8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 6, 2009
 

PHARMACYCLICS, INC.
(Exact name of registrant as specified in its charter)
Delaware	000-26658	94-3148201
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)
995 E. Arques Avenue Sunnyvale, California		94085-4521
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (408) 774-0330

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01. Other Events.

On December 6, 2009, Pharmacyclics, Inc. (the “Company”) announced interim results from a Phase I/II study showing safety and clinical activity in patients with relapsed / recurrent non-Hodgkin’s Lymphoma (NHL) treated with its HDAC inhibitor PCI-24781 as a single agent. The data were presented December 6, 2009 at the 51st American Society of Hematology annual meeting being held in New Orleans, Louisiana.

On December 7, 2009, the Company announced interim data from a Phase I study of their novel orally administered Bruton’s tyrosine kinase (Btk) inhibitor PCI-32765 in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL).

A conference call to discuss the trial results discussed herein and in the press releases attached hereto has been set up for Tuesday, December 8, 2009 at 8:00 a.m. Pacific Time (11:00 a.m. Eastern Time).

The foregoing descriptions are qualified in their entirety by reference to the Company’s press releases dated December 6, 2009 and December 7, 2009, copies of which are attached hereto as Exhibit 99.1 and 99.2 and are incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d)  Exhibits

Exhibit No.	Description
99.1	Press Release dated December 6, 2009
99.2	Press Release dated December 7, 2009

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date:  December 7, 2009	Pharmacyclics, Inc.
	By:	/s/ Rainer Erdtmann
		Rainer Erdtmann
		Vice President of Finance

EX-99.1

Exhibit 99.1

Pharmacyclics, Inc. Reports Interim Safety and Clinical Data from a Phase I/II Clinical Trial of its oral HDAC Inhibitor PCI-24781 in Lymphoma at the American Society of Hematology Annual Meeting

NEW ORLEANS, LA and SUNNYVALE, CA, December 6, 2009 -- Pharmacyclics, Inc. (NASDAQ:PCYC) today announced interim results from a Phase I/II study showing safety and clinical activity in patients with relapsed / recurrent non-Hodgkin’s Lymphoma (NHL) treated with its HDAC inhibitor PCI-24781 as a single agent. The data were presented today at the 51st ASH Annual Meeting being held in New Orleans, LA (Abstract # 2726).

PCI-24781 is an oral pan-HDAC inhibitor which is currently in multiple clinical trials for solid and hematological malignancies (PCYC-0401 single center, solid tumor cancer patients IV administered drug; PCYC-0402 multi-center, solid cancer patients orally administered; PCYC-0403 multicenter, lymphoma cancer patients orally administered). This compound, which has been optimized for the best combination of potency and pharmacokinetics (PK), has potent anti-tumor activity in a variety of preclinical tumor models (Buggy et al Mol Cancer Ther 5:1309-1317, 2006) and has also demonstrated safety and clinical benefit in human solid tumors (Undevia et al, ASCO 2008).

In a review of the clinical data at the end of the Phase I dose-escalation portion of the current lymphoma trial, it was revealed that PCI-24781 has shown strong signs of efficacy with minimal toxicity as a single agent in lymphoma, with 1 Complete Response (follicular lymphoma), 4 Partial Responses (2 follicular lymphoma, 1 diffuse large B-cell lymphoma, 1 mantle cell lymphoma) and 6 Stable Disease in 16 patients evaluated for response (after 2 cycles). Partial Response is defined as a 50% reduction in tumor size. The Overall Response Rate (Partial and Complete Response) has been 31%, with responses being observed in each of the four cohorts. Of 4 follicular lymphoma patients evaluated in this trial, 3 had objective responses (1 Complete Response and 2 Partial Responses).

The patients enrolled in this trial were heavily pre-treated (mean = 3 prior treatments) and had diverse histologies, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma. A total of 25 patients were enrolled, with 5 still on study after 5-10 cycles of treatment.  Dose limiting toxicities observed in this trial were reversible thrombocytopenia (n=3), diarrhea (n=1) and renal failure (n=1). Of note, no pericarditis, pericardial effusion, or QT prolongation were seen at any dose level of PCI-24781.  The dose and schedule have been optimized for the Phase II portion of the study.

"At completion of the Phase I stage of this clinical trial, PCI-24781 showed encouraging clinical activity as a mono-therapy in relapsed/refractory non-Hodgkin's lymphoma including several complete and partial remissions.  Furthermore, due to its favorable side effect profile, pharmacokinetics, and large therapeutic window, it has the potential to be a class leader in the competitive HDAC inhibitor arena," said Dr. Andrew Evens, principal investigator of the study, and Assistant Professor of Medicine and Director of Translational Therapeutics in the Division of Hematology/Oncology at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago.

A conference call to discuss these trial results has been set up for Tuesday December 8, 2009 at 8:00 a.m. PDT (11:00 a.m. EDT). To participate in the conference call, please dial 877-700-2945 for domestic callers and 706-643-1591 for international callers. The conference ID is 45071660. To access the audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. The archived version of the webcast will be available on the company's website for one month.

About HDAC Inhibitors

Histone deacetylases (HDACs) are a family of related enzymes important in managing a multitude of cellular functions. HDAC inhibitors are a new class of drugs that modulate transcriptional activity in cells and may block angiogenesis and cell cycling, key components of tumor proliferation. HDAC inhibitors also appear to promote apoptosis (cell death) in tumor cells. Scientists have been searching for more selective inhibitors, which may offer the potential for treating a variety of diseases including cancer and inflammatory disorders while improving safety.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin's lymphoma (NHL) is a type of malignant disease that occurs within the lymphatic system and the fifth most common form of cancer. It is caused by the abnormal proliferation of white blood cells, which spreads through the lymphatic system.  NHL can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. NHL can be broadly classified into two main clinical categories: indolent lymphomas, mainly characterized as follicular lymphomas, which tend to grow relatively slowly; and aggressive lymphomas, mainly typified as diffuse large B-cell lymphomas (DLBCL), which grow much more rapidly.

Follicular lymphoma is a long lasting disease whereby patients are prone to multiple relapses after initial therapy; and the disease is incurable with current available treatments.  Approximately 18,500 new cases of follicular lymphoma are diagnosed annually in the United States.  According to the National Cancer Institute's SEER database the incidence of NHL (all types including Follicular and Aggressive) is projected at nearly 66,000 in 2009 and that 19,500 patients are expected to die from this disease in the United States in 2009.  According to the Leukemia & Lymphoma Society (LLS), there are approximately 452,723 people in the U.S. living with NHL (with active disease or in remission).

About Pharmacyclics

Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of immune mediated disease and cancer. The purpose of the company is to create a profitable business by generating income from products it develops, licenses and commercializes, either with one or several potential partners or alone as may best forward the economic interest of its stakeholders. The Company endeavors to create novel, patentable, differentiated products that have the potential to significantly improve the standard of care in the markets it serves. Presently, Pharmacyclics has four product candidates in clinical development and two product candidates in pre-clinical development. It is Pharmacyclics' business strategy to establish collaborations with large pharmaceutical and biotechnology companies for the purpose of generating present and future income in exchange for adding to their product pipelines. Pharmacyclics strives to generate collaborations that allow it to retain valuable territorial rights and simultaneously fast forward the clinical development and commercialization of its products. 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 regarding our expectations and beliefs regarding our future results or performance. 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", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. Our actual results could differ materially from those projected in the forward-looking statements. Additionally, you should not consider past results to be an indication of our future performance. For a discussion of the risk factors and other factors 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.

Contact:

Ramses Erdtmann

VP Finance

Phone: 408-215-3325

EX-99.2

Exhibit 99.2

PHARMACYCLICS, INC. ANNOUNCES PRESENTATION OF INTERIM RESULTS FROM PHASE I TRIAL OF ITS FIRST-IN-HUMAN BTK INHIBITOR PCI-32765

New Orleans, LA, and Sunnyvale, CA December 7, 2009 - Pharmacyclics, Inc. (Nasdaq: PCYC) today announced interim data from a Phase I study of their novel orally administered Bruton’s tyrosine kinase (Btk) inhibitor PCI-32765 in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL). These data are being presented at the American Society of Hematology (ASH) 51st Annual Meeting taking place this week in New Orleans, LA.

The multi-center dose escalation Phase I study is being conducted in collaboration with investigators at leading lymphoma centers including Stanford University, MD Anderson Cancer Center, the University of Chicago, the University of Vermont, and US Oncology group. The trial was designed to explore up to 6 dose levels with a minimum of 4 evaluable patients per cohort. Each cycle of treatment consists of 28 consecutive days of dosing followed by 7 days of rest.  Safety is evaluated at the end of the first cycle and efficacy at the end of the second. At least one full cycle of treatment has been completed for each patient in the first 3 cohorts. Data from the second cohort demonstrated that PCI-32765 fully occupied the active site of the target enzyme Btk in peripheral blood cells with minimal variability, fully inhibited surrogate biomarkers for up to 24 hours, and was well tolerated by patients.

In the first 2 dose cohorts, 16 heavily pretreated and progressing lymphoma patients with a variety of B-cell malignancies were evaluated. In the first dose cohort, 7 patients were treated with PCI-32765 resulting in 2 partial responses (e.g. a 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes per the Revised Response Criteria for Malignant Lymphoma Bruce D. Cheson J Clin Oncol 25:579-586,) one in mantle cell lymphoma, one in follicular lymphoma and one patient with stable disease for approximately 5 cycles. In the second dose cohort, 9 patients were treated resulting in 3 partial responses (one patient with mantle cell lymphoma and two patients with chronic lymphocytic leukemia (CLL/SLL)) and 2 patients with stable disease for approximately 2 cycles. The overall response rate (ORR), considering only partial and complete responses, was 31% for the first two dose cohorts.

Additionally, as of December 5, 2009, an interim evaluation has been made on 3 of the 6 patients in the third dose cohort. Each of these 3 patients suffered from CLL/SLL.  All three have been evaluated as partial responders.  At this point the Partial Response Rate in CLL/SLL patients is 5 out of 6.

The trial is currently enrolling at a rapid rate. We anticipate the fourth dose cohort to commence in December 2009. At this time the company anticipates dosing only the first 5 dose cohorts to complete this Phase I study, as per the protocol dosing will continue to three levels above full kinase occupancy.

As of December 5, 2009, all stable and responding patients remain on study with 2 patients from cohort 1 dosed for more than 6 months. Only 3 of 16 patients experienced adverse events greater than Grade 2: one patient had a dose limiting toxicity with the onset of neutropenia, an abnormal reduction of white blood cells; one patient had hypokalemia, a lower than normal amount of potassium in the blood, the same patient also had hypophosphatemia, a low level of phosphorus in the blood; and one patient had viral adenitis a viral infection of the lymph nodes, which is a common occurrence in this type of patient. The drug was well tolerated in the remaining thirteen patients.

"PCI-32765 appears to be well tolerated by patients at oral doses that are able to fully inhibit the enzyme Btk" said Dr. Ranjana Advani, Associate Professor, Stanford University Medical Center and principal investigator of the trial. "In addition, we now have evidence of drug activity”.

A conference call to discuss these trial results has been set up for Tuesday December 8, 2009 at 8:00 a.m. PDT (11:00 a.m. EDT). To participate in the conference call, please dial 877-700-2945 for domestic callers and 706-643-1591 for international callers. The conference ID is 45071660. To access the audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. The archived version of the webcast will be available on the company's website for one month.

Bruton's Tyrosine Kinase and Immune Diseases

B-cells are immune cells, which are activated by antigens, pathogens or, in the case of autoimmunity, by host tissues. B-cells produce antibodies, which when self-reactive can trigger autoimmune disease. Activation of B-cells is also thought to play a major role in lymphomas where continuous, or tonic, stimulation results in uncontrolled B-cell proliferation. Btk is a type of enzyme known as a tyrosine kinase inside B-cells that plays an early key role in B-cell activation. Drugs that can inhibit Btk may prevent B-cell activation and therefore may play a role in the treatment of lymphomas or autoimmune disease. Other tyrosine kinases are important in cell signaling and have been targets for other drugs such as Gleevec® (imatanib mesylate), which is approved for treatment of certain leukemias. New drug or biological candidates targeting B-cells, including Rituxan for lymphomas and rheumatoid arthritis, are aimed at eliminating abnormally functioning B-cells.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin's lymphoma (NHL) is a type of malignant disease that occurs within the lymphatic system and the fifth most common form of cancer. It is caused by the abnormal proliferation of white blood cells, which spreads through the lymphatic system.  NHL can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. NHL can be broadly classified into two main clinical categories: indolent lymphomas, mainly characterized as follicular lymphomas, which tend to grow relatively slowly; and aggressive lymphomas, mainly typified as diffuse large B-cell lymphomas (DLBCL), which grow much more rapidly.  According to the National Cancer Institute's SEER database the incidence of NHL (all types including Follicular and Aggressive) is projected at nearly 66,000 in 2009 and that 19,500 patients are expected to die from this disease in the United States in 2009.  According to the Leukemia & Lymphoma Society (LLS), there are approximately 452,723 people in the U.S. living with NHL (with active disease or in remission).

About Pharmacyclics

Pharmacyclics® is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of immune mediated disease and cancer. The purpose of the company is to create a profitable business by generating income from products it develops, licenses and commercializes, either with one or several potential partners or alone as may best forward the economic interest of its stakeholders. The Company endeavors to create novel, patentable, differentiated products that have the potential to significantly improve the standard of care in the markets it serves. Presently, Pharmacyclics has four product candidates in clinical development and two product candidates in pre-clinical development. It is Pharmacyclics' business strategy to establish collaborations with large pharmaceutical and biotechnology companies for the purpose of generating present and future income in exchange for adding to their product pipelines. Pharmacyclics strives to generate collaborations that allow it to retain valuable territorial rights and simultaneously fast forward the clinical development and commercialization of its products. 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 regarding our expectations and beliefs regarding our future results or performance. 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", "should", "would", "project", "plan", "predict", "intend" and similar expressions are intended to identify such forward-looking statements. Our actual results could differ materially from those projected in the forward-looking statements. Additionally, you should not consider past results to be an indication of our future performance. For a discussion of the risk factors and other factors 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.

Contact

R. Erdtmann

VP Finance

Phone: 408-215-3325