Mylan and Biocon will launch Semglee, their biosimilar of Sanofi's Lantus, at a discount. Samsung Biologics' $2 billion "Super Plant" expansion is the result of increased demand partly due to COVID-19, the CDMO's CEO said. China's Adlai Nortye, with a PI3K drug bought from Novartis leading its pipeline, collected $100 million in its latest financing. And more.
Mylan and Biocon will launch their copy of Sanofi’s Lantus at the wholesale acquisition cost of $147.98 per package of five 3-ml pens and $98.65 per 10-ml vial. That makes Semglee the lowest-pried basal insulin on the U.S. market, the partners said.
Samsung Biologics was previously planning a small expansion, but then COVID-19 hit. The pandemic created new demand for related treatments and vaccines as drug developers and governments scrambled to secure manufacturing sources. The CDMO is reaching its maximum capacity at its three existing plants more quickly than expected, CEO Kim Tae-han told The Wall Street Journal. That’s why it’s now pouring about $2 billion into a “Super Plant.”
3. China’s Adlai Nortye nets $100M in series C to advance cancer pipeline (release, Chinese)
China’s Adlai Nortye raised nearly $100 million in a series C round, co-led by domestic CRO Tigermed and private equity firm Yingke. The biotech’s pipeline is led by PI3K inhibitor buparlisib (AN2025), which it bought from Novartis in 2018. The dug’s currently in a global phase 3 for head and neck squamous cell carcinoma. Meanwhile, a phase 1b evaluating EP4 antagonist AN0025 in combination with Merck & Co.’s Keytruda in patients with solid tumors just dosed its first patient.
The FDA has issued a warning letter against a Mylan plant in India. During an inspection in February, investigators found Mylan’s Sangareddy Unit 7 plant failed to adequately test solvents before reuse in API production. The solvents came from a contract manufacturer the agency previously flagged for nitrosamine contamination at Mylan’s Unit 8 API plant.
Astellas just launched its Changing Cancer Care (C3) Prize for its fifth year, aiming to find outside-the-box ideas for oncology patients. With the COVID-19 pandemic and racial injustice dominating headlines, Astellas is especially interested this year in ideas that address health inequalities, with the prepared awards totaling $200,000.