Johnson & Johnson and Basilea Pharmaceutica were recently handed a warning from the Food and Drug Administration because of their clinical trials on Ceftobiprole. Johnson & Johnson, based in the U.S, deals with consumer and pharmaceutical packaged goods and medical devices. The firm has its headquarters in New Jersey. The brands by Johnson & Johnson include numerous household first aid and medication supplies (Johnson & Johnson, 2013, 1). The brands under the company include Band-Aid, Clean & Clear facial wash, Tylenol medications, Neutrogena skin and beauty products and Johnson’s line of baby products. On previous occasions, the firm has been involved in different clinical trials for its different products (Johnson & Johnson, 2013, 1). In 2012, the firm received its latest approval for a compound used in the treatment of tuberculosis. Food and Drug Administration approved Sirturo as a medicine for the fight against tuberculosis infections.
Basilea Pharmaceutical Limited is a biopharmaceutical company based in Switzerland. The firm formed as a spin-off company from Hoffmann-La Roche. The firm is activity engaged in the production of antifungal and antibacterial drugs and agents meant to combat drug resistance. This company has numerous subsidiaries in countries such as Germany, France, Denmark, Spain, China, U.S.A and U.K. Basilea Pharmaceutical had 196 employees in June 2007 (Basilea Pharmaceutica, 2013, 1). Currently, the firm is involved in marketing Toctino used for the treatment of hand eczema in countries such as France, Denmark, Switzerland, Germany and United Kingdom. An additional 14 countries have approved the use of Toctino. Johnson & Johnson and Basilea Pharmaceutical are engaged in the development of ceftobiprole, which is a cephalosporin antibiotic used against methicillin resistant Staphylococcus aureus (Basilea Pharmaceutica, 2013, 1). This drug is an investigational drug that reached the third phase of clinical trials before Johnson & Johnson received the warning letter from Food and Drug Administration.
The two firms are naturally bound to produce or develop the drug because of their facilities and capabilities in pharmaceutical research. Basilea has immense capabilities in the development and identification of new drug compounds that have efficacy against numerous disease causing agents. Most importantly, the firm specializes in identifying drug resistant bacteria species and compounds that can eliminate the resistant bacteria (Basilea Pharmaceutica, 2013, 1). Conversely, Johnson & Johnson has immense capabilities in biopharmaceutical research through clinical studies. Basilea relied on the clinical experiences of Johnson & Johnson for the approval of this product. The responsibilities of Johnson & Johnson were to provide adequate clinical data that could be used for the approval of the drug by regulatory agencies in the U.S and Europe. Additionally, Johnson & Johnson
sponsored clinical trials on the drug (Johnson & Johnson, 2013, 1). Basilea Pharmaceutical was responsible for the development of the drug. This means that the firm was responsible for ensuring the safety of the drug and efficacy against a host of drug resistant bacteria.
Ceftobiprole is a fifth generation drug that has activity against cephalosporin. This drug is a cephalosporin antibiotic that acts on Staphylococcus aureus that is resistant to methicillin treatment. Additionally, the compound has resistance against enterococci, Streptococcus pneumonia and Pseudomonas aeruginosa. Basilea Pharmaceutical discovered this drug (Gould, & Meer, 2005, 676). However, the firm engaged Johnson & Johnson to develop the drug through their Pharmaceutical Research and Development Division.
According to Basilea Pharmaceutical, ceftobiprole is an innovative drug that has activity against numerous bacterial agents including Gram-negative pathogens and MRSA. Additionally, no single antibiotic can claim such activity as ceftobiprole. The drug stops the 2a penicillin binding proteins (PBP) of methicillin resistant pathogens such as Staphylococcus aureus. Additionally, the drug stops the binding abilities of 2x PBP of pathogens such as Streptococcus pneumonia (Crowe, McCarthy, and Mills, 2010, 457). The compound is also resistant to Staphylococcal beta-lactamase.
The pharmaco-dynamic and pharmacokinetic principles of ceftobiprole are well understood and known. The compound is a pro-drug that is rapidly converted and turned to an active drug. It undergoes renal excretion with reduced hepatic metabolism. The main metabolite is a beta-lactam ring. This ring metabolite accounts for at least 4 percent of the exposure of the single dose. Following exposure, the pharmacokinetics of ceftobiprole becomes linear (Gould, & Meer, 2005, 680). It is essential to note that steady state drug concentrations are achieved after the first day of dosing.
This compound has a market in the multi-drug resistant organisms. The drug is active against microorganisms that have resistance to a number of antibiotics. The drug has its market well spread in the outpatient and inpatient healthcare settings. Public knowledge about the drug has increased demand for the drug because of its abilities to control and prevent the spread of these pathogens in hospitals (Keegan, 2008, 51). There is an overwhelming burden to healthcare following an exponential rise in organisms that are resistant to various antibiotics. Additionally, it is essential to highlight the decreasing interest and research in new drugs and strategies for dealing with these organisms.
Description of the Market in Which This Product Will Be Competing
This product will be competing in the anti-infective and multi-drug resistant drug markets. It is essential to note that the research and development of these drugs takes approximately 10 years and requires between $800 million and $1.7 billion dollars in funding. This is an enormous investment for a single pharmaceutical company, especially without any guarantee for returns on investment (Selzer, 2009, 402). The drug will compete with molecular entities that were approved by the FDA during the 1990s.
Several novel agents for treating MRSA infections were approved by the FDA in the last 10 years. These agents include linezolid, quinapristin, datomycin and tigecycline. The slow development of drugs that can target these pathogens has left practitioners with the only option of approaching MRSA using multiple antibiotics (Selzer, 2009, 407). Hospitalized patients can get infections from hospital-acquired pneumonia and ventilator associated pneumonia. Other sources of infections include wound infection and urinary tract infections (Crowe, McCarthy, and Mills, 2010, 460). These forms of infections may be polymicrobial in nature. Though using multiple antibiotics is not the optimal strategy, practitioners can only use this available option.
Clinical trials on Ceftobiprole medocaril showed positive results in the treatment of complicated skin conditions and skin structures that arise from MRSA and hospital associated pneumonia (Interscience Conference on Antimicrobial Agents and Chemotherapy. & American Society for Microbiology, 2008, 160). Initially, the compound was approved for the Canadian market, but later withdrawn. Before the agent can be approved for the U.S, European and Canadian market, it must undergo additional clinical trials that will contribute to additional data on the efficacy of the compound. During trials, the sponsor of the trial searched for the adverse effects of the drug. The study subjects showed tolerance to the drug with side effects including taste disturbance, nausea, vomiting, diarrhea and caramel taste (Interscience Conference on Antimicrobial Agents and Chemotherapy. & American Society for Microbiology, 2008, 164).
The design of the clinical trials for the drug had inadequacies and unethical provisions especially with study participants. FDA identified these inadequacies and wrote a warning letter to Johnson & Johnson
concerning the study design and progression. Johnson & Johnson was the sponsor of the clinical trial through its subsidiary Cilag GmbH International. During the clinical trial, Johnson & Johnson had all the rights and responsibilities for the drug. GDA concluded that Johnson & Johnson did not follow the applicable statutory requirements and regulations governing the conduction of clinical trials and investigations. FDA found objectionable conditions in the sponsorship of the two-phase three trials. Johnson & Johnson was looking for indications that ceftobiprole has efficacy against soft tissue infections and complicated skin, which suggests that the drug is beneficial to patients with these conditions.
Johnson & Johnson and Basilea Pharmaceutica entered into an agreement that would see the development and commercialization of a drug or compound product developed by Basilea Pharmaceutica. This compound had proven efficacy against multi-drug resistant bacteria pathogens. During the clinical trials, Johnson & Johnson showed that the drug was active against soft tissue infections and skin conditions that resulted from infections with multi drug resistant bacteria. However, FDA did not give market access authorization because the clinical trials did not meet the standards and specification of the FDA. Basilea Pharmaceutica noted that negligence and failure to follow FDA regulations led to the loss of $130 million and the rejection of the compound by American and European health authorities. The drug was novel and it could have competed effectively with multiple antibiotics that were used by doctors for treating multiple drug resistant bacteria. These loss of market led Basilea Pharmaceutica to take back the development and commercialization responsibilities it had given to Johnson & Johnson. The FDA cited objectionable conditions found during FDA investigations into Johnson & Johnson Pharmaceutical Research and Development of the compound, particularly the company’s role as the sponsor of clinical trials.