborate in the development of ocular and nasal formulations of Topigen compounds using Novasorb, which aids products' penetration into tissues such as nasal mucus and the surface of the eye. Those formulations will be designed to afford greater bioadhesiveness and hence efficacy for multitarget compounds administered through the nose or the eye.

No financial terms were disclosed.

Novagali Pharma, which is based in Evry, France, is developing novel delivery systems for drugs to treat eye diseases such as dry eye, glaucoma, age-related macular degeneration and diabetic retinopathy.

The lead product in Novagali's pipeline is Vekacia (Nova22007), a cyclosporine A cationic emulsion that is being developed for the treatment of moderate to severe dry eye. At the beginning of April Novagali reported positive results from a Phase III trial of Vekacia in the treatment of vernal keratoconjunctivitis in children. The product was granted orphan drug status in that indication by the European Medicines Agency in March 2006.

At the end of April, moreover, the FDA approved an investigational new drug application for a pivotal Phase III trial of Nova22007 in the U.S. Novagali hopes to file the product for regulatory approval in Europe in 2008 and launch it in 2009.

Novagali has a second product in clinical development and that is Nova21027, which is in Phase II trials for the treatment of glaucoma.