Friday, December 19, 2014

Last chance for the CLL (chronic lymphocytic leukemia) Survey and the News About the Agreement between Gilead and Ono

We are taking down the survey at midnight tonight Pacific Time, so if you haven't completed it, please let us know what will be important to you in a CLL website and support groups.

Here is the link to the survey: https://cllsociety.questionpro.com

And thanks so much to the over 400 of you that completed the survey and the many who have made a donation to the CLL Society Inc. to jumpstart our process.

                                  


Finally I want to share this press release from Gilead:

ONO  AND  GILEAD  ANNOUNCE  EXCLUSIVE  LICENSE  AGREEMENT  TO  DEVELOP  BTK  INHIBITOR,  ONO-4059,  FOR  THE  TREATMENT  OF
B-CELL  MALIGNANCIES  AND  OTHER  DISEASES

-- Companies will Collaborate Jointly on Global Development of ONO-4059 --

Osaka, Japan, and Foster City, CA, December 18, 2014 - ONO PHARMACEUTICAL CO., LTD. (“ONO”) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the companies have entered into an exclusive license agreement for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of B-cell malignancies and other diseases.  Under the terms of the agreement, Gilead will pay ONO an upfront payment plus additional payments based upon achievement of certain development, regulatory and commercial milestones.  The companies will collaborate jointly on global development of ONO-4059.  Gilead will have exclusive rights to develop and commercialize ONO-4059 in all countries of the world outside of Japan, South Korea, Taiwan, China and the Association of Southeast Asian Nations (ASEAN) countries, where ONO retains development and commercialization rights.  
ONO-4059 is a selective, once-daily, oral inhibitor of BTK, which has been shown to play a role in the survival and proliferation of malignant B-cells.  ONO has presented preliminary Phase 1 data showing clinical activity in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) at several scientific conferences.  ONO and Gilead plan to develop ONO-4059 for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with approved and investigational agents, including combinations with kinase inhibitors in Gilead’s portfolio. 
“We are pleased to partner with Gilead to accelerate worldwide development and commercialization of ONO-4059,” said Gyo Sagara, ONO’s President, Representative Director and Chief Executive Officer.  “Our goal is to bring better therapeutic options as quickly as possible for the patients with B-cell malignancies or other diseases in the world, and we believe we can fulfill the goal by pursuing the development of ONO-4059 with Gilead.”
“With this agreement, Gilead now has compounds targeting four unique signaling pathways associated with B-cell malignancies – PI3K delta, Syk, JAK and BTK,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer.  “In addition to evaluating ONO-4059 in combination with standards of care, we believe there is an opportunity to combine this compound with Gilead’s other kinase inhibitors with a goal of achieving more pronounced and more durable response rates.  We look forward to working with ONO to move the ONO-4059 development program forward as quickly as possible.”
About ONO PHARMACEUTICAL
ONO PHARMACEUTICAL, headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the diabetes and oncology areas.  For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.  The company’s mission is to advance the care of patients suffering from life-threatening diseases.  Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks that the parties will be unable to develop and commercialize ONO-4059, as a potential monotherapy and in combination with other therapies, for the treatment of B-cell malignancies or other diseases.  These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.  The reader is cautioned not to rely on these forward-looking statements.  These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, as filed with the U.S. Securities and Exchange Commission.  All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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This is good news as we need more options and Gilead is a smart company that has a strong track record on getting new and important drugs approved. It also has other small molecules including idelalisib that might make sense in combination therapies. The market seems to approve of the move as this joint effort should increase the likelihood we will be seeing ONO-4059 become commercially available.

Ibrutinib is a great BTK inhibitor and has set the bar very very high in terms of its response rates and tolerability, but still it won't be the right choice for all patients due to some intolerance or adverse outcomes or lack of efficacy, so having another Bruton Tyrosine Kinase inhibitor option is something all patients should want.

And waiting in the sidelines is Acerta's ACP-196- no data to report yet, but the buzz about this new BTK inhibitor is very promising.

Abbvie, Janssen, Pharmacyclics and others are looking at new non-chemo combos in trials in the hope of going from control to cure. More on these trials and plans soon.

2014 was a great year for those with CLL. 2015 may be even better.

Happy Holidays to all.

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1 Comments:

Anonymous Branko said...

Brian, thank you so much for this blog and all work that you are doing. Happy Holidays and all the best to you and your family!

December 24, 2014 at 10:25 AM  

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