Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
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`Home page > Media > Latest News
`> Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage for Glatiramer Acetate Given Three Times Weekly
`for Relapsing-Remitting Multiple Sclerosis
`
`e Latest News
`
`Latest News
`
`<
`
`Teva Announces Top-
`Line Results from
`GALA Phase III Trial
`Evaluating a New
`Dosage for Glatiramer
`Acetate Given Three
`Times Weekly for
`Relapsing-Remitting
`Multiple Sclerosis
`
`The GALA study evaluating glatiramer acetate 40
`mg/1 ml administered three times weekly met primary
`endpoint significantly reducing the annualized relapse
`rate (ARR) by 34.4 percent compared to placebo
`
`JERUSALEM——(BUSINESS WIRE)——Jun. 14, 2012-— Teva
`Pharmaceutical Industries Ltd. (NYSE: TEVA) today
`announced positive top—line results from the GALA
`(Glatiramer Acetate Low—Frequency Administration)
`Phase III clinical trial assessing the efficacy, safety and
`tolerability of 40 mg/1 ml glatiramer acetate injection
`
`http://Wwwtevaphann.com/news/teva_announces_top_line_results_from_gala_phase_iii_tri. .. 2/5/20 1 6
`Mylan Pharms. Inc. Exhibit 1018 Page 1
`
`Mylan Pharms. Inc. Exhibit 1018 Page 1
`
`

`
`Teva Announces Top—Line Results from GALA Phase III Trial Evaluating a New Dosage
`
`Page 2 of 7
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`<
`
`(GA) administered subcutaneously three times a wee|<
`compared to placebo in relapsing—remitting multiple
`sclerosis (RRMS) patients. Study results showed that
`GA 40 mg/1 ml significantly reduced disease activity,
`while maintaining a favorable safety and tolerability
`profile.
`
`The one—year randomized, double—blind placebo-
`controlled study recruited more than 1,400 patients at
`155 multinational sites. Results showed that GA 40
`mg/1 ml met the study’s primary endpoint by
`significantly reducing the annualized relapse rate
`(ARR) by 34.4 percent compared to placebo
`(p<0.0001). Initial analysis of the data indicates that
`secondary clinical endpoints were achieved, with the
`exception of reduction in brain atrophy. Following the
`initial 12-month, placebo—controlled phase, there will
`be an ongoing open—label extension of the trial.
`
`“We are pleased with the results of this study that
`show the potential of 40 mg/1 ml glatiramer acetate to
`offer patients an effective and safe treatment option
`with COPAXONE® using a more convenient dosing
`regimen” said Serge Stankovic, Senior Vice President
`of Clinical Research, Global Branded R&D, Teva
`Pharmaceutical Industries Ltd. “We remain focused on
`the continued research and development of products
`aimed at improving the treatment experience for
`patients with MS.”
`
`Further analyses of the GALA study data are ongoing,
`and detailed results will be presented to the scientific
`community in the near future. Teva plans to work with
`health authorities to determine next steps.
`
`The most commonly reported adverse events in the
`study were injection site reactions, headaches and
`nasopharyngitis. The overall frequencies of adverse
`events were comparable to those observed in the
`placebo group.
`
`ABOUT THE STUDY
`
`The multinational Phase III Glatiramer Acetate Low-
`frequency Administration (GALA) trial was designed to
`examine the safety, efficacy and tolerability of
`glatiramer acetate (GA) 40 mg/1 ml injection
`administered three times a week compared to placebo
`in a randomized double—blind placebo—controlled
`design in patients with relapsing—remitting multiple
`
`>
`
`tri... 2/5/2016
`http://wvvw.tevapharm.com/news/teva _announces top line results from gala phase iii
`Mylan Pharms. Inc. Exhibit 1018 Page 2
`
`Mylan Pharms. Inc. Exhibit 1018 Page 2
`
`

`
`Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
`
`Page 3 of 7
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`<
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`sclerosis. The 40 mg/1 ml dose is higher than the
`currently marketed 20 mg/1 ml daily COPAXONE®
`(glatiramer acetate injection). The primary endpoint of
`the study is the total number of confirmed relapses
`during a 12-month, placebo—controlled phase.
`
`ABOUT COPAXONE®
`
`COPAXONE® (glatiramer acetate injection) is indicated
`for the reduction of the frequency of relapses in
`relapsing—remitting multiple sclerosis, including
`patients who have experienced a first clinical episode
`and have MRI features consistent with multiple
`sclerosis. The most common side effects of
`COPAXONE® are redness, pain, swelling, itching, or a
`lump at the site ofinjection, flushing, rash, shortness
`of breath, and chest pain. See additional important
`information at:
`httpzl[www.sharedsolutions.comlredirectlPrescribinglnformation
`For hardcopy releases, please see enclosed full
`prescribing information. COPAXONE® is now approved
`in more than 50 countries worldwide, including the
`United States, Russia, Canada, Mexico, Australia,
`Israel, and all European countries.
`ABOUT TEVA ‘
`
`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. 5.
`Private Securities Litigation Reform Act of 1995:
`
`This release contains forward—loo|<ing statements,
`which express the current beliefs and expectations of
`management. Such statements are based on
`
`http ://wwwtevapharm.com/news/teva_announces_top_line_results_from_gala_phase_iii_tri. .. 2/5/20 1 6
`Mylan Pharms. Inc. Exhibit 1018 Page 3
`
`Mylan Pharms. Inc. Exhibit 1018 Page 3
`
`

`
`Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
`
`Page 4 of 7
`
`<
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`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-loo|<ing
`statements. including statements relating to the results
`of the GALA phase III trial and the potential efficacy or
`future market or marketability of glatiramer acetate 40
`mg/1 ml. Followingfurtheranalysis, Teva's
`interpretation of the results could differ materially
`depending on a number of factors, and we caution
`investors not to place undue reliance on the forward-
`looking statements contained in this press release as
`there can be no guarantee that the results from the
`phase III trial discussed in this press release will be
`confirmed upon full analysis ofthe results ofthe trial
`and additional information relating to the safety,
`efficacy or tolerability of glatiramer acetate 40 mg/1
`ml may be discovered upon further analysis of data
`from the phase III trial. Even if the results described in
`this release are confirmed upon full analysis of the
`GALA study, we cannot guarantee that glatiramer
`acetate 40 mg/1 ml will be approved for marketing in
`a timely manner, if at all, by regulatory authorities in
`the EU or in the U.S. Important factors that could
`cause or contribute to such differences include risks
`relating to: our ability to develop and commercialize
`additional pharmaceutical products, competition for
`our innovative products, especially Copaxone®
`(including competition from innovative orally-
`adininistered alternatives, as well as from potential
`generic equivalents), competition for our generic
`products (including from other pharmaceutical
`companies and as a result ofincreased governmental
`pricing pressures), competition for our specialty
`pharmaceutical businesses, our ability to achieve
`expected results through our innovative R&D efforts,
`the effectiveness of our patents and other protections
`for innovative products. decreasing opportunities to
`obtain U.S. market exclusivity for significant new
`generic products. our ability to i clentity, consummate
`and successfully integrate acquisitions (including the
`acquisition of Cephalon], the effects of increased
`leverage as a result of the acquisition of Cephalon, the
`extent to which any manufacturing or quality control
`problems damage our reputation for high quality
`production and require costly remediation, our
`potential exposure to product liability claims to the
`extent not covered by insurance, increased
`
`>
`
`tri... 2/5/2016
`http://www.tevapharrn.com/news/teVa_announces top line results from gala phase iii
`Mylan Pharms. Inc. Exhlblt 1018 Page 4
`
`Mylan Pharms. Inc. Exhibit 1018 Page 4
`
`

`
`Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
`
`Page 5 of 7
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`(
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`government scrutiny in both the U.S. and Europe of
`our agreements with brand companies, 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®, our
`exposure to currency fluctuations and restrictions as
`well as credit risks, the effects of reforms in healthcare
`regulation and pharmaceutical pricing and
`reimbursement, any failures to comply with complex
`Medicare and Medicaid reporting and payment
`obligations, governmental investigations into sales
`and marketing practices (particularly for our specialty
`pharmaceutical products), uncertainties surrounding
`the legislative and regulatory pathway for the
`registration and approval of biotechnology-based
`products, adverse effects of political or economical
`instability, major hostilities or acts of terrorism on our
`significant worldwide operations, interruptions in our
`supply chain or problems with our information
`technology systems that adversely affect our complex
`manufacturing processes, any failure to retain key
`personnel (including Cephalon employees) or to
`attract additional executive and managerial talent, the
`impact of continuing consolidation of our distributors
`and customers, variations in patent laws that may
`adversely affect our ability to manufacture our
`products in the most efficient manner, potentially
`significant impairments ofintangible assets and
`goodwill, potential increases in tax liabilities, the
`termination or expiration of governmental programs or
`tax benefits, environmental risks and other factors that
`are discussed in our Annual Report on Form 20—F for
`the year ended December 31, 2011 and in our other
`filings with the U.S. Securities and Exchange
`Commission. Forward-lool<ing statements speak only
`as ofthe date on which they are made and the
`Company undertakes no obligation to update or revise
`any forward—lool<ing statement, whether as a result of
`new information, future events or otherwise.
`
`Source: Teva Pharmaceutical Industries Ltd.
`
`Teva Pharmaceutical Industries Ltd.
`
`IR:
`
`United States
`Kevin C. Mannix, 215-591-8912cg
`OI’
`
`http ://www.teVapham1.com/news/teva_announces_top_line_results_from_gala_phase_iii_tri. .. 2/5/20 1 6
`Mylan Pharms. Inc. Exhibit 1018 Page 5
`
`Mylan Pharms. Inc. Exhibit 1018 Page 5
`
`

`
`Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
`
`Page 6 of 7
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`Israel
`
`Tomer Amitai, 972-3-926-7656
`or
`
`PR:
`
`United States
`Denise Bradley, 215-591-8974a
`OI‘
`
`Israel
`Shir Altay-Hagoel, 972-3-926-7590
`
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`Teva Announces Top-Line Results from GALA Phase III Trial Evaluating a New Dosage
`
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