Company (Location)

Product

Description

Indication

Status (Date)#

Pfizer Inc. (New York)

Tofacitinib

Oral JAK inhibitor

Rheumatoid arthritis

Phase III data showed it met all primary efficacy endpoints (9/9)

Access Pharmaceuticals Inc. (Dallas)

MuGard

Mucoadhesive wound liquid

Oral mucositis

It was effective in preventing, delaying and managing radiotherapy- and chemotherapy-induced oral mucositis, and reduced the need for opiate pain medicine and tube feeding (9/29)

Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Conn.)

Afatinib

An EGFR/HER2 inhibitor

HER2-positive breast cancer

Started two global Phase III trials (9/7)

Exelixis Inc. (South San Francisco)

Cabozantinib

A dual inhibitor of MET and VEGFR

Medullary

thyroid cancer

The pre-specified number of progression-free survival events required for unblinding data in its pivotal Phase III trial has been reached (9/8)

Galena Biopharma Inc. (Portland, Ore.)

NeuVax

An E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony-stimulating factor

Breast cancer

Contracted with Aptiv Solutions to manage its Phase III trial to be conducted under an SPA (9/30)

OncoGenex Inc. (Bothell, Wash.)

Custirsen

Clusterin inhibitor

Cancer pain

Amended the SPA to expand the inclusion criteria for the 300-patient Phase II trial for more than 12 weeks in men with metastatic castrate-resistant prostate cancer (9/20)

RXi Pharmaceuticals Corp. (Worcester, Mass.)

NeuVax

Cancer vaccine

HER2 positive breast cancer

The FDA lifted the partial clinical hold and the company is on schedule to begin Phase III in early 2012 (9/13)

Topotarget A/S (Copenhagen, Denmark)

Belinostat

An HDAC inhibitor

Peripheral T-cell lymphoma

Completed enrollment for the pivotal trial of belinostat for monotherapy treatment (9/27)

Karo Bio AB (Huddinge, Sweden)

Eprotirome

Liver-selective thyroid hormone receptor agonist

Heterozygous familial hyper-cholesterolemia

Received approval to start a Phase III study (9/20)

AB Science SA (Paris)

Masitinib

Protein kinase inhibitor

Primary progressive multiple sclerosis or relapse-free secondary multiple sclerosis

Recruited the first patient in a Phase III study (9/7)

BioDelivery Sciences International Inc. (Raleigh, N.C.)

Buprenorphine

Opioid analgesic delivered with BEMA

Chronic pain

Phase III data in a mixed opioid-naive and opioid experienced population failed to reach its primary endpoint of overall difference in pain intensity compared to placebo (9/30)

Eisai Europe Ltd. (Hatfield, UK; a division of Eisai Co. Ltd.; Tokyo)

Zonegran

Zonisamide

Partial-onset seizures in epilepsy

Phase III data showed it was more effective than placebo and was well tolerated (9/1)

Durect Corp. (Cupertino, Calif.)

Posidur

Uses Durect's technology to deliver bupivacaine

Postoperative pain relief

Dosed the last patient in a Phase III trial (9/7)

Trophos SA (Marseille, France)

Olesoxime

Dosed with 330-mg oral capsules once a day

Amyotrophic lateral sclerosis

The last of 500 patients has now completed the pivotal Phase III efficacy study of olesoxime (9/23)

Amylin Pharmaceuticals Inc. (San Diego), Eli Lilly and Co. (Indianapolis) and Alkermes Inc. (Waltham, Mass.)

Bydureon

Exenatide extended-release for injectable suspension

Diabetes

New analyses demonstrated patients treated with Bydureon saw improvements in select cardiovascular risk factors compared to patients who received commonsly prescribed diabetes treatments (9/13)

Generex Biotechnology Corp. (Worcester, Mass.)

Generex

Oral-lyn

A Buccal spray insulin

Diabetes

A trial in subjects with impaired glucose tolerance showed a significant reduction of HbA1c compared to the control group (9/19)

Sanofi SA (Paris)

Lyxumia

Lixisenatide; a once-daily GLP-1 receptor agonist

Type II diabetes

Achieved its primary efficacy endpoint of significant HbA1c reduction vs. placebo in patients uncontrolled on metformin in the company's GetGoal-F1 trial (9/13)

Vivus Inc. (Mountain View, Calif.)

Avanafil

A phosphodiesterase-5 inhibitor

Erectile dysfunction (ED) in diabetics

Phase III data showed male diabetics receiving the drug had a significant improvement in ED (9/14)

Vivus Inc. (Mountain View, Calif.)

Qnexa

Phentermine/topiramate

Diabetes

Patients treated for more than two years with Qnexa had reductions in progression to Type II diabetes and improvements in glycemic status, and had a greater percent weight loss with Qnexa compared to placebo in the diabetic and metabolic syndrome subgroups (9/19)

Cubist Pharmaceuticals Inc. (Lexington, Mass.)

CB-183,315

Oral novel lipopeptide

Clostridium difficile-associated diarrhea

Company plans to move into pivotal testing in the first half of 2012 (9/30)

Durata Therapeutics Inc. (Morristown, N.J.)

Dalbavancin

A long-acting intravenous lipoglycopeptide

Acute bacterial skin and skin structure infections

Started enrolling patients in a second pivotal Phase III study (9/30)

Gilead Sciences Inc. (Foster City, Calif.)

HIV Quad regimen

Elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate

HIV

The second pivotal Phase III trial met the expectations by demonstrating noninferiority, though not superiority, at week 48 compared to ritonavir-boosted atazanavir plus Truvada (9/21)

Medivir AB (Huddinge, Sweden) and Tibotec Pharmaceuticals (Cork, Ireland)

TMC435

Protease inhibitor

Hepatitis C virus

Enrollment is completed in three Phase III studies (9/1)

Trius Therapeutics Inc. (San Diego)

Tedizolid phosphate

TR-701; a second generation oxazolidinone

Acute bacterial skin infection

Completed enrollment in the first of two Phase III trials (9/19)

Vertex Pharmaceuticals Inc. (Cambridge, Mass.)

Incivek

Telaprevir

Hepatitis C virus

Phase III data showed that 65% of patients responded to Incivek combination treatment (9/16)

Ampio Pharmaceuticals Inc. (Greenwood Village, Colo.)

Zertane

Oral drug

Premature ejaculation

Phase III data showed there were no treatment-related serious adverse events and few adverse events during the 12-week extesion study, and there were no reports of dependency or tolerability issues (9/27)

BHR Pharma LLC (Herndon, Va.)

BHR-100

Intravenous progesterone

Traumatic brain injury

Enrolled 200 patients in the Phase III trial (9/8)

Biopartners GmbH (Baar, Switzerland) and LG Life Sciences Ltd. (Seoul, South Korea)

LB03002

Injectable therapy

Growth hormone deficiency

Phase III data showed it maintained expected growth rates for patients over 24 months, increasing IGF-1 levels toward normal (9/28)

Keryx Biopharmaceuticals Inc. (New York)

Zerenex

Ferric iron-based phosphate binder

Hyperphos-phatemia

Completed enrollment in the long-term study component of its Phase III registration program (9/20)

Protalix BioTherapeutics Inc. (Carmiel, Israel)

Taliglucerase alfa

A plant-cell expressed form of glucocerebrosidase

Gaucher disease

Phase III data showed at doses of 60 U/kg or 30 U/kg it reduced mean spleen volume by 38% and 26.9%, respectively (9/9)

Santarus Inc. (San Diego)

Budesonide MMX

A locally acting corticosteroid developed in a tablet formulation using Cosmo's MMX multi-matrix system technology

Ulcerative colitis

Analysis of top-line safety data from a 12-month extended-use study in patients treated daily with either budesonide MMX 6 mg or placebo showed a similar frequency of treatment-related adverse events for both groups and no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans (9/21)

SARcode Bioscience Inc. (Brisbane, Calif.)

SAR 1118

A first-in-class molecule that inhibits T-cell inflammation

Dry eye

Enrolled the first patient in its pivotal Phase III trial (9/15)

Soligenix Inc. (Princeton, N.J.)

orBec

Oral beclomethasone dipropionate

Acute gastrointestinal graft-vs.-host disease

Halted its confirmatory Phase III trial after an independent data safety monitoring board concluded the study was "highly unlikely" to meet its predetermined efficacy endpoint; no safety concerns were raised (9/16)

Tarsa Therapeutics Inc. (Philadelphia)

Ostora

An oral recombinant salmon calcitonin tablet

Postmenopausal osteoporosis

Phase III data showed that the drug achieved all of its efficacy endpoints and that the safety profile did not differ substantially from nasal calcitonin or placebo (9/20)

Trophos SA (Marseille, France)

Olesoxime

Promotes survival of neurons and other cells under stress conditions through interactions with the mitochondrial permeability transition pore

Spinal muscular atrophy

Completed enrollment of more than 160 patients in its pivotal trial (9/9)

Veloxis Pharmaceuticals A/S (Horsholm, Denmark)

LCP-Tacro

Once-daily treatment

Kidney transplant

Phase III data showed it is noninferior in efficacy compared to twice-daily standard tacrolimus (9/7)

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.