Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvement

Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Testosterone Gel 1.62%, a generic version of AbbVie Inc.'s AndroGel 1.62% Absence of endogenous testosterone Filed an abbreviated NDA with the FDA 4/2/13 Almirall SA (Barcelona, Spain) and Forest Laboratories Inc. (New York) Aclidinium bromide and formoterol fumarate A long-acting muscarinic beta2 agonist and a long-acting beta2 agonist Chronic obstructive pulmonary disorder Top-line Phase III data

Company (Location) Product Description Indication Status Date Pfizer Inc. (New York) Prevenar 13 Pneumococcal polysaccharide conjugate vaccine Infections Phase III data showed it met all primary and secondary objectives focused on immunogenicity, tolerability and safety in adults 18 to 49 4/30/13 Tetraphase Pharmaceuticals Inc. (Watertown, Mass.) Antibiotics Two next-generation antibiotic candidates Community-acquired multidrug-resistant infections Studies demonstrated efficacy 4/30/13 Trius

The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda. Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology

As regulators, payers and drug developers become more comfortable with their use, interest in companion diagnostics to help direct targeted medicines to the right patient populations has surged in the past couple of years. Drug companies are certainly recognizing that companion diagnostics, when co-developed with potential therapeutics, can assist in regulatory approvals. The early applications have mainly been with cancer therapies and 2011 served as a pivotal year in the demonstration of the

Company (Location) Product Description Indication Status Date AbbVie Inc. (Chicago) and Enanta Pharmaceuticals Inc. (Watertown, Mass.) ABT-450/r, ABT-267 and ABT-333 In combination with ribavirin; direct-acting antivirals Hepatitis C virus genotype 1 Phase IIb data showed greater than 90% sustained viral response rates 4/24/13 Achillion Pharmaceuticals Inc. (New Haven, Conn.) ACH-3102 Pan-genotypic NS5A inhibitor Hepatitis C virus genotype 1 Phase II data showed it was active against both wild

Company (Location) Product Description Indication Status Date AUTOIMMUNE Acorda Therapeutics Inc. (Ardsley, N.Y.) rHIgM22 A remyelinating antibody Multiple sclerosis Enrollment began in the first trial 4/24/13 Arena Pharmaceuticals Inc. (San Diego) APD334 An oral drug targeting the sphingosine 1-phosphate subtype 1 receptor Autoimmune diseases Initiated dosing in a Phase I trial 4/8/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-8400 An agonist of Toll-like receptors 7, 8 and 9 Psoriasis

By any measurement the U.S. biotechnology industry is the envy of the world. Perspectives on the reasons for the nation's dominance in this sector are provided by the latest Scientific American Worldview Scorecard, which for the past five years has been ranking countries on their global competitiveness in biotechnology. The 2013 edition reflects increased global competition and a growing list of countries being added to the rankings. The first Scorecard, published in 2009, analyzed 36 countries

Company (Location) Product Description Indication Status Date AUTOIMMUNE Rigel Pharmaceuticals Inc. (South San Francisco) and AstraZeneca plc (London) Fostamatinib Oral spleen tyrosine kinase inhibitor Rheumatoid arthritis Missed the X-ray endpoint of modified Total Sharp score, but hit statistical significance in ACR20 scoring, although the Phase III still fell short of those achieved by Pfizer Inc.'s approved Xeljanz 4/8/13 CANCER Array BioPharma Inc. (Boulder, Colo.) ARRY-520 A selective KSP

Array BioPharma Inc., a biotech known for its drug discovery engine, is expanding its capabilities, starting its first Phase III clinical trial for MEK 162. (See BioWorld Today, May 8, 2013.) As part of its partnership with Novartis AG to develop the MEK inhibitor, Array retained co-development rights, which allows it to run clinical trials to further the development of the compound. "The agreement is that Array will be entitled to run a clinical trial with 162. The spirit is that we would be

Company (Location) Product Description Indication Status Date AUTOIMMUNE Genzyme Corp. (Cambridge, Mass.) Aubagio Teriflunomide; once-daily Multiple sclerosis Was approved in Argentina in a 14 mg formulation for patients with relapsing forms 4/9/13 CANCER Celgene Corp. (Summit, N.J.) Revlimid Lenalidomide Transfusion-dependent anemia CHMP adopted a positive opinion for Revlimid 4/29/13 Curis Inc. (Lexington, Mass.) Erivedge Vismodegib Symptomatic metastatic basal cell carcinoma CHMP recommended

Company (Location) Product Description Indication Status Date CANCER CytRx Corp. (Los Angeles) Aldoxorubicin Tumor-targeting doxorubicin conjugate (formerly INNO-206) Soft tissue sarcomas Reached an agreement with the FDA for an SPA for a global Phase III 4/24/13 CARDIOVASCULAR Amarin Corp. plc (Bedminster, N.J., and Dublin, Ireland) Vascepa Icosapent ethyl capsules High triglycerides FDA accepted its supplemental NDA for use as an adjunct to diet 4/24/13 Santarus Inc. (San Diego) and Pharming

Financings Arrowhead Research Corp. completed a $36 million private offering to advance its pipeline. Cardio3 BioSciences closed a $25 million investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure. Galapagos NV raised $70.7 million in an over-subscribed private placing. Idera Pharmaceuticals Inc. closed a $16.5 million underwritten public offering. Isis Pharmaceuticals Inc. priced a public offering seeking to raise $171 million. Lumena

"It's very clear that we need certain types of data in animal models before we move into the clinic, and then in Phase I or Phase Ib see evidence of proof of concept in a pre-selected patient population. If we don't see that, we cannot bring such a drug into Phase III and just see what happens. Patients don't benefit from this type of approach." – Carlo Toniatti, head of research at the Institute for Applied Cancer Science and the Center for Co-Clinical Trials at the University of Texas MD

Company Drug Indication BioAlliance Pharma SA Sitavig Recurring herpes labialis Sucampo Pharmaceuticals Inc. Amitiza Opioid-induced constipation Tris Pharma Inc. Karbinal ER Seasonal and perennial allergic rhinitis