Ceftobiprole for diabetic foot infections

NewsBot · Jan 10, 2007

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Press Release:
Basilea Announces Positive Top-Line Results On Second Pivotal Phase III Ceftobiprole Trial

-- 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.
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NewsBot · Oct 8, 2007

Press release:
Johnson & Johnson Unit Reveals Positive Data On Ceftobiprole

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.
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NewsBot · Jan 10, 2008

Press Release:
FDA sets February meeting for J&J drug
January 10, 2008: 11:45 AM EST

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.
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NewsBot · Feb 13, 2008

Forbes are reporting:
Basilea says FDA advisory committee drops meeting on skin treatment

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.
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NewsBot · Mar 18, 2008

Press Release:
FDA issues Approvable Letter for ceftobiprole, a new anti-MRSA broad-spectrum antibiotic
Basel, Switzerland, March 18, 2008

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.
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Bloomberg are reporting:
Basilea Falls Most Ever as Drug Fails to Get Approval

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.
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admin · Mar 26, 2008

Johnson & Johnson Gets FDA Approvable Letter for Ceftobiprole
FDAnews Drug Daily Bulletin March 26, 2008 | Vol. 5 No. 60

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.
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NewsBot · Apr 4, 2008

The efficacy and safety of ceftobiprole in the treatment of complicated skin and skin structure infections: evidence from 2 clinical trials.
Deresinski SC.
Diagn Microbiol Infect Dis. 2008 Apr 1 [Epub ahead of print]

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.
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Admin2 · Apr 4, 2008

The links in this Wikipedia article are live and can be followed.

Ceftobiprole

Chemical compound

Ceftobiprole, sold under the brand name Zevtera among others, is a fifth-generation^[7] cephalosporin antibacterial used for the treatment of hospital-acquired pneumonia (excluding ventilator-associated pneumonia) and community-acquired pneumonia. It is marketed by Basilea Pharmaceutica under the brand names Zevtera and Mabelio.^[8]^[9]^[10]^[11]^[12]^[13] Like other cephalosporins, ceftobiprole exerts its antibacterial activity by binding to important penicillin-binding proteins and inhibiting their transpeptidase activity which is essential for the synthesis of bacterial cell walls. Ceftobiprole has high affinity for penicillin-binding protein 2a of methicillin-resistant Staphylococcus aureus strains and retains its activity against strains that express divergent mecA gene homologues (mecC or mecALGA251). Ceftobiprole also binds to penicillin-binding protein 2b in Streptococcus pneumoniae (penicillin-intermediate), to penicillin-binding protein 2x in Streptococcus pneumoniae (penicillin-resistant), and to penicillin-binding protein 5 in Enterococcus faecalis.^[14]
For adults with Staphylococcus aureus bloodstream infections (bacteremia), the most common side effects include anemia, nausea, low levels of potassium in the blood (hypokalemia), vomiting, diarrhea, increased levels of certain liver tests (hepatic enzymes and bilirubin), increased blood creatinine, high blood pressure, low white blood cell count (leukopenia), fever, abdominal pain, fungal infection, headache and shortness of breath (dyspnea).^[15] For adults with acute bacterial skin and skin structure infections, the most common side effects include nausea, diarrhea, headache, injection site reaction, increased levels of hepatic enzymes, rash, vomiting and altered taste (dysgeusia).^[15] For adults with community-acquired bacterial pneumonia, the most common side effects include nausea, increased levels of hepatic enzymes, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, vein inflammation (phlebitis), high blood pressure and dizziness.^[15] For children with community-acquired bacterial pneumonia, the most common side effects include vomiting, headache, increased levels of hepatic enzymes, diarrhea, infusion site reaction, vein inflammation (phlebitis) and fever.^[15]
Ceftobiprole medocaril was approved for medical use in the United States in April 2024.^[15]

^ Hebeisen P, Heinze-Krauss I, Angehrn P, Hohl P, Page MG, Then RL (March 2001). "In vitro and in vivo properties of Ro 63-9141, a novel broad-spectrum cephalosporin with activity against methicillin-resistant staphylococci". Antimicrobial Agents and Chemotherapy. 45 (3): 825–836. doi:10.1128/AAC.45.3.825-836.2001. PMC 90381. PMID 11181368.

^ Jones RN, Deshpande LM, Mutnick AH, Biedenbach DJ (December 2002). "In vitro evaluation of BAL9141, a novel parenteral cephalosporin active against oxacillin-resistant staphylococci". The Journal of Antimicrobial Chemotherapy. 50 (6): 915–932. doi:10.1093/jac/dkf249. PMID 12461013.

^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.

^ "Zevtera Product information". Health Canada. 23 April 2010. Retrieved 13 April 2024.

^ "Zevtera Product information". Health Canada. 20 March 2018. Retrieved 13 April 2024.

^ https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218275s000lbl.pdf

^ Scheeren TW (1 January 2015). "Ceftobiprole medocaril in the treatment of hospital-acquired pneumonia". Future Microbiology. 10 (12): 1913–1928. doi:10.2217/fmb.15.115. PMID 26573022.

^ "Basilea announces distribution agreement with Cardiome to commercialize antibiotic Zevtera/Mabelio (ceftobiprole) in Europe and Israel". Basilea (Press release). 12 September 2017. Retrieved 7 April 2024.

^ "Basilea to launch Zevtera/Mabelio (ceftobiprole medocaril) in Europe through a commercial services provider" (Press release). Basilea Pharmaceutica. Archived from the original on 31 March 2019. Retrieved 20 September 2016.

^ "Basilea announces launch of antibiotic Zevtera (ceftobiprole medocaril) in Germany". Basilea (Press release). 5 December 2014. Retrieved 7 April 2024.

^ "Swissmedic approves Basilea's antibiotic Zevtera (ceftobiprole medocaril) for the treatment of pneumonia". Basilea (Press release). 22 December 2014. Retrieved 7 April 2024.

^ "Basilea signs exclusive distribution agreement for Zevtera (ceftobiprole medocaril) in the Middle East and North Africa with Hikma Pharmaceuticals LLC". Basilea (Press release). 15 October 2015. Retrieved 7 April 2024.

^ "Basilea announces that Health Canada approved Zevtera for the treatment of bacterial lung infections". Basilea (Press release). 12 October 2015. Retrieved 7 April 2024.

^ Syed YY (September 2014). "Ceftobiprole medocaril: a review of its use in patients with hospital- or community-acquired pneumonia". Drugs. 74 (13): 1523–1542. doi:10.1007/s40265-014-0273-x. PMID 25117196. S2CID 2925496.

^ ^a ^b ^c ^d ^e "FDA Approves New Antibiotic for Three Different Uses". U.S. Food and Drug Administration (FDA) (Press release). 3 April 2024. Retrieved 12 April 2024. This article incorporates text from this source, which is in the public domain.

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NewsBot · Jun 30, 2008

Press Release:
Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives its first marketing authorization by Health Canada
Basel, Switzerland, June 30, 2008

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.
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NewsBot · Sep 15, 2008

Press Release:
FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter

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.
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NewsBot · Nov 13, 2008

Press Release:
Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives approval by Swissmedic

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.
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NewsBot · Nov 26, 2008

Rejected by FDA

Press Release:
FDA rejects Johnson & Johnson infection treatment

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.
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NewsBot · Feb 20, 2010

Press Release:
Europe Panel Rejects Basilea Pharmaceutica's Antibiotic Ceftobiprole

BASEL, SWITZERLAND--(Marketwire - 02/19/10) - Basilea Pharmaceutica Ltd. (SIX: BSLN) announces that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

The sponsor Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, has been notified that the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI.

The MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag in June 2007. After a positive opinion from the CHMP in November 2008, the European Medicines Agency took the unusual step of halting the European Commission authorization process on ceftobiprole pending completion and assessment of Good Clinical Practice (GCP) inspections.

The CHMP now stated that inspections showed that the phase III studies supporting the MAA had not been conducted in compliance with GCP in some sites. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about how reliable the results were. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.

Janssen-Cilag aims to discuss with the CHMP as soon as possible the best path forward for ceftobiprole in Europe.

Basilea is committed to take those steps necessary to allow ceftobiprole to be more widely available to patients in need of new treatment options to fight potentially deadly resistant bacterial infections. The company is reviewing all strategic options to protect the interests of the company and its shareholders.

Due to the deficiencies identified by the U.S. Food and Drug Administration (FDA) in Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'s (Johnson & Johnson PRD) conduct of the clinical investigations and Basilea's claimed breaches of the License Agreement, Basilea submitted a Request for Arbitration under the License Agreement for ceftobiprole in February 2009. Basilea's claims under arbitration include that Johnson & Johnson PRD breached the License Agreement by, among other things, causing the delay in the approval of ceftobiprole in the U.S. and EU. Basilea's initial significant damage claims, including milestone payments and additional damages, in the arbitration will increase as a result of this further delay. Basilea anticipates an arbitration decision prior to the end of 2010.

Regulatory key events

In December 2009, the FDA issued to the sponsor, Johnson & Johnson PRD, a Complete Response Letter on ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI), indicating that the Agency cannot approve the NDA in its present form. In order to address the deficiencies, the FDA recommended that two new, adequate, and well-controlled studies to evaluate the safety and efficacy of ceftobiprole for the treatment of cSSSI should be conducted. Johnson & Johnson PRD communicated that it intends to discuss the best path forward with the FDA as soon as possible.

In August 2009, the FDA issued to Johnson & Johnson PRD a Warning Letter on its role as a sponsor of clinical trials. The Agency noted that under the terms of the agreement between Basilea and Cilag GmbH International, a Johnson & Johnson company, all rights and responsibilities for ceftobiprole clinical trials were transferred to Johnson & Johnson PRD and the FDA concluded that Johnson & Johnson PRD did not adhere to the applicable statutory requirements or FDA regulations governing the conduct of clinical investigations. The FDA found numerous objectionable conditions during its investigation into Johnson & Johnson PRD's role as a sponsor of the two phase III trials of ceftobiprole for the treatment of cSSSI.

In February 2005, Basilea granted Cilag GmbH International an exclusive worldwide license to develop, manufacture and commercialize ceftobiprole.
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Ceftobiprole for diabetic foot infections

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Ceftobiprole for diabetic foot infections

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Pravibismane for diabetic foot infections

Homeopathy for Diabetic Foot Ulcers

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Low Plasma Arginine among Patients with Diabetic Foot Ulcer

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