Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
AUTOIMMUNE | ||||
UCB SA (Brussels, Belgium) |
Cimzia |
Certolizumab pegol |
Rheumatoid arthritis |
Data showed that adding Cimzia to current therapy was associated with a rapid and consistent clinical response in a diverse group of patients (5/31) |
CANCER | ||||
Advantagene Inc. (Auburndale, Mass.) |
ProstAtak |
Cancer vaccine |
Prostate cancer |
Secured an SPA with the FDA to begin a pivotal Phase III study (5/20) |
Amgen Inc. (Thousand Oaks, Calif.) |
Xgeva |
Denosumab |
Bone metastases |
Phase III data showed it significantly increased bone metastasis-free survival compared to placebo (5/18) |
Biothera (Eagan, Minn.) |
Imprime PGG |
Designed to bind to and direct neutrophils and to work synergistically with antitumor monoclonal antibodies |
Recurrent or progressive KRAS wild-type colorectal cancer |
Began dosing patients in a Phase III trial (5/19) |
Celgene Corp. (Summit, N.J.) |
Revlimid |
Lenalidomide maintenance therapy |
Multiple myeloma |
Phase III data showed it significantly improved overall survival, with a rate of 90% for treated patients vs. 83% for placebo patients (5/6) |
Endo Pharmaceuticals Holdings Inc. (Chadds Ford, Pa.) and Bioniche Life Sciences Inc. (Belleville, Ontario) |
Urocidin |
Intravesical formulation of Mycobact-erial cell wall-DNA complex |
Bladder cancer |
Phase III data showed the product was well tolerated and the overall one-year disease-free survival rate was 25% (5/19) |
Millennium (Cambridge, Mass.) |
Velcade |
Bortezomib |
Relpased multiple myeloma |
Data from three studies showed median overall survival was between 20 and 29 months (5/6); data in newly diagnosed patients after autologous stem cell transplant showed significant improvements in response rates and progression-free survival (5/9) |
Talon Therapeutics Inc. (San Mateo, Calif.) |
Marqibo |
Vincristine sulfate liposomes injection |
Non-Hodgkin lymphoma |
Began a Phase III trial (5/11) |
CARDIOVASCULAR | ||||
Amarin Corp. plc (Mystic, Conn.) |
AMR101 |
An omega-3 fatty acid |
High triglycerides |
Phase III data showed it reduces triglyceride levels and improves a broad array of lipid and nonlipid parameters, without a significant increase in LDL-C (5/20) |
Merck & Co. Inc. (Whitehouse Station, N.J.) |
tafluprost |
Preservative-free prostaglandin analogue ophthalmic solution |
Open-angle glaucoma or ocular hypertension |
Phase III data showed patients experienced a reduction in intraocular pressure comparable to patients taking twice-daily preservative-free timolol maleate (5/3) |
CENTRAL NERVOUS SYSTEM | ||||
Pacira Pharmaceuticals Inc. (Parsippany, N.J.) |
Exparel |
A bupivacaine-based product |
Postsurgical pain after augmentation mammoplasty; after hemorrhoidectomy |
Phase III data demonstrated its utiltiy (5/9); Phase III showed it met its primary endpoint of reducing pain and opioid use in the first 72 hours (5/17); pivotal data showed statistically significant lower pain intensity (5/24) |
DIABETES | ||||
Arena Pharmaceuticals Inc. (San Diego) |
Lorqess |
Lorcaserin |
Obesity |
Meta-analyses of three Phase III trials showed it caused statistically significant weight loss compared with placebo at one year among 7,500 obese and overweight, diabetic and nondiabetic adults (5/27) |
INFECTION | ||||
NanoBio Corp. (Ann Arbor, Mich.) |
NB-001 |
Topical treatment |
Cold sores |
Began two Phase III trial (5/12) |
MISCELLANEOUS | ||||
Abbott (Abbott Park, Ill.) |
Humira |
Adalimumab |
Ulcerative colitis |
Phase III data showed it met its primary endpoint of clinical remission in adults (5/11) |
Alimera Sciences Inc. (Atlanta) |
Iluvien |
Fluocinolone acetonide intravitreal insert |
Diabetic macular edema |
Phase III data showed improvement in visual acuity of 15 letters or more in 33.6% (trial A) or 42.4% (trial B) of patients after 30 months (5/4) |
Amsterdam Molecular Therapeutics (Amsterdam, the Netherlands) |
Glybera |
Alipogene tiparvovec; a gene therapy |
Lipoprotein lipase deficiency |
An efficacy study showed improved chylomicron metabolism could be used as a biomarker for increased lipoprotein lipase activity in patients missing the gene that produced this protein (5/23) |
InSite Vision Inc. (Alameda, Calif.) |
AzaSite Plus and DexaSite |
A topical combination antibiotic/corticosteroid product for blepharitis and a candidate for non-bacterial blepharitis |
Blepharitis |
FDA has agreed to an SPA for the Phase III trial (5/26) |
InterMune Inc. (Brisbane, Calif.) |
Pirfenidone |
Oral therapy |
Idiopathic pulmonary fibrosis |
Two Phase III trials showed positive results in terms of lung function, walking tests and progression-free survival (5/17) |
Keryx Biopharma-ceuticals Inc. (New York) |
Zerenex |
Ferric citrate |
Hyperphos-phatemia |
Phase III data in end-stage renal disease patients on dialysis showed changes in mean serum phosphorus of -2.0 mg/dL for the 6-g dose group and -2.2 mg/dL for the 8-g group (5/2) |
Omeros Corp. (Seattle) |
OMS103HP and OMS302 |
Added to standard irrigation solutions and delivered intraoperatively to block the molecular-signaling and biochemical cascade caused by surgical trauma |
Arthroscopic meniscectomy and intraocular lens replacement surgery |
Advancing both candidates into Phase III trials in Europe and North America (5/20) |
Sucampo Pharmaceuticals Inc. (Bethesda, Md.) and Abbott (Abbott Park, Ill.) |
Lubiprostone |
Capsules |
Chronic idiopathic constipation |
Phase III data showed it met its primary endpoint of changing the baseline number of bowel movements after a week of treatment; it was well tolerated with no severe adverse events (5/11) |
Vivus Inc. (Mountain View, Calif.) |
Avanafil |
A phosphodiesterase 5 inhibitor |
Erectile dysfunction |
Phase III data showed it met all the primary endpoints (5/18); in patients following radial prostatectomy, it showed it met the primary endpoints (5/26) |
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. |