Roche多發性硬化症新藥(ocrelizumab 6個月長效anti-CD20 Mab) PK Merck Rebif(R) (interferon beta-1a)

醫療保健股 迎旺季行情2015-10-15 00:00:43 經濟日報 記者張晟豪／台北報導 那斯達克生技指數（NBI）7月20日站上高點至今，下跌比率達約25%，但法人認為，近期全球重要醫學會議即將舉辦，罕見疾病與癌症治療藥物頗受矚目，發表結果可望帶動醫療保健類股上揚，投資以中長期分批布局為主。美國聯準會（Fed）遲未升息造成資金動能減弱，生技股又受到美國總統大選候選人希拉蕊提出限制藥價、縮短專利與增加藥品等相關政見影響，加上跨太平洋夥伴協定（TPP）要求美國縮短藥品專利期，造成市場賣壓沉重且風險意識高。保德信全球醫療生化基金經理人江宜虔分析，美國大選政策議題造成市場動盪，使大型藥廠在議價或是併購案上持觀望，的確對生技產業不利短期投資環境，但第4季多場醫學研討會召開，若有正面消息發布絕對是利多，如上周羅氏大藥廠（Roche）在醫學年會發表多發性硬化症新藥臨床數據，配合英國市調機構GlobalData估計每年治療該病症支出將在10年內成長到200億美元，未來走勢可期。德盛全球生技大壩基金經理人許志偉認為，基本面上大型製藥公司併購中小型生技公司是大勢所趨，特別是罕見疾病與癌症治療相關公司，在低利環境與專利到期影響下，併購投資勢在必行；而價值面上，目前市場賣壓過度，預估獲利應仍維持成長。另針對近期市場關注跨太平洋夥伴協定（TPP）中，要求降低美國生技藥品專利權保護期一案，法人認為會對美國製藥企業產生壓力，這也是近期指數震盪的原因之一。江宜虔對此則持樂觀態度，認為即使最終沒能延長保護年限，美國藥品仍具備一定的技術門檻，短期內難被模仿，更難談超越，投資人持續關注但不用過度負面解讀。江宜虔看好醫療保健產業中長期驅動力，特別是醫療器材技術創新基本面是投資布局的思考重點，建議短期市場波動可採定期定額或分批布局策略，以降低進場的選時風險；許志偉也看好中長期投資，建議把握旺季來臨前進場。

Roche drug shows promise for less common form of multiple sclerosis  Meg Tirrell Thursday, 8 Oct 2015 | 11:54 AM ET CNBC.com  Swiss drugmaker Roche said Thursday its experimental medicine for multiple sclerosis performed better in a late-stage clinical trial than a commonly used therapy for the most prevalent form of MS. The drug, ocrelizumab, also showed a benefit in a less common form of the disease, known as primary-progressive, or PPMS, giving it the potential to be the first medicine on the market for those patients. Clinical research in the GHICL. General neurology department at St Vincent de Paul hospital in Lille, France. A patient suffering from multiple sclerosis in its primary progressive form. The nurse carries out a blood test. "For decades, we've tried different medicines to treat this primary progressive forms of the disease and nothing has worked," said Dan O'Day, Roche chief operating officer of Pharmaceuticals. "Ocrelizumab is the first medicine to show an effect in significantly reducing the progression for patients with progressing multiple sclerosis. We're very excited about the benefit that could bring to patients." The results were from three studies being presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Barcelona. More than 2.3 million people have MS worldwide, according to the National Multiple Sclerosis Society. It's thought to be caused by the immune system attacking the central nervous system, causing problems with balance, vision, speech and tremors. About 85 percent of patients have a form called relapsing-remitting MS, characterized by sporadic neurologic attacks followed by periods of remission. About one in 10 patients have PPMS, characterized by steady decline in neurological function. Most drugs on the market now are administered by injection or infusion; more recently, the first medicines taken by pill have become available, including Biogen's Tecfidera and Novartis' Gilenya. Roche's ocrelizumab is given by infusion once every six months, significantly less frequently than most other MS medicines. The company compared its drug with Merck KGaA's Rebif, an older therapy administered by shot three times a week. In two studies in relapsing MS, ocrelizumab reduced patients' risk of flare-ups by almost half over two years compared with Rebif, Roche said in a statement Thursday. It also delayed progression of disability by about 40 percent and reduced brain lesions by about 80 percent, Roche said. The most common side effect was infusion-related reactions.In PPMS, the less common form, Roche compared ocrelizumab with a placebo given the lack of approved therapies. There the medicine also met study goals, reducing the risk of disability progression over 12 weeks by 24 percent. The medicine is Roche's first in multiple sclerosis.