Teva Admits to Making False Statements in US Gianvi™ Label and Agrees to Corrective Measures

WAYNE, N.J., June 17 /PRNewswire/ -- In a June 16, 2010 proceeding before Judge Virginia Kendall in US Federal Court in the Northern District of Illinois, Teva Pharmaceuticals USA Inc. admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi™, falsely claimed that the ethinyl estradiol in the product was stabilized by Bayer's  patented "betadex as a clathrate" formulation, and in fact, that Gianvi does not have Bayer's patented stabilization formulation.  Gianvi is Teva's product and is sold as a generic version of Bayer HealthCare's leading oral contraceptive YAZ® (drospirenone & ethinyl estradiol).

In response to Bayer's motion for a temporary restraining order and at the end of the hearing before Judge Kendall on the motion, Teva agreed to correct the false label by sending weekly e-mail or fax messages to US pharmacists nationwide for a period of three months.  The e-mail or fax messages to pharmacists will provide corrected Physician Prescribing Information that removes the false claim that the ethinyl estradiol in Gianvi is stabilized by betadex as a clathrate and calls the pharmacist's attention to this corrective label change.

Teva also agreed not to ship any additional Gianvi product containing promotional materials, package inserts or any other material falsely claiming that the ethinyl estradiol in Teva's Gianvi is stabilized by betadex as a clathrate. Teva reported that it has already provided the US Food and Drug Administration (FDA) with corrected Physician Prescribing Information for Gianvi and that it has corrected the Gianvi label information on the Teva USA website.

Finally, Teva agreed to send, by e-mail or fax, the corrected Physician Prescribing Information to all known wholesalers, distributors and chain retailers that received Gianvi, and direct them to the label change.

As a result of Teva's agreement to take measures Bayer requested in its emergency motion, the Court denied Bayer's motion for a temporary restraining order without prejudice as moot.  Teva was ordered by Judge Kendall to file a compliance report on its progress on these actions by 5:00 pm on Friday, June 18, 2010.  

Bayer is pleased with the Court's decision and is committed to vigorously enforcing its intellectual property.  Bayer has also filed suit against Teva for patent infringement in the states of Delaware and Nevada.  

About Use of Betadex as a Clathrate

YAZ contains drospirenone and ethinyl estradiol.  In YAZ, the ethinyl estradiol is enclosed within a beta-cyclodextrin (betadex) clathrate.  A clathrate is a molecule that forms a "cage" around another molecule or molecules.  The betadex clathrate in YAZ is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation.  This patented technology enhances the product's shelf life.  

About YAZ®

YAZ (drospirenone & ethinyl estradiol) is indicated for:

• The prevention of pregnancy in women who elect to use an oral contraceptive.
• Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.
• The effectiveness of YAZ for PMDD when used for more than 3 menstrual cycles has not been evaluated. YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).
• Treatment of moderate acne vulgaris
• In women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of moderate acne only if the patient desires an oral contraceptive for birth control.

Important Safety Information About YAZ

Who Shouldn't Take Any Oral Contraceptives (OCs)? Some women should not use OCs, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant.

In Addition, Who Shouldn't Take YAZ? YAZ each contain drsp®, a different kind of hormone that for some may increase potassium too much. Therefore, you should not take YAZ if you have kidney, liver, or adrenal disease because this could cause serious heart and health problems. Tell your doctor if you are on daily long-term treatment for a chronic condition such as cardiovascular disease or chronic inflammatory disease. Women who take certain drugs (see below) should have their potassium levels checked in the first month of taking YAZ.

What Drugs May Increase Potassium? NSAIDs-ibuprofen (Motrin®, Advil®), naproxen (Naprosyn®, Aleve®, and others) when taken long-term and daily for arthritis or other diseases or conditions, potassium-sparing diuretics (spironolactone and others), potassium supplementation, ACE inhibitors (Capoten®, Vasotec®, Zestril®, and others), angiotensin-II receptor antagonists (Cozaar®, Diovan®, Avapro®, and others), aldosterone antagonists, and heparin.

What Are The Risks Involved With Taking Any Oral Contraceptive (OC)? OCs can be associated with an increased risk of several serious cardiovascular side effects, including blood clots, stroke, and heart attack. Women, especially those 35 and over, are strongly advised not to smoke because it increases these risks. OCs do not protect against HIV infection or other STDs.

The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were present in all YAZ clinical trials included: upper respiratory infection, headache, breast pain, vaginal moniliasis, nausea, abdominal pain, dysmenorrhea, urinary tract infection, accidental injury, sinusitis, emotional lability, suspicious Papanicolaou smear, weight gain, depression, menstrual disorder, and asthenia.

The most frequent (greater than 1%) side effects, which may or may not be related to YAZ, that were either unique to each trial type or occurred in only two types of clinical trials included:

In the contraception trial: leukorrhea, diarrhea, vomiting, vaginitis, flu syndrome, moniliasis, allergic reaction, cystitis, tooth disorder, sore throat, infection, fever, surgery, back pain, migraine, dyspepsia, rhinitis, acne, gastroenteritis, bronchitis, pharyngitis, skin disorder, intermenstrual bleeding, decreased libido, pain, increased cough, dizziness, pain in extremity, and pelvic pain.

In the PMDD trials: intermenstrual bleeding, decreased libido, nervousness, menorrhagia, pain in extremity, migraine, vaginitis, hyperlipidemia, back pain, diarrhea, increased appetite, enlarged abdomen, and acne.

In the acne trials: metrorrhagia, flu syndrome, menorrhagia, gastroenteritis, tooth disorder, infection, vomiting, pharyngitis, sore throat, arthralgia, bronchitis, rhinitis, amenorrhea, and urine abnormality.

Please see full prescribing information at www.yaz-us.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-Looking Statement

This release may contain forward-looking statements which are based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports which are available on our website. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

SOURCE Bayer HealthCare Pharmaceuticals