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Forest Labs To Acquire Cerexa


Posted on 2006-12-14 11:23:00



Forest Laboratories, Inc. today announced that it has signed a definitive merger agreement to acquire Cerexa, Inc., a privately held biopharmaceutical company based in Alameda, California, in a cash transaction. Under the terms of the agreement, Forest will acquire Cerexa for a total of $480 million.

Forest will obtain worldwide development and marketing rights (excluding Japan) to two injectable antibiotics and an option to a third, early stage injectable antibiotic. The lead compound, ceftaroline acetate, which is entering Phase III studies, is a next generation, broad-spectrum, hospital-based cephalosporin antibiotic that exhibits bactericidal activity against the most resistant strains of Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus) as demonstrated in a completed Phase II comparative trial in patients with complicated skin and skin structure infections (cSSSI). Ceftaroline has also demonstrated bactericidal activity against penicillin-resistant Streptococcus pneumoniae (PRSP) and common gram-negative bacteria. Ceftaroline is being developed for initial indications of cSSSI and community acquired pneumonia (CAP).

Phase III studies for cSSSI are planned to begin in the first quarter of 2007 while the CAP Phase III program is scheduled to begin in the second quarter of calendar 2007. In March 2006 the FDA granted ceftaroline Fast Track designation for the treatment of cSSSI caused by MRSA. In granting this designation, the FDA noted that ceftaroline has the potential to address an unmet medical need due to its potential ability to benefit patients who are unresponsive to existing therapies or who are unable to tolerate existing therapies due to serious toxicities that are present in such therapies. If the Phase III studies are successful and Forest receives FDA marketing approval, Forest plans to launch ceftaroline with these two initial, cSSSI and CAP indications in the 2010 or 2011 timeframe. Additional indications will also be pursued under future supplemental filings.

As a hospital-based product Forest would detail the product utilizing its existing hospital based salesforce, a subset of the company's total sales force. Forest will also explore options for commercialization outside the U.S. (excluding Japan) including but not limited to out-licensing marketing rights or acquiring a non-U.S. hospital-based salesforce.

The second product, ME1036, a broad-spectrum parenteral carbapenem, is currently in preclinical development and has demonstrated excellent preclinical activity against both aerobic and anaerobic Gram-positive and Gram-negative bacteria, including common drug-resistant pathogens. Unlike carbapenems that are available today, ME1036 is highly active against MRSA, PRSP, vancomycin-intermediate susceptible Staphylococcus aureus (VISA) and vancomycin-resistant Enterococcus faecalis (VRE). For this product, Forest's marketing rights do not include Japan and certain other Asian countries.

An issued composition of matter patent covering ceftaroline expires in December 2018 and an extension of the patent term is expected under the Hatch Waxman legislation. There are several filed patent applications covering ME1036.


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