European CHMP adopts negative opinion on ceftobiprole
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG / European CHMP adopts negative opinion on ceftobiprole processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, February 19, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announces that the European Committee for Medicinal Products for Human Use
(CHMP) adopted a negative opinion on the Marketing Authorization Application
(MAA) for ceftobiprole for the treatment of complicated skin and soft tissue
infections (cSSTI).
The sponsor Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson
company, has been notified that the CHMP adopted a negative opinion on the MAA
for ceftobiprole for the treatment of cSSTI.
The MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag
in June 2007. After a positive opinion from the CHMP in November 2008, the
European Medicines Agency took the unusual step of halting the European
Commission authorization process on ceftobiprole pending completion and
assessment of Good Clinical Practice (GCP) inspections.
The CHMP now stated that inspections showed that the phase III studies
supporting the MAA had not been conducted in compliance with GCP in some sites.
The CHMP indicated that, although the study results suggested that the medicine
was beneficial to patients, it was concerned about how reliable the results
were. The Committee therefore recommended that, in light of the uncertainty
surrounding the results, ceftobiprole should not be granted marketing
authorization.
Janssen-Cilag aims to discuss with the CHMP as soon as possible the best path
forward for ceftobiprole in Europe.
Basilea is committed to take those steps necessary to allow ceftobiprole to be
more widely available to patients in need of new treatment options to fight
potentially deadly resistant bacterial infections. The company is reviewing all
strategic options to protect the interests of the company and its shareholders.
Due to the deficiencies identified by the U.S. Food and Drug Administration
(FDA) in Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'s
(Johnson & Johnson PRD) conduct of the clinical investigations and Basilea's
claimed breaches of the License Agreement, Basilea submitted a Request for
Arbitration under the License Agreement for ceftobiprole in February 2009.
Basilea's claims under arbitration include that Johnson & Johnson PRD breached
the License Agreement by, among other things, causing the delay in the approval
of ceftobiprole in the U.S. and EU. Basilea's initial significant damage claims,
including milestone payments and additional damages, in the arbitration will
increase as a result of this further delay.
Basilea anticipates an arbitration decision prior to the end of 2010.
Regulatory key events
In December 2009, the FDA issued to the sponsor, Johnson & Johnson PRD, a
Complete Response Letter on ceftobiprole for the treatment of complicated skin
and skin structure infections (cSSSI), indicating that the Agency cannot approve
the NDA in its present form. In order to address the deficiencies, the FDA
recommended that two new, adequate, and well-controlled studies to evaluate the
safety and efficacy of ceftobiprole for the treatment of cSSSI should be
conducted. Johnson & Johnson PRD communicated that it intends to discuss the
best path forward with the FDA as soon as possible.
In August 2009, the FDA issued to Johnson & Johnson PRD a Warning Letter on its
role as a sponsor of clinical trials. The Agency noted that under the terms of
the agreement between Basilea and Cilag GmbH International, a Johnson & Johnson
company, all rights and responsibilities for ceftobiprole clinical trials were
transferred to Johnson & Johnson PRD and the FDA concluded that Johnson &
Johnson PRD did not adhere to the applicable statutory requirements or FDA
regulations governing the conduct of clinical investigations. The FDA found
numerous objectionable conditions during its investigation into Johnson &
Johnson PRD's role as a sponsor of the two phase III trials of ceftobiprole for
the treatment of cSSSI.
In February 2005, Basilea granted Cilag GmbH International an exclusive
worldwide license to develop, manufacture and commercialize ceftobiprole.
About ceftobiprole
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic exhibiting
activity against a wide spectrum of Gram-positive bacteria, including the
'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and
penicillin-resistant Streptococcus pneumonia as well as many clinically
important Gram-negative bacteria, including Pseudomonas. Ceftobiprole is
marketed in Canada (ZEFTERA(TM)) for the treatment of cSSSI, including non-limb
threatening diabetic foot infections without concomitant osteomyelitis and in
Switzerland (Zevtera(TM)) for the treatment of cSSTI including diabetic foot
infections without concomitant osteomyelitis.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Friday, February 19, 2010, 3:00 p.m (CET), during which the company will discuss
today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 4166 (USA)
+44 (0) 207 107 0611 (UK)
A playback will be available 1 hour after the conference call until Tuesday,
February 23, 2010, 6 p.m. (CET). Participants requesting a digital playback may
dial:
+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 14060 followed by the # sign.
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
(isavuconazole) in phase III clinical development. Toctino® (alitretinoin) is
marketed in Denmark, France, Germany, Switzerland and the United Kingdom and is
approved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands and
Spain. Toctino® has been recommended for approval in 16 additional European
countries. Furthermore, a phase III clinical program 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). Basilea has set up commercial organizations in
Canada, France, Germany, the Nordics, Switzerland and the United Kingdom, while
it is building sales and marketing organizations in other countries to
commercialize alitretinoin.
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., MBA |
|Head Public Relations & |Head Corporate Development |
|Corporate Communications | |
|+41 61 606 1460 |+41 61 606 1233 |
|media_relations(at)basilea.com |investor_relations(at)basilea.com |
|
+----------------------------------------+-------------------------------------+
This press release can be downloaded from www.basilea.com
[HUG#1386358]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
WKN: A0B9GA;ISIN: CH0011432447;
Press release (PDF): http://hugin.info/134390/R/1386358/345007.pdf
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Datum: 19.02.2010 - 05:11 Uhr
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