BioWorldJan. 2, 1991Vol. 3, No. 1


By Cynthia Robbins-Roth, Ph.D.Editor in ChiefFor those who dream of a self-sustaining biotechnologyindustry, 1990 was an eye-opener, as 20 products marchedinto the market or received federal approval.

They included the unusual, including the first recombinantproduct approved for use in the food processing industry(Pfizer Inc.'s rennin for cheese making) and a substitute formany animals used in product toxicity tests (Marrow-TechInc.'s Skin2 human skin toxicity test).

The products' parents included newcomers (such as Enzon Inc.'sfirst product approval, with PEG-adenosine deaminase) andindustry veterans (Genentech Inc.'s gamma interferon wasapproved for treating chronic granulomatous disease, and itstissue plasminogen activator was granted expanded approvalthat included treatment of pulmonary embolism.).

A larger group of 24 products, including 17 therapeutics,stands in the wings awaiting Food and Drug Administrationreview. This cast, which includes the colony-stimulating factorsInterleukin-2 and Factor VIII, has even greater marketpotential than the 1990 crop of products. It undergirds thesizeable valuations of some biotechnology stocks.

After years of plotting the sales potential of various products,Wall Street analysts and investors anxiously await theproducts' marketplace performances.

While potential products raise hopes, they are also holdingcaptive the valuations of some companies with productspending FDA review. Cetus' stock took a steep dive last summerwhen an FDA advisory panel requested more informationbefore recommending approval of the company's IL-2 fortreating kidney cancer. A reshuffled upper management,layoffs and changes in the company's product focus soonfollowed at Cetus, which aims to soon deliver the requesteddata. Meanwhile, Cetus' closest IL-2 rival, Hoffmann-La Roche,has yet to file for IL-2 market approval.

Genetics Institute Inc. faces similar regulatory waits for keyproducts now before the FDA. Once approved, GI'serythropoietin (EPO), which is to be marketed in the UnitedStates by Chugai/Upjohn, will challenge the 19-month lead heldby Amgen's Epogen. Both EPO products are enmeshed in a fightover who holds the dominant patent rights. Investors,expecting a finding in GI's favor, have spurred its share priceinto the low $40s from a 1989 close of $34.13.

GI's granulocyte macrophage colony stimulating factor (GM-CSF) has not yet received an advisory committee'srecommendation for approval, although several analystsbelieve this will come in the first quarter of 1991. GI's rivals,Amgen and Immunex Corp., both received in December votes ofconfidence from the advisory panel.

The year also saw the initiation of clinical testing for 11 newproducts, with another four scheduled to start soon. These newproducts cover a broad range of technologies, including newAIDS vaccines, monoclonal antibody-based therapeutics fortreating immune-related diseases, growth factors for healingwounds and fighting infections, and relaxin for easingchildbirth.

(c) 1997 American Health Consultants. All rights reserved.