FDA accepts for review the Complete Response submission to
ceftobiprole NDA
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Basel, Switzerland, September 1, 2009 - Basilea Pharmaceutica Ltd.announces that the U.S. Food and Drug Administration (FDA) hasaccepted the response submitted by the sponsor Johnson & JohnsonPharmaceutical Research & Development, L.L.C. (PRD) as complete. TheComplete Response submission addresses the FDA Complete ResponseLetter issued in November 2008 concerning the ceftobiprole NDA forcomplicated skin and skin structure infections.The FDA informed Johnson & Johnson PRD that it considers theresubmission a complete, class 2 response."We are pleased that the FDA has accepted for review the submissionrelated to the Complete Response Letter. We look forward to theadvancement of ceftobiprole through the FDA review process,"commented Dr. Anthony Man, CEO.Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic.It is marketed in Canada (ZEFTERA(TM)) for the treatment ofcomplicated skin and skin structure infections (cSSSI), includingnon-limb threatening diabetic foot infections without concomitantosteomyelitis and in Switzerland (Zevtera(TM)) for the treatment ofcomplicated skin and soft tissue infections (cSSTI) includingdiabetic foot infections without concomitant osteomyelitis.Ceftobiprole is being developed through an exclusive worldwidecollaboration between Basilea Pharmaceutica International Ltd. andCilag GmbH International, a Johnson & Johnson company.About BasileaBasilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integratedresearch and development operations are currently focused on newantibacterial, antifungal and oncology agents to fight drugresistance and on the development of dermatology drugs. Basilea'sproducts are targeted to satisfy high medical and patient needs inthe hospital and specialty care setting. The company owns adiversified portfolio including two commercialized drugs (Toctino®,ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug in phase III(isavuconazole). Toctino® (alitretinoin) is marketed in the UnitedKingdom, Denmark and Germany and is approved in Austria, Belgium,Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoinhas been recommended for approval in Italy and is under regulatoryreview in Canada, Switzerland and 15 additional European countries.Furthermore a phase III clinical trial on alitretinoin for thetreatment of severe chronic hand eczema is ongoing in the U.S.Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM)and in Switzerland under Zevtera(TM). Ceftobiprole is underregulatory review in the U.S. and marketing applications aresubmitted in the EU and several other countries. The company has setup commercial organizations in UK, Denmark, Germany and Canada, whileit is building sales and marketing organizations in other countriesto commercialize alitretinoin and to co-promote ceftobiprole, subjectto approval.DisclaimerThis communication expressly or implicitly contains certainforward-looking statements concerning Basilea Pharmaceutica Ltd. andits business. Such statements involve certain known and unknownrisks, uncertainties and other factors, which could cause the actualresults, financial condition, performance or achievements of BasileaPharmaceutica Ltd. to be materially different from any futureresults, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providingthis communication as of this date and does not undertake to updateany forward-looking statements contained herein as a result of newinformation, future events or otherwise.For further information, please contact:+--------------------------------------------------------------+| Media Relations | Investor Relations ||-----------------------------+--------------------------------|| Adesh Kaul | Barbara Zink, Ph.D. || Head Public Relations & | Head Corporate Development || Corporate Communications | +41 61 606 1233 || +41 61 606 1460 | investor_relations(at)basilea.com || media_relations(at)basilea.com | |+--------------------------------------------------------------+This press release can be downloaded from www.basilea.comThe press release can also be downloaded from the following link:http://hugin.info/134390/R/1338502/319382.pdf --- End of Message ---Basilea Pharmaceutica AGGrenzacherstrasse 487
P.O Box Basel SwitzerlandWKN: A0B9GA; ISIN: CH0011432447; Index: SLIFE, SMCI, SPI, SPIEX, SBIOM;Listed: Main Market in SIX Swiss Exchange;
Datum: 01.09.2009 - 07:15 Uhr
Sprache: Deutsch
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