Astellas Pharma: telavancin enters EU battle for MRSA market share
2nd May 2007
By Jonathan Angell

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.

http://www.pharmaceutical-business-review.com/article_feature.asp?guid=4DDD5C52-
B5BC-4768-BB69-F9B439D4BE54

[
My take:
Telavancin is a lipoglycopeptide.  Sounds like it's a next-generation
variant on vancomycin.

Iclaprim is a diaminopyrimidine and dihydrofolate inhibitor.  Sounds
very much like a next-generation variant on trimethoprim.  (Trimethoprim
is familiar to many of us sinus sufferers as one of the two active
ingredients in Bactrim.
]