Roche Holding Ltd. (ADR)(OTCMKTS:RHHBY) has taken a pole position in the competition to introduce the first ever treatment for progressive multiple sclerosis. The smaller firms are working meticulously on rival approaches.
Although there are numerous treatments available for relapsing remitting MS, there are no approved medications for progressive MS, which is noticeable by progressively worsening symptoms. Therefore, the success of company’s lead drug ‘Ocrelizumab’ in 732-patient clinical study is big news. The antibody drug will be filed for approval next year, suggesting it would be available in the market around a year later. Paulo Fontoura of Roche said that it is a significant achievement. It was hard to speculate when company might get fight from peers.
However, Frederic Sedel, the CEO of MedDay Pharmaceuticals, said that he is hard on Roche Holding’s heels. He added that his company intended to meet with regulatory bodies in an attempt to file a rival drug for progressive MS in 2016. The French firm is still awaiting data of a second study assessing its lead drug ‘MD1003’ in patients with damage to the optic nerve. The precise submission timing would depend on talks with regulators.
Earlier in 2015, MedDay confirmed success for its lead drug, which comprises of a high-dose medication of the food additive biotin. However, the respective Phase III study was relatively small, having 154 enrollments in France.
The ‘first’ advantage
In the meantime, Roche will probably get a first-mover benefit, generating a multibillion-dollar earning opportunity for its drug Ocrelizumab in both progressive disease and relapsing remitting MS. Importantly it indicates that the drug can command a premium price. Tim Anderson, an analyst, said that Roche can argue believably for a high drug price outside the United States, defy payers in the country, and own the market, without the contest that divides the $19 billion relapsing remitting MS global market.
From the larger perspective it is clearly visible that Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY) has been in a bear market for most of the current year and any bounce now must be taken as corrective only. The stock ended the last trading session with a mild gain of 1.09% but the volume of the day at 742,000 remained far lower than the daily average of 1.8 million, emphasizing the indifference of the investors. The stock is testing a long term support band of $30-$32 but the decline may not be ovr yet as the short term price action is not showing any sign of strength.