||| Menü 
Startseite
Firmenveranstaltungen, Neuemissionen

10/11
09/11
08/11
07/09
08/09
09/09
10/09
11/09
12/09
01/10
02/10
03/10
Geschäftsberichte, Werbung, Earnings, Marketing, Verordnungen

10/11
09/11
03/09
04/09
05/09
06/09
08/09
09/09
10/09
11/09
12/09
01/10
02/10
Fusionen, Übernahmen

11/11
12/08
01/09
02/09
03/09
04/09
05/09
06/09
07/09
08/09
09/09
10/09
11/09
Personal, Belegschaft, Meldungen zu Produkten

06/08
07/08
08/08
09/08
10/08
11/08
12/08
01/09
02/09
03/09
04/09
05/09
06/09
07/09
08/09

Datenschutz
Impressum
Bankleitzahlen - online.de


FDA accepts for review the Complete Response submission to ceftobiprole NDA

Basel, Switzerland, September 1, 2009 - Basilea Pharmaceutica Ltd.
announces that the U.S. Food and Drug Administration (FDA) has
accepted the response submitted by the sponsor Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. (PRD) as complete. The
Complete Response submission addresses the FDA Complete Response
Letter issued in November 2008 concerning the ceftobiprole NDA for
complicated skin and skin structure infections.

The FDA informed Johnson & Johnson PRD that it considers the
resubmission a complete, class 2 response.
"We are pleased that the FDA has accepted for review the submission
related to the Complete Response Letter. We look forward to the
advancement 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 of
complicated skin and skin structure infections (cSSSI), including
non-limb threatening diabetic foot infections without concomitant
osteomyelitis and in Switzerland (Zevtera(TM)) for the treatment of
complicated skin and soft tissue infections (cSSTI) including
diabetic foot infections without concomitant osteomyelitis.

Ceftobiprole is being developed through an exclusive worldwide
collaboration between Basilea Pharmaceutica International Ltd. and
Cilag GmbH International, a Johnson & Johnson company.

About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated
research and development operations are currently focused on new
antibacterial, antifungal and oncology agents to fight drug
resistance and on the development of dermatology drugs. Basilea's
products are targeted to satisfy high medical and patient needs in
the hospital and specialty care setting. The company owns a
diversified portfolio including two commercialized drugs (Toctino®,
ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug in phase III
(isavuconazole). Toctino® (alitretinoin) is marketed in the United
Kingdom, Denmark and Germany and is approved in Austria, Belgium,
Finland, France, Luxemburg, the Netherlands and Spain. Alitretinoin
has been recommended for approval in Italy and is under regulatory
review in Canada, Switzerland and 15 additional European countries.
Furthermore a phase III clinical trial on alitretinoin for the
treatment 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 under
regulatory review in the U.S. and marketing applications are
submitted in the EU and several other countries. The company has set
up commercial organizations in UK, Denmark, Germany and Canada, while
it is building sales and marketing organizations in other countries
to commercialize alitretinoin and to co-promote ceftobiprole, subject
to approval.

Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements concerning Basilea Pharmaceutica Ltd. and
its business. Such statements involve certain known and unknown
risks, uncertainties and other factors, which could cause the actual
results, financial condition, performance or achievements of Basilea
Pharmaceutica Ltd. to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing
this communication as of this date and does not undertake to update
any forward-looking statements contained herein as a result of new
information, 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@basilea.com |
| media_relations@basilea.com | |
+--------------------------------------------------------------+


This press release can be downloaded from www.basilea.com

The press release can also be downloaded from the following link:


This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Copyright © Hugin AS 2009. All rights reserved.



 
 ||| Themen-Infos 
· Mehr zu dem Thema Contracts & Corporate events & IPOs &

Der meistgelesene Artikel zu dem Thema Contracts & Corporate events & IPOs &:
Change on the Board of Directors of Feintool Holding AG

 ||| Artikel Bewertung 
durchschnittliche Punktzahl: 0
Stimmen: 0

Bitte nehmen Sie sich einen Augenblick Zeit, diesen Artikel zu bewerten:

Exzellent
Sehr gut
gut
normal
schlecht



Web site engine's code is Copyright © 2003 by PHP-Nuke. All Rights Reserved. PHP-Nuke is Free Software released under the GNU/GPL license.
Erstellung der Seite: 0.078 Sekunden