Good News for Bristol-Myers - Analyst Blog

The US Food and Drug Administration (FDA) delivered a boost to pharma giant Bristol-Myers Squibb Company (BMY) by accepting the supplemental Biologics License Application (sBLA) for the subcutaneous formulation of Orencia (abatacept) for treating adults suffering from moderate to severe rheumatoid arthritis (RA).

The confirmation of the receipt of the sBLA, filed with the FDA in the third quarter of 2010, was received on October 4, 2010. The application was filed on the basis of data from four multinational late-stage studies conducted for the RA indication. The program evaluated 1,847 adults suffering from moderate to severe RA.

RA, a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints, inhibits mobility due to the affected joints losing their shape and alignment. The incidence of RA is on the rise and the market has a huge unmet need.

We note that Orencia is already approved for multiple indications both in adults and children.  Orencia' s approval for the additional indication would be a further feather in Bristol-Myers' cap. The drug would target a highly lucrative RA market which is expected to register a 6% annual growth and reach $14.3 billion by 2017 according to GlobalData.

Follow-up data released for Sprycel

Bristol-Myers and partner Otsuka Pharmaceutical Co., Limited recently presented 18 month follow-up data from the late-stage DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) study. The study is evaluating the safety and efficacy of 100mg once daily Sprycel (dasatinib) versus Novartis' (NVS) Gleevec (imatitinib) (400 mg daily) as a first-line therapy in adults suffering from Philadelphia chromosome-positive chronic myeloid leukemia (CML), in chronic phase.

Results after 18 months were consistent with the 12-month data which indicated improved response rates for patients treated with Sprycel. The 12-month data formed the basis of the FDA approval of the drug as a first-line therapy for adults newly diagnosed with chronic phase CML. The approval came in October 2010 following the review of the sNDA for the leukemia drug on a priority basis.

Bristol-Myers in Neutral Lane

We currently have a Neutral recommendation on Bristol-Myers. Our biggest concern regarding the company is the high exposure to generic risk on many of its leading drugs. We expect Bristol-Myers to look to bolster its revenues through partnering deals and acquisitions.