Tag Archives: biotech

United Therapeutics Down As FDA Rejects Medtronic’s Remodulin Pump

Biotech United Therapeutics ( UTHR ) said Thursday that the Food and Drug Administration had rejected its partner Medtronic ‘s ( MDT ) application for approval of a device to deliver the former’s lung-disease drug Remodulin, sending United Therapeutics’ stock down sharply. Remodulin, a treatment for pulmonary arterial hypertension, became a top seller for United Therapeutics in injectable form, but the company has been developing different delivery methods that broaden the patient base and also help extend the drug’s patent life. United Therapeutics had hoped that Medtronic’s implantable device could treat patients with the most severe forms of the disease, who can currently only use the intravenous form. United Therapeutics’ brief SEC filing didn’t say why the FDA had rejected the device, and Medtronic has said nothing about it, although the FDA’s response letter arrived over a week earlier. The filing did say that the letter had “noted various measures that Medtronic should take” to make the filing approvable, which the two companies were currently discussing. United Therapeutics also noted that it’s filed for a label extension on Remodulin to approve it for use through the device, which is due for a decision by October. United Therapeutics’ stock hit a 17-month low of 109.44 in early trading on the stock market today . By mid-morning it was down 8.5% near 111, while Medtronic stock was down more than 1%, near 73.50. A top-rated stock a year ago, United Therapeutics retains a stellar IBD EPS Rank of 98, but quarterly results that missed analyst estimates and increasing competition started pressuring the stock, even before the biotech sell-off started in August. This made the pump financially important, according to RBC Capital Markets analyst Michael Yee. “Investors view the ‘implantable pump’ as an important near-term program that could stop or slow erosion of Remodulin generic with a settlement with ( Novartis ( NVS ) unit) Sandoz set to allow a version starting June 2018,” Yee wrote in a research note. “If this pump is continuously delayed, then there’s less time to convert patients over to it and bring the approvability into question, and (it) increases risk of generic erosion of the core franchise.”

Gilead, Biogen Down On Patent Rulings; Ionis, Merck, Forward Rise

Big biotechs Gilead Sciences ( GILD ) and Biogen ( BIIB ) were both trading down Wednesday morning after receiving unfavorable patent news. Late Tuesday,  Ionis Pharmaceuticals ( IONS ) said that it and its big pharma partner Merck ( MRK ) had won a case alleging that Gilead’s hepatitis C virus (HCV) drug sofosbuvir, which is sold individually as Sovaldi and as an ingredient in Harvoni, infringed on patents that Ionis and Merck had obtained from earlier research. “We used our expertise in a 1998 collaboration with Merck to discover and develop modified nucleosides that benefit patients with HCV,” said Ionis CEO Stanley Crooke in the press release . The case goes back to 2013, when sofosbuvir was on the verge of FDA approval and Merck sought a 10% royalty on sales from Gilead. Gilead sought a judgment invalidating the patents, though it conceded that it had infringed them. The case went to a jury, which ruled Tuesday that the patents were in fact valid. There was no word on damages, though Ionis said that it’s entitled to 20% of the damages. Leerink analyst Geoffrey Porges said that the awards won’t be huge and that more litigating would delay them. “We continue to expect that any damages awarded in this case will be relatively modest, the equivalent of a single-digit royalty, significantly less than the 10% Merck was seeking,” Porges wrote in a research note. “In spite of whatever damages the jury awards Merck, Gilead has already indicated that it will appeal.” Ionis stock popped to an eight-week high of 46.05 early on the  stock market today , though midday it was down a fraction, near 41.50. Gilead stock, though, was down more than 3% near 90, while Merck was up a fraction near 53. Patent Office Will Review Biogen’s Tecfidera Biogen stock, meanwhile, was off 1.2%, near 257, in midday trading Wednesday, after the U.S. Patent and Trademark Office (USPTO) reversed an earlier decision and decided to review a patent on Biogen’s top-selling drug, Tecfidera. Hedge-fund manager Kyle Bass filed the request for a review; last year, he launched an unusual short-selling strategy by filing such requests on a number of blockbuster drugs, which he said had “BS patents.” The USPTO initially denied his request in September, but on Tuesday it changed its tune. Coincidentally or not, European Union authorities earlier this month invalidated the European equivalent of the same patent , which expires in 2028. In addition, Forward Pharma ( FWP ) is separately challenging the patent; its stock was up 4% near 17 in midday trading Wednesday. “Today’s decision is just a first step in the (review) process, and nothing happens yet in the USA, and as of today Tecfidera still enjoys 10-year exclusivity in EU (would protect it to 2024 in EU),” wrote RBC Capital Markets analyst Michael Yee in a research note. “Even though the … patent expires in February 2028, consensus did not assume this would get full protection and already assumed/expected generics to launch at some point.”

Amgen Wins Patent Suit Against Regeneron/Sanofi Drug Praluent

Amgen ( AMGN ) won a patent suit against its fellow biotech Regeneron Pharmaceuticals ( REGN ) and partner Sanofi ( SNY ) related to their rival cholesterol drugs Wednesday. Amgen sued in October 2014, charging that Regeneron’s and Sanofi’s co-developed drug Praluent violated patents that Amgen held on its drug Repatha. The two drugs are similar, both being proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Amgen had been slightly ahead in its development timeline, but Regeneron bought a priority-review voucher that let it launch Praluent last July, about a month ahead of Repatha. The case went to a jury, which on Wednesday ruled in favor of Amgen that its patents were valid. Amgen also asked for a permanent injunction, which will be decided in a hearing scheduled for March 23-24. Regeneron’s general counsel, Joseph LaRosa, said in a press release that the companies will appeal. “This is a complex area of law and science, and we believe the facts and controlling law support our position,” said LaRosa. “We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals.” Evercore ISI analyst Mark Schoenebaum wrote that the appeal could take an additional 12 to 18 months. “Recall, no new arguments are able to be presented in the Appeals Court (appeal is fact-based) and so the bar is relatively high,” he wrote in an email to clients. Analysts have expected the likeliest outcome to the suit would be a royalty paid to Amgen on Praluent sales. Schoenebaum estimated that a 5% royalty could peel 1% off Regeneron’s 2020 EPS. Trading on Regeneron shares were halted midday in the stock market today while the news came out, after rising 2.6% in morning trading. When trading resumed in the early afternoon, Regeneron stock was down more than 1%. Amgen stock, meanwhile, was down a fraction Wednesday afternoon, near 143, while Sanofi stock, which was not halted, was down nearly 2%, near 40.50.