Government, Industry Could Help Bring Alzheimer's Drug to Market With PM-Alzheimer's Disease
Nov. 13, 1986
Government, Industry Could Help Bring Alzheimer's Drug to Market With PM-Alzheimer's Disease Bjt
NEW YORK (AP) _ A drug that shows preliminary promise against Alzheimer's disease isn't eligible for a patent, but it could be brought to market with the help of corporate sponsors or limited federal protection, officials say.
The drug, called tetrahydroaminoacrine or THA, was found to improve the memory in 16 of 17 Alzheimer's patients in experiments reported today in the New England Journal of Medicine.
Four pharmaceutical companies have refused to try developing the drug and getting federal approval to sell it because it lacks a patent, said William K. Summers, an assistant professor at the University of California, Los Angeles, who directed the study.
Without a patent a pharmaceutical firm would not have exclusive rights to selling THA, he said. The substance was discovered in 1909 and is no longer patentable, he said.
Summers said Wednesday he has applied to patent the method of using the drug instead, to attract pharmaceutical companies. A method patent, like a patent on a substance, gives 17 years of protection, said Summers' patent attorney, R. Danny Huntington of Alexandria, Va.
If the method patent falls through, Summers said in a telephone interview, the briefer patent-like protections offered by federal law ''would be good things to fall back on.''
Despite the initial cold shoulder, THA may find a sponsoring company through the Commission on Drugs for Rare Diseases, part of the Pharmaceutical Manufacturers Association, said Lawrence Weaver, executive director of the commission.
The group finds sponsors for research and other activities needed to bring an economically unattractive drug to market, Weaver said. Although Alzheimer's is not considered a rare disease, the commission might help with THA because of its unattractiveness so far to pharmaceutical firms.
The commission, made up of eight pharmaceutical company scientists, has been finding about two sponsors a year for ''orphan drugs,'' he said.
Orphan drugs are those which are commercially unattractive to develop and bring to market, usually because the diseases they treat are so rare that the commercial outlook is dim.
A company might agree to take on such a drug for reasons of goodwill, Weaver said.
Federal law offers two possible avenues of support for drugs like THA.
Under one provision, if a drug is not patentable and the FDA has not approved it before, a drug company can get exclusive rights to market it for five years after the FDA approves it for sale.
The second avenue applies to orphan drugs. Federal law allows tax breaks for research, and if FDA approves it for marketing, seven years of protection against another company's marketing the same drug for the same purpose, said Dr. Stephen Fredd, acting director of FDA's office of orphan products development.
THA would not meet one definition of an orphan drug, which is one used in a disease that affects 200,000 or fewer people in the United States. But Fredd said another definition might apply: a drug whose developing and marketing costs are shown to be not recoverable through sales in the United States.
Alzheimer's is the primary cause of senility among the elderly. An estimated 1.5 million to 3 million Americans have the illness, and it causes more than 100,000 deaths each year.
''It's not easy to demonstrate that you're going to lose money,'' Fredd said in a telephone interview. ''In all honesty, it's generally not the intention of drug companies to lose money.''
But even with a lot of buyers, money could be lost if the product is priced low enough, he said.
Some companies ''really want to do some public service,'' he said, and there are ''some chief executives who believe that something that really looks compelling for Alzheimer's disease would do their company a lot of good even if it couldn't be patented.''
That benefit would be in the form of public relations and the fact that the company name would be put in front of prescribing doctors, which could help with sales of other products, he said.