Ken Kam's Best Ideas Blog

Elan acquired Maxipime and Azactam in 2000 when it acquired Dura Pharmaceuticals. These two drugs generated a little over $140 million of revenues during the first 9 months of 2005. Azactam lost its patent protection in October. Maxipime will lose its patent protection in 2007.

Maxipime and Azactam belong to a class of antibiotics called cephalosporins that are used to treat a wide range of bacterial infections. The problem with antibiotics is that they never kill all of the bacteria. The bacteria that survive go on to produce new strains that grow increasingly more resistant to a specific antibiotic with each use. As a result, there is a constant need to develop new generations of antibiotics to use against bacteria that have grown resistant to older drugs. Maxipime and Azactam are both 4th generation cephalosporins.

Maxipime is the only antibiotic with an FDA-approved indication for empiric monotherapy in febrile neutropenia (a fever associated with an abnormally low number of white blood cells) and the only antibiotic with this indication for pediatric patients. About half of cancer chemotherapy patients develop neutropenia, which places them at risk for infections that can require hospitalization, delay chemotherapy treatment and reduce its effectiveness.

Elan’s press release talks of nearly 1.5 million potential patients in the U.S. for Maxipime. The problem is that there are a number of older cephalosporins that are still effective. Doctors want to use the newer drugs sparingly to slow the evolution of bacteria that is resistant to the newest drugs. As bacteria that is resistant to the older drugs becomes more prevalent, use of 4th generation cephalosporins will grow. Consequently, these drugs should produce steady, though unspectacular sales until generic competition starts to encroach.

The Bottom Line: very little impact.