PRESS RELEASE FDA issues Complete ... - Basilea Pharmaceutica
PRESS RELEASE FDA issues Complete ... - Basilea Pharmaceutica
PRESS RELEASE FDA issues Complete ... - Basilea Pharmaceutica
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<strong>PRESS</strong> <strong>RELEASE</strong><br />
<strong>FDA</strong> <strong>issues</strong> <strong>Complete</strong> Response Letter for ceftobiprole<br />
Basel, Switzerland, November 26, 2008 - <strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. announces<br />
that the U.S. Food and Drug Administration (<strong>FDA</strong>) issued to the sponsor, Johnson<br />
& Johnson <strong>Pharmaceutica</strong>l Research and Development, L.L.C. (J&JPRD), a<br />
<strong>Complete</strong> Response Letter for ceftobiprole for the treatment of complicated skin<br />
and skin structure infections including diabetic foot infections.<br />
Ceftobiprole showed in two large multinational, double-blind, randomized phase III clinical<br />
studies, that it was effective, as demonstrated by meeting the primary endpoint using a 10%<br />
non-inferiority margin. A safety profile consistent with the cephalosporin class of antibiotics was<br />
demonstrated. Ceftobiprole has been approved or recommended for approval in a number of<br />
territories including the European Union.<br />
The <strong>FDA</strong> indicated in a <strong>Complete</strong> Response Letter to J&JPRD that further resolution of specific<br />
deficiencies of study conduct is necessary. As a result of <strong>FDA</strong> audits at investigator sites and of<br />
the sponsor J&JPRD, the Agency suggested that J&JPRD have additional clinical site audits<br />
performed.<br />
The <strong>FDA</strong> indicated from their sponsor/monitor inspection that there was a failure to ensure<br />
proper monitoring of the studies. The Agency has requested information on J&JPRD’s clinical<br />
quality assurance programs and also asked for a new audit plan that also addresses<br />
deficiencies in contract research organization monitoring. The <strong>FDA</strong> indicated to J&JPRD that<br />
they are unable to review the clinical data included in the submitted complete response until<br />
<strong>issues</strong> of data integrity have been resolved. The <strong>FDA</strong> has indicated to J&JPRD the need to fully<br />
respond to this action letter within one year.<br />
“Ceftobiprole is a novel antibiotic addressing the very serious medical need related to resistant<br />
bacterial infections including MRSA. The drug met its primary clinical endpoint and was<br />
approved or recommended for approval in a number of countries including the EU based on<br />
two large independent and well designed trials. We are deeply disappointed with the further<br />
delay in the review of the U.S. NDA application. We will be working with J&JPRD and the <strong>FDA</strong> to<br />
address these outstanding <strong>issues</strong> as soon as possible. These events have not altered in any way<br />
our confidence in the efficacy and safety profile of ceftobiprole and its potential to satisfy a<br />
high medical need”, said Dr. Anthony Man, <strong>Basilea</strong>’s CEO.<br />
The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure<br />
infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These<br />
trials comprise data from over 1600 patients including those with diabetic foot infections caused<br />
by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus<br />
aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase<br />
III clinical studies, ceftobiprole was effective as demonstrated by achievement of the noninferiority<br />
endpoint to single drug or two-drug combination comparators, respectively.<br />
The New Drug Application (NDA) was submitted to the <strong>FDA</strong> by Johnson & Johnson<br />
<strong>Pharmaceutica</strong>l Research and Development, L.L.C. The <strong>FDA</strong> issued an Approvable Letter in<br />
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<strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com
March, 2008. The questions in the Approvable Letter were addressed in a complete response<br />
package that was filed and accepted by the <strong>FDA</strong> for review in September 2008.<br />
Ceftobiprole is marketed in Canada and approved in Switzerland. Ceftobiprole received a<br />
positive opinion from the CHMP in the European Union in November 2008 and is under review in<br />
a number of other countries.<br />
Conference Calls<br />
<strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. will hold two conference calls on November 26, 2008, one at<br />
8:30 a.m. (CET) and one at 4 p.m. (CET) to discuss today’s press release.<br />
The Company invites you to participate in the conference call on November 26, 2008, 8:30 a.m.<br />
(CET).<br />
Dial-in numbers are:<br />
+41 (0) 91 610 56 00 (Europe and ROW)<br />
+44 (0) 207 107 0611 (UK)<br />
+1 (1) 866 291 4166 (USA)<br />
A second conference call is scheduled on November 26, 2008, 4 p.m. (CET).<br />
Dial-in numbers are:<br />
+41 (0) 91 610 56 00 (Europe and ROW)<br />
+44 (0) 207 107 0611 (UK)<br />
+1 (1) 866 291 4166 (USA)<br />
About <strong>Basilea</strong><br />
<strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss<br />
Exchange (SIX:BSLN). <strong>Basilea</strong>’s integrated research and development operations are currently<br />
focused on new antibacterial and antifungal agents to fight drug resistance and on the<br />
development of dermatology drugs. <strong>Basilea</strong>’s products are targeted to satisfy high medical and<br />
patient needs in the hospital and specialty care setting. The company owns a diversified<br />
portfolio including two commercialized drugs (alitretinoin, ceftobiprole) and one investigational<br />
drug (isavuconazole) in phase III. Alitretinoin (Toctino®) is marketed in the United Kingdom, in<br />
Denmark and in Germany and is approved in Finland and France. Alitretinoin has been<br />
recommended for approval in six additional EU Member States and is under regulatory review in<br />
Canada and Switzerland. Ceftobiprole is marketed in Canada and approved in Switzerland.<br />
Ceftobiprole received a positive opinion from the CHMP and is under review by regulatory<br />
authorities in several other countries. The company has set up commercial organizations in UK,<br />
Denmark and in Germany while it is building sales and marketing organizations to commercialize<br />
alitretinoin and to co-promote ceftobiprole subject to approval.<br />
Disclaimer<br />
This communication expressly or implicitly contains certain forward-looking statements<br />
concerning <strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. and its business. Such statements involve certain known<br />
and unknown risks, uncertainties and other factors, which could cause the actual results,<br />
financial condition, performance or achievements of <strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. to be<br />
materially different from any future results, performance or achievements expressed or implied<br />
by such forward-looking statements. <strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. is providing this communication<br />
as of this date and does not undertake to update any forward-looking statements contained<br />
herein as a result of new information, future events or otherwise.<br />
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<strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com
For further information, please contact:<br />
Media Relations Investor Relations<br />
Jean-Christophe Britt, Ph.D.<br />
Corporate Communication & Public Relations<br />
+41 61 606 1354<br />
media_relations@basilea.com<br />
This press release can be downloaded from www.basilea.com<br />
Page 3 of 3<br />
Barbara Zink, Ph.D., MBA<br />
Head Corporate Development<br />
+41 61 606 1233<br />
investor_relations@basilea.com<br />
<strong>Basilea</strong> <strong>Pharmaceutica</strong> Ltd. • Grenzacherstrasse 487 • PO Box • CH-4005 Basel • Switzerland • www.basilea.com