LONDON, UK / ACCESSWIRE / July 28, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Bristol-Myers Squibb Co. (NYSE: BMY) ("BMY"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=BMY. The Company announced on July 26, 2017 that the European Commission (EC) has approved its drug ORENCIA® (abatacept) used alone or in combination with methotrexate for the treatment of adult patients with active Psoriatic Arthritis (PsA) who have previously not responded adequately to disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, and for whom additional systemic therapy for psoriatic skin lesions is not required. For immediate access to our complimentary reports, including today's coverage, register for free now at: http://protraderdaily.com/register/.
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EC's Approval and Its Impact
The EC's approval is based on the results of two clinical trials PSA-I and PSA-II. During those trials, a large percentage of patients achieved an ACR 20 response, which was the primary endpoint of these trials, after they were treated with ORENCIA® either as an intravenous (IV) dose of 10 mg/kg or via a 125-mg subcutaneous injection (SC). In both studies, the responses were seen regardless of prior tumor necrosis factor inhibitor (TNFi) treatment.
The receipt of approval from the EC allows BMY to expand the marketing of ORENCIA® as a treatment for PsA across all 28 Member States of the European Union. This is the second time that the EC has given the approval for ORENCIA® in less than a year. The first approval was given by the EC in September 2016 for use of ORENCIA® in combination with methotrexate (MTX) in the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. With the current approval, ORENCIA® now has the distinction of being approved for treatments in Europe for three autoimmune conditions - RA, juvenile idiopathic arthritis (JIA), and, now, PsA.
Key Highlights of the Clinical Trials
In the Phase-3 PsA-II study, it was noted that the proportion of radiographic non-progressors in total PsA-modified SHS on x-rays at Week 24 was greater where patients were treated with ORENCIA® 125 mg SC than placebo estimate of difference. In the 24-week placebo-controlled period, no adverse reactions were noted (which were more than 2% in either of the treatment groups). The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis. The most common adverse effects that occurred in patients while taking ORENCIA® were headache, upper respiratory tract infection, nasopharyngitis, and nausea, and these occurred at a rate of ? 10%.
What is Psoriatic Arthritis?
Psoriasis is an autoimmune condition that occurs when one's skin cells develop too quickly. The excess skin cells create scaly lesions on the skin, called flare-ups. It is estimated that about 30% of people with psoriasis also develop a form of inflammatory arthritis called PsA. PsA is an autoimmune disease that occurs when the body's immune system mistakenly attacks healthy tissue, in this case, the joints and skin. This causes inflammation that triggers joint pain, stiffness, and swelling. Without treatment, PsA can cause permanent joint and tissue damage.
ORENCIA® (abatacept) is a biologic DMARD. It is a prescription medicine that is available in injection form both for intravenous use and for subcutaneous use. It is used for the treatment of Adult RA, JIA, and Adult PsA. For patients with Adult PsA, it helps reduce signs and symptoms when used on a standalone basis or when used in combination with other PsA treatments.
About Bristol-Myers Squibb (NYSE: BMY)
Bristol-Myers Squibb is a global biopharmaceutical company focused on helping to address the unmet medical needs of patients with serious diseases. It is helping patients worldwide with its wide array of medicines for the treatment of diseases in areas like oncology, cardiovascular, immunoscience, and fibrosis. BMY is committed to the discovery and development of transformational medicines for patients suffering from immune-mediated disease and has a robust pipeline of immunomodulatory therapies.
In FY16, the Company invested $4.9 billion in R&D, which included the discovery and development of new medicines. BMY facilities are located across North America, Europe, Asia, and Latin America.
Last Close Stock Review
Bristol-Myers Squibb's share price finished yesterday's trading session at $54.24, dropping 3.11%. A total volume of 21.21 million shares have exchanged hands, which was higher than the 3-month average volume of 7.52 million shares. The Company's stock price rallied 15.85% in the past six months. Shares of the Company have a PE ratio of 18.78 and have a dividend yield of 2.88%. The stock currently has a market cap of $90.15 billion.
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