Friday, drug maker Forest Laboratories Inc. (FRX), said the the U.S. Food and Drug Administration has approved Teflaro for the treatment of community-acquired bacterial pneumonia, and also for skin related infections.
The approval follows the FDA's Anti-Infective Drugs Advisory Committee's 21-0 vote favoring approval of the drug, earlier this month. The panel also voted 18-0 in favor of drug for treatment of skin and skin structure infections.
The FDA approval for Teflaro, or ceftaroline fosamil, also includes cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection, including cases caused by methicillin-resistant Staphylococcus aureus. The drug's efficacy and safety was established in pivotal trials in 1219 patients.
Commenting on the results, Forest Laboratories Chief Executive Officer Howard Solomon said, "Our success in gaining approval for Teflaro is a significant milestone for our new anti-infective franchise. Achieving a first cycle approval from the FDA is a tribute to the excellent design and execution of a complex clinical development program as well as the virtues of the product itself..."
As bacterial resistance to antibiotics increase, there is a strong demand for newer anti-infectives given that many bacterial infections have few potent treatment options, with rates of pneumonia and skin infections also increasing.
In 2008, the global anti-infective market was valued at $66.5 billion with antibacterial agents accounting for over 50% of sales.
Ceftaroline belongs to a class of antibiotics known as cephalosporin, which has been used for decades. Ceftaroline is a novel, bactericidal, broad-spectrum injectable cephalosporin shown in pre-clinical and clinical trials to have activity against both gram-positive pathogens, including methicillin-resistant Staphylococcus aureus and Streptococcus pneumoniae, and common gram-negative pathogens.
Forest obtained the worldwide rights, excluding Japan, to ceftaroline in 2007 when it acquired Cerexa, Inc., a privately held biopharmaceutical company. Two years later, Forest Laboratories and AstraZeneca agreed to co-develop and commercialize ceftaroline in all markets outside the U.S., Canada and Japan.
According to Forest Laboratories, which makes drugs like Lexapro for treating depression and Alzheimer drug Namenda, two Midstage studies dubbed Focus I and Focus II, studied adult patients who were hospitalized with moderate to severe community-acquired bacterial pneumonia or CABP needing treatment with intravenous antimicrobials.
To study the effect of Teflaro, a responder analysis was conducted in patients. A responder was a patient who on the fourth day of therapy was in stable condition.
In Focus I of the midstage study, Teflaro-treated patients had a higher response rate of 69.6% compared with 58.3% for ceftriaxone-treated patients on Day 4. In Focus II study, Teflaro-treated patients had a response rate of 69% versus 61.4% for ceftriaxone-treated patients on Day 4.
In Focus I, Teflaro-treated patients had a clinical cure rate of 86.6%, more than the 78.2% reported in ceftriaxone-treated patients in the clinically evaluable population. In Focus II, Teflaro treated-patients had a clinical cure rate of 82.3% compared with 77.1% in ceftriaxone-treated patients.
Subsequent studies, Canvas I and Canvas II, showed Teflaro-treated patients with a response rate of 74% compared to 64.6% for vancomycin plus aztreonam-treated patients on Day 3. In Canvas II, Teflaro-treated patients had a response rate of 74%, higher than the 68.1% reported for vancomycin plus aztreonam-treated patients on Day 3.
Clinical cure rate in Canvas I for Teflaro-treated patients showed a higher rate at 91.1% compared with 93.3% in vancomycin/aztreonam-treated patients. In Canvas II, Teflaro-treated patients had a clinical cure rate of 92.2% versus 92.1% in vancomycin/aztreonam-treated patients.
The most common possible side effects related to ceftaroline include diarrhea, headache, nausea and insomnia.
FRX closed Friday's regular trade at $33.05, down $0.52 or 1.55%, on a volume of 2.94 million shares on the NYSE. In after hours, the stock gained $0.94 or 2.84%.
by RTT Staff Writer
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