BASEL, SWITZERLAND--(Marketwire - January 05, 2012) -
Basilea Pharmaceutica AG /
Basilea to file application for marketing authorization of ceftobiprole for
treatment of pneumonia
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Basel, Switzerland, January 5, 2012 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
today announced that it will apply in the second half of 2012 for approval of
its antibiotic ceftobiprole in Europe. In addition, reporting of topline data
for the alitretinoin U.S. phase III study for chronic refractory hand eczema
will occur in the first quarter of this year. Basilea thus has the potential
two regulatory submissions in 2012.
Basilea has completed investigator site audits of two international double-
randomized controlled phase III studies of ceftobiprole for the treatment of
severe community-acquired and hospital-acquired pneumonia. The audits included
26 investigator sites, covering more than one third of patients of both
On the basis of these audits and following health authority feedback on
potential filing strategies, Basilea has decided to apply in the second half
2012 for the approval of ceftobiprole in Europe for pneumonia treated in the
CEO Dr. Anthony Man commented: "Ceftobiprole is a unique antibiotic that has
potential to provide broad antibacterial coverage in the treatment of patients
with severe and life-threatening pneumonia. Based on independent site audits
the robustness of the trial data we plan to file an application for marketing
approval for severe pneumonia treated in the hospital setting. We target
in Europe in the second half of 2012. We will finalize our filing plans for
U.S. upon additional discussions with the FDA."
All patients of the alitretinoin U.S. phase III HANDEL study have completed
blinded six-month follow-up period after end of treatment. The company is
preparing the database lock and subsequent unblinding of data. The U.S.
includes comprehensive safety assessments such as bone mineral density
measurements, audiological, ophthalmological and psychiatric assessments.
Following detailed analyses of this study, Basilea plans to discuss with the
the design of a risk evaluation and mitigation strategies (REMS) program to
support a potential New Drug Application (NDA) filing.
Dr. Man stated: "We expect topline data from this comprehensive study in the
first quarter. We plan to file by the end of 2012 after bone mineral density
data is available at mid-year and we have had a subsequent pre-NDA meeting
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Thursday, January 5, 2012, 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 Monday,
January 9, 2012, 6 p.m. (CET). Participants requesting a digital playback may
+41 (0) 91 612 4330 (Europe and ROW)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)
and will be asked to enter the ID 13427 followed by the # sign.
Inappropriate initial antimicrobial therapy is associated with excess
in patients with serious bacterial infections including severe pneumonia
in the hospital. In order to provide appropriate initial therapy, empiric
treatment should include antibiotics covering methicillin-resistant
Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.
Ceftobiprole is an investigational new broad-spectrum cephalosporin antibiotic
for the potential first-line (empiric) treatment of severe multi-drug
bacterial infections. Available data demonstrate activity against a wide range
of Gram-positive bacteria, including the MRSA 'superbug' as well as
relevant Gram-negative bacteria such as Pseudomonas spp. and Acinetobacter
Ceftobiprole has been tested in a large clinical program including two phase
studies each in the indications of pneumonia (patients hospitalized with
community-acquired pneumonia and patients with hospital-acquired pneumonia)
complicated skin and skin structure infections. In total, more than 3000
patients were enrolled in these studies.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed
the SIX Swiss Exchange (SIX: BSLN). Basilea Pharmaceutica International Ltd.'s
fully integrated research and development operations are focused on
antifungals and oncology drugs, as well as on the development of dermatology
drugs, targeting the medical challenge of resistance and non-response to
treatment options in the hospital and specialty care setting.
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,
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.
This press release can be downloaded from www.basilea.com.
Press release (PDF):
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE