Food And Drug Approvals And Applications
Copley Pharmaceutical
Hydrocortisone Valerate Cream USP, 0.2%
Hydrocortisone Valerate Cream USP, 0.2% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. As of June 1998, the yearly market for the brand was $34 million. Copley Pharmaceutical, Inc. is the first generic applicant approved by the FDA to manufacture Hydrocortisone Valerate Cream USP, 0.2%. The Hydrocortisone Valerate Cream USP, 0.2% is therapeutically equivalent to Westcort Cream 0.2%, made by Westwood-Squibb Pharmaceuticals.
For more information: Barbara L. Morse, vice president, Administration and Corporate Communications, Copley Pharmaceutical, Inc. Tel: 781-575-7304.
King Pharmaceuticals, Inc.
Fluogen
Fluogen is an influenza virus vaccine, trivalent, types A and B, manufactured at and marketed under the name of King's wholly owned subsidiary, Parkedale Pharmaceuticals. King recently received a supplemental approval by the FDA for the expansion of its Fluogen production facility, approving eight new set incubators and two new virus incubators.
For more information: Kyle P. Macione, executive vice president, Investor Relations, King Pharmaceuticals, Inc. Tel: 423-989-8077.
EntreMed Inc.
Thalidomide
Thalidomide, an angiogenic inhibitor, has received orphan drug designation as a treatment for Kaposi's sarcoma, a form of skin cancer most frequently associated with Acquired Immune Deficiency Syndrome (AIDS). Orphan drug designation by the FDA is intended to encourage research and development of new therapies for diseases affecting less than 200,000 U.S. residents.
For more information: Mary P. Sundeen, director of Research Operations, EntreMed Inc. Tel: 301-738-2490.
Immunex Corporation
Enbrel
An FDA Arthritis Advisory Committee will review data on Immunex's investigational product, Enbrel (etanercept) for the treatment of active rheumatoid arthritis, on September 16, 1998, at a meeting in Gaithersburg, Maryland. Enbrel is a protein-based drug comprising only human amino acid sequences, scientifically referred to as a recombinant version of the soluble p75 TNF receptor linked to the Fc portion of human IgG1. It competitively inhibits the binding of TNF to its cell surface receptors and thereby inhibits TNF biological activity. Enbrel is thought to interfere specifically with the inflammatory process in RA, which may be driven by TNF. In RA, excess TNF combines with cell surface TNF receptors and produces a cascade of damaging and inflammatory effects on joints.
For more information: Tim Warner, Immunex. Tel: 206-470-4193.
Hoechst Marion Roussel and 3M Pharmaceuticals
QVAR
QVAR (beclomethasone dipropionate), an inhaled corticosteroid proposed for the long-term control of asthma symptoms, has had its filing for a New Drug Application accepted by the FDA. If approved, the drug will be available as a chlorofluorocarbon-free (CFC-free) metered dose inhaler (MDI).
For more information: Charles F. Rouse III, Hoechst Marion Roussel. Tel: 816-966-4052 or Julie Gladman, Hoechst Marion Roussel. Tel: 816-966-4274.
BioChem Pharma, Inc.
Zeffix
BioChem Pharma, Inc., through its licensee Glaxo Wellcome, has received regulatory approval to market Zeffix (lamivudine), an oral anti-viral treatment for chronic hepatitis B from the Bureau of Food and Drugs in the Philippines. Zeffix is administered as a convenient, once daily tablet. Data published last month in The New England Journal of Medicine showed that treatment with Zeffix for one year was associated with substantially reduced liver inflammation compared to placebo as assessed by biopsy. Patients treated with Zeffix (100 mg per day) also had a 98% reduction in hepatitis B DNA (a marker of viral replication) and a significantly higher rate of seroconversion (an immune response to the virus that is thought to predict long lasting remission of the disease).
For more information: Christine Lennon, Corporate Communications, BioChem Pharma, Inc. Tel: 514-978-7771.