Company* |
Product | Description |
Indication | Status |
| | ||||
AUTOIMMUNE | ||||
La Jolla |
Riquent |
Abetimus sodium; B-cell toleragen; designed to reduce levels of antibodies to double-stranded DNA |
Lupus |
Received approvable letter from FDA saying additional trial would be needed to demonstrate efficacy (10/14) |
CANCER | ||||
Adventrx |
CoFactor |
Form of folic acid that is designed to enhance the antitumor effects of 5-FU |
Pancreatic cancer |
The FDA granted orphan status to the drug in that indication, for which Phase II trials are being planned (10/5) |
Celegene |
Thalomid (FDA-approved) |
Thalidomide |
Multiple myeloma |
The FDA said the supplemental NDA was approvable pending submission of data from the completed E1A100 trial (10/22) |
GenVec |
TNFerade |
Adenovector with TNF-alpha gene and a radiation-responsive promoter |
Various cancers |
The FDA requested trials be put on hold due to the potential increase in blood clots seen in a Phase II trial in esophageal cancer (10/7) |
Gloucester |
FK228 |
Depsipeptide; bicyclic peptide, histone deacetylase inhibitor |
Cutaneous T- cell lymphoma |
The FDA granted fast-track status to the product as monotherapy in relapsed or refractory patients (10/12) |
ILEX |
Campath (FDA-approved) |
Alemtuzumab; humanized monoclonal antibody that binds to CD52 on cell surfaces |
B-cell chronic lymphocytic leukemia |
The FDA approved a new single- dose vial that is three times more concentrated than the marketed Campath ampoule (10/18) |
Kosan |
17-AAG |
17-allylamino-17-demeth- oxygeldanamycin; analogue of the polyketide geldanamycin |
Multiple myeloma; chronic myelogenous leukemia |
The FDA granted orphan status to the drug in multiple myeloma (10/20); the FDA granted orphan status to the drug in CML (10/26) |
Medarex Inc. |
MDX-060 |
Fully human anti-CD30 antibody |
Hodgkin's disease |
The FDA granted orphan designation in that indication, in which it is in Phase II testing (10/6) |
Medarex Inc. |
MDX-010 and MDX-1379 |
Fully human anti-CTLA-4 antibody; gp100 melanoma peptide vaccine |
Metastatic melanoma |
The FDA granted fast-track status to the combination for previously treated, unresectable Stage III and IV metastatic disease (10/5) |
Onyx |
Sorafenib (BAY 43-9006) |
RAF kinase and VEGF inhibitor |
Renal-cell carcinoma |
The FDA granted orphan designation to the product in that indication, for which a Phase III trial is ongoing (10/27) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Soft-tissue sarcomas |
The FDA granted orphan status to the drug in that indication (10/7) |
PharmaMar |
Aplidin |
Antitumor agent derived from the marine tunicate Aplidium albicans |
Multiple myeloma |
The FDA granted orphan status to the drug in that indication (10/6) |
Regeneron |
VEGF Trap |
Intravenous product |
Undisclosed |
The FDA granted fast-track status to the product in an undisclosed niche cancer indication (10/28) |
Valera |
Vantas |
Implant that delivers histrelin, a synthetic agonist of LHRH, over one year |
Advanced prostate cancer |
The FDA approved the product for the palliative treatment of advanced disease (10/13) |
Vion |
Cloretazine |
Sulfonyl hydrazine DNA alkylating agent |
Acute myelogenous leukemia |
The FDA granted orphan designation to the product in AML, for which a Phase III trial is ongoing (10/26) |
CENTRAL NERVOUS SYSTEM | ||||
Celgene Corp. |
Focalin XR (FDA-approved) |
Dexmethylphenidate hydrochloride extended-release capsule; a form of Ritalin |
Attention deficit/ hyperactivity disorder |
The FDA accepted for review the NDA filed by Novartis Pharma AG for both adult and pediatric ADHD (10/25) |
Neurocrine |
Indiplon |
Immediate-release form of a non- enzodiazapine agent that targets the GABA-A receptor |
Insomnia |
The company filed an NDA with the FDA; a filing on the modified-release form of the drug was planned for November (10/19) |
INFECTION |
||||
Nabi Bio- |
StaphVAX |
Staphylococcus aureus polysaccharide conjugate vaccine |
S. aureus infections |
The FDA named the Phase III drug a fast-track product for preventing S. aureus infections in end-stage renal disease patients (10/13) |
Peninsula |
Doripenem (S-4661) |
Agent from the carbapenem class of beta-lactam antibiotics |
Nosocomial pneumonia |
The FDA granted fast-track designation to the product, which is in six Phase III trials (10/27) |
Trimeris Inc. |
Fuzeon (FDA-approved) |
Enfuvirtide; HIV fusion inhibitor |
HIV |
The FDA granted traditional approval to the product, which previously had been granted accelerated approval (10/15) |
MISCELLANEOUS | ||||
Cellegy |
Cellegesic |
Nitroglycerin ointment |
Pain from anal fissures |
The FDA granted priority review to the NDA, which was filed in June (10/14) |
Chiron Corp. |
Pulminiq |
Cyclosporine inhalation solution |
For use in patients getting lung transplants |
Filed NDA with the FDA seeking approval for increasing survival and preventing chronic rejection in allogeneic lung transplants, in combination with immunosuppressive therapy (10/14) |
Dyax Corp. |
DX-88 |
Recombinant small protein designed to inhibit human plasma kallikrein |
Hereditary angioedema |
The FDA granted fast-track status to the product in that indication (10/12); Dyax said the FDA will require additional clinical work, an action that delays the develop- ment time frame (10/22) |
Genaera |
Squalamine |
Anti-angiogenesis agent; vascular endothelial growth factor inhibitor |
Wet age-related macular degeneration |
The FDA granted fast-track status to the drug, which is in Phase II trials in that indication (10/4) |
Inamed Corp. |
Hylaform Plus |
Hylan-B gel; large-particle size hyaluronic acid-based dermal filler |
Facial wrinkles and folds |
The FDA approved the product for correcting moderate to severe facial wrinkles and folds (10/13) |
InfaCare |
Stanate |
Injectable agent designed to turns off the body's production of bilirubin |
Jaundice |
The FDA lifted a clinical hold that had been placed on clinical trials (10/28) |
ISTA |
Vitrase (FDA-approved) |
Ovine hyaluronidase formulation |
For use as a spreading agent |
The FDA extended from three years to five years (until May 2009) the product's market exclusivity for helping in the dispersion and absorption of other drugs (10/28) |
ISTA |
Istalol (FDA-approved) |
Liquid formulation of |
Glaucoma |
The FDA said Istalol is not bio-equivalent to other available timolol maleate solutions, which makes it ineligible for |
Serono SA |
Luveris |
Follitropin alfa for injection; recombinant human luteinizing hormone |
Infertility |
The FDA approved the product for use with Gonal-f to stimulate follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (10/15) |
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Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; 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; NYSE = New York Stock Exchange. | ||||
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