Company* (Symbol)

Product

Description

Indication

Status (Date)**

CANCER

Access Pharmaceuticals Inc. (OTC BB: AXCS)

OraRinse

0.5% mucoadhesive solution of amlexanox

Mucositis

Received clearance to begin Phase II trial (1/27)

AltaRex Corp. (Canada; TSE:AXO)

OvaRex MAb

Anti-idiotype induction therapy-based vaccine; consists of modified murine monoclonal antibody that binds to CA125 cancer antigen

Advanced-stage ovarian cancer

Company developed a clinical plan in conjunction with FDA which, if successfully accomplished, would allow a substantially improved manufacturing process with cell culture production by Lonza Biologics (unit of Algroup; Switzerland) without having to repeat ongoing trials (1/3)

AVAX Technologies Inc. (AVXT)

O-Vax

Haptenized autologous cell vaccine

Advanced-stage ovarian cancer

Investigational new drug application (IND) accepted; FDA authorized AVAX to begin Phase II trials (1/18)

Cell Pathways Inc. (CLPA)

Aptosyn

Exisulind; orally active drug designed to induce apoptosis in precancerous cells; inhibits a cyclic GMP phosphodiesterase

Regression and prevention of precancerous polyps in patients with familial adenomatous polyposis

FDA advised it plans to evaluate the new drug application (NDA) without requiring input from the Oncologic Drugs Advisory Committee (1/11)

Celltech Chiroscience plc (LSE:CCH) and Wyeth-Ayerst Laboratories (pharmaceutical division of American Home Products Corp. [NYSE:AHP])

Mylotarg (CMA-676)

Gemtuzumab zogamicin; humanized recombinant antibody linked with a cytotoxic anti-tumor anti-biotic called calicheamicin, isolated by Wyeth researchers from a bacterium in caliche clay, a soil found in Texas; antibody portion is specific for CD-33 antigen, a protein commonly expressed by myeloid leukemia cells

CD-33-positive relapsed adult acute myeloid leukemia

Wyeth received priority review status for NDA (1/5)

EntreMed Inc. (ENMD)

Angiostatin

Recombinant human anti-angiogenic protein

Cancer

Received permission to begin Phase I clinical testing (1/31)

Maxim Pharmaceuticals Inc. (AMEX:MMP)

Maxamine Therapy

H2 receptor agonist; combination therapy with low-dose interleukin 2

Acute myelogenous leukemia

FDA granted orphan drug status (1/5)

CENTRAL NERVOUS SYSTEM

Boston Life Sciences Inc.

Altropane

Radioimaging probe for dopamine neurons

Diagnosis of attention deficit-hyperactivity disorder

After discussions with FDA, company said it expects to initiate Phase II/III trial program at the end of 1Q:00 (1/25)

Immunex Corp. (IMNX)

Novantrone (FDA-approved)

Mitoxantrone for injection concentrate

Relapsing-remitting and secondary progressive multiple sclerosis

FDA's Peripheral and Central Nervous System Drugs Advisory Panel unanimously recommended approval (1/28)

Chimeric Therapies Inc.*

Graft engineering technology that processes donor bone marrow in such a way as to allow only a partial transplant

Sickle cell anemia

Received clearance to begin clinical testing (1/31)

NiCox SA (France; NM:NicOx)

NCX 4016

Nitric oxide-releasing derivative of acetylsalicylic acid, the active ingredient in aspirin

Pain and inflammation

Submitted IND (1/27)

Nouvel Pharma Inc. (subsidiary of NeoPharma Production AB; Sweden)

Duodopa

Liquid preparation of levodopa/carbidopa for administration to the small intestine via intraduodenal infusion

Advanced-stage Parkinson's disease

Granted orphan drug status (1/25)

INFECTION

BioCryst Pharmaceuticals Inc. (BCRX) and R.W. Johnson Pharmaceutical Research Institute (unit of Johnson & Johnson; NYSE:JNJ)

BCX-1812

Oral small-molecule inhibitor of neuraminidase enzyme, which promotes spread of the influenza virus by breaking the chemical strands that hold new viruses to cell surfaces

Influenza infection

RWJ notified U.S. clinical investigators that discussions with the FDA are continuing, and that it expects to have more information in the coming weeks regarding the timing of U.S. trials (1/7)

Enzon Inc. (ENZN) and Schering Plough Corp. (NYSE:SGP)

PEG-Intron Powder for Injection

Long-acting dosage form of Schering-Plough's Intron A (recombinant interferon alfa-2b) conjugated to polyethylene glycol

Chronic hepatitis C virus infection in adult patients with compensated liver disease

Submitted biologics license application (BLA) (1/5)

Ribozyme Pharmaceuticals Inc. (RZYM) and Eli Lilly and Co. (NYSE:LLY)

LY466700 (formerly Heptazyme)

Synthetic ribozyme designed to selectively cut hepatitis C virus RNA and inhibit viral replication

Hepatitis C infection

Submitted IND (1/11)

SYNSORB Biotech Inc. (Canada; SYBB)

Synsorb Cd

Product that binds to toxins secreted by bacteria in the gastrointestinal tract

Prevention of recurrence of Clostridium difficile-associated disease

Received formal notification of fast-track designation (1/11)

MISCELLANEOUS

Alexion Pharmaceuticals Inc. (ALXN)

5G1.1

Anti-inflammatory inhibitor of the fifth component of the complement cascade (C5)

Severe psoriasis

Filed IND and commenced Phase Ib trial (1/11)

Amgen Inc. (AMGN)

NESP; novel erythropoiesis stimulating protein

Renal disease

Submitted NDA (1/25)

Kineret

Recombinant form of the cytokine interleukin-1ra, which selectively blocks the effects of IL-1, a cytokine released as part of the disease process in rheumatoid arthritis

Rheumatoid arthritis

Filed BLA (1/25)

Cellegy Pharmaceuticals Inc. (CLGY)

Tostrelle

Transdermal testoster-one gel

Postmenopausal testosterone deficiency

IND approved (1/6)

Centocor Inc. (CNTO)

Remicade (FDA- approved)

Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha

Prevention of joint damage in patients with rheumatoid arthritis

Priority review status granted (1/27)

Corixa Corp. (CRXA) and Genesis Research & Development Corp. Ltd.* (New Zealand)

PVAC

Immunotherapeutic derivative of Mycobacterium vaccae

Moderate to severe psoriasis

Received FDA clearance to initiate Phase II trials (1/11)

Inhale Therapeutic Systems (INHL) and Aventis Behring LLC (plasma protein business of Aventis Pharma AG (NYSE:AVE)

Inhaleable formulation of alpha 1 proteinase inhibitor (human)

Congenital emphysema caused by alpha 1 antitrypsin deficiency

Received orphan drug designation and initiated Phase I trial (1/13)

InKine Pharmaceutical Company Inc. (INKP)

Diacol

Sodium phosphate tablets

Purgative agent for adults undergoing colonic cleansing for diagnostic procedures

NDA accepted for filing (1/24)

Unigene Laboratories Inc. (OTC BB: UGNE)

Nasal calcitonin formulation

Osteoporosis

Filed IND (1/6)

Notes:

* Indicates a privately held company

** The dates listed indicate the issue dates of press releases, and are not necessarily the dates on which stated events took place.

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; LSE = London Stock Exchange; NM = Nouveau Marche; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange; ND = Not disclosed

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