Basilea provides update on ceftobiprole's U.S. regulatory status

Basilea provides update on ceftobiprole's U.S. regulatory status

BASEL, Switzerland, June 25, 2014 (GLOBE NEWSWIRE) -- Basilea Pharmaceutica
Ltd. (SIX: BSLN) reports that it had a further discussion regarding
ceftobiprole with the U.S. Food and Drug Administration (FDA) in light of new
regulatory requirements for pneumonia in the U.S. In this recent discussion,
the FDA confirmed that a potential regulatory approval of ceftobiprole for the
treatment of pneumonia in the U.S. would require additional phase 3 data. The
FDA confirmed that the current ceftobiprole studies should be complemented
with prospective data in community and hospital-acquired pneumonia in
accordance with its new guidelines. Basilea does not currently intend to
initiate new phase 3 trials for ceftobiprole without a partner for the U.S.

Ronald Scott, Basilea's Chief Executive Officer, stated: "We are currently
focused on preparing the launch of ceftobiprole for the treatment of community
and hospital-acquired pneumonia in Europe with a pharmaceutical distributor or
contract sales organization. We anticipate that ceftobiprole will be available
in the first key European markets in the second half of this year." He
continued: "Another major milestone for Basilea will be the regulatory
submission of isavuconazole for the treatment of invasive aspergillosis and
mucormycosis. We anticipate filing in Europe mid this year and we also
anticipate a mid-year filing by our partner Astellas in the U.S. We are
excited to potentially adding a second anti-infective to our commercial
portfolio of hospital drugs. The significant overlap in the prescribing base
between ceftobiprole and isavuconazole could provide a unique opportunity to
optimize the value of both drugs by leveraging significant promotional
synergy."

About ceftobiprole

Ceftobiprole (ceftobiprole medocaril) is a broad-spectrum intravenous
antibiotic from the cephalosporin class for the first-line treatment of severe
bacterial infections. Ceftobiprole has gained regulatory authorization from
twelve European states for the treatment of hospital-acquired pneumonia (HAP,
excluding ventilator-associated pneumonia, VAP) and community-acquired
pneumonia (CAP) in patients 18 years of age and older, and is currently under
regulatory review in Switzerland. In the U.S., ceftobiprole is an
investigational drug. Ceftobiprole demonstrated broad-spectrum in-vitro
bactericidal activity against Gram-positive bacteria including
methicillin-resistant and vancomycin-resistant Staphylococcus aureus (MRSA,
VRSA) and penicillin- and ceftriaxone-resistant Streptococcus pneumoniae
(PRSP, CRSP) as well as Gram-negative pathogens including strains of
Enterobacteriaceae and Pseudomonas.

About isavuconazole

Isavuconazole (isavuconazonium sulfate) is an investigational once-daily
intravenous and oral broad-spectrum antifungal for the potential treatment of
severe invasive and life-threatening fungal infections. It is currently in
phase 3 of clinical development. Detailed results from the SECURE phase 3
study were reported in May 2014, while topline data of the VITAL phase 3 study
were reported in February 2014. The two studies will form the basis of a
potential regulatory filing for isavuconazole in Europe and the U.S. mid-2014.

Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of
yeasts (such as Candida species) and molds (such as Aspergillus species),
including emerging and often fatal molds such as those that cause
mucormycosis. In the U.S., isavuconazole was granted FDA fast-track status and
received QIDP and orphan drug designations for invasive aspergillosis and
mucormycosis (zygomycosis).

Isavuconazole is being co-developed with Astellas Pharma Inc. Basilea holds
full rights to isavuconazole in all markets outside of the U.S. and Canada,
where Astellas is the license holder.

Conference call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Wednesday, June25, 2014, 4 p.m. (CEST), during which the company will discuss
today's press release.

Dial-in numbers are:

+41 (0) 58 310 50 00 (Europe and ROW)
+1 (1) 631 570 5613  (USA)
+44 (0) 203 059 5862 (UK)

A playback will be available 1 hour after the conference call until Friday,
June 27, 2014, 6p.m. (CEST). Participants requesting a digital playback may
dial:

+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 14167 followed by the # sign.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed
on the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
and development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical products
in the therapeutic areas of bacterial infections, fungal infections and
oncology, targeting the medical challenge of rising resistance and
non-response to current treatment options.

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
Peer Nils Schröder, PhD     Barbara Zink, PhD, MBA
Head Public Relations &     Head Corporate Development
Corporate Communications
+41 61 606 1102             +41 61 606 1233
media_relations@basilea.com investor_relations@basilea.com

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

Press release (PDF) http://hugin.info/134390/R/1801512/620981.pdf

HUG#1801512
 
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