Data Presented At ACR, Bristol-Myers Inks Immuno-Oncology Deal

Several companies were present at the annual meeting of the American College of Rheumatology (ACR) presenting data on approved as well as pipeline candidates. Meanwhile, Bristol-Myers (BMY - Free Report) announced an immune-oncology deal and also provided updates on some of its cancer treatments.

Recap of the Week’s Most Important Stories

Data Presented at ACR: Quite a few companies presented data at the annual meeting of the American College of Rheumatology (ACR). Sanofi (SNY - Free Report) and partner Regeneron presented results on sarilumab from their late-stage SARIL-RA-MONARCH study, which demonstrated sarilumab’s superiority versus AbbVie’s Humira in adults with active rheumatoid arthritis (RA). Top-line results from this study were previously announced in Mar 2016.

Roche (RHHBY - Free Report) was also present at ACR with late-stage data showing that Actemra/RoActemra is superior to steroids alone in maintaining steroid-free remission for people with giant cell arteritis. The company expects to submit these results to regulatory authorities by year end.

Meanwhile, Novartis presented new data on its IL-17A inhibitor, Cosentyx, showing long-lasting efficacy in psoriatic arthritis over 3 years including patient-reported pain. Pfizer (PFE - Free Report) also presented new data on Xeljanz from the phase III Oral Psoriatic Arthritis TriaL (OPAL) studies, Broaden and Beyond. Other companies like Glaxo and Lilly also presented data at ACR.

Bristol-Myers Announces Deal, Provides Pipeline Updates: Bristol-Myers entered into an immune-oncology focused collaboration with Enterome, a company focused on the development of pharmaceuticals and diagnostics based on the gut microbiome. The agreement will see the companies working on the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be used as potential companion diagnostics and therapeutics for cancer. The companies will also work on identifying novel microbiome-derived biomarkers to improve clinical outcomes for patients treated with Bristol-Myers’ immuno-oncology portfolio. Bristol-Myers also presented data on Opdivo and Yervoy from a study evaluating the combination treatment in previously treated patients with advanced form of bladder cancer. Interim data was also presented on the combination of lirilumab and Opdivo for the treatment of patients with advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN) and on urelumab plus Opdivo in hematologic and solid tumors.

Sanofi PCSK9 Cardiovascular Outcomes Study to Continue as Planned:Sanofi and partner Regeneron will be continuing with the ODYSSEY OUTCOMES study on Praluent as planned instead of stopping it early, based on the recommendation of an independent Data Monitoring Committee (DMC) following a second pre-specified interim analysis. Praluent is one of two PCSK9 inhibitors (the other being Repatha) currently available in the market. While both drugs have been touted as having blockbuster potential, sales have disappointed so far and are yet to pick up significantly. Focus remains on cardiovascular outcomes study data, which if positive, are expected to boost sales significantly.

Sanofi also announced that it got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Suliqua, a once-daily titratable fixed-ratio combination of Lantus (basal insulin glargine 100 Units/mL) and GLP-1 receptor agonist Lyxumia (lixisenatide) for the treatment of type II diabetes.

Allergan Seeks FDA Approval for Avastin Biosimilar: Allergan (AGN - Free Report) and partner Amgen have filed a BLA seeking FDA approval for ABP 215, a biosimilar candidate to Roche’s cancer treatment Avastin (bevacizumab). The companies believe theirs is the first Avastin biosimilar application to be submitted in the U.S. We note that just a few days back, Mylan and partner Biocon had announced the submission of a biosimilar version of Roche’s Herceptin (trastuzumab) in the U.S.

J&J Provides Regulatory Updates: Johnson & Johnson’s (JNJ - Free Report) Janssen Biotech has submitted a BLA for guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Guselkumab is one of the key candidates in J&J’s pipeline. J&J also announced that Stelara’s label has been expanded in the EU to include the treatment of moderately to severely active Crohn’s disease in adult patients who have not responded adequately or have lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. J&J is a Zacks Rank #3 (Hold) stock.

Teva Reports 3Q Results, Sets Aside $520 Million for Settlement of FCPA Investigations: Teva’s (TEVA - Free Report) third quarter results were disappointing with the company missing on revenues and lowering its outlook for the year. In addition to announcing third quarter results, Teva is setting aside $520 million related to the settlement of U.S. Foreign Corrupt Practices Act (FCPA) investigations into conduct in three countries, Russia, Mexico and Ukraine, from 2007-2013. The company is in advanced discussions with the DoJ and the SEC to settle the investigations.


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