Novartis gains exclusive rights to Debio 025, an antiviral agent in Phase IIb development as potenti
(Thomson Reuters ONE) - Novartis International AG / Novartis gains exclusive rights to Debio 025, an antiviral agent in Phase IIb development as potential first-in-class hepatitis C therapy processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement. * Phase II results demonstrate efficacy of Debio 025, a cyclophilin inhibitor, against hepatitis C virus when used alone or in combination with current standard therapy(1) * Cyclophilin inhibitors evolving as new class of medicines with potential to become part of future standard of care for treating hepatitis C * Hepatitis C is one of the world's most common liver diseases, current therapies may only be effective in around 50% of patients(2) * Novartis to make upfront payment to Debiopharm Group(TM), with Debiopharm eligible for milestones and royalties on future salesBasel, February 9, 2010 - Novartis has gained exclusive rights to develop andmarket Debio 025 (alisporivir), a potential first-in-class antiviral agentcurrently in Phase IIb development for the treatment of hepatitis C. Debio 025is the first in a new class of drugs called cyclophilin inhibitors which couldbecome part of the future standard of care for the disease.Debio 025 has been in-licensed from Debiopharm Group(TM), an independentbiopharmaceuticals company based in Switzerland, under an agreement which givesNovartis exclusive worldwide development and marketing rights (excluding Japan).Under the terms of the agreement, Novartis will make an upfront payment toDebiopharm, and Debiopharm will be eligible for milestone payments, and forroyalties on future sales of Debio 025, if it is approved. The transaction issubject to customary regulatory approvals."Hepatitis C is sometimes referred to as a 'silent epidemic' because the viruscan lie dormant in the body for years or even decades before the symptoms becomeapparent," said David Epstein, CEO of the Novartis Pharmaceuticals Division."Novartis is dedicated to developing medicines that will reduce the impact ofthis disease on patients, and we believe that Debio 025 could prove an importantstep forward by significantly enhancing the efficacy of existing therapy thatforms the standard of care for hepatitis C."More than 170 million people worldwide are infected with hepatitis C virus(HCV)(3), and this can cause serious liver disease leading to cirrhosis or livercancer which may result in death. There is an urgent need for more effectivemedications, often used in combination, as current therapy is only effective inaround 50% of patients with the most prevalent form of the virus, calledgenotype 1(2).Cyclophilin inhibitors such as Debio 025 provide a novel approach to treatmentby targeting host proteins that are involved in the growth of the hepatitis Cvirus. Results of a Phase II study show that Debio 025 significantly reduced HCVreplication when used alone, and had an important additive anti-HCV effect (4.6log(10) reduction) in combination with pegylated interferon alfa-2a intreatment-na? patients(1). No significant safety issues have been identifiedso far.A double-blind, placebo-controlled Phase IIb study is now under way to assessthe efficacy and safety of Debio 025 in combination with the current standard ofcare for hepatitis C - peginterferon alfa-2a plus ribavirin - in treatment-na?patients. The study is being conducted in patients with the most common genotype1. Debio 025 is also effective against other genotypes of the virus(1,4).The in-licensing of Debio 025 represents a further expansion of the Novartishepatitis C portfolio following the filing of Joulferon(®)/Zalbin(®)(albinterferon alfa-2b) for European and US regulatory approval at the end of2009. In Phase III studies, Joulferon dosed every two weeks showed similarefficacy to peginterferon alfa-2a dosed weekly while requiring half the numberof injections. Albinterferon alfa-2b is being developed and will beco-commercialized in the US together with Human Genome Sciences, who filed forUS approval under the brand name Zalbin(®) .DisclaimerThe foregoing release contains forward-looking statements that can be identifiedby terminology such as "potential," "eligible," "could," "will," "can,""dedicated," "believe," "may," or similar expressions, or by express or implieddiscussions regarding potential regulatory approval of Novartis' acquisition ofrights to Debio 025, potential marketing approvals for Debio 025, or forJoulferon/Zalbin, or regarding potential future revenues from such products. Youshould not place undue reliance on these statements. Such forward-lookingstatements reflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors that may causeactual results to be materially different from any future results, performanceor achievements expressed or implied by such statements. There can be noguarantee that Novartis will receive the necessary regulatory approvals tocomplete its acquisition of the rights to Debio 025. Nor can there be anyguarantee that Debio 025 or Joulferon/Zalbin will be approved for sale in anymarket. Nor can there be any guarantee that these products will achieve anyparticular levels of revenue in the future. In particular, management'sexpectations regarding these products could be affected by, among other things,unexpected regulatory actions or delays or government regulation generally;unexpected clinical trial results, including unexpected new clinical data andunexpected additional analysis of existing clinical data; the company's abilityto obtain or maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and general publicpricing pressures; the impact that the foregoing factors could have on thevalues attributed to the Novartis Group's assets and liabilities as recorded inthe Group's consolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertainties materialize, orshould underlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date and does notundertake any obligation to update any forward-looking statements contained inthis press release as a result of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on healthcare, Novartis offers adiversified portfolio to best meet these needs: innovative medicines,cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools andconsumer health products. Novartis is the only company with leading positions inthese areas. In 2009, the Group's continuing operations achieved net sales ofUSD 44.3 billion, while approximately USD 7.5 billion was invested in R&Dactivities throughout the Group. Headquartered in Basel, Switzerland, NovartisGroup companies employ approximately 100,000 full-time-equivalent associates andoperate in more than 140 countries around the world. For more information,please visit http://www.novartis.com.References1. Flisiak R, et al. The cyclophilin inhibitor Debio 025 combined with PEGIFNalpha2a significantly reduces viral load in treatment-na? hepatitis Cpatients. Hepatology 2009;49 (5):1460-8.2. Hoofnagle JH. A step forward in therapy for hepatitis C. N Engl J Med.2009;360 (18):1899-901.3. Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001;345(1):41-52.4. Flisiak R, et al. The cyclophilin inhibitor Debio-025 shows potentanti-hepatitis C effect in patients coinfected with hepatitis C and humanimmunodeficiency virus. Hepatology. 2008;47(3):817-26. # # #Novartis Media Relations Eric Althoff John Taylor Novartis Global Media Relations Novartis Pharma Communications +41 61 324 7999 (direct) +41 61 324 6715 (direct) +41 79 593 4202 (mobile) +41 79 593 4279 (mobile) eric.althoff(at)novartis.com
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