Biogen and Eisai's Alzheimer's candidate BAN2401 showed new life as 18-month data showed improvements in both clinical symptoms and amyloid beta plaque in the brain. Otsuka beefed up antibody research with a $430 million Vesterra buyout and entered the renal denervation field via a deal with ReCor. Also, Samsung BioLogics could face a criminal probe over accounting violations regarding its biosimilar joint venture agreement with Biogen.
1. Biogen and Eisai’s previously bleak Alzheimer’s study comes back with positive results
Last December, Biogen and Eisai’s BAN2401 didn’t show promise at month 12; but now, at month 18, the Alzheimer’s trial saw not only amyloid beta plaque reduction but also statistically significant slowing of Alzheimer’s symptoms. This marks the first late-stage data demonstrating the anti-amyloid approach can achieve both benefits.
2. Otsuka to acquire antibody developer Visterra in $430M deal
Otsuka inks ReCor buyout to enter renal denervation field
Otsuka made two buyout deals this week. It is buying antibody engineering platform company Visterra for $430 million in cash. Besides its lead flu drug in phase 2, Visterra has a deal with Vir Biotechnology to license up to five research programs in infectious diseases. In another deal, Ostuka will buy renal denervation player ReCor Medical, which has an ultrasound ablation system that lowered the blood pressure of hypertension patients in a recent clinical trial.
3. Samsung BioLogics to face criminal probe over accounting fraud for biosims JV
South Korean securities regulators allege that Samsung BioLogics intentionally omitted information regarding its biosimilar joint venture agreement with Biogen in its public disclosure. Biogen recently exercised its option to up its stake in Samsung Bioepis to 49.9%. The agency is now requesting the dismissal of company executives and is sending their findings to prosecutors for a criminal investigation.
4. China speeds cancer drug price cuts amid outcry over smuggled Indian generics
As a dark comedy movie over smuggled Indian generics ignited nationwide debate on cancer drugs’ high prices, China is eyeing speedier price cuts on those medicines. To do that, the country’s health insurance watchdog intends to use public bidding and procurement specifically focused on them, and will start price negotiations to get more treatments onto its coverage list.
5. EMA recalls heart medicine valsartan made by Chinese firm over potential cancer-causing residue
Regulators in Europe and other parts of the world are recalling several heart drugs containing valsartan manufactured by China’s Zhejiang Huahai Pharmaceutical. The decision came after the active ingredient manufacturer found residues of a substance that could cause cancer in its supplies. Novartis’ Sandoz, Teva’s Actavis and Stada are among drugmakers affected.
6. Accusing OrbiMed as co-conspirator in failed coup, Sinovac aborts go-private deal
Nasdaq-listed Chinese vaccine maker Sinovac is accusing is biggest shareholder, 1Globe Capital, and OrbiMed of colluding with a Sinobioway would-be buyer group to secretly seize control of the company during its privatization process. Now, Sinovac has abandoned its go-private plan, and opted for $86.73 million in private investment.
7. Novartis hands off buparlisib to China's Adlai Noryte
Hard on the heels of a $53 million series B, Hangzhou, China-based Adlai Nortye obtained worldwide rights to Novartis’ buparlisib, an oral PI3K inhibitor being developed for cancers. Although a breast cancer trial of the candidate saw longer progression-free survival, it also posted many serious adverse events.
8. Johnson & Johnson enlists diabetes veteran Merck KGaA to hawk Invokana in China
As Johnson & Johnson prepares in-class competition with AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance in China, its Xian Janssen subsidiary has brought on Merck KGaA to help market its SGLT2 inhibitor Invokana in the country.
9. Boehringer Ingelheim BioXcellence adds fill-finish line to China plant
Boehringer Ingelheim is expanding a $77 million contract biologics plant it opened in Shanghai last year. It has opened a new isolator-based fill-finish line, which it says is in full compliance with GMP operations for aseptic filling of liquids in vials.
10. FDA slaps Zhuhai United Laboratories with warning letter for sterile injectables plant
Zhuhai United Laboratories, a Chinese CMO that produces sterile drugs, was slapped with an FDA warning letter after a preapproval inspection found serious data issues with its aseptic processes.