智擎胰臟癌新藥獲韓國上市許可 亞洲首個上市國 2017年09月21日11:57 智擎（4162）宣布，已接獲授權夥伴Ipsen公司的通知，
Ipsen Completes Acquisition of ONIVYDE® (irinotecan liposome injection) and Additional Oncology Assets from Merrimack Pharmaceuticals Ipsen announced today that it has completed its acquisition of global oncology assets from Merrimack Pharmaceuticals, in Cambridge, MA., focusing on ONIVYDE® (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy, in combination with fluorouracil and leucovorin.1,[1] Ipsen has gained exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S., as well as the current licensing agreements with Shire for commercialization rights ex-U.S. and PharmaEngine for Taiwan. The acquisition also includes the Merrimack commercial and manufacturing infrastructure for Onivyde®, and generic doxorubicin HCl liposome injection."The addition of ONIVYDE® to Ipsen's Oncology portfolio is very important, first and foremost for patients with pancreatic cancer across the U.S., as there are limited approved therapies," said Cynthia Schwalm, Executive Vice President and President, North American Commercial Operations, Ipsen. "Together with our experienced commercial and medical teams and the legacy we have gained through the acquisition of ONIVYDE®, we are confident in our ability to meet the growing needs of these patients." Along with this acquisition, Ipsen will continue to advance the clinical development program for ONIVYDE®. Financial terms of the acquisition include an upfront cash payment of $575 million to Merrimack Pharmaceuticals, and up to $450 million upon the approval of potential additional indications for ONIVYDE® in the U.S.
About Pancreatic Cancer Pancreatic cancer is a rare and deadly disease with approximately 338,000[2] new patients diagnosed globally each year, approximately 50,000 of which are in the United States[3]. More than half are diagnosed with metastatic disease, which has an overall 5-year survival rate of less than three percent4, and often rapidly progresses during or shortly after receiving chemotherapy[4]. Pancreatic cancer is the 3rd leading cause of cancer-related death in the United States, surpassing breast cancer.4 It is expected to become the 2nd leading cause of cancer-related death in the U.S. by the year 2030, surpassing colorectal cancer.4,[5]
About ONIVYDE® ONIVYDE® is an encapsulated formulation of irinotecan. This long-circulating liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN-38. ONIVYDE® was approved by the U.S. FDA in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.
Sources :
[1] ONIVYDE® Full Prescribing Information Oct 2015 (v0.1) p. 2.
[2] World Cancer Research Fund International. Cancer Facts and Figures. Pancreatic Cancer Statistics. Accessed on March 27, 2017. http://www.wcrf.org/int/
[3] American Cancer Society. Cancer Facts and Figures 2017. Atlanta: American Cancer Society; 2017. https://www.cancer.org/
[4] Ammermann et al. Decision Resources. Disease Landscape and & Forecast: Pancreatic Cancer. June 2016.
[5] Rahib et al AACR 2014
France's Ipsen to buy Merrimack's pancreatic cancer drug, assets in $1 billion deal Reuters Staff JANUARY 9, 2017 / (Reuters) - French drugmaker Ipsen SA (IPN.PA) said on Monday it would buy some assets of Merrimack Pharmaceuticals Inc (MACK.O), including pancreatic cancer drug Onivyde, for up to $1 billion, barely a month after the U.S. company stopped a breast cancer drug trial. The deal would give Merrimack the resources to fund the development of three new compounds targeting pancreatic, lung, and other types of cancers. It would boost Ipsen's portfolio, which has traditionally focused on endocrinology. Ipsen will pay $575 million at the closing of the deal and up to $450 million more, contingent on some approvals for Onivyde in the United States. Ipsen would get U.S. commercialization rights for Onivyde and Merrimack's current licensing agreements with Shire Plc (SHP.L) outside the United States and with PharmaEngine Inc (4162.TWO) for Taiwan. However, Merrimack said it will retain up to $33 million in milestone payments pursuant to its licensing deal with Shire. The French company would also buy Merrimack's generic version of ovarian cancer treatment doxorubicin hydrochloride liposome injection, marketed as Doxil, in the United States. The deal includes Merrimack's commercial and manufacturing assets, Ipsen said. Merrimack's chief executive resigned in October as it embarked on a restructuring, including job cuts to save costs and focus on research and development. Merrimack said it plans to return at least $200 million to stockholders through a special cash dividend of about $1.54 per common share. It will also return all of the expected $450 million payment to shareholders. Upon completion of the deal, Merrimack would have about 80 employees, just a fifth of its strength prior to the restructuring initiated in October. The deal, to be funded by Ipsen's existing cash and lines of credit, would be dilutive to the drugmaker's earnings in 2017 but will add to earnings from 2018, the company said. MTS Health Partners LP and Dechert LLP advised Ipsen on the deal. BofA Merrill Lynch and Credit Suisse Securities (USA) LLC were advisers to Merrimack. Reuters reported the deal earlier on Sunday, citing people familiar with the matter. Reporting by Ismail Shakil and Rama Venkat Raman in Bengaluru; Editing by Peter Cooney and Gopakumar Warrier
智擎新藥獲韓國藥證 授權金再進帳7.5億元 2017-09-21 20:28經濟日報 記者黃文奇╱即時報導 智擎（4162）新藥授權再傳捷報，該公司宣布授權夥伴Ipse
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