Global Insight Perspective | |
Significance | U.S. pharma Forest Laboratories confirmed yesterday that it has entered into a definitive acquisition agreement to buy the Californian biotech Cerexa. |
Implications | This deal values Cerexa at around US$480 million, and will allow Forest to become increasingly diversified by adding anti-infectives to its current research interests. |
Outlook | The main product candidate that Forest will acquire is the novel cephalosporin, ceftaroline. This product is expected to enter Phase III clinical trials next year, and Forest anticipates that it could reach the market by as early as 2010. |
Forest Buys Route into Anti-Infective Market
Forest Laboratories said yesterday that it has signed a definitive merger agreement to acquire the Californian biopharmaceutical Cerexa, via an all-cash transaction totalling US$480 million. Most notably, the deal will see Forest add anti-infectives to its current therapeutic focus via Cerexa’s leading product candidate, ceftaroline. This product is anticipated to enter late-stage clinical trials in 2007, and Forest predicts it could hit the market by as early as 2010. This represents a significant diversification for the New York-based pharma, although it does fit in well with its mission statement to acquire promising new products from innovative companies worldwide to bolster its pipeline. Additionally, under the terms of this deal Forest may be able to add two further antibiotics to its pre-clinical pipeline, which are currently in early stage development at Cerexa.
Cerexa began operating in July 2005 after being spun out of anti-infectives specialist Peninsula Pharmaceuticals. This occurred as a result of the successful acquisition of the latter company by Johnson & Johnson (J&J) subsidiary Ortho-McNeil Inc. This interaction with J&J provides an interesting link to a potential major rival to ceftaroline, and this issue will be further explained below.
Outlook and Implications
Through its acquisition of Cerexa, Forest will obtain in ceftaroline a next-generation, broad-spectrum, injectable cephalosporin. According to Cerexa, this product "combines the advantages of an enhanced gram-positive spectrum, including bacteriocidal anti-MRSA (methicillin resistant staphylococcus aureus) activity, with broad gram-negative activity, while maintaining the favourable safety profile of cephalosporins". In March 2006, this investigational drug garnered fast track designation from the FDA for the treatment of complicated skin and skin structure infections (cSSI) caused by MRSA. According to Cerexa, in a recently-completed Phase II study evaluating the drug’s efficacy in this indication, it achieved excellent clinical and microbiological response rates and was found to be very safe and effective. The key advantage of ceftaroline over the current gold-standard treatment for MRSA, vancomycin, is that it is bacteriocidal—meaning it actually kills the bacteria rather than simply inhibiting their growth (bacteriostatic).
As a result, if ceftaroline came on the market tomorrow it could meet a significant unmet need. It would, however, be limited to an in-patient setting, because it requires parenteral administration as a pro-drug. Additionally, it is also highly unlikely that an oral version of this drug would ever emerge because of the inherent insolubility of this kind of cephalosporin compound, and the difficulty in the chemistry involved in adding groups that would make it more soluble.
Ceftaroline's development is currently someway behind that of a potential significant rival; Switzerland-based Basilea Pharmaceutica's ceftobiprole. Basilea is currently planning to submit a New Drug Application for ceftobiprole to the U.S. FDA in 2007, and this could have an important impact on ceftaroline's market potential. However, there is likely to be sufficient space in the anti-infectives market for more than one novel cephalosporin. Interestingly, J&J has a significant stake in this similar compound, and this could hint at why ceftaroline was not a part of its take over of Peninsula back in 2005, as having an interest in both of these drugs would have caused a significant clash in J&J's pipeline. Ultimately however, if both of these compounds share similar efficacy and safety profiles (this is currently difficult to assess because of a lack of exactly comparable data), it is likely to be their respective abilities to prevent the emergence of resistance development that will have the greatest effect on their long term commercial impacts. It is in this key battleground that Basilea's antibiotic could garner a significant first-mover advantage.
Related Articles
- Switzerland: 11 December 2006: Basilea Exercises Co-Promotion Option on Antibiotic Ceftobiprole
- United States: 19 July 2006:J&J Reports Solid Earnings Growth in Q2, Updates Near-Term NME Filings
- Switzerland: 2 March 2006: Basilea's Anti-MRSA Drug Shows Promising Phase III Results