Company*
(Country; Symbol)
Product Description Indication Status (Date)
AUTOIMMUNE
Biogen Idec (BIIB) and Elan Corp. plc (Ireland; NYSE:ELN) Tysabri Natalizumab Crohn's disease FDA approved Tysabri for moderate to severe Crohn's disease (1/14)
DOR BioPharma Inc. (DORB) BDP Beclomethasone dipropionate Pediatric Crohn's disease Granted orphan drug designation (1/3)
ZymoGenetics Inc. (ZGEN) and Merck Serono (affiliate of Merck KGaA; Germany) Atacicept Antagonist protein that binds to the TNF cytokines BLyS and APRIL Systemic lupus erythematosus Received an SPA for a Phase II/III trial (1/15)
CANCER
BioDelivery Sciences International Inc. (BDSI) BEMA Fentanyl A dissolvable polymer formulation of the opioid narcotin fentanyl Breakthrough cancer pain FDA accepted for filing its NDA (1/10)
Celsion Corp. (AMEX:CLN) ThermoDox A liposomal encapsulation of doxorubicin Liver cancer Reached an agreement with the FDA on an SPA for a Phase III trial (1/18)
Marshall Edwards Inc. (MSHL) Triphendiol (formerly NV-196) A second-generation form of phenoxodiol Pancreatic cancer and cholangio-carcinoma FDA granted orphan drug status (1/22)
MGI Pharma Inc. (MOGN) and Helsinn Healthcare SA (Switzerland) Aloxi (FDA-approved) Palonosetron hydrochloride Nausea and vomiting associated with chemo-therapy Accepted the sNDA for oral capsules (1/3)
Synta Pharmaceuticals Corp. (SNTA) and GlaxoSmithKline plc (UK) Elesclomol Small molecule, oxidative stress inducer Melanoma FDA granted orphan drug designation (1/28)
TransMolecular Inc.* TM601 Nonradiolabeled version Malignant glioma Granted orphan drug designation (1/7)
Vion Pharmaceuticals Inc. (VION) VNP40101M Cloretazine Relapsed acute myelogenous leukemia FDA lifted a clinical hold on the Phase III trial originally imposed because the advantage seen appeared to be compromised by the mortality observed in the study (1/8)
Xanthus Pharmaceuticals Inc.* Fludarabine phosphate Oral tablets B-cell chronic lymphocytic leukemia Granted orphan drug designation (1/3); FDA accepted for review the NDA (1/22)
CARDIOVASCULAR
Lev Pharmaceuticals Inc. (LEVP) Cinryze C1 inhibitor Hereditary angioedema FDA issued an approvable letter, asking for further information regarding chemistry, manufacturing and controls (1/31)
SkyePharma plc (UK; SKYE; LSE:SKP) and Sciele Pharma Inc. Sular A calcium channel blocking agent that uses the Geo-Matrix technology High blood pressure Approved all four new dosage strengths (1/3)
Speedel Holding Ltd. (Switzerland; PK:SPDHF) and Novartis AG (Switzerland) Tekturna HCT Aliskiren and hydrochloro-thiazide; single-tablet combination Hypertension FDA approved a second product containing SPP100 (1/22)
ZymoGenetics Inc. (ZGEN) Recothrom Thrombin Recombinant, plasma-free thrombin made from Chinese hamster ovary cells For use during surgery to control minor bleeding FDA approved it for use as a topical hemostat (1/17)
CENTRAL NERVOUS SYSTEM
Cephalon Inc. (CEPH) Fentora (FDA-approved) Fentanyl buccal tablet To manage breakthrough pain in opioid-tolerant patients FDA accepted the sNDA (1/25)
CytRx Corp. (CYTR) Arimoclomol Small-molecule designed to protect cells by activating molecular chaperone proteins Amyotrophic lateral sclerosis FDA placed a clinical hold on the the Phase IIb trial for further analysis of data from previously completed animal toxicology studies (1/22)
Jazz Pharmaceuticals Inc. (JAZZ) JZP-8 An intranasal spray formulation incorporating clonazepam Recurrent acute repetitive seizures Received orphan drug designation (1/7)
MAP Pharmaceuticals (MAPP) MAP0004 An inhaled version of dihydroergotamine Migraine Reached an SPA agreement with the FDA on two Phase III trials (1/16)
Medivation Inc. (MDVN) Dimebon Neuroprotectant agent that's been on the market in Russia since 1983 Alzheimer's disease FDA agreed to allow a previously completed Russian study to count as one of two pivotal studies required to gain approval (1/28)
NovaDel Pharma Inc. (AMEX:NVD) ZolpiMist Zolpidem tartrate oral spray Insomnia FDA accepted for filing its NDA (1/23)
Somaxon Pharmaceuticals Inc. (SOMX) Silenor Doxepin hydrochloride Insomnia Submitted an NDA (1/31)
YM Biosciences Inc. (Canada; AMEX:YMI) AeroLEF An inhaled-delivery composition of free and liposome-encapsulated fentanyl Acute pain FDA placed a clinical hold on a Phase II trial, asking for additional safety information on patients from earlier studies who appeared to experience oxygen desaturation (1/17)
DIABETES
Depomed Inc.

(DEPO)

 Glumetza

(FDA-

approved)		 Metformin hydrochloride

extended-release tablets

 Type II diabetes Received approval from the FDA

for the 1,000-mg tablet (1/2)
Takeda Pharmaceutical Co. Ltd. (Japan; FSE:TKD) Alogliptin An oral, once-daily selective dipeptidyl peptidase-4 inhibitor Type II diabetes Submitted an NDA (1/4)
INFECTION
MiddleBrook Pharmaceuticals Inc. (MBRK) Moxatarg Once-daily, extended-release amoxicillin tablet Pharyngitis or tonsillitis secondary to Streptococcus pyogenes FDA approved Moxatarg (1/24)
Tibotec Therapeutics* (division of Ortho Biotech Products LP, a unit of Johnson & Johnson) Intelence Etravirine tablets; a non-nucleoside reverse transcriptase inhibitor HIV infection FDA approved Intelence for HIV patients who have failed treatment with other antiretrovirals (1/22)
Vertex Pharmaceuticals Inc. (VRTX) Telaprevir Protease inhibitor Treatment-naive hepatitis C virus FDA requested an additional 48-week Phase III trial before the company can submit a regulatory filing (1/23)
MISCELLANEOUS
Adolor Corp. (ADLR) Entereg Alvimopan Postoperative ileus FDA committee recommended approval (1/23)
BioSante Pharmaceuticals Inc. (BPAX) LibiGel Transdermal testosterone gel Female sexual dysfunction FDA agreed to an SPA for a Phase III program (1/29)
Cangene Corp. (Canada; TSX:CNJ) Accretropin Somatropin (rDNA origin) injection, a recombinant human growth hormone Growth failure or short stature associated with Turner syndrome FDA approved Accretropin injection (1/24)
Hemispherx Biopharma Inc. (AMEX:HEB) Ampligen A double-stranded RNA toll-like receptor-3 agonist Chronic fatigue syndrome Responded to the FDA's question's regarding the NDA (1/9)
Indevus Pharmaceuticals Inc. (IDEV) Nebido Testosterone undecanoate; a long-acting injectable testosterone therapy Male hypo-gonadism Filed new data with the FDA regarding the existing NDA; it showed lower, more frequent doses were well tolerated and met their efficacy endpoints (1/22)
Ipsen SA (France; PARIS:IPN) Dysport Botulinum neurotoxin Typa A complex Cervical dystonia FDA accepted for review the BLA (1/31)
Ligand Pharmaceuticals Inc. (LGND) and Pfizer Inc. Fablyn Lasofoxifene tartrate tablets; a selective estrogen receptor modulator Osteoporosis in postmeno-pausal women Submitted an NDA (1/15)
MISCELLANEOUS
Luitpold Pharmaceuticals Inc. (subsidiary of Daiichi Sankyo Co.; Japan) Injectafer Ferric carboxymaltose Iron deficiency anemia in postpartum patients or those with heavy uterine bleeding FDA said a safety review raised significant safety concerns of a mortality risk associated with the drug; there were 10 deaths with Injectafer-treated patients compared with one death in control patients (1/31)
Nycomed* (Switzerland) Alvesco Ciclesonide Asthma Received FDA approval for prophylactic and maintenance treatment of asthma (1/16)
Ocera Therapeutics Inc.* AST-120 An oral agent known to adsorb bile acids and bacterial toxins and to mediate inflammation Pouchitis Granted orphan drug designation (1/7)
Omrix Bio-pharmaceutical Inc. (OMRI) and Ethicon Inc.* Evicel fibrin sealant (FDA-approved) A combination of human thrombin and a concentrate of human fibrinogen General surgery procedures FDA approved Evicel for general surgery (1/16)
Ovation Pharmaceuticals Inc.* Clobazam Adjunctive treatment; a 1,5 benzodiazepine with significant anticonvulsant properties Lennox-Gastaut syndrome Granted orphan drug designation (1/4)
Pipex Pharmaceuticals Inc. (AMEX:PP) Coprexa Tetrathiomolybdate Wilson's disease FDA refused to file the NDA (1/29)
TAP Pharmaceutical Products Inc.* TAK-390MR A proton pump inhibitor Erosive esophagitis and nonerosive reflux disease Submitted an NDA (1/4)
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; 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; FSE = Frankfurt Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; PK = Pink Sheets; TSX = Toronto Stock Exchange.