West Coast Editor

Sirion Therapeutics Inc.'s buyout by the shell firm Tenby Pharma Inc., which will become Sirion's parent holding company, brings $25 million in financing from North Sound Capital LLC to boost Sirion's trio of pipeline products, including one due to enter Phase III trials next year.

Susan Benton, co-founder and chief commercial officer of Tampa, Fla.-based Sirion, said the company had "less than $10 million" before the investment, and estimated the burn rate at "a couple million dollars per month" - but said she could not estimate how long the available cash will last, because other projects are in the works.

"We're looking at buying a revenue stream [by acquiring marketed products]," she told BioWorld Today. "We have three big things we're looking at."

Tenby will change its name to Sirion Holdings Inc., with Barry Butler, Sirion's president and CEO, serving in the same capacities at Tenby. The board will be made up of Roger Vogel, Sirion's chief medical officer, Kevin Kinsella of Avalon Ventures (one of Sirion's first financial backers), and Kenneth Widder, former chairman and CEO of Sytera Inc., acquired by Sirion in July. (See BioWorld Today, Aug. 17, 2006.)

Tenby was established in March for the purpose of buying Sirion, Benton said, calling the resulting entity "a very closely held public company" that might eventually seek listing to trade on a public board.

Meanwhile, Rx Development Resources LLC, the ophthalmic-focused clinical research organization bought by Sirion this summer, will be conducting preclinical through Phase II studies with Sirion's pipeline, and strategic partners will do Phase III trials on a contract basis.

"We built the CRO, too," Benton said, noting that RxDR was founded in 2003 by Butler and Vogel.

From La Jolla, Calif.-based Sytera came the rights to ST-602, bound for Phase II trials late this year. Designed to inhibit formation of retinol, ST-602 could reduce the formation of lipofuscin in the eye, and work against such diseases as age-related macular degeneration, geographic atrophy and Stargardt's disease.

The farthest-along candidate, ST-601, is an ophthalmic steroid emulsion from Senju Pharmaceutical Co. in Japan, where scientists have studied the drug extensively against inflammatory diseases in humans. Sirion aims to start the Phase III program in the first half of next year.

"We're not calling any of our products 'lead,'" Benton said, though ST-601 is likely to reach the market first. Sirion plans to handle commercialization without partners.

In Japan, ST-601 beat the efficacy of betamethasone (the gold standard there) in comparison trials, but the side-effect profile did not satisfy overseas regulators.

"They're all about safety first," Benton said. "Here, we hit things with big guns, and deal with the collateral damage" by using supplemental therapies.

Clinical work also begins in the first half of next year with ST-603, a topical form of cyclosporine A, gained through a licensing deal with Laboratorios Sophia S.A. de C.V., of Guadalajara, Mexico, in June. The drug is given through the Sophisen delivery system, which deploys a polydisperse solution as a carrier.

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