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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
September 5, 2007
PHARMACYCLICS, INC.
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995 E. Arques Avenue
Sunnyvale, California 94085-4521
(408) 774-0330
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 September 5, 2007, Pharmacyclics, Inc. a Delaware corporation (the "Registrant"), announced the results from three open-label,
multi-center Phase 2 clinical trials evaluating Xcytrin® (motexafin gadolinium) Injection, the company's lead
product candidate, as a single-agent and in combination with chemotherapy as a second-line treatment for patients with non-small
cell lung cancer (NSCLC) who failed at least one platinum-based chemotherapy regimen. The results were presented at the
12th World Conference on Lung Cancer of the International Association for the Study of Lung Cancer.
The information in this report, including the exhibit hereto, shall not be deemed to be "filed" for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2)
of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be
incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Pharmacyclics, Inc., whether
made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.
Xcytrin® is a registered trademark of Pharmacyclics, Inc.
Item 9.01 Financial Statements and Exhibits. Exhibit No. Description 99.1 Press Release of Pharmacyclics, Inc. dated September 5, 2007. SIGNATURE 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 hereunto duly authorized. Date: September 5, 2007
INDEX TO EXHIBITS
Exhibit Description Press Release of Pharmacyclics, Inc. dated September 5, 2007.
PDF
EXHIBIT 99.1
Contacts:
Leiv Lea Carolyn Bumgardner Wang
PHARMACYCLICS ANNOUNCES
ENCOURAGING PHASE 2 DATA WITH XCYTRIN® IN RECURRENT NON-SMALL
CELL LUNG CANCER PATIENTS SEOUL, Korea and SUNNYVALE, Calif., -- September 5, 2007 --
Pharmacyclics, Inc. (Nasdaq: PCYC) today announced results from three open-
label, multi-center Phase 2 clinical trials evaluating Xcytrin®
(motexafin gadolinium) Injection, the company's lead product candidate, as a
single-agent and in combination with chemotherapy as a second-line treatment for
patients with non-small cell lung cancer (NSCLC) who failed at least one
platinum-based chemotherapy regimen. The results were presented today at the
12th World Conference on Lung Cancer of the International Association for the
Study of Lung Cancer. The first Phase 2 trial is evaluating the safety, tumor response and survival
in patients with recurrent NSCLC who are treated with Xcytrin as a single agent.
Patients in the trial were randomized to receive either a 10mg/kg dose of
Xcytrin every week, or a 15mg/kg dose every three weeks. Of 60 evaluable
patients, there was a confirmed response rate of 5%, or three partial responses
(using Response Evaluation Criteria in Solid Tumors). Seventeen patients (30%)
had stable disease. Median survival was 9.2 months, with one year survival of
34%. The most common severe (grade 3 or higher) side effects were
hypophosphatemia (23%), fatigue (12%), dyspnea (8.3%), hypoxia (6.7%), and
pneumonia (6.7%). A second ongoing study is evaluating Xcytrin in combination with
Alimta® (pemetrexed) and has enrolled 52 patients of which 35 are
evaluable for survival and 24 are evaluable for response at this time. Patients
have received a median of three cycles (range of 1-12 cycles) of 15mg/kg Xcytrin
with a standard dose of Alimta every 21 days. Eighteen of the 24 patients with
response data receiving Xcytrin and Alimta have achieved stabilization of their
tumors (75%), with three of the 18 still on treatment. Patients still on
treatment remain under evaluation for tumor response. For the 35 patients
evaluable for survival, the median survival time exceeds one year with an
actuarial one year survival of 52%. The most common severe side effects were
asthenia (11.4%), pneumonia (8.6%), thrombocytopenia (8.6%), and neutropenia
(8.6%). The third ongoing study is testing the combination of Xcytrin plus
Taxotere® (docetaxel) and has enrolled 35 patients of which 23
are evaluable for response at this time. Patients have received a median of four
cycles (range of 1-9 cycles) of 15 mg/kg Xcytrin with a standard dose of
Taxotere every 21 days. One patient (4%) receiving Xcytrin and Taxotere has a
partial remission, and 17 patients (74%) have achieved stabilization of their
tumors. Seven patients still on treatment remain under evaluation for tumor
response. The median survival time is 8.6 months with a one year actuarial
survival of 34%. The most common severe side effects were neutropenia (19.4%),
asthenia (12.9%), and febrile neutropenia (9.7%). With currently available therapies, response rates to second-line treatments
for NSCLC range from 4% to 10% with median survivals of about 6 months.
Currently approved agents for second-line treatment of NSCLC include Alimta,
Tarceva® and Taxotere. "These results support Xcytrin's activity in lung cancer, with patients who
failed previous treatment with a platinum therapy exhibiting tumor responses and
a high proportion of stable disease following single-agent treatment with
Xcytrin," said Richard A. Miller, M.D., president and CEO of Pharmacyclics.
"Although early, the combination studies are very promising with stable
disease and very encouraging survival seen in a substantial proportion of
patients." About Non-Small Cell Lung Cancer The American Cancer Society estimates that there will be more than
213,000 new cases of lung cancer in the United States in 2007. Lung cancer is
the leading cause of cancer death, and accounts for over 160,000 deaths in the
United States each year. The most common form of lung cancer, non-small cell, is
incurable in advanced stages. Lung cancer frequently spreads to other body
parts, including the brain. Xcytrin in Second-Line Lung Cancer Pharmacyclics is developing Xcytrin as an anti-cancer agent with a
novel mechanism of action that is designed to selectively concentrate in tumors
and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug
that has been shown to disrupt redox-dependent pathways in cells and inhibit
oxidative stress-related proteins such as thioredoxin reductase. Its
multifunctional mode of action, including its magnetic resonance imaging
detectability, provides the opportunity for Xcytrin to be used in a broad range
of cancers. The target for Xcytrin is the enzyme thioredoxin reductase, which is
frequently overexpressed in lung cancer cells. This enzyme has been shown to
confer to cancer cells characteristics of aggressive tumor growth and resistance
to chemotherapy. About Pharmacyclics Alimta® and Gemzar® are registered trademarks
of Eli Lilly and Company. Tarceva® is a registered trademark of Genentech. Taxotere® is a registered trademark of Sanofi-Aventis. NOTE: Other than statements of historical fact, the statements made in this
press release about our NDA filing, enrollment and future plans for our clinical
trials, progress of and reports of results from preclinical and clinical
studies, clinical development plans and product development activities are
forward-looking statements, as defined in the Private Securities Litigation
Reform Act of 1995. The words "believe," "will," "may," "continue," "plan,"
"expect," "intend," "anticipate," variations of such words, and similar
expressions also identify forward-looking statements, but their absence does not
mean that the statement is not forward-looking. The forward-looking statements
are not guarantees of future performance and are subject to risks and
uncertainties that may cause actual results to differ materially from those in
the forward-looking statements. Factors that could affect actual results include
risks associated with the fact that data from preclinical studies and Phase 1 or
Phase 2 clinical trials may not necessarily be indicative of future clinical
trial results; our ability to obtain future financing and fund the product
development of our pipeline; the possibility that the FDA refuses to approve our
NDA; because our Phase 3 clinical trial known as the SMART (Study of
Neurologic Progression with Motexafin Gadolinium And
Radiation Therapy) trial failed to meet its primary endpoint, the
FDA may require additional data, analysis or studies before the NDA is approved
by the FDA; the outcome of any discussions with the FDA; the initiation, timing,
design, enrollment and cost of clinical trials; unexpected delays in clinical
trials and preparation of materials for submission to the FDA as part of our NDA
filing; our ability to establish successful partnerships and collaborations with
third parties; the regulatory approval process in the United States and other
countries; and our future capital requirements. For further information about
these risks and other factors that may affect the actual results achieved by
Pharmacyclics, please see the company's reports as filed with the U.S.
Securities and Exchange Commission from time to time, including but not limited
to its annual report on Form 10-K for the period ended June 30, 2006 and its
subsequently filed quarterly reports on Form 10-Q. Forward-looking statements
contained in this announcement are made as of this date, and we undertake no
obligation to publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise. ### M.33G
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PHARMACYCLICS, INC.
By: /s/ LEIV LEA
Name: Leiv Lea
Title: Vice President, Finance & Administration
and CFO and Secretary
Pharmacyclics, Inc.
(408) 774-0330
WeissComm Partners
Pharmacyclics is a pharmaceutical company developing innovative products to
treat cancer and other serious diseases. The company is leveraging its small-
molecule drug development expertise to build a pipeline in oncology and other
diseases based on a wide range of targets, pathways and mechanisms. Its lead
product, Xcytrin® (motexafin gadolinium) Injection, has completed
Phase 3 clinical trials and several ongoing Phase 1 and Phase 2 clinical trials
are evaluating Xcytrin, either as a single agent or in combination with
chemotherapy and/or radiation in multiple cancer types. A New Drug Application
for use of Xcytrin in combination with whole brain radiation therapy for
treatment of brain metastases from non-small cell lung cancer was filed with the
Food and Drug Administration in April 2007. More information about the company,
its technology, and products can be found at www.pharmacyclics.com. In addition,
more information about advocacy on behalf of Xcytrin can be found at
www.yourcanceryourchoice.com. Pharmacyclics®,
Xcytrin® and the "pentadentate" logo® are
registered trademarks of Pharmacyclics, Inc./(
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