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New CCR5 Drug INCB9471 from Incyte Corp.
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Del. drug company develops HIV blocker
Incyte's product likely to be first 'CCR5 antagonist' on market
By GARY HABER, delawareonline.com, The News Journal
Posted Sunday, April 29, 2007
A small pharmaceutical company outside Wilmington has developed a promising new type of HIV drug that could make it a key player in the fight against the virus that causes AIDS.
Scientists at Incyte Corp., which employs 186 people at its headquarters at DuPont Co.'s Experimental Station research complex, have developed INCB9471, which is one of a new class of drugs, called CCR5 antagonists. These drugs keep the human immunodificiency virus from invading the body's healthy immune cells by blocking the CCR5 receptor, one of the pathways by which the virus enters the cells.
They differ from other types of HIV drugs, such as protease inhibitors like Abbott Laboratories' Kaletra or non-nucleoside reverse transcriptase inhibitors like Bristol-Myers Squibb's Sustiva, which keep the virus from replicating after it has entered a cell.
CCR5 antagonists are drawing a lot of interest from drug makers besides Incyte.
At least four others, including pharmaceutical giants Pfizer Inc. and Schering Plough Corp., are developing such drugs.
The entire field got a huge boost Tuesday when a Food and Drug Administration advisory panel voted to recommend that the agency approve Pfizer's drug, maraviroc.
Maraviroc would become the first CCR5 antagonist on the market if the FDA, as expected, approves the drug this summer.
Meanwhile, Incyte, which started developing its CCR5 antagonist in 2004, is having its own success.
In January, the company released the results of a mid-stage clinical trial of a group of seven patients who took the drug for two weeks.
Patients showed a 99 percent reduction in the presence of the HIV virus, compared with virtually no decrease in patients taking a placebo.
The company will undertake a six-month clinical trial with 400 to 500 patients later this year, followed by a late-stage clinical trial that would involve more than 1,000 patients.
Incyte executives say the drug could reach the market by 2011 or 2012.
CCR5 antagonists are an important treatment option for patients who develop resistance to other classes of HIV drugs, said Dr. Susan Szabo, medical director for the HIV program at Christiana Care Health System.
Although Pfizer's maraviroc will have a head start, the Incyte drug offers some key advantages, say Incyte executives and analysts who follow the company.
For one thing, it is taken once daily and remains in the body longer than maraviroc, which has to be taken twice a day. That could be a boon for patients who juggle a variety of different pills and don't always take their medicine on the prescribed schedule.
"Once a day is a really nice option, a really beneficial option," for patients for whom compliance is "a huge issue," Szabo said.
Also, Incyte's new drug, unlike maraviroc, doesn't need to be taken with ritanovir, a protease inhibitor that slows down the body's metabolism so the drug stays in the body longer. Some patients have difficulty tolerating ritanovir, which has also been associated with an increased risk of heart disease.
"The prolonged duration of effect with INCB9471 is particularly unique and could translate into a best-in-class profile, as it may provide greater antiviral coverage for patients with imperfect compliance," Thomas Wei, an analyst with Piper Jaffray, wrote in a Jan. 9 research note. "In addition, there have been no significant safety concerns to date with this compound, which is encouraging, but will need to be further evaluated in larger studies."
Sapna Srivastava, a Morgan Stanley analyst, in a Feb. 15 research note, put chances of the drug reaching the market at nearly 42 percent -- high odds in the drug development business.
If Incyte's new drug is approved, it could be a moneymaker for the company, which has yet to bring a drug to market and lost $74.2 million last year on revenue of $27.6 million, primarily revenue from a licensing deal with Pfizer.
The drug could generate $400 million a year in sales by 2017, David Witzke, an analyst with Banc of America Securities, said in a note on Jan. 8.
But navigating a new drug through clinical trials and FDA approvals is a risky endeavor, and a company's stock can drop significantly if a promising drug candidate doesn't pan out.
Incyte's shares, for example, tumbled more than 40 percent on April 3, 2006, after the company announced it was ending development of DFC, or Reverset -- a different type of HIV drug from what Incyte is now testing -- after some patients in a clinical trial showed signs of inflammation of the pancreas.
The stock has soared since then, gaining more than 126 percent.
Despite the new drug's promise, Incyte executives say it is just part of a full development pipeline, and that one of the company's other compounds could gain FDA approval first.
"It's one of a number of very promising things we have going on," said Dr. Paul Friedman, a Harvard-trained physician and Incyte's president and chief executive officer. "Certainly, it's not something we're pinning all our hopes on."
The company has at least six other drugs in preclinical or human trials, including drugs for diabetes, cancer, multiple sclerosis and lupus.
The company's deal with Pfizer, inked last year, could be worth as much as $803 million to Incyte if development and sales goals are met.
Pfizer bought the right to develop Incyte's CCR2 antagonist drugs to treat a variety of inflammatory diseases, including rheumatoid arthritis. Incyte kept the rights to develop a CCR2 antagonist to treat multiple sclerosis and lupus.
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