Agouron, Bristol Myers, Others Aim to Set Their HIV Drugs Apart
Bloomberg News September 25, 1998, 5:19 p.m. ET
Agouron, Bristol Myers, Others Aim to Set Their HIV Drugs Apart
San Diego, Sept. 25 (Bloomberg) -- As potential combinations of AIDS drugs reach mindboggling complexity, drugmakers are arming themselves with arsenals of studies to try to distinguish their treatments from the rest.
Today, at a massive infectious disease conference in San Diego, Bristol-Myers Squibb Co. and Agouron Pharmaceuticals Inc. benefited from studies showing their drugs may need to be taken less often than others, such as Merck and Co.'s Crixivan, in the powerful protease inhibitor class.
''We're excited,'' said Richard Colonno, who leads research into new drugs for infectious disease at Bristol-Myers, the second largest U.S. drugmaker by sales. Bristol-Myers' experimental treatment ''has the potential to be a once-a-day drug,'' he said.
Bristol Myers shares rose 11/16 to close at 100 5/8, while Merck fell 5 5/8 to 131 1/2. Agouron shares fell 1/4 to 32 3/8.
While Agouron's Viracept has been on the market for well over a year, Bristol-Myers is only in early stages of testing its new drug. The fact that it's already boasting about a potentially easier dosing regimen is a sign of the complexity of AIDS treatment and the competition in a drug market that IMS Health projects will reach $2 billion this year in the U.S. alone.
AIDS doctors must weigh the benefits of powerful drugs such as the protease inhibitors sold by Agouron and Merck & Co. against the side effects they carry and the risk that inconvenient drug regimens will cause patients to skip doses. Too many missed doses means patients can develop HIV mutations and ending up with a drug-resistant virus.
Sustiva's Rapid Acceptance
The problem has led to rapid acceptance of DuPont Co.'s recently approved drug, Sustiva. While not a protease inhibitor, the drug has been shown to be powerful and is the first approved AIDS medication that can be taken just once a day. DuPont has shipped more than 90,000 bottles of the drug in its first week.
''Clearly, there's still a need to have newer and better drugs for HIV,'' said David Cooper, a leading AIDS specialist from Sydney, Australia. DuPont's Sustiva and new drugs close to market developed by Glaxo Wellcome Plc, Vertex Pharmaceuticals Inc. and Gilead Sciences Inc. ''will provide useful additions,'' he said.
Other new drugs and all-new approaches may offer even more hope, experts said. Some of those drugs, including ones under development at Triangle Pharmaceuticals Inc., Warner-Lambert Co., Abbott Laboratories, Trimeris Inc. and Pharmacia & Upjohn Inc. were highlighted in a session last night at the Interscience Conference on Antimicrobial Agents and Chemotherapy held this year in San Diego.
Still, the really new approaches are likely several years away, and doctors must cope with what they have now.
Risk of 'Squandering' Drugs
Choosing which drugs to use first is important. If a combination doesn't work, a patient's virus may be resistant not only to the drugs in the original combination but to others as well. The problem is especially evident among protease inhibitors.
''We've really got to be careful not to squander the great drugs that we have,'' Cooper said.
For companies, that means proving to doctors with studies that their drug is the best option for a newly diagnosed patient. A spate of such studies will appear at ICAAC over the next few days. It also means looking for continued research that promotes the idea of early treatment.
In a ''viewpoint'' in a recent edition of the prestigious U.K. medical journal, the Lancet, AIDS researcher Jay Levy questioned the ''hit early'' approach. Levy, of the University of California at San Francisco, claimed that doctors are being too aggressive and treating patients who may be better served by waiting until their immune systems can't handle HIV on their own.
Drawbacks
His argument hinged in part on the drawbacks of powerful drug combinations, which are becoming more obvious. Several studies to be presented at ICAAC detail what researchers believe are metabolic side effects of the protease inhibitor drugs, causing problems ranging from bizarre humps of fat to an increased risk of diabetes.
There is some debate about whether the side effects are caused by protease inhibitors alone or whether they are caused by an interaction of drugs, by the rapid reduction of HIV or perhaps even by other drugs taken in combination with the protease inhibitors. The effects appeared after the advent of protease inhibitors, also sold by Roche Holding AG and Abbott Laboratories, but the protease inhibitors for the first time also allowed patients to see dramatic reductions in HIV and, in some cases, to come back literally from the brink of death.
On the other side of the fence are scientists led by Bruce Walker of Massachusetts General Hospital who have done research showing that hitting the virus earlier with aggressive regimens means the immune system will sustain less damage and will be more likely to be able to fight HIV.
''It just depends on where the balance of the tradeoff is,'' Cooper said. ''That question obviously has to be answered.''
--Kristin Jensen and Kerry Dooley in San Diego through the |