FDA issues Warning Letter to Johnson & Johnson Pharmaceutical
Research and Development related to ce
(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, August 18, 2009 - Basilea Pharmaceutica Ltd.announces that the company was notified today that the U.S. Food andDrug Administration (FDA) issued to Johnson & Johnson PharmaceuticalResearch and Development, L.L.C. (J&JPRD) a Warning Letter related toclinical trials for ceftobiprole for the treatment of complicatedskin and skin structure infections.The Warning Letter to Johnson&Johnson PRD relates to observationsfrom FDA sponsor and clinical site inspections conducted during thefirst part of 2008.Consistent with Basilea's earlier press releases, the Warning Letterasserts that there was a failure to ensure proper monitoring of thestudies as well as deficiencies in study conduct.The FDA has posted the Warning Letter at www.fda.gov.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).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 ||----------------------------------+--------------------------------|| Jean-Christophe Britt, Ph.D. | Barbara Zink, Ph.D. || Corporate Communication & Public | Head Corporate Development || Relations | +41 61 606 1233 || +41 61 606 1354 | 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/1335700/317529.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: 19.08.2009 - 00:02 Uhr
Sprache: Deutsch
News-ID 4841
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London
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Business News
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Research and Development related to ce"
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