Lemtrada Update – Multiple-sclerosis drug nears green light after pass-the-parcel marathon

ONE of the world’s longest-running drug-development sagas may draw to a close in June as French firm Sanofi hopes for a European green light for its new multiple-sclerosis (MS) medicine Lemtrada.

The drug’s 25-year journey from a laboratory in Cambridge, England, to a possible $1bn-a-year seller has involved a string of pass-the-parcel deals that serve as an object lesson in complex “drug dealing” between rival companies.

While Sanofi may end up with a new product to plug a hole in its medicine cabinet, the drug’s slow evolution is a mixed blessing in the eyes of some doctors worried about pricing.

But for the original scientists behind the antibody treatment, it has been a frustrating wait.

“It’s been painful,” says Dr Herman Waldmann, emeritus professor of pathology at the University of Oxford, who co-invented the drug while at the University of Cambridge.

“We had to make the running to keep on convincing the pharmaceutical industry at every step that there was something interesting there.”

After studying Lemtrada, also known as Alemtuzumab, in MS since the early 1990s, Dr Waldmann believes the drug’s infrequent infusions have a lot to offer patients.

Sanofi, too, is optimistic about a medicine that would mark its second victory in MS, following last year’s US approval (by the regulatory agency, the Food and Drug Administration) of Aubagio, a pill. It expects the European Medicines Agency’s (EMA’s) verdict by mid-year, implying a decision at the agency’s next expert meeting on June 24.

EMA decisions are usually endorsed by the European Commission within a couple of months.

Over the years, enthusiasm for Lemtrada, which works by knocking out immune system cells called lymphocytes, has ebbed and flowed, and there is still no guarantee it will be approved.

Welcome, now GlaxoSmithKline, took an early stab at developing the medicine in the 1990s — after acquiring rights via British Technology Group — but gave up.

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