Basilea's Antibiotic Ceftobiprole Obtains Regulatory Approval In Europe For Pneumonia

BASEL, Switzerland, Oct. 23, 2013 (GLOBE NEWSWIRE) --
Basilea Pharmaceutica Ltd. (SIX: BSLN)announced today the approval of its antibiotic ceftobiprole in Europe.Ceftobiprole is indicated for the treatment of hospital-acquired pneumonia(excluding ventilator-associated pneumonia) and community-acquired pneumonia inadults. Ceftobiprole has broad-spectrum activity against many pathogens thatcause pneumonia including Gram-positive pathogens such as penicillin-resistantStreptococcus pneumoniae (PRSP), methicillin-resistant Staphylococcus aureus(MRSA) and various Gram-negative pathogens including Pseudomonas species.Basilea submitted the ceftobiprole Marketing Authorization Application under theDecentralized Procedure (DCP) initially in 12 European Union Member Statesincluding the major markets in Europe. In accordance with the DCP, each of theinvolved Member States are expected to grant national authorizations within thecoming months."Basilea is committed to develop new medicines that fight the increasing threatof resistance," stated Basilea's Chief Executive Officer Ronald Scott. "TheEuropean approval of ceftobiprole in pneumonia marks another significantmilestone for our company. Ceftobiprole has the broadest spectrum of activity ofany approved anti-MRSA agent. It is the first broad-spectrum anti-MRSAcephalosporin monotherapy for both hospital- and community-acquired pneumonia.We will work with authorities, hospital formularies, clinicians and potentialpartners to bring this new antibiotic to patients as soon as possible."Basilea's Chief Medical Officer Prof. Achim Kaufhold added: "Ceftobiprole hasbroad-spectrum activity against many pathogens that cause pneumonia. Itsspectrum extends to isolates resistant to other commonly used antibiotics likepenicillin-resistant Streptococcus pneumoniae (PRSP), methicillin-resistantStaphylococcus aureus (MRSA) or Staphylococcus aureus strains resistant tovancomycin or linezolid. In the phase 3 pneumonia studies ceftobiprole wascomparable to a standard-of-care regimen consisting of two drugs. Ceftobiprolemay simplify physicians' treatment choice when the causative organism of aninfection is not known and offers coverage over a broad range of bacteria rightfrom the start of empiric therapy."The European authorities' positive decision will support additional regulatorysubmissions in many markets around the world. In Switzerland, a ceftobiproleMarketing Authorization Application for the treatment of hospital- andcommunity-acquired pneumonia in adults is currently under review by theregulatory authority Swissmedic.About ceftobiproleCeftobiprole medocaril (ceftobiprole) is a broad-spectrum intravenous antibioticfrom the cephalosporin class for the treatment of hospital-acquired pneumonia(excluding ventilator-associated pneumonia) and community-acquired pneumonia.Ceftobiprole has demonstrated broad-spectrum activity against Gram-positivebacteria including methicillin-resistant and vancomycin-resistant Staphylococcusaureus (MRSA, VRSA) and penicillin- and ceftriaxone-resistant Streptococcuspneumoniae (PRSP, CRSP) as well as Gram-negative pathogens including strains ofEnterobacteriaceae and Pseudomonas species.About hospital-acquired and community-acquired pneumoniaHospital-acquired pneumonia is one of the most common infections in thehospital, accounting for approximately 25% of all intensive care unit (ICU)infections, and is associated with significant mortality.[1],[2] Community-acquired pneumonia is a common condition with up to 60% of the patientsrequiring hospital admission and intravenous antibiotics.[3] Prompt empiricintervention with an appropriate broad-spectrum antibiotic treatment is acceptedas best medical practice. The increasing incidence of bacteria resistant to manyestablished antibiotics is a major concern.Conference callBasilea Pharmaceutica Ltd. invites you to participate in a conference call onWednesday, October 23, 2013, 4 p.m. (CEST), during which the company willdiscuss 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,October 25, 2013, 6 p.m. (CEST). Participants requesting a digital playback maydial: +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 15072 followed by the # sign.About BasileaBasilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed onthe SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research anddevelopment operations of its Swiss subsidiary Basilea PharmaceuticaInternational Ltd., the company focuses on innovative pharmaceutical products inthe therapeutic areas of bacterial infections, fungal infections and oncology,targeting the medical challenge of rising resistance and non-response to currenttreatment options.DisclaimerThis communication expressly or implicitly contains certain forward-lookingstatements concerning Basilea Pharmaceutica Ltd. and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors, which could cause the actual results, financial condition, performanceor achievements of Basilea Pharmaceutica Ltd. to be materially different fromany future results, performance or achievements expressed or implied by suchforward-looking statements. Basilea Pharmaceutica Ltd. is providing thiscommunication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, futureevents 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                || | |+-----------------------------+--------------------------------+This press release can be downloaded from[1] Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of    hospital-acquired and ventilator-associated pneumonia. Clinical Infectious    Diseases 2010; 51: S48-S53.[2] Barbier F, Andremont A, Wolff M, Bouadma L. Hospital-acquired pneumonia and    ventilator-associated pneumonia: recent advances in epidemiology and    management. Current Opinion in Pulmonary Medicine 2013; 19: 216-228.[3] Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Critical Care    Clinics 2013; 29:    563-601.Press release (PDF):[HUG#1737484]