Company* (Symbol)

Product

Description

Indication

Status (Date)

CANCER

Akorn Inc. (AKRN)

AK-1003

Photodynamic drug targeted to large feeder vessels

Age-related macular degeneration

Submitted IND (6/30)

Ligand Pharmaceuticals Inc. (LGND)

Targretin Gel

Bexarotene 1%; topical therapy based on synthetic retinoid that selectively activates retinoid X receptors

Cutaneous lesions in patients with early-stage cutaneous T-cell lymphoma

Received approvable letter (6/12); cleared for marketing (6/29)

Millennium & Ilex Partners LP (joint venture of Millennium Pharmaceuticals Inc. [MLNM] and Ilex Oncology Inc. [ILXO]) and Schering AG (Germany)

Campath

Alemtuzumab; humanized monoclonal antibody that specifically targets and binds to CD52 cell surface antigen on lymphocytes

B-cell lymphocytic leukemia

Received a complete response letter for BLA delineating deficiencies; companies plan to respond rapidly (6/26)

CARDIOVASCULAR

Aventis Behring LLC (unit of Aventis SA [France; NYSE:AVE])

Helixate FS

Recombinant, non-plasma-derived factor VIII product

Hemophilia A

Cleared for marketing (6/29)

Bayer Corp. (unit of Bayer AG; Germany)

Kogenate FS Antihemo-philiac Factor

Recombinant factor VIII formulated with sucrose

Hemophilia A

Cleared for marketing (6/28)

Genentech Inc. (NYSE:DNA)

TNKase

Tenecteplase; second-generation, single-bolus recombinant plasminogen activator with greater specificity to fibrin than Genentech's first-generation tissue-plasminogen activator (Activase)

Acute myocardial infarction

Cleared for marketing (6/2)

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

(Formerly Novastan)

Argatroban; synthetic small molecule derived from arginine; acts as a direct inhibitor of thrombin

Prevention or treatment of thrombosis associated with heparin-induced thrombocytopenia

Cleared for marketing (6/30)

CENTRAL NERVOUS SYSTEM

Cima Labs Inc. (CIMA) and AstraZeneca plc (UK; NYSE: AZN)

­

Fast-dissolving formulation of the Zomig (zolmitriptan) anti-migraine medication

Migraine

AstraZeneca filed NDA (6/5)

Elan Corp. plc (Ireland; NYSE:ELN)

Ziconotide

Intrathecally delivered N-type neuronal calcium channel blocker

Severe pain

Received approvable letter (6/28)

Ligand Pharmaceuticals Inc. (LGND) and Elan Corp. plc (Ireland; NYSE: ELN)

Morphelan

Once-daily, modified-release, oral dosage form of morphine

Management of pain in oncology and HIV patients

Elan filed NDA for the product, to be marketed by Ligand (6/8)

Novartis Pharmaceuticals Corp. (unit of: Novartis AG [Switzerland; NYSE: NVS])

Zelmac

Tegaserod; targets 5-H4 serotonin receptors in the gastrointestinal tract

Abdominal pain or discomfort and constipation in women with irritable bowel syndrome

FDA's Gastrointestinal Drugs Advisory Committee recommended approval (6/26)

INFECTION

Abbott Laboratories (NYSE:ABT)

ABT-378/r

Lopinavir/ritonavir; HIV protease inhibitor

HIV infection and AIDS

Submitted NDA based on ongoing Phase II/III trials (6/1)

Access Pharmaceuticals Inc. (AMEX:AKC)

OraDisc

Polymer disc formulation of amlexanox that adheres to the disease site and slowly erodes, releasing the drug

Canker sores

FDA cleared Phase III trial following successful initial irritation study (6/26)

Avanir Pharmaceuticals (AMEX:AVN)

­

Docosonal 10% cream

Oral-facial herpes (cold sores)

Received approvable letter for over-the-counter product (6/1)

Gilead Sciences Inc. (GILD) and Hoffmann-La Roche Inc. (Switzerland)

Tamiflu (FDA-approved)

Oseltamivir phosphate; oral neuraminidase inhibitor

Acute illness due to influenza in children 1 year old and older

Submitted application for new indication (6/16)

Hemispherx Biophamra Inc. (AMEX:HEB)

Ampligen

Double-stranded synthetic RNA compound poly I: poly C12U

HIV patients with multidrug resistance

Received FDA approval to conduct Phase II/III trial (6/26)

Palatin Technologies Inc. (AMEX: PTN) and Mallinckrodt Inc. (NYSE:MKG)

LeuTech

Antibody-based infection imaging agent

Diagnosis of equivocal appendicitis

FDA scheduled advisory panel meeting for 7/10 (6/5)

Shearwater Polymers Inc.* and F. Hoffmann-La Roche Ltd. (Switzerland)

Pegasys

Peginterferon alfa-2a; once-weekly injection of pegylated version of interferon alfa-2a

Chronic hepatitis C in non-cirrhotic and cirrhotic patients with compensated liver disease

Filed NDA (6/5)

MISCELLANEOUS

Bioject Medical Technologies Inc. (BJCT)

Cool.click

Needle-free device that delivers Saizen (recombinant pediatric growth hormone) through the skin in a fine mist in less than a second

Treatment of growth hormone deficiency in children

Cleared for marketing (6/26)

Genentech Inc., Tanox Inc. (TNOX) and Novartis Pharmaceuticals Corp. (unit of Novartis AG [Switzerland; NYSE:NVS])

­

Recombinant humanized monoclonal antibody to immunoglobulin E

Asthma and allergy

Submitted BLA (6/5)

Genzyme General (GENZ)

Fabrazyme

Agalsidase beta; enzyme replacement therapy

Fabry disease

Filed BLA (6/23)

Immunex Corp. (IMNX) and American Home Products Corp. (NYSE:AHP)

Enbrel (FDA-approved)

Etanercept; recombinant, soluble T75 tumor necrosis factor receptor (TNFr) linked to the Fc portion of human IgGi

Reduction of signs and symptoms and delay of structural damage in patients with moderately to severely active rheumatoid arthritis

Label expanded to include new indication (6/6)

Interneuron Pharmaceuticals Inc. (IPIC) and Madaus AG (Germany)

­

Trospium chloride

Urinary incontinence

After meeting with the FDA to discuss existing European efficacy and safety data, Interneuron said it plans to initiate clinical trials later this year (6/6)

Lifecore Biomedical Inc. (LCBM)

Intergel Adhesion Prevention Solution

Combines hyaluranon and iron to create ferric hyaluranon

Reduction of post-surgical adhesion formation after certain pelvic abdominal procedures

Filed amendment to PMA in response to decision of General and Plastic Surgery Advisory Panel's decision not to recommend approval (6/5)

Millennium Pharmaceuticals Inc. (MLNM) and Genentech Inc. (DNA)

LDP-02

Humanized monoclonal antibody against alpha-4 beta-7, an integrin on inflammatory cells that causes the cells to adhere to the gastrointestinal tract

Ulcerative colitis

Submitted IND to begin Phase II trials (6/12)

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

Liquid Norditropin

Premixed liquid formulation of recombinant somatropin and pen device for delivery

Growth hormone deficiency in children

Cleared for marketing (6/21)

Organogenesis Inc. (AMEX:ORG) and Novartis Pharmaceuticals Corp. (unit of Novartis AG [Switzerland; NYSE:NVS])

Apligraf (FDA-approved)

Living human skin equivalent, composed of living human keratinocytes and fibroblasts

Diabetic foot ulcers

FDA approved additional indication (6/20)

Oxford GlycoSciences plc (UK; LSE:OGS)

OGT 918

Oral capsule formulation of a glucosyltransferase inhibitor

Gaucher disease

Granted fast-track status (6/20)

Serono Inc. (Switzerland; SWX:SEO)

Gonal-F (FDA-approved)

Follitropin alfa for injection; recombinant follicle-stimulating hormone

Female infertility

New dosage approved (6/5)

Serono Inc. (Switzerland; SWX:SEO)

Gonal-F (FDA-approved)

Follitropin alfa for injection; recombinant follicle-stimulating hormone

Male infertility

New indication approved (6/2)

Transkaryotic Therapies Inc. (TKTX)

Replagel

Agalsidase alfa; enzyme

Fabry disease replacement therapy

Submitted BLA (6/16)

Notes:

* Privately held.

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

AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over the Counter Bulletin Board; SBI=Stockholm Borsinformation; SSE = Swedish Stock Exchange; TSE = Toronto Stock Exchange

ND = Not disclosed.

BLA = Biologics License Application

IND = Investigational New Drug Application

NDA = New Drug Application

PMA = Pre-market Approval Application

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