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.