9.’24l2015
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`News Release- Teva Pharmaceuticals in the US
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`Pharmaceuticals
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`N EWS R ELEASE
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`TEVA ANNOUNCES U.S. FOA APPROVAL OF THREE-TIMES-A-WEEK OOPAXONE® (ELATIRAMER
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`ACETATE INJECTION) 4OMl3/Ml.
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`New Formulation of COP/iXONE® Offers Patients and Their Physicians Ability to Dose Less Frequently
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`JERUSALEM—~(BUS|NESS WlRE)—-Jan. 28, 2014- Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
`announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's
`supplemental new drug application (SNDA) for three-times-a-week COPAXONE® 40mgi'mL, a new dose of
`COPAXONE®. This new formulation will allow for a less frequent dosing regimen administered
`subcutaneously for patients with relapsing forms of multiple sclerosis (MS). in addition to the newly approved
`dose. daily COPAXOl\iE® 20 rngi'n"il_ will continue to be avaiiable. The daily subcutaneous injection was
`approved in 1996.
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`"The availability of three-times-a-week COPAXONE® 40 mgi'mL is a significant advancement for patients as
`they now have the option of effective and safe treatment with COPAXONE®, while reducing the number of
`injections by 60 percent." said Omar Khan, M.D., Professor of Neurology and Chair of the Department of
`Neurology, Wayne State University School of Medicine, Detroit, MI. "Patients in the U.S. can now benefit from
`an improved dosing regimen without compromising the known benefits of COPAXONE®."
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`The FDA approval is based on data from the Phase Ill Glatiramer Acetate Low-Frequency Administration
`(GALA) study of more than ‘I400 patients, which showed that a 40 mgilmL dose of COPAXONE® administered
`subcutaneousiy three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a
`favorable safety and tolerability profile in patients with re|apsirig—remitting MS.
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`"For more than 20 years, Teva has pursued its multiple sclerosis research with the goal of providing effective,
`safe and tolerable therapies for MS patients," said Larry Downey, President, North America Specialty
`Medicines. "We have progressively invested in the innovation of COPAXOl\iE®in an effort to understand the
`needs and to ease the burden of patients who live with relapsing forms of MS every day. Today we are proud
`to continue to deliver on that investment by offering the freedom to close three-times—a-week with
`COPAXONE® 40 mgfm L."
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`Three-times«a-week COPAXONE® 40mgimL is available for shipping to distribution outlets immediately, and
`will be available to patients within days. Teva's Shared So|utions® patient support center has been scaled to
`support current patients as they transition to the new, three-times-a-week 40mglmL formulation. Patients may
`call their doctors or Teva's Shared Solutions® (1-800-887-8100) and make a request. in addition, Shared
`Solutions® provides 24f? nurse support, financial and benefits investigation as well as identification of
`pharmacy distribution options to enable financial and physical access to COPAXONE®. Shared Solutions also
`provides free injection training as well as ongoing compliance and adherence support services.
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`About coPAxoNE®
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`COPAXONE® (glatirarner acetate injection) is indicated for the treatment of patients with relapsing forms of
`multipie SCIBTOSES. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a
`lump at the site of injection, flushing, rash, shortness of breath, and chest i:@oa$ietii(mlili1j:ol1iabitii1c()6i3it
`inforlmgtioen ft: W.CopaxonePrescribing|nformation.com. For hardcopy releasesjzfilfirilaelspefiiiggéfid full
`httptf/news.tevaug.com/jzgo-enix.zhtrnl?c=251945&p=iroi-newsArticleJ3rint&lD=1894511
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`9l24l2016
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`News Release - Teva Pharmaceuticals in the US
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`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.
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`Important Safety Information about COPAXONE®
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`Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a
`short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth
`andlor redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These
`symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves
`without further problems. During the postmarketing period, there have been reports of patients with similar
`symptoms who received emergency medical care. If symptoms become severe, patients should call the
`emergency phone number in their area. Patients should call their doctor right away if they develop hives.
`skin rash with irritation, dizziness, sweating. chest pain, trouble breathing, or severe pain at the injection site.
`if any of the above occurs, patients should not give themselves any more injections until their doctor tells
`them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its
`own. This pain should only last a few minutes. Patients may experience more than one such episode, usually
`beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest
`pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or,
`rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow
`proper injection technique and inform their doctor of any skin changes. The most common side effects of
`COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of
`breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list,
`patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they
`have while taking COPAXONE®.
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`Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit
`www.fda.govlmedwatch or call 1-800-FDA—1088.
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`About Teva
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`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 1,000 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 $20.3 billion in net revenues in 2012.
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`Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Refonn Act of 1995: The
`following presentation 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 for our innovative medicines, especially
`Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential
`purported generic equivalents), competition for our generic products (including from other pharmaceutical
`companies and as a result of increased governmental pricing pressures), competition for our specialty
`pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative,
`R&D efforts, the effectiveness of our parents and other protections for innovative products, decreasing
`opportunities to obtain U. 8. market exclusivity for significant new generic products, our ability to identify,
`consummate and successfully integrate acquisitions and license products, our ability to reduce operating
`expenses to the extent and during the limeframe intended by our cost restructuring program, uncertainties
`relating to the replacement of and transition to a new President & Chief Executive Officer, the effects of
`increased leverage as a result of recent acquisitions, 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 government scrutiny in
`both the U. S. and Europe of our settlement agreements with brand companies and liabilities arising from
`class action litigation and other third-party claims relating to such agreements, potential liability for sales of
`generic medicines prior to a final resolution of outstanding patent litigation, our exposure to currency
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`News Release - Teva Pharmaceuticals in the US
`9/2-#2016
`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 medicines (and our ongoing FCPA investigations and related matters),
`uncertainties surrounding the legislative and regulatory pathways for the registration and approval of
`biotechnology—based medicines, adverse effects ofpolitical or economic instability, corruption, major hostilities
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`Source: Teva Pharmaceutical industries Ltd.
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`Teva Pharmaceutical industries Ltd.
`lR Contacts:
`United States
`Kevin C. Mannix, (215) 591-8912
`Ran Meir, (215) 591-3033
`Israel
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`Tomer Amitai, 972 (3) 926-7656
`or
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`PR Contacts:
`lsrael
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`lris Beck Codner, 972 (3) 926~7’687
`United States
`Denise Bradley, (215) 591-8974
`Nancy Leone, (215) 28443213
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`http:llnews.tevaEfigfil3noG£<.§htrnI?c=251945&p=irol-newsArtic|e__print&lD=1894511
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