Variety Marks 1990 Crop of Products

By Cynthia Robbins-Roth, Ph.D.
Editor in Chief

For those who dream of a self-sustaining biotechnology industry, 1990 was aneye-opener, as 20 products marched into the market or received federal approval (Seerelated chart, Page 2).

They included the unusual, in the first recombinant product approved for use in thefood processing industry (Pfizer Inc.’s rennin for cheese making) and a substitutefor many animals used in product toxicity tests (Marrow-Tech Inc.’s Skin2 human skintoxicity test).

The products’ parents included newcomers (such as Enzon Inc.’s first productapproval, with PEG-adenosine deaminase) and industry veterans (Genetech Inc’s gammainterferon was approved for treating chronic granulomatous disease, and its tissueplasminogen activator received expanded approval for treating pulmonary embolism).

A larger group of 24 products, including 17 therapeutics, stands in the wings awaitingFood and Drug Administration review. This cast, which includes the colony-stimulatingfactors Interleukin-2 and Factor VIII, has even greater market potential than the 1990crop of products. It undergirds the sizeable valuations of some biotechnology stocks.

While potential products raise hopes, they are also holding captive the valuations ofsome companies with products pending FDA review. Cetus’ stock took a steep dive lastsummer when an FDA advisory panel requested more information before recommending approvalof the company’s IL-2 for treating kidney cancer. A reshuffled upper management,layoffs and changes in the company’s product focus soon followed at Cetus. Meanwhile,Cetus’ closest IL-2 rival, Hoffmann-La Roche, has yet to file for IL-2 marketapproval.

Genetics Institute Inc. faces regulatory waits for key products now before the FDA.GI’s erythropoietin (EPO), which is to be marketed in the United States byChugai/Upjohn, faces a 19-month-and-growing lead by Amgen’s Epogen.

GI’s granulocyte macrophage colony stimulating factor (GM-CSF) has not yetreceived an advisory committee’s recommendation for approval, although severalanalysts believe this will come in the first quarter of 1991. GI’s rivals, Amgen andImmunex Corp., both received in December votes of confidence from the advisory panel.

This year also saw the initiation of clinical testing for 11 new products. Theseproducts cover a broad range of technologies, including new AIDS vaccines, monoclonalantibody-based therapeutics for treating immune-related diseases, growth factors forhealing wounds and fighting infections, and relaxin for easing childbirth.