FDA Panel Delays Decision on Cetus’ Proleukin
A Food and Drug Administration panel Monday dealt a blow to loss-weary Cetus Corp. when it postponed a decision on the firm’s application to market Proleukin, its costliest and most important product, to treat kidney cancer.
The panel, whose recommendations are almost always accepted by the FDA, said it needed more time to review data that Cetus submitted as late as last Friday and would probably request additional meetings between Cetus officials and FDA staff.
The delay, although not as devastating as an outright denial, is at best greatly frustrating to Cetus, the Emeryville, Calif.-based biotechnology company that has invested more than $100 million developing Proleukin. Proleukin is a genetically engineered form of Interleukin-2, a protein that regulates the immune system. The company still has cash reserves but lately has admitted a great need for revenue from Proleukin.
After the four-hour panel review, Cetus Chief Executive Robert A. Fildes said “this product can play a significant role in altering the dismal progress of kidney cancer for many patients. We continue to believe that this drug should be licensed quickly. . . . It is a tragedy that Americans do not have access to a drug developed in the United States that is already approved in nine European countries.”
The postponement also is a damper on the financial community’s hopes that four biotech drug reviews this week would reignite enthusiasm in biotechnology issues. But in heavy over-the-counter trading Monday, the price of Cetus stock closed down $1.75 cents at $14.125. More than 3 million shares were traded.
The panel did recommend approval, however, for Genentech to market its gamma interferon to a very narrow class of patients who suffer from an inherited immune system disorder called chronic granulomatous disease.
Each FDA application is seen as a first step for these drugs, all belonging to the family of immune system regulators. This group of proteins is viewed by scientists and researchers as holding great potential for widespread use in the treatment of cancers and other pernicious diseases. For the companies, they are viewed as the products that could finally lift the biotechnology business out of a morass of red ink.
For Cetus, the trouble has been in finding the one application for Proleukin that will produce the best results and win its first FDA approval. Some critics have accused Cetus of “shopping for a disease” to fit its cure. Interleukin-2 has been in several different clinical trials since Dr. Steven Rosenberg of the prestigious National Cancer Institute began first tests on humans in early 1984.
Proleukin has been controversial because it has shown only moderate success while producing serious side effects. The FDA’s dilemma is to balance that against the glum outlook for patients without the drug.
Sales of Proleukin in European countries and Cetus’ other revenues are not substantial enough to offset its costs in developing the product, said Steven Gerber, biotech analyst at Bateman Eichler, Hill Richards in Los Angeles. And without U.S. approval, European sales could flatten or even fall off.
The approval would open an estimated $20 million to $40 million annual market to Cetus, and Gerber called that “crucial for the company. . . . If approval, for example, is delayed for six months, well, the timing is less crucial than the fact of approval.”
BIOTECH PRODUCTS BEING CONSIDERED
Products and action on the FDA Advisory Committee agenda:
MONDAY:
* Delays making a recommendation on Cetus’ application to market interleukin-2 drug for treatment of kidney cancer.
* Recommends approval for Genentech to market its gamma interferon, Actimmune, for treatment of a rare disorder.
TUESDAY:
* Considers application by Immunex to market its version of a “colony stimulating factor” for use in bone marrow transplants.
* Considers application by Schering-Plough to market Intron, an alpha interferon licensed from Biogen, for use in treating hepatitis-C patients.
