Due to a possible Velcade rival and several drugs losing exclusivity, Takeda is expecting revenue to come in flat or slightly decline in the current fiscal year. Several Indian drugmakers and their executives have been named in a U.S. generics price-fixing lawsuit filed by 44 states. Daiichi Sankyo's FLT3 leukemia prospect quizartinib was struck down by an FDA advisory committee. And more.
1. New Velcade rival, looming Uloric patent loss will cost post-Shire Takeda growth: CEO
In the first look at Takeda Pharmaceutical’s combined business after the Shire buyout, the Japanese company is guiding revenue to come in flat or slightly decline in fiscal year 2019. Inflammatory bowel disease therapy Entyvio and multiple myeloma drug Ninlaro will still press ahead. But Velcade could face a new copycat in July. Gout drug Uloric could also drop 30%-plus as it is pushed later into treatment, and it'll lose patent protection around June.
In what could be “the largest cartel case in the history of the United States,” as Connecticut Attorney General William Tong called it, 44 states sued 20 generics makers for price fixing. Though Teva played the organizer role, others “willingly participated,” the suit claims. Among the defendants are Indian drugmakers Aurobindo, Dr. Reddy’s, Glenmark, Lupin and some of their executives.
3. Daiichi's leukemia drug falls amid FDA adcomm's trial concerns
FDA questions credibility of Daiichi data ahead of adcomm
It was a good news, bad news FDA cancer advisory committee meeting for Daiichi Sankyo. The experts voted 3 to 8 against leukemia drug quizartinib, as questions around the reliability of its phase 3 results had emerged ahead of the meetup. Separately, the panel voted 12 to 3 in favor of the company’s pexidartinib for the rare, benign cancer known as giant cell tumor of the tendon sheath.
4. Novartis’ slow-rolling Kymriah wins coverage in Japan at $305K: report
After snagging the first Japanese CAR-T approval in March, Novartis has won the go-ahead to sell Kymriah under the country’s national insurance system. The approved price, 33.5 million yen ($305,000), makes it the most expensive treatment offered by the system, according to Nikkei Asian Review. The Japanese authority estimates 216 patients a year will be eligible for it.
5. FDA finds testing issues at Torrent plant
The FDA has issued a 17-page Form 483 to Torrent Pharmaceuticals’ Indrad plant, which was recently involved in the recalling of tainted losartan drugs. Investigators found that in about two years, among 340 finished product batches tested out of specification, the plant retested 73% and then reversed those findings.
6. Takeda addressing Gammagard Liquid supplies but says it will take time
Shire’s new $1 billion plant in Georgia is now Takeda’s problem. The first product from it will be immune deficiency treatment Gammagard Liquid. But because it normally takes seven to 12 months to make and supply the plasma-derived product, Takeda said supply constraint will likely persist throughout 2019.