(rh-Lubricin治療乾眼症) 4人虛擬公司 獲 Novartis授權$1 Billion

評價生醫股 要了解產業特性 2017-05-02 01:31 經濟日報 記者黃文奇／整理 瑞士大藥廠諾華（Novartis）本月6日宣布，從Lubris Bio Pharma取得治療乾眼症以及其他眼疾的產品ECF-843，而這個產品的初步價值，除歐洲以外的全球授權簽約授權金和未來的權利金，上看10億美元。ECF-843是一種重組人類Lubricin蛋白(rh-Lubricin)，這是在組織和組織間天然產生的物質，在二期臨床實驗顯示可降低眼睛的眼部異物感、燒灼／刺痛、粘黏、視力模糊，以及畏光等症狀，有效緩解中度到重度乾眼症病患的痛苦。Lubris Bio Pharma這家被估值高達300億元「小而貴」的公司，是總部位於美國波士頓的虛擬公司，研發團隊僅四名員工，專注研發Lubricin（人體內源性糖蛋白）。對於這個引進ECF-843開發權利案，諾華全球研發負責人及首席科學官Vasant Narasimhan表示，ECF-843有望成為第一個可迅速緩解乾眼症症狀的處方藥物，可以為全球大約3.44億名乾眼症患者提供治療新選擇。一家只有四名員工的新藥開發公司，卻獲得諾華青睞，顯示全球大廠對生技醫藥產業的評價邏輯，重視的不在當下是否賺錢，而是著眼於技術未來發展性為核心，換言之，就是公司發展的潛力與未來價值。生技醫藥的龐大風險與失敗機率背後卻蘊藏爆炸性的價值，是最令人著迷的地方。一般來說，國際專業藥廠進行新藥價值評估時，大多係針對新藥的全球市場價值進行評價，主要採用「淨現值法」，也就是以該新藥在未來專利到期前的獲利預估，扣除支出，使用某折現率，計算到某年的現有價值，作為新藥的價值計算基礎。過去一年，台灣生技產業面臨許多瓶頸，生技類股表現不佳，跌幅高達25.46%，位居各類股之冠，產業市值蒸發1,800億元。更有甚者，上周（4月24日）上櫃的小分子抗癌藥物新藥公司生華科及去年12月上櫃全球最大藥效評估模型設計公司中美冠科-KY皆面臨IPO當日收盤價跌破發行價格之命運，蜜月行情失靈，在在顯示台灣股市對於生技醫藥股的價值認同無法與國際同步。事實上，在台灣資本市場，一家新藥開發公司從申請公開發行到完成上市櫃，與其他產業申請公司上市櫃無異，都必須耗費冗長的時間來走完成繁雜的程序。過程中需有二家以上推薦證券商，由證券商進行多年的輔導、流程規劃與進度掌控；需有會計師對財務報表查核、內部控制制度審查；也要有律師對公司業務及程序進行適法性的評估；上市櫃前審議委員會對財務及業務嚴格檢視；主管機關更是高度監管。在承銷價格的計算方面也非常嚴謹，包括以市價基礎法之本益比法及股價淨值比法、成本法之帳面價值法以及收益基礎法等進行比較測試，同時配合國際市場地位、產業未來發展前景及市場環境等因素來訂定承銷價格。生技醫藥股在主管機關如此縝密周延的上市櫃審查制度下，好不容易拿到入場資格掛牌上櫃，掛牌價格竟不獲投資人肯定。對照過去生技醫藥股曾是台股新興主流類股，並且吸引國際生醫業者紛紛來台申請掛牌而紅極一時的景象，令人不勝唏噓。生物科技是小英政府選擇生技醫藥作為台灣未來的策略性產業，更是充滿機會的潛力產業；台灣醫藥研發人才齊聚，尤其臨床醫學和華人特有疾病的研究，在國際上已經名列前茅；反觀為台灣建立起「代工王國」美名的電子資訊專業代工，卻勞力高度密集，附加價值極低，更面臨紅色供應鏈激烈的價格競爭。對投資人來說，新藥開發尚屬陌生領域，尤其國內新藥開發公司大多屬於中小型企業，資金規模小，加上新藥開發過程不但沒有獲利來源更需要不斷燒錢。倘若投資人用財務報表的數字來評論生技醫藥股，以評估電子業等其他類股的思維來投資生技醫藥股，那麼難免將落入買高賣低且隨波逐流的窘境。因此，如何使投資人更加瞭解生技醫藥產業的評價特性與發展潛力，使台灣生技醫藥產業與資本市場得以有效結合，是一個十分值得重視的課題。（本文是鑽石生技投資分析室提供）

4-Person Biotech Pens R&D Deal Worth $1 Billion With Drug Giant Novartis April 7, 2017 By Mark Terry, BioSpace.com Breaking News Staff  Swiss-based Novartis (NVS) exercised an option to in-license ECF843 for dry eye and other ophthalmic indications from a four-person biotech company, Lubris BioPharma, based in the Boston area. Although financial details were not disclosed, a source told The Boston Business Journal that after upfront payments and potential milestones, it could be worth $1 billion. ECF843 is described as "recombinant human lubricin (rh-Lubricin) protein." Lubricin is a naturally-occurring protein in the human body, which, as John Carroll describes in Endpoints News, "is found just about wherever two tissues in the bodies meet." Lubris isolated and industrialized it. In a Phase II clinical trial in 40 patients with moderate to severe dry eye, ECF843 was tested against standard therapy, sodium hyaluronate (HA). Carroll writes, "Symptoms of the disease dropped 70 percent from baseline and CEO Ed Truitt tells me that when the study transitioned to self-application Lubricin patients used much less of it to get better results." The results were published in the journal The Ocular Surface. The results stated, "The primary endpoint was met. Lubricin supplementation achieved greater than a 72 percent reduction from baseline in foreign body sensation (<.013), burning/stinging, pain, sticky feeling (P<.0432), blurred vision (P<.0013), and photophobia (P<.011) in at least one eye." With little or no fanfare, Novartis signed an option deal with Lubris last year. Novartis gets the technology for eye-related indications globally except in Europe. Lubris has a licensing deal for Europe with Italian drug company Dompe Group. Lubris will also retain the commercial rights for non-ophthalmological indications, for example, osteoarthritis."ECF843 has the potential to be the first therapeutic to provide rapid relief of dry eye symptoms and significantly improve signs," said Vasant Narasimhan, Novartis' Global Head, Drug Development and Chief Medical Officer, in a statement. "Exercising our option to in-license ECF843, along with our recent acquisition of Encore Medical for the treatment of presbyopia, underscores our commitment to treating diseases of the front of the eye which impact millions of people worldwide."

Lubris is a virtual company. The company's chief executive, Truitt, is based in Seattle. There's also an office in Framingham, Mass. One of its scientific founders, Tannin Schmidt, is at the University of Calgary, and the other, David Sullivan, is at Mass Eye and Ear. To date, funding has been generated by angel investors and high net worth individuals. Carroll writes, "Now that Novartis has put money into the company, following a European deal with Milan-based Dompe Group, Truitt has a 'substantial runway' to go after the next set of non-eye targets, says the CEO. That will start with dry mouth, maybe a side effect of head and neck cancer therapy that destroys the salivary glands. Interstitial cystitis, recoating the damaged bladder lining, is on the short list."