To: Montana Wildhack who wrote (6957 ) 3/18/2001 6:23:30 PM From: Joe Krupa Read Replies (1) | Respond to of 14101 Here's a copy of a link just posted by ticktalker over on SH:sharecast.com (Here's the text of the article as well)Provalis drug By Robin Davison Fri 2 Mar 2001 LONDON (SHARECAST) - UK healthcare group Provalis is gearing up for the launch of a new drug later this month which could dramatically change its fortunes, but surprisingly the stock market has not yet attributed any value to it. Provalis In three weeks' time, Provalis expects to launch Pennsaid, a topical version of the widely-used anti-inflammatory drug diclofenac, for treating pain associated with osteoarthritis (OA), one of the most common ailments affecting the over-65s. Provalis licensed UK rights to this product from the Canadian biotech firm Dimethaid Research in January, against what it says was stiff competition from a number of lager pharmaceutical companies. However, its shares moved little in response to the deal and have traded within a narrow range since then. The shares closed at 19.25p yesterday, capitalising the company at £45m and valuing its technology at just £33m, subtracting its year-end cash balance of £12m. | Pennsaid can be rubbed directly on to the joints affected by OA to relieve the painful swelling that characterises the condition. Despite the fact that the localised nature of OA would normally lend itself to site-specific treatment, the poor efficacy of available topical drugs means that most patients receive so-called non-steroidal anti-inflammatory drugs (NSAIDs) orally, which are well known to cause side effects. The most problematic of these is damage to the stomach and gut, which in the UK alone causes some 12,000 hosptial visits and 2,000 deaths per year (usually as a result of bleeding ulcers). Pennsaid is a solution of diclofenac containing an agent called DMSO which allows it to penetrate through the skin. Its nearest competitor is Voltaren Emulgel, a topical gel form of diclofenac sold by Swiss pharmaceutical group Novartis, which is popular in the UK despite the problem of poor absorption. However, Provalis will want to position Pennsaid to compete in the oral market for NSAIDs. The NSAID market is dominated by oral products and valued at some £220m per year in the UK. If Provalis can capture only a small portion of this, it would dramatically increase the sales of its healthcare division, which are currently running at just over £5m per year on an annualised basis. Provalis will, however, face stiff competition from the major players in the pharmaceutical industry and has only 42 sales representatives. But Dimethaid’s studies with Pennsaid give the drug an enviable profile and show that it provides better pain relief than either diclofenac, naproxen (another commonly used NSAID) and even the blockbuster drug Celebrex, sold by the US pharmaceutical giant Pharmacia. Provalis has not disclosed its pricing strategy for Pennsaid, although chief executive Phil Gould said it will be “competitive on the basis of treatment cost per day”. Gould is reluctant to comment on sales projections as he is keen to avoid the risk of disappointing the market, but said Pennsaid could easily become Provalis’s top-selling product. John Kwok, analyst at house broker Old Mutual Securities, predicts £6m peak sales for Pennsaid in 2006, but said this figure is likely to be very conservative if Pennsaid takes sales from oral NSAIDs. Gould said Provalis will also make a good gross margin on Pennsaid, which it will buy as a finished product from Dimethaid. The Pennsaid launch comes as Provalis also enjoys success with its other main product, the Glycosal point-of-care testing system for glycated haemoglobin. The system measures the quality of glucose control in diabetes and the test is typically taken once every three months. Glycosal recently received its approval in the US and Japan and has already been launched in more than 40 countries in Europe and other regions. To date, Provalis has shipped 1,500 Glycosal instruments, which sell to users for an average of $800, and 170,000 individual tests, which retail for an average of $8. Demand is also growing fast and Provalis has increased the manufacturing runs to 135,000 tests per month. Provalis is using revenue from its healthcare (pharmaceutical marketing) and medical diagnostics divisions to fund therapeutics research and development, which is focused on developing a range of vaccines for infectious disease. These include vaccines for streptococcus pneumoniae, which causes pneumonia in adults, and Group B streptococcus, which affects infants. Both vaccines are ready for clinical development. Provalis reported its results for the half year to December 31 yesterday, showing a 56% reduction in net losses to £2.1m on revenues from continuing operations of £3.6m, up 13%. Send your comments to Robin Davison