Eleven biotech products are currently pending approval at FDA,out of a total 143 that have reached clinical testing, accordingto a survey released by the Pharmaceutical ManufacturersAssociation (PMA) on Wednesday.

The pending applications include:

-- Four human growth hormones: Bio-Technology GeneralCorp.'s BioTropin; Novo Nordisk A/S's Norditropin; GenentechInc.'s Nutropin; and Serono Laboratories Inc.'s Saizen;

-- Centocor's Centoxin monoclonal antibody for sepsis andseptic shock;

-- Genentech's Pulmozyme for cystis fibrosis;

-- Two imaging agents: Hybritech Inc.'s Hybri-CEAker for coloncancer imaging and Immunomedics Inc.'s ImmuRAID-CEA tomeasure extent of disease staging of colon cancer;

-- Additional indications for three products already on themarket: Sandoz Pharmaceuticals' Leucomax for treatment oflow white blood-cell counts; Amgen Inc.'s Neupogen for severechronic neutropenia in bone marrow transplantation; and OrthoBiotech's Orthoclone OKT3 for renal prophylaxis.

PMA notes that in 1988, when it conducted its first biotechsurvey, there were 81 biotech products in development; in theassociation's last survey, conducted in 1991, there were 132products in development. To date, a total of 19 biotechnologymedicines and biologics have been approved by the FDA.

Of the 143 products now in development, 59 are for cancer orcancer-related conditions, 23 for HIV infection and AIDS, 11 forsepsis and eight for rheumatoid arthritis. Thirty-three of theseproducts are in Phase III testing and 53 are in Phase II.

The vast majority of products, 50, are monoclonal antibodies.There are 20 vaccines, 11 interferons, 10 interleukins, ninegrowth factors, 6 colony stimulating factors, four humangrowth hormones, three tumor necrosis factors, and tworecombinant soluble CD4s. There is also one clotting factor, onedismutase, one erythropoietin, one gene therapy, one tissueplasminogen activator, and 23 other products.

For the 143 products in development, PMA said 63 companiesare engaged in 170 separate research projects (some productsare being studied for more than one indication). Noting themerging of biotechnology into the pharmaceutical industry,PMA president Gerald Mossinghoff cited an April 1993 studyby the Boston Consulting Group that found that 33 percent ofresearch projects in major pharmaceutical companies werebased on biotechnology, compared to two percent in 1980. Thestudy further found that in some larger pharmaceuticalcompanies, up to 70 percent of research projects were based onmolecular biology.

PMA also reports that 4,446 biotechnology patents were issuedby the U.S. Patent and Trademark Office in 1992. Of these,2,094 were health-care patents. The U.S. was the country oforigin for 1,441 of them. A total of 178 health-care patentsusing genetic engineering were issued, 80 to corporations, 38 toforeign entities, 25 to universities, 20 to nonprofitorganizations, eight to individuals and seven to the U.S.government.

Releasing the survey at a press conference in Washington, D.C.,PMA used the event as a forum to speak against mandatoryprice controls on prescription drugs. Gordon Binder, Amgenchairman and chief executive officer and PMA board member,asserted that "the loss of incentives and resulting lack of accessto investment capital from this policy could be devastating tomany biotechnology companies. It runs the risk of losing worldleadership in biotechnology to competitors in Europe and Japan,who have targeted biotechnology for aggressive expansion."

-- Brenda Sandburg News Editor

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