Poniard Pharma suspends efforts to obtain regulatory approval for picoplatin in SCLC
Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, announced a clinical and regulatory update on its lead product candidate, picoplatin. Following a detailed analysis of primary and updated data from the phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the US Food and Drug Administration (FDA), the company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time.
The company will focus its resources on developing pivotal clinical strategies for picoplatin in small cell lung cancer, as well as colorectal, prostate, and ovarian cancers. Pursuant to this decision, the company announced that it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives aimed at enabling the execution of these strategies and optimizing shareholder value. These alternatives could include capital raising alternatives, merger, sale or partnership.
"Leveraging key insights from the SPEAR study, we plan to redirect our resources toward developing multiple registration strategies to advance picoplatin to market," stated Ronald A. Martell, chief executive officer of Poniard. "Picoplatin has demonstrated promising clinical activity, including favourable survival and safety data in small cell lung cancer, as well as in a variety of other solid tumours. This versatility is at the core of the drug's value proposition and what we believe makes it an attractive development candidate. In the Company's current position, we believe that a full review of strategic alternatives offers us the best opportunity to achieve our objectives for our shareholders."
In connection with this action, Poniard announced a restructuring of its workforce, eliminating those positions focused on pursuing an NDA filing for SCLC, along with certain supporting functions. This reduction in personnel will decrease the number of employees by approximately 45 per cent, to a total of 12, effective April 30, 2010. Poniard will continue to provide clinical and regulatory support activities for its current studies. Poniard expects the reduction in force to result in an approximately $2.2 million decrease in operating expenses in 2010, net of a charge in the second quarter of approximately $0.5 million related to the workforce reduction.
Martell concluded: "Internally, our efforts will now be focused on developing registration strategies and exploring strategic alternatives to support the continued development of picoplatin in colorectal, prostate, ovarian and small cell lung cancers. We regret that this decision will affect those individuals charged with pursuing a regulatory application in SCLC, and we thank them for their service to the company."
The company expects that efficacy and safety data from the SPEAR study will be presented at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting taking place June 4-8, 2010 in Chicago.
With respect to the review of strategic alternatives, there can be no assurances that any particular alternative will be pursued or that any transaction will occur, or on what terms. The Company does not plan to release additional information about the status of the review of alternatives until a definitive agreement is entered into or the process is otherwise completed.
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