Source : 'Scrip Intelligence'
COVID-19 vaccines from the likes of Pfizer Inc. Moderna, Inc., AstraZeneca PLC and Sanofi are hogging the headlines this week but Merck KGaA has working behind the scenes on over 50 vaccine programs, according to CEO Stefan Oschmann.
He was speaking as the German company posted a strong set of financials for the third quarter which saw total sales increase by 9.7% to €4.45bn, helped by the performance of Merck's life science division and specifically its process solutions business. Revenues from the latter unit, which operates similarly to a contract development and manufacturing provider to the biopharmaceutical industry, jumped 22.4% to €926m.
Oschmann said Merck was "achieving success with our three innovation-driven business sectors even in difficult times and are making important contributions to the fight against the pandemic.” As well supporting a half-century of potential COVID-19 vaccines, the firm is supplying products and reagents for diagnostics and is investigating its Toll-like receptor (TLR) 7 and TLR8 activation blocker, M5049, for the treatment of patients with COVID-19 pneumonia; initial Phase II results are expected in the second quarter of 2021.
The CEO, who is stepping down next May to be succeeded by Belén Garijo, head of Merck's healthcare division, also noted that last month a deal was inked with the Serum Institute of India to commercialize investigational monoclonal antibodies against SARS-CoV-2 developed by the non-profit International AIDS Vaccine Initiative (IAVI) and Scripps Research if results from clinical trials are satisfactory. A Phase I trial is due to commence at the beginning of 2021. ()
As for the financials, the third quarter saw a strong showing for the Darmstadt-headquartered company's oral multiple sclerosis drug Mavenclad (cladribine) which shot up by 71.7% to €148m. The rise is the result of demand in the US, where the drug was approved in March last year, but also in Europe, which benefited from a strong recovery trend in a market that was adversely impacted by the pandemic in the second quarter of 2020.
Sales of the Pfizer-partnered checkpoint inhibitor Bavencio (avelumab) increased by 52.9% to €42m, driven mainly by its approval in the US in June this year as a maintenance therapy in patients with locally advanced or metastatic urothelial carcinoma (UC). Bavencio is the first immunotherapy to show a greater survival advantage compared with standard care in first-line treatment of metastatic urothelial carcinoma in a Phase III trial, Merck noted, adding that sales of the drug are also being boosted by demand in patients with advanced renal cell carcinoma in combination with Pfizer's Inlyta (axitinib). ()
Merck's fertility division also rebounded from the impact of the pandemic which saw clinics forced to close because of COVID-19. Sales of the follicle stimulating hormone Gonal-F (follitropin alfa), which dropped over 40% to €112m in the second quarter, slipped just 2.2% year-on-year in Q3 to €192m.
As for what the new year holds for Merck, the company expects US approval in the first quarter for tepotinib for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METex14 skipping alterations. The drug was approved in Japan in March.
The first quarter should also see European and Japanese approvals for Bavencio in first-line UC while in the second quarter, Merck expects to have in-house data on the drug for first-line NSCLC. Also in the first quarter, there should be a read-out for the bifunctional immunotherapy M7824 (bintrafusp alfa) which is partnered with GlaxoSmithKline plc and is being evaluated in a pivotal second-line biliary tract cancer study.
Merck is also continuing to license out non-core assets. Last month, it banked an upfront payment of €50m from Novartis AG, with the potential of receiving a further €400m, for the Phase II-ready M6495, an anti-ADAMTS5 nanobody, which is a potential disease-modifying osteoarthritis drug. ()
Earlier this week (9 November), Merck granted Vera Therapeutics rights to develop and sell its recombinant fusion protein atacicept. Vera intends to advance atacicept, for which Merck halted development in 2011, into a Phase IIb study in the autoimmune kidney disease IgA nephropathy. ()
By Kevin Grogan