West Coast Editor

Abeille Pharmaceuticals Inc.'s therapeutic entry into chemotherapy-induced nausea and vomiting (CINV), a transdermal patch known as AB-1001, drew a potential $21 million marketing deal with SymBio Pharmaceuticals Ltd., which gained rights in Japan, China, Korea, Taiwan and Singapore.

Due for Phase III trials in the second quarter of this year, the patch delivers the 5-Hydroxytryptamine3 (5HT3) antagonist granisetron, sold as Kytril in oral and intravenous forms by Nutley, N.J.-based Hoffmann-La Roche Inc.

"The main advantage would be to sustain the effect over a five-day period," said Suresh Borsadia, president and CEO of Princeton, N.J.-based Abeille. Among the available CINV drugs, only Aloxi (palonosetron), the second-generation 5HT3 antagonist from MGI Pharma, of Minneapolis, provides long-lasting relief, "and even that does not last beyond three days," Borsadia said.

Other marketed 5HT3 antagonists for CINV include ondansetron, sold in injectable, tablet and liquid forms as Zofran by London-based GlaxoSmithKline plc, and Anzemet (dolasetron) tablets and liquid from Paris-based Sanofi-Aventis Group.

In the deal with Tokyo-based SymBio, Abeille gets an undisclosed up-front fee plus milestone payments as well as double-digit royalties, and the firm has granted the right of first refusal on Abeille's next product in the space. This would be a cortical steroid with multiple potential indications beyond CINV, such as cachexia.

Abeille retains U.S. rights to AB-1001. "We are talking to some companies here and Europe, but as of today, the marketing rights are still available," Borsadia said.

Founded in November 2003, the virtual firm Abeille (with two employees) made its initial capitalization in June 2004, and is focusing on CINV as well as metabolic disorders. "We look to take products at least through Phase II and preferably beyond" before partnering, he told BioWorld Today.

The firm's name is the French word for honeybee, meant to signify the strategy of "taking the best from various sources," as the bee collects nectar to make honey, Borsadia said.

Another CINV drug making news last month was South San Francisco-based Hana Biosciences Inc., which in February said a manufacturing problem might delay FDA approval of its oral spray ondansetron, known as Zensana. Analysts predicted that launch could be pushed out as far as the second quarter of 2009 from the original Prescription Drug User Fee Act action date of April 30.

Bellevue, Wash.-based Scolr Pharma Inc. has an interest in ondansetron, too; the firm recently reported positive preliminary results from a pilot bioavailability study of its refined 24-hour Controlled Delivery Technology-based ondansetron tablets.

In the 5HT3-antagonist space, A.P. Pharma, of Redwood City, Calif. (which reported earnings Thursday), targets next year for a regulatory filing related to its Phase III version of granisetron called APF530, formulated with the firm's Biochronomer bioerodible delivery system. No drug in the class has yet been approved for preventing both acute and delayed CINV for moderately and highly emetogenic chemo.

Also in February, Valeant Pharmaceuticals International, of Aliso Viejo, Calif., acquired rights to the cannabinoid-based CINV agent nabilone in the UK and other European markets from Cambridge Laboratories Ltd., of Wallsend, UK, for $14 million. Valeant markets nabilone in the U.S. and Canada under the brand name Cesamet.

Regarding Aloxi, MGI and partner Helsinn Healthcare SA, of Lugano, Switzerland, said a five-year U.S. patent extension has been granted. Stockholm, Sweden-based Biovitrum AB recently bought exclusive license and distribution rights to Aloxi in Nordic territories from Helsinn.

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