Collaborative R&D, Co-Development and Licensing Agreement for JAK1/JAK2 Inhibitor and INCB28050 -- Current Agreements
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Dealdoc Collaborative R&D, co-development and licensing agreement for JAK1/JAK2 inhibitor and INCB28050 Incyte Eli Lilly Dec 21 2009 © 2009-2021, Wildwood Ventures Ltd. All rights reserved. Collaborative R&D, co-development and licensing agreement for JAK1/JAK2 inhibitor and INCB28050 Incyte Companies: Eli Lilly Announcement date: Dec 21 2009 Deal value, US$m: 805.0 : sum of license fee and milestone payments First amendment to collaborative R&D, co-development and licensing Related contracts: agreement for JAK1/JAK2 inhibitor and INCB28050 • Details • Financials • Termsheet • Press Release • Filing Data • Contract Details Announcement date: Dec 21 2009 Start date: Dec 18 2009 Bigpharma Biotech Industry sectors: Drug delivery Pharmaceutical Compound name: Baricitinib/ INCB28050 Asset type: Compound Immunology Therapy areas: Musculoskeletal » Arthritis » Rheumatoid arthritis Drug delivery Technology types: Small molecules Co-development Co-promotion Deal components: Collaborative R&D Licensing Option Stages of development: Phase II Geographic focus: Worldwide Financials Deal value, US$m: 805.0 : sum of license fee and milestone payments Upfront, US$m: 90.0 : license fee 635.0 : based on development, regulatory, and commercialization of compounds 19.0 : triggered by advances into phase IIb clinical trial Milestones, US$m: 11.0 : additional milestone payment triggered by phase II clinical trial milestone 50 : sum of milestone payment triggered by phase III program in 2012 n/d : incremental royalty rate increase across all tiers upto the high Royalty rates, %: twenties on potential future global sales n/d : upper royalty rate on higher sales n/d : Incyte to fund thirty percent of development costs from the initiation Funding, US$m: of a Phase IIb trial © 2009-2021, Wildwood Ventures Ltd. All rights reserved. Termsheet 15 November 2012 Incyte Corporation has earned a $50 million milestone payment from Eli Lilly and Company based on the formal initiation of the rheumatoid arthritis Phase III program for baricitinib, Incyte’s oral JAK1/JAK2 inhibitor, formerly known as INCB28050. The Phase III program is being conducted by Lilly as part of the exclusive worldwide License, Development and Commercialization Agreement for baricitinib. 21 December 2009 Exclusive worldwide license and collaboration agreement for the development and commercialization of JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. Lilly will receive worldwide rights to develop and commercialize INCB28050 as an oral treatment for all inflammatory conditions. Incyte will receive an initial payment of $90 million and up to $665 million in additional development, regulatory, and commercialization milestones, as well as tiered, double-digit royalty payments on future global sales with rates ranging up to twenty percent. Incyte will retain the option to co-develop its JAK1/JAK2 inhibitors with Lilly on a compound-by-compound and indication-by-indication basis beginning at the initiation of Phase IIb development. Incyte would be responsible for funding thirty percent of the associated future global development costs from the initiation of a Phase IIb trial. Incyte would receive an incremental royalty rate increase across all tiers resulting in effective royalty rates ranging up to the high twenties on potential future global sales for compounds and/or indications that Incyte elects to co-develop. Incyte consider exercising a co-development option would be in the second half of 2010. Press Release 15 November 2012 Incyte Corporation (INCY) Wins $50 Million From Eli Lilly and Company (LLY) as RA Drug Enters Phase 3 WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (INCY) announced today that it has earned a $50 million milestone payment from Eli Lilly and Company based on the formal initiation of the rheumatoid arthritis (RA) Phase III program for baricitinib, Incyte’s oral JAK1/JAK2 inhibitor, formerly known as INCB28050. The Phase III program is being conducted by Lilly as part of the exclusive worldwide License, Development and Commercialization Agreement for baricitinib About the Phase III Program Four Phase III RA studies are planned, which will investigate the safety and efficacy of baricitinib 2 mg and 4 mg once daily in patients with active RA who are methotrexate-naive, biologic-naive or biologic-experienced. Patients completing any of the four studies will be eligible for enrollment in a fifth study, a long-term extension. Information about the clinical trials can be viewed at www.clinicaltrials.gov. About Incyte Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, please visit the Company’s website at www.incyte.com. 21 December 2009 Incyte Corporation (INCY) Sells Autoimmune Therapies to Eli Lilly and Company (LLY) (JOBS) for up to $755 Million INDIANAPOLIS and WILMINGTON, Del., Dec. 21 /PRNewswire-FirstCall/ -- Eli Lilly and Company and Incyte Corporation announced today that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis. Lilly will receive worldwide rights to develop and commercialize INCB28050 as an oral treatment for all inflammatory conditions. In exchange for these rights, Incyte will receive an initial payment of $90 million and is eligible for up to $665 million in additional potential development, regulatory, and commercialization milestones, as well as tiered, double-digit royalty payments on future global sales with rates ranging up to twenty percent if a product is successfully commercialized. © 2009-2021, Wildwood Ventures Ltd. All rights reserved. "This new alliance with Incyte reinforces Lilly's commitment to expand our presence in inflammation and autoimmunity through the development of a new class of oral anti-inflammatory therapies," said Eiry Roberts, M.D. Lilly vice president for autoimmune product development. "We look forward to continuing the development of INCB28050 in RA and initiating additional clinical studies to help address the unmet patient needs from debilitating autoimmune and inflammatory diseases." Incyte will retain the option to co-develop its JAK1/JAK2 inhibitors with Lilly on a compound-by-compound and indication-by-indication basis beginning at the initiation of Phase IIb development. Incyte will retain the option to co-develop its JAK1/JAK2 inhibitors with Lilly on a compound-by-compound and indication-by-indication basis beginning at the initiation of Phase IIb development. Under the agreement if Incyte elects to co-develop any compounds and/or indications, Incyte would be responsible for funding thirty percent of the associated future global development costs from the initiation of a Phase IIb trial. Incyte would receive an incremental royalty rate increase across all tiers resulting in effective royalty rates ranging up to the high twenties on potential future global sales for compounds and/or indications that Incyte elects to co-develop. Incyte expects that the earliest it would consider exercising a co-development option would be in the second half of 2010, concurrent with the potential initiation of a Phase IIb trial with INCB28050. As a result of this transaction, Lilly expects to incur a charge to earnings in the fourth quarter of 2009 of approximately $.05 per share. The company reconfirmed its full-year 2009 earnings-per-share guidance of $3.90 to $4.00 per share on a reported basis, or $4.30 to $4.40 per share on a pro forma non-GAAP basis. About JAK Inhibition There are four known JAK enzymes: JAK1, 2, 3 and TYK2. These enzymes are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in RA patients. Cytokines such as interleukin-6, -12, and -23 signal through the JAK pathway and have been clinically validated as therapeutic targets in inflammatory diseases. Additional JAK-dependent cytokines have also been implicated in a number of inflammatory and autoimmune diseases suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. About Incyte Incyte Corporation is a Wilmington, Delaware-based drug discovery and development company focused on developing proprietary small molecule drugs for oncology, inflammation and diabetes. Incyte's most advanced compound, INCB18424, is in Phase III development for myelofibrosis. For additional information on Incyte, visit the Company's web site at www.incyte.com. 6 May 2010 Incyte arthritis drug shows promise, triggers milestone May 6, 2010 (Reuters) - Biotechnology firm Incyte Corp (INCY.O) said data from a mid-stage trial of its experimental rheumatoid arthritis treatment showed the drug was safe and effective. Positive data triggers $30 mln milestone from Eli Lilly. 6 May 2010 Incyte Reports First Quarter 2010 Financial Results Completes patient enrollment for Phase III trials for INCB18424 for myelofibrosis Describes positive top-line Phase II results for INCB28050 for rheumatoid arthritis To receive $30 million from Lilly in connection with a milestone for its JAK1/JAK2 Inhibitor,