Tag Archives: biotech

Regeneron/Sanofi Drug Beats Humira In Rheumatoid Arthritis Trial

A drug candidate that Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) jointly developed has beaten AbbVie ’s ( ABBV ) best-selling rheumatoid-arthritis (RA) drug in a late-stage study, the companies said Friday. Regeneron and Sanofi said that their monoclonal antibody sarilumab met the trial’s main goal of improving symptoms after 24 weeks of a biweekly dosing regimen. Some 72% of patients on sarilumab achieved at least a 20% improvement in signs and symptoms based on American College of Rheumatology criteria, in contrast to 58% of the patients in the Humira group. Both groups experienced about the same rate of negative side effects, though the sarilumab group showed a higher rate of neutropenia, or lowering of white blood cells. Humira is currently the top-selling RA drug and, indeed, the top-selling drug of any kind in the world today, but its number of competitors is rising. Last fall baricitinib, a drug that Eli Lilly ( LLY ) and Incyte ( INCY ) co-developed, also beat Humira in a head-to-head trial; unlike the injectable Humira and sarilumab, it is delivered orally. Roche ’s ( RHHBY ) intravenous medicine Actemra has also bested Humira in trials. Regeneron and Sanofi have already applied for FDA approval of sarilumab based on earlier data, with a decision due by Oct. 30. RBC Capital Markets analyst Adnan Butt called the news a “modest positive” but added that investors are still concerned with some nearer-term issues with Regeneron’s stock. Among them is a pilot program to test changes in Medicare Part B , announced this week, that could affect a great deal of the reimbursement for Regeneron’s flagship drug Eylea, and a patent lawsuit that Amgen ( AMGN ) filed over another monoclonal antibody in the Regeneron/Sanofi partnership, Praluent. “All else being equal, beating Humira is certainly better than not beating it, but at least some of the discussed overhangs may need clearing before the pipeline receives more credit,” wrote Butt in a research note. By late morning on the stock market today , AbbVie stock was up almost 3% near 58. Sanofi was up 2% near 41, while Regeneron stock was up a fraction near 381.

Biogen’s Best-Selling Drug Loses Patent In EU, Says Cowen

A European court revoked a patent on Biogen ‘s ( BIIB ) multiple-sclerosis drug Tecfidera on Thursday, according to an analyst at Cowen & Co. Eric Schmidt wrote in a brief note Thursday afternoon that a European Union court had revoked European Patent EP2137537, which covered the 480-mg-per-day dose of Tecfidera, which first launched in 2013. The patent, which expires in 2028, is one of four that Biogen holds on Tecfidera in the EU, along with a 10-year period of market exclusivity due to its classification as a “new active substance.” “The U.S. patent equivalent of the ‘537 patent is the ‘514 patent, which is being challenged in an interference proceeding by Forward Pharma ( FWP ),” Schmidt wrote. “While we don’t know the rationale behind the revocation of the ‘537 patent, we assume it also has to do with Forward Pharma, which claims an earlier filing date for a similar invention.” Schmidt wrote that Biogen will probably appeal the decision, which would suspend the revocation for as long as four years as the court battle goes on. If the appeal fails, he estimates that over $1 billion in sales — about a quarter of the worldwide total — will be at risk. Tecfidera is currently Biogen’s top-selling drug, providing a third of revenue last year. The news came out shortly before the close, as Biogen stock followed the rest of the market by rising early but then erasing its gains. It close down 1.4% at 251.97. Forward Pharma closed down 0.8% at 13.17 but was up 6% in after-hours trading.

Medicare Part B Changes Could Hit Big Biotech Drugs, Say Analysts

Drug stocks fell Wednesday as Wall Street sorted through the impact of proposed changes to Medicare Part B reimbursement designed to drive down the prices of some expensive hospital drugs. Late Tuesday, the Center for Medicare & Medicaid Services proposed a pilot program testing a new reimbursement scheme for Medicare Part B, which covers drugs administered in hospitals or doctors’ offices. Currently, CMS will pay back the price of the drug plus 6% for the health care provider, which critics say encourages doctors to prescribe more expensive drugs. Under the proposed rule, doctors would get just a 2.5% premium plus a flat fee of $16.80 per drug per day, which would somewhat reduce the disparity between different-priced drugs. CMS also proposed reducing or eliminating the portion that the patient has to pay for the drug, and tying the reimbursement level to the effectiveness of a drug for a given indication. Thus, if the same drug works well for one condition but only so-so for another, CMS would reimburse it at different levels for each condition. The agency also wants to create online “decision support tools” to help physicians determine the most effective drug to use in a given situation. Another test would let CMS enter voluntary risk-sharing agreements with drug makers linking price adjustments with patient outcomes. There will be a comment period on the CMS proposal until May 9. At that point, CMS plans to place providers into two different groups, one using the old reimbursement method and one the new one, and study the differences between the groups over the course of five years. It plans to start testing its other ideas starting January 2017. The reimbursement proposal drew the most attention from Wall Street. The covered drugs would be mostly infused or injected treatments for serious conditions, as opposed to pills that the patient can take on her or his own, and so, potentially affects some of the drug industry’s biggest cash cows. “For the big biotechs, the most notable drugs that would fall under this theoretical test would be drugs that include Amgen ( AMGN ) (U.S. Neupogen, Neulasta … also Kyprolis, Xgeva/Prolia, Vectibix, about 35%+ of total sales), Celgene ( CELG ) (U.S. Abraxane is 6% of revenue — the other notable drugs are orals),” wrote RBC Capital Markets analyst Michael Yee in a research note. Credit Suisse analyst Vamil Divan agreed about Amgen, adding that Regeneron Pharmaceuticals ( REGN ) and Biogen ( BIIB ) also depend on drugs under the Medicare Part B umbrella. The new immunotherapy drugs from Bristol-Myers Squibb ( BMY ) and Merck ( MRK ), such as Opdivo, Keytruda and Yervoy, also are covered by Part B, but Yee argued that they aren’t chosen for price reasons. “Consensus understands these drugs are chosen for high efficacy or where there aren’t equivalent drugs that aren’t also infused, not because of the 6% reimbursement,” Yee wrote. Amgen stock hit a five-month low and ended the day down 2.6%, at 140.90. Regeneron tumbled 5.1% to 374.75. Celgene fell 1.1% and Biogen was off 2.2%. Bristol-Myers stock fell 1.1%, while Merck slipped a fraction.