Watson launches Generess Fe low-dose oral contraceptives in the U.S.

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.

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 and through educational programs that inform women, health care providers, and policy makers about contemporary women's health issues," said Jo Parrish, VP Institutional Advancement, SWHR.

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.

Source:

Watson Pharmaceuticals, Inc.

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