Biotechnology Companies in the News — December 2012

Editor’s Note: The home page of the BioNJ website provides an up-to-the-minute headline service where readers can access press releases issued by New Jersey-based biotechnology companies. Go to the “New Jersey Biotechnology Company News” section on the BioNJ home page to read the latest news. Companies wishing to appear in the Biolines Biotechnology Companies in the News section are encouraged to email their news releases to BioNJ.

November 29
Merck Provides Update on EU Marketing Authorization Application for Ridaforolimus

Merck Launches Maternal Health Awareness Campaign, Once Upon a Birth, with Actress Melissa Joan Hart

NPS Pharmaceuticals Announces Publication of Pivotal Phase 3 Study of Gattex® (teduglutide) in Short Bowel Syndrome-Intestinal Failure Patients

ThromboGenics’ Shares to Join the STOXX600 Index

ThromboGenics Lands Licensing Deal of the Year at SCRIP Awards 2012

November 28
Senesco to Present on SNS01-T at 54th American Society of Hematology Annual Meeting

Celgene Corporation to Webcast at an Upcoming Investor Conference and the 54th American Society of Hematology Annual Meeting

November 27
Targeted Medical Pharma Signs Agreement to Assign Certain Accounts Receivables to Cambridge Medical Funding Group

Arno Therapeutics Completes $12.7 Million Financing

NPS Pharmaceuticals to Present at Deutsche Bank BioFEST Conference

Merck Increases Quarterly Dividend

Merck and Endocyte Announce Acceptance for Review of European Marketing Authorization Applications for Vintafolide and Companion Diagnostic Etarfolatide for Folate-Receptor Positive Platinum-Resistant Ovarian Cancer

Bracco Diagnostics Inc. Issues Voluntary Nationwide Recall of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes due to Presence of Particulates

Unigene and Tarix Pharmaceuticals Enter Definitive Licensing Agreement for “Peptelligence-Engineered” Txa127

American CryoStem Corporation and XeoStem LLC Complete Adipose Stem Cell Processing and Tissue Banking Agreement

November 26
Senesco Technologies Provides Corporate Update

November 21
Senesco Announces Quotation of Common Stock on the Over-the-Counter Securities Market

November 20
Lexicon Pharmaceuticals to Present at the Piper Jaffray Annual Healthcare Conference

November 19
Senesco Announces Delisting of Common Stock from NYSE MKT LLC and Pending Transfer to an Over-the-Counter Securities Market

INCRAFT™ AAA Stent-Graft System One-Year Follow-Up Data Presented at 2012 Veith Symposium

November 16
Unigene to Announce Third Quarter 2012 Financial Results on November 20, 2012

November 15
Foster Wheeler Joint Venture with Three Streams Engineering Ltd. Awarded Contract for Canadian Oil Sands Project

NovaDel Reports Unaudited Financial Results for the Nine Months Ended September 30, 2012

Celldex Therapeutics Announces Positive Three-Year Survival Data for Rindopepimut Phase 2 Clinical Program

November 14
Photocure Presentation at Jefferies 2012 Global Healthcare Conference

Soligenix Reports Third Quarter 2012 Financial Results and Highlights Recent Accomplishments

ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Long-Term Efficacy and Safety in Adult Patients Co-Infected with HIV-1 and Hepatitis B and/or C in a Subgroup Analysis at 240 Weeks

Dendreon Appoints Lindsay Rocco to Lead Corporate Communications

Durata Therapeutics Relocating Corporate Headquarters to Chicago

Forxiga™ (dapagliflozin), First-In-Class SGLT2 That Works Independently of Insulin, Now Approved in European Union for Treatment of Type 2 Diabetes

Bristol-Myers Squibb Foundation’s Together on Diabetes™ Marks World Diabetes Day with Second Annual Report and Two New Grants in India

CorMedix: Final Closing of 2012 Financing

November 13
Antares Pharma Announces Positive Results from Final MTX Medi-Jet™ Clinical Study

New Data Demonstrate KRYSTEXXA®-Treated Refractory Chronic Gout Patients Experienced Significantly Improved Health-Related Quality of Life

Temptime Corporation Receives Grand Challenges Explorations Grant for
Groundbreaking Research in Global Health and Development

ADMA Biologics Reports 2012 Third Quarter Results

US Government OKs SAFE-BioPharma® as Trust Framework Provider

Lupus Patients Treated With Epratuzumab Report Improvements in Health-Related Quality Of Life

Oral Apremilast Achieves Statistical Significance for the Primary Endpoint of ACR20 in the First Phase III Study (PALACE-1) in Patients with Psoriatic Arthritis

November 12
Lexicon Pharmaceuticals to Present at the Jefferies 2012 Global Healthcare Conference

Long-Term Efficacy and Safety Results of Epratuzumab in Lupus Presented at Rheumatology Conference

New Head-to-Head Patient Reported Outcomes Data for Orencia® SC (abatacept) vs. Humira® (adalimumab) Presented at the 2012 American College of Rheumatology Annual Scientific Meeting

Bristol-Myers Squibb’s Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93 Percent of Genotype 1b Treatment-Naive Patients In Phase IIb Study

Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial

Cyclacel Reports Third Quarter 2012 Financial Results

New Data Published in Annals of the Rheumatic Diseases Confirm Long-Term Safety and Efficacy of KRYSTEXXA® for the Treatment of Refractory Chronic Gout

November 11
Merck Presents Early-Stage Interim Data for MK-3475, an Investigational Therapy for the Treatment of Advanced Melanoma

November 10
Interim Phase II Data of Merck’s Investigational MK-5172 in Combination Therapy in Chronic Hepatitis C Virus Genotype 1 Infection to be Presented at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Merck Reports New Phase III Analyses on Anemia Management Strategies Used With VICTRELIS® (boceprevir) Combination Therapy, Including Cirrhotic Patients

November 9
Cyclacel Pharmaceuticals to Announce Release of Third Quarter 2012 Financial Results

Immunomedics Named Edison Patent Award Winner in Biotechnology by Research & Development Council of New Jersey

Celldex Therapeutics Announces Upcoming Presentation at Lazard Capital Markets Healthcare Conference

Durata Therapeutics Reports Third Quarter 2012 Financial and Corporate Results

Arno Therapeutics Reports Progress in Development of Clinical Biomarkers to Support Treatment of Breast Cancer with Onapristone

Chiromics and Bristol-Myers Squibb Form Drug Discovery Strategic Alliance

Chiromics and GlaxoSmithKline Enter into Collaboration

ABRAXANE® Demonstrates Statistically Significant Improvement in Overall Survival for Patients with Advanced Pancreatic Cancer in Phase III Study

As Biotech Investments Continue to Decline, New Life Sciences Angel Group Launched in NYC

November 8
FDA Grants Soligenix Fast Track Designation for SGX203 for the Treatment of Pediatric Crohn’s Disease

Antares Pharma to Present at the Jefferies 2012 Global Healthcare Conference

Enzon Announces Two Oral Presentations at the Symposium of Drug Delivery Systems in Nanjing, China

Bristol-Myers Squibb to Present New Investigational Data on Orencia® (abatacept) at the 2012 American College of Rheumatology Annual Scientific Meeting

Columbia Laboratories Reports Third Quarter 2012 Financial Results

Durata Therapeutics to Present at Credit Suisse 2012 Healthcare Conference

Global Life Sciences Hiring Demand Retreated 12.1% in Q3

Immunomedics Announces First Quarter Fiscal 2013 Results and Clinical Program Developments

Savient Pharmaceuticals Reports Third Quarter 2012 Financial Results

November 7
Cyclacel to Present at Lazard Healthcare Conference

NPS Pharmaceuticals to Present at Upcoming Healthcare Conferences

Aegerion Pharmaceuticals Announces Third Quarter 2012 Financial Results

Antares Pharma Reports Third Quarter 2012 Financial and Operating Results

Bristol-Myers Squibb Foundation Announces Centers of Excellence Conference to Share Insights from Asian-Pacific Community Groups on Viral Hepatitis Management in Honor of the 10-Year Anniversary of Delivering Hope™

Bristol-Myers Squibb to Present at Credit Suisse Healthcare Conference

Celgene Corporation to Webcast at Two Upcoming Investor Conferences and the American College of Rheumatology

November 6
Personalized Medicine Potential of Cyclacel’s Innovative and Diverse Oncology Pipeline Highlighted at NCRI Cancer Conference

PTC Therapeutics Appoints Geoffrey McDonough, M.D. to Board of Directors

NPS Pharmaceuticals to Report Third Quarter 2012 Financial Results

IMS Health to Issue Third-Quarter 2012 Financial Results on November 12, Conference Call for Note Holders Scheduled for November 16

Aegerion Pharmaceuticals Announces Presentation at Jefferies Global Healthcare Conference in London

November 5
Cyclacel Receives $1.9 Million Translational Medicine Grant Award From the UK Biomedical Catalyst to Advance Its CYC065 Targeted Drug for Leukemias

Immunomedics Reports Potential Product Advances at the 2012 Annual Meeting of the American Society of Hematology

FDA Designates Durata Therapeutics’ Dalbavancin a Qualified Infectious Disease Product (QIDP)

Celldex Announces Upcoming Data Presentation at the American Society of Hematology 54th Annual Meeting and Exposition

Amicus Therapeutics Announces Updated Results From Phase 2 Extension Study of Migalastat HCl for Fabry Disease

Amicus Therapeutics Announces Third Quarter 2012 Financial Results & Corporate Updates

Lexicon Pharmaceuticals Reports on Clinical Program Status and 2012 Third Quarter Results

LX4211 Phase 2b Results Presented at American Heart Association Annual Conference

Emergency Hypertensive Acute Heart Failure Study PRONTO Demonstrates Clevidipine Superior to Standard of Care

November 3
Skuldtech and AB Science Announce the Identification of New Predictive Markers for Pancreatic Cancer Survival Associated with Masitinib Treatment

November 2
Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus

Bristol-Myers Squibb and Pfizer Announce New Data on Stroke Prevention in Atrial Fibrillation to be Presented at American Heart Association 2012 Scientific Sessions

Aerie Pharmaceuticals Announces Positive Phase 2a Clinical Results for its Novel, Dual Mechanism Compound, AR-13324, for the Treatment of Glaucoma

Aegerion Pharmaceuticals Announces Publication in the Lancet of Data From Its Pivotal Phase III Study of Lomitapide in Adult Patients with Homozygous Familial Hypercholesterolemia (HoFH)

Hypertensive Acute Heart Failure Study Results to Be Presented at American Heart Association Scientific Sessions 2012

November 1
Cyclacel Announces Publication of Phase 2 Results for Sapacitabine in Elderly AML Patients in the Lancet Oncology

Columbia Laboratories Expects Ongoing Email and Phone Outages into Next Week

Merck Resolves Previously Disclosed Missouri Consumer Class Action Lawsuit Related to Vioxx

Bristol-Myers Squibb Receives Positive Decision from National Institute of Health and Clinical Excellence (NICE) for YERVOY®(ipilimumab)

Portola, Bristol-Myers Squibb and Pfizer Sign Clinical Collaboration Agreement to Study ELIQUIS® and Portola’s Universal Factor Xa Inhibitor Antidote PRT4445

October 31
Advaxis Updates Phase 2 Cervical Cancer Trial Data

Advaxis Announces $11.4 Million in Financial Commitments

Enzon Reports Third Quarter 2012 Results

October 29
Celldex Therapeutics Makes Significant Advancements in the Field of Protein-Based Vaccine Development

October 26
Results Third Quarter and First Nine Months 2012

Presentation of Third Quarter and First Nine Months 2012 Results

Columbia Laboratories Confirms FDA Denies Watson’s Appeal Related to Prochieve NDA for the Prevention of Preterm Birth

October 25
Columbia Laboratories Receives Nasdaq Minimum Bid Price Non-compliance Letter

Celgene Reports Third Quarter 2012 Operating and Financial Results

Durata Therapeutics Completes Target Enrollment in Phase 3 DISCOVER 2 Clinical Trial Comparing Dalbavancin to Vancomycin and Linezolid in ABSSSI Patients

October 24
Positive Results from Phase 2b Study of Ophthotech’s Novel Anti-PDGF Combination Agent Fovista™ to Be Presented at AAO Retina Subspecialty Day

Ezose Sciences Forms Alliance with Fast Forward to Discover Biomarkers to Diagnose Multiple Sclerosis

October 23
Ipsen US Awards up to $300,000 for Dystonia Fellowship Grants in 2013

Presentation of the Third Quarter 2012 Report

Pomalidomide Demonstrated Significant Progression-Free Survival and Overall Survival Advantages in Phase III Study of Heavily Pre-Treated Myeloma Patients

Pinsonault Unveils Keynote Lineup for the Spring 2013 Managed Markets Summit

Merck Announces Results from New Phase III Study Amongst Women for Corifollitropin Alfa, an Investigational Fertility Treatment for Controlled Ovarian Stimulation

Bard Announces Third Quarter Results

Bard Acquires Neomend, Inc.

SAPPHIRE Worldwide Study Data Presented at TCT 2012

October 22
ViroStatics AV-HALT Phase 2a Study in HIV/AIDS Paper Published in PLoS ONE

NPS Pharmaceuticals Reports Characteristics of Patients Who Achieved Independence from Parenteral Support in STEPS 2 Study of Gattex® (teduglutide) in Adult Short Bowel Syndrome

STENTYS Self-Apposing® Stent Continues to Demonstrate Low Mortality at One Year in APPOSITION III Trial

PTC Therapeutics Receives $1 Million Grant Award from the National Institutes of Health (NIH) to Support Research for a Treatment for Dengue Fever

Amicus Therapeutics Achieves Target Enrollment in Second Phase 3 Fabry Monotherapy Study

October 19
Precision Spine™ Plans to Introduce Three New Products at North American Spine Society Meeting in Dallas

Aegerion Pharmaceuticals to Webcast Investor Event

October 18
Aerie Pharmaceuticals Appoints Richard J. Rubino as Chief Financial Officer

Lexicon Announces Pricing of Common Stock Offering

October 17
VICTRELIS® (boceprevir) Awarded 2012 Prix Galien USA Best Pharmaceutical Agent

Bristol-Myers Squibb’s YERVOY® (ipilimumab) Awarded Prestigious Prix Galien USA Prize for Best Biotechnology Product

Lexicon Announces Proposed Common Stock Offering

Trading of Common Stock of Aegerion Pharmaceuticals Halted Today

FDA Advisory Committee Recommends Approval of Lomitapide for Treatment of Homozygous Familial Hypercholesterolemia (HoFH)

October 16
NPS Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Review Gattex® New Drug Application for the Treatment of Adults with Short Bowel Syndrome

Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting

AB Science Confirms the Filing for the Marketing Authorization Application to the European Medicines Agency of Masitinib in the Treatment of Pancreatic Cancer

Fraunhofer and University of Delaware to Host Technology Summit

FDA Advisory Committee Unanimously Recommends Approval of Gattex® (teduglutide) for Adults with Short Bowel Syndrome (SBS)

Amicus Therapeutics Announces Data Presentations and Posters at Upcoming Scientific Meetings

Unigene’s Licensee, Tarsa Therapeutics, Reports Positive Clinical Data in Phase 2 Study of Oral Calcitonin for Prevention of Postmenopausal Osteoporosis

October 15
AiCuris and Merck Enter Exclusive Worldwide License Agreement for Investigational Portfolio Targeting Human Cytomegalovirus

New Data from REPLACE Study Show Initiation of Bone Remodeling for Natpara®-Treated Patients with Hypoparathyroidism

Celgene Corporation to Announce Third Quarter 2012 Results on October 25, 2012

Durata Therapeutics Names Allison Wey as Vice President, Investor Relations and Public Affairs

CircuLite® Announces Four Presentations at Transcatheter Cardiovascular Therapeutics Conference

STENTYS to Present One-Year Interim Results From APPOSITION III Study at TCT Conference

U.S. Food and Drug Administration Approves Labeling Update for BARACLUDE® (entecavir) (0.5 mg/1 mg Tablets) to Include Data on African Americans and Liver Transplant Recipients with Chronic Hepatitis B in Adult Patients

Unigene’s Oral Pth Program Featured at Asbmr 2012 Annual Meeting

Cyclacel’s Sapacitabine Nearly Doubles Expected Survival of Elderly Patients with MDS After Front-Line Therapy Failure

The Medicines Company to Announce Third Quarter 2012 Financial Results on Wednesday, October 24, 2012

October 13
Merck Researchers Present BMD Data from a Phase II Study of Odanacatib, Merck’s Investigational Cat-K Inhibitor for Post-Menopausal Osteoporosis

October 12
FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex® (teduglutide) for Adult Short Bowel Syndrome

FDA Approves ABRAXANE® for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Updated Phase 2 Survival Data of Cyclacel’s Sapacitabine for MDS Presented at
the Eighth Annual Hematologic Malignancies 2012 Conference

Second Phase 2 Trial of Telotristat Etiprate Shows Positive Results in Carcinoid Syndrome

Lexicon Initiates Phase 3 Clinical Trial of Telotristat Etiprate in Patients with Carcinoid Syndrome

October 11
Medicare Ruling Concerns Hospital CEOs, but Better Reporting, New Antibiotic Technology Can Lower Cardiac Device Infection Rates

On World Sight Day, Merck and Partners Mark 25 Years of Successful Collaboration To Help Eliminate River Blindness

CorMedix Successfully Completes and Passes ISO 13485 Certification Audit

Amicus Therapeutics Announces Positive Pompe Program Updates

October 10
Bard Declares Quarterly Dividend

October 9
Merck to Move Global Headquarters Within New Jersey

Lexicon Initiates Phase 3 Clinical Trial of Telotristat Etiprate in Patients with Carcinoid Syndrome

Immunomedics Discovers Potential New Therapy for Graft-Versus-Host Disease

Antares Pharma Announces Closing of Public Offering of Common Stock

October 8
Celgene Corporation to Announce Third Quarter 2012 Results on October 25, 2012

October 4
The Medicines Company Discontinues Phase 2b Trial of MDCO-2010

October 3
Durata Therapeutics to Present at 11th Annual BIO Investor Forum

Hospitals, Healthcare Providers to Benefit from New Premier Agreements for Blood/Specimen Collection and Ancillary Products

Soligenix Announces Formation of Acute Radiation Syndrome Scientific Advisory Board

Antares Pharma Announces Pricing of Public Offering of Common Stock

Sanofi and Bristol-Myers Squibb Announce Restructuring of Alliance Agreement

October 2
Antares Pharma Receives Development Milestone Payment

Catalent Announces Global Alliance with PAREXEL to Streamline Clinical Trial Material Supply Chain Process

FierceMedicalDevices Names TYRX® as One of Its “Fierce 15” Medical Device and Diagnostic Companies of 2012

Antares Pharma Announces Proposed Public Offering of Common Stock

October 1

Hospitals, Healthcare Providers to Benefit from New Premier Agreements for Safety Phlebotomy

ELIQUIS® (apixaban) Demonstrates Consistent Reductions in Stroke and Systemic Embolism, Major Bleeding and Mortality Compared to Warfarin in Patients with Nonvalvular Atrial Fibrillation at Varying Risk for Stroke and Bleeding

Bristol-Myers Squibb to Announce Results for Third Quarter on October 24

Photocure to Exit Allumera Business

September 29
New Four- and Five-Year Survival Data for YERVOY®(ipilimumab) in Treatment-Naïve and Previously-Treated Metastatic Melanoma Presented at the ESMO 2012 Congress (European Society for Medical Oncology)

September 28
Soligenix Announces Presentation of OrbeShield™ Data at Annual Radiation Research Society Meeting

PTC Therapeutics Appoints Jerome B. Zeldis, M.D., Ph.D. to Board of Directors

Bristol-Myers Squibb Appoints Frances Heller Senior Vice President, Business Development

September 26
Alitair Receives Notice of Patent Allowance from the USPTO for Safer Formulation of Benzonatate

STENTYS Launches New Stent-Delivery System to Facilitate Implantation in More Complex Vessel Anatomies

FDA Acknowledges Receipt of Resubmission of the ELIQUIS®(apixaban) New Drug Application to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

September 25
Antares Pharma Announces Successful Results from Vibex MTX Actual Human Use Study

CorMedix: Initial Close on Financing and Extension Granted to Regain Compliance with NYSE Amex Listing Standards

Bristol-Myers Squibb Foundation Celebrates Hispanic Heritage Month

September 24
Savient Pharmaceuticals Names John P. Hamill Chief Financial Officer

September 21
ELIQUIS® (apixaban) Receives CHMP Positive Opinion for the Prevention of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

Vanderbilt University and Bristol-Myers Squibb Sign Collaboration Agreement to Develop Novel Treatments for Parkinson’s Disease

Global Life Sciences Executive Search and Interim Management Specialist RSA Places Actinium Pharmaceuticals CEO

Agreement for Daratumumab Receives Antitrust Clearance

September 20
Pilot Study in Patients with Head and Neck Cancer Finds That Derma Sciences’ MEDIHONEY® Reduces Hospital Stays in the U.K.

Savient Announces Multiple Abstracts Related to KRYSTEXXA® in the Treatment of Refractory Chronic Gout to be Presented at the 2012 ACR/ARHP Annual Meeting

Aegerion Pharmaceuticals Observes First Annual FH Awareness Day

Unigene to Present at the 2012 Obesity Society’s 30th Annual Scientific Meeting

Agile Therapeutics to Present at CBI’s Forum on Phase II-III Clinical Study Optimization

September 19
Unigene and Tarix Pharmaceuticals Report Highly Increased Oral Bioavailability of “Peptelligence-Engineered” TXA127

Baxter and Onconova Announce European Licensing Agreement for Anti-Cancer Compound Rigosertib

CRI Lifetree Appoints Alicia Craig-Rodriguez and Jose Marcos to Leadership Team

Ten Pharmaceutical Companies Unite to Accelerate Development of New Medicines

Celgene Corporation Announces Pomalidomide Will Be Reviewed at FDA Advisory Committee

September 18
Senesco Technologies Reports Fiscal Year 2012 Financial Results

Bristol-Myers Squibb Announces Dividend

Earlier in 2012
Alfagene Bioscinces and IZEN BIO Sign MOU. Click here to read the press release.