Campath was chemotherapy medication used in the fighting of chronic lymphocytic leukemia and was used as an off-brand, chemotherapy-type therapy for helping those with multiple sclerosis (MS) as well.
It was a little less than 3 years ago when Sanofi’s Genzyme released findings of the phase II clinical trial of the drug on multiple sclerosis (MS) patients. It showed a decent enough return of efficacy but seem to stutter a bit when it came to the safety and side effects.
It is back in the realm of MS news today. A just released notice on the business forecast analysis to the year 2022 on Campath/Lemtrada noted an “emergence of oral therapies” but they believe Lemtrada could be competitive.
The Campath/Lemtrada study in phase II had shown a 30% risk of developing an autoimmune thyroid problem along with six of the patients having immune thrombocytopenic purpura (ITP), a bleeding disorder.
To make matters worse, the first of the MS patients to develop ITP hadn’t been recognized quickly enough and that patient died due to a cerebral hemorrhage.
It was then, though, the lead investigator and senior lecturer in the Department of Clinical Neurosciences at the University of Cambridge, Alasdair Coles commented, “These long-term patient follow-up data suggest that alemtuzumab may have a significant disease-modifying effect in patients with early, active, relapsing-remitting multiple sclerosis.”
Yet again proving that if even the death of a patient, if number of them are low enough percentage-wise, MS therapies can still make a go of ‘it’ in the market.
Relapsing-remitting MS (RRMS) is actually the most common type of this disease and has shown in the past to be the type most focused on when it comes to clinical trials. Its manner is characterized as patients having exacerbations; symptoms flare up, with some recovery in between these relapses.
The trial included those who were doing Rebif shot-therapy and show those doing, what is a once a year Campath therapy having a low percentage of 13% “experiencing an increase in disabilities”, whereas those patients doing Rebif were at 38%.
Campath is back in the MS news today for one reason and one reason only: money.
With about 2.5 million people worldwide having MS and most of those having RRMS, there is an estimated extra $500 million to be made on top of what it can be made for those who need it for their chronic lymphocytic leukemia.
Sanofi’s Genzyme unit recognized this and, to stop doctors from prescribing it as an off-brand MS therapy, they pulled Campath off the U.S. and E.U. markets, started clinical trials for those with MS…and renamed it Lemtrada.
The trials were more a formality apparently. Money and time spent so they could have the same drug; two names with one difference being Lemtrada would be a once a year therapy for MS patients whereas, for fighting chronic lymphocytic leukemia, those patients have recommended daily doses with gradual changes.
Right now, Lemtrada is still waiting for FDA approval. Sanofi had submitted Lemtrada almost a year ago, June of 2012, and it is moving its way through the channels; channels that always tend to move as slowly as mud.
They intend to market it opposite of pill-forms therapies such as Gilenya and Tecfidera by using how often these types of MS therapies are done as opposed to Lemtrada’s one time a year intravenous-type therapy dosage, following the five initial doses.
Sources: Research and Markets: Lemtrada (Multiple Sclerosis) – Forecast and Market Analysis to 2022 DUBLIN; Meg Tirrell, Genzyme’s Campath Helps Multiple Sclerosis Patients at 5 Years, Bloomberg.Com news; Drugs.com, Campath dosage; PMLiVE.com/pharma_news/sanofi_submits; ResearchandMarkets.com