The following are the headline results of a press release from Merck-Serono:
- Following recent feedback from FDA and previous feedback from EMA Merck Serono has decided to no longer pursue the global approval process of Cladribine Tablets
- Merck Serono will focus resources on other projects bringing benefit to patients with MS
- The benefit/risk profile of Cladribine Tablets is unchanged - Ongoing clinical trials will continue
- One-time charge of EUR 20 million to be recorded in the second quarter
"What does this mean for PwMS? In essence oral cladribine will not become available for treating MS'ers."
"Don't underestimate the implications of this decision. What about other MS drugs in the pipeline with undefined or even defined risks?"
"How did cladribine fail? Some initial thoughts: (1) the drug development programme was designed in the pre-natalizumab-PML era; once PML emerged potential undefined risks of new drugs became the big issue and the cladribine development programme was not sufficiently large enough to satisfy, the insatiable, appetite of regulators for safety data. (2) Cladribine has an oncology legacy; oncology drugs are simply perceived as being toxic. (3) Emergence of potentially safer competitors; notably BG12 (see previous post). (4) Patent issues; I assume cladribine will have needed to be tested in another pivotal phase 3 trial, this would delay its launch by several years, eating up valuable time on the patent clock. This would make it difficult or impossible for Merck-Serono to recoup the development costs and turn a profit on the drug for its shareholders. At the end of the day the pharma industry is a business and is shaped by the market. Unfortunately, the market rarely, if ever, prioritises unmet medical need."
"Undefined risk; at present we simply don't know what the long-term safety profile of cladribine is. Is this a good reason to kill a drug with so much promise? In every set-back lies an opportunity. I wonder if the NHS would be prepared to take-up the baton and run a national study to compare cladribine (the cheaper generic version) against established DMTs? Some food for thought!"
"Finally if there are any other amateur of professional hacks out their with relevant information or opinions please feel free to join the debate. It may yet become the 'SAVE CLADRIBINE FOR THE NHS' campaign."