-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QFr0/HMml03ARjeCMLpUNltLb+ddQV24IsL4VyIOToaEKRH/esp2yvIvdwtk1S4P d3P1z0T+oERPkPGGVgUJAQ== 0000921895-11-000400.txt : 20110302 0000921895-11-000400.hdr.sgml : 20110302 20110302114629 ACCESSION NUMBER: 0000921895-11-000400 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110302 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110302 DATE AS OF CHANGE: 20110302 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PHARMACYCLICS INC CENTRAL INDEX KEY: 0000949699 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943148201 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26658 FILM NUMBER: 11655023 BUSINESS ADDRESS: STREET 1: PHARMACYCLICS INC STREET 2: 995 E ARQUES AVE CITY: SUNNYVALE STATE: CA ZIP: 94085-4521 BUSINESS PHONE: 408 774 0330 MAIL ADDRESS: STREET 1: PHARMACYCLICS INC STREET 2: 995 E ARQUES AVE CITY: SUNNYVALE STATE: CA ZIP: 94085-4521 8-K 1 form8k07380_03022011.htm form8k07380_03022011.htm
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): March 2, 2011
 
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 7.01.
Regulation FD Disclosure.
 
On March 2, 2011, Pharmacyclics, Inc. (the “Company”) announced that further advancement of its preclinical molecule PCI-45292, a Btk inhibitor with exceptionally potent anti-arthritis activity in mice and rats, has been suspended following results from the current set of preclinical toxicology studies. PCI-45292 has been under preclinical development for the treatment of immune mediated diseases.
 
The Company stated that the undesired effect observed with its pre-clinical molecule PCI-45292 has not been observed with its clinical Btk Inhibitor PCI-32765 even at higher dose levels in preclinical safety studies and is not considered to be related to the inhibition of Btk.  The Company also stated that its broad clinical development for PCI-32765 in B-cell malignancies in particular in chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma continues as outlined in its last quarterly update.
 
The Company’s press release related to the foregoing is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
Item 9.01.
Financial Statements and Exhibits.
 
(d)    Exhibits.
 
 
Exhibit No.
 
Description
       
 
99.1
 
Press Release of Pharmacyclics, Inc. dated March 2, 2011.
 
 
 

 
 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
 
March 2, 2011
 
PHARMACYCLICS, INC.
 
 
By:
/s/ Rainer M. Erdtmann
 
Name: Rainer M. Erdtmann
 
Title: Vice President, Finance & Administration and Secretary
 
EX-99.1 2 ex991to8k07380_03022011.htm ex991to8k07380_03022011.htm
Exhibit 99.1
 
Contact:
Ramses Erdtmann
Vice President of Finance
Phone: 408-215-3325


Update on Preclinical Finding and Development Timeline for PCI-45292

SUNNYVALE, CA, March 2, 2011
 
Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that further advancement of PCI-45292, a Btk inhibitor with exceptionally potent anti-arthritis activity in mice and rats, has been suspended following results from the current set of preclinical toxicology studies.  The company hopes to have a new clinical development candidate identified within approximately 6 months.

PCI-45292 has been under preclinical development for approximately 1 year as a potential new agent for the treatment of immune mediated diseases. A recent evaluation of tissues from animals dosed with PCI-45292 has revealed an undesirable target-organ effect.  The effect, which was noted at all dose levels in a rat animal model, but absent in another animal model, precludes establishing a starting dose for human clinical trials.

The undesired effect observed with PCI-45292 has not been observed with our Btk Inhibitor PCI-32765 even at higher dose levels in preclinical safety studies and is not considered to be related to the inhibition of Btk.  Our broad clinical development for PCI-32765 in B-cell malignancies in particular in chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma continues as outlined in our last quarterly update.

We have readily identified the portion of the PCI-45292 molecule directly responsible for these target organ changes. We have now turned our attention to evaluating a related series of molecules with the focus on eliminating the target-organ effect.  Our commitment to advancing a safe and effective Btk inhibitor into the clinic for immune mediated diseases remains strong.

“While we are disappointed with the delay of the program we are pleased with the quality of the research that was able to identify this effect early in development, allowing us to make adjustments pre-clinically. We remain dedicated to developing important, new targeted therapies that are safe and effective and advance the standard of care for patients,” said Bob Duggan, Chairman of the Board and Chief Executive Officer.

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 medial healthcare needs; and to identify promising product candidates based on scientific development expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Presently, Pharmacyclics has four product candidates in clinical development and several preclinical molecules in lead optimization. We are committed to high standards of ethics, scientific rigor, and operational efficiency as we move each of these programs to viable commercialization.
 
 
1

 
 
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 forwa rd-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.
 
 
2

 
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-----END PRIVACY-ENHANCED MESSAGE-----