Humor and Quirks Humor and Quirks
Wed, December 11, 2024
Tue, December 10, 2024
[ Tue, Dec 10th 2024 ] - The New Yorker
The Dawn of the Bionic Man
[ Tue, Dec 10th 2024 ] - Mercury News
California News
[ Tue, Dec 10th 2024 ] - ABC News
Entertainment News
Mon, December 9, 2024
[ Mon, Dec 09th 2024 ] - BBC
Beds, Herts & Bucks
[ Mon, Dec 09th 2024 ] - Uproxx
The Best TV Shows Of 2024
[ Mon, Dec 09th 2024 ] - Paste
The 25 Best PC Games of 2024
[ Mon, Dec 09th 2024 ] - CNET
Top News Stories
Sun, December 8, 2024
Sat, December 7, 2024
[ Sat, Dec 07th 2024 ] - Newsweek
Russia-Ukraine War
[ Sat, Dec 07th 2024 ] - imdb.com
Canada's 30 Funniest TV Shows
[ Sat, Dec 07th 2024 ] - Daily Mail
UK Celebrity News
[ Sat, Dec 07th 2024 ] - Food Safety News
Food Safety News
Fri, December 6, 2024
[ Fri, Dec 06th 2024 ] - Graphic
Latest Ghana News Headlines Today
[ Fri, Dec 06th 2024 ] - The Columbian
Clark County News
[ Fri, Dec 06th 2024 ] - who13
Cyclones react to 10 wins
[ Fri, Dec 06th 2024 ] - TravelPulse
Hotels and Resorts News
[ Fri, Dec 06th 2024 ] - Business Standard
Share Market Today
[ Fri, Dec 06th 2024 ] - Reuters
Aerospace & Defense
Thu, December 5, 2024
[ Thu, Dec 05th 2024 ] - Interest
All news stories
[ Thu, Dec 05th 2024 ] - Stereogum
When Comedians Make Serious Music
[ Thu, Dec 05th 2024 ] - Paste
The 30 Best TV Shows of 2024
[ Thu, Dec 05th 2024 ] - Phil Bruner
Featured News Stories
[ Thu, Dec 05th 2024 ] - Phil Bruner
Swattie Survival Guide
Wed, December 4, 2024
[ Wed, Dec 04th 2024 ] - Phil Bruner
California News
[ Wed, Dec 04th 2024 ] - Phil Bruner
President Joe Biden
Tue, December 3, 2024
[ Tue, Dec 03rd 2024 ] - Phil Bruner
The 40 Best Games of 2024
[ Tue, Dec 03rd 2024 ] - Phil Bruner
Boku No Roblox Codes
[ Tue, Dec 03rd 2024 ] - Phil Bruner
Yonhap News Agency
[ Tue, Dec 03rd 2024 ] - Phil Bruner
Beds, Herts & Bucks
[ Tue, Dec 03rd 2024 ] - Phil Bruner
Transfer news and rumors
Mon, December 2, 2024
[ Mon, Dec 02nd 2024 ] - Phil Bruner
Watch Samaa News Live
[ Mon, Dec 02nd 2024 ] - Phil Bruner
UK Celebrity News
[ Mon, Dec 02nd 2024 ] - Phil Bruner
The 100 Best Albums of 2024
[ Mon, Dec 02nd 2024 ] - Phil Bruner
From the Newspaper
[ Mon, Dec 02nd 2024 ] - Phil Bruner
South Australia
[ Mon, Dec 02nd 2024 ] - Phil Bruner
Whanganui Chronicle
Sun, December 1, 2024
[ Sun, Dec 01st 2024 ] - Phil Bruner
Wildlife Oddities of the Week
Sat, November 30, 2024
Fri, November 29, 2024
[ Fri, Nov 29th 2024 ] - Phil Bruner
Hotels and Resorts News
[ Fri, Nov 29th 2024 ] - Phil Bruner
The Best Jokes of 2024
Thu, November 28, 2024
[ Thu, Nov 28th 2024 ] - Phil Bruner
Climate and Environment
[ Thu, Nov 28th 2024 ] - Phil Bruner
December 2024 Issue
Wed, November 27, 2024
[ Wed, Nov 27th 2024 ] - Phil Bruner
Decoding Gen Z's content diet
Tue, November 26, 2024
[ Tue, Nov 26th 2024 ] - Phil Bruner
Illustrated Humor in the News
[ Tue, Nov 26th 2024 ] - Phil Bruner
World News
[ Tue, Nov 26th 2024 ] - Phil Bruner
Alexandra Petri
Mon, November 25, 2024
[ Mon, Nov 25th 2024 ] - Phil Bruner
Legal IT's Leading News Source
[ Mon, Nov 25th 2024 ] - Phil Bruner
All Kent news
Sun, November 24, 2024
Mon, December 15, 2008
[ Mon, Dec 15th 2008 ] - Market Wire
fasdfasddva s gfg h

Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline Phase III CLL Study


//health-fitness.news-articles.net/content/2013/ .. th-patient-in-frontline-phase-iii-cll-study.html
Published in Health and Fitness on Thursday, April 11th 2013 at 4:01 GMT by Market Wire   Print publication without navigation


Pharmacyclics Triggers Fourth Milestone Payment for Enrollment of 5th Patient in Frontline... -- SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ --

SUNNYVALE, Calif., April 11, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: [ PCYC ]) announced today that the Phase III clinical trial (RESONATE™-2), a monotherapy trial using ibrutinib versus chlorambucil in elderly patients with newly diagnosed chronic lymphocytic leukemia / small lymphocyctic lymphoma (CLL/SLL) has enrolled its fifth patient. The enrollment of the fifth patient has subsequently triggered a fourth $50 million milestone payment obligation from Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, worldwide collaborator on ibrutinib in oncology.

This trial is a randomized, multicenter, open-label Phase III study of ibrutinib (PCI-32765) as a monotherapy versus chlorambucil in patients 65 years or older with treatment-naïve CLL/SLL. The study design is in accord with a Special Protocol Assessment (SPA). The study is designed to demonstrate superiority of ibrutinib with the primary endpoint of progression-free survival (PFS); the comparator is single agent chlorambucil. This global study is planned to enroll 272 patients worldwide.

Further information about this trial can be found at [ www.clinicaltrials.gov ]:
NCT01722487 – "A Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (RESONATE™-2)."

About the Janssen Collaboration
As previously announced on December 8, 2011, Pharmacyclics entered into a worldwide collaboration with Janssen to develop and commercialize ibrutinib, a novel, oral, first-in-class Bruton's Tyrosine Kinase (BTK) inhibitor. Pharmacyclics received from Janssen an upfront payment totaling $150 million upon signing the contract. With the dosing of a fifth patient in the RESONATE™-2 study, as announced today, a milestone payment of $50 million has been earned. To date, $200M in milestones have been earned and Pharmacyclics may receive up to an additional $625 million in development and regulatory milestone payments; for total potential upfront and milestone payments of $975 million.

Following regulatory approval, both Pharmacyclics and Janssen will book revenue and co-commercialize ibrutinib. In the US, Pharmacyclics will book sales and take the lead role in US commercial strategy development. Both Pharmacyclics and Janssen will share in commercialization activities. Outside the United States, Janssen will book sales and perform commercialization activities. Profits and losses from the commercialization activities will be split 50/50 on a worldwide basis. Development and commercialization activities under the collaboration will be managed through a shared governance structure. Each company will lead development for specific indications as stipulated in a global development plan. Except in certain cases, in general, development costs are shared on a 40/60 basis (Pharmacyclics 40% and Janssen 60%).

About Ibrutinib
Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulation of apoptosis, adhesion, and cell migration and homing. Through these multiple signals, BTK regulation helps to direct malignant B-cells to lymphoid tissues, thus allowing access to a micro environment necessary for survival.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenström's macroglobulinemia and multiple myeloma. To date five Phase III trials have been initiated with ibrutinib and a total of 26 trials are currently registered on [ www.clinicaltrials.gov ].

About Pharmacyclics
Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Presently, Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The Company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.

The Company is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at [ http://www.pharmacyclics.com ].  

NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words "anticipate", "believe", "estimate", "expect", "expectation", "goal", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our annual report on Form 10-K and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management's expectations or otherwise, except as may be required by law.

SOURCE Pharmacyclics, Inc.



RELATED LINKS
[ http://www.pharmacyclics.com ]

Publication Contributing Sources