Biotech Values

[DewDiligence]

Who would’ve thought PFE’s biggest-selling drug would be a vaccine?
When Lipitor goes off-patent in less than two years, the Prevnar franchise,
which got a boost today, will attain the #1 ranking in PFE’s portfolio.
(Enbrel will be bigger, but PFE splits Enbrel revenues with AMGN.)

http://blogs.forbes.com/sciencebiz/2010/02/pfizers-next-top-seller

›Pfizer's Next Top Seller

February 24, 2010 - 3:06 pm
By Matthew Herper

The vaccine expected to become Pfizer's top seller after the cholesterol drug Lipitor loses patent protection next year just cleared two important hurdles.

Both the Food and Drug Administration and a key panel convened by the Centers for Disease Control & Prevention cleared wide use of Pfizer's Prevnar 13 vaccine to protect millions of infants and toddlers against the pneumococcus bacterium.

There are no surprises in the FDA label, and the CDC's Advisory Committee on Immunization Practices (ACIP) voted that the new vaccine should replace the existing Prevnar vaccine immediately to prevent bacterial diseases including meningitis and bloodstream infections. Prevnar 13 will cost $108, 30% more than the current vaccine, but it protects against strains of the pneumococcus bacteria that the existing vaccine does not. This price increase accounts for much of the projected increases in sales of Prevnar, which had 2010 sales of $3 billion.

Prevnar has been a huge success not only financially but medically, says William Schaffner, chair of the department of preventative medicine at Vanderbilt University. The vaccine has dramatically reduced the incidence of not only severe infections in children, but also ear and respiratory infections that can be caused by pneumococcus. (Other bugs can cause these childhood nuisances, too.) It has also reduced the number of infections the bacteria has caused in older people, who have not been vaccinated, because of 'herd immunity,' he says. Because children don't have the bacteria in their bodies, they can't pass them on to the adults around them.

But the current Prevnar vaccine only provides immunity against seven strains of bacteria. As these have vanished, other strains of pneumococcus have started to emerge. Although they are nowhere as prevalent as pneumoccus was pre-Prevnar, they are becoming more common. Most worrisome is a strain called 19A. "It is now the most common cause of invasive, serious pneumococcal disease in children. It’s crept up slowly and it’s especially vicious because it’s multiply antibiotic resistant," says Schaffner. Pfizer is also studying Prevnar 13 to prevent pneumonia in adults, and expects to file an application with the FDA by the end of the year.

ACIP says all unvaccinated children should receive Prevnar 13, not the previous version of Prevnar. Those who are in the middle of the four-course vaccination schedule with Prevnar should switch to the newer vaccine. Children younger than 5 who have already been fully vaccinated with the existing Prevnar should get a booster dose of Prevnar 13. Kids at high risk, like those with AIDS or sickle-cell anemia, can get the vaccine up until age six. Mark Swindell, the president of vaccines at Pfizer, says t making sure pediatricians give a Prevnar 13 shot to children who have already gotten Prevnar will be a key part of the company's marketing strategy. The committee also okayed using Merck's Pneumovax vaccine after Prevnar in very high-risk cases up to age 18.

Deutsche Bank pharmaceuticals analyst Barbara Ryan estimates that Prevnar will generate global sales of $4.6 billion in 2014 [assuming it obtains FDA approval for adults]. By then Lipitor sales will have dropped 67% to $3.6 billion due to the U.S. patent expiration on the drug.‹