U.S. invalidates two Copaxone patents
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The U.S. Patent and Trademark Office said Wednesday that two patents for Teva Pharmaceuticals’ best-selling multiple sclerosis drug Copaxone are not valid.
The patents, which expire in 2030, covered a 40-milligram injection of Copaxone that Teva had introduced to maintain its dominance in the MS market after its original, 20-milligram daily version began facing generic competition last year. When U.S. drug maker Mylan filed with the U.S. Food and Drug Administration to bring out a generic version of the 40-milligram drug, it also petitioned the patent office to review the Copaxone patents’ validity.
Mylan asserted that a less-frequently administered drug was obvious and not deserving of legal protection. A decision on a third Copaxone patent is due by September 1.
Teva spokeswoman Denise Bradley said the company would appeal the decision. Teva shares finished down 3.3% at 195.70 shekels ($51.85). (Yoram Gabison)
Mylan caves in to pressure and offers EpiPen discount
Mylan said Thursday it would reduce the out-of-pocket cost of its severe-allergy treatment EpiPen through a discount program, a day after Democratic presidential candidate Hillary Clinton joined lawmakers in criticizing the drug’s high price.
The company did not lower the drug’s list price, but offered users a savings card, which will cover up to $300 of EpiPen 2-Pak’s price. The price of the product, which Mylan acquired in 2007, has zoomed to $600, up from $100 in 2008, putting the company under fire from politicians this week.
Clinton’s comments came after a bipartisan group of lawmakers called for investigations into the price increase of EpiPens, which are preloaded injections of epinephrine (adrenaline) that people use if they are having a dangerous allergic reaction that could result in death if untreated.
Mylan shares, which had fallen more than 10% this week through Wednesday’s close, ended down 4.4% at 165 shekels ($43.72) in Tel Aviv. (Reuters)
Ethiopia says ICL owes $55 million in taxes on potash project
Israel Chemicals faces a $55-million tax bill from the Ethiopian government on its stalled potash venture. A tax authority committee rejected an appeal by Allana Afar, a wholly owned ICL subsidiary, on the assessment, saddling ICL with a bill more than double the $27 million it had already set aside.
The dispute dates back to when the unit was owned with the Canadian company Allana Potash. ICL is considering what steps to take next. In the meantime, the project remains stalled in a dispute with the Ethiopian government over the terms of its license. Investment has been frozen, 120 workers have been laid off and a question mark hangs over the status of the project, which, under the terms of the original license awarded to Allana, was supposed to begin operations last October.
The Ethiopian project is supposed to act as an alternative source of potash in case ICL fails to get its Israeli Dead Sea license renewed after 2030. ICL shares ended down 1.5% at 15.55 shekels ($4.14). (Yoram Gabison)
Pharma woes weigh on Tel Aviv shares
Pharma and biotech stocks weighed on the Tel Aviv Stock Exchange yesterday after comments from Democratic presidential candidate Hillary Clinton and U.S. lawmakers about high drug prices sent biotech stocks spiraling on Wall Street a day earlier.
The TA-25 and TA-100 indices were both down almost 1%, closing at 1,453.84 and 1,281.38 points, respectively, in heavy trading of more than 1.5 billion shekels ($400 million). The biomed index finished down 1.9% at 462.47 shekels. Besides Mylan, whose EpiPen pricing set off the controversy, Perrigo lost 2.35% to 336.60 shekels, and Opko Health 4% to 34.49 shekels. Other big losers were Bezeq, down 1.2% to 7.37 shekels, and Rami Levy, down 2.8% to 149.90 shekels.
The supermarket chain’s 5.5% rise in net profit was outweighed by other parameters that showed it was feeling pressure from rival Super-Sol. Energy shares gained, with Delek Drilling up 2.5% to 14.11 shekels and Avner ahead 2.6% to 2.68 shekels. (Guy Erez)