Staff Writer

While most biotechs hope to one day license their products to a big pharma partner, Synosia Therapeutics is doing just the opposite.

Earlier this year, the San Francisco-based company licensed five drug candidates from F. Hoffmann-La Roche Ltd., and on Monday it announced a license for a sixth and an option for a seventh from Novartis AG.

The ability to obtain access to "clinically-enabled compounds sitting on the shelf at big pharma" is part of what makes Synosia unique, said President and CEO Ian Massey.

In fact, the company was founded to take advantage of the "significant discovery investment" made by big pharma in the central nervous system (CNS) field over the past decade, according to Bradley Bolzon, managing director with founding investor Versant Ventures.

In the Novartis deal, Synosia gained exclusive, worldwide rights outside of Japan to develop and commercialize rufinamide for the treatment of mood disorders. Tokyo-based Eisai Co. Ltd. holds worldwide rights to the drug for epilepsy and has gained European approval in a severe form of epilepsy called Lennox-Gastaut Syndrome (LGS). The wealth of clinical data generated by both Eisai and Novartis will allow Synosia to advance into Phase II trials in the second half of this year.

Rufinamide is an orally bioavailable sodium channel blocker with both anti-epileptic and anxiolytic activity. Synosia plans to initially evaluate the drug, renamed SYN-111, in general anxiety disorder and bipolar disorder, where the company said it may relieve anxiety without the risk of dependence associated with benzodiazepines or the adverse sexual side effects associated with serotonin or serotonin-norepinephrine blockade.

Terms of the Novartis deal were not disclosed, but Massey said Novartis has "some options to negotiate" regarding a future interest in the drug. Synosia also has an option to an undisclosed CNS compound from Novartis and expects to make a licensing decision within a year.

The Novartis deal follows an agreement with Roche in January through which Synosia licensed five CNS compounds.

Four of the molecules are clinically-enabled, including SYN-114, a small-molecule 5-HT6 receptor antagonist for cognitive disorders; SYN-115 a selective A2A receptor inhibitor for Parkinson's disease and drug dependency; SYN-116, an IP-receptor inhibitor for acute and postoperative pain; and SYN-117, a selective dopamine â-hydroxylase inhibitor for Parkinson's disease and drug dependency. Also included was SYN-119, a preclinical mGluR-1 receptor agonist for drug dependency.

Roche retains options to opt-in on two of the compounds, while Synosia will exclusively develop and commercialize the other three. Massey said the company will move three of the four clinically-enabled drugs into clinical trials in late 2007 or early 2008, while SYN-119 has another year of preclinical work ahead.

As it moves its newly-licensed drugs into the clinic, Synosia plans to start with small trials using imaging tools and biomarkers to generate extensive pharmacokinetic and pharmacodynamic data.

That will be used to select the optimum dose, route of administration and indication for each drug. Bolzon described the approach as combining "exploratory studies" that take advantage of recent advances in CNS with a "very experienced clinical development team" to manage the risk within the company's broad portfolio.

And the portfolio shows no signs of slowing. Massey said Synosia is "looking at other opportunities" to license clinically-enabled molecules with potential CNS applications.

Founded in February 2006, Synosia was spun out of EuroVentures Inc., an incubator wholly owned by Versant Ventures. The company raised $2.5 million in seed funding from Versant, Abingworth Management and 5AM Ventures, then followed it with a $30 million Series A2 financing led by Novo AS.

Massey joined the company from Roche, and Chief Business Officer Herve Girsault joined from Novartis, providing in-roads for the licensing deals.

Synosia has since established an office in Basel, Switzerland to liaise with its two pharma partners, both of which are based there.

The company changed its name from Synosis to Synosia last month to avoid similarities to other companies and to better reflect a combination of knowledge and sensory perception, Massey said.

Editor's note: NewCo News is a feature that periodically will examine young companies working in the biotechnology field.