Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva
Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced that the
U.S. Food and Drug Administration (FDA) has accepted for filing its New
Drug Application (NDA) for Quartette™ (levonorgestrel/ethinyl estradiol
tablets and ethinyl estradiol tablets). The company is seeking approval
to manufacture and market Quartette™, the first ascending-dose, extended
regimen oral contraceptive for the prevention of pregnancy. The NDA was
submitted to the FDA on May 31, 2012.
The submission was based on a clinical development program including
results from Phase I, Phase II, and Phase III clinical trials designed
to evaluate the safety and efficacy of Quartette™ in the prevention of
pregnancy. The clinical trials involved more than 3,000 female subjects.
“Quartette™ is an ascending dose regimen oral contraceptive intended for
prevention of pregnancy. We looked at when and why breakthrough bleeding
occurs and designed Quartette™ to have less disruptive, unscheduled
bleeding,” said Nancy Ricciotti, senior director of clinical affairs,
Teva Women's Health R&D. “Quartette builds upon our heritage in
providing women with innovative, extended-cycle contraceptive products
and we look forward to the potential to offer the first ascending-dose
extended regimen birth-control option.”
Women may experience breakthrough bleeding (BTB) with any birth control
pill, especially during the first few months. Numerous studies of
extended regimens have shown that unscheduled BTB often increases
typically during the first few months of treatment.i,ii,iii,iv
BTB is one of the reasons a large number of women discontinue extended
Quartette™ is a trademark of Barr Laboratories, Inc.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 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
leading 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 CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $18.3 billion
in net revenues in 2011.
Teva’s Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995: The following discussion and analysis
contains forward-looking statements, which express the current beliefs
and expectations of management. Such statements 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
develop and commercialize additional pharmaceutical products,
competition from the introduction of competing generic equivalents and
due to increased governmental pricing pressures, the effects of
competition on sales of our innovative medicines, especially Copaxone®
(including competition from innovative orally-administered alternatives
as well as from potential generic equivalents), potential liability for
sales of generic medicines prior to a final resolution of outstanding
patent litigation, including that relating to our generic version of
Protonix®, the extent to which we may obtain U.S. market exclusivity for
certain of our new generic medicines, the extent to which any
manufacturing or quality control problems damage our reputation for high
quality production and require costly remediation, our ability to
identify, consummate and successfully integrate acquisitions (including
the acquisition of Cephalon), our ability to achieve expected results
through our innovative R&D efforts, dependence on the effectiveness of
our patents and other protections for innovative medicines, intense
competition in our specialty pharmaceutical businesses, uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based medicines, our potential exposure to
product liability claims to the extent not covered by insurance, 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 and pharmaceutical pricing and reimbursement,
adverse effects of political instability and adverse economic
conditions, 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, interruptions in our
supply chain or problems with our information technology systems that
adversely affect our complex manufacturing processes, the impact of
continuing consolidation of our distributors and customers, the
difficulty of complying with U.S. Food and Drug Administration, European
Medicines Agency and other regulatory authority requirements,
potentially significant impairments of intangible assets and goodwill,
potential increases in tax liabilities resulting from challenges to our
intercompany arrangements, the termination or expiration of governmental
programs or tax benefits, any failure to retain key personnel or to
attract additional executive and managerial talent, environmental risks,
and other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2011, in this report and in our other
filings with the U.S. Securities and Exchange Commission (“SEC”).
Forward-looking statements speak only as of the date on which they are
made, and we undertake no obligation to update any forward-looking
statements or other information contained in this report, whether as a
result of new information, future events or otherwise. You are advised,
however, to consult any additional disclosures we make in our reports to
the SEC on Form 6-K. Also note that we provide a cautionary discussion
of risks and uncertainties under “Risk Factors” in our Annual Report on
Form 20-F for the year ended December 31, 2011. These are factors that
we believe could cause our actual results to differ materially from
expected results. Other factors besides those listed could also
adversely affect us. This discussion is provided as permitted by the
Private Securities Litigation Reform Act of 1995.
i Loudon NB.etal.BM7. 1977;2:487-90.
Kwiecien M, et. al. Contraception. 2003;67:9-13.
Miller Land Hughes JP. Obstetrics & Gynecology. 2003;101:652-61.
Sulak PJ, etal. Obstetrics & Gynecology. 1997;89:179-83.
Seasonique Prescribing Information.
vii Archer DF, et al. Contraception.
2006: 74; 439-445.