Novartis enters into agreement for exclusive US and Canadian rights
to Fanapt(TM), an FDA-approved o
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Fanapt (iloperidone), an antipsychotic therapy, is indicated in US for the acute treatment of schizophrenia in adults, set for US launch in early 2010 * Addition of Fanapt will strengthen Novartis psychiatry portfolio and build on history in schizophrenia * Schizophrenia is a chronic, severe and disabling psychiatric disorder estimated to affect more than two million adults in the US and nearly 250,000 Canadians * Rights to Fanapt acquired from Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million; Vanda eligible for milestones and sales royaltiesBasel, October 12, 2009 - Novartis Pharma AG has entered into anagreement for exclusive US and Canadian rights to Fanapt(TM)(iloperidone), a new oral medication that is approved by the US Foodand Drug Administration (FDA) for the acute treatment of adults withschizophrenia. Novartis plans to launch Fanapt in the US in early2010.As part of the agreement with Vanda Pharmaceuticals Inc., Novartiswill have exclusive commercialization rights to the oral formulationof this medicine in the US and Canada as well as exclusive rights todevelop and commercialize a long-acting injectable (or "depot")formulation of this medicine for these markets.Schizophrenia is a severe psychiatric disorder that is estimated toaffect more than 2 million adults in the US and nearly 250,000Canadians. Fanapt belongs to a class of medication for schizophreniaknown as atypical antipsychotics."Schizophrenia remains one of the most chronic and debilitating ofthe major psychiatric illnesses, underscoring the need for newtreatment options," said Ludwig Hantson, PhD, Head of Pharma NorthAmerica, CEO, Novartis Pharmaceuticals Corporation. "With the launchof Fanapt in early 2010, we will broaden our presence in psychiatryand build on the heritage of Novartis in offering innovativetreatments for devastating psychiatric diseases."Novartis was a pioneer in offering Clozaril® (clozapine) as the firstatypical antipsychotic medication in the 1970s, which was considereda breakthrough for patients with treatment-resistant schizophrenia.Novartis also offers medications for Alzheimer's disease, attentiondeficit hyperactivity disorder (ADHD), Parkinson's disease andmultiple sclerosis.Vanda completed Phase III clinical trials in 2006 and gained USregulatory approval for this medicine in May 2009.Terms of the agreementNovartis will make an upfront payment to Vanda of USD 200 million forthe exclusive rights to commercialize the oral tablet, which isalready approved in the US, in the territory of the US and Canada, aswell as to develop and commercialize a depot formulation of Fanaptfor patients in this territory. Vanda will be eligible for additionalpayments upon achieving defined development and commercial milestonesand will also receive sales royalties. Vanda will retain rights todevelop and commercialize Fanapt outside the territory of US andCanada, but Novartis has the option to enter into discussions withVanda to co-commercialize Fanapt or receive sales royalties outsidethis territory. The consummation of the transaction is subject to thereceipt of customary regulatory approvals, which are expected by theend of 2009.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "set," "will," "eligible," "plans,""option," "expected," or similar expressions, or by express orimplied discussions regarding the potential consummation of theacquisition of Fanapt by Novartis, potential additional marketingapprovals for Fanapt products, Novartis obtaining potentialadditional marketing rights to Fanapt, or regarding potential futurerevenues from Fanapt. You should not place undue reliance on thesestatements. Such forward-looking statements reflect the currentviews of management regarding future events, and involve known andunknown risks, uncertainties and other factors that may cause actualresults with Fanapt to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that the proposed Fanaptacquisition will be completed in the expected form or within theexpected time frame or at all. Nor can there be any guarantee thatFanapt products will be approved for sale in any additional marketsor that Novartis will obtain marketing rights to Fanapt in additionalmarkets. Neither can there be any guarantee that Fanapt will achieveany particular levels of revenue in the future. In particular,management's expectations regarding Fanapt could be affected by,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 each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com. # # #Novartis Media RelationsCentral media line: +41 61 324 2200Eric Althoff Benjamin AtkinsNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +41 61 324 8738 (direct)+41 79 593 4202 (mobile) +41 79 825 1046 (mobile)eric.althoff(at)novartis.com benjamin.atkins(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1346595/323779.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: 12.10.2009 - 23:59 Uhr
Sprache: Deutsch
News-ID 6821
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 304 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis enters into agreement for exclusive US and Canadian rights
to Fanapt(TM), an FDA-approved o"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
