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Pfizer Setback opens door for Abbott Niaspan/Somcor Combination Therapy
 
 
  Halt of testing `big setback' in race for new cholesterol pill
 
By Bruce Japsen
Tribune staff reporter
Published December 5, 2006
 
NEW YORK -- It may be at least two years before American consumers have an all-in-one pill to treat heart disease after Pfizer Inc. on Saturday announced it has dropped testing of its leading candidate because a trial resulted in more deaths than expected, analysts predicted Monday.
 
While Lipitor and other statin-class drugs, which lower bad cholesterol, are huge moneymakers for the pharmaceutical industry, companies have long been searching for their Holy Grail: a pill that lowers bad cholesterol while raising so-called good cholesterol. The company that wins regulatory approval first stands to reap billions in the $32 billion worldwide cholesterol treatment market.
 
Pfizer appeared to be on its way with its drug torcetrapib, which would replace revenue lost when cholesterol drug Lipitor, the world's top-selling prescription drug, with more than $12 billion in sales last year, loses patent protection in 2010.
 
But the weekend's news sent Wall Street and the medical community looking for the next blockbuster brand cholesterol drug--which is not only the pharmaceutical industry's most lucrative market, but also one that holds perhaps the greatest promise in preventing the nation's leading cause of death: cardiovascular disease.
 
Investors Monday began placing their bets on North Chicago-based Abbott Laboratories, which is finalizing an acquisition of a New Jersey drugmaker working on ways to raise HDL, or good cholesterol, and has a combination pill that analysts say could be on the market in 2008. Abbott on Monday said the Federal Trade Commission closed early a regulatory waiting period, clearing the way for the acquisition to move ahead.
 
On Pfizer's dismal news, the value of its shares fell nearly 11 percent, to $24.90, and wiped out more than $20 billion of the company's market capitalization in heavy trading on the New York Stock Exchange. But shares of Abbott gained 3.3 percent, to $48.10, despite recent investor worries about its drug and medical device pipeline.
 
"Even though we have reduced the risk of heart disease, it is still the No. 1 cause of death in this country, so this is a big setback," said Dr. Matthew Sorrentino, a cardiologist and associate professor of medicine at University of Chicago Hospitals.
 
Existing treatments, particularly statin-class drugs like Pfizer's Lipitor and Merck & Co.'s Zocor, have been hailed for lowering LDL, the bad cholesterol. But analysts and doctors say a combination pill will be more convenient and address multiple issues facing consumers--in particular, an aging population of overweight Baby Boomers.
 
"People have done well on statins and this information will not impact statins at all because they will still be mainstay therapy, but the hope was that we could go beyond what statins have done," Sorrentino said. "We had a lot of hopes for this medication."
 
Although Pfizer shocked many observers two years ago when it said it would spend more than $800 million to develop torcetrapib, the New York drug giant now appears to be a low bar in what companies will do to protect their cholesterol franchise.
 
For example, Abbott last month unveiled plans to pay $3.7 billion--a staggering 56 percent premium--for shares of Kos Pharmaceuticals Inc. of New Jersey to gain access to a pill known as Niaspan that includes a B vitamin found to raise HDL.
 
Doctors say Pfizer's pill worked by blocking a protein in the body that would metabolize HDL and therefore allow HDL and its good properties to circulate longer in the blood system.
 
In Pfizer's study of 15,000 patients, 82 taking torcetrapib and Lipitor together died, compared with 51 taking Lipitor alone. Patients' problems ranged from high blood pressure to congestive heart failure.
 
"From an Abbott perspective, the torcetrapib discontinuation will eliminate one major competitor from the combination therapy, HDL-raising market," said Glenn Reicin, an analyst with Morgan Stanley in New York.
 
While Niaspan had less than $500 million in annual sales, Kos has been working on a drug called Simcor that combines the HDL-raising qualities of Niaspan with generic Zocor, known for its LDL-lowering powers.
 
Although Niaspan works differently in the body than Pfizer's torcetrapib, the drug has some sales-limiting side effects such as flushing and sweating in some patients, doctors say.
 
In clinical trials, Kos and Abbott are hoping to reduce side effects in a newer version of Niaspan as well as the combination pill Simcor that could be submitted to the Food and Drug Administration late next year for approval. Thus, Abbott has little room for error with Zocor-maker Merck developing a combination pill that analysts say is at least a year behind Simcor.
 
"Abbott/Kos will be the first company on the market with a combination product, as we expect a Simcor launch in 2008," Reicin said. "Given the torcetrapib news and Abbott's being first to market before Merck, we think that our current estimates for $250 million in 2010 sales for Simcor will likely prove conservative."
 
Analysts who follow Pfizer were predicting torcetrapib sales of $2 billion by 2010, so Abbott could get a chunk of that should Simcor win approval.
 
Given Pfizer's stumbles and the pressure on drugmakers to come up with blockbuster drugs, some began to speculate Abbott's deal to buy Kos could unravel if Pfizer or another company moved to make a higher bid and derail the purchase.
 
The tender offer for Kos shares is expected to close at midnight Eastern time Dec. 12.
 
"We suspect that most of the shares for the Kos acquisition have been tendered and that there is little risk to the deal closing or a renegotiation of price given this news," Reicin said.
 
 
 
 
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