Poniard Pharmaceuticals, Inc, a biopharmaceutical company focused on oncology, signed an agreement with W. C. Heraeus GmbH for the commercial manufacture and supply of picoplatin active pharmaceutical ingredient (API). Financial terms were not disclosed.

Poniard is investigating picoplatin, the company's lead product candidate, in four clinical trials, including the ongoing pivotal phase III trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumours.

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.

"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 would 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.
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 tumours. Picoplatin has been evaluated in more than 750 patients and has anti-tumour 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 III 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 US Food and Drug Administration (FDA) with overall survival as the primary endpoint. The company is also evaluating intravenous picoplatin in ongoing phase II clinical trials for the treatment of hormone refractory prostate cancer (HRPC) and metastatic colorectal cancer (mCRC). Oral picoplatin is being evaluated in a phase I clinical trial in solid tumours. Picoplatin has not been approved by any regulatory authority for use in humans.