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Press Release: Basilea Announces Positive Top-Line Results On Second Pivotal Phase III Ceftobiprole Trial
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-- Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that the second pivotal ceftobiprole phase III study in complicated skin infections met its primary endpoint of statistical non-inferiority versus combination therapy. Ceftobiprole demonstrated high cure rates in patients with complicated Gram-positive as well as Gram-negative skin infections, including diabetic patients with foot infections. A first regulatory submission is planned this year. Ceftobiprole is an anti-MRSA, broad-spectrum cephalosporin developed in collaboration with Cilag GmbH International, a Johnson & Johnson company.
"Complicated skin infections require rapid medical intervention, typically before the causative pathogens are identified. The potent anti-MRSA activity of ceftobiprole, combined with its broad-spectrum activity, provided broad coverage of the clinically relevant pathogens in this important clinical setting. In particular, ceftobiprole, as a single agent, was clearly as effective as a combination regimen of standard broad-spectrum therapy in patients with difficult-to-treat diabetic foot infections," commented Dr. Rienk Pypstra, Chief Development Officer of Basilea.
This second pivotal double-blind study (STRAUSS II -- study of resistant Staphylococcus aureus in complicated skin and skin structure infections) treated 828 patients with either ceftobiprole or the combination of ceftazidime plus vancomycin in a 2:1 randomization. Almost one third of patients had diabetic foot infections of which three quarters were moderate to severe cases.
Ninety-one percent of clinically evaluable patients were cured with ceftobiprole compared to 90% of patients treated with combination therapy. The clinical response in patients with diabetic foot infections was 86% for ceftobiprole and 82% for comparator combination therapy, respectively. Over twenty percent of microbiologically evaluable patients had confirmed methicillin-resistant Staphylococcus aureus (MRSA) infections. The clinical cure rate for ceftobiprole in MRSA patients was 91% compared to 86% for the comparator regimen. One third of patients had infections involving a Gram-negative pathogen. The microbiologic eradication rates in these patients were similar at 84% in both treatment groups. Ceftobiprole was well tolerated. Adverse events were comparable between the two treatment groups.
"These are very strong clinical data. These results show that ceftobiprole monotherapy is non-inferior to standard combination therapy. Ceftobiprole has FDA fast track designation. With two positive phase III trials in complicated skin infections, we plan the first regulatory filing for ceftobiprole this year. We have reached another major milestone on the route to commercialization of ceftobiprole with our partner Cilag GmbH International. We are now closer to providing physicians with a new therapeutic option to treat patients with complicated bacterial skin infections," said Dr. Anthony Man, Basilea's CEO.
Press release: Johnson & Johnson Unit Reveals Positive Data On Ceftobiprole
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Johnson & Johnson's (JNJ) Pharmaceutical Research & Development unit said results from a Phase III trial showed that its investigational antibiotic ceftobiprole was found to clinically cure 86% of patients with diabetic foot infections, including some infections that were caused by methicillin-resistant Staphylococcus aureus (MRSA).
The company said the trial, which enrolled 257 patients, showed ceftobiprole was well tolerated in the treatment of complicated skin and skin structure infections, including diabetic foot infections.
Ceftobiprole belongs to a class of antibacterial agents known as cephalosporins, which are used to treat serious infections caused by Gram- negative and Gram-positive bacteria.
Press Release: FDA sets February meeting for J&J drug
January 10, 2008: 11:45 AM EST
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Government advisers will meet in late February to review Johnson & Johnson's antibiotic to treat foot infections related to diabetes.
The Food and Drug Administration's panel of outside antibiotic experts will consider approval of the company's ceftobiprole at a Feb. 28 meeting, according to a notice posted to the agency's Web site. The FDA is not required to follow the panel's recommendations, though it often does.
The New Brunswick, N.J.-based company previously reported that ceftobiprole cured 86 percent of patients with diabetic foot infection in company studies. The drug also showed some effectiveness at treating infections caused by the antibiotic resistant bacteria, Staphylococcus aureus.
Forbes are reporting: Basilea says FDA advisory committee drops meeting on skin treatment
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Basilea Pharmaceutica AG said the US Food and Drug Administration (FDA) has cancelled a meeting of its anti-infective drugs advisory committee on Basilea's complicated skin infection treatement ceftobiprole.
The meeting was scheduled for Feb 28, 2008.
A spokesman for the Basel-based drug maker said it was not informed by the FDA about the reasons behind the decision to cancel the meeting but that the situation regarding the expected approval and launch remain unchanged.
According to analysts, the health regulator may cancel a meeting if it is deemed unnecessary given the convincing nature of the data accompanying a drug application.
Press Release: FDA issues Approvable Letter for ceftobiprole, a new anti-MRSA broad-spectrum antibiotic
Basel, Switzerland, March 18, 2008
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Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections.
The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections.
Dr. Anthony Man, CEO of Basilea said, "We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C., to quickly address the questions from the FDA."
The New Drug Application (NDA) was submitted to the FDA by Basilea’s co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Ceftobiprole is currently under review by regulatory authorities in Canada, the European Union and in Switzerland.
The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Bloomberg are reporting: Basilea Falls Most Ever as Drug Fails to Get Approval
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Basilea Pharmaceutica AG, the Swiss biotechnology company working with Johnson & Johnson on anti- infective drugs, fell the most ever in Zurich trading after it failed to get U.S. approval for its ceftobiprole antibiotic.
Basilea plunged as much as 27 percent to 134.9 Swiss francs, the steepest drop since the shares started trading in March 2004, and declined 34.8 francs, or 19 percent, at 10:16 a.m. local time. That gives the company a market value of 1.43 billion francs ($1.45 billion).
The Food and Drug Administration sent an ``approvable letter'' saying it needs more information before it can allow sales of the treatment, the Basel-based company said today. The regulator wants to inspect study sites, get more information on the drug's use in diabetic foot infections and assess data already provided by the company. Ceftobiprole, developed with a J&J unit, treats complicated skin infections, including the so- called superbug MRSA, or methicillin-resistant Staphylococcus aureus.
`There is a fair chance that 9 to 12 months from now we'll hear of approval from the FDA, but the big question is whether that will include diabetic foot infections,'' Andrew Weiss, an analyst at Bank Vontobel in Zurich, said in a telephone interview. Approval for this use would give the medicine an advantage over competing products, he said.
Basilea Chief Executive Officer Anthony Man declined to comment on a possible timeline for FDA approval in a conference call with analysts. The regulator hasn't requested additional studies, he said, and doesn't have concerns about side effects.
J&J agreed in 2005 to pay Basilea 370 million Swiss francs to jointly develop ceftobiprole, which is part of a group of antibiotics known as cephalosporins. The U.S. drugmaker bought rights to the treatment after Roche Holding AG decided not to develop the medicine.
Ceftobiprole has been submitted for approval in Europe, Canada and Switzerland in addition to the U.S. Basilea is also studying for use against pneumonia.
The Swiss company said in October ceftobiprole worked as well as current treatments in a study of patients who developed pneumonia while in hospital. J&J said the drug cured 86 percent of patients with diabetic foot infections in another trial.
The FDA said it needs more information to approve ceftobiprole, the product of a joint development program between the Swiss pharmaceutical company Basilea Pharmaceutica AG and Johnson & Johnson (J&J).
Ceftobiprole (ceftobiprole medocaril) is a novel cephalosporin antibiotic to treat complicated skin and skin structure infections, including diabetic foot infections. Ceftobiprole is designed for infections due to methicillin-resistant Staphylococcus aureus (MRSA) and hospital-acquired pneumonia, including ventilator-associated pneumonia due to suspected or proven MRSA. The NDA was submitted last May.
According to Basilea, FDA approval is subject to clinical study site inspections, the assessment of clinical and microbiological data “and further characterization of patients with diabetic foot infections.” The companies said they are reviewing the letter and intend to move quickly to address the agency’s questions. The product is being reviewed in the European Union, Switzerland and Canada.
Complicated skin and skin structure infections (cSSSIs) are common and are associated with significant health and economic costs. These infections are predominantly characterized by infection with Staphylococcus aureus, and SENTRY Surveillance data indicate that the occurrence of this pathogen in cSSSIs has increased and that almost half of the isolated pathogens are virulent methicillin-resistant S. aureus (MRSA). Surveillance data also indicate that Gram-negative isolates are not uncommon in cSSSIs. In the past, empiric antimicrobial coverage of both Gram-positive and Gram-negative infections has generally necessitated the use of at least 2 antimicrobial agents. Ceftobiprole, a novel advanced-generation pyrrolidinone cephalosporin, is currently under review by the Food and Drug Administration as therapy for cSSSIs. This article presents a summary of the results of 2 recently published multicenter noninferiority trials involving approximately 1600 patients with a variety of cSSSIs. In the 1st trial, which included patients with Gram-positive cSSSI, the clinical cure rate at the test-of-cure (TOC) visit (the primary end point) among patients receiving ceftobiprole was 93.3%. The 2nd trial included a broad range of cSSSIs of varying pathogenicity. In this trial, the clinical cure rate among patients receiving ceftobiprole for S. aureus and MRSA infection was 94.6% and 91.8%, respectively. Ceftobiprole's capacity as a broad-spectrum agent was demonstrated in the 2nd trial, in which the clinical cure rate at TOC was 90.5% against a variety of infections and pathogens (including Gram negatives). In addition, the cure rate among patients with moderate to severe diabetic foot infection who received ceftobiprole was 86.2%, and these patients experienced a shorter length of stay in the hospital than those who received a comparator. This article also addresses the results of these trials in the context of the current medical need for safe broad-spectrum antimicrobial agents with MRSA coverage.
Press Release: Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives its first marketing authorization by Health Canada
Basel, Switzerland, June 30, 2008
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Basilea Pharmaceutica Ltd. announces that ceftobiprole (ZEFTERA™), the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Health Canada authorizing the marketing of ceftobiprole for the treatment of complicated skin and soft tissue infections including diabetic foot infections. In addition, Basilea announces further organizational changes in preparation of product commercialization.
Dr. Anthony Man, CEO of Basilea said, “The availability of ZEFTERA™ is an important advance in the fight against infections due to potentially deadly bacteria, including MRSA and we are delighted by this first regulatory approval in Canada. The labeling reflects our conviction that ZEFTERA™ is an innovative broad-spectrum, first-line treatment which may be used before knowing the exact bacteria causing the infection. This marketing authorization signals the start of a new era for Basilea as we commercialize the first of a number of innovative compounds in our pipeline.”
Basilea Pharmaceuticals Corp. will co-promote the drug in Canada under the trade name ZEFTERA™ with its local partner Janssen-Ortho, Inc. Ceftobiprole is currently under review by regulatory authorities in the U.S., the European Union, Australia, Russia, South Africa and Switzerland.
About ZEFTERA™
ZEFTERA™ (ceftobiprole medocaril for injection) is the first approved broad-spectrum anti-MRSA antibiotic belonging to the cephalosporin class. It is specially designed to bind the penicillin-resistant targets in many Gram-positive bacteria of the cocci-type, resulting in bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae. Ceftobiprole as a single intravenous agent has demonstrated broad-spectrum activity against many other Gram-positive as well as Gram-negative bacteria, frequently associated with community and hospital-acquired infections.
Health Canada has indicated ZEFTERA™ for: “The treatment of the following infections when caused by susceptible strains of the designated microorganisms in patients 18 years of age and older: Complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis caused by: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus aureus (including methicillin-resistant isolates), and Streptococcus pyogenes.”
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International. Basilea Pharmaceutica Ltd. has also exercised its option to co-promote ceftobiprole in the U.S. and in the major European markets together with Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and the respective Janssen-Cilag companies in Europe. Basilea maintains an option to co-promote the drug in Japan and China.
Press Release: FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
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Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA) Approvable Letter.
The Complete Response addresses the FDA Approvable Letter received in March, 2008 related to the ceftobiprole NDA for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. The FDA informed Basilea's co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. that it considers the response a class two Complete Response.
"We are very pleased that the FDA has accepted for review our complete response to the NDA approvable letter. We have worked diligently with our partner to achieve this important step in the review process. We look forward to continue to work closely with the FDA as it moves forward with the ceftobiprole NDA submission review." commented Dr. Anthony Man, Basilea's CEO.
Ceftobiprole obtained regulatory approval from Health Canada authorizing the marketing of ZEFTERA(TM) for the treatment of complicated skin and skin structure infections including diabetic foot infections. Ceftobiprole is also currently under review by regulatory authorities in the European Union, Switzerland and other countries.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson & Johnson company.
Press Release: Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives approval by Swissmedic
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Basilea Pharmaceutica Ltd. announces that ceftobiprole (Zevtera(TM)), the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Swissmedic for the treatment of complicated skin and soft tissue infections including diabetic foot infections.
Dr. Anthony Man, CEO of Basilea said, "We are delighted by this approval of ceftobiprole by Swissmedic. This is an important moment for our company and brings a novel and effective treatment against resistant bacteria to patients and physicians here in Switzerland."
The Swiss marketing authorization certificate may be used to facilitate regulatory approval and market entry in other countries including Asia and South America.
The regulatory dossier to Swissmedic was submitted by Basilea's license partner Janssen-Cilag AG, a Johnson & Johnson company, who will commercialize ceftobiprole in Switzerland under the trade name Zevtera(TM).
Ceftobiprole is marketed in Canada and is currently under regulatory review by regulatory authorities in the U.S., the European Union and in other countries. Subject to approval, Basilea will co-promote ceftobiprole in the U.S. and in the major European markets together with the respective Janssen-Cilag companies.
Press Release: FDA rejects Johnson & Johnson infection treatment
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Johnson & Johnson said Wednesday the U.S. Food and Drug Administration rejected its new-drug application for ceftobiprole, an antibiotic for the treatment of complicated skin and skin-structure infections, including diabetic-foot infections.
J&J's Pharmaceutical Research & Development unit said the FDA in a letter said the company needs to conduct additional audit work of clinical-investigator sites and to address specific questions related to site monitoring. J&J and its partner Swiss-based Basilea Pharmaceutica Ltd. are reviewing the FDA's letter and said they will continue to work with the agency to resolve any issues.
The companies initially asked for approval of the drug in May of 2007, but in March of this year the FDA asked for more information on the drug candidate. It has already been approved in Canada and Switzerland and an advisory committee in Europe has recommended approval in the European Union for the treatment of skin and soft-tissue infections.
Ceftobiprole is a broad-spectrum therapy to treat an antibiotic-resistant germ called MRSA that has been most commonly found in hospitals. Basilea said on its Web site that the rising incidence of methicillin-resistant staphylococcus aureus has focused attention on the need for a broad spectrum of antibacterials that also cover resistant bacteria.
Ceftobiprole for diabetic foot infections
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