Under the agreement, Heraeus will manufacture picoplatin active pharmaceutical ingredient (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.
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 tumors.
Ronald Martell, president and COO of Poniard, said: “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.”