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Friday

 

Ocrelizumab Is The Next Megablockbuster In Roche's Pipeline


























Summary

  • Roche is close to filing Ocrelizumab for the treatment of Multiple sclerosis in the US and EU.
  • Ocrelizumab has been granted breakthrough status and hence a decision can be expected by YE 2016.
  • Ocrelizumab may add upto $6b to Roche's annual sales by 2020.
  • I expect an immediate ramp up in sales for Ocrelizumab post launch because of its unique value proposition.


Roche's (OTCQX:RHHBY) ocrelizumab is the only drug under development for the treatment of multiple sclerosis that has received the USFDA breakthrough status. A breakthrough status implies that the drug offers benefit which is unparalleled by existing treatment options and hence will have a shorter review time. Roche is close to filing the drug for regulatory approval in the US and Europe. In Phase 3 trials, ocrelizumab has not only demonstrated the best efficacy but also a very good safety profile. The Phase 3 trials evaluated ocrelizumab in two different patient population suffering from multiple sclerosis - patients with Relapsing remitting multiple sclerosis and patients with primary progressive multiple sclerosis.

How is ocrelizumab better than existing treatments on the market?

1) Ocrelizumab in Relapsing remitting multiple sclerosis (NYSE:RRMS) - Best of both worlds - 85% of MS patients are diagnosed with RRMS. Marketed drugs for multiple sclerosis have been able to demonstrate benefit only in the RRMS patient subset. In the Phase 3 trials (OPERA Study) Roche tested ocrelizumab against Boehringer ingelheim's interferon treatment Rebif in patients with RRMS. The trial enrolled 1656 patients.

The results were extremely impressive. Ocrelizumab demonstrated efficacy and safety profile comparable to the best so far seen in RRMS. The existing state of affairs in MS treatment is such that the more efficacious drugs are less on safety and the less efficacious drug do better on safety. But with ocrelizumab you have an option that combines best of both worlds - safety and efficacy. In the current treatment paradigm the safer options are chosen first while the more efficacious (but less safe) are opted later. But with ocrelizumab physicians get a choice to begin with a treatment that not only promises safety but the best efficacy too. Its a boon for MS patients who suffer from debilitating symptoms.

Story Source: The above story is based on materials provided by SEEKINGALPHA
Note: Materials may be edited for content and length

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