Healthcare Industry News:  Age-related Macular Degeneration 

Biopharmaceuticals Ophthalmology Mergers & Acquisitions

 News Release - September 18, 2006

Sirion Therapeutics, Inc. Combines With Tenby Pharma Inc.

Tenby Pharma Emerges with $25 Million in Financing

TAMPA, Fla., Sept. 18 (HSMN NewsFeed) -- Tenby Pharma Inc. announced today its acquisition of Sirion Therapeutics, Inc. as a wholly owned subsidiary. From Tenby Pharma's inception until the consummation of the Sirion acquisition, Tenby Pharma was a shell company with no business or operations and only nominal assets. Pursuant to the transaction, Sirion's former stockholders acquired control of Tenby Pharma and Tenby Pharma became the parent holding company for Sirion and its businesses. Additionally, in connection with the transaction, Tenby Pharma secured $25 million in financing from funds affiliated with North Sound Capital LLC to develop and commercialize the Sirion portfolio of products.

It is anticipated that Tenby Pharma will undergo a name change to Sirion Holdings, Inc. Barry Butler, President and CEO of Sirion Therapeutics, Inc., has been appointed to serve as President and CEO of Tenby Pharma. Kevin J. Kinsella of Avalon Ventures, Kenneth J. Widder, MD, former Chairman and CEO of Sytera, Roger Vogel, MD, Chief Medical Officer of Sirion Therapeutics, and Barry Butler have been appointed to serve as the initial Board of Directors of the combined companies.

Barry Butler said, "Sirion's initial financial backers, NovaQuest (a division of Quintiles Transnational Corp.), and Avalon Ventures, have been great partners. Their support has allowed us to grow very rapidly. We believe that adding North Sound Capital to our investment team gives us the kind of financial backing we need to continue to advance our strategic goals."

Sirion Therapeutics has been actively consolidating technology and resources in the ophthalmic industry. Prior to the transaction with Tenby, Sirion executed two separate acquisitions. In July 2006, Sirion acquired Sytera, Inc., a biopharmaceutical company, and in August 2006, Sirion acquired Rx Development Resources, LLC, a clinical research organization focused primarily on ophthalmology. Through the acquisition of RxDR, Sirion gained personnel experienced in bringing ophthalmic products to the market. RxDR was founded in 2003 by Barry Butler and Roger Vogel.

Sirion currently has three products in various stages of clinical development:
  • ST-601. ST-601 is a potent ophthalmic steroid emulsion with indications for steroid responsive inflammatory ophthalmic diseases. The company acquired the rights to market ST-601 in the United States through an exclusive license agreement with Senju Pharmaceutical Co., LTD of Japan in April 2006. ST-601 has been studied extensively in Japan, including clinical trials in human subjects. It is anticipated that a Phase III program will be initiated in the first half of 2007.

  • ST-602. ST-602 is a product aimed at reducing the accumulation of lipofuscin in the eye by inhibiting the formation of serum retinol. It is theorized that the accumulation of lipofuscin in the eye is responsible for vision loss in such diseases as dry Age-related Macular Degeneration, geographic atrophy and Stargardt's disease. Sirion acquired the rights to ST-602 through its acquisition of Sytera. It is anticipated that Phase II trials will commence in late 2006.

  • ST-603. ST-603 is a topical preparation of cyclosporine A in the patented Sophisen ophthalmic delivery system. Sirion acquired the rights to market ST-603 in the United States through an exclusive license agreement with Laboratorios Sophia, S.A. de C.V. of Mexico in June 2006. It is anticipated that a clinical program with this product will begin in the first half of 2007.
About Tenby Pharma Inc. and Sirion Therapeutics, Inc.

Tenby Pharma Inc. is a holding company for Sirion Therapeutics, Inc. Sirion Therapeutics is a Tampa, Florida based biopharmaceutical company with offices in La Jolla, California, dedicated to the development and commercialization of innovative ophthalmic products. For more information regarding Sirion, please visit Sirion Therapeutics' website at and see Tenby Pharma's filings with the Securities and Exchange Commission.

Forward-Looking Statements

This press release contains forward-looking statements, including statements relating to our product development schedule, anticipated clinical trials, future capital requirements and other matters. In some cases, you can identify forward-looking statements by terminology such as "may," "might," "will," "should," "intends," "expects," "plans," "goals," "projects," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" or other comparable terminology. These forward-looking statements are only predictions, are uncertain and involve substantial known and unknown risks and uncertainties which may cause actual results to differ materially from the results anticipated by these forward-looking statements. Except as required by applicable law, we do not intend to update any of these forward-looking statements. Among the factors that could cause actual results to differ materially are the following: the success or failure of research and development activities; decisions by regulatory authorities regarding whether and when to approve our drug applications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of our products; difficulties or delays in manufacturing; problems with our relationships with sole-source suppliers; the impact of existing and future regulatory provisions on our products; product liability claims and related legal defense and settlement costs; our ability to protect our patents and other intellectual property; and the impact of acquisitions, divestitures, restructurings or similar events. A further description of these risks, uncertainties, and other matters can be found in Tenby Pharma's most recent Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission and our future Annual, Quarterly and Current Reports on Forms 10-K, 10-Q and 8-K.

Source: Sirion Therapeutics

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