Tuesday, November 22, 2016

國光 助攻充填 四價流感疫苗Flublok (Protein Sciences).FDA獲藥證/ 自行開發四價流感疫苗 台歐收案2000人 (估2018年歐盟藥證)

國光生技流感疫苗過關政院投資虧轉盈有望 鄭國強 2016-10-20生技業不一定是門好生意,但對連續虧損的國光生技來說,行政院開發基金的13%持股,快要可以獲利了,19日國光生技宣布,與美國Protein Sciences公司(簡稱PSC)合作的四價疫苗(可以防疫較多流感),7日已獲得美國藥證可以上市,另外自行開發的流感疫苗也將在歐洲、台灣臨床實驗,順利的話2018年可以上市。國光生技已經連虧數年,這次有新的營運機會,總經理留忠正被記者問起,「是不是在2018年就可以轉虧為盈?」他笑了一下說「不敢開出時間表,但可以說快了。」行政院開發基金與中鋼為國光生技前十大股東,都有納稅人的錢,開發基金持股13.36%為最大股東,加上中鋼共持有約15%持股,意思是,國光每虧100元,開發基金就要虧13.36 。然而國光生技宣布明年獲利的新動能,是與美國PSC公司合作生產最先進的基因重組技術產製的四價流感疫苗,已經取得藥證這項合作開始於 2014年,由國光為 PSC 三期臨床試驗分批進行無菌充填,其後再經過量產規模充填及製程確效,留忠正表示,「國光負責PSC製造的疫苗充填,若有瑕疵,整批疫苗就無效了,因此美國FDA今年3月底來台查廠,這個月7日就發給PSC藥證。取得藥證後,PSC預計將於 2017 年開始商業量產,並開始在美國銷售,將會提升國光的營收、盈餘。至於國光生技自行研發的新型四價季節流感疫苗,除了已經在台灣申請藥證之外,在歐洲的臨床三期非劣性試驗,亦已在比利時展開。業務副總高聖凱表示,這項2000名受測者的大型臨床實驗在國內是頭一遭,其中一千名在歐洲進行、一千名在台灣進行。高聖凱說,臨床試驗預計可於今年底完成,在明年完成結案報告後提出藥證申請,如果進行順利,預計於2018年可以獲得歐盟頒發藥證,成為國產疫苗進入歐洲的首例。留忠正打趣說,疫苗和新藥不一樣,新藥是大家都想嘗試一下,看看有沒有效,但疫苗是每年到了某個季節才會想起它,因此它的營收型態較平穩、季節性,未來進入高齡化社會,相信對疫苗的需求會更穩定。

Adimmune Successfully Places NT$1.5 BN Guaranteed Convertible Bonds

Adimmune  Posted on: 24 Oct 16 TAIPEI, Taiwan, Oct. 21, 2016 /PRNewswire/ -- Taiwan-based vaccine provider Adimmune (4142 TT) successfully placed NT$ 1.5 bn (~US$ 48 mn) guaranteed convertible bonds due 2021 (the "Bonds"). This is the largest fund raising event in Taiwan's healthcare sector in 2016. The net proceeds of the issue of the Bonds will be used primarily to support its strategy of investment in innovative vaccines and expansion into new markets; the remaining proceeds will further strengthen Adimmune's financial position. Adimmune's aseptic filling line has already obtained US cGMP certification, and the recombinant 4 strains seasonal flu vaccine, in collaboration with Protein Sciences Corporation, has been approved by US FDA. These vaccines are expected to start commercial production in 2017 with sales commencing in the US the same year. In Europe, a Phase III non-inferiority clinical trial of 4 strains seasonal flu vaccine was recently launched in Belgium. The recruitment of the trial is expected to be completed by the end of 2016 and approval to be obtained by third quarter of 2018, pending results of the trial. In addition, Adimmune has applied for the approval of 4 strains seasonal flu vaccine in Taiwan and is expected to obtain approval by 2017. "We are very grateful for the strong institutional investor support of our convertible bond issuance," stated Vic Chang, CFO of Adimmune. "It is a challenging time globally for innovative biotech companies to raise funds and we feel that the success of this issuance is indicative of how Adimmune's dedication and potential in this sector has been recognized by the investment community." Adimmune's 9-month revenue for 2016 was up 90% YoY, ahead of market expectations. The strong growth is on the back of new orders from Japan and the US, as well as an expanded vaccination plan by the Taiwan government.

About Adimmune: Adimmune is the No.1 flu vaccine provider in Asia to obtain US, EU, China and Taiwan cGMP, and will obtain Japan cGMP in 2017. The Company has ample capacity in flu vaccine of 25mn doses/year and pre-filled syringe (PFS) of 25mn doses/year. Its solid capability in high-quality commercial scale human vaccine manufacturing has enabled Adimmune to expand its business to China, Europe, Japan and the US. Currently Adimmune is the largest provider of flu vaccine (3 strains) and sole provider of Japanese Encephalitis vaccine and Tetanus vaccine in Taiwan. Adimmune is listed on the Taiwan Stock Exchange (4142 TT). For more information, please visit http://www.adimmune.com.tw.

High Antigen Flu Vaccine Gets FDA Approval October 11, 2016 The Food and Drug Administration (FDA) has approved a quadrivalent formulation of Flublok influenza vaccine (Protein Sciences). Flublok Quadrivalent contains the three strains found in trivalent Flublok plus an additional B strain.  Compared to other quadrivalent influenza vaccines, Flublok Quadrivalent contains three times more active ingredient, making it the first high antigen quadrivalent vaccine approved by the FDA. In a clinical study of 9,000 adults 50 years of age and older, people who received Flublok Quadrivalent were over 40% less likely to get cell-culture confirmed influenza than those that received a leading egg-produced quadrivalent flu vaccine.  Flublock Quadrivalent is indicated for active immunization against disease caused by influenza A virus subtypes and influenza B virus contained in the vaccine. It is approved for patients 18 years of age and older. Just like the trivalent formulation, Flublok Quadrivalent is a recombinant protein-based vaccine that contains no egg proteins, antibiotics, or preservatives.

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