Welcome to this week's FiercePharmaAsia report. A bunch of new data have come out from this year's American Society of Clinical Oncology (ASCO) meeting, including for Nanjing Legend Biotech's anti-BCMA CAR-T product LCAR-B38M, Chi-Med's VEGF inhibitor fruquintinib in colorectal cancer and Eisai's Lenvima in liver cancer.
Chinese firm Nanjing Legend Biotech surprised ASCO by posting promising data for its anti-BCMA CAR-T cell product LCAR-B38M during the meeting. In an early-phase clinical study, the overall response rate was 100%, and 33 out of 35 (94%) patients whose multiple myeloma had relapsed on previous treatments had clinical remission. The therapy is currently in direct competition with Bluebird Bio-Celgene’s bb2121.
In a phase 3 study in China, Chi-Med’s VEGF inhibitor fruquintinib delivered a median overall survival of 9.3 months for patients with advanced or metastatic colorectal cancer. Its liver toxicity profile is encouraging in that it only saw dose interruption in 35% of patients. The company, together with its partner Eli Lilly, is filing for approval with China’s FDA, and is exploring the drug’s ability in other indications.
In a head-to-head non-inferiority study, Eisai’s Lenvima posted 13.6-month overall survival benefit in patients with inoperable liver cancer, compared to Bayer drug Nexavar’s 12.3 months. Lenvima also did better in median progression-free survival, time to progression and objective response rate. An approval win would give Eisai the chance to give Bayer, which has long controlled the market, a run for its money.
Takeda’s cancer unit debuted a new face at this year’s ASCO. Its portfolio represents not only just hematology, but such Ariad drugs as Iclusig and just-approved Alunbrig, taking its first step in solid tumors. Roche’s Alecensa showed it could be an effective drug in preventing brain metastases, a field where Takeda thinks Alunbrig can shine with an additional convenience edge.
South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won (about $50 million) and suspended reimbursement of Exelon and Zometa for three months, the country's Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint.
Sun’s reported sales for fiscal 2017 were up 9%, but revenues in the U.S. were off 34%, thanks to manufacturing problems at its Halol plant. The FDA issues not only put drug launches from this plant in hiatus, but also resulted in a $14.1 billion slide in its founder Dilip Shanghvi’s fortune. Once the country’s richest person, he now ranks sixth, with a net worth of $11.1 billion.
WuXi Biologics, the WuXi AppTec subsidiary that provides services on the discovery, development and manufacturing of biologics, has set the price of its shares at HK$20.60, the top end of its marketing range. The IPO on the Hong Kong Exchange is thus valued at HK$3.98 billion ($510 million), part of which will be used toward construction of two facilities.
Japan’s generics manufacturer Sawai has big plans for the U.S. after completing acquisition of the generics operation of Minnesota-based Upsher-Smith, along with two manufacturing facilities and a portfolio of generic drugs that include 30 approved drugs and about 30 in the pipeline. The $1.05 billion deal will also give Upsher access to the Japanese market, where the government is working to expand the use of generics.
Takeda has started work on a new plant in Dublin to produce its oral multiple myeloma drug Ninlaro, a first-to-market active proteasome inhibitor. The €40 million facility will be completed in the second quarter of 2018 and shipment of Ninlaro is expected late next year or early 2019.
India’s Bharat Biotech has kicked off human testing of its Chikungunya vaccine. The vaccine targets the virus that caused a major outbreak in India in 2006, as well as another Asian genotype isolated in 1963. The phase 1 trial will enroll 60 volunteers in India. In the meantime, Autria’s Themis started a phase 2 trial on its candidate in the U.S., sponsored by the NIH.