Novartis gains exclusive worldwide rights to PTK 0796, in Phase III
study as potential first-in-clas
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * PTK 0796 potentially the first broad-spectrum antibiotic given by once-daily infusion or tablet to treat infections caused by drug-resistant bacteria such as MRSA * Oral form of PTK 0796 could offer a convenient way for patients to continue outpatient antibiotic treatment after leaving hospital * New antibiotics needed in fight against bacterial resistance, with an estimated 150,000 deaths a year from hospital-acquired infections across US[1] and EU[2] * Novartis to make upfront payment to Paratek Pharmaceuticals; Paratek eligible for milestones and royalties on future salesBasel, October 8, 2009 - Novartis has gained exclusive worldwiderights to market PTK 0796, potentially the first once-dailybroad-spectrum antibiotic that can be given by intravenous (IV)infusion or oral tablet to treat a wide variety of life-threateninginfections, including those caused by highly resistant bacteria suchas methicillin-resistant Staphylococcus aureus (MRSA) and multi-drugresistant Streptococcus pneumoniae (MDRSP).Under the agreement with Paratek Pharmaceuticals, a privately heldcompany based in Boston, Massachusetts, the companies will shareresponsibility for developing PTK 0796. A Phase III study is alreadyunder way in complicated skin and skin structure infections (cSSSI),and clinical trials are planned in a number of other potentialindications.Because PTK 0796 may be given as a once-daily 30-minute IV infusionor daily oral tablet, it could offer patients a convenient way tocontinue antibiotic treatment after they have been discharged fromhospital. Its broad spectrum of activity means it could be used as asingle agent against a range of bacteria, unlike other antibioticswhich may have to be used in combination."As the first in a new class of antibiotics, PTK 0796 is beingdeveloped to address the growing problem of bacterial resistance tocurrently available antibiotics," said Joe Jimenez, CEO of theNovartis Pharmaceuticals Division. "It will potentially benefitpatients by offering a flexible and highly effective approach to thetreatment of a number of critical infections, and should form animportant addition to our growing portfolio of antibiotic medicines."The in-licensing of PTK 0796 represents a further expansion of theNovartis infectious diseases portfolio following the acquisition ofProtez Pharmaceuticals in June 2008. The Protez transaction coveredthe North American and European rights to PTZ601 (razupenem),currently in Phase II development as the first injectablebroad-spectrum antibiotic in the carbapenem class to cover MRSA.PTK 0796, a first-in-class aminomethylcycline, has shownbroad-spectrum activity against a wide range of bacteria, includingboth Gram-positive and Gram-negative strains - a basic classificationderived from the staining process used to analyze the cell wall - aswell as atypical and anaerobic bacteria, which grow with little or nooxygen.In addition, PTK 0796 has shown activity against multi-drug resistantbacteria such as MRSA, vancomycin-resistant enterococci (VRE) andGram-negatives producing ESBL (extended-spectrum beta-lactamase).These bacteria have developed resistance during decades of antibioticuse, so many of the standard therapies are no longer effective.Studies have estimated there were nearly 100,000 deaths fromhospital-acquired infections in the US in 2002[1], and around 50,000deaths a year in the EU[2].Clinical studies involving a total of more than 500 patients haveshown that PTK 0796 has a favorable safety and tolerability profile.A Phase II study in cSSSI found that clinical success rates amongevaluable patients (n=188) were 98% for PTK 0796 and 93% forlinezolid (Zyvox®*)[3]. In this study PTK 0796 was used as a singleagent, whereas Zyvox was used for Gram-positive infections only andan additional antibiotic had to be given for Gram-negative cases. Thestudy met its primary safety and tolerability endpoints by showing norelevant difference between PTK 0796 and linezolid in terms ofadverse events[3]. In this study, approximately 50% of the infectingbacteria were MRSA[3].The Novartis portfolio of medicines for hospital-based infectionsincludes Cubicin® (daptomycin), marketed by Novartis in the EU andother countries for treating complicated skin and soft tissueinfections (cSSTI), right-sided infective endocarditis (RIE) due toStaphylococcus aureus (S. aureus), and S. aureus bacteremia (SAB)when associated with RIE or cSSTI. Cubicin is the first of a newclass of antibiotics called cyclic lipopeptides.Terms of the agreementThe agreement states that Novartis will make an upfront payment toParatek in return for the exclusive rights to commercialize PTK 0796worldwide. Both companies will share responsibility and costs fordeveloping PTK 0796. Paratek will be eligible to receive futuremilestone payments, and will also receive a royalty on net sales ofPTK 0796 around the world.* Zyvox is a registered trademark of Pfizer Inc.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "potential," "potentially,""could," "eligible," "future," "can," "will," "planned," "may,""should," or similar expressions, or by express or implieddiscussions regarding potential future regulatory filings ormarketing approvals for PTK 0796, or the timing of any such potentialfilings or approvals, or regarding potential future revenues from PTK0796, PTZ601 or Cubicin. You should not place undue reliance on thesestatements. Such forward-looking statements reflect the current viewsof the Company regarding future events, and involve known and unknownrisks, uncertainties and other factors that may cause actual resultsto be materially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that PTK 0796 will be submitted or approved for sale in anymarket, or that any such approvals will occur at any particular time.Nor can there be any guarantee that PTK 0796, PTZ601 or Cubicin willachieve any particular levels of revenue in the future. Inparticular, management's expectations regarding these drugs could beaffected by, among other things, unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; unexpected regulatory actions ordelays or government regulation generally; the company's ability toobtain or maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on the values attributed to the Group's assets and liabilitiesas recorded in the Group's consolidated balance sheet, and otherrisks and factors referred to in Novartis AG's current Form 20-F onfile with the US Securities and Exchange Commission. Should one ormore of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult 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.References[1] Klevens RM, et al. Estimating Health Care-Associated Infectionsand Deaths in U.S. Hospitals, 2002. Public Health Reports Mar-Apr2007 Vol. 122 p.160-166.[2] Surveillance of Nosocomial Infections in Europe Analysis Results- HELICS European Database, including 2005 data.[3] Paratek Pharmaceuticals. Data on file. # # #Novartis Media RelationsEric Althoff John TaylorNovartis Global Media Novartis Pharma CommunicationsRelations +41 61 324 6715 (direct)+41 61 324 7999 (direct) +41 79 593 4279 (mobile)+41 79 593 4202 (mobile) john.taylor(at)novartis.comeric.althoff(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/1346369/323386.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: 08.10.2009 - 07:15 Uhr
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