Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

La Jolla Pharmaceutical Co. (LJPC)

Riquent

B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA

Lupus

La Jolla submitted an NDA seeking approval in treatment of patients with lupus who are at risk of renal disease (12/16)

CANCER

Allos Therapeutics Inc. (ALTH)

RSR13

Efaproxiral; small-molecule radiation sensitizer

Brain metastases from breast cancer

Allos submitted the final component of its NDA to market the drug as an adjunct to whole-brain radiation therapy (12/4)

AmpliMed Corp.*

Amplimexon

Imexon injection

Pancreatic cancer

FDA granted the product orphan designation in that indication (12/4)

Genentech Inc. (NYSE:DNA)

Avastin

Antibody designed to inhibit VEGF

First-line metastatic colorectal cancer

The FDA accepted the Avastin BLA for filing; it is under priority review, with action expected by the end of March 2004 (12/1)

Genta Inc. (GNTA)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced malignant melanoma

Genta completed its NDA submission of drug in combination with dacarbazine (12/9)

Inex Pharmaceuticals Corp. (Canada; TSE:IEX)

Onco TCS

Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology

Relapsed, aggresive non-Hodgkin's lymphoma

Inex submitted the chemistry, manufacturing and control section of an NDA to the FDA; the complete filing is expected in 1Q:04 (12/2)

Millennium Pharmaceuticals Inc. (MLNM)

MLN2704

Monoclonal antibody directed at prostate-specific antigen conjugated to chemotherapeutic agent DM1

Metastatic androgen- independent prostate cancer

FDA granted fast-track status to the product (12/4)

Pharmacyclics Inc. (PCYC)

Xcytrin

Motexafin gadolinium; small molecule from the texaphyrin class

Brain metastases from non-small-cell lung cancer

The FDA granted fast-track status to Xcytrin (12/2)

Telik Inc. (TELK)

Telcyta

Small-molecule pro-drug

Third-line therapy for metastatic non-small-cell lung cancer

FDA granted Telcyta fast-track status (12/2)

CARDIOVASCULAR

Alexion Pharmaceuticals Inc. (ALXN)

Eculizumab

A humanized monoclonal antibody C5 complement inhibitor

Paroxysmal nocturnal hemoglobinuria

The FDA designated the product orphan status in that indication (12/8)

CV Therapeutics Inc. (CVTX)

Ranexa

Ranolazine; partial inhibitor of fatty-acid oxidation

Angina

FDA briefing document before panel meeting pointed to safety concerns; panel members suggested the drug was approvable pending another trial in a broader patient population (12/9)

Miravant Medical Technologies Inc. (MRVT)

PhotoPoint MV2101

Photodynamic therapy

Hemodialysis access graft disease

The FDA granted orphan drug designation to the drug for preventing the disease in patients with new vascular grafts (12/18)

Pharmion Corp. (PHRM)

Vidaza

Azacitidine for injectable suspension; demethylating agent

Myelodysplastic syndromes

Pharmion submitted an NDA for the product, which has orphan and fast-track status (12/29)

DIABETES

Amylin Pharmaceuticals Inc. (AMLN)

Symlin

Pramlintide acetate; an analogue of human amylin

Types I and II diabetes

Amylin received a second approvable letter from the FDA that asked for additional data on patient populations and methods of use (12/17)

Insmed Inc. (INSM)

SomatoKine

Composition of insulin-like growth factor-1 and its primary binding protein, BP3

Extreme insulin resistance

The FDA granted orphan designation to the drug in that indication (12/15)

INFECTION

Acambis plc (UK; ACAM)

Arilivax

Live, attenuated vaccine to prevent yellow fever

Yellow fever

Acambis filed a BLA with the FDA seeking approval of the vaccine; the product, approved in 10 countries, is sold outside the U.S. by Chiron Corp. (12/12)

Stressgen Biotechnologies Corp. (Canada; TSE:SSB)

HspE7

Heat-shock protein

Recurrent respiratory pappilomatosis

The FDA designated HspE7 a fast-track product (12/4)

Trimeris Inc. (TRMS) and Hoffmann-La Roche Inc.

Fuzeon (FDA-approved)

Enfuvirtide; HIV fusion inhibitor

HIV

Companies submitted 48-week data to FDA to support application for full approval; drug has accelerated approval (12/16)

MISCELLANEOUS

Altus Biologics Inc.*

TheraCLEC

Oral enzyme-replacement therapy

Malabsorption due to exocrine pancreatic insufficiency

The FDA designated TheraCLEC a fast-track product (12/1)

Anika Therapeutics Inc. (ANIK)

Orthovisc

High-molecular-weight form of hyaluronic acid

Osteoarthritis of the knee

The FDA issued an approvable letter on the premarket approval application, pending inspection of the manufacturing facility (12/2)

Cardiome Pharma Corp. (Canada; TSE:COM)

Oxyprim (oxypurinol)

Xanthine oxidase inhibitor that is the active metabolite of allopurinol

Gout

Cardiome submitted an NDA seeking approval for treating allopurinol-intolerant hyperuricemia (gout); drug has orphan status (12/23)

Dyax Corp. (DYAX) and Debiopharm SA* (Switzerland)

DX-890

Protein inhibitor of human neutrophil elastase

Cystic fibrosis

FDA granted orphan designation to the drug for CF (12/15)

Inspire Pharmaceuticals Inc. (ISPH)

Diquafosol tetrasodium

Ophthalmic solution

Dry eye

FDA sent approvable letter asking for an additional clinical study; Inspire plans to ask if study completed after NDA filing would be sufficient (12/22)

Nastech Pharmaceutical Co. Inc. (NSTK) and Questcor Pharmaceuticals Inc.

Nascobal

Nasally delivered formulation of cyanocobalamin

Vitamin B-12 deficiency

Companies filed NDA seeking approval of new formulation; Nastech developed the product and Questcor owns worldwide rights (12/30)

Ortec International Inc. (OTC BB:ORTN)

OrCel

Collagen sponge seeded with allogeneic epidermal and dermal cells

Venous leg ulcers

Ortec submitted the first of two modules of its premarket approval application; the filing was scheduled to be completed by the end of January 2004 (12/23)

Serono SA (Switzerland; NYSE:SRA)

Zorbtive (FDA-approved)

Somatropin for injection; also named Serostim

Short bowel syndrome

The FDA approved the recombinant human growth hormone (12/2)


Notes:

* Privately held

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

ASX = Australian Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange.

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