Company* |
Product | Description |
Indication | Status |
CANCER | ||||
Ariad |
AP23573 |
Small molecule designed to inhibit cell-signaling protein mTOR |
Bone and soft-tissue sarcomas |
The FDA granted fast-track designation to the product, which is in Phase II trials (4/20) |
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BioAlliance |
Doxorubicin Transdrug |
Polymer formulated as a nanoparticle used to deliver the cancer drug |
Hepatocellular carcinoma |
The FDA granted orphan designation to the product in that indication, for which Phase I/II trials are ongoing (4/25) |
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Celgene |
Revlimid |
Lenalidomide; derivative of Thalomid (thalidomide) |
Myelodysplastic syndromes |
Completed rolling NDA submission seeking approval as treatment for transfusion-dependent MDS patients with a 5q-deletion chromosomal abnormality (4/7) |
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EntreMed |
Panzem |
2-methoxyestradiol; naturally occurring metabolite of endogenous estrogen |
Ovarian cancer |
The FDA granted orphan status to the drug in that indication, for which a Phase I trial has been completed (4/14) |
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PharmaMar |
Yondelis |
Trabectedin; ET-743; derived from the sea squirt Ecteinascidia turbinata |
Ovarian cancer |
The FDA granted orphan designation to the drug, which is partnered with Johnson & Johnson (4/7) |
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CARDIOVASCULAR | ||||
Cangene |
WinRho SDF (FDA-approved) |
Antibody to certain types of red blood cells |
Immune thrombocytopenic purpura |
The FDA approved the liquid formulation of the product, which is marketed by Baxter (4/11) |
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CENTRAL NERVOUS SYSTEM | ||||
Alkermes Inc. |
Vivitrex |
Long-acting, injectable form of naltrexone |
Alcohol dependence |
Submitted NDA to the FDA seeking approval of the product (4/1) |
| ||||
Neurocrine |
Indiplon |
Capsule formulation of a non-benzodiazepine agent that targets the GABA-A receptor |
Insomnia |
Company resubmitted NDA to address formatting difficulties from the initial filing in late 2004 (4/15) |
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Prestwick |
Tetrabenazine |
Dopamine depletor that works by selectively blocking the VMAT2 transporter |
Chorea associated with Huntington's disease |
Filed NDA with the FDA; the drug is approved in Europe, Canada and Australia, and has orphan designation in the U.S. (4/26) |
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DIABETES | ||||
Amylin |
Byetta |
Exenatide; Incretin mimetic |
Type II diabetes |
The FDA approved the drug as an adjunctive therapy to improve blood sugar control in patients not achieving adequate control on metformin and/or a sulfony- lurea (4/29) |
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INFECTION | ||||
Gilead |
Tamiflu (FDA-approved) |
Oseltamivir; an oral neuraminidase inhibitor |
Influenza |
Partner Hoffmann-La Roche Inc. filed a supplemental NDA seeking to extend the prophylaxis indication to include children ages 1 through 12 (4/18) |
| ||||
MISCELLANEOUS | ||||
Adolor Corp. |
Entereg |
Alvimopan capsules; mu opioid antagonist |
Post-operative ileus |
The FDA extended the target action date from April 25 to July 25, 2005, on the NDA, which was filed in June (4/19) |
| ||||
Critical |
Zyflo Filmtab (FDA-approved) |
Zileuton tablets; 5-lipoxygenase inhibitor |
Asthma |
Filed supplemental NDA seeking approval of new manufacturing process (4/1) |
| ||||
Halozyme |
Cumulase |
Ex vivo formulation of recombinant human PH20 hyaluronidase |
Treatment of oocytes |
Received 510(k) clearance from the FDA for treating oocytes to facilitate certain in vitro fertilization procedures (4/19) |
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Halozyme |
Enhanze SC |
Formulation of recombinant human hyaluronidase |
For use as a spreading agent |
The FDA granted priority review to the NDA, which was filed in March (4/6) |
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Insmed Inc. |
SomatoKine |
Composition of insulin-like growth factor-1 and its primary binding protein, BP3 |
Growth hormone insensitivity syndrome |
The FDA granted priority review to the NDA, which was filed in January; the user-fee goal date is July 3 (4/13) |
| ||||
Ortec |
OrCel |
Collagen sponge seeded with allogeneic epidermal and dermal cells |
Venous ulcers |
The FDA requested a confirmatory trial to demonstrate safety and effectiveness (4/29) |
| ||||
Protein Design |
Terlipressin |
Peptide derived from the natural hormone lysine- vasopressin |
Type 1 hepatorenal syndrome |
The FDA granted fast-track designation to the product; Phase III trials are ongoing in the condition, which entails renal failure (4/20) |
| ||||
Santarus Inc. |
Zegerid |
Immediate-release capsule formulation of the proton pump inhibitor omeprazole |
Gastrointestinal conditions |
Submitted NDA to the FDA seeking approval for treating heartburn and symptoms of other conditions (4/28) |
| ||||
Sucampo |
Lubiprostone |
Agent that activates specific chloride channels on cells lining the small intestine |
Chronic idiopathic constipation |
Filed NDA with the FDA seeking approval to treat CIC and associated symptoms (4/1) |
| | ||||
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; TSE = Toronto Stock Exchange. | ||||
