West Coast Editor

Ophthalmics-targeted Sirion Therapeutics Inc. pulled down $45 million in a Series B financing to boost a pipeline led by ST-601, the Phase III emulsion acquired last year for inflamed eyes.

"If all of our trials go well, this [cash] should get us to three new drug applications," said Todd Creech, vice president of finance for Tampa, Fla.-based Sirion, adding that the cash is expected to take the company into 2009.

Sirion started enrolling patients in January in two Phase III trials with ST-601 (difluprednate) for postsurgical use, gained in an exclusive licensing agreement with Osaka, Japan-based Senju Pharmaceutical Co. Ltd.

Also ongoing is a Phase II trial with oral fenretinide, now known as ST-602, which reduces lipofuscin buildup in the eye by blocking serum retinol formation in such conditions as dry age-related macular degeneration, geographic atrophy and Stargardt's disease (a form of macular dystrophy that starts much earlier in life than AMD). The study started enrolling in December, and will sign up as many as 225 patients with GA at about 20 sites. Sirion got the compound in the buyout of Sytera Inc., of San Diego. (See BioWorld Today, Aug. 17, 2006.)

"We have the most advanced program, as far as these new mechanisms of action go," Creech said, noting that ST-602 takes aim at the most severe form of dry AMD, called geographic atrophy. Headline-stealing wet AMD is characterized by blood vessel growth, whereas the slower-to-progress dry form involves lesions.

"Right now, there really isn't anything out there treating dry AMD - it's like before Visudyne [verteporfin, QLT Inc.] there wasn't anybody treating wet AMD," he said. "There will be others for dry AMD coming as the population ages, but we're out in front of the pack, and that's why we kept the lab in San Diego," which was part of the Sytera takeover.

Fenretinide, which has many other potential applications outside of AMD (including some cancers), slows production of the toxic vitamin A byproduct called A2E, which encourages lipofuscin growth.

Among the firms taking an interest in dry AMD (a larger market than wet) is Exton, Pa.-based Othera Pharmaceuticals Inc., which has an eye drop known as OT-551. Last fall, the National Eye Institute started a 10-patient Phase II trial with the compound, and Othera plans to conduct this year its own, larger Phase II study with OT-551 against geographic atrophy.

Also, South San Francisco-based Genentech Inc., in its $919 million buyout of Tanox Inc., of Houston, is getting the preclinical compound TNX-234 for dry AMD. (See BioWorld Today, Nov. 13, 2006.)

Sirion's clinical work with another compound, ST-603, started in the first quarter of this year. A topical preparation of cyclosporine A, the compound is delivered by way of Sirion's Sophisen system, which deploys a polydisperse solution as a carrier. "We'll start a Phase III program with cyclosporine in the next couple of months," Creech said.

The company also has ST-605, a topical gel with ganciclovir for viral and superficial eye infections, already marketed in Europe by Laboratoires Thea, of Clermont-Ferrand, France, under the brand name Virgan. ST-605 is bound for Phase III trials, too.

"There's a chance we may not have to [conduct the study], but we're planning on it," Creech said.

Sirion's approach "from the get-go has been to either acquire or in-license products that are being developed in the U.S., and roll them up into one ophthalmic company," he said, although the firm has been developing its own leads in the San Diego lab.

Creech formerly worked with Sirion investor NovaQuest, a group within Quintiles Inc., while others come from the sales and marketing side of big pharma. Barry Butler, president and CEO, worked for London-based GlaxoSmithKline plc and for Bausch & Lomb, of Rochester, N.Y.

Sirion, about a month after merging with Sytera, was taken over by the shell firm Tenby Pharma Inc., which became Sirion's parent holding company and brought $25 million in financing from North Sound Capital LLC. (See BioWorld Today, Sept. 19, 2006.)

Aisling Capital, of New York, led the Series B, which included a handful of new backers: Investor Growth Capital, Atlas Venture, Advent International and Bear Stearns Healthcare Value Partners.

"There's a scenario where this money could get us into profitability," Creech told BioWorld Today. Sirion likely "will look at the public markets in the next 12 months to 18 months," he said.