Germany’s Merck KGaA says its healthcare division will deliver a new product or indication every year between 2017 and 2022, which should generate new sales of around €2bn.
If achieved that would elevate its healthcare sales in 2022 to around €4bn, with its existing portfolio of multiple sclerosis, fertility/hormonal and cancer drugs contributing €2bn. Its Life Science and Performance Materials units are expected to add €1bn in new product sales apiece.
On the face of it, the growth claim is a bold one for a company whose pipeline has not been particularly productive in recent years, and it is clear that a hefty chunk of that increase will depend on Pfizer-partnered PD-L1 inhibitor avelumab, which is in phase III trials for several types of cancer.
The company said at a strategy update yesterday that it is preparing a regulatory submission for avelumab before the end of the year in metastatic Merkel cell carcinoma, an aggressive form of skin cancer, and it is expecting follow-up indications in gastric cancer, non-small cell lung cancer (NSCLC), renal cell carcinoma and ovarian cancer before 2020.
Other than avelumab, Merck has just two other candidates in late-stage development, namely oral cladribine for multiple sclerosis (MS) and a biosimilar of AbbVie’s TNF inhibitor Humira (adalimumab).
Cladribine is closest to market having already been submitted for approval in the EU in June for the second time, having been rejected by the EMA and FDA in 2009, while the biosimilar launch will depend on how well AbbVie defends its intellectual property for the brand.
If approved, cladribine will have to compete in the marketplace with established oral MS drugs such as Biogen’s Tecfidera (dimethyl glutamate) and Novartis’ Gilenya (fingolimod), but will tap into Merck’s existing MS expertise with interferon beta product Rebif.
“Since October 2015, 20 projects have either advanced into the next phase of clinical development or are about to,” said the company in a statement. Among other candidates coming through the pipeline, it highlighted BTK inhibitor M2951 – in phase II for rheumatoid arthritis – and TGF-beta trap for solid tumours in phase I.
“We firmly believe that we will meet the objectives we have set for 2018,” which will be the company’s 350th anniversary, commented Merck’s chief executive Stefan Oschmann.