ARRY: Known, current, collaborations:
Our largest partners, from whom we are receiving research funding or have the potential for future milestones or royalties, include Celgene Corporation, AstraZeneca, Genentech, InterMune, Ono Pharmaceutical Co., Ltd., Amgen Inc., Eli Lilly and Company (ICOS Corporation), Japan Tobacco Inc., and Takeda Pharmaceutical Company, Ltd.
Celgene:
Celgene – Research Program
We entered into a worldwide strategic collaboration with Celgene, in September 2007, focused on the discovery development and commercialization of novel therapeutics in cancer and inflammation. Under the agreement, Celgene made an upfront payment of $40 million to us and, in return, we granted Celgene an option to select drugs developed under the collaboration that are directed to two of four mutually selected discovery targets. We will be responsible for all discovery and clinical development through Phase 1 or Phase 2a. At which time, Celgene will have the option to select drugs resulting from up to two of these four therapeutic programs and will receive exclusive worldwide rights to those drugs, except for our limited co-promotional rights in the U.S. Additionally, we are entitled to receive, for each drug, potential milestone payments of approximately $200 million, if certain discovery, development and regulatory milestones are achieved and $300 million if certain commercial milestones are achieved, as well as royalties on net sales. Array will retain all rights to the other programs.
Genentech:
Genentech – Oncology Programs
We entered into a licensing and collaboration agreement with Genentech in December 2003 to develop small molecule drugs against multiple therapeutic targets in the field of oncology. We initiated this collaboration with Genentech to advance two of our proprietary oncology programs into clinical development. These programs include small molecule leads we had developed along with additional, related intellectual property. Under the agreement, Genentech made an up-front payment to us, provides research funding and paid a milestone payment to us for nominating a clinical candidate and advancing it into regulated safety assessment testing. In addition, Genentech has agreed to make potential additional development milestone payments and pay us royalties on any resulting product sales. Genentech is responsible for clinical development and commercialization of the resulting products.
In April 2005, we expanded out collaboration agreement with Genentech to develop clinical candidates directed against an additional cancer target. Under the expanded agreement, we receive additional research funding, as well as potential research and development milestone payments and product royalties based on the success of the new program. Genentech has the sole responsibility for clinical development and commercialization of any resulting products. In October 2005, we further expanded our collaboration with Genentech; under the current agreement, we expect to receive a total of $50 million in research funding through December 2008, plus milestone royalty payments based on success of the programs. Genentech may terminate its agreement with us upon 120 days’ notice.
AstraZeneca:
AstraZeneca – MEK for Cancer Program / AZD6244 (ARRY-886) and AZD8330 (ARRY-704)
In December 2003, we entered into an out-licensing and collaboration agreement with AstraZeneca to develop our MEK program solely in the field of oncology. Under the agreement AstraZeneca acquired exclusive worldwide rights to our clinical development candidate, AZD6244 (ARRY-886), together with AZD8330 (ARRY-704) and another second-generation compound for oncology indications we developed during the collaboration. We retain the rights to all non-oncology therapeutic indications for MEK compounds not selected by AstraZeneca for development. To date, we have earned $21.5 million in up-front and milestone payments. The agreement also provides for research funding, which is now complete, and potential additional development milestone payments of approximately $75 million and royalties on product sales. AstraZeneca is responsible for further clinical development and commercialization for AZD6244, and for clinical development and commercialization for AZD8330 and for the third compound it licensed.
Intermune:
InterMune – Hepatitis C Virus Programs
Array and InterMune scientists have collaborated since 2002 to discover novel small molecule inhibitors of the Hepatitis C Virus (HCV) NS3/4 protease. During the collaboration, our team of scientists discovered ITMN-191, which InterMune is now developing. Under the terms of agreement, InterMune funded drug discovery, preclinical testing, process development and manufacturing in conformity with current Good Manufacturing Practices, or cGMP. InterMune will make milestone payments to us based on the selection and progress of clinical drug candidates, as well as royalties on sales of any products derived from the collaboration. As a result of our research progress, we received our first milestone payment from InterMune in June 2004. Research funding under this agreement ended June 30, 2007.
We designed compounds under this program using computational modeling techniques and optimized them to achieve superior efficacy and targeted tissue penetration. During 2006, we produced and delivered cGMP clinical supplies of ITMN-191, and InterMune initiated a Phase 1 clinical trial. We received a $500,000 milestone payment in February 2007 after the first subject was dosed.
Lilly:
We entered into a collaboration agreement with ICOS Corporation in 1999 to create small molecule CHK-1 inhibitors. Array and ICSO scientists invented IC83, and Array received a milestone payment after the first patient was dosed with this molecule in a Phase 1 clinical trial in early 2007. The agreement provided research funding, which has now ended, and Array is entitled to receive additional milestone payments based on Eli Lilly’s achievement of clinical milestones. Eli Lilly acquired ICOS in 2007.
VentiRx Pharma:
3/13/07: Entered into a license agreement with VentiRx Pharmaceuticals Inc., granting VentiRx exclusive worldwide rights to Array’s toll-like receptor (TLR) program. Array received an equity stake in VentiRx, a privately held company, as well as an up-front payment, and is entitled to receive potential milestone payments and royalties on product sales. Array retains the option to acquire a 50% ownership position in all VentiRx clinical oncology products developed under this agreement.
