Company* (Country; Symbol) Product Description Indication Status (Date)
AUTOIMMUNE
Amgen Inc. (AMGN) Enbrel (FDA-approved) Etanercept Plaque psoriasis Phase III data showed that Enbrel significantly reduced the symptoms and signs in children and adolescents (1/17)
Genentech Inc. (NYSE: DNA) and Biogen Idec (BIIB) Rituxan (FDA-approved) Rituximab Rheumatoid arthritis Phase III met its primary endpoint of a significantly greater proportion of Rituxan-treated patients achieving an ACR20 response at week 24, compared to placebo (1/25)
CANCER
Agennix Inc.* Talactoferrin A recombinant form of human lactoferrin Non-small-cell lung cancer Started a pivotal Phase III (1/17)
Cell Genesys Inc. (CEGE) GVAX A nonpatient-specific therapy comprised of tumor cells genetically modified to secrete granulocyte-macrophage colony-stimulating factor Hormone-refractory prostate cancer An independent data monitoring committee recommended that the Phase III trial continue (1/14)
Kosan Biosciences Inc. (KOSN) KOS-953 Tanespimycin; Hsp 90 inhibitor Multiple myeloma Opened enrollment in Phase III (1/4)
CARDIOVASCULAR
Cogentus Pharmaceuticals Inc.* CGT-2168 An antiplatelet drug that combines clopidogrel and gastroprotectant omeprazole To reduce gastrointestinal side effects in patients on antiplatelet therapy Enrolled the first patient in its pivotal Phase III study (1/15)
Gentium SpA (Italy; GENT) Defibrotide Single-stranded DNA designed to protect vascular endothelial cells Severe veno-occlusive disease Data safety monitoring board initiated the planned interim analysis of the Phase III study and concluded there were not safety concerns (1/24)
Nuvelo Inc. (NUVO) Alfimeprase Thrombolytic drug; recombinant enzyme that acts by directly degrading fibrin Peripheral arterial occlusion Phase III data from two failed trials showed that 34.9% of patients receiving alfimeprase met the endpoint vs. 37.2% of patients receiving intrathrombus placebo and 18.4% receiving peri-thrombus placebo in NAPA-2; NAPA-3 data showed 29.4% of alfimeprase patients achieved a 30-day open vascular surgery avoidance compared to 17.6% in the intrathrombus placebo arm (1/25)
CENTRAL NERVOUS SYSTEM
Acorda Therapeutics Inc. (ACOR) Fampridine-SR A sustained-release tablet form 4-aminopyridine Multiple sclerosis Phase III data showed it does not increase a patient's risk of developing cardiac arrhythmias, or an irregular heart beat (1/28)
Cadence Pharmaceuticals Inc. (CADX) Acetavance Intravenous acetaminophen drug Postoperative pain Failed to significantly reduce postoperative pain over placebo in a pivotal study (1/11)
Vivus Inc. (VVUS) Qnexa A combination phentermine-topiramate drug Obesity Started a six-month extension study (1/9)
DIABETES
Biodel Inc. (BIOD) VIAject Fast-acting human insulin Type I diabetes Completed enrollment in two pivotal trials (1/4)
Novo Nordisk AS (Denmark; NYSE:NVO) and Aradigm Corp. (OTC BB:ARDM) AERx iDMS An electronic pulmonary delivery system for administering fast-acting human insulin by inhalation Diabetes Terminating development because an inhaled insulin product does not appear to be profitable; it was in nine Phase III trials (1/15)
INFECTION
Accentia Bio-pharmaceuticals (ABPI) SinuNase Intranasal amphotericin B Chronic sinusitis Of 80% of patients, 20% are achieving the primary endpoint of complete resolution of both cardinal symptoms and another 23% are achieving complete remission of a cardinal symptom at 16 weeks (1/7)
Avexa Ltd. (Australia; PK:AVXAF) ATC Apricitabine HIV Started a Phase III program (1/3)
Human Genome Sciences Inc. (HGSI) Albuferon Albinterferon alfa-2b Chronic hepatitis C An independent data monitoring committee found a higher rate of serious pulmonary adverse events in the higher dose group, prompting HGS to reduce dosing in the two Phase III trials (1/23)
MISCELLANEOUS
AMAG Pharmaceuticals Inc. (AMAG) Ferumoxytol Intravenous treatment Iron deficiency anemia in patients with chronic kidney disease Deaths from its Phase III study were lower for the treated group; none were considered treatment-related (1/31)
Ambrilia Biopharma Inc. (Canada; TSX:AMB) Octreotide Prolonged-release formulation; acetate for injectable suspension Acromegaly Phase III data showed the primary objective comparing C2L to SandostatinLAR was met (1/22)
Arpida Ltd. (Switzerland; SWX:ARPN) TLT Topical terbinafine Onychomycosis Began patient screening for a pivotal Phase III (1/22)
BioSante Pharmaceuticals Inc. (BPAX) LibiGel Transdermal testosterone gel Female sexual dysfunction Initiated a Phase III study (1/7)
Halozyme Therapeutics Inc. (HALO) Hylenex A liquid injectable drug formulation that includes recombinant human hyaluronidase A spreading agent to increase the absorption and dispersion of other injected drugs and for subcutaneous fluid administration Data from a volunteer study showed it could be delivered rapidly subcutaneously in a well-tolerated manner without the need for an infusion pump (1/8)
Inspire Pharmaceuticals Inc. (ISPH) Bilastine Oral antihistamine Allergic rhinitis Decided to discontinue development due to the FDA's request for an expanded QT/QTc comparative trial (1/14)
Isolagen Inc. (AMEX:ILE) Isolagen Therapy Injectable therapy Naolabial folds or wrinkles Completed injections in the pivotal Phase III trials (1/15)
MAP Pharmaceuticals Inc. (MAPP) Unit Dose Budesonide Nebulized version of budesonide Pediatric asthma Started a Phase III trial (1/7)
QuatRx Pharmaceuticals Co. (QTRX) Ophena Ospemifene; nonestrogen prescription treatment Vulvovaginal atrophy Pivotal data showed it met all of its co-primary endpoints (1/3)
XenoPort Inc. (XNPT) XP13512 Gabapentin drug Restless legs syndrome Second Phase III data showed a statistically significant lower proportion of relapse with the drug compared to placebo (1/15)
Notes:

* Privately held.

SPA = Special protocol assessment. Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; PK = Pink Sheets; TSX = Toronto Stock Exchange.