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All Eyes On Rising New Company

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By MICHAEL SASSO, The Tampa Tribune

Published: October 12, 2007

TAMPA - The Tampa Bay area isn't known for its leading pharmaceutical companies.

But way off the radar, a start-up Tampa company called Sirion Therapeutics has caught the eye of venture capitalists, scoring $75 million in financing, and it has designs on becoming a force in the treatment of eye diseases and conditions.

Sirion has some major hurdles ahead, including winning drug approval from the Food and Drug Administration and surpassing several competitors with their own ophthalmic treatments. However, financiers like the fact that Sirion is headed by industry veterans who cut their teeth with Bausch & Lomb and have deep ties in the close-knit world of ophthalmology.

If its drugs win approval, the potential market for its products could be in the hundreds of millions of dollars, Sirion Chief Executive Officer Barry Butler said.

From its headquarters in the Sabal Park business district east of Tampa, Sirion is developing and testing four drugs and treatments for eye conditions. To date, Sirion hasn't developed the drugs on its own, but instead has licensed them from other pharmaceutical companies around the world.

Sirion may seek final FDA approval for three of the drugs within a year:

•Difluprednate, which eases eye inflammation.

•Ganciclovir, a gel that treats herpes, which can target the eye.

•Cyclosporine ophthalmic solution, which treats dry eye.

The company's potential blockbuster, though, is called fenretinide, Butler said. Less tested than the other three, fenretinide appears to counter a disease called age-related macular degeneration. The disease attacks the central portion of the retina, called the macula, and is the leading cause of vision loss among seniors.

If fenretinide is proved effective and clears the FDA, it could be huge win for the small Tampa company, said George Williams, a retinal surgeon from Michigan and spokesman for the American Academy of Ophthalmology. Doctors can slow the progression of age-related macular degeneration with high doses of vitamins, Williams said, but there are no effective treatments for the late stages of the disease that hurt vision, particularly the 'dry form' of the disease that fenretinide targets, Williams said.

There may be a few hundred thousand people in the United States who have the disease's dry form, have lost some vision and might use a drug like fenretinide, Williams said. However, Sirion has some serious competition: At least three other drug companies are developing their own competing treatments, Williams said.

Already, Sirion has grown from a handful of people to 54 employees in just two years, 41 of whom are in Tampa and 13 of whom are at a research lab in San Diego. The median annual salary is about $80,000, Butler said. Six were former employees or consultants for Bausch & Lomb in Tampa.

If fenretinide wins regulatory approval, the company might have to expand exponentially, Butler said.

'Fenretinide is a potential blockbuster drug,' Butler said. 'It would change the face of the company.'

Breaking Away

Sirion got its start, Butler said, because he and some colleagues at Bausch & Lomb didn't want to relocate up North.

Bausch & Lomb has operated a research and development and manufacturing plant in north Tampa for years, but about 2001 it decided to move some managers and research teams to its headquarters in Rochester, N.Y. Butler, who was an executive in charge of strategy, and several other Bausch & Lomb executives were so sour on moving to Rochester that they broke off and formed their own company.

Butler and Sirion's chief medical officer, Roger Vogel, initially formed a company called Acsentient that licensed and marketed ophthalmic drugs. Shortly after the company formed, the venture capital market dried up and money for expansion grew tight.

'We had the unfortunate timing of trying to raise capital right before September 11,' Butler said.

Regrouping, they decided to change course until the economy came back. They launched a consulting company called Rx Development Resources in Tampa in 2003, which developed business models for tiny pharmaceutical companies and helped them with their clinical tests.

In November 2005 - with the venture capital market back in force - Butler and Vogel took another stab at forming a drug company, and the money began to pour in.

They won a $5 million investment from a subsidiary of the big Raleigh, N.C.-based drug services firm Quintiles Transnational in February 2006. Seven months later, Sirion landed $25 million from North Sound Capital of Greenwich, Conn., and in April it landed another $45 million from Aisling Capital of New York and other firms. The $75 million total is believed to be one of the highest venture capital amounts ever invested in an ophthalmic drug company.

Andrew Schiff, a physician and executive of Aisling Capital, said Sirion was attractive because its drugs are in the late stages of testing and target eye diseases or conditions afflicting a huge number of people.

'These folks have very strong backgrounds, a lot of background and experience in developing and getting drugs approved,' Schiff said.

Getting Ready To Go Public

For now, Sirion is ramping up its Tampa operations in anticipation of winning FDA approval, adding up to two employees a week. Its Tampa workers include teams who do sales and marketing, accounting and help steer drugs through clinical trials. Where it used to just license drugs from other companies, it has now bought a lab in San Diego to develop its own drug compounds, Butler said.

Today, the management team owns just 13 percent of Sirion, with the venture capitalists owning the rest. The VC firms also hold four of the company's seven board seats.

At this point, with Sirion close to submitting its drugs for federal approval, becoming a public company is the best way to help it grow, Butler said. The company may hold an IPO as early as the first half of 2008.

'When a lot of the uncertainty's beaten out of a company, it's time to go public,' he said.

Reporter Michael Sasso can be reached at (813) 259-7865 or msasso@tampatrib.com.

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