-----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, RHx/ItK9I9F9DrGZONXbRAv+TF2aMGOAcVE2mWT3pdIsLKM5ilrHTSCmlUTp8J6E UMll7KGw5dwJZMVr99A/hw== 0001104659-08-020032.txt : 20080327 0001104659-08-020032.hdr.sgml : 20080327 20080326201335 ACCESSION NUMBER: 0001104659-08-020032 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080324 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080327 DATE AS OF CHANGE: 20080326 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PONIARD PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0000755806 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 911261311 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-16614 FILM NUMBER: 08713315 BUSINESS ADDRESS: STREET 1: 7000 SHORELINE COURT STREET 2: SUITE 270 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 2062817001 MAIL ADDRESS: STREET 1: 300 ELLIOTT AVENUE WEST STREET 2: SUITE 500 CITY: SEATTLE STATE: WA ZIP: 98119-4114 FORMER COMPANY: FORMER CONFORMED NAME: NEORX CORP DATE OF NAME CHANGE: 19920703 8-K 1 a08-9209_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

 

March 24, 2008

Date of Report (Date of earliest event reported)

 

Poniard Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Washington
(State or Other Jurisdiction
of Incorporation)

 

0-16614
(Commission File No.)

 

91-1261311
(IRS Employer
Identification No.)

 

7000 Shoreline Court, Suite 270, South San Francisco, CA
(Address of principal executive offices)

 

94080
(Zip Code)

 

(650) 583-5272

(Registrant’s telephone number, including area code)

 

 

(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:

 

o Written communication 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))

 

 



 

Section 1 – Registrant’s Business and Operations

 

Item 1.01.                                          Entry into a Material Definitive Agreement.

 

On March 24, 2008, Poniard Pharmaceuticals, Inc. and W.C. Heraeus GmbH entered into a Commercial Picoplatin Active Pharmaceutical Ingredient Manufacturing Agreement.  Under the Manufacturing Agreement, Heraeus will produce picoplatin active pharmaceutical ingredient (API) for final dosage pharmaceutical products which are intended to be used by Poniard for commercial purposes and may be used for additional clinical trials and development activities. The Manufacturing Agreement provides that Heraeus will finance and install certain designated equipment for picoplatin API manufacture and that Poniard will repay the investment based on manufacture and delivery of picoplatin API by Heraus under the Manufacturing Agreement.  Unless terminated, the Manufacturing Agreement continues for an initial term ending December 31, 2013, subject to extension.  The Manufacturing Agreement generally may be terminated on thirty days’ prior written notice: (i) upon mutual agreement of the parties; (ii) by either party if there is a breach by the other party that remains uncured for thirty days, or if the other makes a general assignment for the benefit of creditors, or if a petition in bankruptcy or under any insolvency law is filed and not dismissed within sixty days, or if the other party or its personnel performing services under the Manufacturing Agreement is debarred; or (iii) by Poniard if there is a change of control of Heraeus.

 

The foregoing is qualified in its entirety by reference to the Manufacturing Agreement, which will be filed as an exhibit to Poniard’s Quarterly Report on Form 10-Q for the quarter ending March 31, 2008.

 

On March 26, 2008, the Company issued a press release announcing the Manufacturing Agreement.  A copy of the press release is attached hereto as Exhibit 99.1.

 

Item 9.01.

 

Financial Statements and Exhibits.

 

(d)

 

Exhibits.

 

 

 

 

 

Exhibit 99.1 –

Press Release dated March 26, 2008

 

1



 

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 hereunto duly authorized.

 

 

Poniard Pharmaceuticals, Inc.

 

 

Dated:   March 26, 2008

By:

/s/ Caroline Loewy

 

 

Caroline Loewy
Chief Financial Officer

 

2



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

Exhibit 99.1

 

Press Release dated March 26, 2008

 

3


EX-99.1 2 a08-9209_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

Poniard Pharmaceuticals Announces Commercial Manufacturing Agreement with W. C. Heraeus GmbH for Picoplatin

 

South San Francisco, Calif. (March 26, 2008) – Poniard Pharmaceuticals, Inc. (NASDAQ: PARD), a biopharmaceutical company focused on oncology, announced an agreement with W. C. Heraeus GmbH for the commercial manufacture and supply of picoplatin active pharmaceutical ingredient (API). Poniard is investigating picoplatin, the Company’s lead product candidate, in four clinical trials, including the ongoing pivotal Phase 3 trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumors.

 

“This agreement is a major step forward in the development of picoplatin as a commercial oncology product and to ensure that picoplatin is available to patients and oncologists once FDA approval is obtained,” said Ronald Martell, president and chief operating officer of Poniard Pharmaceuticals. “Heraeus is a high-quality partner which will provide Poniard with access to large-scale production, and has the capacity to meet our production and quality goals. They are a leader in the manufacture of pharmaceuticals, precious metals and synthesis chemistry.”

 

Under the agreement, Heraeus will manufacture picoplatin API to meet cGMP requirements, and be ready to ship commercial quantities of picoplatin by 2009. Heraeus is the current manufacturer of picoplatin API for the Company’s four ongoing clinical trials.

 

About Picoplatin

 

Picoplatin is a chemotherapeutic agent with an improved safety profile compared to existing platinum-based chemotherapeutics. It was designed to overcome platinum resistance associated with the treatment of solid tumors. Picoplatin has been evaluated in more than 750 patients and has anti-tumor activity in multiple indications, with less severe kidney and nerve toxicity than is commonly observed with other platinum chemotherapy drugs.

 

Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) with overall survival as the primary endpoint. The Company also is evaluating intravenous picoplatin in ongoing Phase 2 clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic colorectal cancer (mCRC). Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans.

 

About Poniard Pharmaceuticals

 

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. For additional information please visit www.poniard.com.

 



 

About Heraeus

 

The precious metals and technology group Heraeus is a global, family-owned company active in the businesses of precious metals, sensors, dental and medical products, quartz glass and specialty lighting sources. With revenues exceeding EUR 10 billion and more than 11,000 employees in more than 100 companies worldwide, Heraeus has been a globally recognized precious metals and materials specialist for more than 155 years.

 

This release contains forward-looking statements, including statements regarding the Company’s business objectives and strategic goals, drug development plans, results of clinical trials and the potential safety and efficacy of its products in development. The Company’s actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company’s research and development activities; the results of pre-clinical and clinical testing; the receipt and timing of required regulatory approvals; the market’s acceptance of the Company’s proposed products; the Company’s anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company’s ability to preserve and protect intellectual property rights; the Company’s dependence on third-party manufacturers and suppliers; the Company’s lack of sales and marketing experience; the Company’s ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company’s current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.

 

© 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.

 

Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.

 

For Further Information:

 

Brendan Doherty

Poniard Pharmaceuticals

Corporate Communications

7000 Shoreline Court, Suite 270

South San Francisco, CA 94080

650-745-4425

bdoherty@poniard.com

 

# # #

 

2


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