Company*
(Symbol)

Product

Description

Indication

Status
(Date)

CANCER

AEterna Laboratories Inc. (Canada; AELA; TSE:AEL)

AE-941/Neovastat

Orally bioavailable naturally occurring antiangiogenic product that blocks two regulators of angiogenesis, VEGF and MMPs

Multiple myeloma

FDA and Canadian health authorities approved the conduct of the pivotal trial, which will be conducted at 20 hospitals throughout Canada, the U.S. and Europe(12/19)

Hemosol Inc. (Canada; TSE:HML)

Hemolink

Highly purified human-derived hemoglobin replacement product

Non-small-cell lung cancer

Company filed an IND application to begin a Phase I/II study in patients with non-small-cell lung cancer who are experiencing chemotherapy-associated anemia (12/21)

Maxim Pharmaceuticals Inc. (MAXM)

Maxamine

Histamine dihydrochloride

Advanced metastatic melanoma

The FDA's Oncologic Drugs Advisory Committee recommended against the NDA for Maxamine as an adjuvant to interleukin-2 to treat patients who have liver metastases (12/13)

Millennium Pharmaceuticals Inc. (MLNM) and Ilex Oncology Inc. (ILXO)

Campath

Alemtuzumab; humanized monoclonal antibody

Chronic lymphocytic leukemia

The Oncologic Advisory Committee voted 14-to-1 to recommend accelerated approval of Campath (12/15)

OSI Pharmaceuticals Inc. (OSIP)

Unnamed compound

Small molecule developed to block tumor-induced angiogenesis; orally active potent and selective inhibitor of the vascular endothelial growth factor receptor

Cancer

Company said Pfizer Inc. has opened an IND for Phase I trials in the U.S. (12/20)

Praecis Pharmaceuticals Inc. (PRCS) and Amgen Inc. (AMGN)

Abarelix depot-M

Gonadotropin-releasing hormone antagonist

Prostate cancer

Companies sumbitted an NDA (12/13)

Scotia Pharmaceuticals plc (UK; LSE:SOH)

Foscan

Photodynamic therapy

Head and neck cancer

FDA is allowing the company to submit an amended NDA including 83 additional patients studied (12/6**)

CARDIOVASCULAR

Texas Biotechnology Corp. (AMEX:TXB) and SmithKline Beecham plc (NYSE:SBH)

Argatroban

Anticoagulant; synthetic direct thrombin inhibitor that blocks the activity of thrombin

Heparin-induced thrombocytopenia

Companies submitted a supplemental NDA to expand the use of Argatroban (12/21)

The Medicines Co. (MDCO)

Angiomax

Bivalirudin; a thrombin-specific anticoagulant

Unstable angina

FDA approved the marketing of Angiomax for unstable angina in patients undergoing percutaneous transluminal coronary angioplasty (12/18)

United Therapeutics Corp. (UTHR)

UT-15 or Uniprost

Analogue of prostacyclin

Pulmonary arterial hypertension

FDA decided UT-15 does not need to be presented to the Cardiovascular and Renal Drugs Advisory Committee (12/14)

CENTRAL NERVOUS SYSTEM

Amarin Corp. plc (UK; AMRN)

LAX-101

Investigational compound to treat Huntington's disease

Huntington's disease

FDA cleared the IND, allowing a pivotal Phase III study to begin; it will enroll over 100 patients in the U.S., Canada and the UK (12/11)

Celgene Corp. (CELG)

d-MPH

d-methylphenidate; chirally pure version of Ritalin

Attention deficit disorder and attention deficit hyperactivity disorder

FDA accepted for filing the NDA (12/27)

Orphan Medical Inc. (ORPH)

Xyrem

Sodium oxybate oral solution

Narcolepsy

FDA accepted the NDA for filing (12/4)

Praecis Pharmaceuticals Inc. (PRCS)

Apan

A drug developed with LEAP technology

Alzheimer's disease

Company submitted an IND application to initiate Phase I trials (12/29)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Symlin

Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin

Type I and Type II diabetes

Company submitted an NDA to market Symlin as an adjunctive therapy to insulin (12/7)

INFECTION

Aviron (AVIR)

FluMist

Intranasal vaccine

Influenza

FDA accepted for review the BLA (12/29)

Gliead Sciences Inc. (GILD) and F. Hoffmann-La Roche Inc.

Tamiflu (FDA-approved)

Oseltamivir phosphate

Acute illness due to influenza

FDA granted marketing approval of Tamiflu in a liquid suspension for children ages 1 to 12 (12/14)

ICN Pharmaceuticals Inc. (NYSE:ICN) and Schering-Plough Corp. (NYSE:SGP)

Rebetol (FDA-approved)

Oral formulation of ribavirin

Hepatitis C

Schering-Plough submitted a supplemental NDA to the FDA seeking approval to market Rebetol separately and used in combination with Intron A injection (12/15)

MISCELLANEOUS

Genzyme General (GENZ)

Fabrazyme

Agalsidase beta; enzyme replacement therapy

Fabry disease

FDA completed its review of the BLA and requested additional data (12/26)

Gliatech Inc. (GLIA)

Adcon-L; Adcon-P

Gel to inhibit postsurgical scarring

Postsurgical scarring

FDA sent the company a letter questioning its methods of recording and presenting clinical trial data; it suspended review of three pre-market approval applications-two Adcon-L supplemental applications and the modular submission for Adcon-P (12/23)

Sepracor Inc. (SEPR) and Schering-Plough Corp. (NYSE:SGP)

Desloratadine

Antihistamine, nonsedating disintegrating tablet

Seasonal allergic rhinitis and chronic idiopathic urticaria

Schering-Plough submitted NDAs for two formulations of desloratadine (12/13)

Notes:

* Privately held **Denotes the date item ran in BioWorld International

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

AMEX = American Stock Exchange; CDNX = Canadian Venture Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange

BLA = Biologics License Application; NDA = New Drug Application

ND = Not disclosed

ASH = American Society of Hematology meeting