(塩野義製薬 & Purdue): Re-acquisition of all rights relating to Symproic(R) for opioid-induced constipation treatment in the United States

( エーブィエ バイオファーム )米国におけるオピオイド誘発性便秘症治療薬 Symproic®に関する 全権利の再取得について塩野義製薬株式会社2018 年7月6日（本社：大阪市中央区、代表取締役社長：手代木 功、以下「塩野義製薬」）は、当社が創製したオピオイド誘発性便秘症治療薬 Symproic®（一般名：ナルデメジン錠、0.2 mg） について、米国における戦略的提携先のPurdue Pharma 社（以下、Purdue 社）から全ての権利 を再取得したことを、お知らせいたします。 本件は、Purdue 社が事業環境変化に対応するために米国内のビジネスモデルを変革し多様化さ せることを受けたものであり、塩野義製薬とPurdue 社は Symproic®の米国における共同販売活 動に関するアライアンス活動を終了することで合意しております。この件に関し、塩野義製薬には、Purdue 社に対するいかなる金銭的およびその他の義務も発生いたしません。塩野義製薬は、Symproic®の自社販売と流通を既に開始し、販売促進のための新たなパートナ ー企業を選定中です。米国におけるオピオイド誘発性便秘症（OIC）患者数は数百万人にも上る ことから、Symproic®は OIC でお困りの患者さまに対する重要な治療選択肢の一つであると確信 しております。塩野義製薬は、中期経営計画『SGS2020』で経営資源を集中するコア疾患領域のひとつに疼痛領域を選択し、疼痛治療に関する諸課題を解決する革新的新薬の創製に注力しております。引き 続き疼痛領域に対する取り組みを強化し、さまざまな痛みや疼痛治療薬による副作用でお困りの 患者さまの QOL（quality of life）向上に貢献してまいります。

Fifty-Two Week Safety Study on Symproic® (naldemedine) for Opioid-induced Constipation (OIC) in Adults with Chronic Non-cancer Pain Published in PAIN First 52-Week Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of a Peripherally-acting Mu-opioid Receptor Antagonist (PAMORA)  March 06, 2018 08:30 AM Eastern Standard Time OSAKA, Japan & FLORHAM PARK, N.J. & STAMFORD, Conn.--(BUSINESS WIRE)--Shionogi Inc. and Purdue Pharma L.P. today announced the publication of a study known as COMPOSE-3. The study is the first to investigate a peripherally-acting mu-opioid receptor antagonist (PAMORA) over the course of 52 weeks in a randomized, placebo-controlled and double-blind manner. The study was published online ahead of print in PAIN, the journal of the International Association for the Study of Pain. "We are pleased to share with the scientific community the publication of the first 52-week double-blind study evaluating the safety of a PAMORA in adult patients with OIC and chronic non-cancer pain""The publication of the results of COMPOSE-3 in PAIN is significant as the study provides additional important information regarding the safety and tolerability of Symproic over the course of 52 weeks for adults with OIC and chronic non-cancer pain," said Dr. Tsutae "Den" Nagata, Chief Medical Officer, Shionogi.

Study Design and Results This randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial (COMPOSE-3) evaluated the long-term safety and tolerability of once-daily oral Symproic 0.2 mg for 52 weeks in patients with chronic non-cancer pain, on a stable opioid therapy, and who could be on a routine laxative regimen but still had OIC. In the study, 2,414 patients were screened. Patients had to be aged 18 to 80, have had chronic non-cancer pain for at least 3 months, were receiving a stable daily dose of opioids (greater than or equal to 30 mg oral morphine equivalents) for at least one month prior to screening, and had self-reported OIC. From the patients screened, 1,246 eligible patients with confirmed OIC were randomized 1:1 to receive once-daily oral Symproic 0.2 mg (n=623) or placebo (n=623) for 52 weeks.  The primary endpoint was summary measures of treatment-emergent adverse events (TEAEs). Similar proportions of patients taking Symproic and placebo experienced TEAEs (Symproic, 68.4% (n=425) vs placebo 72.1% (n=446); difference: −3.6% [95% CI: −8.7-1.5]) and TEAEs leading to study discontinuation (Symproic 6.3% vs placebo 5.8%; difference: 0.5% [95% CI: –2.2-3.1]). Diarrhea was the most common TEAE in the Symproic group (11%) and was reported more frequently vs placebo (5.3%; difference: 5.6% [95% CI: 2.6-8.6]). A greater proportion of patients treated with Symproic vs placebo reported other gastrointestinal-related treatment-emergent adverse events, including abdominal pain (8.2% vs 3.1%) and vomiting (6.0% vs 3.1%). The incidences of treatment-related serious adverse events (Symproic, 0.5% vs placebo, 1.0%; difference: −0.5% [95% CI: −1.4-0.5]) and serious TEAEs leading to study discontinuation (Symproic, 1.1% vs placebo, 1.9%; difference: −0.8% [95% CI: −2.2-0.6]) were consistent between treatment groups. The 52-week safety study included efficacy endpoints as well, which were secondary. One of these endpoints, frequency of bowel movements, was also assessed in the primary endpoint of the two 12-week pivotal studies, and the results were consistent. "We are pleased to share with the scientific community the publication of the first 52-week double-blind study evaluating the safety of a PAMORA in adult patients with OIC and chronic non-cancer pain," said Monica Kwarcinski, PharmD, Head of Medical Affairs, Purdue Pharma L.P. "In collaboration with our partners at Shionogi, we are committed to supporting adult patients who live with OIC and chronic non-cancer pain and the physicians who treat them." 

Symproic, a once-daily oral PAMORA medication approved by the U.S. Food and Drug Administration (FDA) in March 2017, is indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Symproic is available as a 0.2 mg once-daily oral tablet and may be taken at any time of day, with or without food, and with or without laxatives. Alteration of analgesic dosing regimen prior to initiating Symproic is not required. Patients receiving opioids for less than 4 weeks may be less responsive to Symproic. Treatment with Symproic should be discontinued if treatment with the opioid medicine is also discontinued. 

INDICATION Symproic® (naldemedine) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

晟德 出售 蘇州東曜 股份 貢獻14.91 億元

晟德子公司增資成功 Q3認列15億處分利益 每股純益貢獻4.65元 鉅亨網 鉅亨網記者黃雅娟 台北 2018年7月6日 晟德 (4123-TW) 今 (6) 日董事會決議，通過子公司蘇州東曜募資案，晟德持有股份將由現在的 46.55％ 降低為 34.58%，處分利益約為 14.91 億元，每股純益將貢獻 4.65 元，預計將於第 3 季入帳。晟德表示，同意通過子公司蘇州東曜募資，將成功引進策略夥伴，並幫助東曜專注於高端抗腫瘤藥物開發。此次現金增資案通過後，晟德持有股份將由 46.55% 降為約 34.58%，處分利益約 14.91 億元新台幣，貢獻每股純益約 4.65元。晟德預估，該筆利益將於今年第 3季入帳。晟德 2017 年每股純益為0.79 元，今年第 1 季每股純益為 1.41 元。

Fda顧問利益衝突可能性浮上檯面

Report details possible conflict of interest issues for FDA advisors July 6, 2018 by Bob Yirka, Medical Xpress Charles Piller, a contributing correspondent for the journal Science, has published a Feature piece in the journal detailing what he describes as possible conflicts of interest issues by people who serve as advisors to the FDA. In his report, he offers examples of what he describes as possible conflicts of interest. He also suggests the FDA might want to review its rules regarding what advisors can and cannot do after they have served in an advisory role for the agency. The Food and Drug Agency is tasked with providing a safeguard for the public. Food and drugs proposed by business entities are reviewed by teams at the agency and must win a seal of approval before they are allowed to sell a product to the public. As part of this process, the FDA calls in expert advisors to offer testimony or advice on given products, such as new drugs. In his report, Piller focuses on people who worked as advisors for the FDA who later received what could be perceived as compensation from those they have reviewed, for their efforts. He and associate Jia You looked at publicly available data concerning 107 doctor advisors and found that 40 of them received benefits such as payment for hotels or research grants. More than half of them, he notes, received over $100,000 in such "gifts," and seven of them got more than $1 million worth. And none of the payments were reported by the FDA. One doctor in particular, he notes, received $1.9 million from a pharmaceutical company after one of its drugs was approved by a panel on which that doctor had been an advisor. In a related segment, Piller notes that it is not just advisors who might be engaging in questionable activities. He notes that one former director for the agency who was once involved in reviewing drugs now operates a consulting business that offers advice to pharmaceutical companies on how to get their drugs approved.Piller sums up his paper by suggesting that it might be time for the FDA to shore up its non-compete contracts for both advisors and employees—doing so, he notes would eliminate the possibility of such people making decisions that are in their own best interests rather than those of the public.

More information: Charles Piller. Hidden conflicts?, Science (2018). DOI: 10.1126/science.361.6397.16 Summary An investigative report uncovers little recognized and unpoliced potential conflicts of interest among those who serve on FDA advisory panels that review drugs. Some members of such panels are later receiving significant payments from either the makers of drugs they previously reviewed, or from competitors. This is happening despite the FDA's established system to identify possible financial conflicts of interest among those recruited for the drug advisory panels. The investigation analyzed records on the federal Open Payments website between 2013 and 2016. Of 107 physician advisors who voted on FDA advisory committees during this time, 26 later took more than $100,000 from the makers of drugs, or from competing firms. in post-hoc earnings or research support. Even though these payments might not be truly "quid-pro-quo," according to Vinay Prasad, an oncologist who also studies financial conflicts that exist in drug approvals, those asked to weigh in stand to gain tremendously in their further professional careers. "It's in their best interest to play nice with the companies." FDA may also have missed or judged insignificant financial ties physicians had before their service on the drug approval advisory panels.

香蕉屬低GI食物綠香蕉更強抗性澱粉減肥好幫手: 綠色GI 42

香蕉5大驚人好處，營養師讚「神補品」！ 2018年7月6日 下午5:00 【早安健康／營養師Stella】最近香蕉因產量過剩而帶動了眾多新聞話題，撇開這些新聞不看，身處在有「香蕉王國」美譽的台灣，我們有的確有必要了解一下這個我們從小看到大的水果，特別是在它正值盛產、價格便宜的時候。香蕉，這個有「智慧之果」別稱的水果到底有什麼營養？吃香蕉對健康又有什麼好處？今天就讓我們來認識這個集便利、美味於一身的水果～香蕉！

香蕉營養知多少？ 香蕉堪稱食用最方便的水果，在眾多水果中，它是唯一不用削、不需切，輕易就可撥開外皮食用的水果，故可說是外食族、上班族及懶得吃水果者最便利的水果選擇。 一根中等香蕉約150公克重，可提供127大卡的熱量、2.2公克蛋白質、33公克的碳水化合物(醣)、2.4公克纖維，且富含鉀和維生素B6。 若以每日營養需求來看，其纖維和鎂含量可滿足每日需求的10%左右，維生素C為16%，鉀27.6%、維生素B6則為41.3%。 另外，香蕉還含酚類化合物、生物鹼、單寧、類黃酮、皂素等植化素；根據USDA資料庫，每百公克的抗氧化指數(ORAC)為795 µmol TE。雖然水果富含果糖和葡萄糖等單糖，但香蕉因含纖維及抗性澱粉，故升糖指數並不高，根據國際GI資料庫，香蕉的GI為51，屬於低GI食物(註)，所以適量食用時並不需要過於擔心其對血糖的影響。 (註)香蕉的GI值因成熟度與品種不同而有所差異，其GI值約介於46~70間，屬於低GI及中GI食物。由於隨著水果的成熟，澱粉會轉變為單糖，因此成熟香蕉的GI會高於未熟的香蕉。舉例，未熟透的香蕉GI為30，有點熟但帶些綠色的香蕉為42，全熟的為52。

(中美貿易戰影響?) 臺灣保健食品廠大江中國市場微商直銷商營收貢獻五十倍成長

大江上月營收再攻頂 2018-07-06 00:01經濟日報 記者黃文奇/台北報導 大江生醫（8436）6月營收再創單月新高，首度突破6億元大關，達到6.22億元，較去年同期的3.34億元，年增86.4%，累計上半年營收達到29億元，較去年同期的17.65億元，年增64.4%。大江表示，6月營收持續創高，主要仍來自中國大陸市場的業績貢獻，產品領域以膠原蛋白飲料、粉包等為大宗，而拉貨最強勁的客戶也是直銷商與微商。大江昨日股價受到中美貿易戰效應影響，加上近日股價漲多，出現回檔，昨收505元，下跌32元，跌幅5.96%。大江近日股價首度登上500元俱樂部，並超過譜瑞-KY進入台股高價榜第八名，由於譜瑞昨日也受到國際情勢影響導致股價跌破500元大關，大江仍居其上。在營運概況上，法人認為，大江5月營收首度突破5億元、6月則突破6億元，展望7月營運也可望續強，仍有望持續創高，對下半年營運也正面看待。由於大江6月營收將續創高，上半年營收年增突破六成，法人估，大江第2季獲利也將改寫單季獲利新高紀錄，而下半年成績將有望優於上半年，全年獲利也將創下新高紀錄。大江是台灣績優保健食品廠，八年來營收成長50倍，林詠翔去年接董座後，營運持續每月創高，今年首季營收12.75億元，稅後純益2.23億元，年增八成，每股稅後純益（EPS）2.57元。大江現在處於「欠貨」的狀態，客戶應接不暇，目前大陸仍是出貨的主要地區，客戶以直銷商、微商為主；美國地區開始進入成長期，產品以乳化魚油先發，因此公司今年規劃擴產，明年在台灣將建構全自動倉儲系統，全面提升營運效率。法人分析，依大江當前訂單能見度來看，第2季營收、獲利都將繼續創高，單季營收年增率保守估計六至八成以上，獲利年增可望優於營收，估第2季EPS站穩3元以上，預期全年EPS有機會超過12元。