Recently, Bristol-Myers Squibb Co. (BMY) announced that its rheumatoid arthritis candidate, BMS-945429/ALD518, met the primary goal in a 16-week multiple dose mid-stage study (n=132). The positive results from the study encouraged the company to pursue further development of the candidate. The company intends to present the data from the study at the Annual Congress of the European League against Rheumatism.
Bristol is co-developing the candidate with privately held Alder Biopharmaceuticals Inc. via an agreement signed last year. BMS-945429/ALD518 is an antibody which is being developed as a potential therapy for rheumatoid arthritis. Under the deal, Alder granted Bristol global exclusive rights to develop and commercialize the candidate for all potential indications — excluding cancer.
The study evaluated the safety and efficacy of BMS-945429/ALD518 in patients suffering from rheumatoid arthritis which was inadequately controlled by methotrexate. There was significant improvement in patients in all the three studied doses (80 mg, 160 mg and 320 mg) at week 12 compared to placebo. After 16 weeks, 75% to 82% of patients displayed at least a 20% improvement, as against 36% of those treated with placebo.
There were no serious adverse events observed in the study. The most common adverse events were increases in liver enzymes observed in 17% of patients treated with BMS-945429/ALD518 as against none in the placebo group. The incidence was most frequent in the 320 mg dose group. The adverse event caused 4 patients to opt out of the trial.
BMY Inks Deals
Recently Bristol-Myers inked deals with Parexel International Corp. (PRXL) and Icon to aid its drug development program. Even though the financial terms of the contracts were undisclosed, the deals are expected to support development of Bristol’s pipeline over the next three years. Parexel and Icon provide clinical development services to the biopharmaceutical industry.
Our Take
Even though patent expirations loom large on Bristol in the near future, we believe the company has taken some measures — like the Medarex acquisition, among others — to counter the loss of revenues resulting from the patent expirations of its key drugs.
The company intends to launch five compounds — apixaban, belatacept, brivanib, dapagliflozin and ipilimumab — by 2012. The new launches are expected to drive growth in 2013 and beyond.
Currently we are Neutral on Bristol-Myers. Our Neutral stance indicates that the stock is expected to perform in line with the US equity market over the next six to twelve months. We advise investors to retain the stock over the time period.
Read the full analyst report on “BMY”
Read the full analyst report on “PRXL”
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