Although Topigen Pharmaceuticals Inc. and Novagali Pharma SA may not appear at first to have much in common, the two companies swapped technologies through a strategic collaboration and cross-licensing agreement.

Terms of the deal were not disclosed, but Topigen President and CEO Paul Wotton said the agreement involves a "sharing of technologies" in which Topigen will provide access to its RNA targeting platform while Novagali will provide a license to its topical drug delivery formulation. The deal allows both privately held companies to leverage their strengths while expanding into a new area.

Financial considerations will not come into play until further "down the road," Wotton said, adding that such an arrangement could likely "only happen between two biotechs."

Montreal-based Topigen is developing a pipeline of inhaled small molecules and RNA-targeted oligonucleotides for respiratory diseases. The company's lead compounds are TPI ASM8, a Phase II inhaled RNA-targeted asthma drug, and TPI 1020, a Phase II inhaled nitric-oxide formulation of budesonide licensed from NicOx SA for use in treating chronic obstructive pulmonary disease. Topigen also is developing earlier-stage programs in COPD and allergic rhinitis. (See BioWorld Today, Oct. 28, 2005.)

The agreement with Novagali provides Topigen with an exclusive license to use Novagali's Novasorb topical delivery technology in the development of an RNA-targeted drug for allergic rhinitis.

Topigen already is conducting preclinical studies with TPI ALR8, a derivative of asthma drug TPI ASM8. Both drugs are chemically modified antisense oligonucleotides designed to affect multiple inflammatory cytokine receptors, creating a synergy between pathways that would allow for low-dose treatment.

While TPI ASM8 is inhaled to the lungs, TPI ALR8 will be delivered intranasally, which is where Novagali's Novasorb topical delivery technology comes into play. "We believe [the Novasorb technology] would improve uptake of the drug into the nasal membrane," Wotton said.

Novasorb is a cationic emulsion designed to improve retention time for drugs delivered via tissues such as the cornea and conjunctiva. Although it has not been tested in human nasal membranes, Wotton said the approach is "very appropriate" for developing a product that's "efficacious and easy on the nose."

The Novasorb technology has served as the backbone for Evry, France-based Novagali's pipeline of ophthalmic specialty pharmaceuticals. Chief among them are Cationorm, an OTC dry-eye drug, and Nova22007, a Phase III severe chronic allergic conjunctivitis treatment. Novagali's pipeline includes several other treatments for conditions of the anterior and posterior segment of the eye, including a glaucoma drug.

In exchange for licensing Novasorb to Topigen, Novagali gets an exclusive worldwide license to use Topigen's RNA-targeting platform technology to develop an ophthalmic product to treat and prevent allergic eye diseases. These diseases are mediated by many of the same chemokines and cytokines involved in asthma, where Topigen's RNA-targeting approach already has generated positive data in initial Phase II trials.

The two companies plan to form a collaborative committee to advise each other on the development of both the ocular and nasal Novasorb RNA-targeted products. If all goes well, the intranasal formulation for allergic rhinitis will enter the clinic in 18 to 24 months.

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