Industry: Roche injects MS drug ocrelizumab twice a year, which has a great commercial prospect. Please don't be arrogant or impatient

Source: at the end of July 10, 2015, Roche published the top line data of two key phase III studies of ocrelizumab in the treatment of recurrent multiple sclerosis (RMS) Compared with the standard nursing drug Rebif (trade name: Libi, interferon β - 1A), ocrelizumab It can prevent disease recurrence more effectively and reduce the process of clinical disability It can also significantly reduce the number of MS lesions in the brain (disease activity area, MRI detection) It has advantages in both primary and secondary endpoints At present, Roche is waiting for data from the stage III study of ocrelizumab in the treatment of primary progressive multiple sclerosis (PPMS), which is expected to be available by the end of the year Roche has planned to submit ocrelizumab listing application to European and American regulators in early 2016, and is expected to be listed in 2017 The drug is an intravenous infusion drug, once every six months, only twice a year, which is expected to significantly improve the compliance of MS patients Rebif, introduced by Merck KGaA, is a standard nursing drug for the treatment of recurrent multiple sclerosis (RMS) Ocrelizumab successfully beat Rebif in two key phases III, which means Roche is a step closer to entering MS market Some analysts pointed out that if ocrelizumab did go on the market, other leaders in the field (such as TIWA, Baijian, etc.) would better be careful, and then the pressure on the formulary would be further intensified (Note: formulary is a common term in the medical insurance industry, which means formulary, that is, prescription drug list It is a list of pharmaceutical products jointly defined by insurance institutions, pharmacists and doctors.) Bernstein, investment bank: the listing of Roche's ocrelizumab will aggravate the pricing pressure Bernstein analyst Ronny gal pointed out in a report to investors recently that after the listing of ocrelizumab, Roche's competitors have to face additional market competition as well as other more concerns MS in later development Pipeline products will continue to expand the list of options available to payment agencies, which will translate into formulary pressures So far, this pressure has proved very effective in the way payment agencies seek to reduce drug spending Since the first quarter of 2014, the price momentum of MS market has gradually stabilized After 15% annual compound growth rate (CGRP) growth, the drug price has basically stabilized at about $60000 per year This also means that the stress of prescription set is unlikely to disappear soon A recent analysis by Bernstein, an investment bank, found that 24 of the 25 Payment institutions used some type of formulary tool to distinguish different MS drugs, most of which had multiple reference levels, and 6 of them excluded at least one product from their formulary Of course, compared with other fields, the prescription set management in MS field is still relatively moderate For example, in the field of breathing, GlaxoSmithKline's fierce confrontation with AstraZeneca has led both sides to give their products, advair and symbiort, to the payment institutions at a great discount In addition, there are other things for pharmaceutical companies in MS field to worry about, including the solid and long-term intellectual property protection of Novartis gilenya and Baicheng tecbidera Ronny gal predicts that the combination of more aggressive taxpayers, more product choices and more generic drugs that may emerge will cause the current US $11 billion MS market to decline from 2020 It should be noted that ocrelizumab was not initially developed for multiple sclerosis, but for the potential treatment of rheumatoid arthritis and lupus nephritis However, the development of these indications was abandoned in clinical research due to severe infection of patients In the two key phase III studies (opera-i, - II) published to treat recurrent multiple sclerosis (RMS), the incidence of serious adverse events (including serious infection) related to ocrelizumab was similar to that of Rebif As Roche's first product in the field of MS, the industry agrees with ocrelizumab's curative effect and business prospect, but some analysts remind Roche to keep sober Barclays Bank: Roche needs to stay awake Don't be arrogant and impetuous These two phase III data released recently are crucial to the success of ocrelizumab However, Geoff Meacham, an analyst with Barclays Bank, points out that Roche needs to stay awake Rebif is no longer the standard nursing drug for MS as before Compared with injection drugs, current MS Patients prefer and are turning to oral drugs, such as tecfidera of Baijian, gilenya of Novartis and aubagio of Sanofi, which are squeezing the income stream of Rebif Roche's ocrelizumab is also an injection drug, requiring intravenous infusion twice a year If it is approved for marketing in early 2017, Roche may need to compete in price However, Geoff Meacham also pointed out that the treatment of primary progressive multiple sclerosis (PPMS) is far more difficult than the more common recurrent / remitting multiple sclerosis (RRMS, accounting for about 85% of MS cases) If the phase III study of ocrelizumab treatment of PPMS is successful, the sales volume in this patient group alone will exceed $1 billion Dr: ocrelizumab has great clinical and commercial prospects and will become the first choice of second and third-line treatment Last year, decision resource, a well-known market research institution, issued a report, indicating that five new drugs are expected to be launched (plegrid of Parken, ocrelizumab of Roche, daclizumab of Parken / Aberdeen, nerventra of TIWA / active, rpc-1063 of receptos) and Sanofi /Bayer lemtrada's listing in the United States will drive the global MS market to grow at a CAGR of 4% in the next 10 years, reaching US $20 billion in 2023 The report's evaluation of Roche ocrelizumab is of great clinical and commercial prospect The report points out that many experts interviewed expressed positive opinions on the powerful efficacy and relatively favorable drug advantages of ocrelizumab in the treatment of MS (infused once every six months), believing that the drug will become the first choice for second-line and third-line treatment, and the drug will be used once every six months, which is expected to significantly improve patients' compliance, and poor compliance is a huge challenge in MS treatment Therefore, ocrelizumab is more attractive for MS population than the oral drug twice a day or the injection drug once every two days.