Articles

E-mail RSS

Watson Pharmaceuticals, Inc. WPI, a leading specialty pharmaceutical company, announced recently that the U.S. Food and Drug Administration has approved MIXJECT, the new delivery system for TRELSTAR (triptorelin pamoate for injectable suspension), a palliative treatment for advanced prostate cancer. MIXJECT, developed and manufactured by Medimop Medical Projects Ltd. a subsidiary of West Pharmaceutical Services, Inc., combines the proven efficacy of TRELSTAR DEPOT 3.75 mg and TRELSTAR LA 11.25 mg with new features that make preparation, administration and disposal easier.

These new features include: a smaller 21-gauge needle for improved patient comfort; reconstitution without the use of a needle; and a shield covering the needle both before and after drug administration. The system is specifically designed to encourage compliance with OSHA (Occupational Safety and Health Administration) regulations within the medical community.

"At Watson, we understand what matters most for the physicians who prescribe our products and for the patients whose lives are impacted by them. Through these types of innovations, we are committed to developing effective, safe and convenient treatments that improve the lives of patients with urological conditions," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "The new MIXJECT drug delivery system was designed with a smaller needle size and updated features that promote OSHA compliance based on the needs and suggestions from our customers in collaboration with our partner, West."

About TRELSTAR
TRELSTAR is a synthetic hormone known as a luteinizing hormone releasing hormone (LHRH) agonist, which suppresses the production of testosterone in the testicles. The growth of the prostate is regulated in part by the level and activity of testosterone. TRELSTAR is available in a 4-week depot formulation (TRELSTAR DEPOT) and a 12-week long-acting formulation (TRELSTAR LA), offering an alternative treatment for prostate cancer when orchiectomy (removal of the testicles) or estrogen administration are either not indicated or unacceptable to the patient. TRELSTAR does not require refrigeration and should be stored at controlled room temperature.

TRELSTAR offers reliable, sustained testosterone suppression and durable reduction in PSA (prostate-specific antigen) levels. Clinical studies with patients receiving TRELSTAR demonstrated that greater than 94 percent of all patients maintained castrate testosterone levels (50 ng/dL) from months two through nine. In that time period, the mean testosterone concentrations were maintained below 20 ng/dL in 96 percent of patients treated with TRELSTAR(R) DEPOT and 92 percent treated with TRELSTAR LA. PSA levels in these studies also were reduced by 97 percent through month nine. Patients participating in clinical trials reported that TRELSTAR administration was well tolerated, with a low incidence of injection site pain.

Important Safety Information
In clinical trials, the most common adverse events occurring in patients were hot flushes, skeletal pain, impotence and headache. As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels and may initiate or worsen symptoms during this transient period. Rare post-marketing reports of anaphylactic shock and angioedema have been reported. TRELSTAR is contraindicated for use in women who are or may become pregnant. For additional information, please discuss with your physician or contact Watson Medical Communications at 866-75-J3315.

About Prostate Cancer
Prostate cancer is the most common cancer in men in the U.S., excluding skin cancer, and is estimated to account for 25 percent of all new cancers diagnosed in men. According to the American Cancer Society, approximately 186,320 new cases of prostate cancer are expected to be diagnosed in 2008 in the U.S.; 28,660 men with prostate cancer are expected to die this year(1). The majority of cases diagnosed are in men over the age of 65. Prostate cancer can be detected early through regular digital rectal examinations and PSA testing. Low PSA levels typically are found in the blood of healthy men; the amount of PSA in the blood normally increases in the presence of prostate cancer.

About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

For more information, visit Watson Pharmaceuticals' Web site at www.watson.com.

About West
West is the world's premier manufacturer of components and systems for improving the safety and effectiveness of therapeutic and diagnostic health care delivery systems. This includes ready-to-sterilize and ready-to-use stoppers and seals for vials, plungers and other prefillable syringe components and an assortment of safety, reconstitution and delivery system capabilities and services. The Company also provides products with application to the personal care, food and beverage markets. West's customers include the world's leading pharmaceutical, biotechnology, generic drug and medical device producers. Headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and Australia. For more information, visit West at westpharma.com.

(1) American Cancer Society. Cancer Facts & Figures 2008. Atlanta: American Cancer Society; 2008. Page 10.

SOURCE: Watson Pharmaceuticals, Inc.