Basilea awarded USD 130 million by arbitral tribunal
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Basilea Pharmaceutica AG /
Basilea awarded USD 130 million by arbitral tribunal
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Basel, Switzerland, November 29, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
announced today that the tribunal has found Johnson & Johnson in breach of its
License Agreement with Basilea. The tribunal awarded Basilea approximately
USD 130 million as compensation for lost payments related to ceftobiprole,
including milestones, other damages and interest.
The tribunal at the Netherlands Arbitration Institute has found Johnson &
Johnson, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. and
Cilag GmbH International [collectively Johnson & Johnson] in breach of its
License Agreement with Basilea, which caused the rejection of ceftobiprole, a
novel anti-MRSA broad-spectrum antibiotic, by health authorities.
The tribunal awarded an amount of approximately USD 130 million, including lost
milestones, other damages and interest. The award is immediately enforceable.
"This award in our favor has validated our grounds for arbitration," said Dr.
Anthony Man, CEO of Basilea. "Ceftobiprole is a very innovative drug. It has
activity against a wide range of bacteria, including MRSA and many Gram-negative
pathogens, that no other single antibiotic can currently provide. Patients are
dying from serious resistant bacterial infections in hospitals. This is a very
unfortunate situation in which patients have not been able to access this
potentially life-saving drug. We are pleased that we will gain full control of
the development and commercialization of ceftobiprole. We are now focusing on
completing the return of ceftobiprole to Basilea at the latest by February 2011
so that we can move forward with its future development and make this important
drug available again to patients as soon as possible."
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 pneumoniae as well as many clinically important Gram-
negative bacteria, including Pseudomonas spp. Ceftobiprole's key features may
allow physicians to use it as the first treatment when MRSA is proven or
suspected. The rights for ceftobiprole are being transferred back to Basilea
from Cilag GmbH International, a Johnson & Johnson company.
Background information
In February 2010, the European Committee for Medicinal Products for Human Use
(CHMP) stated to the sponsor Janssen-Cilag International NV, a Johnson & Johnson
company, that inspections showed that the phase III studies supporting the
Marketing Authorization Application (MAA) had not been conducted in compliance
with Good Clinical Practice (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.
In December 2009, the FDA issued to the sponsor Johnson & Johnson Pharmaceutical
Research and Development, L.L.C. (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.
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.
Due to the deficiencies identified by the FDA in Johnson & Johnson PRD's 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
included 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.
In 2008, the FDA issued an Approvable Letter and a Complete Response Letter to
the sponsor Johnson & Johnson PRD. In the same year the CHMP made a
recommendation for approval in Europe, which was subsequently suspended.
In 2007, Marketing Authorization Applications were submitted by Johnson &
Johnson PRD and Janssen-Cilag in the U.S., Europe and other countries.
In February 2005, Basilea granted Cilag GmbH International an exclusive
worldwide license to develop, manufacture and commercialize ceftobiprole.
Conference call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Monday, November 29, 4 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) 203 059 5862 (UK)
A playback will be available 1 hour after the conference call until Wednesday,
December 1, 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 15440 followed by the # sign.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Its fully integrated research and development
operations are currently focused on antibiotics, antifungals and oncology drugs,
as well as on the development of dermatology drugs, targeting the medical
challenge of resistance and non-response to current treatment options in the
hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only approved
treatment for severe chronic hand eczema unresponsive to potent topical
corticosteroids, in Denmark, France, Germany, Switzerland and the United Kingdom
and has appointed distributors for Toctino® in other selected European markets,
Canada and Mexico. Furthermore, a phase III clinical program on alitretinoin for
the treatment of severe chronic hand eczema is ongoing in the U.S. The company
has entered into a global partnership with Astellas Pharma Inc. for its phase
III compound isavuconazole, a potential best-in-class azole antifungal, for the
treatment of life-threatening invasive fungal infections. Full rights to
ceftobiprole for the treatment of potentially life-threatening resistant
bacterial infections, are being transferred from Cilag GmbH International, a
Johnson & Johnson company, back to Basilea.
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#1466412]
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
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Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Press release (PDF):
http://hugin.info/134390/R/1466412/404219.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 29.11.2010 - 07:16 Uhr
Sprache: Deutsch
News-ID 49171
Anzahl Zeichen: 10915
contact information:
Town:
Basel
Kategorie:
Business News
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