業界首例! 台微體擬發行ADR 2015-09-21 01:17:25 經濟日報 記者黃文奇／台北報導台微體搶「台美通」，規劃做生技首個ADR。台灣微脂體總經理葉志鴻表示，公司近期董事會已經通過、授權經營團隊規劃在美國執行存託憑證（ADR），暫訂發行單位上限總數為5,550張，換言之，台微體股票將在美國掛牌，藉此打通公司金脈。生技公司近期吹起海外存託憑證，繼安成藥上周宣布發行海外存託憑證（GDR）後，台微體也積極評估讓台美資金互通。與安成藥不同的是，葉志鴻表示，此次台微體評估赴美做ADR並非募資，而是拿一成的老股執行，目的就在讓美國的投資人「看見台灣」，提升公司能見度。台微體目前資本額5.55億元，以ADR發行股數5,550張來算，等於股權的10%，目前台微體在外流通股數不足3萬張，比重不小。葉志鴻表示，公司的市值在台灣被嚴重低估，此舉不僅有利公司股票流通性，也將有機會讓公司回歸合理市值。葉志鴻表示，公司有意發行ADR規劃已久，機緣是近期美國前三大券商積極遊說，而提入董事會並通過後，經營團隊也將與美國券商積極評估此事。此外，公司目前仍有20餘億元現金部位，也有房地等資產並不缺錢，毋需發行新股募資。台微體是旅美微脂體技術專家洪基隆創辦，公司今年獲選為公司治理A++榮譽，為上櫃生技公司唯一獲此殊榮者，由於美國投資人重視企業的公司治理，推估台微體因此獲美大型券商青睞，主動接觸，而該榮譽也將有助台微體在美掛牌。 葉志鴻說，若ADR順利執行，未來台微體等於在台美兩地同時掛牌，由於在美有一成的公司股票可供買賣，其交易的活絡程度，也將影響台灣市場的判斷，對公司市值也有提升作用。至於對於公司的估值，葉志鴻說，公司一直以來在國際上都有「做為比較標竿」的對象，譬如，美國有家小公司叫做Flexion，旗下僅有一項產品，即微脂體長效性退化性關節炎用藥，開發進度約比台微體的TLC599超前兩年，市值卻是台微體的四倍，每股約25美元。葉志鴻說，他有信心公司的TLC599在包覆技術與藥效方面，優於Flexion的產品，因此希望公司的估值，在順利登上美國資本市場後，能有所提升，他也將繼續把公司治理帶向高峰。
公司治理A++ 國際廠想提親 台灣微脂體是上櫃生技公司中，僅有獲得公司治理A++殊榮的奇葩，顯示公司資訊透明度是同業中最高；台微體總經理葉志鴻表示，他與經營團隊銳意讓台微體真正「國際化」，要讓全世界「都看得懂新藥開發」。台微體近兩年歷經生技風暴、股價回檔，市值一度僅剩高檔時的四分之一。不過，大股東之一的股市聞人林滄海無畏生技風暴，去年還繼續加碼增持該公司，目前在台微體前十大股東名冊中，林滄海竄至前四大，持股比重近5%，僅次於國際創投Burrill、永豐餘的上智創投、國泰人壽。據悉，台微體公司時常獲得國際大廠探詢「是否出售」，但多僅止於接觸便未再深談，葉志鴻表示，一般人可能以為台微體姿態高，必定以天價讓買家知難而退，但事實上是，只要價格「合理」，公司從未排除任何合作的可能性。葉志鴻指出，要國際大廠來併購台灣的生技公司不容易，因為生技圈中，併購只有在三種條件下會發生，除了產品，再來就是技術、通路，其中技術最為關鍵。他解釋，產品可以技轉，不一定要全面收購，因為「喝牛奶不需買一頭牛」，至於通路，台灣市場太小，沒有併購台灣通路的必要，而技術就更是關鍵了，台微體所有產品都是自家獨門技術平台所開發，具有不可取代性。
Flexion Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies. Our lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.
As a lean specialty pharmaceutical team, our goal is to cost effectively develop and commercialize novel therapies that will provide safe, substantial and sustained pain relief to the sufferers of musculoskeletal (MSK) diseases, the first of which is OA. We focus on product candidates that provide long-lasting analgesia locally while avoiding systemic side effects. We also aim to :Mitigate development risk and expedite regulatory timelines to product approval: We seek to mitigate development risk by selecting product candidates with validated mechanisms of action. Target multiple points in the OA pain treatment spectrum: To maximize the likelihood of bringing products to market successfully, each of our three product candidates targets different elements of the OA treatment continuum. Leverage our management team's expertise: Our co-founders, Dr. Clayman and Dr. Bodick, have significant capability, developed during their combined 35 years at Eli Lilly and Company, in both rapidly progressing new drugs to meaningful clinical proof of concept and in conducting successful pivotal clinical programs leading to regulatory submissions. Our senior management team includes members who are highly capable in the design and implementation of effective drug development programs.
PROGRAMS & PIPELINE
Current therapies addressing the OA pain treatment spectrum have limitations and do not adequately address pain management. Oral drugs are associated with serious side effects and are eventually ineffective at managing OA pain as the disease progresses. Intra-articular (IA) therapies, including steroids and Hyaluronic Acid (HA) preparations, are generally well-tolerated but provide pain relief that is insufficient or inadequate in duration. All IA therapies approved for OA are immediate-release solutions that leave the joint within hours to days and are absorbed systemically, which may result in undesirable side effects. As such, we believe there is a significant commercial opportunity for a portfolio of compounds that deliver significant and durable analgesia to OA patients with moderate to severe pain in a safe and effective manner. This starts with treating OA, but extends through patients undergoing total joint arthroplasty (TJA), Our product candidates are designed to deliver anti-inflammatory and analgesic effects directly to the site of disease, optimizing sustained local drug concentration to yield a durable and clinically meaningful response. Our therapies are also designed to limit systemic exposure to the drugs, which remains a major concern in the many OA patients with concomitant co-morbidities. A summary of our portfolio and their respective status is below:
FX006: For moderate-to-severe OA Development Stage: Phase 3; get details about ongoing pivotal study from clinicaltrials.gov. FX006, is a first-in-class injectable, sustained-release, intra-articular (in the joint), steroid treatment for patients with moderate to severe OA pain, which has demonstrated clinically meaningful and significantly better pain relief compared to standard of care in a Phase 2b OA clinical trial. FX006 was specifically designed to address the limitations of current IA therapies by providing long lasting, local analgesia while avoiding systemic side effects. Some features of FX006 include: Proven anti-inflammatory 505(b)(2) registration pathway Prolonged efficacy Absence of systemic steroid side effects
FX007: For post-operative pain Development Stage: Pre-clinical FX007 is a preclinical, small-molecule TrkA receptor antagonist designed to address post-operative pain, including patients who have received total joint arthroplasty (TJA). Some features of FX007 include: Powerful non-narcotic analgesic with validated pain pathway Novel mechanism of action
FX005: for end-stage OA Development Stage: Completed a Phase 2a (PoC) study FX005 is a sustained-release p38 MAP, or mitogen-activated protein, kinase inhibitor that has both analgesic and anti-inflammatory properties. In a Phase 2a proof of concept clinical trial FX005 demonstrated significant effects on both pain relief and function improvement and was very well tolerated. We believe FX005 may prove to be an effective therapy for OA patients with end-stage disease. Some features of FX005 include: Anti-inflammatory, analgesic Disease-modifying potential Novel mechanism of action
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