Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
Ardea Biosciences Inc. (San Diego) |
Lesinurad |
An oral, once-daily inhibitor of URAT1 |
Gout |
Started the first of four planned Phase III trials (12/20) |
Genzyme Corp. (division of Sanofi SA; Cambridge, Mass.) |
Teriflunomide |
Oral therapy |
Multiple sclerosis |
Top-line Phase III data of teriflunomide compared to interferon beta 1a showed no statistical superiority on its primary composite endpoint, risk of treatment failure (12/21) |
Human Genome Sciences Inc. (Rockville, Md.) and GlaxoSmithKline plc (London) |
Benlysta |
Belimumab |
Systemic lupus erythematosus |
Started dosing in a Phase III trial (12/16) |
UCB Pharma SA (Brussels, Belgium) |
Cimzia |
Certolizumab pegol |
Rheumatoid arthritis |
Began a trial of Cimzia plus methotrexate compared with Humira plus methotrexate (12/22) |
CANCER | ||||
Celgene International Sarl (Boudry, Switzerland) |
Revlimid and Rituxan |
Lenalidomide combined with anti-CD20 antibody rituximab |
Follicular lymphoma |
Started a Phase III study (12/15) |
Celldex Therapeutics Inc. (Needham, Mass.) |
Rindopepimut |
Immunotherapeutic vaccine |
Surgically resected epidermal growth factor variant III-positive glioblastoma |
Launched the Phase III trial, which is expected to enroll up to 440 patients (12/2) |
Nektar Therapeutics Inc. (San Francisco) |
NKTR-102 |
Single agent |
Metastatic breast cancer |
Started a pivotal Phase III trial evaluating NKTR-102 as a single agent (12/13) |
Novartis AG (Basel, Switzerland) |
Everolimus |
Oral therapy |
Metastatic breast cancer |
Phase III data showed improvement in disease control (12/8) |
CARDIOVASCULAR | ||||
Amgen Inc. (Thousand Oaks, Calif.) |
Nplate |
Romiplostim |
Primary immune thrombocytopenia |
Phase III data demonstrated the drug's safety and efficacy in adults (12/15) |
Santarus Inc. (San Diego) and Pharming Group NV (Leiden, the Netherlands) |
Rhucin |
Recombinant human C1 inhibitor |
Hereditary angioedema |
Data showed clinical response rates of 93%, 96% and 88% for the 100 U/kg, 50 U/kg and 2100 U Rhucin doses, respectively, compared with 41% in the placebo group (12/8) |
Theratechnol-ogies Inc. (Montreal) |
Egrifta |
Tesamorelin; a synthetic analogue of human growth hormone-releasing factor |
Muscle wasting in chronic obstructive pulmonary disease |
Company is halting the clinical program and downsizing with a goal of becoming profitable in 2013 (12/9) |
CENTRAL NERVOUS SYSTEM | ||||
Alkermes plc (Dublin, Ireland) |
ALKS 9070 |
Long-acting, injectable that converts into aripiprazole once in the body |
Schizophrenia |
Advancing it into a Phase III trial (12/20) |
AstraZeneca plc (London) and Targacept Inc. (Winston-Salem, N.C.) |
TC-5214 |
Nicotinic channel modulator |
Major depressive disorder |
Topline results showed it missed its primary endpoint in the second of four Phase III studies (12/21) |
Curemark LLC (Rye, N.Y.) |
CM-AT |
An enzyme replacement therapy |
Autism |
Phase III data showed statistically significant effects compared to placebo in core and noncore symptoms of the disorder (12/8) |
Pacira Pharmaceuticals Inc. (Parsippany, N.J.) |
Exparel |
Bupivacaine liposome injectable suspension |
Postsurgical analgesia |
Phase III data demonstrated statistically significantly lower pain scores and decreased opioid requirements for up to 72 hours with Exparel compared to placebo (12/20) |
Salix Pharmaceuticals Ltd. (Raleigh, N.C.) and Progenics Pharmaceuticals Inc. (Tarrytown, N.Y.) |
MNTX |
Oral methylnaltrexone |
Opioid-induced constipation in chronic, noncancer pain patients |
Phase III data showed it demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms in a Phase III trial (12/21) |
Trophos SA (Marseille, France) |
Olesoxime |
Acts via a neuroprotective mechanism |
Amyotrophic lateral sclerosis |
Failed to demonstrate efficacy in a pivotal Phase III trial (12/14) |
Vivus Inc. (Mountain View, Calif.) |
Qnexa |
Phentermine/topiramate |
Obesity in diabetic patients |
Data showed Qnexa resulted in excess weight loss of 33%, compared with 7.4% in the placebo group, after 56 weeks of treatment (12/8); data showed significantly more placebo patients than Qnexa patients became diabetic over the two years of the SEQUEL extension trial (12/9) |
DIABETES | ||||
Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) |
Linagliptin |
A DPP-4 inhibitor |
Type II diabetes |
In combination with metformin, it showed meaningful reductions in blood glucose in adults in a Phase III trial (12/9) |
Bristol-Myers Squibb Co. (New York) |
Dapagliflozin |
An insulin-independent oral agent that inhibits sodium-glucose co-transporter 2 |
Type II diabetes |
Phase III data of dapagliflozin plus glimepiride reduced blood sugar levels at 24 weeks compared to placebo plus glimepiride (12/9) |
Zealand Pharma A/S (Copenhagen, Denmark) and Sanofi SA (Paris) |
Lyxumia |
Lixisenatide |
Type II diabetes |
Top-line Phase III data showed that Lyxumia in combination with Lantus achieved the primary endpoint of significantly reducing HbA1c with a significant improvement in two-hour postprandial glucose levels compared to insulin treatment alone (12/7) |
INFECTION | ||||
Anacor Pharmaceuticals Inc. (Palo Alto, Calif.) |
AN2690 |
Tavaborole; a topical antifungal |
Onychomycosis |
Completed enrollment of about 600 patients in the second of its two Phase III trials (12/28) |
Boehringer Ingelheim GmbH (Ingelheim, Germany) |
BI 201335 |
An oral protease inhibitor |
Chronic hepatitis C virus |
Randomized the final patient to treatment in its Phase III program (12/12) |
Cubist Pharmaceuticals Inc. (Lexington, Mass.) |
CXA-201 |
Ceftolozane/tazobactam |
Complicated intra-abdominal infections |
Started a pivotal Phase III trial (12/14) |
Gilead Sciences Inc. (Foster City, Calif.) |
Ritonavir |
Boosting agent; part of the Quad HIV regimen (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate) |
HIV |
Phase III trial met its 48-week primary endpoint of noninferiority (12/6) |
Gilead Sciences Inc. (Foster City, Calif.) |
Elvitegravir |
An integrase inhibitor |
HIV |
Top-line Phase III data showed it was noninferior to the integrase inhibitor raltegravir after two years of therapy (12/12) |
Merck & Co. Inc. (Whitehouse Station, N.J.) and Roche AG (Basel, Switzerland) |
Victrelis and mericitabine |
Protease inhibitor and an oral HCV NS5B nucleoside polymerase inhibitor |
Hepatitis C virus |
Started the first of a series of trials to test combinations of marketed and investigational medicines (12/19) |
Trius Therapeutics Inc. (San Diego) |
Tedizolid |
Antibiotic |
Gram-positive infections |
Hit all primary and seondary endpoints in the first Phase III trial (12/20) |
MISCELLANEOUS | ||||
Amicus Therapeutics Inc. (Cranbury, N.J.) |
Amigal |
Migalastat HCL |
Fabry disease |
Completed enrollment in a Phase III trial (12/21) |
BioSante Pharmaceuticals Inc. (Lincolnshire, Ill.) |
LibiGel |
Testosterone gel |
Hypoactive sexual desire disorder |
Phase III data showed the drug did not meet any of its primary or secondary endpoints (12/16) |
Columbia Laboratories Inc. (Livingston, N.J.) |
Vaginal progesterone |
8% gel |
Preterm birth |
A meta-analysis of data from five studies found that administering the gel to asymptomatic women with a sonogrpahic short cervix in the mid-trimester of pregnancy significantly reduced the risk of preterm birth and neonatal morbidity (12/15) |
Denali Concreate Management Inc. (Carson City, Nev.) |
CF101 |
Oral small molecule that down-regulates the PI3K/PKB/Akt pathway |
Dry eye syndrome |
Began patient enrollment for a Phase III trial that will enroll 231 patients (12/22) |
Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) |
Eylea |
Aflibercept injection |
Wet age-related macular degeneration |
Two-year data suggested that it offered only modest benefit in a head-to-head comparison with Lucentis (12/6) |
Tranzyme Pharma Inc. (Research Triangle Park, N.C.) and Norgine BV (Amsterdam, the Netherlands) |
Ulimorelin |
An intravenous ghrelin agonist |
For patients undergoing partial bowel resection |
Completed patient enrollment in ULISES 007, the first of two pivotal Phase III studies (12/9) |
Vivus Inc. (Mountain View, Calif.) |
Avanafil |
A selective phosphodiesterase Type 5 inhibitor |
Erectile dysfunction |
Met all its endpoints by demonstrating sustained improvement from baseline in an open-label, long-term study (12/6) |
|
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. # The date indicated refers to the BioWorld Today issue in which the news item can be found. SPA = Special Protocol Assessment. | ||||