The federal Food and Drug Administration on Friday rejected a Newport Beach company's drug as a possible treatment for pre-AIDS conditions and has chastised the company for misrepresenting results of its studies on the drug.
However, Newport Pharmaceuticals International put on a positive face Friday and said it was confident that additional information it was preparing for the FDA would secure Isoprinosine's approval.
The regulatory agency, which must clear all drugs tested and sold in the United States, would not reveal its reasons for not approving Newport Pharmaceutical's application for Isoprinosine. However, the FDA did hint at its reasons in a separate letter--which it did make public--that was critical of the company's data for showing only small and limited effects of the drug in what in some cases were "scientifically inadequate" sample sizes.
"The FDA's letter stated deficiencies . . . that I consider to be manageable," said Alvin Glasky, the controversial president of Newport Pharmaceuticals. "We're still confident that we can obtain approval," Glasky added.
However, sources close to the FDA, who spoke only on the condition they not be identified, said the double-barreled blast from the FDA meant there was little hope that the drug would ever be approved.
Dumping of Stock
Investors seemingly agreed and Friday were feverishly dumping Newport Pharmaceutical's stock. As almost 2.5 million shares were exchanged in over-the-counter trading, the stock lost more than half its value, closing at $6.50 a share, down $6.675.
Through the years, 16-year-old Newport Pharmaceuticals has unsuccessfully sought approval for use of Isoprinosine--its only product--for a variety of ailments, from herpes to hepatitis. Many times along the way, the company has announced its applications, and its failures--making it stand out in the usually close-mouthed drug industry.
After years of fighting for a spot on pharmacy shelves in the United States, Isoprinosine gained attention because of the epidemic of acquired immune deficiency syndrome. When the company identified it in late 1984 as a possible treatment for early stage AIDS, it caught not only the interest of the investment community but also the quick and careful attention of national researchers and regulatory agencies.
Although it continues to be tested for its ability to stimulate the body's immune system (a key problem in AIDS victims), privately, researchers have expressed serious doubts about its usefulness.
The FDA sent two letters to Newport Pharmaceuticals late this week. The first, sent and received Thursday, makes clear the FDA's displeasure with a press conference the company held Feb. 13 in Los Angeles.
Among its complaints, the letter said the company's claims of the drug's effects cannot be substantiated by the data submitted to the FDA. It also said the company's claims could be in violation of FDA law that prohibits a company from representing a drug as effective before approval has been granted.
The letter said "such misrepresentations of the currently available data should stop. These activities only serve to further confuse an already complicated subject area."
Firm Denies Charge
"We do not believe we have touted the efficacy of the drug," Glasky said Friday. He said the Feb. 13 press conference was called to calm "wild speculation" that the drug was about to be approved by the FDA.
The six-month time period for FDA action on the company's application expires March 3, and many analysts and industry observers had been expecting a response.
Glasky said he recognized the FDA's first letter as a "slap" at the company, and said the FDA "obviously wants us to close our mouth" about the drug's possible effectiveness. But, he said, he and the FDA both had adopted a "conciliatory" attitude in "several discussions" held after the receipt of the two letters.
The company said the FDA's second letter, sent and received Friday, says the new drug application "was deemed not approvable." The FDA, which said it does not disclose such matters, refused to discuss the second letter. Glasky said the letter is not the harshest form of rejection possible from the FDA and allows the company to submit additional information that might lead to approval.
However, FDA officials said that, if the company does submit additional information, the regulatory agency would have another six months in which to make a ruling on the application.
Many involved in treating patients with early AIDS symptoms have said the FDA's actions will do little to stop the use of Isoprinosine.
Won't Stop Victims
Both Dr. Neil Schram, chairman of the Los Angeles City/County AIDS Task Force, and Luis Maura, director of client and community relations for AIDS Project Los Angeles, said they doubt that the FDA statement will slow the stream of AIDS patients who go to Mexico to obtain Isoprinosine.
"I suspect that nothing said today by the FDA will make people stop taking the drug," Schram said.
In the United States, Isoprinosine is undergoing clinical trials, and use of it at a dozen compassionate-care centers was approved. Physicians who administer Isoprinosine to their patients have variously declined to comment on progress so far or have also criticized Newport Pharmaceuticals for appearing to tout the drug before its approval.
Times Medical Writer Harry Nelson contributed to this story.