Nutra Pharma Corp., a biotechnology holding company that owns rights to intellectual property related to the development of drugs for Multiple Sclerosis and HIV, has announced that its minority holding, ReceptoPharm, Inc., has been GMP-qualified (Good Manufacturing Practices) for the purpose of manufacturing their drugs for human clinical trials in the European Union (EU).
ReceptoPharm had invited an audit earlier this year in order to identify areas of potential weakness prior to initiating the production of their lead drug products to supply upcoming clinical trials. The EU drug production standards are higher than that of the US-FDA, making it essential to have lab certification for support of a clinical trial application. Though not required, the Company plans to invite local FDA inspectors in preparation for future submissions to the U.S. regulatory agency.
"This transition underlies our elevation from a research and development company to a clinical trial-ready organization," commented Paul Reid, PhD, ReceptoPharm's CEO. "This is a great milestone accomplishment considering today's strict regulatory environment. With these hurdles cleared the Company can now focus on preparing for clinical trials and meeting other clinical trial requirements," he concluded.
As part of the GMP process, considerable effort has been expended on securing raw material supplies and qualifying the vendors to ensure adequate supplies of drugs would be available beyond the clinical trial stage. During this period the Company has assembled its Common Technical Document (CTD), the basic instrument used to support clinical trial applications principally in the EU. With the completed CTD, the Company can now rapidly complete regulatory applications.
ReceptoPharm is currently involved in two clinical trial applications: the first for the AMN (Adrenomyeloneuropathy) study planned for the U.K. and a second in association with Celtic Biotech in Ireland where ReceptoPharm will be responsible for producing the clinical drug supplies. Furthermore, the Company is preparing to initiate clinical trials in HIV/AIDS and MS (Multiple Sclerosis) and is actively preparing applications for these indications. The Company is still in the process of identifying suitable clinical trial sites, but the completed CTD allows the clinical trial applications to be rapidly assembled.
"Regulatory approvals are a necessary part of business in the biotechnology arena," commented Rik J. Deitsch, Nutra Pharma's CEO. "Having this GMP-certification will allow ReceptoPharm to move their projects forward quickly. Additionally, the completed CTD will streamline the regulatory process for the Company. These are important steps that are necessary to bring us through the drug approval process both in the US and the EU," he added.
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). The recent GMP-qualification of ReceptoPharm's facilities should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.