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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
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Bioprogress | LSE:BPRG | London | Ordinary Share | GB0032681628 | ORD 1P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 50.00 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
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0 | 0 | N/A | 0 |
RNS Number:3073D BioProgress PLC 05 September 2007 For Immediate Release 5 September 2007 BioProgress plc Pipeline Update London, UK, 5 September 2007: BioProgress plc ('BioProgress' or the 'Company') (AIM: BPRG), the specialty pharmaceutical and OTC product healthcare company, provides an update to its previous product development announcement released on 31 May 2007. BioProgress has eleven integrated enabling delivery technologies with pharmaceutical and OTC healthcare applications. The Company has in development over 45 patent protected products (an increase from the previous 30) which utilize these core enabling systems. These developments are either BioProgress's own product developments or from working with partners. Since the last update, BioProgress has successfully completed a validation of the FastWrap concept, a fast dissolving tablet technology using the TabWrapTM enabling system. Significant technical data has been generated which clearly shows its superiority over other established pharmaceutical technologies. In addition, the Company has launched XLWrap, again using the TabWrapTM enabling system in order to create modified release products. BioProgress has one product in development with a further three products being targeted for partnering during 2008 whose branded equivalent sales are in excess of $4 billion sitting within the analgesic and gastro-intestinal markets. The developments can be divided into three main categories: 1. Line extensions for acquired pharmaceutical brands; 2. Innovative Products suitable for out-licensing or for sale by Dexo BioPharm; and 3. OTC and Nutritional Products; 1. Line extensions for acquired Pharmaceutical Brands Collunovar OraDisc Further to the previously announced licensing agreement with Uluru Inc, BioProgress is expected to file for regulatory approval of the OraDiscTM B product during Q4 2007. The product is planned to be launched under the Collunovar brand in certain European countries. OraDiscTM B is a product developed from Uluru's adhesive film technology which incorporates 15 milligrams of benzocaine for the treatment of oral pain. The product is designed to adhere to the mucosal surface and selectively deliver pain relief to a localised area. Compared with currently marketed gel products, OraDiscTM B is designed to provide a significantly greater period of pain relief as the adhesive film is designed to erode over a 1 - 1.5 hour period. The market for oral pain relief in the United Kingdom alone is estimated at approximately $60million. Based upon similar product launches, BioProgress expects penetration rates in core EU, CIS and Middle Eastern markets to reach approximately 12% within the first three years of product launch with peak annual sales in excess of #25m. RocGelTM RocGelTM, a gastro-intestinal brand acquired from ToniPharm, is currently exceeding growth expectations with current growth rates at over 29%. The brand, due to its exceptional promotional response, has accelerated the development and scale up of DBP272, DBP276 and DBP278 using the Company's SoluPol technology. The products are planned to be filed with different regulatory authorities during H2 2008. Commercialisation and partner programs for these products have commenced throughout the world. BioProgress is expecting that its core SoluPol product developments in the Gastro-Intestinal market will reach peak annual sales from regulatory approval of over $100m. BioProgress intends to market the brand as RocGelTM on a Global basis. DBP272 is also being planned to be partnered in Western Europe and within the US. In addition to the previously announced development within the gastro-intestinal field, BioProgress has commenced the development of an enhanced generic version of a blockbuster gastrointestinal product using its XLWrap technology platform. The product will be available for both prescription and OTC use. The product is in partnership discussions for US market. BioProgress believes that its can generate up to $200m annual revenues gastro-intestinal franchise in its major territories. Ah-Chew Ah-Chew is a range of products within the US market that are categorised as DESI products, products that do not require any pre-FDA approval. These products are currently being converted to utilise the FastWrap and Meltums enabling systems for a variety of combinations as well as the previously announced developments using the SoluleavesTM technology. Due to the high barriers to competition regarding the Company's patented systems, BioProgress believes that it will achieve an additional $15-20m in sales during the 2008-2009 winter seasons. With the patented systems around the Ah-Chew developments, BioProgress's profile as an innovative product development partner is currently being raised. Additional revenue is expected to be generated, including development income and supply agreements within the DESI category throughout 2008 and beyond. The Company is targeting contract revenues in excess of $30m per annum to third party companies within the US. 2. Innovative Products suitable for out-licensing or for sale by Dexo BioPharm In addition to its current partner programs, BioProgress is focusing on several areas that are able to generate substantial revenue from its innovative products. It is concentrating its efforts in the analgesic, cough/cold and gastro-intestinal (including nausea) markets, both in the prescription and OTC markets. Non-core innovations are currently either in or are planned to be in partnership programs where BioProgress will seek to focus on long term supply and revenue sharing agreements. Additional income is being generated from licensing and development revenues within the partnership program. DBP117 - Anti-Migraine As previously announced, BioProgress is developing a triptan drug within its SoluleavesTM and WafertabTM technology platforms. New manufacturing techniques have been developed, taken from the development work carried out on its DBP121 smoking cessation program. The product is entering into commercial scale up during Q4 2007. It is anticipated that revenues will be generated from partnership deals early in 2008. From new market assessments and data, BioProgress has increased its revenue expectations to reach 3% of the global $3.1billion triptan market, increased from 1-1.5% DBP118 - Anti-emesis The development program is currently on track in line with the Company's expectations which are that the product will enter into pharmacokinetic studies during 2008 with the product being filed using the NDA 505 (b) (2) regulatory pathway. Significant partnership interest has been generated from both the Far East and Eastern Europe. The Company is expecting peak sales revenues to be in the region of $32-40m per annum. DBP121 - Anti Smoking Using an innovative patented solution to the technical challenges of nicotine replacement therapy, BioProgress is on track with its development and partnership program and looks forward to updating the market in due course. In addition to the SoluleavesTM/ WaferTabTM technology, BioProgress is pleased to announce the successful formulation of a MeltumsTM formulation which is designed to release the nicotine over a 10-15 minute period in order to maximise the absorption of nicotine. The product is designed to be complimentary to the existing thin strip development and forms part of the commercialisation and partnership program. The development of two innovative dosage forms using BioProgress technology in this area increases the value proposition to partners. With the unique manufacturing requirements of this technology, long term supply agreements are at the core of the partnership programs generating long term sustainable revenues to the business. Such supply revenues could reach in excess of $500m over a 10 year period. DBP167 - Novel Analgesic BioProgress has made significant progress in the development of rapid release products. Initially, DBP167 was developed for breakthrough pain. Due to its success and its core focus on pain, the product has been positioned for a range of line extensions. These utilise the full range of the Company's enabling systems including: *NRobeTM *FastWrap *XLWrap *SoluPol *Meltums In addition to the basic analgesic product, additional combinations are planned including the addition of decongestants such as phenlyephrine, the only systemic decongestant available OTC. Work has commenced to create a first in class cough/ cold remedy using this technology. The product range will be targeted for both prescription and OTC use. The first product will be submitted to the EU regulatory authorities in early Q4 2007, ahead of schedule. This product, which creates a novel liquid preparation, is being targeted for the relief of acute pain especially that associated with headache and migraine. The product does not contain opiate analgesia and therefore removes the issues around potential abuse and rebound headaches. This range is a premium analgesic range, with unique properties that the current leading brands are unable to compete with. Clinical data supporting the product is strong showing a speed of onset of analgesia in just a few minutes. The Company believes that this unique selling point, as well as the ability to create patient friendly products that ease issues around swallowing, are primary market drivers. BioProgress has over the next five years committed to a strong development and commercialisation program regarding this technology. The core market, apart from Europe, will be the United States, Japan and China. The range will be extended into the Dexo US cough/cold prescription franchise with a range of patented products. The Company believes that its annual peak sales value on a global basis will be in excess of $300m with all of the different variants. Revenue will be generated from partner income - milestones and supply agreements - which will be used to promote the brands in its core territories. 3. OTC and Nutritional Products The acquisition of Melbrosin in June 2007 has increased the number of product developments within the nutritional, herbal and Vitamin Mineral Supplement (VMS) categories. In addition, with the exclusive relationship with the Christian Doppler Institute in Vienna, BioProgress has access to a unique pipeline to integrate its enabling systems with natural based medicines. The Company is currently integrating the Kudos range of products into the German market for sale through its own sales and marketing business unit. According to a recent survey conducted by Apotheken Umschau, six out of ten Germans would prefer their doctor to prescribe them a herbal remedy rather than a synthetic medicine. The study, involving 1978 Germans, found that more that four-fifths of the participants - 83.5% - felt that the importance of herbal medicines would increase. BioProgress is successfully working with the Melbrosin team to integrate its core technologies such as TabWrapTM, Meltums and SoluleavesTM into a range of herbal products that can be both prescribed and sold over the counter. The Kudos lifestyle range has been complemented with the successful development and launch of a novel topical product for the treatment of cellulite. The patented formulation highlights the versatility of the product development team and its ability to take a product from concept to sales in record time. In addition, using the recently generated FastWrapTM scientific data, BioProgress has increased the range of products within the analgesic and cough/ cold therapeutic areas in development. The Global OTC market for analgesics and cough/cold products is worth $16.7 billion per annum. Due to the innovation of this novel patented pharmaceutical technology, BioProgress has increased its expectations to achieve sales penetration rates of 2.5 per cent of the relevant market share. The first European TabWrapTM product will be launched in Spring 2008 in Germany. This product is a different analgesic product to DBP216 and will have a superior FastWrapTM version available later in the year. The Company believes that it will achieve Euro6-12 million peak annual sales within the German market alone. Launches, subject to regulatory approval, are expected in other Dexo subsidiaries. Other Development Programs BioProgress is focussed on delivering its development program. Significant work and forward planning has occurred ensuring that BioProgress has the manufacturing capability to fulfil its sales expectations. New manufacturing techniques, and additional recent advances in improving the film itself, ensure that the Company is able to meet its current film requirements. The Company has made a quantum leap in its knowledge of product formulation using soluble polymers. As a consequence of its own programme and significant diligence issues, BioProgress terminated its proposed completion of the in-licensing of MuGard from Access Inc. The decision was made due also to the advances with the Company's own SoluPol system. This action saved the Company significant capital expenditure which is being placed into its own development program where the Company makes high operating and net margins. Since the previous product development update, BioProgress has seen the validation of its technology with the registration of two medical devices with HypozalixTM, the Group's artificial saliva product. Steve Martin, Chief Development Officer, BioProgress PLC said: "The Company is now at the strongest point it has ever been, with a depth of product development that is both low risk, low development spend but highly desirable within the global marketplace. The Company is generating revenues from its development and licensing program, a key validation of our intellectual property. Through the generation of robust scientific data, the Company has worked hard to ensure that it is able to create sustainable ongoing revenues, and looks forward to maximising shareholder value." For further information: BioProgress Plc + 44 (0) 20 7098 9881 Richard Trevillion, CEO Steve Martin, CDO Hiral Patel, CFO Buchanan Communications + 44 (0) 20 7466 5000 Rebecca Skye Dietrich/Mark Court About BioProgress BioProgress plc is an innovative specialty pharmaceutical and healthcare business based around its platform technologies in polymer and film systems. Listed on London's AIM in May 2003, The company has over 80 patents granted or in application within 24 patent families and has product development agreements and strategic alliances with several global companies. As a virtually integrated business, BioProgress has acquired sales and marketing resources within Europe and the US as a launch mechanism for its own pharmaceutical products. The business continues to develop innovative delivery mechanisms using its XGELTM polymer technology. For further information please go to www.bioprogress.com Forward-Looking Information The Ordinary Shares of BioProgress plc are registered under the US Securities and Exchange Act of 1934. To the extent that this announcement contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, this paragraph applies. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may vary materially from the expectations contained in the forward-looking statements. The forward-looking statements in this release include statements addressing future financial and operating results and the timing and benefits of the reorganisation. Detailed information about factors pertinent to the business of the company that could cause actual results to differ is set forth in the Company's filings with the Securities and Exchange Commission. The Company is under no obligation to (and expressly disclaim any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events or otherwise. This announcement is for information only and does not constitute an offer or invitation to acquire or dispose of any securities or investment advice. The distribution of the announcement and/or issue of securities in certain jurisdictions may be restricted by law. Persons into whose possession this announcement comes are required to inform themselves about and to observe such restrictions. This information is provided by RNS The company news service from the London Stock Exchange END DRLLIMPTMMTMBFR
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