News

New Brunswick, NJ, January 28, 2002 — New Jersey-based pharmaceutical companies extended their decade-long dominance of the industry by developing 15 of the 24 new drugs approved by the U.S. Food and Drug Administration (FDA) in 2001.  They were also responsible for the development of two of the eight newly approved biologics.

With over 53 percent of the total drugs and biologics approved, New Jersey companies surpassed all other states.  California was second with seven approvals, North Carolina with two and Texas, New York, Illinois, Tennessee, Florida and Indiana each had one approval.

New Jersey-based companies developed several “first” therapies (medicines that are the first in a new class of drugs) for diseases, and other significant advances in therapies.  These include:

• Bextra® from Pharmacia Corporation for the treatment of arthritis, which affects 800,000 to 900,000 Americans.

• Reminyl® from Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical for the treatment of Alzheimer’s disease, which affects nearly half of all Americans 85 and older.

• Invanz, the first in a new class of antifungals, from Merck & Co., Inc.

• Two cancer treatments from Novartis Pharmaceuticals Corporation, and one from Berlex Laboratories.

• Axert from Pharmacia Corpoation for the treatment of migraine headaches, which affect about 10 percent of Americans.

• The first non-steroid cream for dermatitis from Novartis Pharmaceuticals Corporation.

• PEG-Intron from Schering-Plough Corporation for the treatment of hepatitis C.

Commenting on the findings, HealthCare Institute of New Jersey President Bob Franks said, “For the first time, New Jersey-based pharmaceutical companies have developed more than half of the medicines approved by the FDA in a given year.  This is a remarkable achievement.”

Franks continued:  “To develop these drugs, which will improve the quality of life and extend the lives of many Americans, the industry devotes more dollars to research and development than any other industry.  These impressive results show that this substantial investment is reaping benefits for all Americans, and for billions of people around the world.”

The complete list of the 17 drugs and biologics from New Jersey companies approved by the FDA is as follows:

• Arixtra (fondaparinux sodium), from Organon, Inc., which reduces the risk of blood clots after orthopedic surgery for hip fracture, hip replacement, and knee replacement.

• Axert? (almotriptan malate), from Pharmacia Corporation, a tablet for the acute treatment of migraine with or without aura (sensory phenomena that occur before a migraine) in adults.

• Bextra® (valdecoxib), from Pharmacia Corporation, a tablet for the treatment of signs and symptoms of osteoarthritis and adult rheumatoid arthritis and the treatment of pain associated with menstrual cramping.

• Cancidas® (caspofungin acetate), developed by Merck & Co., Inc., is the first in a new class of antifungals, called echinocandins or glucan synthesis inhibitors, introduced in more than a decade. This new medicine will treat certain life-threatening fungal infections that are becoming more prevalent as the number of people with compromised immune systems is increasing. Cancidas is indicated for the treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal therapies.

• CLARINEX® (desloratadine), a product of Schering-Plough Corporation, is a new once-daily, nonsedating antihistamine that provides 24-hour relief from the symptoms of seasonal allergic rhinitis. An H-1 receptor antagonist, CLARINEX taken once daily in clinical trials significantly reduced total symptom scores of the nasal and non-nasal symptoms of seasonal allergies.

• Definity (vial for perflutren lipid microsphere injectable suspension), from Bristol-Myers Squibb Medical Imaging, Inc., is an ultrasound contrast agent for use with suboptimal echocardiograms.

• Elidel (pimecrolimus cream 1%), a product of Novartis Pharmaceuticals Corporation, is the first non-steroid cream for mild to moderate atopic dermatitis in patients age 2 years and older.

• Foradil® (formoterol fumarate), developed by Novartis Pharmaceuticals Corporation, is for the maintenance treatment of asthma and bronchospasm in reversible obstructive airways disease.

• Gleevec® (imatinib mesylate), an orphan drug developed by Novartis Pharmaceuticals Corporation, is for the treatment of chronic myeloid leukemia. Orphan drugs are those that affect fewer than 200,000 patients.

• Invanz (ertapenem sodium), a drug from Merck & Co., Inc., is a new once-a-day injectable antibiotic for the treatment of moderate to severe infections in adults caused by many common gram-positive and gram-negative aerobic and anaerobic bacteria. Invanz is a structurally unique 1-b methyl-carbapenem related to the class of antibiotics known as beta-lactams, which includes penicillins and cephalosporins.

• NuvaRing® (etonogestrel/ethinyl estradiol), developed by Organon, Inc., is a monthly contraception method. A vaginal ring is inserted and left in place for three weeks, followed by a ring-free period of one week.

• Ortho Evra (norelgestromin/ethinyl estradiol), a product of Ortho-McNeil Pharmaceutical, a member of the Johnson & Johnson family of companies, is a birth control patch for the prevention of pregnancy.

• Reminyl® (galantamine hydrobromide), a product from Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical, members of the Johnson & Johnson family of companies, is for the treatment of moderate Alzheimer’s disease. Reminylâ is derived from the daffodil bulb.

• Yasmin® (drospirenone and ethinyl estradiol), developed by Berlex Laboratories, is a new low-dose, monophasic oral contraceptive and the first and only birth control pill to contain the progestin drospirenone. As an analogue of spironolactone, widely used by ob/gyns for many women, drospirenone exhibits antimineralocorticoid activity that influences the regulation of water and electrolyte balance in the body.

• Zometa (zaledronic acid), developed by Novartis Pharmaceuticals Corporation, is an injection for the treatment of hypercalcemia due to malignancy.

• Campath® 1-H (alemtuzumab), a biologic developed by Berlex Laboratories, is a humanized monoclonal antibody used for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have been treated with alkylating agents and who have failed fludarabine therapy. The only monoclonal antibody indicated for patients with B-CLL, Campath works by targeting the CD52 antigen to clear the blood and bone marrow of cancer cells.

• PEG-Intron (peginterferon alfa-2b), developed by Schering-Plough Corporation, is a powder for injection for use both as monotherapy and in combination with REBETOL capsules for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age.  The PEG-Intron and REBETOL treatment regimen is the first and only pegylated interferon-based combination therapy approved in the United States.

The HealthCare Institute of New Jersey promotes public awareness of the state’s research-based pharmaceutical and medical technology industry.  The Institute includes 19 worldwide pharmaceutical and medical technology leaders headquartered in New Jersey.