Company**

Product

Description

Indication

Type Action (Date)

CANCER

Antisoma plc*

Theragyn

Murine monoclonal antibody HMFG1, linked to yttrium-90

Adjuvant treatment of ovarian cancer

Received orphan drug designation (3/29)

DiagnoCure Inc. (Canada)

Immunocyt

Test for bladder cancer that uses 3 monoclonal anti-bodies to detect specific cell markers

Early diagnosis of bladder cancer

FDA began examination of registration file (3/14)

ImClone Systems Inc.

C225

Chimeric monoclonal anti-body to epidermal growth factor receptor

Treatment of advanced squamous cell head and neck cancer

FDA approved initiation of pivotal Phase III trial (3/9)

Ligand Pharmaceuticals Inc. and Wyeth-Ayerst Laboratories (division of American Home Products Corp.; NYSE:AHP)

ERA-923

Tissue selective estrogen receptor modulator

Treatment of breast cancer

Submitted IND (3/1)

CARDIOVASCULAR

BioTime Inc.

Hextend

Blood plasma volume expander

Treatment of hypovolemia

Approved for marketing (3/31)

Novo Nordisk A/S (NYSE:NVO; Denmark)

NovoSeven

Recombinant factor VIIa

Treatment of bleeding episodes in hemophiliacs whose bodies reject other coagulation factors

Approved for marketing (3/26)

Pharming Group NV (U.K.)

­

Recombinant human C1 elasterase inhibitor

Prophylaxis and acute treatment of hereditary and acquired angioedema

Received orphan drug designations in both prophylactic and treatment indications (3/22)

Pharmacia & Upjohn (NYSE: PNU)

Fragmin (FDA-approved)

Dalteparin sodium injection; low-molecular-weight heparin

Prevention of deep vein thrombosis following hip replacement surgery

Approved for marketing (3/31)

Texas Biotechnology Corp.

Novastan

Synthetic molecule (argatro-ban) derived from arginine; acts as direct inhibitor of thrombin

Treatment of heparin-induced thrombocytopenia

Resubmitted NDA, following consultation with FDA that resulted in collection and analysis of a more comparable historical control group for Phase III trial (company received not-approvable letter in 5/98 following 8/97 submission of original NDA) (3/22)

CENTRAL NERVOUS SYSTEM

Vanguard Medica Group plc (U.K.) and Elan Corp plc (Ireland)

Frovatriptan

5HT 1B/1D agonist

Treatment of migraine

NDA accepted for review (3/26)

DIABETES

Ergo Science Corp.

Ergoset tablets

Low-dose, oral formulation of bromacriptine (ergot alkaloid; generic dopamine agonist

Treatment of Type II diabetes

Ergo said it would appeal not-approvable letter sent 11/98 (3/19)

INFECTION

Avanir Pharmaceuticals

­

N-docosanol 10% cream; long-chain fatty acid that interferes with viral entry into cells

Treatment of oral-facial herpes

Company representatives met with the FDA's Division of Dermatological and Dental Products to discuss 3/99 response to not-approvable letter received 12/98; agency said it would continue evaluation and respond to the company; process will likely require at least 1 more meeting (3/8; 3/18)

BioChem Pharma Inc. (Canada) and Glaxo Wellcome plc (NYSE:GLX; U.K.)

Epivir (a.k.a. 3TC; FDA-approved)

Lamivude; nucleoside analogue; oral dosage

Treatment of HIV infection

Label changed to include expanded prescribing information for use in infants, children and adolescents; adult portion of label also expanded (3/24)

Chiron Diagnostics (business unit of Bayer AG; Germany)

Quantiplex HIV-1 RNA 3.0 Assay

Automated test with dynamic range of 50 to 500,000 copies/ml; test capable of identifying as little as 50 copies per ml of HIV-1 (sub-types A-F)

Detection of HIV

Initiated premarket approval process (3/30)

Digene Corp.

Hybrid Capture II HPV DNA Test

Assay that detects DNA from 18 different human papillomavirus types

Detection of human papillomavirus

Cleared for marketing (3/19)

Magainin Pharmaceuticals Inc. and Smith-Kline Beecham plc (NYSE:SBH; U.K.)

Locilex Cream (formerly Cytolex)

Pexiganan acetate; topical (1% cream); broad-spectrum anti-infective; synthetic magainin (natural host-defense peptide isolated from frogs)

Infection in diabetic foot ulcers

FDA's Anti-Infectives Drug Advisory Committee voted 7-4 against recommending approval; Magainin plans to meet with agency officials to review meeting (3/4)

Nabi and Cangene (Canada)

Nabi-HB

Hepatitis B immune globulin (human, plasma-derived, 5% protein formulation); product undergoes solvent/detergent filtration and nano-filtration

Treatment following exposure to hepatitis B virus

Approved for marketing (3/25)

Roche Molecular Systems (unit of Roche Holding AG; Switzerland)

Amplicor HIV-1 Monitor

Ultrasensitive assay; quantitates HIV-1 RNA levels down to 50 copies per ml of plasma (uses PCR amplification)

Measurement of viral load (circulating virus) in HIV-infected patients (used to prove efficacy of anti-retroviral therapies)

Approved for marketing (3/3)

Trinity Biotech plc (Ireland)

Uni-Gold Strep A test

Qualitative assay for Strep A antigen, which can be carried out directly on throat swabs

Diagnosis of Streptococcus A infection

Approved for marketing (3/15)

MISCELLANEOUS

Anika Therapeutics Inc. and Zimmer Inc. (subsidiary of Bristol-Myers Squibb Co. (NYSE: BMY)

Orthovisc

High molecular-weight, naturally derived form of hyaluronic acid

Treatment for osteoar-thritis of the knee

Received FDA approval under an IDE to begin Phase III trial (3/29)

The Ares-Serono Group (Switzerland)

Rebif

Recombinant interferon beta 1a

Multiple sclerosis

Received complete response letter to BLA, asking for clarification of clinical information and data, and stating Rebif may not be approved while orphan exclusivity remains in effect for Biogen Inc.'s Avonex or Chiron Corp.'s Betaseron (3/1)

Connetics Corp.

Luxiq

Betamethasone valerate foam, 0.12%; stabilized foam formulation of mid-potency steroid

Relief of inflammatory and pruritic manifestations of corticoid-responsive dermatoses of the scalp

Approved for marketing (3/2)

Cypress Bioscience Inc. and Fresenius Hematology Inc. (subsidiary of Fresenius AG; Germany)

Prosorba column

Disposable filter that uses Protein A to remove immune complexes from patient's blood

Treatment of moderate-to-severe rheumatoid arthritis

Approved for marketing (3/16)

Chiroscience Group plc (U.K.)

Chirocaine

Levobupivacaine; chiral version of bupavicaine

Long-acting local anesthetic

Received approvable letter (3/1)

Duramed Pharmaceuticals Inc.

Cenestin tablets

Plant-derived (soy and yams) synthetic complex mixture conjugated estrogens product

Treatment of hot flashes, night sweats and other moderate-to-severe vasomotor symptoms associated with menopause

Approved for marketing (3/25)

Genelabs Technologies Inc.

GL701 (DHEA)

Dehydroepiandosterone (naturally occurring hormone produced by adrenal glands)

Treatment for systemic lupus erythematosus

Received fast-track designation (3/31)

Ortec International Inc.

Composite Cultured Skin

Bioengineered bovine collagen matrix seeded with epidermal and dermal cells (biologically active wound dressing)

Treatment of venous ulcers

Received FDA approval to add five clinical sites to ongoing feasibility trial (bringing total to 8) (3/2)

Sepracor Inc.

Xopenex

Levalbuterol HCL inhalation solution; therapeutically active (R)-isomer of racemic albuterol; in 2 dosage strengths for use with a nebulizer

Treatment and prevention of bronchospasm

Approved for marketing (3/26)

NOTES:

Not all the companies represented in this chart are biotechnology firms. Large pharmaceutical companies are included from time to time when the products they are developing address overwhelmingly important diseases such as AIDS and cancer, and where biotech companies are developing competing products.

ASX = Australian Stock Exchange; TSE = Toronto Stock Exchange

* Private companies are indicated with an asterisk.

** Unless otherwise noted, the trading symbols forpublic biotechnology companies can be found by referring to the BioWorldStock Report For Public Biotechnology Companies on pp. 16-17.