More R & D gives rise to 30 new drugs

Record spending in research and development by pharmaceutical companies contributed to the FDA approval of 30 new drugs and nine new biologics in 1998, according to a report from Washington-based Pharmaceutical Research and Manufacturers of America.

Companies spent more than $21 billion on research and development last year, and experts expect them to spend as much as $24 million in 1999. This represents a 17% increase over last year's spending.

The approved medicines treat diseases that affect more than 180 million patients, according to PhRMA. Listed below is a summary of last year's R & D highlights.

AIDS, cancer and heart disease drugs

Three new AIDS and AIDS-related drugs reached the marketplace in 1998: Sustiva, Ziagen and Vitravene. Sustiva, a DuPont Pharmaceuticals product, was the first anti-HIV medicine approved for once-daily dosing. Ziagen, a Glaxo Wellcome product, was the first new nucleoside analogue reverse transcriptase inhibitor to be approved in more than three years. Vitravene, a treatment for cytomegalovirus that resulted from a collaboration between Isis Pharmaceuticals and CIBA Vision Corp. (the eye care unit of Novartis), was also the first in its class to receive FDA approval.

Four new cancer medicines - Herceptin, Xeloda, Valstar and Thyrogen - were also approved in 1998.

Herceptin, a Genentech drug, and Xeloda, a Hoffman-LaRoche drug, were both developed to target metastatic breast cancer. Herceptin was the first monoclonal antibody approved to treat the disease, and Xeloda was the first oral anti-cancer drug for patients whose tumors were resistant to chemotherapy and other standard treatments. Valstar, meanwhile, was developed by Anthra Pharmaceuticals to treat a cancer of the bladder. It is now being marketed by Medeva Pharmaceuticals. And Thyrogen, a product developed by Genzyme, was developed for the follow-up screening of patients who have been treated for thyroid cancer.

Six new medicines were approved to treat cardiovascular diseases, according to PhRMA. They are Cor Therapeutics' Integrillin, Merck's Aggrastat, Diatide's Acutect, Astra Pharmaceuticals' Atacand, Boehringer Ingelheim's Micardis and Hoechst Marion Roussel's Refludan, the first product approved to treat patients with blood-clotting complications associated with heparin-induced thrombocytopenia.

Muscoskeletal and neurologic drugs

Celebrex, Arava and Enbrel were approved to treat rheumatoid arthritis.

Pfizer and Searle collaborated to develop and market Celebrex, a COX-2 inhibitor that may cause fewer gastrointestinal side effects than NSAIDs.

Hoechst Marion Roussel's Arava was the first new disease-modifying agent specifically developed for rheumatoid arthritis in more than a decade, according to PhRMA. Enbrel, an Immunex product, was notable as both the first biologic and the first biologic-response modifier developed for the disease.

For Paget's disease, a bone disease affecting the skull, backbone and pelvis, Proctor & Gamble developed Actonel. For migraine, Merck developed Maxalt and Glaxo Wellcome developed Amerge. Cephalon developed Provigil for narcolepsy. And for Parkinson's disease, Hoffman-LaRoche developed Tasmar, the first in a new class of drugs called COMT inhibitors.

Urological and related drugs

Pfizer stole the media limelight and set sales records with its development and FDA approval of Viagra for erectile dysfunction. It was the first in a new class of phosphodiesterase type 5 inhibitors. GelTex Pharmaceuticals also introduced Renagel to the urology market; the product is indicated for the reduction of serum phosphorus in patients with end-stage renal disease.

Pharmacia & Upjohn developed and brought to market Detrol, the first new medication to be developed for bladder control in more than 20 years. Abbott Laboratories developed Zemplar, the first vitamin D analog to prevent and treat secondary hyperparathyroidism associated with chronic renal failure.

Other new drugs

Singulair, an antiasthma medicine developed by Merck, was the first in a new class of leukotriene-blocker drugs approved for patients as young as six years old and developed for once-daily use.

In the ophthamology market, Axopt was developed by Alcon Laboratories for the relief of intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Lotemax, a Bausch & Lomb and Pharmos product, was also approved for the treatment of steroid responsive inflammatory conditions of the eye.

Celgene Corp.'s Thalomid was approved for the treatment of a complication of leprosy.

Centocor developed Remicade, the first medicine primarily indicated for Crohn's disease, and Orphan Medical developed Sucraid, an oral replacement therapy for sucrase deficiency.

Hoechst Marion Roussel made headlines by developing Priftin, the first new pulmonary tuberculosis treatment in 25 years.

Forest Laboratories received approval for Celexa, a new antidepressant; Novartis received approval for Simulect for the prevention of acute-rejection episodes in kidney transplant patients; SangStat received approval for Thymoglobulin, also for the prevention of kidney loss in transplant patients and Medimmune brought Synagis, the first monoclonal antibody approved for an infectious disease, to market. PR