`
`Contact:
`Elana Hotzman
`Tova Pharmaceutical Industries Ltd.
`'9‘}? (3) 926-7554
`Kevin Mannlx
`Tova North America
`(TEES) 59:45912
`
` YEVA PHAHMACEUTiCAL iNDUSTRl£5 L'flill. Website: wwwxevapharmxom
`
`For immediate Reiease
`
`TEVA PROVSDES UFBATE ON FORTE TRIAL
`
`Jerusalem, Israel Juiy "it. 2008 -— Tova Pharmaceutical industries Ltd. (NASDAQ: TEVA) today
`annOunced toprline recutts from a Phase III study designed to assess the efficacy, safety and
`tolerabiiity of glatiramer acetate (GA) 40mg as compared to the approved COPAXONE‘E 20mg in
`the treatment of
`relapsing-remitting multiple Sclerosis
`(RRMSfi. The 40mg dose did not
`demonstrate increased efficacy in reducing the relapse rate; however, the higher dose maintained
`the tavoraole safety and tolerability profile at cor-Axon? 20mg.
`
`Seventy~eight percent {73%) of CiDF‘MtCiEiIE‘a 20mg treated patients remained relapse—tree
`throughout the study. Moreover, patients that completed one year at treatment with COPAXONi-Z”
`20mg experienced a very low annualized relapse rate of 0.27. This robust effect was also
`reflected in a remarkable reduction of inflammatory activity as measured by MRI.
`
`"While the trial did not demonstrate an enhanced efficaCy at the higher dose level, the study
`reaffirms that COPAXONE“ 20mg, the leading multiple sotorosis therapy. remains the optimal
`treatment 6059 with unmatched long term atticacy confirmed over it) years,“ said Moshe Manor,
`Group Vice President -— Global Innovative Resources.
`“Tova is committed to ongoing
`research in the field of multiple sclerosis and will continue to move forward towards providing
`additional treatment options to multiple sclerosis patients”.
`
`Tova wilt 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, doubleblind study. designed to assess the efficacy. safety and tolerability of 40mg
`glatiramer acetate, as compared to the currently approved CGPAXONE" {glatiramer 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 trial‘s primary clinical outcome measure was rate of
`continued relapses.
`
`About copuoue"
`Current data Suggest COPAXONE" {glatiramer acetate in'ection) is a selective MHC (Major
`Histocompatability Complex) class it modulator. COPAXON
`is indicated for the reduction of the
`frequency of relapses in RRMS. COPAXONEQ is very welt tolerated and the most common side
`olfacts of COPAXQNE‘D are redness, pain. swelling, itching, or a lump or an indentation at the site
`at iniectlon. weakness, infection, pain, nausea. joint pain, anxiety and muscle stiffness.
`
`Exhibit A
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`MYLAN INC. EXHIBIT NO. 1046 Page 1
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`MYLAN INC. EXHIBIT NO. 1046 Page 1
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`including the United States. all
`(3(_‘1F’mic;lislEa is rtow approved in 51 countries worldwide.
`European countrios, Gamma. Mexico, Australia and israul. in Europe, COPAXONEG is marketed
`by Tova Fharmaoeuticai industries Ltd. and sanofi-aventis.
`in North America. COPAXGNE” is
`marketed by Tova Neuroscience, loo.
`
`Sou additions: important information at httpjiwwwfiaPAXONE.oomfpifindexhtm! or coil t~8fl€l~
`8878100 for olootronic releases.
`
`About Multipfo sclerosis
`is
`it
`Multiple Sciorosis (MS) is the leading cause of neurological disability in Young adults.
`estimated that 400,060 people in the United States are affected by Ihia disease, and that over
`one miiilcn people are affected worldwide. MS is a progressivo. demyalinating disease of the
`central nervous system affecting the brain, spinal cord and opzic nerves.
`
`including
`Patiants with MS may experience physical symptoms andior cognitive impairments.
`weakness. fatigue. ataxia. physical dysfunction. bladder and bowei problems, sensory effects.
`and visual impairmant. MS also has a significant impact on the sufferers' social functioning and
`overall. quality of life.
`
`About Tova
`Tova Pharmaceutical industries Ltd, headquartered in lsraei, is among the too 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. Teva’s innovative REID focuses on
`developing novel drugs for diseases of the central nervousrsystem.
`
`5311:; Harbor Statement ufider the U. ‘3. Private Securities Litigation Fleiorm Act a! 1995:
`This release contains femarduioaxing statements. which express the current beliefs and exuectations cl managemem.
`Euch statements are based on managamant's current beliefs and expectations and involve a number of Known and
`unknown risks and uncerlaintias that could cause Tara's future rasuits, podormaoca or achievemenls to differ significantly
`from this results. performance or achievements expressed or implied by such Earward~icoi<ing statements. Important
`lactoro that could cause or contribute to such differences include risks relating to: Tova‘s ability to accurately predict future
`market conditions, potential lianiilty for sales of generic products prior to a final resolution of outstanding patent litigation,
`including} Ilia: reialing to tho generic versions of Anagram. Neurontinfal. Lotrem, FamvirtE and Protonix®. Yova's ability to
`succossfully develop and commercialize additional} pharmaceutical products.
`the introduction of competing generic
`equivalents. tho oxiant to which Tova may obtain US. mamot exclusivity for certain at its new generic products and
`regulalory changes that may prevent Tova from utilizing exclusivity periods, competi‘lion from brandmame companies that
`are under increased oressure to counter generic products, or comoetitors that seek to delay the introduction of generic
`products, the impact of consolidation of our distributors and cuslomers. the effects of cotrlpetition on our innovative
`products. especially Gopaxonw sales, the impact of pharmaceutical imiustry regulation and pending legislation that could
`affect the pharmaceutical industry, the difficutly of predicting US. Food and Drug Administration, European Medicines
`Agency and other reguialory authority aporovals.
`the regulatory environment and changes in the health policies and
`structures of various countries. our ability to achieve expected results though our innovative RM) efforts. Teva's ability to
`ouccessiullv identify.
`consummate and integrate
`acquisitions
`(inciuding the oeoding acquisition 01‘ Bentley
`Pharmacouticals. Inc]. polemial exposure to product liability claims to the extent not covered by insurance. degendence
`on the elfacliveness of our patients and other protections for innovative products, significant operaiions worldwide that
`may be adversely affected by terrorism, political or economical inSlabilily or maior hostilities, supply interruptions or delays
`that could result from the complex manufacturing of our products and our global supply chain. environmental risks.
`fluctuations in currency. exchange and interest rates. and other factors that are discussed in Teva‘s Annual Report on
`Form 2047 and its other filings with the us. Securities and Exchange.- Commission, Forward-looking statements speak
`only as of the date on which they are made and the Company undertakes no obligation to update or revise any lorward~
`looking statement. whether as a result of new information, future events or otherwise.
`
`M w...“
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`MYLAN INC. EXHIBIT NO. 1046 Page 2
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`MYLAN INC. EXHIBIT NO. 1046 Page 2
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