Kirin-Amgen, Inc.

Amgen and Kirin have decided to dissolve their joint venture, Kirin-Amgen. Amgen and Kirin Holdings have decided to dissolve their joint venture, Kirin-Amgen . It will become a wholly-owned subsidiary of Amgen. The venture was formed in 1984 with the intention of funding the worldwide development of Epogen (epoetin alfa). The collaboration expanded to include Neupogen (filgrastim), Neulasta (pegfilgrastim), Aranesp (darbepoetin alfa), Nplate (romiplastim) and brodalumab. The intellectual property was held by Kirin-Amgen, and licensed the marketing rights in specific Asian markets to Kyowa Hakko Kirin (KHK) , Kirin’s pharmaceutical subsidiary. It also licensed other territories to Amgen. Under the new arrangement, Kirin-Amgen will pay Kirin $780 million. Amgen will make more payments to Kirin related to specific sales that Amgen has valued at about $30 million. Because Amgen will be the sole owner of Kirin-Amgen, Amgen will own the product rights and any remaining cash held by Kirin-Amgen. The Asian territory marketing rights held between Kirin-Amgen and KHK will stay the same. The new agreement is expected to close in the fourth quarter of this year or the first quarter of 2018. “Our historic partnership with Kirin played a pivotal role in the growth of Amgen from a small, venture-backed start-up to one of the world’s largest biotechnology companies,” said Robert Bradway, chairman and chief executive officer at Amgen, in a statement. “I would like to thank Kirin for more than three decades of partnership, which has enabled us to reach patients suffering from serious illness around the world with meaningful therapies. We look forward to continuing what has been Amgen’s longest-running collaboration through our ongoing relationship with KHK.” Kirin is better known as a brewer. It said in a statement that its pharmaceuticals and biochemical business will stay central to the company and not be affected by the termination of the joint venture deal. Amgen released its third-quarter financial results on Oct. 25, reporting total revenues for the quarter of $5.8 billion, a 1 percent decrease from the previous year’s third quarter. GAAP earnings per share (EPS) grew 3 percent to $2.76. The company also provided an update on its Puerto Rico operations, as of five weeks after Hurricane Maria. The company indicated it was providing support to its staff and the local community while pushing its business continuity plans and restoring manufacturing at its site in Juncos. Its drug substance manufacturing and packaging facilities are fully operational and expected to resume formulation, filling and small molecule commercial production by the end of October 2017. Related to Hurricane Maria, Amgen incurred $67 million in pre-tax expenses, or $0.07 EPS, in the third quarter. In the upcoming fourth quarter, it expects additional pre-tax expenses related to the hurricane from $75 million to $100 million, which is $0.08 to $0.11 EPS. It didn’t expect a significant impact to its full-year 2018 results, but the figures also do not include possible insurance recoveries. Also, in the third quarter of 2017, Amgen generated $3.3 billion of free cash flow. “We are seeing strong, volume-driven growth in our recently launched products, as we also effectively manage the life cycle of our mature products,” Bradway said in a statement. “Disciplined expense management and ongoing process improvements continue to provide the financial flexibility needed to invest in our best opportunities for long-term growth.”

June 2, 2015 By Mark Terry , BioSpace.com Breaking News Staff Amgen , headquartered in Thousand Oaks, Calif., announced today a collaboration with Roche on a Phase Ib clinical trial to evaluate talimogene laherparepvec combined with atezolizumab, also known as MPDL3280A for the treatment of triple-negative breast cancer and colorectal cancer with liver metastases. Amgen did not respond to a request for comment by deadline. Talimogene laherparepvec is Amgen ’s cancer immunotherapy. MPDL3280A is Roche ’s investigational anti-PDL1 therapy. Talimogene is designed to selectively replicate in tumors and cause an immune response to the cancer cells, while not stimulating immune response to normal cells. The company said the theory behind combining the two drugs is to both active an anti-tumor immune response while blocking inhibitory T-cell checkpoints. In other words, they hope to stimulate the body’s immune reaction to the cancer cells while blocking certain activity that puts the brakes on T cells. “Atezolizumab is our most advanced cancer immunotherapy with 10 ongoing Phase III pivotal trials across lung, bladder, breast and kidney cancers,” said Sandra Horning , chief medical officer and head of Roche ’s Global Product Development in a statement. “We are looking forward to working with Amgen on this trial, which can inform potential future treatment options for patients affected by very difficult-to-treat tumor types.” This is not the first collaboration between Amgen and Roche . In October 2013 Amgen entered into a definitive agreement with Roche to buy Roche ’s rights to filgrastim and pegfilgrastim in about 100 markets. Roche held the rights to the two compounds under a license from Kirin-Amgen, Inc. , a joint venture between Amgen and Kirin Holdings Co. Limited , of Japan, for Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. The two compounds are white blood cell boosting therapeutics. Amgen markets them in the U.S. and Europe under the names Neupogen and Neulasta. Only last week Amgen announced an expanded collaboration agreement with Merck & Co. to evaluate the safety and efficacy of talimogene laherparepvec in combination with Merck ’s Keytruda, an anti-PD-1 therapy, in a Phase I trial. The companies also announced a global, randomized Phase III trial to evaluate the combination in patients with regionally or distantly metastatic melanoma. “We believe that talimogene laherparepvec has potential in several cancer types based on its proposed mechanism of action to initiate tumor antigen release and presentation, important steps in activating a systemic anti-tumor immune response,” said Sean Harper , executive vice president of research and development at Amgen in a statement. “Talimogene laherparepvec and Keytruda are designed to result in anti-tumor immune responses through different and potentially complementary mechanisms of action.” It was noted by analysts in a report published by Moody’s titled “ Biosimilars: Parsing the Industry’s Pipelines ,” that Roche , Amgen and AbbVie are three companies most vulnerable to competition from biosimilars. Specifically, Amgen ’s Neulasta, Roche ’s Rituxan and AbbVie ’s Humira. Biosimilars are a drug that are very similar to known drugs, but which have the same therapeutic action and can be marketed competitively. Perhaps ironically, Amgen ’s pipeline for biosimilars is one of the most ambitious in the field. “There’s already lots of competition, and we’re used to having to compete on value,” said Geoff Eich , executive director of Amgen ’s biosimilars division in a statement. “This is the natural evolution.” Although a collaboration between Amgen and Roche is probably not directly related to biosimilar competition, if Amgen ’s combination treatment studies with Roche and Merck are successful, testing for talimogene laherparepvec in combination with other anti-PDL1 therapies may be down the road. In November 2014, Merck announced it was working with Pfizer Inc. to jointly develop and commercialize MSB0010718C, an investigational anti-PD-L1 antibody for multiple types of cancer. Will PfizerKline Become the Next Pharma Player? The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.” Gregg Gilbert , a biotech analyst at Deutsche Bank , wrote in a note to investors “Introducing PfizerKline ” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer ’s earnings per share by 10 percent to 16 percent beginning in 2016. “We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.” We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "will-pfizerkline-become-next-pharma-player", placeholder: "pd_1432740672" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));