Pharmacyclics Receives 2014 Society for Medicines Research Award for Drug Discovery for Ibrutinib (IMBRUVICA®)

SUNNYVALE, Calif., Dec. 4, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that it has won the prestigious 2014 Society for Medicines Research Award for Drug Discovery for its discovery of ibrutinib (IMBRUVICA^®). The award was presented by The Society of Medicines Research at its biennial award lecture in Kensington, London.

This independent research award recognizes outstanding development in the multidisciplinary field of drug discovery and is bestowed toward compounds which demonstrate a novel mechanism of action, a novel molecular interaction principle, a high degree of clinical benefit, and a significant ability to address an unmet medical need.

"We are pleased to be recognized with this honor for our scientific innovation and excellence toward the development of IMBRUVICA by such a prestigious body of scientists and researchers," said Betty Y. Chang, Ph.D., Vice President, Research at Pharmacyclics, who has worked since 2009 on studying the Bruton's tyrosine kinase (BTK) pathway and leads the research of the Pharmacyclics BTK inhibitors. "Our understanding of the biologic and pharmacologic sciences, combined with our operational expertise, have allowed us to bring forward one of the most promising new treatments for patients with B-cell malignancies, which continues to demonstrate strong potential for use in hematologic and other applications."

IMBRUVICA acts as a covalent inhibitor of a protein called BTK, a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

"IMBRUVICA's success in treating patients with chronic lymphocytic leukemia and mantle cell lymphoma, coupled with Pharmacyclics' research leadership in bringing a new class of therapies to the market made it the top candidate for receiving our biennial scientific innovation and excellence award," said Richard Davenport, Ph.D., Media Relations Officer for The Society for Medicines Research.

Dr. Chang accepted the award on behalf of the company and provided the SMR Award Guest Lecture, entitled "Bench to Bedside: From PCI-32765 to ibrutinib to IMBRUVICA^®".

IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

About IMBRUVICA^®
IMBRUVICA^® (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).¹ BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.^1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.¹

IMBRUVICA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with del 17p,¹ a genetic mutation that occurs when part of chromosome 17 has been lost.

IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate (ORR). Improvements in survival or disease-related symptoms have not been established. Continued approval for the MCL indication may be contingent upon verification of clinical benefit in confirmatory trials.¹

IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and multiple myeloma (MM). Over 4,600 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 13 Phase III trials have been initiated with IMBRUVICA and 55 trials are registered on www.clinicaltrials.gov. The overall clinical development program in CLL currently includes seven Phase III trials and covers all lines of therapy and various combinations of treatments.

IMBRUVICA was one the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.

INDICATIONS
IMBRUVICA is indicated to treat people with:

• Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
•  Chronic lymphocytic leukemia (CLL) with 17p deletion (a genetic mutation that occurs when part of chromosome 17 has been lost).
• Mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Accelerated approval was granted for this indication based on overall response rate. Improvements in survival or disease-related symptoms have not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Patients taking IMBRUVICA for CLL should take 420 mg taken orally once daily (or three 140 mg capsules once daily).

Patients taking IMBRUVICA for MCL should take 560 mg taken orally once daily (or four 140 mg capsules once daily).

Capsules should be taken orally with a glass of water. Capsules should be taken whole. Do not open, break, split or chew the capsules.

IMPORTANT SAFETY INFORMATION
Warnings and Precautions include hemorrhage, infection, cyptopenias, atrial fibrillation, second primary malignancies, and embryo-fetal toxicity.

The most common adverse reactions include thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, pyrexia, vomiting, and decreased appetite.

For additional important safety information, please see Full Prescribing Information at http://www.imbruvica.com/downloads/Prescribing_Information.pdf.

About Pharmacyclics
Pharmacyclics^®, Inc. (NASDAQ: PCYC) is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. The company's mission 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 needs. It will do so by identifying and controlling promising product candidates based on scientific development and administrative expertise, developing its products in a rapid, cost-efficient manner, and pursuing commercialization and/or development partners when and where appropriate.

Pharmacyclics markets IMBRUVICA and 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 commercialization. Pharmacyclics is headquartered in Sunnyvale, CA. To learn more, visit www.pharmacyclics.com. Pharmacyclics is on Twitter. Sign up to follow our Twitter feed @pharmacyclics at http://twitter.com/pharmacyclics.

IMBRUVICA is a registered trademark of Pharmacyclics, Inc.

¹ IMBRUVICA Prescribing Information, July 2014.
² Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed November 2014.

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SOURCE Pharmacyclics, Inc.

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