DEESIDE, U.K., June 17, 2004 (PRIMEZONE) -- Provalis plc (LSE:PRO) (Nasdaq:PVLS), the Medical Diagnostics and Pharmaceuticals Group, is pleased to announce that, on schedule, it has filed the USA regulatory submission with the FDA for its G5 diabetes glycated haemoglobin test.
Regulatory clearances are being sought in the USA for 510K and prescription home use marketing approvals, which additionally confers CLIA waiver. These allow the Company to fully exploit the sales potential of G5 into all physicians' offices and also to be available eventually to diabetics for use at home.
In further preparation for the launch of the product in the USA, Provalis has now appointed its three vice-presidents of sales to cover the central, west coast and east coast regions. They, together with Bert Valada the General Manager of Provalis Diagnostics (USA), have collectively over 100 years of diagnostics sales experience in the USA and are now building the network of national sub-distributors ready for product launch in the autumn (fall) of this year.
Phil Gould, Chief Executive Officer of Provalis said "We are delighted with the high quality of the clinical data we have generated with G5 and that we have now filed on schedule the USA regulatory submission with the FDA. With an experienced sales team now recruited in the USA, we look forward to a successful product launch in the autumn of this year".
Provalis' Internet Website: http://www.provalis.com
"Safe Harbor" Statement under the US Private Securities Litigation Reform Act of 1995:
Statements in this announcement that relate to future plans, expectations, events, performances and the like are forward-looking statements as defined in the US Private Securities Litigation Reform Act of 1995. Actual results of events could differ materially from those described in the forward-looking statements due to a variety of factors. Such factors include, among others: the viability of the Group's products, which are at various stages of development; the generation of sufficient operating cash flow by the Group's pharmaceutical and medical diagnostic businesses to finance the ongoing development of these businesses as well as the Group's research and development activities; the success of the Group's research and development strategy and activities; uncertainties related to future clinical trial results and the associated regulatory process; the execution and success of collaborative agreements with third parties; availability and level of reimbursement for the Group's products from government health administration authorities or other third-party payors; the rate of net cash utilisation within the Group and, hence, the Group's possible need for additional capital in the short, medium and/or long term; the Group's intellectual property position and the success of patent applications for its products and technologies; the Group's dependence on key personnel; general business and economic conditions; the impact of future laws, regulations and policies; stock market trends in the Group's sector; and other factors beyond the Group's control that may cause the Group's available capital resources to be used more quickly than expected. These and other factors that could affect the Company's future results are more fully described in its filings with the US Securities and Exchange Commission, in particular the latest 20-F filing, copies of which are available from the Company Secretary at the Company's registered address.
About Provalis plc
Provalis plc (LSE:PRO) (Nasdaq:PVLS) is a diversified healthcare group with two operating businesses:
- Medical Diagnostics - develops and sells to world markets medical diagnostic products for chronic disease management. The business' principal products are Glycosal(R) and Osteosal(R) in the areas of diabetes and osteoporosis respectively.
- Pharmaceuticals - sells and markets its own, and third party, branded, prescription medicines in the UK and Ireland to GPs and hospitals through its own regionally managed sales force. The business' principal product is Diclomax(R), a medicine for use in the treatment of musculo-skeletal disorders, and it also sells products in the areas of gastroenterology, osteoporosis, migraine and dermatology.
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