Medeva PLC Reports New Drug Application Submitted in U.S. for Bladder Cancer Treatment AD32.

LONDON--(BUSINESS WIRE)--January 8, 1997--Medeva PLC (NYSE:MDV), the international pharmaceutical company, today announced that a New Drug Application has been filed with the US Food & Drug Administration for AD32, its new treatment for bladder cancer. The regulatory filing has been made by Anthra Pharmaceuticals Inc. ("Anthra") from whom Medeva acquired the exclusive US marketing rights to AD32 in July 1997.

Commenting on the announcement, Medeva's Chief Executive Dr. Bill Bogie said, "AD32 is one of our four lead development projects and we are pleased to be passing this milestone on schedule. In the USA, bladder cancer is normally treated by urologists, a focused group of about 7,000 physicians and an ideal target group for Medeva's US niche marketing strategy."

The filing is for a first indication, using AD32 to treat refractory carcinoma-in-situ ("CIS") of the bladder. On approval the drug will receive "orphan drug" status for this indication conferring a seven year period of marketing exclusivity. Clinical trials for treating papillary cancer, are currently in progress with a license submission planned for early 2000.

Background

Bladder cancer can be categorized into three classifications: papillary tumors, carcinoma-in-situ and metastatic or invasive cancer. Papillary tumors are localized tumors which can be surgically removed via transurethral resection of the bladder. Papillary tumors of the bladder comprise approximately 80% of all new bladder cancer cases diagnosed each year in the USA. When diagnosed at a localized/papillary stage, the five year survival rate is 93%.

CIS constitutes 15-20% of all new bladder cancer cases diagnosed each year in the USA. CIS is a regional cancer which is routinely treated with BCG by installation of the drug into the bladder (intravesicular). Patients respond favorably to BCG approximately 70% of the time. However some 30% do not respond and some of these non-responders have their bladder removed (cystectomy). The five year survival rate for CIS is 49%. Metastatic or invasive cancer is a relatively rare but serious cancer which is often treated with intravenous chemotherapy and/or radiation and/or cystectomy. The five year survival rate for metastatic/invasive cancer of the bladder is 6%.

An estimated 54,000 new cases of bladder cancer are diagnosed annually in the USA. Approximately 10,000 patients have cystectomies each year, half of which are performed following unsuccessful BCG treatment. Of these 5,000, about 60% are potential candidates for bladder salvage therapy with AD32. A six dose intravesicular treatment course of AD32 for these candidates represents a potential market of $15-18 million per annum. An additional 145,000 patients with papillary bladder tumors are potential candidates for treatment using AD32 upon approval of the secondary indication representing a market of some $145 million.

Studies involving patients with CIS refractory to other therapies have demonstrated the drug's activity in this setting. Successful treatment can enable patients to be spared radical surgery.

Medeva PLC is an international company developing, manufacturing and marketing prescription pharmaceutical products in the following main therapeutic areas: respiratory care, vaccines, CNS therapies (attention deficit disorder and anti-obesity), gastroenterology and hospital products (pain management and anaesthetics). In the UK, Medeva is the sole producer of human vaccines, including flu, childhood and traveler's vaccines. In the US, Medeva is the leading manufacturer and distributor of methylphenidate. Medeva also has operations in France, Spain, Belgium, Republic of Ireland and a further subsidiary in Switzerland specializing in gastro-intestinal products.

Medeva's ordinary shares trade on the London Stock Exchange and its ADRs, each equal to four ordinary shares, trade on the New York Stock Exchange under the symbol MDV. Additional information on Medeva can be accessed on the company's home page: http://www.medeva.com

CONTACT: Medeva PLC

Dr. Michael Young, Dr. Terry Coyne,

Alexandra Hockenhull, 011-441-71-839-3888

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Taylor Rafferty Associates

James P. Prout, 212-889-4350