BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Tuesday, 24 December 1996.
The FDA letter cites the information submitted by Matrix to be inadequate and said that the AccuSite application is consequently unapprovable as submitted. The FDA's response raised issues relating to clinical matters (the importance of the persistence of one side effect as it relates to product equivalence, length of patient follow-up, and a potential risk of serious side effects -- though no such side effects were observed in clinical studies), chemistry matters (e.g., expiration dating and sampling plans) and microbiology issues (e.g., filter and equipment sterilization validations). The Company does not view the chemistry or microbiology issues to be serious and feels it can address these issues relatively rapidly. As to the clinical issues, the Company feels it cannot accurately assess these matters until they are discussed with the FDA.
"We will be seeking to meet with the FDA at the agency's earliest convenience to discuss our application for AccuSite," said Craig R. McMullen, president and chief executive officer of Matrix. "While we are continuing to evaluate the FDA's letter, we plan to work with the agency to address their questions."
Matrix originally filed its NDA for AccuSite in September of 1995. In the fall of 1996, the FDA inspected and recommended approval of Matrix's manufacturing facilities.
AccuSite has been approved for marketing in the United Kingdom as a treatment for genital warts and is scheduled to be launched in the United Kingdom in January. AccuSite is under review for marketing approval by regulatory agencies in France, Italy, Sweden and Germany, and in December, 1996, the Company filed for marketing clearance in other European countries under the European Union Mutual Recognition process.
AccuSite is a biodegradable, injectable gel that contains fluorouracil (5-FU) as the active agent. Using Matrix's patented drug delivery technology, AccuSite delivers 5-FU directly to the site of disease and provides for sustained release of the drug at the diseased site.
Genital warts, also known as condyloma acuminata, is a sexually transmitted disease caused by the human papillomavirus (HPV). The limited effectiveness of current therapies, the high rate of recurrence and its association with development of cervical and genital cancers have led to identification of the disease as a major public health concern.
Located in Fremont, Matrix Pharmaceutical, Inc. uses patented drug delivery technologies to develop novel site-specific treatments for cancer and serious skin diseases. Matrix's second product, IntraDose(TM) Injectable Gel, is in a multinational Phase III study for the treatment of head and neck cancers and other accessible tumors. Phase II clinical studies of IntraDose in other indications and clinical trials of additional Matrix products are expected to begin in 1997.
This press release contains certain statements of a forward-looking nature relating to future events such as actions by regulatory authorities. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties. These include the timing and content of decisions of regulatory authorities and other factors and uncertainties set forth under the heading "Risk Factors" in the Company's report on Form 10-Q for the quarter ended September 30, 1996, which could cause actual results to differ materially from those described in the forward-looking statements.
CONTACT: Matrix Pharmaceutical, Inc. Peter Dworkin Senior Director, Investor Relations and Corporate Communications 510/494-7750
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