FDA Submissions, Approvals And Other Actions: December 2006
Company* (Country; Symbol) | Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
Elan Corp. plc (Ireland; NYSE:ELN) and Biogen Idec Inc. (BIIB) | Tysabri (FDA-approved) | Natalizumab; humanized monoclonal antibody that inhibits adhesion molecules on immune cells | Crohn's disease | Elan and Biogen Idec submitted a supplemental BLA (12/15) |
NicOx SA (France; Eurolist:NICOX) | HCT 3012 | Naproxcinod; nitric oxide-donating derivative of naproxen | Osteoarthritis | FDA said a large cardiovascular outcomes study would not be required for NDA submission (12/11) |
Nuvo Research Inc. (Canada; TSX:NRI) | Pennsaid | 1.5% w/w diclofenac sodium solution; topical nonsteroidal antiinflammatory drug | Osteoarthritis of the knee | FDA issued an approvable letter (12/29) |
| CANCER | ||||
Access Pharmaceuticals Inc. (AMEX:AKC) | MuGard | Oral rinse | Oral mucositis in cancer patients | FDA approved MuGard (12/13) |
Adventrx Pharmaceuticals Inc. (AMEX:ANX) | ANX-530 | Vinorelbine emulsion | Cancer | FDA accepted an IND and the company plans to start recruitment of 28 patients for a Phase I trial (12/26) |
Biomira Inc. (Canada; BIOM; TSX:BRA) | Stimuvax | Liposomal vaccine encapsulating a sequence of the MUC1 cancer mucin | Non-small-cell lung cancer | Reached an agreement with the FDA on an SPA for a Phase III trial with about 1,300 patients (12/12) |
Cyclacel Pharmaceuticals Inc. (CYCC) | CYC116 | Orally available inhibitor of aurora kinases A and B and VEGFR2 | Cancer | Submitted an IND to begin clinical trials (12/13) |
Exelixis Inc. (EXEL) | XL518 | A specific inhibitor of MEK | Cancer | Company submitted an IND to the FDA (12/21) |
Genta Inc. (GNTA) | Genasense | Chemotherapy booster | Chronic lymphocytic leukemia | FDA declared the product non-approvable (12/15) |
Hana Biosciences Inc. (HNAB) | Marqibo | Vincristine sulfate liposomes injection | Acute lympho-blastic leukemia | Hana filed a request for an SPA with the FDA for the design of a proposed registration trial (12/21) |
IDM Pharma Inc. (IDMI) | Junovan | Mifamurtide for injection | Resectable high-grade osteosarcoma | FDA accepted for review the NDA (12/26) |
Medarex Inc. (MEDX) | MDX-010 | Ipilimumab; a fully human antibody against CTLA-4, a molecule on T cells | Metastatic melanoma | FDA granted fast-track designation for MDX-010 used in combination with chemotherapy in untreated patients and as a monotherapy in second-line patients (12/7) |
Millennium Pharmaceuticals Inc. (MLNM) | Velcade (FDA-approved) | Bortezomib; proteasome inhibitor | Mantle cell lymphoma | FDA granted full approval of Velcade to treat patients who have received at least one prior therapy (12/8) |
Pharmacyclics Inc. (PCYC) | Xcytrin | Motexafin gadolinium; inhibits the enzyme thioredoxin reductase | Non-small-cell lung cancer metastasized to the brain | Company submitted its NDA based on pooled data from two Phase III trials (12/22) |
| CARDIOVASCULAR | ||||
Biopure Corp. (BPUR) | Hemopure | Hemoglobin glutamer-250 (bovine) | Hemorrhagic shock resulting from traumatic injury | FDA committee voted against the U.S. Navy's proposed Phase II/III 10,100-patient study, suggesting a pre-hospital Phase II/IIb study be designed in a smaller patient population (12/15) |
Cardiome Pharma Corp. (Canada; CRME; TSX:COM) and Astellas Pharma U.S. Inc. (PK:ALPMF) | Vernakalant hydrochloride | Intravenous formulation | For the acute conversion of atrial fibrillation | Resubmitted the NDA (12/19) |
Encysive Pharmaceuticals Inc. (ENCY) | Thelin | Sitaxsentan sodium | Pulmonary arterial hypertension | FDA informed the company that its response to the July 24 approvable letter is not complete (12/14); FDA accepted for review the company's complete response and issued a new PDUFA date of June 15 (12/29) |
Medicure Inc. (Canada; AMEX:MCU; TSX:MPH) | MC-1 | Naturally occurring small molecule that protects cardiomyocytes | Coronary artery bypass surgery | Completed an SPA with the FDA for the Phase III study, which will include about 3,000 patients (12/12) |
ZymoGenetics Inc. (ZGEN) | RhThrombin | Recombinant human thrombin | To control bleeding during surgery | Company submitted a BLA to the FDA (12/18) |
| CENTRAL NERVOUS SYSTEM | ||||
Labopharm Inc. (Canada; TSX:DDS) | Tramadol | Once-daily, controlled-release analgesic | Pain | Company submitted a complete response to the approvable letter (12/20) |
Memory Pharmaceuticals Corp. (MEMY) | MEM 3454 | Nicotinic alpha 7 receptor partial agonist | Alzheimer's disease | FDA completed its review of the IND and released the clinical hold; the Phase IIa trial will start in the first quarter of 2007 (12/11) |
New River Pharmaceuticals Inc. (NRPH) and Shire plc (UK) | Vyvanse | Lisdexamfetamine dimesylate (formerly NRP104) | Attention deficit hyperactivity disorder | FDA issued a second approvable letter; it did not request any additional studies (12/22) |
Pozen Inc. (POZN) | Trexima | Drug combines sumatriptan with naproxen sodium in a single tablet | Migraine | FDA completed its initial review of the company's response to the June 8 approvable letter and requested additional analyses and supporting information relating to the data submitted (12/13) |
DIABETES | ||||
Amylin Pharmaceuticals Inc. (AMLN) | Byetta (FDA-approved) | Exenatide; incretin mimetic | Type II diabetes | Received FDA approval to broaden the use in diabetics who are using a thiazolidinedione alone or in combination with metformin but have not achieved adequate glycemic control (12/22) |
INFECTION | ||||
ISTA Pharmaceuticals Inc. (ISTA) | Bepotastine | Eye-drop formulation | Allergic conjunctivitis | Company filed an IND with the FDA to start a Phase II/III trial in the first quarter (12/21) |
Neurorecovery Inc.* | Ampydin | 4-Aminopyridine; immediate release version | Guillain-Barre syndrome | Received orphan drug status for chronic functional motor and sensory deficits resulting from Guillain-Barre syndrome (12/20) |
Panacos Pharmaceuticals Inc. (PANC) | PA-1050040 | Second-generation HIV maturation inhibitor | HIV | Company filed an IND with the FDA and plans to begin Phase I trials in the first quarter (12/22) |
SIGA Technologies Inc. (SIGA) | SIGA-246 | Orally active antiviral agent | Smallpox | Received orphan drug designation (12/20) |
Theravance Inc. (THRX) | Telavancin | A bactericidal injectable antibiotic; lipoglycopeptide | Skin and skin structure infections caused by Gram-positive bacteria | Filed for FDA approval (12/8) |
Trillium Therapeutics Inc.* | TTI-1612 | Small, orally available receombinatn protein | Necrotizing enterocolitis | FDA and the European Medicines Agency designated TTI-1612 an orphan drug (12/19) |
VaxGen Inc. (PK:VXGN) | rPA102 | Recombinant anthrax vaccine | Anthrax | FDA's Center for Biologics Evaluation and Research maintained a clinical hold on the second Phase II trial due to concerns about the vaccine's stability (12/18) |
MISCELLANEOUS | ||||
BioSante Pharmaceuticals Inc. (AMEX:BPA) | Bio-E-Gel (Elestrin) | Estradiol; topical estrogen | To treat hot flashes | FDA approved the product to treat moderate-to-severe vasomotor symptoms associated with menopause (12/18) |
Genzyme Corp. (GENZ) | Renvela | Sevelamer carbonate; an improved formulation of Renagel (sevelamer hydrochloride) | Chronic kidney disease | Company filed an NDA with the FDA for the control of serum phosphorus levels in chronic kidney disease patients on dialysis (12/21) |
ICo Therapeutics Inc.* (Canada) | iCo-007 | An antisense drug that inhibits c-Raf | Eye disease | Company submitted an IND with the FDA (12/21) |
Indevus Pharmaceuticals Inc. (IDEV) | Sanctura XR | Trospium chloride; a once-daily formulation | Overactive bladder | FDA accepted for review its NDA (12/13) |
Vivus Inc. (VVUS) | EvaMist | A once-a-day transdermal spray that delivers estradiol | Vasomotor symptoms associated with menopause | FDA accepted for review the NDA (12/12) |
Notes: | ||||
* Privately held. | ||||
BLA = Biologics license application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; 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; PK = Pink Sheets; TSX = Toronto Stock Exchange | ||||