‘I
`
`III!
`Website: wwvnteva hanmcom
`EV‘ P"‘m”‘°E""°“‘ '"°"sm'E5 ‘'79’
`
`
`Contact:
`
`Elana Holzman
`Kevin Mannlx
`
`Tova Pharmaceutical Industries Ltd.
`Tova North America
`
`972 (3) 926-7554
`(215) 59!-89 I2
`
`For Immediate Release
`
`TEVA PROVIDES UPDATE ON FOBTE TRIAL
`
`Jerusalem, Israel July 7. zooe — Teva Pharmaceutical industries Ltd. (NASDAQ: TEVA) today
`announced top-line results (mm a Phase III study designed to assess the eflicacy. safety and
`toiarabitlty of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE’ 20mg in
`the treatment of
`relapsing-remitting multiple sclerosis (Rt-'1MS}. The 40mg dose did not
`demonstrate increased etllcacy in reducing the relapse rate; however, the higher dose maintained
`the favorable safety and tolerability prollle or cor=Axo~E° 20mg.
`
`Seventy-eight percent (78%) ol cOPAxONE" 20mg treated patients remained roIapse—lree
`throughout the study. Moreover. patients that completed one year at treatment with COPAXONE’
`20mg experienced a very low annualized relapse rate of 0.27. This robust effect was also
`reflected in a remarkable reduction ol inflammatory activity as measured by MRI.
`
`‘While the trial did not demonstrate an enhanced ellicacy at the higher dose level, the study
`reallirms that COPAXONE‘ 20mg. the leading rnuttlpre sclerosis therapy. remains the optimal
`treatment dose with unmatched long term etllcecy conlirrned over to years,“ said Moshe Manor,
`Group Vice President — Global
`lnnovatlve Resources.
`“Teva is committed to ongoing
`research in the maid or multiple sclerosis and will continue to move lorward towards providing
`additional treatment options to multiple sclerosis patients’.
`
`Tova will continue to analyze the study results to better understand the effect of GA 40mg on
`patients. The Company is also evaluating the use of GA for additional indications.
`About the study
`A randomized. doubIe~bllnd study. designed to assess the elllcacy. safety and tolerability ot 40mg
`glatlramer acetate. as compared to the currntly approved COPAXONE.° (glatirarner acetate)
`20mg dose.
`
`The study was conducted in 136 centers In North America. Argentina. Europe and Israel. and
`included 1.155 patients with FIRMS. The trials primary clinical outcome measure was rate at
`contlmted relapses.
`
`About commons‘
`Current data suggest cOPAXONE° lglatlramer acetate inaction) is a selective MHC (Major
`Histocompatability complex) class ll modulator. COPAXON
`is indicated for the neduction of the
`lrequency at relapses in RRMS. COPAXONE‘ is very well tolerated and the most common side
`elfects cl COPAXONE° are redness. pain. swelling. itching, or a lump or an indentation at the site
`at injection. weakness. Infection. pain. nausea. ioirrt pain. anxiety and muscle stiffness.
`
`.1.
`
`Exhibit A
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`I
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`AMNEAL
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`EXHIBIT NO. 1046 Page 1
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` AMNEAL
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`
`States. all
`including the Uni
`coi>AxoNE° in now approved in 51 countries worldwide.
`is marketed
`European countries, Canada, Mexico. Australia and lsrael. in Europe, COPAXON
`by Tova Pharmaceutical Industries Ltd. and sanoil-aventis. in North America. COPAXONE’ is
`marketed by Tova Neuroscience. Inc.
`
`See additional important information at http:llwww.COPAXONE.com!pi/indoxhtrnl or call 1-800-
`887-8100 tor eiectronic releases.
`
`About Multiple sclerosis
`is
`it
`Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults.
`estimated that d00,000 people in the United States are aitected by this disease, and that over
`one million people are attracted worldwide. MS is a progressive. demyelinating disease of the
`central nervous system alfecting the brain. spinal cord and optic nerves.
`
`Patients with MS may experience physical symptoms and/or cognitive impairments. including
`weakness. latigue. ataxia. physical dysiunction. bladder and bowel problems. sensory ettects.
`and visual impairment. MS also has a significant impact on the sulierers' social functioning and
`overall quality of lite.
`
`'
`About Tove
`‘reva 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. rnanulactures and markets generic and innovative human pharmaceuticals
`and active pharmaceutical Ingredients. as well as animal health pharmaceutical products. Over
`80 percent of 'i’eva's sales are in North America and Europe. Teva's innovative 8&0 focuses on
`developing novel drugs tor diseases of the central nervoussystem.
`
`sure Harbor atonement underthe U. 8. Private Securities Litigation notorm Act ot 1905:
`This release contains lorvrard-looking staternertts. which express the current beliefs and expectations of manegemerrt
`Such statements are based on management's current lreliels and expectations and involve a number of known and
`unknown risks and uncertainties that could cause Tova‘: ruture results, pertormance or acnievemanu to litter significantly
`from the results. porter-mance or aarievernonts expressed or implied by such lotvvard-looking statements. Important
`factors that could caweeor contribute to such dlflerenoes Include risks relating to: Tove’-5 ability to accurately predict luture
`market conditions. potential liability tor sales ol generic products prior to a linel resolution of outstanding patent litigation.
`incluaino that reiatiflo to the generic versions ot Allegretto. Neuronlino. Lotrew. Farr-virib and Protor-lam. Teva's ability to
`suocesslully develop and commercialize adritional pharmaceutical products.
`the introduction ol competing enerlc
`equivalents, the extent to which Tova may obtain US. market exclusivity for certain of its new generic products and
`requlalory changes that may prevent Tevn irorrr utilizing exclusivity periods. competition from brandrierne comparies that
`are under increased pressure to counter generic products. or competitors that seek to delay the inlroductlon of generic
`products, the impact of consaiidetion or our distributors and customers, the etimts of competition on our innovative
`products. especially Gopuoneo sales. the impact or pharmaceutical Industry regulation and pending legislation that could
`enact the pharmaceutical industry. the dlfliculty of predicting iJ.S. Food and Drug Administration. European Medicines
`Agency and other rqulatory authority approvals, the regrletory environment and changes in the health policies and
`structures ol various countries. our ability to achieve expected results though our innovative Rani) elforts. Teva'e ability to
`suocessluiiy identity. consummate and integrate acquisitions
`(including the pending acquisition at Bentley
`Pharmaceuticals. Inc). potential exposure to product liaalllly claims to the extent not covered by insurance. dependence
`on the aliectiveness of our patents and other protections for Innovative products. significant operations worldwide that
`may be adversely aflected by terrorism, politics or economical instability of mlibf hostilities. supply interruptions or delays
`that could result from the complex rnanutaoiunng of our products and our global supply chain. environmental risks.
`mcluatlom In currency. exchange and interest rates. and other motor: that are discussed In Tova‘: Annual Recon on
`Form 20-F end its other filngs with the us. Securities and Exchange Commission. Forward-looking statements spool:
`only as 0? the date on which they are made and the Company undertakes no obligation to update or revise any forward-
`looliing stalernent. whether as a result or new inlon-nation. More events or otherwise.
`
`_........—,.._.~_
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`AMNEAL
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`EXHIBIT NO. 1046 Page 2
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` AMNEAL