Immunology and Biotherapies

KeywordsAdverse reactions; Cytokines; Monoclonal antibodies; Bone morphogenic proteins;Colony-stimulating factors; Interferons; Interleukins; Tumor necrosis factor alfa;Adalimumab; Certolizumab; Etanercept; Golimumab; Infliximab; Abciximab;Alemtuzumab; Bevacizumab; Cetuximab; Daclizumab; Natalizumab; Ranibizumab;Rituximab; Tocilizumab; Trastuzumab

Via Krishan Maggon

REPORTS FULL-YEAR ADJUSTED EPS OF $3.32, UP 5.7 PERCENT; GAAP EPS $1.10- DELIVERS FOURTH-QUARTER ADJUSTED REVENUE OF $5.371 BILLION, UP 8.9 PERCENT OVER FOURTH-QUARTER 2013 (UP 5.1 PERCENT ON A REPORTED BASIS); GAAP REVENUE $5.452 BILLION- REVENUE GROWTH IN THE QUARTER REFLECTS 14.4 PERCENT GLOBAL OPERATIONAL SALES GROWTH FROM HUMIRA (UP 10.6 PERCENT ON A REPORTED BASIS) AND STRONG GROWTH FROM OTHER KEY PRODUCTS- DELIVERS ADJUSTED GROSS MARGIN IMPROVEMENT OF 410 BASIS POINTS IN THE FOURTH QUARTER- REPORTS FOURTH-QUARTER ADJUSTED EPS OF $0.89, UP 8.5 PERCENT; GAAP EPS ($0.51)- LAUNCHES INTERFERON-FREE HCV REGIMEN FOLLOWING APPROVAL IN UNITED STATES, EUROPE AND CANADA- CONFIRMS 2015 ADJUSTED EPS GUIDANCE RANGE, REFLECTING INDUSTRY-LEADING GROWTH VERSUS THE PRIOR YEAR

 

 Global HUMIRA sales increased 10.6 percent, or 14.4 percent on an operational basis, excluding the impact of foreign exchange rate fluctuations.  

Via Krishan Maggon

Abstract

While for a century therapeutics has been dominated by small molecules, i.e. organic chemicals of ~400Da absorbable via the gut, this is no longer the case. There are now a plethora of important medicines which are proteins and injectable, which have dramatically improved the therapy of many inflammatory diseases and of cancer. Most of these are monoclonal antibodies, some are receptor Ig Fc fusion proteins, others are cytokines or enzymes. The key to this new aspect of therapeutics has been the filling of unmet needs, and the consequent commercial success, which promoted further research and development. The first ‘biologic’ for a common disease, rheumatoid arthritis (RA), was a monoclonal antibody, infliximab, to human tumour necrosis factor (TNF). This was based on our work, which is described in this review, summarizing how TNF was defined as a good target in RA, how it was developed is described here, as well as future indications for anti-TNF and related agents. Biologics are now the fastest growing sector of therapeutics.

Via Krishan Maggon