PARSIPPANY, N.J., May 2, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced the U.S. commercial launch of Generess Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) 0.8 mg/25 mcg, a new low-dose oral contraceptive option that's highly effective at preventing pregnancy and proven to provide users with short, lighter, predictable periods.
(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)
Generess Fe offers a once-daily 24/4 dosing regimen. Extending the duration of the active combined oral contraceptive treatment from 21 to 24 days and decreasing the drug-free interval to 4 days has been proven to decrease overall bleeding, especially withdrawal bleeding. In clinical trials, women taking Generess Fe experienced shorter periods that decreased in length over time. In addition, for many women taking Generess Fe, periods were more predictable withdrawal bleeding typically began on Day 27, and the incidence of breakthrough bleeding decreased over time.
As part of the Generess Fe launch, Watson has created a unique "I am Generess" patient support program. The "I am Generess" program caps participant cost for the new oral contraceptive at $25 per prescription, while also donating $5 in the patient's name to their choice or choices of certain women's charities. The charities currently included in the "I am Generess" program are:
- The Rape, Abuse & Incest National Network (RAINN), the nation's largest anti-sexual violence organization and operator of the National Sexual Assault Hotlines;
- The National Coalition Against Domestic Violence (NCADV), whose mission is to organize for collective power by advancing transformative work, thinking and leadership of communities and individuals working to end the violence against women and children; and
- The Society for Women's Health Research (SWHR), the nation's only non-profit organization whose mission is to improve the health of all women through research.
"Thanks to the support of the 'I am Generess' program, women can make a difference in the fight against sexual violence with RAINN. Since 1994, RAINN has helped over 1.5 million people through the National Sexual Assault Hotlines and educated millions about sexual violence through our public awareness programs. By choosing RAINN when women fill their monthly prescription, they can empower thousands of women to take the first step towards recovery, reclaim their lives, and ensure that no one has to go it alone," said Katherine Hull, spokesperson for RAINN.
"The National Coalition Against Domestic Violence is excited to partner with Watson and the 'I Am Generess' program. In order to stop violence in the home, we need everyone to take a stand and take action. This program will provide critical information to people who need it and support to NCADV to help us reach our vision of every home a safe home," said Rita Smith, Executive Director, NCADV.
"The Society for Women's Health Research is pleased to be a recipient of charitable donations through the Generess program. These donations will help SWHR to continue its mission to improve the health of women through research that investigates how sex differences affect health andthrough educational programs that inform women, health care providers, and policy makers about contemporary women's health issues," said Jo Parrish, VP Institutional Advancement, SWHR.
Details about Generess Fe and the "I am Generess" program are available at www.generess.com.
Proven Highly Effective, Safe and Well Tolerated
Generess Fe was studied in a multicenter, non-comparative, open label study with a treatment duration of 12 months. In 1,677 women aged 18-46, Generess Fe was proven effective in preventing pregnancy, with a Pearl Index of 2.01 pregnancies per 100 women-years of treatment.
Weight increase while taking Generess Fe was reported in only 2.3% of patients. In addition, a low number of women (0.3%) stopped taking GENERESS Fe due to a decrease in libido.
Important Safety Information
Women who are over 35 years old and smoke should not use Generess Fe. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
Generess Fe is contraindicated in pregnant patients, and those with a high risk of arterial or venous thrombotic disease, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, or liver disease. Use of Generess Fe should be stopped if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Generess Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, Generess Fe treatment should be discontinued. Generess Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic, should be monitored while using Generess Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Generess Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated. The most commonly reported adverse events associated with the use of GENERESS Fe included nausea/vomiting, headaches/migraine, depression/mood complaints, dysmenorrhea, acne, increased weight, breast pain/tenderness and anxiety. Generess Fe will not protect against HIV infection (AIDS) or other sexually transmitted diseases.
About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," " intends, " "believes," "expects," "anticipates," "potential," "could," "would," "should," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations, including Medicaid; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; the ability to obtain and enforce patents and other intellectual property rights; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Watson's reports filed with the SEC, including, but not limited to, their respective quarterly reports on form 10-Q for the quarter ended March 31, 2011 and Annual Reports on Form 10-K for the year ended December 31, 2010. Watson does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
CONTACTS:
Investors:
Patty Eisenhaur
(862) 261-8141
Media:
Charlie Mayr
(862) 261-8030
SOURCE Watson Pharmaceuticals, Inc.
