Sanofi-Aventis Announces Commercial Availability Of Twice-Yearly ELIGARD(R)
BRIDGEWATER, N.J., Feb. 17 /PRNewswire-FirstCall/ -- The sanofi-aventis Group announced today the commercial availability in the United States of ELIGARD 45 mg (leuprolide acetate for injectable suspension) the first six- month injectable hormonal therapy for the palliative treatment of advanced prostate cancer patients. ELIGARD 45mg was approved by the U.S Food and Drug Administration on December 16, 2004, as a new option for the palliative treatment of advanced prostate cancer.
"The recent FDA approval of a six-month dosage form of ELIGARD 45mg is significant news for advanced prostate cancer patients and their physicians. ELIGARD effectively lowers testosterone and prostate-specific antigen (PSA) levels, thus providing patients with the added convenience of needing only two injections per year," said Oliver Sartor, M.D., Director of the Stanley Scott Cancer Center and Chief of the Hematology/Oncology Section at the Louisiana State University Health Sciences Center. "This new formulation will be of interest to those physicians who treat advanced prostate cancer patients by providing them with a new option to tailor the management of this condition to their patients' lifestyles."
ELIGARD 45 mg, a luteinizing hormone-releasing hormone (LHRH) agonist, is injected under the skin (subcutaneously) with a small-gauge needle. Once injected, it forms a solid bead that slowly releases ELIGARD's active substance, leuprolide acetate, over the course of six months. With the six-month formulation physicians and patients now have the flexibility to choose a more convenient formulation.
"Patients who can benefit from the six-month formulation of ELIGARD include those who express a desire for fewer injections, travel a great deal or may be away from home for long periods, patients with restrictive work schedules, and those who live far from their physician's office or have transportation difficulties," said Oliver Sartor, M.D., Director of the Stanley Scott Cancer Center and chief of the Hematology/Oncology Section at Louisiana State University Health Sciences Center. "Although this formulation offers physicians and patients greater convenience, it is still important for patients to see their physicians on a regular basis for overall management of advanced prostate cancer."
About the Clinical Trial
The FDA approval was based on data from an open-label, multicenter clinical trial involving 111 advanced prostate cancer patients. ELIGARD 45 mg was administered once every six months as monotherapy for 12 months. Five of the patients in the clinical trial had stage A disease, 43 had stage B, 19 had stage C, and 44 had stage D. Two patients withdrew by Day 29.
The efficacy of ELIGARD 45 mg was measured by its ability to achieve and maintain castrate serum testosterone suppression over the 12-month study period. Serum testosterone was suppressed to below castrate threshold (less than or equal to 50 ng/dL) by Day 28 in 108 of the 109 (99.1 percent) patients.
A total of 106 patients enrolled in the clinical study received both injections of ELIGARD 45 mg. Once castrate suppression was achieved, only one patient experienced an increase or breakthrough of serum testosterone (>50 ng/dL) during the study. All five nonevaluable patients who achieved castration by Day 28 of the study maintained castration until withdrawing from the study. One hundred and three of the 111 patients initially enrolled completed the clinical trial.
The most frequently reported adverse events were hot flashes, fatigue, testicular atrophy, and transient (lasting for one minute or less) burning/stinging at the injection site. The majority (70%) of the hot flashes were mild.
ELIGARD should not be used by women, children, or anyone who is allergic to the drug leuprolide acetate or any of the ingredients of ELIGARD. Like other LHRH agonists, ELIGARD causes a transient increase in serum concentrations of testosterone during the first two weeks of treatment. Patients may experience worsening of existing symptoms or new symptoms in the first few weeks of treatment including bone pain, nerve damage, blood in the urine, or difficulty urinating. However, within 2 to 4 weeks patients experience a reduction of blood serum testosterone levels.
ELIGARD 45 mg uses the ATRIGEL(R) drug delivery system to provide continuous release of leuprolide acetate over the six-month treatment period. The ATRIGEL drug delivery system consists of a biodegradable polymer mixed with the active drug just prior to administration. The mixture is injected just under the skin as a viscous liquid. The liquid quickly solidifies into a bead of medication that slowly dissolves to release a continuous supply of leuprolide acetate for the six-month period.
The sanofi-aventis Group currently markets several formulations of the LHRH agonist in the U.S. including ELIGARD one-month (7.5 mg), three-month (22.5 mg), and four-month (30 mg) extended-release products. This family of products will continue to be available for the palliative treatment of advanced prostate cancer.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications, is available by calling sanofi-aventis Product Information at 1-800-446-6267.
Prostate cancer is the most common cancer (excluding skin cancer) of American men. It's estimated that about 231,000 new cases of prostate cancer will be diagnosed in the United States, and 30,000 men will die of this disease this year.( ) Moreover, prostate cancer is more common among African American men than white men, and African American men are more than twice as likely to die from the disease.
The chance of developing prostate cancer increases as a man ages. Men over the age of 65 make up more than 70 percent of new prostate cancer cases. Because prostate tumors differ greatly in their stage at diagnosis, degree of aggressiveness, rate of progression, and impact on men's lives, no single treatment plan fits all men diagnosed with prostate cancer.
The sanofi-aventis Group is the world's 3rd largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York .
The sanofi-aventis Group conducts business in the U.S. through its affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by Sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
U.S. Contact: Marisol Peron, 908-243-7592,
CONTACT: Marisol Peron of sanofi-aventis, +1-908-243-7592,Marisol.Peron@sanofi-aventis.com
Web site: http://www.sanofi-aventis.com/
Company News On-Call: http://www.prnewswire.com/comp/232375.html