Protocols

Erytech shares soar on positive results for PhIIb pancreatic cancer trial; ArQule’s tivantinib fails yet again in PhIII cancer study

→ France’s Erytech Pharma says it garnered positive data in a Phase IIb study of eryaspase combined with chemo for second-line metastatic pancreatic cancer, sending shares $ERYP rocketing up 75%. The drug hits its co-primary endpoints with significant improvements for progression-free survival as well as overall survival. Pascal Hammel, principal investigator of the study, commented: “These results generated by eryaspase in combination with the standard of care are highly encouraging and compare favorably to gemcitabine or FOLFOX treatment administered alone. The results of this study support eryaspase as a potential treatment option for patients with metastatic pancreatic cancer in the second-line setting.”

→ You can score another flop for ArQule’s tivantinib. The biotech and its partners at Kyowa Hakko say that the drug failed a Phase III study for 190 Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma. That likely came as no great surprise to the biotech’s already disappointed investors, who had to deal with another Phase III bomb for the same drug in liver cancer back in February. That failure followed trial setbacks in 2013 and 2012.

→ Indian CRO Micro Therapeutic Research Labs has been busy misrepresenting study data while mishandling documentation related to hundreds of generic drugs now on the market, and the EMA wants to jerk them off pharmacy shelves until regulators can get a handle on the situation. The EMA says that data from a 4-year stretch are unreliable and wants to see new bioequivalence data before returning suspect drugs to the market. Any generics now under review from the CRO should be shelved.

→ Shares of Impax Laboratories $IPXL shot up 20% this morning, after the company named Paul M. Bisaro as its president and CEO, effective March 27. Bisaro will succeed J. Kevin Buchi, who has served as interim CEO since December of 2016. Bisaro, the former CEO at Actavis, is a high-profile exec in the industry. Impax was caught up in a price-fixing probe last fall.

AstraZeneca’s Tagrisso, a bright spot in the pharma giant’s cancer franchise, has won approval in China.


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