IHS Global Insight Perspective | |
Significance | AstraZeneca beefs up its pipeline with the acquisition of French antibiotics specialty company Novexel in a deal worth up to US$505 million. This deal will strengthen its ties with Forest Laboratories (U.S.), which has the rights to one of Novexel's drugs. |
Implications | AstraZeneca now has the rights to two experimental antibiotics drugs: late-stage ceftazidime/NXL-104, Phase II ceftaroline/NXL-104 (CEF104) and Phase II NXL-103. Upon completion of the deal Forest Labs will pay AstraZeneca US$210 million for the rights to ceftazidime/NXL-104 in the United States and Canada. |
Outlook | This deal is an important addition to AstraZeneca's pipeline and it gives AstraZeneca the opportunity to explore a therapeutic area with high unmet need. |
U.K. pharma giant AstraZeneca has announced its planned acquisition of French speciality pharmaceutical company Novexel. The deal gives AstraZeneca access to Novexel's experimental antibiotic drugs ceftazidime/NXL-104 (CAZ104) and ceftaroline/NXL-104 (CEF104) for the treatment of complicated skin and skin-structure infections and community-acquired bacterial pneumonia (CAP). According to the terms of the deal, AstraZeneca will make an initial cash payment of US$350 million to Novexel, another cash payment of US$80 million at closing as well as potential US$75 million, contingent upon the achievement of development milestones. Ceftazidime/NXL-104 is due to enter Phase III development in 2010 for the treatment of serious infections such as intra-abdominal, urinary tract and CAP, with regulatory filings planned for 2012. Ceftaroline/NXL-104 is to enter Phase II development in 2010 for the treatment of complicated urinary tract infections. Novexel's clinical pipeline also includes NXL-103 which is in Phase II development for the treatment of acute bacterial skin and skin structure infections. NXL-103 has already shown efficacy in the treatment of CAP in a Phase II trial.
Ties with Forest Labs Strengthened
U.S. firm Forest Laboratories is currently responsible for the development and commercialisation of ceftaroline, having inlicensed the treatment from Novexel. AstraZeneca recently entered a co-development deal with Forest for ceftaroline, in which it gained the rights to commercialise the drug outside the United States, Canada, and Japan for an undisclosed sum (see United Kingdom: 12 August 2009: Forest Labs in Research Pact with AstraZeneca). Forest is due to initiate U.S. regulatory filings for the drug before the end of 2009, with European fillings planned for 2010. The difference between ceftaroline and ceftaroline/NXL-104 is that the latter is a combination treatment which uses Novexel's proprietary beta-lactamase inhibitor. Upon AstraZeneca's completion of the acquisition of Novexel, Forest Labs will acquire the full worldwide rights to ceftaroline/NXL-104 and the rights to ceftazidime/NXL-104 in the United States and Canada for US$210 million. AstraZeneca will also receive the royal payments for the ceftaroline/NXL-104 combination attributable to Novexel under the original transaction between Novexel and Forest Labs.
Outlook and Implications
In light of the fact that AstraZeneca is already in possession of the commercialisation rights to ceftaroline, this deal comes as no surprise. AstraZeneca has been active this year in terms of making strategic acquisitions and in licensing new drugs (see United Kingdom: 22 September 2009: AstraZeneca and Nektar in Licensing Deal). This strategy has been employed in response to generic exposure to some major revenue earners such as Seloken/Toprol-XL (metoprolol tartrate/metoprolol succinate) and Casodex (bicalutamide) coupled with generic threats to its blockbuster (see United Kingdom: 16 December 2009: Generic Firms Win First Round of Crestor Patent Litigation Battle as FDA Panel Backs Drug's Expanded Uses). In terms of its expertise in developing drugs for the treatment of serious infections, this is not a traditional area of focus for the company. It does not currently have any such investigative treatments in its pipeline and there is only one such drug in its portfolio, Merrem/Meronem (meropenem) which has been inlicensed from Japanese company Sumitomo Pharmaceuticals. AstraZeneca has signalled that this is an area of growth which it is willing to penetrate therefore this move reinforces the idea of the need for pharmaceutical companies to diversify their areas of growth. Due to increasing reports of resistance to currently marketed antibiotics, there is a high unmet need for anti-infection drugs and this appears to be the main driving force behind this acquisition. There are currently few such treatments available on the market. One of the leaders in this field is Basilea (Switzerland) and their antibiotic drug Zevtera (ceftobiprole) has been approved for use in the European Union, Switzerland and Canada. However the drug approval process is still ongoing in the United States where it has been subject to delays (see United States: 1 September 2009: J&J Address FDA Concerns over Ceftobiprole NDA). Given the delays also experienced by other producers of antibiotic drugs such as dalbavancin (Pfizer; U.S.) and iclaprim (Actino; Switzerland) it remains to be seen how Forest Labs and AstraZeneca will progress with regulatory fillings for ceftaroline.