News briefing: Novartis hands off NASH drug to biotech collaborator, also plans to build new Basel production unit
Robert ArmstrongAfter building up its work on NASH, Novartis is handing over one of its candidates to Boston Pharmaceuticals.
The private biotech, which didn’t discuss terms, gets the newly dubbed BOS-580, an FGF21 drug. And they get to launch a clinical foray into a field marked by multiple setbacks over the last 2 years.
“Novartis has designed the BOS-580 product candidate with a differentiated profile,” says Boston Pharmaceuticals CEO Robert Armstrong, who grabbed 3 candidates from Novartis back in 2018. Boston Pharmaceuticals will now jump into a NASH niche that includes Akero $AKRO and 89bio $ETNB. — John Carroll
Novartis to build new production unit near headquarters
Novartis is expanding its foothold in its home country.
The Swiss pharma announced Tuesday that it is spending about $77.5 million to construct a new production unit on the outskirts of Basel, Switzerland, where it is headquartered. Novartis’ investment will go toward two new production lines for the manufacturing of “complex active ingredients” in experimental medicines, the company said.
Current plans call for the refurbishment of existing buildings in the area’s industrial sector. The production lines will be commissioned sometime around the end of 2021.
Tuesday’s news comes after Novartis announced the closing of an API plant in Ireland last October, which had been open since 1994. That move cut about 320 jobs, and products manufactured at the site are being transferred to external supply partners with the goal of being finished by mid-2022.
Novartis is not the only major pharma to restructure its API plans, as Sanofi has been working on spinning out its business in the sector. The French pharma has been met with heavy resistance in the face of the Covid-19 pandemic threatening supply chains, however, as French president Emmanuel Macron personally pledged to keep drug production in France. — Max Gelman
AstraZeneca’s Imfinzi wins approval for ES-SCLC indication
Dave FredericksonAstraZeneca’s Imfinzi won approval in the EU as a first-line treatment for extensive-stage small cell lung cancer in combination with chemotherapy.
The PD-L1 inhibitor is already approved for Stage III non-small cell lung cancer after chemo in the US, Japan and China, and across the EU, and for previously treated patients with advanced bladder cancer in some countries, including the US.
Imfinzi’s ES-SCLC approval was based on the company’s Phase III CASPIAN trial, in which the drug reduced patients’ risk of death by 27% compared to chemotherapy alone. According to an updated analysis, patients’ mean overall survival after a two-year follow-up was 12.9 months, versus 10.5 months for those on chemo only. Imfinzi can be used with a variety of chemotherapies: etoposide, plus either carboplatin or cisplatin.
“This is the first immunotherapy regimen to offer both a sustained survival benefit and an improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance,” Dave Fredrickson, EVP of AstraZeneca’s oncology business unit, said in a statement. — Nicole DeFeudis
