FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. (NYSE: FRX) announced today that Teflaro^TM (ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). The efficacy and safety of Teflaro was established in pivotal trials including 1219 patients treated with the drug.

“We eagerly anticipate the commercial launch of Teflaro and remain committed to bringing additional new treatments to market that target infectious diseases.”

Teflaro is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. Forest expects Teflaro to be available to wholesalers by January 2011.

"Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications," said Dirk Thye, President of Cerexa, a wholly-owned subsidiary of Forest Laboratories, Inc. "We eagerly anticipate the commercial launch of Teflaro and remain committed to bringing additional new treatments to market that target infectious diseases."

Howard Solomon, Chairman and Chief Executive Officer of Forest 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. Teflaro is the fourth new drug approval in the last three years from the fourth different division of the FDA. We are very proud of all of our Forest colleagues who have contributed to Teflaro's acquisition, development and approval. We look forward to providing more treatment options for healthcare providers and patients in the future."

FOCUS I and FOCUS II Phase 3 Clinical Study Results

FOCUS I and FOCUS II studied adult patients who were hospitalized with moderate to severe CABP requiring treatment with intravenous antimicrobials.

To evaluate the treatment effect of Teflaro, a responder analysis was conducted in CABP patients. A responder was defined as a patient who on Day 4 of therapy was in stable condition based on accepted clinical criteria; this was defined as normalization of vital signs and improvement from baseline on at least one respiratory symptom (cough, dyspnea, pleuritic chest pain, or sputum production) while not worsening on any of these four respiratory symptoms. This analysis of the pivotal trial data served as an important element of the FDA's efficacy evaluation.

In FOCUS I, Teflaro-treated patients had a response rate of 69.6% compared with a response rate of 58.3% for ceftriaxone-treated patients on Day 4. In FOCUS II, Teflaro-treated patients had a response rate of 69% compared with a response rate of 61.4% for ceftriaxone-treated patients on Day 4.

The protocol-specified analyses included clinical cure rates at the test of cure (TOC; 8-15 days after end of therapy). In FOCUS I, Teflaro-treated patients had a clinical cure rate of 86.6% compared with a rate of 78.2% in ceftriaxone-treated patients in the clinically evaluable (CE) population. In FOCUS II, Teflaro treated-patients had a clinical cure rate of 82.3% compared with a rate of 77.1% in ceftriaxone-treated patients in the CE population.

CANVAS I and CANVAS II Phase 3 Clinical Study Results

The CANVAS I and CANVAS II trials evaluated Teflaro monotherapy versus vancomycin plus aztreonam in adult patients with complicated skin and skin structure infections caused by gram-positive and gram-negative bacteria.

To evaluate the treatment effect of Teflaro, a responder analysis was conducted in ABSSSI patients with either a major abscess with ≥ 5 cm of surrounding erythema, wound infection, or deep/extensive cellulitis requiring treatment with IV antimicrobials. A responder was defined as a patient who on Day 3 achieved both cessation of lesion spread and absence of fever.

In CANVAS I, Teflaro-treated patients had a response rate of 74% compared with a response rate of 64.6% for vancomycin plus aztreonam-treated patients on Day 3. In CANVAS II, Teflaro-treated patients had a response rate of 74% compared with a response rate of 68.1% for vancomycin plus aztreonam-treated patients on Day 3. This analysis of the pivotal trial data served as an important element of the FDA's efficacy evaluation.

The protocol-specified analyses included clinical cure rates at the TOC (8-15 days after the end of therapy). In CANVAS I, Teflaro-treated patients had a clinical cure rate of 91.1% compared with a rate of 93.3% in vancomycin/aztreonam-treated patients in the CE population. In CANVAS II, Teflaro-treated patients had a clinical cure rate of 92.2% compared with a rate of 92.1% in vancomycin/aztreonam-treated patients.

Safety

Each of the studies also indicated that Teflaro was well-tolerated. The overall rate of adverse events was comparable between the two treatment groups. The overall discontinuation rate for Teflaro-treated patients was 2.7% compared to a rate of 3.7% for the comparator group-treated patients. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.