Plan B® One-Step-New FDA-Approved One-Pill Emergency Contraceptive
Single-dose Formulation Can Be Taken Right Away
NORTH WALES, Pa.--(Business Wire)--
Teva Pharmaceuticals, Inc. (NASDAQ: TEVA) announced today that the U.S. Food and
Drug Administration (FDA) has approved its New Drug Application (NDA) for Plan
B® One-Step emergency contraception (levonorgestrel tablet, 1.5 mg). Now, with
new Plan B® One-Step, women can help prevent an unintended pregnancy after
unprotected sex or contraceptive failure with just one pill in one dose. The FDA
is expanding over-the-counter (OTC) access to Plan B® One-Step for consumers age
17 or older; women younger than age 17 will require a prescription. The product
will be available at licensed U.S. retail pharmacies within the next month.
"With Plan B® One-Step, emergency contraception is now available in just one
pill that can be taken right away when the unexpected happens," notes Amy
Niemann, General Manager, Senior Vice President of Teva Women`s Health. "We`re
proud to offer women this new, innovative emergency contraceptive option that
builds upon the trust that women have come to know with Plan B®."
"I prefer one-pill dosing for my patients because it allows them to act more
quickly, while providing a high level of safety and efficacy," comments Ashlesha
Patel, MD, MPH, Division Director of Family Planning Services, John H. Stroger,
Jr., Hospital of Cook County in Chicago. "Emergency contraception is more
effective the sooner it`s taken, and Plan B® One-Step provides a back-up plan
that`s just one pill away."
"Plan B® One-Step is an exciting milestone in women`s reproductive health, and I
applaud Teva for continuing to develop products that empower women," says Kelli
Conlin, President of the National Institute for Reproductive Health. "Healthcare
providers and women`s advocates have been eager for a one-pill emergency
contraceptive for years and are happy to see it finally come to fruition."
About Plan B® One-Step
Plan B® One-Step (www.PlanBOneStep.com) will be available OTC at the pharmacy
for consumers age 17 or older with government-issued proof-of-age
identification. Women younger than age 17 will require a prescription to
purchase Plan B® One-Step.
When taken as directed, within 72 hours (3 days) of unprotected sex or
contraceptive failure, Plan B® One-Step is highly effective in reducing the
chance of pregnancy. About seven out of eight women who would have gotten
pregnant will not become pregnant after taking it. Plan B® One-Step should be
taken as soon as possible after unprotected sex-the sooner it is taken, the more
effective it will be. Plan B® One-Step will not work if a woman is already
pregnant and it will not terminate an existing pregnancy.
Consumers Are "In the Know"…And Pharmacists Are, Too
Awareness of Plan B® has increased significantly since OTC approval in 2006.
Today, more than 88 percent of 18-to-30-year-olds categorize Plan B® as
emergency contraception, up from 64 percent in 2006. Among those familiar with
Plan B®, there is high awareness of what it is, where to get it, and how to use
it. Eighty-six percent of individuals understand that the product prevents
rather than terminates pregnancy and that it is NOT RU-486.
Additionally, U.S. retail pharmacists are overwhelmingly compliant with
dispensing guidelines. In fact, just one year after OTC approval, 99 percent of
pharmacists who sold Plan B® were aware of its dual-label status and 95 percent
were comfortable selling/dispensing Plan B®.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the world's leading generic
pharmaceutical company. The Company develops, manufactures and markets generic
and innovative human pharmaceuticals and active pharmaceutical ingredients, as
well as animal health pharmaceutical products. Over 80 percent of Teva's sales
are in North America and Europe.
Important Safety Information
PLAN B® ONE-STEP IS INTENDED TO PREVENT PREGNANCY AFTER KNOWN OR SUSPECTED
CONTRACEPTIVE FAILURE OR UNPROTECTED INTERCOURSE.
Plan B® One-Step isn`t effective if you`re already pregnant, and it won`t
terminate an existing pregnancy. Plan B® One-Step doesn`t protect against HIV
and other sexually transmitted diseases (STDs). Side effects may include changes
in your period, nausea, lower abdominal pain, fatigue, headache, dizziness, and
breast tenderness. If your period is more than a week late, you may be pregnant.
If you have severe abdominal pain, you may have an ectopic pregnancy, and should
get immediate medical help. Please see full product information
enclosed.Important product information is also available on
www.PlanBOneStep.com, by calling 1-800-330-1271, or by speaking to your
pharmacist. You are encouraged to report negative side effects of prescription
drugs to the FDA at fda.gov/medwatch or call 1-800-FDA-1088.
Teva`s Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:
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 versions of Neurontin, Lotrel, Protonix and Ortho Tri-Cyclen Lo, the
current economic conditions, competition from brand-name companies that are
under increased pressure to counter generic products, or competitors that seek
to delay the introduction of generic products, the effects of competition on our
innovative products, especially Copaxone sales, dependence on the effectiveness
of our patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of pharmaceutical
industry regulation and pending legislation that could affect the pharmaceutical
industry, our ability to achieve expected results though our innovative R&D
efforts, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
uncertainty surrounding the legislative and regulatory pathway for the
registration and approval of biotechnology-based products, the regulatory
environment and changes in the health policies and structures of various
countries, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, our ability to
successfully identify, consummate and integrate acquisitions, including the
integration of BarrPharmaceuticals, Inc., the potential exposure to product
liability claims to the extent not covered by insurance, our exposure to
fluctuations in currency, exchange and interest rates, significant operations
worldwide that may be adversely affected by terrorism, political or economical
instability or major hostilities, our ability to enter into patent litigation
settlements and the intensified scrutiny by the U.S. government, the termination
or expiration of governmental programs and tax benefits, impairment of
intangible assets and goodwill, environmental risks, and other factors that are
discussed in this report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
Plan B® One-Step is a registered trademark of Women`s Capital Corporation, a
subsidiary of Duramed Pharmaceuticals, Inc.
Plan B® One-Step Resources & Multimedia
* Plan B® Online Press Room
* Plan B® One-Step Fact Sheet
* Plan B® One-Step Timeline
* Plan B® One-Step Resources
* Plan B® One-Step Product Images (High Res) (Low Res)
* Plan B® Video/B-Roll (WMV)
Communications Strategies, Inc.
Heather Rose, 973-635-6669
heather.rose@cstratinc.com
or
Teva Pharmaceuticals
Denise Bradley, 215-591-8974
denise.bradley@tevausa.com
Copyright Business Wire 2009
© Thomson Reuters 2009 All rights reserved



