FDA Approves MIXJECT(TM), a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceuticals, Inc.'s TRELSTAR(R) DEPOT and TRELSTAR(R) LA
Published: Apr 30, 2008
CORONA, Calif., April 30 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has approved MIXJECT(TM), the new delivery system for TRELSTAR(R) (triptorelin pamoate for injectable suspension), a palliative treatment for advanced prostate cancer. MIXJECT(TM), developed and manufactured by Medimop Medical Projects Ltd. a subsidiary of West Pharmaceutical Services, Inc., combines the proven efficacy of TRELSTAR(R) DEPOT 3.75 mg and TRELSTAR(R) 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(TM) 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."
TRELSTAR(R) 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(R) is available in a 4-week depot formulation (TRELSTAR(R) DEPOT) and a 12-week long-acting formulation (TRELSTAR(R) 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(R) does not require refrigeration and should be stored at controlled room temperature.
TRELSTAR(R) offers reliable, sustained testosterone suppression and durable reduction in PSA (prostate-specific antigen) levels. Clinical studies with patients receiving TRELSTAR(R) 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(R) LA. PSA levels in these studies also were reduced by 97 percent through month nine. Patients participating in clinical trials reported that TRELSTAR(R) 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(R) 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.
The mission of Watson Urology is to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are creating the differences that make life more livable.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.
MIXJECT(TM) is manufactured by and is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc.
(1) American Cancer Society. Cancer Facts & Figures 2008. Atlanta: American Cancer Society; 2008. Page 10.
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611,
or Rashelle Isip of Ogilvy Public Relations, +1-212-880-5354, for Watson
Web site: http://www.watsonpharm.com/