Just as India's Lupin inked a deal to sell its Japanese operation, fellow generics maker Sandoz penned a €400 million deal to buy Aspen's business in the country. Dr. Reddy's North American sales dropped sharply because of its generic Zantac recall. Aslan's lead drug, varlitinib, failed to move the needle in a phase 3 biliary tract cancer trial. And more.
Two generics makers made opposite decisions in Japan this week. Novartis’ Sandoz unit inked a deal to buy Aspen Pharmacare’s Japanese operations for up to €400 million ($442 million). The deal covers about 20 off-patent drugs, primarily anesthetics and specialty brands, that raked in about $141 million in revenue for the fiscal year ended in June, as well as a dedicated sales organization. At the same time, India’s Lupin, after selling a sterile injectables plant in Japan and the drugs it makes there, has unloaded the rest of its Kyowa Pharmaceutical Industry operation to a Japanese private equity firm for about $526 million.
Dr. Reddy’s Laboratories said its North American sales in the most recent quarter were down about $25 million, or 14%, compared with the previous quarter. Much of that stemmed from the recall of its generic Zantac from the U.S. market after concerns about a possible carcinogen in the drug.
The possibility that Aslan Pharma’s varlitinib will ever work looks even dimmer now. The Singapore biotech said the pan-HER inhibitor failed a phase 3 trial in biliary tract cancer, showing no significant improvement in stalling cancer’s progression. The shortfall comes after another flop for the drug back in January in gastric cancer.
Roche’s Japanese subsidiary Chugai is suing Alexion for infringing upon its patented drug delivery technology. The suit centers on Ultomiris, which Chugai alleges uses its technology to cut the half-life of the antibody—and hence extend the dosing interval—versus its predecessor Soliris. Alexion actually tried to license Chugai’s technology back in 2012 and 2013, the suit claims.
CDMO Fujifilm Diosynth Biotechnologies is pouring $120 million into a new building at its Dallas campus for gene therapy production. The company intends to add 75 to 100 more scientists when the first phase of the new project is ready in 2021, a Fujifilm spokeswoman said.
Takeda announced that in a phase 3 trial, patients who hadn’t undergone stem cell transplants and were taking Ninlaro as a first-line maintenance treatment had significant survival benefits over those on a placebo. The goal is to make Ninalro the first drug approved for “switch” maintenance in multiple myeloma.
In a lawsuit, attorneys for Sandra Hagenbrock, a former national account director for Sun Pharma, claimed her superiors directed her to tout unapproved uses of prostate cancer med Yonsa. After refusing to follow orders, Hagenbrock said, she was fired. This is the second suit filed against the Indian drugmaker on similar claims related to Yonsa.
Mylan is the latest to receive the FDA’s ire for the global recall of sartan-based drugs. Mylan failed to present written procedures to control the testing and handling of valsartan API at an Indian plant, the FDA said in its November 5 letter. The process was “inadequate” to prevent “contamination and cross-contamination” of possible carcinogens, it said.
In an FDA warning letter, the agency found the cleaning procedures at a Zydus Cadila plant in India were so bad that in a sampling, investigators found 10 different tablet products that were cross-contaminated with API residue from other drugs during production.