ZOELY? (nomegestrol acetate/ 17ß-estradiol) Approved in the European Union: A Unique Monophasic Combination Oral Contraceptive
UTRECHT, The Netherlands and WHITEHOUSE STATION, New Jersey, August 2, 2011 (ots/PRNewswire) -- - MSD and Teva Bring Forward New Contraception Option for Women
Teva Pharmaceuticals Europe BV, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. , and MSD (known as Merck in the United States and Canada) , today announced that ZOELY(TM), a new oral contraceptive (nomegestrol acetate 2.5 mg /17beta-estradiol 1.5 mg), has been granted Marketing Authorization by the European Commission for the prevention of pregnancy in women.
ZOELY is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of two hormones; nomegestrol acetate, a highly selective progesterone-derived progestin and 17beta estradiol, an estrogen that is similar to the one naturally present in a woman's body. This innovative combination will be made available to women in a regimen that contains twenty-four days of active pills and four days of placebo pills. ZOELY is more than 99 percent effective in preventing pregnancy when used as directed.
"The approval of ZOELY further reinforces MSD's longstanding commitment to providing women with greater choice in contraceptive options," said Terrie Curran, general manager and global franchise leader, Women's Health, MSD. "We're delighted to add ZOELY to our robust women's health portfolio through the strong collaborative relationship we have established with our colleagues at Théramex, now a subsidiary of Teva."
"The EU Marketing Authorization for ZOELY marks an important step in creating a strong women's healthcare franchise for Teva in Europe," said Christophe Hubert, vice-president Women's Health Teva Europe and president of Théramex, Teva's Women's Health specialist subsidiary. "The acquisition of Théramex in January this year gives us a platform to leverage our capability in women's healthcare, and the launch of ZOELY is part of our developing business in this area."
The Marketing Authorization of ZOELY applies to all 27 European Union (EU) Member States plus the EEA-EFTA states (Iceland, Liechtenstein and Norway).
Information on the clinical program for ZOELY
The efficacy and safety of ZOELY has been demonstrated in two randomized, open-label comparative trials with more than 3,200 women treated for up to 13 consecutive cycles. The Pearl Index (PI) was the primary efficacy endpoint used to assess the contraceptive reliability for both studies and found ZOELY to be highly effective in preventing pregnancy.
In the clinical trial performed in the European Union, 1589 women were treated with ZOELY for up to 13 cycles. The Pearl Index for women aged 1835, (n=1315) including method and user failure, was calculated as 0.38 (upper limit 95% confidence interval 0.97). The PI calculation was based on pregnancies that occurred after the onset of treatment and within two days after the last pill intake.
In a separate randomized, open label trial, 32 women were treated for six cycles with ZOELY. After discontinuation of ZOELY, 79% of women returned to ovulation within the first twenty-eight days.
Important Safety Information
ZOELY is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Like other COCs, ZOELY also is contraindicated in patients with presence or history of venous thrombosis (deep venous thrombosis, pulmonary embolism), arterial thrombosis (e.g., myocardial infarction) or prodromal conditions (e.g. transient ischaemic attack, angina pectoris). Furthermore, ZOELY is contraindicated in patients with the presence or history of cerebrovascular accident, and those with history of migraine with focal neurological symptoms. ZOELY is also contraindicated in patients with the presence of a severe or multiple risk factor(s) for venous or arterial thrombosis such as: diabetes mellitus with vascular symptoms, severe hypertension, and severe dyslipoproteinemia.
ZOELY is contraindicated in patients with hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). Furthermore, ZOELY is contraindicated in patients with pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, patients with the presence or history of severe hepatic disease as long as liver function values have not returned to normal, and patients with the presence or history of liver tumours (benign or malignant). ZOELY is also contraindicated in patients with known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts), and patients with undiagnosed vaginal bleeding.
The use of any COC, including ZOELY, carries an increased risk of venous thromboembolism (VTE) compared with no use. The excess risk of VTE is highest during the first year a woman ever uses a COC. Epidemiological studies have also associated the use of COCs with an increased risk for arterial (myocardial infarction, transient ischaemic attack) thromboembolism. The risk of arterial thromboembolic complications or of a cerebrovascular accident in COC users increases with age and smoking. Women over 35 years of age should be strongly advised not to smoke if they wish to use a COC. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of ZOELY use.
An increased risk of cervical cancer in long-term users of COCs (> 5 years) has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV). No epidemiological data on the risk of cervical cancer in users of ZOELY are available. A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs. The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare. A relationship between COC use and clinical hypertension has not been established. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. Diabetic women should be carefully observed while taking a COC, especially in the first few months of use.
Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
In clinical studies, adverse reactions that were reported by greater than 10% of users as possibly treatment related included acne and changes to menstrual periods. In addition 1%-10% of users reported the following adverse events as possibly treatment related: decreased interest in sex, depression, headache or migraine, nausea, heavy menstrual periods, weight gain, breast pain, and pelvic pain.
Before initiating ZOELY treatment, the full prescribing information should be consulted.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 42,000 people around the world and reached $16.1 billion in net sales in 2010.
About Teva Women's Health in Europe
Teva's Women's Health business in Europe was established following the acquisition of Théramex in January 2010. Teva offers a large portfolio of products in the areas of gynaecology, osteoporosis, peri-menopause, menopause and contraceptives, and includes trusted brand names such as Orocal(R), Colpotrophine(R), Lutenyl(R), Monazol(R), Estreva(R), Antadys(R) and Leeloo Ge(R), sold primarily in France and Italy.
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships.
Teva's SafeHarbor Statement under the U. S. Private Securities Litigation Reform Act
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic version of Protonix(R), the extent to which any manufacturing or quality control problems damage our reputation for high quality production, the effects of competition on sales of our innovative products, especially Copaxone(R) (including potential generic and oral competition for Copaxone(R)), the impact of continuing consolidation of our distributors and customers, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, intense competition in our specialty pharmaceutical businesses, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, dependence on the effectiveness of our patents and other protections for innovative products, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, our potential exposure to product liability claims to the extent not covered by insurance, the termination or expiration of governmental programs or tax benefits, current economic conditions, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of
Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (http://www.sec.gov).
Media Contacts: Ian McConnell Merck/MSD +1(908)423-3046 Megan Wilkinson Merck/MSD +1(267)305-6463 Paul Williams Teva Pharmaceuticals Europe BV +44-7798-582889 Investor Contacts: Carol Ferguson Merck +1(908)-423-4465 Elana Holzman Teva +972(3)926-7554