US FDA approves Extavia® - the first in a new portfolio of planned MS
therapies from Novartis to hel
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Extavia is branded version of interferon beta-1b, a standard-of-care for multiple sclerosis in the US for more than 16 years[1] * MS affects around 400,000 people in US[2] - one of the most common neurological disorders in young adults[3] * FDA approval marks important step forward for Novartis, laying foundation for innovative approach to treatment of MSBasel, August 17, 2009 - The US Food and Drug Administration (FDA)has approved Extavia® (interferon beta-1b), the first in a newplanned portfolio of multiple sclerosis (MS) medicines from Novartisto help patients manage this devastating disease.Extavia is approved by the FDA for the treatment of relapsing formsof MS to reduce the frequency of clinical exacerbations. The therapyis also indicated for patients who have experienced a first clinicalepisode of MS and have features consistent with the disease as shownby magnetic resonance imaging (MRI)[4].The same medicinal product as Betaseron®*, Extavia offers patientsand physicians a new branded version of interferon beta-1b, afirst-line disease-modifying therapy that has been a standard-of-carefor MS in the US for more than 16 years[1]. Extavia will be marketedby the Pharmaceuticals Division of Novartis."Interferon is a mainstay of treatment in MS," said Doug Jeffery, MD,Associate Professor at Wake Forest University Baptist Medical Centerin Winston-Salem, North Carolina, USA. "With the approval of Extavia,patients have another option with a well-established safety andefficacy profile to help manage this disease."MS is estimated to affect approximately 400,000 patients in theUS[2], of whom more than 80% have relapsing-remitting MS[5]. MS isone of the most common causes of neurological disability in youngadults. It is a chronic autoimmune disease in which the body's immunesystem attacks the myelin sheath, or protective tissue surroundingthe nerve fibers that carry electrical signals in the brain[6]. Thedestruction of myelin causes problems with muscle control andstrength, vision, balance, sensation and mental function[7]."Novartis has been a leader in neuroscience for more than 50 years,having pioneered a number of breakthrough therapies which remainimportant treatments to this day," said Joe Jimenez, CEO of theNovartis Pharmaceuticals Division. "We are committed to providing newapproaches to MS care, and the FDA approval of Extavia marks thebeginning of our long-term commitment to the MS community in the US."Extavia will be available to patients in the US this fall. Along withtheir prescription for Extavia, patients will be given access to asupport program including a nurse helpline, one-on-one injectiontraining and reimbursement support services. Extavia patients willhave an autoinjector available to them from Novartis."MS is unpredictable and can be difficult to manage," said AaronMiller, MD, Professor of Neurology at Mount Sinai School of Medicinein New York, USA. "Support programs are an essential element to helppatients and physicians effectively manage this complicated disease."MS typically presents in relapsing forms involving acuteself-limiting attacks of neurological dysfunction (known asexacerbations or relapses), followed by complete or partialrestoration of function[6].Interferon beta-1b has been shown to reduce annualized relapse ratesby 34% (p=0.0001)[8], with patients nearly twice as likely to remainrelapse-free for more than two years compared to those receivingplacebo (31% vs. 16%, p=0.007)[8]. In addition, treatment withinterferon beta-1b may slow disease progression[9]. After two years,almost three-quarters of patients who experienced a single episode ofneurological disease lasting 24 hours or more did not progress toclinically definite MS[10].In the European Union Extavia is available in 12 countries and isapproved for relapsing-remitting MS as well as early MS (defined as asingle demyelinating event with an active inflammatory process) and asteadily worsening form of the disease known as secondary progressiveMS with relapses.* Novartis gained the rights to seek approval for its own brandedversion of interferon beta-1b through agreements with Bayer Schering,the company that markets Betaseron.Betaseron is marketed under the name of Betaferon® outside the US.Betaseron and Betaferon are registered trademarks of Bayer ScheringPharma AG.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "planned," "may," "committed,""long-term commitment," "will," "can," "likely," or similarexpressions, or by express or implied discussions regarding potentialfuture multiple sclerosis products or regarding potential futurerevenues from Extavia or other multiple sclerosis products. Youshould not place undue reliance on these statements. Suchforward-looking statements reflect the current views of managementregarding future events, and involve known and unknown risks,uncertainties and other factors that may cause actual results to bematerially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that any additional Novartis multiple sclerosis productswill be approved for sale in any market. Nor can there be anyguarantee that Extavia or such other products will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding such products could be affectedby, among other things, unexpected regulatory actions or delays orgovernment regulation generally; unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; competition in general;government, industry and general public pricing pressures; thecompany's ability to obtain or maintain patent or other proprietaryintellectual property protection; the impact that the foregoingfactors could have on the values attributed to the Novartis Group'sassets and liabilities as recorded in the Group's consolidatedbalance sheet, and other risks and factors referred to in NovartisAG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Novartis is providing the information in thispress release as of this date and does not undertake any obligationto update any forward-looking statements contained in this pressrelease as a result of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References1. FDA approves Betaseron® for use after the first event suggestiveof multiple sclerosis [press release]. Wayne, NJ: Berlex: 23 October2006.2. National Multiple Sclerosis Society website:http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx.Accessed August 12, 2009.3. Multiple Sclerosis International Federation website.http://www.msif.org/en/about_ms/what_is_ms.html. Accessed August 12,2009.4. Extavia Prescribing Information, August 14, 2009.5. Habermann, T. and Amit K. Ghosh ed. Mayo Clinic Internal MedicineConcise Textbook. Florence, KY: Informa HealthCare, 2007.6. National Multiple Sclerosis Society website.http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx.Accessed August 12, 2009.7. Multiple Sclerosis International Federation website.http://www.msif.org/en/about_ms/symptoms.html. Accessed August 12,2009.8. The IFNB Multiple Sclerosis Study Group. Interferon beta-1b iseffective in relapsing-remitting multiple sclerosis. Neurology.1993;43:655-661.9. Betaseron (interferon beta-1b) Prescribing Information. Availableonline athttp://berlex.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf.10. Kappos L, Freedman MS, Polman CH, et al. Treatment withinterferon beta-1b delays conversion to clinically definite andMcDonald MS in patients with clinically isolated syndromes.Neurology. 2006;67:1242-1249. # # #Novartis Media RelationsCentral media line: +41 61 324 2200Eric Althoff ÿsa JosefssonNovartis Global Media Novartis PharmaRelations Communications+41 61 324 7999 (direct) +41 61 324 0161 (direct)+41 79 593 4202 (mobile) +41 79 515 2253 (mobile)eric.althoff(at)novartis.com asa.josefsson(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth +41 61 324 North America:Metzler-Arnold 9980Pierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830Bringer 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 8425 Edwin Valeriano +1 212 830Hungerbuehler 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1335044/317162.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;
Datum: 17.08.2009 - 07:15 Uhr
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