-----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, UBs6RTesdteriYi311UM4WFt7ItLGWmq8IXf77fpG3SSSK/k34CSLU1FIMAOeFvn 62q/V9G0PjUJv7+/1o974A== 0001104659-09-068799.txt : 20091207 0001104659-09-068799.hdr.sgml : 20091207 20091207162222 ACCESSION NUMBER: 0001104659-09-068799 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20091207 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091207 DATE AS OF CHANGE: 20091207 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: 091226324 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 a09-34986_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): December 7, 2009

 

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 December 7, 2009, Facet Biotech Corporation (the “Company”) issued (i) a joint press release with Bristol-Myers Squibb Company announcing the presentation of phase 1/2 interim data for elotuzumab in patients with relapsed multiple myeloma (the “Elotuzumab Release”) and (ii) a joint press release with Trubion Pharmaceuticals, Inc. announcing the presentation of data from a phase 1 study of TRU-016 in patients with relapsed and refractory chronic lymphocytic leukemia (the “TRU-016 Release”).  The Elotuzumab Release and TRU-016 Release are furnished as Exhibits 99.1 and 99.2, respectively, to this report.  The information contained in the Elotuzumab Release and TRU-016 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 Exhibits 99.1 and 99.2 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

 

Joint Press Release of Facet Biotech Corporation and Bristol-Myers Squibb Company, dated December 7, 2009, regarding the presentation of phase 1/2 interim data for elotuzumab in patients with relapsed multiple myeloma

 

 

 

99.2

 

Joint Press Release of Facet Biotech Corporation and Trubion Pharmaceuticals, Inc., dated December 7, 2009, regarding the presentation of data from a phase 1 study of TRU-016 in patients with relapsed and refractory chronic lymphocytic leukemia

 

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:    December 7, 2009

Facet Biotech Corporation

 

 

 

By:

/s/ Francis Sarena

 

 

Francis Sarena

 

 

Vice President, General Counsel and Secretary

 

3


EX-99.1 2 a09-34986_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

 

FACET BIOTECH AND BRISTOL-MYERS SQUIBB REPORT PROMISING PHASE I/II INTERIM DATA FOR ELOTUZUMAB IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA

 

Clinical activity seen for elotuzumab plus lenalidomide and
low dose dexamethasone —

 

—Results support initiation of global Phase II study —

 

REDWOOD CITY, California, and PRINCETON, New Jersey, December 7, 2009 — Facet Biotech Corporation (Nasdaq: FACT) and Bristol-Myers Squibb Company (NYSE: BMY) announced that potentially promising data from a Phase I/II study of elotuzumab, an investigational humanized antibody being studied for the treatment of relapsed multiple myeloma (MM), were presented today at the American Society of Hematology (ASH) 2009 Annual Meeting in New Orleans.

 

The ongoing Phase I/II study of elotuzumab plus lenalidomide and low-dose dexamethasone evaluated multiple doses of elotuzumab in patients with multiple myeloma. The interim results given as an oral presentation today showed that of the 28 treated patients in the trial, 23 (82 percent) had an objective response (OR) by International Myeloma Working Group (IMWG) criteria. 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 (DLT) were reported in the study up to the highest dose level of 20 mg/kg and a maximum-tolerated dose (MTD) was not established. Two patients experienced serious adverse events of allergic reactions that were related to elotuzumab and were withdrawn from the study.  These adverse events resolved with treatment. In addition, other adverse events reported for the combination of lenalidomide, dexamethasone and elotuzumab, regardless of causality to disease or study

 



 

drugs, included fatigue, diarrhea, constipation, myelosupression, nausea, muscle spasms, fever, chills and dyspnea. Enrollment for the Phase I portion of the study is completed.

 

“The preliminary data presented today show that elotuzumab in combination with lenalidomide and dexamethasone may have potential as a treatment option for patients with multiple myeloma,” said Faheem Hasnain, president and chief executive officer of Facet Biotech. “We are working closely with our partners at Bristol-Myers Squibb to finalize next steps for the elotuzumab development program, and anticipate initiating a global Phase II study in the first half of 2010.”

 

“We, along with our partner, Facet Biotech, are focusing on the investigation of combinations of potential treatments in the hopes of identifying a more efficacious and tolerable option for patients to help them when faced with this serious disease,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, Bristol-Myers Squibb.

 

“These interim results are of significant scientific and clinical interest. I am very encouraged by the efficacy and safety data seen to date for this combination, which may offer a future treatment option for multiple myeloma patients,” said Sagar Lonial, M.D., of the Winship Cancer Institute at Emory University in Atlanta. “Given that elotuzumab, a humanized antibody, has a novel mechanism of action that appears to work synergistically with lenalidomide, we look forward to advancing clinical studies with this antibody to determine its full potential, with the goal of ultimately improving outcomes for myeloma patients.”

 

The primary objective of the Phase I/II study is to evaluate the maximum tolerated dose (MTD) of elotuzumab in combination with lenalidomide and low dose dexamethasone in patients with relapsed MM. The study is also evaluating safety, pharmacokinetics (PK) and clinical response.  Elotuzumab in three escalating dose cohorts (5, 10 and 20 mg/kg) is administered by IV infusion.

 

Interim results from another Phase I/II study were also presented today at the ASH annual meeting. In a study of elotuzumab plus bortezomib in 20 evaluable patients, eight patients, 40 percent, had an OR and 60 percent achieved a clinical response, defined as minimal response or better using the combined European Group for Blood and Marrow Transplant (EBMT) and IMWG criteria. No DLTs

 

2



 

were reported and an MTD was not established. The study continues to enroll patients at the 20 mg/kg dose level.

 

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. In nonclinical studies, elotuzumab has been shown to induce antibody-dependent cellular cytotoxicity (ADCC) against primary myeloma cells and is currently in Phase I/II clinical development.

 

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.

 

About Bristol-Myers Squibb

 

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com.

 

Facet Biotech Forward Looking Statements

 

This press release contains forward-looking statements, including regarding Facet Biotech’s and Bristol-Myers Squibb’s development of elotuzumab and the anticipated initiation of a global Phase II study in the first half of 2010.  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.  As a result, the Phase II trial of elotuzumab may not be initiated by the first half of 2010 or at all. 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

 

3



 

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 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.

 

Bristol-Myers Squibb Forward-Looking Statements

 

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations.  No forward-looking statement can be guaranteed.  Among other risks, there can be no guarantee that the compound described in this release will move from early stage development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K.  Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

 

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

 

Bristol-Myers Squibb

 

Facet Biotech

Media

 

Media and Investors

Jennifer Fron Mauer, 609-252-6579

 

Jean Suzuki, 650-454-2648

jennifer.mauer@bms.com

 

jean.suzuki@facetbiotech.com

or

 

 

Investors

 

 

John Elicker, 609-252-4611

 

 

john.elicker@bms.com

 

 

 

4


EX-99.2 3 a09-34986_1ex99d2.htm EX-99.2

Exhibit 99.2

 

Trubion and Facet Biotech Announce Presentation of Positive TRU-016 Data
at the 2009 ASH Annual Meeting

 

SEATTLE, Wash. and REDWOOD CITY, Calif., Dec. 7, 2009—Trubion Pharmaceuticals, Inc. (Nasdaq: TRBN) and Facet Biotech Corporation (Nasdaq: FACT) today announced the presentation of positive data from a phase 1 study of TRU-016 in patients with relapsed and refractory chronic lymphocytic leukemia (CLL) at the 2009 American Society of Hematology (ASH) Annual Meeting. TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic in development for the treatment of B-cell malignancies.

 

“Unlike other peptide therapies that target CD20, TRU-016 targets CD37 and mediates both immune mediated death and direct killing through a novel mechanism,” said John Byrd, M.D., Interim co-director, Division of Hematology-Oncology, and Professor of Leukemia Research, Department of Internal Medicine at The Ohio State University.  “The favorable toxicity profile and clinical activity with TRU-016 observed to date in this study suggests it has potential to be a major contributor to combination strategies that are impacting CLL treatment outcome.”

 

Data were presented today for 33 patients enrolled in the phase 1 TRU-016 dose escalation trial (abstract 3424). A majority of patients (20/33) had high-risk genomic features associated with a poor prognosis and had received multiple prior therapies. Evidence of TRU-016 biological activity was seen beginning with patients dosed at the 0.3 mg/kg dose-level, including in high-risk patients. Partial response (PR) was observed in five patients, including one patient with the 17p deletion cytogenetic abnormality. Partial response was determined following investigator assessment and the two month confirmation of these responses is pending.  Two patients with leukemia cutis experienced clearing, one complete and one partial.  At the 10 mg/kg dose, four of five patients with elevated peripheral lymphocyte counts were reduced to normal levels. A total of 16 serious adverse events have been reported.  The maximum tolerated dose (MTD) has not yet been reached.

 

“TRU-016 continues to demonstrate activity in clinical trials and it has the potential to be a meaningful therapeutic. Because it targets CD37, TRU-016 uses a different mechanism of action than currently available CD20-directed therapies. There is significant clinical need for effective therapies in CLL without toxicity burdens, especially given that the median age of CLL patients is over 65 years of age,” said Scott C. Stromatt, M.D. senior vice president and chief medical officer at Trubion.

 

“We are pleased with the promising preliminary data from the ongoing phase 1 trial of TRU-016 in CLL and are excited about expanding the scope of the drug’s clinical development program,” said Mark Rolfe, Ph.D., senior vice president and chief scientific officer at Facet Biotech. “We have worked closely with our partners at Trubion to craft a robust development plan for TRU-016, which includes additional clinical trials in other B-cell malignancies, and we look forward to providing an update on our progress in the early part of 2010.”

 

Also at ASH, data were presented from a preclinical study of Trubion’s proprietary TRU-ADhanCe™ technology. TRU-ADhanCe technology is a proprietary, additive method designed to enhance the potency of existing therapies that work through Fc-directed or antibody-directed cellular cytotoxicity (ADCC).

 

Copies of the full data presentations are now available on Trubion’s website at investors.trubion.com/events.cfm and on Facet Biotech’s website at www.facetbiotech.com.

 

About Trubion

 

Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company’s mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient

 



 

experiences. Trubion’s current product candidates are novel single-chain protein, or SMIP, therapeutics, and are designed using its custom drug assembly technology. Trubion’s product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company’s Pfizer collaboration. Trubion’s product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company’s Facet Biotech collaboration. In addition to Trubion’s current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6. More information is available in the investors section of Trubion’s website: http://investors.trubion.com/index.cfm.

 

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.

 

Trubion Forward-Looking Statements

 

Certain statements in this release may constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the potential development and commercialization of TRU-016. These statements are based on current expectations and assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the clinical development of TRU-016, and such other risks as identified in the Company’s quarterly report on Form 10-Q for the period ended September 30, 2009, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the company’s corporate website at http://www.trubion.com. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.

 

Facet Biotech Forward-looking Statements

 

This press release contains forward-looking statements, including regarding Facet Biotech’s and Trubion’s development of TRU-016.  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 TRU-016 could be adversely impacted by changes in Facet Biotech’s and Trubion’s development plans or timelines, including because of unexpected safety or efficacy data observe d during clinical trials, enrollment rates in clinical trials and changes in expected competition. As a result, the clinical trials of TRU-016 in CLL or other B-cell malignancies may not be initiated or continued. The clinical and pre-clinical  results observed to date of TRU-016 may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate TRU-016 to be effective as a therapeutic agent 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 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 ww w.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.

 



 

TRBN-016CLL

 

Contacts:

 

 

Jim DeNike

 

Jean Suzuki

Senior Director, Corporate Communications

 

Facet Biotech Corp.

Trubion Pharmaceuticals, Inc.

 

(650) 454-2648

(206) 838-0500

 

jean.suzuki@facetbiotech.com

jdenike@trubion.com

 

 

http://www.trubion.com

 

 

 

 

 

Waggener Edstrom Worldwide Healthcare

 

 

Amy Petty

 

 

Senior Account Executive

 

 

(617) 576-5788

 

 

amyp@waggeneredstrom.com

 

 

 

# # #

 


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