Company* (Symbol)




Status (Date)


Aphton Corp. (APHT)

GnRH pharmaccine

Immunogen, used in combination with the chemotherapeutic taxotere


prostate cancer

FDA allowed the initiation of a clinical trial (1/16)

Aronex Pharmaceuticals Inc. (ARNX)


Injectable liposomal formulation of all trans retinoic acid (tretinoin)

Acute promyelocytic leukemia

FDA denied approval of the NDA (1/8)

Dendreon Corp. (DNDN)


Designed to induce an immune response against tumor cells that show increased amounts of the protein antigen Her-2/neu

Breast, ovarian and colon cancer

Company received FDA clearance to begin clinical trials (1/9)

FeRx Inc.*


Doxorubicin released through Magnetic Target Carriers, microparticles, composed of elemental iron and activated carbon

Primary liver cancer

Company received orphan drug designation from the FDA (1/29)

ICN Pharmaceuticals Inc. (NYSE:ICN)



Chronic myelogenous leukemia

FDA granted orphan status (1/16)

IDEC Pharmaceuticals Corp. (IDPH)


Radioimmunotherapy; ibritumomab tiuxetan

Low-grade, follicular, CD20-positive transformed, relapsed or refractory, B-cell non-Hodgkin's lymphoma and Rituximab-refractory follicular NHL

FDA accepted the BLA for filing and granted priority review status (1/2)

Matrix Pharmaceuticals Inc. (MATX)

IntraDose Injectable Gel

Biodegradable gel containing cisplatin and epinephrine (intratumoral injection)

Head and neck cancer

Company completed its three-part NDA (1/8)

Maxim Pharmaceuticals Inc. (MAXM)

Ceplene (formerly Maxamine)

Histamine dihydrochloride; an adjuvant to interleukin-2

Advanced metastatic melanoma with liver metastases

FDA issued a nonapprovable letter saying the Phase III was not enough to support approval (1/19)

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

Abarelix depot

Gonadotropin-releasing hormone antagonist

Prostate cancer

FDA accepted and filed the NDA, granting it priority review (1/25)


Collateral Therapeutics Inc. (CLTX) and Schering AG (Germany)


Nonsurgical angiogenic gene therapy product

Stable exertional angina due to coronary artery disease

Schering submitted an application to the FDA for a pivotal Phase IIb/III study (1/10)

Scios Inc. (SCIO)


Nesiritide; a recombinant form of B-type natriuretic peptide, a naturally occurring hormone that aids healthy functioning of the heart

Congestive heart failure

Company filed an amendment to the NDA (1/10)


Centocor Inc.*

Remicade (FDA-approved)

Infliximab; chimeric monoclonal antibody to tumor necrosis factor alpha

Moderately to severely active rheumatoid arthritis

FDA granted marketing approval to Remicade in conjunction with methotrexate for inhibiting the progression of damage in patients (1/2)

Pozen Inc. (POZN)

MT 100

Combination of metoclo-pramide HC1 and naproxen sodium

Migraine headache

FDA requested additional carcinogenicity studies for MT 100, which is in Phase III testing, and despite Pozen's request for a complete waiver of any such studies (1/26)


Amylin Pharmaceuticals Inc. (AMLN)


Pramlinitide acetate; synthetic analogue of human pancreatic hormone amylin

Type I or Type II diabetes

FDA accepted the NDA for review (1/25)


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


Peginterferon alfa-2b; uses pegylation technology

Chronic hepatitis C

FDA granted marketing approval (1/22)


Curis Inc. (CRIS) and Stryker Corp. (NYSE:SYK)

OP-1 implant

Device combining genetically engineered bone morphogenic protein with resorbable collagen scaffold surgically implanted in bone fractures and defects

Nonunion fractures of the tibia

FDA issued a not-approvable letter and recommended that Stryker conduct a new study (1/30)

SkyePharma plc (UK; SKYE; LSE:SKP) and Sanofi-Synthelabo Inc. (France)

Xatral OD

Sustained-release once-daily formulation of alfuzosin 10 mg

Benign prostatic hyperplasia

Companies filed an NDA with the FDA (1/22)

Transkaryotic Therapies Inc. (TKTX)


Agalsidase alfa; enzyme replacement therapy

Fabry disease

FDA completed its review of the BLA and has requested additional data (1/3)


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

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BLA = Biologics License Application; NDA = New Drug Application