Arthritis Treatment News: Abbott, Biotest To Team Up On Treatment For Arthritis, Psoriasis
Abbott, Biotest To Team Up On Treatment For Arthritis, Psoriasis
Abbott Laboratories (ABT) reached an agreement with Biotest AG (BBTAY, BIO.XE) to develop and commercialize the Germany-based company’s treatment for rheumatoid arthritis and psoriasis.
Under the agreement, Abbott will pay an upfront fee of $85 million to Biotest, which specializes in haematology and immunology products. The agreement also includes potential milestone payments of up to $395 million.
The companies will co-promote the treatment in Germany, France, the U.K., Italy and Spain. Abbott will have exclusive rights outside those five markets.
Abbott’s diversified business lineup has cushioned it from some problems facing other large drug makers, such as patent expirations and generic competition. It has made a series of acquisitions in recent years to help reduce its dependence for sales growth on the anti-inflammatory drug Humira, which may face heightened competition in coming years.
Biotest’s treatment, which aims to improve the body’s immune system response to the diseases, is in phase II clinical trials. Preclinical studies are under way to assess potential use in other immune-system related diseases.
“This novel compound will strengthen Abbott’s immunology pipeline and we look forward to continuing to build on our expertise in exploring multiple mechanisms and approaches to treat inflammatory diseases,” said John Leonard, senior vice president of global research and development at Abbott.
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Abbott in April reported a 14% decline in first-quarter earnings on costs associated with acquisitions and employee layoffs, while newly acquired drugs in foreign markets contributed to a 17% increase in revenue.
Abbott shares were up 8 cents at $52.10 in early trading. Biotest’s American depositary shares rose 8 cents to $30.56.
FDA Committee Votes Against Green-Lighting Novartis’ Gouty Arthritis sBLA
An FDA advisory committee has voted against recommending the sBLA for Novartis’ ACZ885 (canakinumab) in the treatment of gouty arthritis in patients who don’t obtain adequate relief using NSAID drugs or colchicine. Although the advisory committee was happy with the efficacy of the drug, its concerns lay with overall safety. The committee has, as a result, suggested ACZ885 may be more suitable for a narrower population of patients. Novartis says it now aims to work with FDA to identify the right patient population.
The recommendation, which FDA is not bound by in terms of making a final regulatory decision, was based on the committee’s review of data from two pivotal Phase III studies in over 450 gouty arthritis patients. Reported by Novartis last month, the study results showed that in comparison with steroid therapy, treatment with ACZ885 led to better pain relief at 72 hours, and a 56% reduction in the risk of new attacks over six months. 28% of patients receiving ACZ885 experienced new attacks over 24 weeks, compared with 49% of patients treated using the injectable steroid triamcinolone acetonide.
ACZ885 is a fully human monoclonal antibody designed to selectively inhibit interleukin-1 beta. The drug is already approved under the brand name Ilaris® in over 45 countries, including the EU and U.S., for the treatment of adults and children with cryopyrin-associated periodic syndromes. Approval applications for canakinumab as a treatment for gouty arthritis in patients for whom other treatment are inadequate were submitted in the EU in 2010 and in the U.S., Canada, and Switzerland in the first quarter of 2011. A final FDA decision is expected during Q3 2011.
Arthritis treatment undergoes Rapidfact testing
Quotient Clinical has announced an agreement with Medigene to undertake a Rapidfact formulation development and clinical testing programme on Rhudex.
This is subject to ethical and Medicines and Healthcare Products Regulatory Agency approval.
Rhudex is a potential first-in-class treatment for rheumatoid arthritis and other inflammatory disorders.
Quotient Clinical’s Rapidfact service makes use of its tightly integrated GMP manufacturing and clinical testing processes and facilities to enable the rapid clinical evaluation of new drug formulations.
Rapidfact is said to enable shortening of project timelines and a reduction of ~90 per cent in API consumption.