Novartis Weighs $4 Million Price Tag For New Gene Therapy Drug
The drug would be used to treat spinal muscular atrophy, a rare genetic disorder whose most severe form is fatal for almost all patients before age 2. In other pharmaceutical news, drugmakers are eyeing changes in the congressional lame duck session to save them money on Medicare, Insys is considering selling off its opioid-related assets and federal inspectors find more problems at Akorn manufacturing plants.
Can Novartis Charge $4 Million For A One-Time Drug?
Novartis believes its new gene therapy is worth more than $4 million for a one-time dose, and the company has some data to back that up. But, with a global spotlight on the escalating cost of medicine, is it politically viable to set a new record for the world’s most expensive drug? The treatment, called AVXS-101, has demonstrated dramatic effects in spinal muscular atrophy, a rare genetic disorder whose most severe form is fatal for almost all patients before age 2. In a 15-patient trial, infants with SMA who got AVXS-101 had a 100 percent survival rate after 24 months, data that convinced Novartis to pay $8.7 billion for the gene therapy’s inventor. (Garde, 11/5)
Pharma Makes Lobbying Push To Roll Back Seniors' Drug Discounts
Pharma giants have been quick to tout their efforts to help the Trump administration rein in runaway drug prices, but behind the scenes the industry has been lobbying furiously to roll back recently mandated medicine discounts for U.S. seniors. Drug companies are focusing lobbying efforts to use a possible lame-duck session of Congress to peel back a legislative loss they suffered earlier this year, according to people familiar with the efforts. On the line for the drug industry is $1.9 billion next year, according to one estimate. Critics say the effort by the industry has the potential to increase costs for some of the most vulnerable and medically fragile Americans: seniors on Medicare. (Koons and Brody, 11/5)
The Wall Street Journal:
Insys Looks To Sell Opioid-Related Assets, Including Subsys
Insys Therapeutics Inc. is looking to sell its opioid-related assets, including Subsys, the fentanyl painkiller that fueled its success and later landed it in legal trouble for aggressive sales practices. Subsys, a mouth-spray version of fentanyl, has been commercially available in the U.S. since 2012 to treat cancer-related pain. Its sales helped make Insys the best-performing initial public offering in 2013. Those fortunes turned when former CEO and co-founder John Kapoor and other executives and managers were arrested and indicted last year as part of a federal probe into alleged bribes for doctors to prescribe large amounts of the drug. They have pleaded not guilty. (Armental, 11/6)
Akorn Is Tagged — Again — By The FDA For Problems At A Manufacturing Plant
Despite disagreeing with accusations that it fails to comply with regulatory practices, Akorn is something of a full employment act for Food and Drug Administration inspectors. The agency released another in an ongoing stream of inspection reports that have found quality control problems at different Akorn plants in the U.S. and elsewhere. The concerns included a failure to review unexplained discrepancies in batches and consistently investigate issues with batch samples; procedures for quality control were not in writing; and a failure to validate procedures to avoid contamination. (Silverman, 11/5)