New Brunswick, NJ, January 18, 2001 — Nearly 40 per cent of the U.S. Food and Drug Administration (FDA) approvals for new medicines in 2000 were given to research-based pharmaceutical companies headquartered in New Jersey.
New Jersey companies again led the nation with 12 of the 33 new drugs and biologics that gained FDA approval. California is in second place, with 4 approvals, and New York in third position, with 3 approvals. In 1999, New Jersey had 17 of the 40 FDA approvals; in 1998, 14 of the 38 FDA approvals were from New Jersey-based companies.
“New Jersey companies are clearly ahead in developing the new, breakthrough medicines that are changing the face of disease treatment,” said William H. Tremayne, President of the HealthCare Institute of New Jersey. “The large number of approvals for New Jersey-based companies in 2000 indicates that New Jersey will continue to dominate drug discovery into this first decade of the new century, as we did in the last decade of the previous century.”
These approvals are for new molecular entities (NME), which are defined by the FDA as “active ingredients that have never been marketed in this country.” The list includes both new drugs and biologics, which are a subset of drug products with a biological manufacturing process (as opposed to a chemical manufacturing process).
New Jersey’s NME approvals include:
- The first in a new class of antibiotics (ZyvoxTM from Pharmacia).
- The first vaccine to help prevent invasive bacterial disease (such as meningitis) in infants and young children (PrevnarTM from Wyeth-Ayerst).
- The first drug approved to treat patients 60 years and older in first relapse with leukemia who are not candidates for chemotherapy (MylotargTM from Wyeth-Ayerst).
- A new medicine for Alzheimer’s disease, the fourth leading cause of death in the United States (Exelon® from Novartis).
- A new treatment for macular degeneration, the leading cause of blindness in people over 50 (VisudyneTM from Novartis and QLT Inc.)
The drugs and biologics approved in 2000 are:
- Exelon® (rivastigmine tartrate), developed by Novartis Pharmaceuticals for treatment of mild to moderate Alzheimer’s disease.
- Lantus® (insuline glargine injection), developed by Aventis Pharmaceuticals, for treatment of adults with type 2 diabetes who require long-acting insulin for the control of hyperglycemia and for adults and children with type 1 diabetes.
- MylotargTM (gemtuzumab ozogamicin), an injection developed by Wyeth-Ayerst Laboratories (a division of American Home Products) for leukemia. This treatment is for patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia who are not candidates for cytotoxic chemotherapy. MylotargTM is the first targeted chemotherapy agent using monoclonal antibody technology, and is an “orphan” drug (a drug that affects fewer than 200,000 patients. Under the Orphan Drug Act, companies receive a seven-year period of marketing exclusivity following approval of an orphan drug and a 50 per cent tax credit for certain clinical research expenses involved in development of the product).
- NovoLog® (insulin aspart), an injection developed by Novo Nordisk Pharmaceuticals for treatment of type 1 and type 2 diabetes.
- PrevnarTM (pneumococcal 7-valent conjugate vaccine) produced by Wyeth Lederle Vaccines (a division of American Home Products). This vaccine is used to immunize against pneumococcal disease in infants and toddlers.
- Protonix® (pantoprazole sodium), from Wyeth-Ayerst Laboratories (a division of American Home Products). This product is for short-term treatment (up to 16 weeks) in the healing and symptomatic relief of erosive esophagitis.
- ReFacto® (antihemophilic factor recombinant), from Genetics Institute, Inc (a division of American Home Products). ReFacto is the first recombinant treatment for the control and prevention of bleeding episodes and for short-term routine and surgical prevention in patients with hemophilia A.
- Rescula® (unoprostone isopropyl ophthalmic solution), from Novartis Ophthalmics (formerly CIBA Vision). This solution lowers intraocular pressure in open-angle glaucoma or ocular hypertension for those who are intolerant of or insufficiently responsive to other intraocular pressure-lowering medications.
- Starlix® (nateglinide), from Novartis Pharmaceuticals. These tablets are an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.
- Trileptal TM (oxcarbazepine), a product of Novartis Pharmaceuticals for the treatment of epileptic partial seizures as monotherapy in adults or adjunctive therapy in adults and children as young as four years old.
- VisudyneTM (verteporfin injection), developed by Novartis Ophthalmics and QLT. This is a treatment of the wet form of age-related macular degeneration.
- ZyvoxTM (linezolid), a product from Pharmacia Corporation, for treatment of infections caused by gram-positive bacteria.
Two New Jersey-based companies also gained FDA approvals for licensing agreements with companies that were granted approvals for NME’s in 2000:
- Pharmacia Corporation has a licensing agreement with Debio Rechereche of Switzerland for Trelstar TMDepot, a treatment for advanced prostate cancer, and
- Daiichi Pharmaceutical has an agreement with SnowBrand Pharmaceuticals for EvoxacTM, a treatment of dry mouth associated with Sjogren’s Syndrome.
New Jersey-based companies also gained numerous FDA approvals for new uses and new forms of previously approved products.
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.