News | October 25, 1999

Genzyme to Market Focal Sealants in NA

Genzyme Surgical Products today announced an agreement under which it will distribute and sell Focal Inc.'s surgical sealants in the North American market following FDA approval. Genzyme will have rights to Focal's products for use in thoracic, cardiovascular, and gastrointestinal surgeries.

Focal is developing a family of FocalSeal surgical sealants, which are biomaterials products designed for use inside the body to seal air and fluid leaks resulting from surgical procedures.

"We are very pleased to be collaborating with Focal to bring its first product to the market in North America," said Duke Collier, president of Genzyme Surgical Products. "Genzyme Surgical Products and Focal are among the leaders in the development of a new generation of sophisticated biomaterials. Our relationship with Focal will strengthen the portfolio of these biomaterials products that we can offer to surgeons and is consistent with our focus on bringing a new generation of products to the cardiothoracic market. This agreement also demonstrates our capacity to derive near-term revenues from products outside of our own pipeline as a result of the strength of our cardiothoracic sales force and our extensive biomaterials experience."

Separately, Genzyme Surgical Products will make a $5 million equity investment in Focal in early November 1999, upon the satisfaction of certain conditions. In addition, Genzyme is committed to make future equity investments of up to $15 million at Focal's option, upon the satisfaction of certain conditions including FDA marketing approval of FocalSeal-L surgical sealant.

In June, Focal completed submission of a Pre-Market Approval (PMA) application for FocalSeal-L surgical sealant, its lead product in the United States. The PMA has been granted expedited review by the FDA. Focal is seeking approval to market the product for use in sealing air leaks following lung surgery.

Genzyme Surgical Products maintains a strong sales presence in the cardiothoracic market, and it expects Focal's lung sealant to complement its portfolio of current products. Genzyme's market-leading Pleur-Evac(R) chest drains and fluid management systems are used in thoracic, cardiovascular, critical care, and trauma surgeries. In addition, Genzyme Surgical Products markets instruments and sutures for use in a wide range of cardiothoracic procedures and has established itself as one of the top competitors in the field of minimally-invasive cardiac surgery.

"We're very excited to establish this strategic partnership with Genzyme Surgical Products," said David M. Clapper, president and chief executive officer of Focal. "Genzyme's well-established and highly-regarded cardiothoracic surgical sales force should significantly enhance the commercial prospects for our products in the United States. Genzyme has tremendous biomaterials marketing experience and a deep biomaterials research and development effort that complements our own."

There is a large, unmet medical need for surgical sealants that can be used as an adjunct to sutures and staples to prevent leakage following surgery. It is estimated that approximately 300,000 lung surgeries are performed each year worldwide, with a significant percentage of patients experiencing air leaks following surgery. As a result, patients may require extended hospitalization, more intensive care, or additional surgical procedures, resulting in substantial additional health care costs.

Wound closure is currently achieved by sutures and staples that facilitate healing by pulling tissues together. However, very often they fail to produce the adequate seal necessary to prevent air and fluid leakage. FocalSeal-L surgical sealant is a synthetic, absorbable, liquid sealant designed to prevent air leaks, including leaks that frequently occur along staple and suture lines on the lungs.

Earlier this year, Focal announced the results of its pivotal U.S. clinical trial of FocalSeal-L surgical sealant for lung surgery. One hundred and eighty patients were enrolled in this trial at Massachusetts General Hospital, the University of Pennsylvania Medical Center, Johns Hopkins Medical Center and Strong Memorial Hospital. The results showed a three-fold difference between the treated group and the control group in the percentage of patients who were leak-free both intra-operatively and post-operatively. In addition, a trend was shown toward earlier chest-drainage tube removal and earlier patient discharge from the hospital in treated patients versus the control group.

Focal is also evaluating the use of a FocalSeal product for several applications in heart surgery and has completed a successful pre-clinical study of the product at the Massachusetts General Hospital.

Genzyme Surgical Products is a leader in the development of biomaterials for adhesion prevention and currently markets several biomaterials products for use in both general and cardiovascular surgery. Genzyme's Seprafilm Bioresorbable Membrane is approved for use in colorectal surgeries and its CV Seprafilm and Sepracoat Coating Solution have been approved in Europe for use in cardiac surgery. Genzyme has initiated a clinical trial in the United States evaluating the use of CV Seprafilm to prevent adhesions following open- heart surgery. Genzyme Surgical Products is also developing biomaterials products for adhesion prevention in several other types of surgery.

Genzyme Surgical Products develops and markets a portfolio of instruments, devices, biomaterials, and biotherapeutics primarily for the cardiovascular and general surgery markets. It is pioneering the field of "biosurgery," which is being created by the increasing convergence of mechanical and biological approaches to surgery and other interventional procedures. A division of the biotechnology company Genzyme Corporation, Genzyme Surgical Products has its own common stock intended to reflect its value and track its economic performance.

Focal Inc. develops, manufactures and commercializes synthetic, absorbable, liquid surgical sealants, tissue coatings and local drug delivery products based on the company's proprietary polymer technology. The company's FocalSeal-L and FocalSeal-S surgical sealant products are currently being developed for use inside the body to seal leaks resulting from pulmonary surgery, neurosurgery, cardiovascular and gastrointestinal surgery. FocalSeal products are marketed outside of North America by Ethicon Inc., a Johnson & Johnson company.

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