-----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, E+tTiFtW3qgKV0S4LPDjvhLUKcVlRjRPFvEMi953Np+Lh7/XTrE4n/RK7vUUAYaS Hg7qfshCknFpjsQaWY7/sQ== 0001104659-10-001016.txt : 20100111 0001104659-10-001016.hdr.sgml : 20100111 20100111090106 ACCESSION NUMBER: 0001104659-10-001016 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100111 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100111 DATE AS OF CHANGE: 20100111 FILER: COMPANY DATA: COMPANY CONFORMED NAME: FACET BIOTECH CORP CENTRAL INDEX KEY: 0001441848 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 263070657 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34154 FILM NUMBER: 10519158 BUSINESS ADDRESS: STREET 1: 1500 SEAPORT BLVD. CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 650-454-1000 MAIL ADDRESS: STREET 1: 1500 SEAPORT BLVD. CITY: REDWOOD CITY STATE: CA ZIP: 94063 FORMER COMPANY: FORMER CONFORMED NAME: Biotech Spinco, Inc. DATE OF NAME CHANGE: 20080804 8-K 1 a10-1534_18k.htm 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):

January 11, 2010

 

Facet Biotech Corporation

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-34154

 

26-3070657

(State or other jurisdiction of
incorporation)

 

(Commission File No.)

 

(I.R.S. Employer Identification No.)

 

1500 Seaport Boulevard
Redwood City, California 94063

(Address of principal executive offices)

 

Registrant’s telephone number, including area code:

(650) 454-1000

 

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)

 

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 7.01. Regulation FD Disclosure.

 

On January 11, 2010, Facet Biotech Corporation (the “Company”) issued a press release announcing the enrollment of the first patient into the randomized phase 2 portion of the ongoing phase 1/2 study of elotuzumab, an investigational humanized antibody being studied for the treatment of relapsed multiple myeloma in combination with lenalidomide and low-dose dexamethasone (the “Release”).  The Release is furnished as Exhibit 99.1 to this report.  The information contained in the Release speaks only as of the date thereof and Facet does not assume any obligation to correct or update this information in the future, except as required by law.

 

The Company is furnishing the information in this Current Report on Form 8-K and in Exhibit 99.1 to comply with Regulation FD.  Such information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Exhibit Description

99.1

 

Press Release of Facet Biotech Corporation, dated January 11, 2010, regarding phase 2 study of elotuzumab in patients with relapsed multiple myeloma

 

2



 

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: January 11, 2010

Facet Biotech Corporation

 

 

 

By:

/s/ Francis Sarena

 

 

Francis Sarena

 

 

Vice President, General Counsel and Secretary

 

3


EX-99.1 2 a10-1534_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

news release

 

For Immediate Release

 

Contact:

 

Jean Suzuki

Investor Relations

(650) 454-2648

jean.suzuki@facetbiotech.com

 

FACET BIOTECH ANNOUNCES ENROLLMENT OF FIRST PATIENT IN PHASE 2 STUDY OF ELOTUZUMAB IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA

 

 — Company to receive $15 million milestone payment from Bristol-Myers Squibb —

 

Redwood City, Calif., January 11, 2010 — Facet Biotech Corporation (Nasdaq: FACT) today announced enrollment of the first patient into the randomized phase 2 portion of the ongoing Phase 1/2 study of elotuzumab, an investigational humanized antibody being studied for the treatment of relapsed multiple myeloma (MM) in combination with lenalidomide and low-dose dexamethasone. As a result, Facet Biotech will receive a $15 million milestone payment from Bristol-Myers Squibb Company (NYSE:BMY), its elotuzumab development partner.

 

“This is an important milestone for the elotuzumab program, as the data to date clearly support further study of this drug in a larger patient population,” said Faheem Hasnain, president and chief executive officer of Facet Biotech. “We presented promising data from the phase 1 portion of the study at the American Society of Hematology meeting in early December 2009, and we believe the future prospects for elotuzumab in the treatment of multiple myeloma are significant. We look forward to the results from this trial.”

 

In the phase 2 portion of the study, up to 60 patients with relapsed MM will be randomized to receive elotuzumab at 10 or 20 mg/kg in combination with lenalidomide and low-dose dexamethasone. The primary endpoint of the study is to evaluate objective response of the combination. Additional endpoints include safety, pharmacokinetics and pharmacodynamics.

 

The phase 1 portion of this study enrolled 28 patients with relapsed MM and evaluated the maximum tolerated dose (MTD) as well as safety, pharmacokinetics and clinical response of elotuzumab at the 5, 10 and 20 mg/kg dose levels in combination with lenalidomide and low-dose dexamethasone. Preliminary results showed that of the 28 treated patients in the trial, 23 (82 percent) had an objective response (OR) by IMWG criteria. Further, a subset analysis showed that of 22 patients who had not previously received lenalidomide treatment, 21 patients (95 percent) achieved an OR. No dose-limiting toxicities were reported in the study up to 20 mg/kg elotuzumab and an MTD was not established. Two patients experienced serious adverse events of allergic reactions that were related to the infusion of elotuzumab and were withdrawn from the study. These adverse events resolved with treatment.

 

For more information about the study, please visit ClinicalTrials.gov, number NCT00742560.

 



 

Separately, Bristol-Myers Squibb has notified Facet Biotech that it has elected not to expand the existing collaboration between the two companies to include PDL241, an investigational humanized antibody in pre-clinical development for immunologic diseases. As a result of this decision, Facet Biotech will not receive from Bristol-Myers Squibb the $15 million opt-in payment or any of the milestone payments related to this compound under Facet Biotech’s collaboration agreement with Bristol-Myers Squibb. Facet Biotech will evaluate opportunities to collaborate with other third parties on the potential development of PDL241.

 

About Elotuzumab

 

Elotuzumab is a humanized monoclonal antibody directed against CS1, a cell-surface glycoprotein that is highly and uniformly expressed on multiple myeloma cells but is minimally expressed on normal cells.  Facet is developing elotuzumab for multiple myeloma in collaboration with Bristol-Myers Squibb Company.  In nonclinical studies, elotuzumab has been shown to induce antibody-dependent cellular cytotoxicity (ADCC) against primary myeloma cells.

 

About Facet Biotech

 

Facet Biotech is a biotechnology company dedicated to advancing its pipeline of five clinical-stage products, leveraging its research and development capabilities to identify and develop new oncology drugs and applying its proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics.

 

Forward-looking Statements

 

This press release contains forward-looking statements, including regarding Facet Biotech’s and Bristol-Myers Squibb’s development of and future prospects of elotuzumab. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Many factors may cause differences between current expectations and actual results. For example, the development of elotuzumab could be adversely impacted by changes in Facet Biotech’s and Bristol-Myers Squibb’s development plans or timelines, including because of unexpected safety or efficacy data observed during clinical trials, enrollment rates in clinical trials, difficulties in supplying clinical sites with study drugs and changes in expected competition. The results observed to date in clinical trials of elotuzumab may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate elotuzumab to be effective in the treatment of patients with MM with an acceptable safety profile. Other factors that may cause Facet Biotech’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are discussed in Facet Biotech’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” sections of the Company’s periodic reports on Form 10-K and Form 10-Q filed with the SEC. Copies of Facet Biotech’s filings with the SEC may be obtained at the “Investors” section of Facet Biotech’s website at www.facetbiotech.com. Facet Biotech expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Facet Biotech’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

 

NOTE: Facet Biotech and the Facet Biotech logo are considered trademarks of Facet Biotech Corporation.

 

2


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