Tag Archives: biib

Lilly Changes Endpoint For Alzheimer’s Drug Trial; Stock Falls

Big pharma Eli Lilly ( LLY ) changed its goals for a much-anticipated clinical trial of its Alzheimer’s disease drug Tuesday, sending the stock down in a bad day overall for drug stocks. Lilly’s phase-three trial of its drug solanezumab, called Expedition-3, had previously targeted two primary endpoints: a slowing of cognitive decline, and a slowing of functional decline. On Tuesday, Lilly said it was going to keep cognitive decline as the primary endpoint, but functional decline would become a key secondary endpoint. Lilly is expecting to report its first results from the trial late this year, and make a decision about filing for approval based on the outcome. “Emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline in Alzheimer’s disease, particularly in earlier stages of the disease,” Lilly said by way of explanation in its press release. Lilly added that “regulators globally will continue to view both cognitive and functional endpoints as necessary for clinical trials in people with mild Alzheimer’s dementia, and regulatory guidance has been to include these as co-primary endpoints,” so it’s not clear how much difference this will make to the drug’s approvability. Nonetheless, a trial that failed a co-primary endpoint would still be a failed trial. “Sounds like Lilly is doing everything they can to improve the success rate of Expedition-3,” wrote Evercore ISI analyst Mark Schoenebaum in an email to clients. Schoenebaum said Lilly told him the decision wasn’t based on data from the trial itself, which the company hasn’t yet seen. Lilly did analyze data from its earlier solanezumab studies Expedition-1 and Expedition-2, however, “and other datasets in the field.” Schoenebaum added that the phase-three trial of a possible competitor from Biogen ( BIIB ), aducanumab, is using a different test that measures both cognitive and functional decline as its sole primary endpoint. Lilly stock hit a 52-week low of 69.60 on the stock market today , on a day when stocks in general and drug stocks in particular were taking a hit. By midday,  it was down 3.5% near 71. Biogen stock was down 2.5% near 250.

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.