Biogen Learns Lessons From Lilly’s Failed Alzheimer’s Drug
Meanwhile, in other pharmaceutical news, the U.S. solicitor general urges the Supreme Court to review a case on biosimilars. And news outlets report on developments from Bristol-Myers, Horizon Pharma and Endo International.
Stat:
Why Biogen Is Breathing A Sigh Of Relief With The Latest Alzheimer's Data
Lilly’s treatment, solanezumab, had no significant effect on the buildup of toxic brain plaques believed by many to be responsible for Alzheimer’s neuron-destroying effects. The company had already disclosed that the treatment failed to improve patients’ cognition and function, but the new data, released Thursday night, shed some important light on the underlying biology. Here’s why it matters: Lilly’s therapy is among many designed to treat Alzheimer’s by clearing away brain deposits of a protein called beta amyloid. Doing so, the thinking goes, can at least delay the progression of the memory-robbing disease. Because Lilly’s failed treatment didn’t have a marked effect on those deposits, the so-called amyloid hypothesis lives to fight another day. (Garde, 12/8)
Stat:
Solicitor General Recommends Supreme Court Favor Biosimilars
In a development with widespread implications for health care costs, the US solicitor general recommended that the US Supreme Court review a heated dispute over a rule that will determine when lower-cost biosimilar medicines can be launched. And the solicitor general also took a position that may provide a boost to biosimilar manufacturers. At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics, but are expected to cost less. (Silverman, 12/8)
New Hampshire Union Leader:
NH To Receive $243K In Abilify Drug Settlement
New Hampshire will receive $243,372 in a settlement with Bristol-Myers Squibb Co. related to its alleged improper marketing of Abilify — an anti-psychotic drug — to elderly patients with dementia and Alzheimer's. Attorney General Joseph A. Foster announced Thursday that he, along with 42 other attorneys general, reached a $19.5 million dollar settlement with the drug company. In a complaint filed in court Thursday along with a settlement agreement, Foster alleges the company engaged in unfair or deceptive trade practices when it marketed Abilify. (12/8)
The Wall Street Journal:
Horizon Pharma Shares Plunge On Failed Late-Stage Study
Horizon Pharma PLC shares slid 20% in trading Thursday after a late-stage study for a genetic disease treatment broadly failed testing. The Irish biopharmaceutical company said phase 3 of its study for a treatment for Friedreich’s ataxia, a genetic disease that impacts one in 50,000 Americans, failed to show statistically significant change. (Moise, 12/8)
The Wall Street Journal:
Endo Sells Back Rights For Opioid Painkiller
Endo International PLC said Thursday that it had sold back the rights to an opioid pain drug to BioDelivery Sciences International Inc., as the market for opioid-based painkillers has come under fire. Regulators and experts say the overuse of opioid-based pain treatments has contributed to an opioid epidemic. Earlier this year, the Centers for Disease Control and Prevention released long-awaited guidelines limiting the prescribing of opioid painkillers. (Hufford, 12/8)