SOUTH SAN FRANCISCO, Calif., Nov. 24 PoniardPharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused ononcology, today announced an agreement with Baxter Oncology GmbH for thecommercial manufacture and supply of injectable picoplatin drug product.Poniard is developing picoplatin, its lead product candidate, as a potentialnew platform product for the treatment of solid tumors. The Company isevaluating picoplatin in four clinical trials, including an ongoing pivotalPhase 3 trial in small cell lung cancer, Phase 2 trials in colorectal andprostate cancers, and a Phase 1 trial of an oral formulation.
"This agreement with Baxter Oncology GmbH for the commercial supply ofpicoplatin represents the achievement of another important milestone in ourplan to develop picoplatin as an oncology platform compound addressingmultiple indications, combinations and formulations," said Ronald Martell,president and chief operating officer of Poniard. "Baxter Oncology GmbH'sindustry-leading technology and state-of-the art finish/fill productioncapabilities will help ensure we meet our production and quality goals as wemove toward commercialization of picoplatin in 2010."
In March 2008, Poniard entered into an agreement with W. C. Heraeus GmbHto manufacture picoplatin active pharmaceutical ingredient (API) and be readyto ship commercial quantities of picoplatin by 2009. Heraeus is the currentmanufacturer of picoplatin API for the Company's four ongoing clinical trials.
Picoplatin has an improved safety profile relative to existingplatinum-based cancer therapies and is designed to overcome platinumresistance associated with chemotherapy in solid tumors. It is being studiedin multiple cancer indications, combinations and formulations. Picoplatin hasbeen evaluated in more than 750 patients and has demonstrated anti-tumoractivity in multiple indications with less severe kidney toxicity(nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observedwith other platinum chemotherapy drugs.
Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in smallcell lung cancer. This registration trial currently is being conducted under aSpecial Protocol Assessment (SPA) from the U.S. Food and Drug Administrationand is evaluating overall survival as the primary endpoint. Picoplatin is alsobeing evaluated in a Phase 2 clinical trial in patients with metastaticcolorectal cancer and in an ongoing Phase 2 clinical trial in patients withhormone-refractory prostate cancer. Oral picoplatin is being evaluated in aPhase 1 clinical trial in solid tumors. The oral formulation of picoplatin hasthe same active pharmaceutical ingredient as the intravenous formulation.Picoplatin has not been approved by any regulatory authority for use inhumans.
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused onthe development and commercialization of innovative oncology products toimpact the lives of people with cancer. For additional information pleasevisit http://www.poniard.com.
Forward Looking Statement
This release contains forward-looking statements, including statementsregarding the Company's business objectives and strategic goals, drugdevelopment plans, timing and results of clinical trials and the potentialsafety and efficacy of its products in development. The Company's actualresults may differ materially from those indicated in these forward-lookingstatements based on a number of factors, including risks and uncertaintiesassociated with the Company's research and development activities; the resultsof pre-clinical and clinical testing; the receipt and timing of requiredregulatory approvals; the market's acceptance of the Company's proposedproducts; the Company's anticipated operating losses, need for future capitaland ability to obtain future funding; competition from third parties; theCompany's ability to preserve and protect intellectual property rights; theCompany's dependence on third-party manufacturers and suppliers; the Company'slack of sales and marketing experience; the Company's ability to attract andretain key personnel; changes in technology, government regulation and generalmarket conditions; and the risks and uncertainties described in the Company'scurrent and periodic reports filed with the Securities and Exchange Commission(SEC), including the Company's Annual Report on Form 10-K for the year endedDecember 31, 2007 and its Quarterly Report on Form 10-Q for the period endedSeptember 30, 2008. Readers are cautioned not to place undue reliance onthese forward-looking statements, which speak only as of the date of thisrelease. The Company undertakes no obligation to update any forward-lookingstatement to reflect new information, events or circumstances after the dateof this release or to reflect the occurrence of unanticipated events.
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SOURCE Poniard Pharmaceuticals, Inc.