Zeneca receives FDA clearance for Zoladex 3-month 10.8 MG depot for treatment of advanced prostate cancer.

WILMINGTON, Del.--(BUSINESS WIRE)--January 12, 1996--Zeneca Inc. today announced that Zeneca Pharmaceuticals has received clearance from the Food and Drug Administration to introduce a new formulation of Zoladex(R) (goserelin acetate implant) for the palliative treatment of advanced prostate cancer(a).

The new formulation, a 10.8-mg goserelin acetate implant given every 3 months, offers greater convenience to patients choosing treatment with a luteinizing-hormone-releasing hormone (LHRH) analogue.

Since 1989, Zoladex has been available as a monthly implant. The growth of prostate cancer can be stimulated by the male hormone testosterone. Treatment with Zoladex as a subcutaneous injection results in a decline in testosterone, which then reduces stimulation of hormone-responsive prostate tumors.

The original 3.6mg formulation of Zoladex was shown to be as effective as orchiectomy (surgical castration) in controlling the spread of prostate cancer, thus offering men a choice between medical treatment and surgery. In controlled studies of patients with advanced prostate cancer, the Zoladex 10.8mg formulation produced pharmacodynamically similar effect in terms of testosterone suppression to that achieved with the 3.6mg formulation.

Zoladex has been found to be generally well tolerated in clinical trials. The most frequently reported adverse events in clinical trials with the 10.8mg formulation were hot flashes and pain (general).

(a) Full prescribing information available on request.

Prostate cancer is the most common cancer (other than certain skin cancers) among men in the United States. According to the American Cancer Society, some 244,000 men will be diagnosed with the disease in 1995, and 40,400 men will die of it.

W. James O'Shea, Vice President, Sales and Marketing, Zeneca Pharmaceuticals, said: "This new formulation of the Zoladex implant may make treatment easier for the thousands of men on medical treatment for advanced prostate cancer who currently must visit their doctors every month for routine care. The three-month formulation represents another effort by Zeneca to offer cancer patients new therapeutic options. The Zoladex three-month depot also represents a considerable technological achievement, given the difficult and complex manufacturing process for Zoladex."

The 1-month Zoladex 3.6mg depot was recently cleared by the FDA for the treatment of advanced breast cancer in premenopausal and perimenopausal women. Since 1993, Zoladex has also been marketed for the treatment of endometriosis, a noncancerous gynecological condition affecting an estimated 5 million women in the US. Sales of Zoladex in the US exceeded $60 million in 1994. Worldwide sales of Zoladex were close to $316 million in the same year.

Zeneca Pharmaceuticals currently ranks No. 2 worldwide in sales of anticancer products and intends to grow further with its commitment to providing improved treatments for the common solid tumors. In 1994, Zeneca spent 25 percent of its $466 million R&D expenditure in this growing therapeutic area.

Zeneca Pharmaceuticals is a business unit of Zeneca Inc. In the US, Zeneca is a $2.5 billion bioscience company with 6,500 employees and 45 manufacturing and research and development sites in 29 states. Zeneca is part of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $6.9 billion international bioscience business.

Background information

Prostate cancer is sensitive to the male hormone testosterone and responds to treatments that remove their source or reduce their concentration in the circulation. Most testosterone is produced in the testicles, and surgical castration (orchiectomy) is a standard treatment for prostate cancer that has spread beyond the prostate capsule. However, many men with advanced prostate cancer prefer to avoid surgery or the disfigurement caused by removal of the testicles.

Zoladex is an analogue of naturally occurring LHRH. Continuous administration of Zoladex results in a significant decline in testosterone production by the testicles. This reduces testosterone stimulation of prostate cancer growth.

The 3-month formulation of Zoladex is a cylindrical implant with a 1.5-mm diameter that contains 10.8 mg of goserelin. Given by subcutaneous injection, the biodegradable implant slowly dissolves, delivering therapeutic levels of the drug continuously over a period of 12 weeks.

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