Regeneron Pharmaceuticals Inc (NASDAQ:REGN) recently released data from a phase-3 monotherapy study of the rheumatoid arthritis (RA) drug, being developed in collaboration with Sanofi. The study was focused on comparing sarilumab, the said drug, with adalimumab, developed by AbbVie as Humira. The results indicated that sarilumab was superior to adalimumab, in improving the symptoms in patients, during week-24.
A total of 369 patients were enrolled in the trial, all of whom had active RA. Moreover, the patients were not responding to methotrexate. Doses of the two drugs were administered to a randomized set of patients, with recursive dosing every 2 weeks. It should be noted here that 200mg of sarilumab was administered to patients, compared with 40mg of adalimumab. However, the study also achieved its secondary goals of determining the rate of improvement in RA patients.
Both drugs were nearly similar for both sets of patients, except for seriously adverse events, which were 5% for sarilumab and 7% for adalimumab. Regeneron is expected to file with the regulatory bodies in EU, during 3Q2016. A total of 7 studies had been initiated on sarilumab, including the monotherapy. As of today, the company has completed a total of 4 studies, while the remaining 3 are still in progress. Added to this, the drug is also awaiting FDA approval, which is expected to be received by October 30, 2016.
Humira is responsible for generating an estimated 60% of AbbVie’s revenues, worth $14 billion. The success of sarilumab could mean trouble for AbbVie. However, it should be noted here that Humira is used for the treatment of other diseases as well. The study also found that sarilumab patients also developed a low white-blood cell count. This could be of significant use to AbbVie down the road, as it tries to convince practitioners that Humira is still the best option.
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) completed the March 14 session, with a decline of 1.02%, after having a trade volume of 1.08 million, to close at a share price of $373.27.