Navigation Links
Infinity And AbbVie Announce Global Strategic Collaboration To Develop And Commercialize Duvelisib (IPI-145) In Oncology
Date:9/3/2014

CAMBRIDGE, Mass. and NORTH CHICAGO, Ill., Sept. 3, 2014 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and AbbVie Inc. (NYSE: ABBV) today announced that they have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of patients with cancer. Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in patients with iNHL, and DUOTM, a Phase 3 study in patients with CLL.

Under the terms of the agreement, Infinity will receive an upfront payment of $275 million and is eligible to receive up to $530 million in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405 million for the achievement of milestones through the first commercial sale of duvelisib. In the U.S., the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the U.S., AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales.

"We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers," said Michael Severino, M.D., AbbVie executive vice president and chief scientific officer. "The addition of duvelisib will complement AbbVie's emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients. We look forward to working with Infinity to bring duvelisib to patients worldwide."

"This collaboration is an important step toward fulfilling Infinity's objective of bringing better treatments to patients and further advances our goal of building a sustainable, fully integrated biotechnology company," stated Adelene Q. Perkins, chair, president and chief executive officer at Infinity. "AbbVie will be a wonderful partner for Infinity, bringing all of the expertise and scale of a successful, well established company, together with the energy, drive, innovation, and nimbleness of a young organization. We look forward to advancing duvelisib through monotherapy studies designed to enable registration and in furthering our shared longer-term vision of combining duvelisib with both current standards of care and novel, targeted therapies."  

Additional Details About the Collaboration
Development and commercialization activities under the collaboration will be managed through a shared governance structure. In the U.S., Infinity and AbbVie will jointly commercialize duvelisib, assuming regulatory approval, with Infinity booking sales, and will share equally in any potential profits or losses. Outside the U.S., AbbVie will be responsible for conducting and funding of any commercialization of duvelisib, and Infinity is eligible to receive tiered royalties on net product sales, with percentages ranging from 23.5 percent to 30.5 percent.

For sales of duvelisib in the U.S., AbbVie and Infinity will share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible for these royalty obligations outside of the U.S. Infinity will also be responsible for the existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide.

As part of the strategic collaboration, the companies will share responsibility for the conduct of specific trials specified within an agreed-upon global development plan, with each company leading the development of certain trials within the plan. For the initial global development plan agreed to by the companies, Infinity will fund the trials it conducts and the companies will share equally the funding of trials conducted by AbbVie. The agreement includes plans to launch multiple Phase 2 and Phase 3 studies of duvelisib in hematologic malignancies over the next several years.

Conference Call Today at 8:30 a.m. ET/7:30 a.m. CT
Infinity will hold a conference call at 8:30 a.m. to discuss the strategic collaboration announced today. A live webcast of the conference call can be accessed in the Investors/Media section of Infinity's website at www.infi.com. To participate in the conference call, please dial (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 97402440. An archived version of the webcast will be available on Infinity's website for 30 days.

About the Development of Duvelisib for the Treatment of Blood Cancers
Infinity and AbbVie are developing duvelisib, an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies.

In 2013, Infinity launched the DUETTSTM (Duvelisib Trials in Hematologic Malignancies) program, a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS program, patient enrollment is ongoing in DYNAMOTM, a Phase 2 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and DUOTM, a Phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) (NCT02004522). DYNAMO+RTM, a Phase 3 study of duvelisib in combination with rituximab in patients with previously treated follicular lymphoma (NCT02204982), is expected to start in 2014.

Additionally, a Phase 1 study of duvelisib in patients with advanced blood cancers is ongoing (NCT01476657).

About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information on Infinity, please refer to the company's website at www.infi.com.

About AbbVie Inc.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on AbbVie's Facebook or LinkedIn page.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the Company's expectations about: the receipt of upfront, milestone, royalty and other payments under the agreement with AbbVie; the therapeutic and commercial potential of duvelisib; the expected benefits of the collaboration with AbbVie; the advancement of duvelisib through clinical trials; plans to conduct additional clinical trials of duvelisib; and its ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that Infinity will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity's product candidates will continue. Further, there can be no guarantee that Infinity's strategic collaboration with AbbVie will continue or that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; a failure of Infinity and/or AbbVie to fully perform under the strategic collaboration and/or an early termination of the collaboration and license agreement; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Infinity's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop its product candidates; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2014, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE AbbVie
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Transonic Systems Selects Infinity Info Systems To Implement Microsoft Dynamics CRM To Drive Business Performance And Operational Excellence
2. Top Active Companies to Watch: Crown Marketing, Herbalife, Novogen, GNC, Pfizer and Infinity Pharmaceuticals
3. Pipeline Initiatives, Partnerships to Drive Growth - Research Report on Pfizer, Theravance, ISIS Pharmaceuticals, Infinity Pharmaceuticals and Ironwood
4. Elektas Leksell Gamma Knife Perfexion and Elekta Infinity Place First and Second in 2013 KLAS Radiation Therapy Report
5. Portfolio Expansions, Product Data, and Announcements by Healthcare Companies - Research Report on Life Technologies, OncoMed, Halozyme Therapeutics, Infinity, and PTC Therapeutics
6. InfinityQS to Host Manufacturing Intelligence Conference in Chicago
7. AbbVie Named to S&P 500 Dividend Aristocrat Index
8. AbbVie Issues Inaugural Full-Year Outlook for 2013
9. AbbVie to Present at Barclays Global Health Care Conference
10. Receptos Licenses Anti-Interleukin-13 Antibody from AbbVie for Phase 2 Development in Orphan Disease
11. AbbVie to Host First-Quarter Earnings Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) announced today ... year-end 2015 results after the Nasdaq market closes on ... live conference call and webcast to discuss its financial ... 11, 2016 at 4:30 p.m. Eastern Time (1:30 p.m. ... http://www.neurocrine.com . --> Participants can access the ...
(Date:2/8/2016)... 8, 2016 --> ... report "Ablation Technologies Market by Product (Radiofrequency, Ultrasound, Irreversible ... Cosmetic Surgery, Ophthalmology, Gynecology) - Global Forecasts to 2020", ... over the forecast period of 2015 to 2020. The ... at CAGR of 10.5% from 2015 to 2020. ...
(Date:2/8/2016)... 8, 2016 Nueterra, the nation,s ... in the development of equity partnerships and ... has divided its interests between two new ... will continue the founding company,s private equity ... a national system of integrated provider networks ...
Breaking Medicine Technology:
(Date:2/8/2016)... , ... February 08, 2016 , ... Delta Dental of ... help combat pancreatic cancer. , Gary D. Radine, who recently retired as president and ... American Cancer Society’s 2015 CEO of the Year , helped lead the effort ...
(Date:2/8/2016)... ... February 08, 2016 , ... Discover the Rocky Mountain region’s longest ... and 700 companies. Attendees also get to see the most incredible gardens and ... Home Show , at the Colorado Convention Center - 700 14th St. Denver CO, ...
(Date:2/8/2016)... ... February 08, 2016 , ... Guruji Mahendra Kumar Trivedi is offering ... 2016 in honor of his birthday on February 10th. During this time, people ... is known by over 250,000 people from over 40 different countries as an “ordinary ...
(Date:2/7/2016)... ... February 07, 2016 , ... ... empowers employers and organizations with the tools and information to lower the costs, ... to cut the cost of providing employee healthcare benefits by as much as ...
(Date:2/6/2016)... ... ... Shark Finds and Kevin Harrington, along with the Product Managers ... Belly Bands. , Having a dog is great—except when it wets every couch, bed, ... works, get Belly Bands, the easiest way to stop dogs from wetting on ...
Breaking Medicine News(10 mins):