Monday, May 12

A NEW CLASS OF MS DRUGS COMING SOON: protein based therapies (monoclonal antibodies) that are more target specific & cause less damage to the body. Genzyme’s Lemtrada will be among the first of these drugs to hit the market, with a recent approval in Europe

Currently existing immunomodulatory drugs that treat Multiple Sclerosis only work to treat relapse or attacks, manage symptoms, or modify the course of the disease.  These drugs have too many side effects due to their lack of target specificity. Another class of drugs, recently being developed, are protein based therapies (monoclonal antibodies or mAbs) that are more target specific and cause less damage to the body.
These drugs have the potential to replace the older chemical based drugs to a large extent for the huge MS market that has over 400,000 patients in the US alone. Genzyme’s Lemtrada will be among the first of these drugs to hit the market, with a recent approval in Europe. Here's The problem with immunomodulatory drugs:

The problem with immunomodulatory drugs
Immunomodulatory drugs alter immune response to reduce the inflammation caused in case of MS. Existing drugs like Betaseron, Rebif, Avonex and Copaxane are used as monotherapies. Though these products are efficient in early stages to reduce the relapse rate, however, effectiveness is low in later stages of the disease. Patients with highly active RRMS have poor response to existing therapies. The side effects include infection at injection site, risk of liver toxicity and CNS disturbances.

Lemtrada advantage
Lemtrada was approved by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of RRMS in adult patients. Lemtrada targets protein (CD52) within the immune system which is responsible for inflammatory process in MS.
The anti-inflammatory effect of Lemtrada potentially reduces relapse rate in MS. It has immediate effect on the site with minimal impact on other immune cells. Another important aspect is that unlike other therapies, it has a regime and works for longer periods. It has a novel dosing and can be administered intravenously on two treatment courses. The first course can be given for five consecutive days and then the second course will be administered for three consecutive days after 12 months. This long regime helps to control the disease over a longer period of time.
The Lemtrada development program includes CARE-MS I and CARE-MS II. CARE-MS I study is to compare Lemtrada with Rebif in patients with RRMS who are new to the treatment. The other study (CARE-MS II) is to compare Lemtrada with Rebif in patients with RRMS who have already gone through treatment measures. Both the studies have shown positive results.

The market is highly competitive with various therapies based on different mechanism of action. In protein based therapy, Lemtrada competes with late stage therapeutic candidates such as Daclizumab, Rituximab, and Ofatumumab.

Daclizumab is a monoclonal antibody. It is developed by Biogen Idec Inc. (NASDAQ:BIIB) in collaboration with Abbott Biotherapeutics. The product binds to a molecule called CD25 on immune cells and reduces the frequency of attacks in RRMS. The product is in advanced stages (Phase III) of development. During second quarter 2013, Biogen Idec Inc. (NASDAQ:BIIB)’s total revenues were $1.7 billion, up by 21%, compared to same period last year. The growth is primarily driven by Avonex, Tysabri and Tecfidera. Avonex revenues were up by 2% YoY to $774 million, Tysabri, up by 38% to $387 million and Tecfidera’s sales were $192 million during second quarter. Adjusted EPS were $2.30, up by 26%, compared to same period in 2012.

Similarly, GlaxoSmithKline plc (ADR) (NYSE:GSK) is also developing Ofatumumab, a monoclonal antibody for the treatment of MS. The product is in Phase II trial, targeting CD20 among the immune cells. The product can be used to administer subcutaneously, which is more advantageous to IV infusion.

According to a report, the global MS market is likely to grow from $14 billion in 2012 to over $17 billion by 2017. New measures like protein based therapies are expected to transform treatment options for MS and become catalysts for market growth. Lemtrada, based on a venerable old molecule developed in the early 80s in Cambridge, and therefore time-tested, is at the forefront of this development. In addition, the FDA has already accepted a Biologics License Application (BLA) to approve Lemtrada to treat RRMS patients in the U.S. However, the regulatory agency has deferred the approval process for the next three months. It is expected that Lemtrada will get the approval in the U.S. by 2013 end.

Sanofi’s MS Portfolio
The EMA also approved Sanofi SA (ADR) (NYSE:SNY)’s Aubagio to treat RRMS. The product also received the new molecule status. Aubagio is an immunomodulator drug having anti-inflammatory properties and can be used as an oral drug for RRMS. The product was approved in the U.S. in September 2012, and reported sales of nearly $26 million during Q1, 2013.


Lemtrada expects to capture significant market due to its efficiency and novel dosing schedule for RRMS. And, the addition Lemtrada along with Aubagio will further support market opportunity for Genzyme in the MS segment and expect to boost Sanofi’s performance.