智擎MM398 轉授權與Baxter 成立癌症藥公司, Baxalta

智擎今年EPS 上看13元 2015-09-30 02:23:08 經濟日報 記者高行／台北報導主攻新藥研發的智擎生技（4162）旗下胰臟癌新藥「MM398」預計年底前完成南韓藥證申請，另預計在第4季取得歐洲藥證，法人預期兩者里程金進帳3,900萬美元（約新台幣12.98億元），帶動全年每股稅後純益（EPS）上看13.77元，成為國內最快開花結果的新藥公司。 智擎旗下「MM398」在去年完成胰臟癌二線治療的三期臨床試驗，數據符合預期，同年9月智擎的美國授權夥伴Merrimack將歐洲和亞洲權利再授權予國際大廠Baxter，並在今年7月攜手成立癌症藥子公司Baxalta，預計10月底完成美國食藥局（FDA）藥證審查，由於「MM398」三期試驗效果明確，加上現階段無藥物使用在胰臟癌二線治療，取得美國藥證機會相當高。智擎和Baxalta目前積極規畫南韓藥證申請，預計年底前將送出，屆時將獲得1,100萬美元（約新台幣3.66億元）的里程金。智擎並同步和歐洲藥物管理局（EMA）積極溝通，在美國藥證取得後的一個月取得歐洲藥證，預計最快第4季再取得里程金2,800萬美元（約新台幣9.32億元）。智擎股價25日收217.5元，上漲10元。智擎說，「MM398」除積極向歐美及南韓申請藥證，也規畫胰臟癌一線治療的臨床二期/三期試驗，並在年底展開胃癌一線治療試驗；腦癌及兒童骨癌臨床二期試驗結果將於明年出爐，各項適應症及市場持續擴大。

Baxalta Spins Off from Baxter Jul 1, 2015 Baxter International today spun off its Baxter BioScience global biopharmaceutical business into Baxalta, saying the new company will focus on developing new treatments for people with orphan diseases and underserved conditions. Baxalta said it will build on its strengths in hematology and immunology, while seeking to expand its oncology portfolio for patients with limited treatment options. The new company also aims to build on its base of $6 billion in annual revenues, saying it plans to generate an additional $2.5 billion in sales by 2020 through launches of 20 new products as well as new indications for existing products. As part of Baxter, the company received seven approvals for new products over the past two years. Baxalta begins life with four products under regulatory review across its three areas of therapeutic focus:

Hematology: Baxalta will add to its roster of existing products, including Advate [Antihemophilic Factor (Recombinant)] and Feiba [Anti-Inhibitor Coagulant Complex (Human)] with new offerings that include BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A to be marketed in the U.S. as Adynovate [Antihemophilic Factor (Recombinant), Pegylated].

Immunology: The company hopes to expand its immune globulin portfolio with a successful launch of Hyqvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] for adults with primary immunodeficiency.

Oncology: Baxalta has filed for approvals with the FDA and European regulators to market MM-398 (irinotecan liposome injection), co-developed with Merrimack Pharmaceuticals for metastatic pancreatic cancer. In March, Baxter and partner CTI BioPharma announced positive Phase III PERSIST-1 trial results for the myelofibrosis treatment pacritinib. Also on the cancer front, Baxalta plans to add the Oncaspar® (pegaspargase) product portfolio for acute lymphoblastic leukemia (ALL), which Baxter said in May it was buying from Sigma-Tau Finanziaria for $900 million. The deal is expected to close in the second half of 2015. In hematology, Baxalta will advance a Phase I/II open-label clinical trial assessing the safety and optimal dosing level of a factor IX (FIX) gene therapy treatment for hemophilia B. The gene therapy "has the potential to redefine the treatment of hemophilia," the company says, by providing a mechanism for the patient's own liver to begin producing FIX over an extended period. Baxalta said it will capitalize on recently acquired technology platforms in immunology and hematology. Baxter in March bought SuppreMol and its portfolio of autoimmune and allergic disease candidates for $225 million, and last year acquired AesRx, whose lead product is the sickle cell disease candidate Aes-103, for an undisclosed price. The new company also promises to maintain a significant R&D operation, which according to the company is now overseeing more than 40 programs in development, 13 of them in late stages. Baxalta employs 16,000 people worldwide, and is headquartered in Deerfield, IL—the headquarters city of its predecessor Baxter—with a Global Innovation and R&D Center set to formally open later this year in Cambridge, MA. A company spokesman told the Boston Business Journal last week that Baxalta is "on track" to have about 400 employees—mostly scientists and business development specialists—based in Cambridge by next year. Baxalta begins trading shares today on the New York Stock Exchange under the symbol BXLT.