Apligraf Approved for Use in Diabetic Foot Ulcers; Only PMA-Approved Product Containing Living Human Cells Gains Second Major Indication.

Business Editors & Health/Medical Writers

CANTON, Mass.--(BW HealthWire)--June 20, 2000

Organogenesis Inc. (AMEX:ORG) today announced that the Company's lead product, Apligraf(R), has been approved by the Food and Drug Administration for use in the treatment of diabetic foot ulcers. Apligraf, supplied as a living, bi-layered skin substitute, is the only product containing living human skin cells to have proven efficacy and gained FDA approval for this major medical need. Apligraf can now be marketed for diabetic foot ulcers as well as for its previously approved use, venous leg ulcers, by marketer Novartis Pharmaceuticals Corporation.

Foot ulcers are a leading cause of hospitalization and of amputation among diabetics, responsible for over 50,000 amputations per year. Up to 800,000 people suffer from diabetic foot ulcers in the US alone. The magnitude of the need has led a number of companies to attempt to develop more effective therapies for these wounds. The challenge has been demonstrating efficacy beyond that achievable with standard care alone. Examination of the results of multiple trials found that diabetic ulcer standard care typically heals fewer than one in three diabetic ulcers within twelve weeks.(1)

In a prospective, randomized pivotal trial, use of Apligraf with standard care healed 56% of diabetic ulcers within twelve weeks, compared with 39% for standard care alone. Apligraf also healed the ulcers significantly faster. Average (median) time to closure was 65 days among wounds treated with Apligraf, compared with 90 days for wounds treated using standard care alone. The patients included in the trial had their ulcers at least two weeks prior to entering the study and failed to make good healing progress during the one week screening phase.

"Historically, when patients were not healing with diabetic ulcer standard care, physicians had few additional treatment options," said Michael Sabolinski, MD, Senior Vice President, Medical and Regulatory Affairs, Organogenesis Inc. "When Apligraf was shown to heal significantly more diabetic foot ulcers, faster, than standard care alone, the Food and Drug Administration worked diligently to expedite their thorough review of this submission. We are delighted our technology now provides physicians with a major new treatment option for these potentially serious wounds."

"The FDA approval for marketing of Apligraf for the treatment of diabetic foot ulcers is a major development for patients who suffer from this condition," said Anthony Venditti, Vice President of the Transplant, Tissue Engineering, and Immunology Business Unit of Novartis Pharmaceuticals Corporation. "Novartis is proud to offer this unique and innovative treatment to the diabetes community."

"Achieving this second major indication for Apligraf underscores Organogenesis' unique expertise in designing, developing and gaining PMA marketing approval for a medical product containing living human cells," said Philip M. Laughlin, President and Chief Executive Officer, Organogenesis Inc. "Additionally, we have now proven the opportunity for Apligraf extends beyond venous leg ulcers. Our goal is to submit a PMA supplement for a third use - reduction in scarring after skin cancer surgery - by the end of next year. We are also leveraging this expertise to our other programs and expect to begin pivotal trials with our second living product, the VITRIX(TM) dermal replacement, later this year."

About Apligraf

Like human skin, Apligraf is made of living skin cells and structural protein. The lower dermal layer combines collagen and human fibroblasts (dermal cells), which produce additional structural proteins. The upper epidermal layer is formed by prompting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf does not contain structures such as blood vessels, hair follicles or sweat glands or other cell types such as Langerhans' cells, melanocytes, macrophages or lymphocytes. Novartis Pharma AG has global Apligraf marketing rights. Apligraf should not be used on infected wounds or on patients with known hypersensitivities to any component of Apligraf. Complete prescribing information is available upon request.

About Organogenesis Inc.

Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective tissue. The Company's product development focus includes living tissue replacements, cell-based organ assist devices and other tissue-engineered products. The Organogenesis research pipeline includes the VITRIX(TM) living dermal replacement product, a coronary vascular graft and a liver assist device.

Statements in this press release which are not historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. There can be no guarantee that the Apligraf skin surgery pivotal trial will be successfully completed or that a PMA supplement based on that trial will be submitted to the FDA during 2001. There can be no guarantee that the VITRIX pivotal trial program will begin in 2000. Apligraf(R) is a registered trademark of Novartis.

(1)Margolis DJ et al., Diabetes Care 1999, 22:692-695.