Ambrx and Zhejiang Medicine have announced that they have formed a collaboration to develop and commercialize ARX788, Ambrx’s most advanced internally developed site-specific antibody drug conjugate targeting Her2-positive breast cancer. Under the terms of the agreement Ambrx and ZMC will continue the development of ARX788, with ZMC bearing the ongoing development cost. ZMC will receive commercial rights in China while Ambrx retains commercial rights outside of China and receives royalties on sales of the product in China. ZMC will manufacture the product to world-class standards for clinical and commercial supplies on a global basis. WuXi PharmaTech will provide integrated services for ARX788, including the development and manufacturing of the toxin, antibody and ADC, pre-clinical development and clinical trials.
Category Archives: alliances
Genmab and ADC Therapeutics have announced that they have partnered to co-develop a new antibody-drug conjugate product conjugate to treat multiple cancer indications. The partnership will provide both the companies with an equal share in the product. ADC will fund and lead the preclinical development and Genmab cannot acquire any development costs before submitting the IND application to conduct clinical studies in patients. A minimum of 25% ownership stake will be maintained by Genmab, as the product advances into clinical development. Further financial terms have not been disclosed.
AstraZeneca has announced that MedImmune, its biologics research and development arm, and NGM Biopharmaceuticals have entered into an exclusive agreement to discover, develop and commercialise therapeutics from NGM’s enteroendocrine cell (EEC) programme for the treatment of type 2 diabetes and obesity. Under the terms of the agreement MedImmune and NGM will jointly develop peptide and antibody drug candidates based on EEC hormones discovered by NGM. MedImmune will have the option to license in these EEC targets, and will be responsible for the global development, manufacture and commercialisation of compounds resulting from the collaboration. MedImmune will make an upfront payment and provide NGM research funding over the course of the collaboration. If development, regulatory and commercial milestones are achieved, NGM will be entitled to receive various payments as well as royalties on worldwide product sales.
Isis Pharmaceuticals and Xenon Pharmaceuticals have announced that Xenon has exercised its option to an exclusive worldwide license to XEN701, an antisense drug discovered in a collaboration between Isis and Xenon. For the license of XEN701, Isis earns a $2 million payment from Xenon. XEN701 is a drug candidate designed to inhibit the production of hepcidin, a target Xenon identified utilizing its extreme genetics platform for the treatment of anemia of chronic disorders. XEN701 is currently being evaluated in studies to support clinical development. Xenon plans to initially develop XEN701 for patients with chronic kidney disease who are intolerant of or who are poor responders to erythropoietin therapy. XEN701 is the first drug to enter development from Isis’ collaboration with Xenon.
In 2010, Isis entered into collaboration with Xenon to discover and develop antisense drugs as novel treatments for ACD. Under the terms of the agreement, Isis received an undisclosed upfront payment in the form of a convertible promissory note from Xenon to discover and develop antisense drugs to the targets hepcidin and hemojuvelin. Upon the identification of a development candidate, Xenon has the option to exclusively license the development and worldwide commercialization rights for these antisense drugs from Isis. Xenon is responsible for all future development and commercialization of XEN701 and Isis is eligible to receive development and commercial milestone payments and royalties from Xenon on sales of XEN701, as well as a portion of sublicense revenue.
Bristol-Myers Squibb and Simcere Pharmaceutical have announced that the companies have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous formulation of Bristol-Myers Squibb’s biologic medicine, Orencia, for the treatment of rheumatoid arthritis. Orencia SC is already on the market for the treatment of rheumatoid arthritis in the US, Europe and Japan. Under the terms of the agreement, Simcere will perform and fund all development and regulatory activities required to obtain market approval for Orencia SC in China, based on a pre-agreed development plan. The companies will share responsibility for commercializing Orencia, and will share profits and losses related to Orencia SC in China. Financial terms were not disclosed.
Takeda and Sea Lane Biotechnologies have announced that they have entered into a discovery license agreement for the use of Sea Lane’s ConCIRT libraries and technology. Under the terms of the agreement, Sea Lane granted Takeda access to its ConCIRT libraries for use in internal biotherapeutic drug discovery programs, and Takeda will be responsible for preclinical research, clinical development, and marketing of selected biotherapeutic products. In return, Sea Lane will receive an up-front payment and milestone option fees for projects initiated under the collaboration. Sea Lane stands to receive downstream milestone option payments. The agreement has an initial term of two years with a pre-negotiated option to extend.
Amgen and Cytokinetics have announced an expansion of their strategic collaboration to include Japan. In 2006, Cytokinetics and Amgen entered into a collaboration to develop small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure. Omecamtiv mecarbil is the most advanced drug candidate in this collaboration. Initially, Cytokinetics’ license to Amgen for omecamtiv mecarbil excluded Japan. Under the amendment to the collaboration, the companies have agreed on terms expanding Amgen’s license for omecamtiv mecarbil and related compounds to include Japan.
In consideration of the expanded license, Cytokinetics will receive $25 million from Amgen consisting of a license fee of $15 million and $10 million for Amgen’s purchase of Cytokinetics` common stock. Cytokinetics is also eligible to receive additional pre-commercialization milestone payments for the development of omecamtiv mecarbil in Japan of up to $50 million as well as royalties on sales of omecamtiv mecarbil in Japan. Under the terms of the amended collaboration agreement, Cytokinetics plans to conduct a Phase I pharmacokinetic study, the costs of which will be reimbursed by Amgen, intended to support the inclusion of Japanese patients in a potential Phase III clinical development program for omecamtiv mecarbil.
CytomX Therapeutics has announced that it has entered into a collaboration with Pfizer to develop antibody-drug conjugates. Under the terms of the agreement, Pfizer has exclusive rights to pursue development and commercialization of select antibody-drug conjugates developed by CytomX. The companies will work together on preclinical research and Pfizer will be responsible for development and potential commercialization of any selected PDCs. CytomX will be eligible to receive up-front, research reimbursement and preclinical milestone payments totaling approximately $25 million and approximately $610 million in regulatory and sales milestone payments, as well as tiered royalties reaching double digits on potential future sales.
Isis Pharmaceuticals has announced that it has earned a $6 million payment from AstraZeneca related to continuation of the research collaboration between Isis and AstraZeneca to discover and develop novel antisense therapeutics to treat cancer. In addition to the research collaboration, which includes three cancer targets, Isis and AstraZeneca are developing two antisense drugs, ISIS-ARRx and ISIS-STAT3Rx, discovered by Isis and licensed to AstraZeneca for the treatment of cancer. In December 2012, Isis entered into a collaboration with AstraZeneca to discover and develop antisense drugs to treat cancer. The collaboration combines AstraZeneca’s experience and expertise in developing anti-cancer agents with Isis’ antisense technology platform to broaden Isis’ cancer franchise. With the $6 million payment, Isis has earned $41 million in upfront and milestone payments from AstraZeneca and is eligible to earn additional milestone payments as the collaboration progresses and royalties on sales of drugs resulting from the collaboration.
AstraZeneca has announced top-line results from OSKIRA-2 and OSKIRA-3, the remaining pivotal Phase III clinical trials investigating fostamatinib. Based on the results from the OSKIRA Phase III programme, including the data previously reported from OSKIRA-1, AstraZeneca has decided not to proceed with regulatory filings for fostamatinib. AstraZeneca will return the rights to the compound to Rigel Pharmaceuticals which will decide whether it will continue the ongoing studies and pursue regulatory filings. As a result of this decision, AstraZeneca will incur a pre-tax impairment charge of around $140 million for the intangible assets relating to fostamatinib. AstraZeneca and Rigel signed the $1.24 billion deal for fostamatinib in 2010.