TEVA PHAFIMACEUTECAL !ll£DUSTRl£5 LTD’. websiws wwwrtevapharmlcom
`
`".I'£ I'll
`
`Contact:
`Einna Hoiztt-tan
`Tova !’h:trma::cut.icai [mtustries Llti.
`9?2 (3) 9257554
`Kevin Mannix
`Tcva Norm America
`(215) 59l«89t2
`
`For immediate Release
`
`TEVA PROVIDES UPDATE ON FORTE TRIAL
`
`Jerusalem, Israel Juiy 7, 2008 — Tova Pharmaceutical industries Ltd, (NASDAQ: TEVA) today
`announced top—lir:e results lrom a F’hase III study designed to assess tho efiicaoy. safety and
`tolerability of glatéramer acetate (GA) 40mg as compared to the approved GOPAXONE“ 20mg in
`the treatment of
`relapsingnrernétting multiple sclerosis {RHMS}. The 4-Omg dose did not
`demonstrate increased efficacy in reducing the relapse rate; however. the higher dose maintained
`the favorable safety and tolerahility profile at COPAXOP-5E“ zomg.
`
`Seventy~eight percent {78%} of COPAXDNE“ 20mg treated patients remained relapse-free
`throughout the study. Moreover, patients that completed one year of treatment with COPAJ(ONE°
`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 MR1.
`
`‘While the trial did not demonstrate an enhanced efficacy at the higher dose level, the study
`reatfirrns that COPAXONE“ 29mg, the leading multiple sclerosis therapy. remains the optimal
`treatment dose with unmatched long term efficacy confirmed over 10 years," said Moshe Manor,
`Group Vice President — Global Innovative Resources.
`“Tova is committed to ongoing
`research in the field at multiple sclerosis and will continue to move forward towards providing
`additional treatment options to multiple scterosis patients”.
`
`Teva wit: continue to analyze the study resutts to better understand the effect of GA 40mg on
`patients. The Company is also evaluating the use ot GA for additional indications.
`About the Study
`A randomized, dcuble—blind study. designed to assess the eltlcacy. safety and tolarabliity of 40mg
`glatiramer acetate, as compared to the currentiy approved COPAXONEQ (glatiramer acetate)
`20mg dose.
`
`The study was conducted in ‘:36 centers in North America. Argentina, Europe and Israel, and
`included 1,155 patients with HHMS. The triafs primary clinical outcome measure was rate at
`conlirmed relapses.
`
`About COPAXONE°
`Current data suggest COPAXONE” tglatirarner acetate inaction) is a selective Mi-IC (Major
`Histocompatability Complex) class It modulator. COPAXON
`is indicated for the reduction of the
`frequency of relapses in FIRMS. COPAXONE® is very well tolerated and the most common side
`effects of COPAXDNE” are redness, pain. swelling, itching, or a lump or an indentation at the site
`oi injection, weakness, infection, pain, nausea. joint pain, anxiety and muscle stitfness.
`
`Exhibit A
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`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 1
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`including this United States, all
`COPAXCDNE” in now approved in 51 countries worldwide.
`European countrws. Ganada. Mexico. Australia and israal. in Europe. COPAXONEQ is marketed
`by Tetra Phat-rnaceutical industries Ltd. and sanoti—aventis.
`in North America, COPAXCNEE“ is
`marketed by Tava Neurosaienca. Inc.
`
`San: additional important iniormation at httpj!\rrvvw.COPA>(C)NE.cornfpi!indax.ittm! or rail E-894)-
`88?-810G tor aiaotrorlic releases.
`
`About Multipta sciarosis
`is
`it
`Multiple Scierosis (MS) is the ieadlng cause of neurological disabiiity in young adults.
`estimated that 406,030 people in the United States are affected by this disease, and that over
`one million people are alfactecl worldwide. MS is a progressive. dernyalinating disease Of the
`central nervous system aifeoting the brain. spinal cord and optic nerves.
`
`including
`Patients with MS may experience physical symptoms and/or cognitive impairments.
`weakness. tatigue. ataxia. physical dysfunction. bladder and bowel problems, sensory effects.
`and visual irntzainnant. M5 also has a significant impact on the sufferers’ social functioning and
`overall quality of life.
`
`About Town
`Tova Pharmaceutical industries L.td., headquartered in israei. is among the top 20 pharmaceutical
`companies in the world and is the wortd’s leading generic pharmaceutical company. The
`Company develops. manufactures and markets generic and innovative human pharrnaceuticais
`and active pharmaceuticai ingredients. as well as animal health pharmaceutical products. Over
`80 percent of Tova's sales are in North America and Europe. Tava's innovative R815 iocusea on
`developing novel drugs for diseases of the central nervoussystem.
`
`Safe Harbor Statement under the H. S. Private Securities Litigation Reform Act of 1995:
`This rotease oonlainrt fomard—iooking statements. which express the current beliefs and expectations of management.
`fiuch statements are based on rnanagarnanrs current ballots and expectations and involve a number of known and
`unknown risks and uncertainties ihal could cause Tewa's future resuils, performance or achievements to differ significantly
`rrom the results. partormance or achievements expressed or implied by such larwardiiooking statements. Important
`factors that could cause or contribute to such diifere.-nces lnciude risks relating to: Teva'5 ability to accurateiy predict future
`market conditions, potential Eiataillty for sales ol generic products prior to a final resolution of outstanding patent iitigation,
`including that rotating to the generic versions of AElegra®, Neuronlincaa, Lotrel®, Famvirtzl and Protonixtaé. ¥ava's ability to
`successfully douaioo and commarcialira aclditionai pharmaceutical products.
`lite:
`introduction 01 competing generic
`equivalents, the extent to which Tava may obtain US. mancat exclusivity for certain at its new generic products and
`regulatory changes that may prevent Tova lrorn utilizing exolusivity periods, competition from brandmame companies that
`are under increased pressure to counter generic products. or competitors that seek to delay the introduction of generic
`products, the impact of consolidation of our distributors and customers.
`the effects of competition on our innovative
`products, especially Gopaxonafi sales. the impant of pharmaceutical industry regulation and pending legislation that could
`affect the pharmaceutical industry, the ctiiticulty of predicting US. Food and Drug Administration, European Medicines
`Agency and other regulatory authority approvals.
`the regulatory environment and changes in me heaitn poiicies and
`structures :3? various countries. our ability to achieve expected results thcmgh our innovative Halt) etforts. "l“eira's abiilty to
`successfully identity,
`consummate and integrate
`acquisitions
`(including the pending acquisition of Bentley
`Phannaceutlcals, inc). potential exposure to product liability claims to the extent not covered by insurance, dependence
`on the effectiveness of our patents and other protections for innovative products. significant operations worldwide that
`may be adversely affected by terrorism, political or economical instability or major hostilities. supply interruptions or delays
`that could result from the complex mariutacluring at our products and our global supply chain. environmental risks.
`iiuctuations in currency. exchange and interest rates. and other factors that are discussed in 'l'ava's Annual Report on
`irorm 20-F and its other filings with the U.S. Securities and Exchange Commission. §’orward—laoking statements speak
`only as at 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 or new intomtation. future events or otherwise.
`
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`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 2