Ciba, Chiron and Focal Announce Collaboration to Prevent Restenosis.

SUMMIT, N.J./EMERYVILLE, Calif./LEXINGTON, Mass.--(HealthWire)-- May 2, 1996--Ciba Pharmaceuticals, Chiron Corporation (NASDAQ: CHIR) and Focal, Inc., today announced a collaborative agreement in the area of restenosis, the reclosure of arteries following angioplasty.

The collaboration will develop novel products designed to prevent restenosis by combining candidates from Ciba's and Chiron's cardiovascular drug pipeline with Focal's unique drug delivery technology.

The worldwide agreement provides for research funding, milestone fees and future royalty payments on product sales to be made to Focal. Under the terms of the agreement, both Ciba and Chiron will receive exclusive rights in selected restenosis fields to Focal's technology for their respective drug compounds entered into the research program. Ciba or Chiron will be responsible individually for developing and marketing the resulting products and Focal will retain manufacturing rights for the final product. Ciba and Chiron will jointly provide funding for certain preclinical studies, after which each company will fund development for its own products. A steering committee composed of representatives from Focal and Ciba or Chiron, depending on product ownership, will direct the research, development and commercialization partnership on a compound-by-compound basis.

Coronary artery disease is the leading cause of death in the U.S. Annually, over 700,000 patients worldwide have an angioplasty procedure performed to increase blood flow through their obstructed coronary arteries. Within several months, approximately 40 percent of these patients will experience restenosis, in which the coronary arteries significantly reocclude, or close, leading to increased morbidity and mortality.

To date, drug therapy alone has not been effective in preventing restenosis. Therefore, additional procedures such as repeat angioplasty to reopen affected arteries or coronary artery bypass surgery to create new vasculature have to be performed. This poses additional risk to patients while increasing physician and hospital costs. A safe and effective drug treatment that can be administered at the time of the initial angioplasty may reduce the occurrence of restenosis along with its associated costs and risks.

Focal's investigational approach to preventing restenosis is to coat the interior wall of the coronary artery with a formulation of its proprietary biodegradable gel together with Ciba's or Chiron's drug. Focal has developed a proprietary fiber-optic, double-balloon catheter for depositing the gel/drug combination at the precise site of the angioplasty injury. A light source in the catheter activates the photosensitive gel, causing it to adhere to the interior wall of the coronary artery. As the gel degrades, the drug is slowly released over time. The theory is that, because of the local administration and the resulting concentration of the drug at the treatment site, only a fraction of a systemic dose is required, and it is anticipated that the gel/drug combination may be more effective and may have fewer side effects than systemically administered drugs.

"Restenosis is an area with clearly unmet medical needs," said Alan J. Main, PhD, senior vice president of research, Ciba Pharmaceuticals. "Our agreement with Chiron and Focal will help put us in a strong position to develop drugs to prevent restenosis using a novel local delivery system. In doing so, we will be continuing our tradition of leadership in cardiovascular research and drug delivery."

"Chiron has an expanding interest in the cardiovascular field driven by potential new products from our own discovery research and several collaborations," said Lewis T. Williams, MD, PhD, president of Chiron Technologies. "Local delivery of new anticoagulants or antiproliferative agents may enhance the efficacy and maximize the safety of these products."

"This collaboration enables Focal to apply its unique delivery approach to a variety of drugs under development at both Ciba and Chiron," indicated Glenn Kazo, vice-president of corporate development, Focal. "Assuming project milestones are met, Focal would receive significant research funding and payments from this three-way deal," Kazo added.

Ciba Pharmaceuticals, headquartered in Summit, N.J., is a division of Ciba-Geigy Corporation of Tarrytown, N.Y., a wholly owned subsidiary of Ciba-Geigy Limited of Basel, Switzerland. Ciba is a leading developer and manufacturer of health-care and agricultural products and specialty chemicals for industry. Ciba Pharmaceuticals is dedicated to discovering, developing, manufacturing and marketing innovative pharmaceuticals that meet unmet medical needs and improve patients' quality of life.

Chiron Corporation is a science-driven healthcare company that combines diagnostic, vaccine, and therapeutic strategies for controlling disease. Headquartered in Emeryville, California, near San Francisco, and with operations on four continents, Chiron had revenues in 1995 of more than $1 billion. Chiron participates in four global healthcare markets: diagnostics, including immunodiagnostics, critical care diagnostics and new quantitative probe tests; therapeutics, with an emphasis on oncology and infectious disease; pediatric and adult vaccines; and ophthalmic surgical products for the correction of vision. Chiron also has research programs underway in gene therapy, combinatorial chemistry, cancer, infectious and cardiovascular disease and critical care through its Chiron Technologies business unit.

Focal, Inc., headquartered in Lexington, Massachusetts, develops novel medical products and devices based on its synthetic, bioabsorbable polymer technology. In addition to pursuing local delivery of pharmaceuticals, the company is developing a family of surgical sealants which are designed to augment or replace sutures and staples used in wound closure. Clinical studies for a product to seal air leaks associated with lung surgery are expected to begin later this year.

CONTACT: Ciba contacts: Mary-Frances Faraji

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Joseph Schepers

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Chiron contact: Larry Kurtz

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Focal contact: Glenn Kazo

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