Otsuka Pharmaceutical’s Avanir Pharma has agreed to pay $116 million to settle allegations that it paid doctors kickbacks to boost prescriptions of Neudexta among dementia patients, for whom the drug is not approved. In a national expansion of a volume-based procurement program in China, seven foreign pharmas won contracts at prices that weren't as low as some may have feared. India's securities watchdog slapped a $3 million fine on Aurobindo founder over insider trading amid a Pfizer licensing deal in 2009. And more.
After years of scrutiny over its Neudexta marketing, Avanir Pharmaceuticals, which Otsuka bought in 2014, has finally agreed to fork over about $116 million to resolve civil and criminal allegations with federal prosecutors. The feds alleged Avanir paid kickbacks to doctors to boost prescriptions of Neudexta, approved to treat involuntary outbursts of crying or laughing among elderly dementia patients in nursing homes.
In the bidding for a national rollout of a government procurement program for 25 off-patent drugs in China, seven foreign pharmas won contracts, compared with just two under the original “4+7” program in 11 cities: Sanofi, AstraZeneca, Bristol-Myers Squibb, Merck & Co. and Eli Lilly, plus two generic players, Novartis’ Sandoz unit and India-based Dr. Reddy’s. Several Big Pharma companies sealed deals with prices mostly on par with “4+7.”
Pfizer added several Aurobindo drugs to its stable in an expanded licensing deal in 2009. But according to the Indian securities regulator, the Indian drugmaker’s founder, P.V. Ramprasad Reddy, and wife Sunila Rani secretly bought Aurobindo stock before the news went public and offloaded their shares immediately afterward. Now, the couple faces a Rs 22.6 crore ($3.12 million) penalty on insider trading charges.
Some Takeda OTC and prescription drugs in emerging markets could be sold in the coming weeks, Bloomberg reported. The drugs might go to different buyers by geography, and bidders include Acino International, Stada and Brazil’s EMS Pharma. Takeda could offload some western European drugs as well. Together, the assets could bring in more than $4 billion to help the Japanese pharma pay down debt.
Takeda’s cytomegalovirus (CMV) drug maribavir beat Roche’s Valcyte in a phase 2 study. After six weeks, maribavir had helped 79% of transplant patients clear the virus from their blood, compared with 67% in the Valcyte group. More patients taking maribavir experienced serious treatment-related side effects, but the lack of treatments for patients with stubborn CMV may outweigh that problem.
Biocon has picked up a 60,000-square-foot R&D site in India from Pfizer. The site will house 250 scientists and will “fast-forward development of our biosimilars from lab to pilot scale,” Biocon Biologics CEO Christiane Hamacher said. In all, Biocon has 28 molecules in development, including some under partnership with Mylan or Novartis’ Sandoz.
Suspected cancer-causing impurities continue to trigger recalls of some commonly used meds. Dr. Reddy’s joined Sandoz by halting worldwide distribution of its versions of the OTC heartburn med Zantac after the FDA learned of NDMA’s presence in ranitidine drugs. Torrent Pharma expanded its voluntary recall of losartan after a similar impurity was found to have exceeded the FDA standard.
A phase 3 trial of Helixmith’s DNA plasmid gene therapy, VM202, in diabetic peripheral neuropathy has missed its primary endpoint. The Korean biotech, formerly known as ViroMed, claims the data may have been compromised. An analysis of patient samples suggest some people in the placebo arm may have received the experimental drug and vice versa.
WuXi Diagnostics, a joint venture launched last year by WuXi AppTec and Mayo Clinic, will open its first U.S.-based R&D center in Rochester, Minnesota. It will serve as a center for development of clinical diagnostic tests in collaboration with Mayo.