Newport Firm’s Drug Gets Last Chance

Drugs like AZT, ddC and CD4 have been getting most of the attention of scientists attending the international AIDS conference in Montreal this week, but officials of Newport Pharmaceuticals Inc. hope that will change Thursday when Isoprinosine, the company’s once highly publicized drug, gets one last chance.

Two months after the tiny Newport Beach drug company gave up research and testing on 19-year-old Isoprinosine, a Danish licensee released a study showing that the drug might be successful at slowing the spread of AIDS if used in the very early stages.

The full results of that test will be released to the scientific community for the first time in a presentation Thursday at the Fifth International Conference on AIDS.

And Newport Pharmaceuticals officials are anxiously awaiting the reaction as they prepare once again to seek U.S. Food and Drug Administration approval for Isoprinosine.

‘Big Event’

“Scientists do not wish to get their information out of the Wall Street Journal,” said Newport’s president, J. Roberts Fosberg, referring to the initial release of partial findings of the Danish test in January. “I think this presentation is a big event scientifically.”

Based on the preliminary findings of the Danish study, some AIDS experts are optimistic about the drug’s effectiveness.

But others remain skeptical of the drug and of the company behind it.

Under past management, Newport had been harshly criticized by the federal Food and Drug Administration for conducting incomplete tests and for improperly promoting Isoprinosine as an AIDS treatment. The drug, Newport’s only proprietary product, has been touted in its history as being everything from a memory stimulator to a treatment for herpes and is sold in more than 90 countries.

But the FDA on three occasions has rejected Newport’s applications to sell Isoprinosine in the United States and has been highly critical of the company’s testing methods and promotional activities.

In the past three years, however, Fosberg has helped restore a working relationship with the FDA. Fosberg, a former executive of Irvine-based Allergan Pharmaceuticals, replaced Newport’s founder, Dr. Alvin J. Glasky, in 1986 after Glasky was criticized by the FDA and by the investment community for hyping Isoprinosine.

In contrast to his predecessor, Fosberg has made few claims about Isoprinosine’s potential. He said the drug may be effective at slowing the spread of AIDS to allow time for other drugs to stop the disease. “But we have no data that (Isoprinosine) stops the disease,” he said.

Fosberg’s actions have not angered regulators or scientists, but they have upset some investors--the value of Newport stock fell by more than 60%, to $2.25 a share from $5.75, on the day after Newport announced it was getting out of the drug development business after pumping more than $6 million into research on the drug.

Newport abandoned Isoprinosine in November, 1988, after a study of its use by 696 AIDS patients in the United States and Britain failed to prove the drug was effective.

Then in January, as Newport officials were working to build the company’s mail-order pharmacy business, Leo Pharmaceuticals in Copenhagen released preliminary results of a study of 866 patients. Leo said the tests showed that Isoprinosine was effective in slowing development of AIDS symptoms when used in the very early stages of the disease.

That announcement restored some buoyancy to Newport’s stock price, and common shares now trade at $6 on the over-the-counter market.

Results of Leo’s six-month blind study, in which half of the patients received Isoprinosine and half took a placebo, showed that 17 patients taking the placebo developed AIDS symptoms, compared with only 2 who received Isoprinosine.

A key difference in the Danish and U.S. studies appears to be in the pool of patients studied, Fosberg said.

In the United States, Newport--anxious to prove the effectiveness of the drug--conducted its tests on homosexual men who had already developed AIDS symptoms, according to medical experts familiar with the study.

But Leo’s study involved heterosexual and homosexual men and women who had tested positive for AIDS but had not developed symptoms at the start of the trial.

Especially Cautious

Fosberg said the firm’s past continues to hurt it, and he said scientists will probably be especially cautious about endorsing the results of the Danish study.

“I hope they are. The study needs to be scrutinized,” Fosberg said.

And many scientists still question Isoprinosine’s effectiveness.

Dr. Sudhir Gupta, chief of basic and clinical immunology and AIDS research at UC Irvine, said he believes that the drug might be effective if used in combination with another drug that actually fights the disease.

But Gupta, who was involved in a study with Isoprinosine earlier in the decade, said the six-month testing period used in the Danish trial is too short a time to determine the drug’s effectiveness.

“One question that needs to be answered is whether the 17 (Danish patients) that developed symptoms were significant candidates to develop the symptoms anyway,” said Bruce Decker, president of the Health Policy Research Foundation in Los Angeles.

Providing concerns such as Decker’s can be answered, Newport hopes to finally qualify Isoprinosine for commercial use in the United States under an FDA policy that enables makers of drugs deemed potentially effective in AIDS treatment to shortcut the otherwise lengthy approval process.

If the FDA is willing to relax its normal standards for Isoprinosine, the drug could be approved as early as the end of the year, said Dr. Steven Gerber, a medical technology analyst at Bateman Eichler, Hill Richards Inc., a Los Angeles investment firm.

ISOPRINOSINE CHRONOLOGY

1968--Newport Pharmaceuticals is founded by Dr. Alvin J. Glasky.

1970--The company purchases the drug Isoprinosine.

1977--FDA rejects Newport’s application to market Isoprinosine for use against herpes genitales. The agency said Newport failed to prove the drug worked and criticized some of its clinical testing as “scientifically unacceptable.”

1981--FDA rejects application of Isoprinosine as a treatment for subacute schlerosing panencephalitis, a rare brain disease.

1986 February--FDA rejects drug as treatment for AIDS and rebuked the company for misrepresenting the drug’s test results.

March--Glasky is removed by Newport’s board of directors as chairman, president and chief executive.

July--Newport hires J. Roberts Fosberg, a former executive vice president of Irvine-based Allergan Pharmaceuticals Inc., as president and chief executive.

1987 April--Newport acquires America’s Pharmacy, a mail-order prescription firm.

1988 November--After a six-month U.S. study, Newport said it will abandon all research and development efforts, saying that Isoprinosine has been proven ineffective as a treatment for AIDS-related complex.

1989 January--Newport said an independent Danish study by one of its licensees showed Isoprinosine has some effectiveness in treating very early stages of AIDS.

March--Newport reports a loss of $5 million for 1988.