Sandoz launches first generic version of Prograf® capsules
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Sandoz is first company to receive US approval to market generic tacrolimus * US sales of Prograf® were USD 929 million annually through April 2009 * Tacrolimus launch demonstrates Sandoz commitment to increasing access for transplant patients to cost-saving treatment optionsHolzkirchen, August 11, 2009 - Sandoz today announced theintroduction of tacrolimus capsules, a generic equivalent ofPrograf®, in the US. Tacrolimus is an immunosuppressive treatmentused to help prevent rejection of a kidney or liver transplant.Sandoz is the first and only company to launch generic tacrolimus inthe US, delivering on its strategy of being first-to-market with keyproducts. With the introduction of tacrolimus, Sandoz is expandingpatient access to cost-saving transplant treatment options in theUS."Tacrolimus is an important new product for Sandoz, furtherstrengthening our diverse portfolio of affordable medicines in thekey US market," said Jeff George, CEO of Sandoz."Sandoz is excited to be the first company to offer this newhigh-quality, affordable treatment option to transplant patients.Sandoz and our parent company Novartis have deep experience in thetransplant field and we are deeply committed to providing morecost-saving treatment options for this community in the future."Novartis pioneered medicines to facilitate transplantation with thediscovery over 25 years ago of cyclosporine (Sandimmune® /cyclosporine USP) and Neoral® (cyclosporine USP MODIFIED), for theprevention of organ rejection following kidney, liver or hearttransplantation.Today, Novartis has the broadest portfolio of immunosuppressants onthe market, including Myfortic® (mycophenolic acid) delayed-releasetablets, indicated for kidney transplants, and Simulect®(basiliximab), for the prevention of acute organ rejection. Theaddition of Sandoz tacrolimus will further increase the breadth ofthis portfolio.According to IMS Health, Prograf had US sales of USD 929 million forthe 12 months through April 2009. Sandoz will market tacrolimus incapsules of 0.5, 1 and 5 mg strengths.About SandozSandoz, a Division of the Novartis group, is a global leader in thefield of generic pharmaceuticals, offering a wide array ofhigh-quality, affordable products that are no longer protected bypatents. Sandoz has a portfolio of about 1000 compounds and sells itsproducts in more than 130 countries. Key product groups includeantibiotics, treatments for central nervous system disorders,gastrointestinal medicines, cardiovascular treatments and hormonetherapies. Sandoz develops, produces and markets these medicinesalong with pharmaceutical and biotechnological active substances andanti-infectives. In addition to strong organic growth in recentyears, Sandoz has made a series of acquisitions including Lek(Slovenia), Sabex (Canada), Hexal (Germany) and Eon Labs (US). In2008, Sandoz employed around 23,000 people worldwide and posted salesof USD 7.6 billion. * * *DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "commitment", "strategy","committed", or similar expressions, or by express or implieddiscussions regarding potential additional marketing approvals orpotential sales of tacrolimus capsules. You should not place unduereliance on these statements. Such forward-looking statementsreflect the current views of the company regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that tacrolimus capsules willbe approved for sale in any additional markets. Nor can there be anyguarantee that tacrolimus capsules will achieve any particular levelsof revenue in the future. In particular, management's expectationscould be affected by, among other things, unexpected regulatoryactions or delays or government regulation generally; the particularprescribing preferences of transplantation physicians and patients;competition in general; government, industry and general publicpricing pressures; unexpected patent litigation outcomes; the impactthat the foregoing factors could have on the values attributed to theNovartis Group's assets and liabilities as recorded in the Group'sconsolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Sandoz is providing the informationin this press release as of this date and does not undertake anyobligation to update any forward-looking statements contained in thispress release as a result of new information, future events orotherwise. * * *For further informationCentral media line : +41 61 324 2200Eric Althoff Anna MannoNovartis Global Media Relations Sandoz US Communications+41 61 324 7999 +1 609 6275240eric.althoff(at)novartis.com anna.manno(at)sandoz.come-mail: media.relations(at)novartis.comNovartis Investor RelationsInternational: North America:Ruth Metzler-Arnold Richard Jarvis +1 212 830 2433Pierre-Michel Bringer Jill Pozarek +1 212 830 2445John Gilardi Edwin Valeriano +1 212 830 2456Thomas Hungerbuehler E-mail:Isabella Zinck investor.relations(at)novartis.comCentral phone no: +41 61 324 7944E-mail:investor.relations(at)novartis.comPrograf® is a registered trademark of Astellas.http://hugin.info/134323/R/1333786/316275.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
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Datum: 11.08.2009 - 07:15 Uhr
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