Five things for pharma marketers to know: Friday, December 19
Roche's hopes to build strength in its core area of breast cancer with Kadcyla and for an Alzheimer's drug under study were dashed as the two drugs failed in clinical trials, Reuters reports. Kadcyla for HER-positive breast cancer failed to outperform its own existing treatment, Herceptin. Roche said also it is discontinuing its Phase-III study of gantenerumab for Alzheimer disease after disappointing results.
But on another front, Roche moved to strengthen its antibody portfolio. The drugmaker will pay $489 million for Dutalys, the Austrian-based biotech which comes with proprietary technology for developing the emerging segment of bi-specific antibodies, Reuters reports.
Eli Lilly is collaborating with Adocia to develop an ultra-rapid insulin. In a worldwide licensing agreement, Adocia and Lilly will work to develop BioChaperone Lispro, a fast-acting insulin for type 1 and type 2 diabetes. Lilly will handle development and manufacturing in a deal worth up to $570 million. The companies will look to advance the potential of the insulin: the goal is to give patients more flexibility in timing of injections and make blood glucose levels less variable.
PTC Therapeutics gained orphan drug designation in a third indication for Translarna (ataluren) . Both the FDA and the European Medicines Agency have granted the status for the protein restoration drug in treating the genetic disorder Mucopolysaccharidosis. The designation means seven years of US market exclusivity if the drug is approved. PTC is developing Translarna as a potential cure for numerous diseases exhibiting a nonsense mutation. It has received orphan status for cystic fibrosis and for Duchenne muscular dystrophy. The drug is now in a Phase-III confirmatory trial for DMD and has launched with conditional approval in Europe.
Humana Medical Plan will revamp its formulary to make HIV/AIDS drugs more available to Florida patients, following the lead of Coventry Healthcare of Florida and Cigna. Humana has pledged to take steps to reduce prices and protocol barriers to the drugs' access. Florida's insurance regulation agency is driving the changes after patient rights groups charged that formulary tier placement and prescribing protocol roadblocks made the medications unaffordable and out-of-reach.