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Astellas Pharma: Telavancin Enters EU Battle for MRSA Market Share

Posted on: Wednesday, 2 May 2007, 09:00 CDT

Having filed telavancin for approval with the EMEA for the treatment of complicated skin and soft tissue infections in adults, Astellas Pharma and its partner Theravance have entered the European battle for MRSA market share. Providing the drug is approved on schedule, Astellas could beat several significant competitors to market, giving the drug a crucial advantage.

Following the US NDA filing of telavancin in February 2007, Astellas has now followed up with a European application. Its latest treatment for serious bacterial infections should strengthen its portfolio of products targeting the hospital market. Akin to many late stage pipeline products currently in development, trial design objectives have been explicitly oriented towards the management of methicillin-resistant Staphylococcus aureus (MRSA).

MRSA has become one of the most common causes of nosocomial infections worldwide. One study demonstrated that some 50% of infectious morbidity in intensive care units were partially due to MRSA. More recently, it has been acknowledged that the pathogen is increasingly being isolated in community-acquired infections, and has been associated with life-threatening conditions including necrotizing pneumonia and necrotizing fasciitis.

There are products on the market for MRSA already. Vancomycin remains a drug of choice, but the risks associated with treatment failure and rising rates of vancomycin resistance have led to clinicians reverting to older drugs, such as co-trimoxazole, clindamycin, minocycline, fluoroquinolones and doxicycline, none of which provide a comprehensive solution to MRSA management.

There are also newer competitors already on the market. If approved, telavancin will enter the market behind a number of key competitors: Pfizer's Zyvox, (linezolid) first launched in the EU in 2001 (and is already exhibiting resistance, but available orally), Cubist and Novartis' Cubicin (daptomycin, shows limited tissue penetration and requires patient monitoring but dosed once daily) and Wyeth's Tygacil (tigecycline, good empiric activity apart from Pseudomonas aeruginosa) in 2006 and Pfizer's Zeven (dalbavancin, available once weekly, but with limited patent coverage left) is likely to launch months before Telavancin.

Nevertheless, if it is approved within expected timelines, telavancin will beat several other key competitors to the EU market, namely Johnson & Johnson's in-licensed compounds ceftobiprole and doripenem (originating at Basilea and Shionogi, respectively), Advanced Life Sciences' cethromycin and Arpida's iclaprim. This offers Astellas crucial time in which to establish its core message: Telavancin is a valuable weapon against MRSA that can be administered at dosing levels that enable rapid bactericidal activity and has a predictable pharmacokinetic profile, making it an effective and safe choice.

Source: Datamonitor

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