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| Share Name | Share Symbol | Market | Stock Type |
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| Medgenics(Regs) | MEDG | London | Ordinary Share |
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| 0.00 | 0.00% | 302.50 | 01:00:00 |
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Posted at 07/7/2012 00:15 by georgio44 Was gonna go to the proactiveinvestors presentations at Mayfair on Thursday night (which obviously included MEDG) but am only into Oilers & Goldies at the moment (just in BOR currently), so decided to give it a miss.Must have been a few eyebrows raised today by those that attended.. I went to the previous Thursday event mainly for the Tomco (TOM) presentation and was impressed by the AAU one (as well as Tomco's). Good luck here.. but a bit too pricey for me now ! |
Posted at 14/10/2011 15:02 by topinfo DJ Medgenics Inc Research Update TIDMMEDG TIDMMEDU TIDMMEDG RNS Number : 2267Q Medgenics Inc 14 October 2011 October 14, 2011 UPDATE ON DEVELOPMENT OF FACTOR VIII BIOPUMP MISGAV, Israel and San Francisco (October 14th, 2011) - Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, announces an update to its previously announced agreement with Baxter Healthcare Corporation for the joint development of the Factor VIII Biopump which expired on September 30, 2011. The Company confirms that it is in active discussions with Baxter regarding the terms for possible further collaboration. The Company will provide a further update with regard to the outcome of such discussions as soon as it is able to do so. About Medgenics Medgenics is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins. Medgenics has three long-acting protein therapy products in development based on this technology: -- EPODURE (now completing a Phase I/II dose-ranging trial) to produce and deliver erythropoietin for many months from a single administration, has demonstrated elevation and stabilization of hemoglobin levels in anemic patients for 6 to more than 24 months; -- INFRADURE (planning to commence a Phase I/II trial in Israel in 1H12) to produce a sustained therapeutic dose of interferon-alpha for use in the treatment of hepatitis C; -- HEMODURE is a sustained Factor VIII therapy for the prophylactic treatment of hemophilia, now in development. Medgenics intends to develop its innovative products and bring them to market via strategic partnerships with major pharmaceutical and/or medical device companies. In addition to treatments for anemia, hepatitis C and hemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products targeting the large and rapidly growing global protein therapy market, which is forecast to reach $132 billion in 2013. Other potential applications for Biopumps include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes. Forward-looking Statements This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company's financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as "estimate," "project," "intend," "forecast," "anticipate," "plan," "planning, "expect," "believe," "will, " "will likely," "should," "could," "would," "may" or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company's assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur. For further information, contact: Medgenics, Inc. Phone: +972 4 902 8900 |
Posted at 26/7/2011 12:37 by andrbea on PLUS markets today (medg = 257p):1 CMCP.G Content 1.15 64.29% 2 MEDG.G Medgenics 257.50 56.06% 3 AMP.GB Amphion 6.63 52.65% 4 MUBL.G Mbl Group 11.50 41.10% 5 ERU.GB Eruma Ord 10.50 35.48% 6 BES.GB Blavod 2.00 29.03% 7 TOM.GB Tomco 0.85 21.43% 8 ATH.GB Ath 58.00 19.44% 9 COMS.G Coms Ord 2.35 17.25% 10 DLG.DE Dialog 14.47 17.13% |
Posted at 19/11/2010 07:37 by sicilian_kan American Society of Nephrology PresentationTIDMMEDG RNS Number : 4719W Medgenics Inc 19 November 2010 Medgenics, Inc. ('Medgenics' or the 'Company') MEDGENICS ANNOUNCES THAT LEADING ANAEMIA EXPERT WILL PRESENT ITS EPODURE STUDY AT AMERICAN SOCIETY OF NEPHROLOGY CONFERENCE 18-21 NOVEMBER 2010 IN DENVER COLORADO Data will be presented on November 19th in the session titled New Therapeutics Targets to Fight Anaemia Misgav, Israel and London, UK - November 19, 2010 - Medgenics (AIM: MEDU MEDG), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce that its phase I/II study of the use of EPODURE Biopumps in treatment of anaemia caused by renal disease is to be presented on Friday, November 19, at the annual convention of the American Society of Nephrology, one of the largest meetings of nephrologists in the world. The presentation will be given by Dr. Anatole Besarab, of Ford Hospital, Detroit MI - a member of the Company's Strategic Advisory Board and a leading authority in renal anaemia. The presentation represents data from the continuation of the Company's phase I/II clinical trial using EPODURE. Chronic kidney disease patients suffering from renal anaemia have been investigated for their response to treatment by EPODURE Biopumps. This report includes data from 6 patients who have received the lower dose (20 IU/kg/day) and 6 patients who have been treated with 40 IU/kg/day; 12 patients in total. Dr. Besarab will review how the results to date attest to the safety, effectiveness and durability of the EPODURE Biopump as a potential sustained treatment alternative to months of injections of EPO and other ESAs (erythropoiesis-stim The presentation will be available on the Company's website (www.medgenics.com). |
Posted at 01/11/2010 07:23 by sicilian_kan RNS Number : 3372VMedgenics Inc 01 November 2010 Medgenics, Inc. ('Medgenics' or the 'Company') Patient reaches 2 years Anaemia Relief from Single Treatment in Clinical Trial Results to be presented at the American Society of Nephrology Annual Convention on Nov 19, 2010 New Biopumps now producing clotting Factor VIII protein for Haemophilia treatment Misgav, Israel and London, UK - November 1, 2010 - Medgenics, Inc. (AIM: MEDG, MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce further positive progress in the Company's ongoing Phase I/II clinical trial with EPODURE to treat anaemia, including the treatment of additional patients with the middle dose range of continuously produced erythropoietin ('EPO'). In addition, the Company announces that it has succeeded in creating Biopumps producing Factor VIII in vitro. The Company views this as further demonstration of the Biopump platform for producing a range of therapeutic proteins. The Company is pleased to report the following updates on the clinical trial, platform development, and commercial partnering: EPODURE Anaemia Clinical Trial · 12 patients have now received their implanted EPODURE Biopumps in the Company's Phase I/II clinical trial, with 5 receiving the dose level of (40 IU/kg/day), and 7 receiving the lower dose (20 IU/kg/day). · One patient has been successfully treated for anaemia for a full 2 years following his single low dose treatment with EPODURE Biopumps in 2008. His haemoglobin levels have remained continuously within the target range of 10-12 g/dl throughout this period without any adverse events and without receiving any EPO injections, whereas he was receiving frequent EPO injections before his EPODURE treatment. (EPO injections are the current standard of care for anaemia and are produced by recombinant DNA in rodent cell culture.) · Another patient, whose haemoglobin level had responded positively to the low dose of EPODURE, but only reached the low end of the target range of 10-12 g/dl, has just become the first patient to receive an additional administration of low dose EPODURE Biopumps to increase haemoglobin level. This parallels intended clinical use whereby, if there is insufficient haemoglobin response to an initial dose of Biopumps, additional Biopumps would be administered to further increase the haemoglobin level to reach the desired range. All previous patients have received only a single administration of a fixed dose, without possibility of subsequent increase. The Company views as a significant advance the approval for and administration of a second dose of Biopumps in a patient, and will be closely monitoring to see if this assists further haemoglobin elevation. · The latest results of the clinical trial are to be presented at the annual convention of the American Society of Nephrology, one of the largest meetings of nephrologists in the world, on November 19th. The presentation will be given by, Prof. Anatole Besarab, of Ford Hospital, Detroit MI - a member of the Company's Strategic Advisory Board and a leading authority in renal anaemia. Factor VIII ("FVIII") Biopump for Haemophilia Medgenics is also pleased to announce that Biopumps are now successfully producing active clotting factor VIII protein: considered by many to be the most challenging of proteins to produce in vitro. The Company views this as a further confirmation of the Biopump Platform, with Factor VIII now joining EPO and Interferon alpha as proteins continuously produced by Biopumps. The Company is continuing development of its FVIII Biopump to further increase FVIII output per Biopump to bring it to target levels thought sufficient to improve blood clotting if they were administered to patients with haemophilia. If successful, this would provide a unique and exciting new therapeutic option for haemophilic patients which could make a major difference in their lives. Medgenics is in advanced discussions with its pharmaceutical partner regarding continuation of collaboration in development of Factor VIII Biopumps for the treatment of haemophilia and will update the market as this moves forward. Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that one of our patients has now passed his second anniversary free of EPO injections and with his haemoglobin right in the target range, and all from a single treatment with EPODURE in October 2008. We are further pleased that we have now treated 12 patients, including 5 who have received the mid-dose level, and look forward to following their response in the coming months. We are further excited about the presentation of our study by Prof Besarab at the upcoming major nephrology conference. Last but not least, we are proud to announce that we have shown we can make Biopumps producing clotting factor VIII for haemophilia, and look forward to further improvements in output with continued collaboration with our pharmaceutical partner." Dr. Eugene Bauer, Chairman of Medgenics commented: "Progress continues on Medgenics' EPODURE program. We are especially pleased that one patient has now been treated for two years without additional intervention. Further, our development program for haemophilia A has progressed to the point of reproducible in vitro expression of active Factor VIII by our proprietary tissue Biopumps, and we are hopeful that our continued development will advance the performance to meet levels we need to give us confidence to move to a clinical level program." |
Posted at 19/7/2010 13:05 by sicilian_kan Excellent news out mid-morning...Medgenics Announce Encouraging New Results TIDMMEDG RNS Number : 5442P Medgenics Inc 19 July 2010 Medgenics, Inc. ('Medgenics' or the 'Company') Medgenics Announces Encouraging New Results in Phase I/II Trials to Treat Anaemia Higher Dose EPO Biopumps Produce Dose-Dependent Increases in Haemoglobin Misgav, Israel and London, UK -19 July 2010 - Medgenics, Inc. (AIM: MEDG, MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, is pleased to announce encouraging new results in the Company's ongoing Phase I/II clinical trials with EPODURE to treat anaemia. As announced on 22 June 2010, two new patients have joined the Company's Phase I/II clinical trial, using Biopumps producing middle dose levels of erythropoietin ('EPO') (40 IU/kg/day). Now, through 4 weeks following treatment, these patients have shown a greater therapeutic response to the higher dose than was obtained in similar patients in the low dose group (20 IU/kg/day). Although individual patient response to EPO dose varies, comparing the response in the corresponding patients treated with half the dose with the response in these two patients receiving the higher dose shows: � 1.1-1.2 g/dl elevation of haemoglobin, versus to 0.5-0.75g/dl in the low-dose group; and � substantially greater rise in new red blood cells (reticulocyte count): 120-200 versus 60 reticulocytes/nl in the comparable patients. Four weeks post-treatment is a typical period used for evaluating initial haemoglobin response to a given EPO dose. Taken together thus far, these findings indicate that the mid-dose patients are having a stronger response than seen in the low dose group. These results, although only in two patients for their first month of treatment, are encouraging early signs of a dose-dependent response - an important objective of the current new stage of the trials. In the first part of the Company's Phase I/II clinical trial, the focus was on the (20 IU/kg/day) dose, equivalent to the lowest recommended dose for EPO, administered in 6 of the patients treated, with one patient treated with the middle recommended dose (40 IU/kg/day). The Biopumps produced EPO continuously in all the patients, elevating or maintaining the haemoglobin levels in most, even with the lowest EPO dose, with most continuing for the 6 month duration of the trial and one for more than 20 months. This second part of the trial is aimed at treating new patients with the medium and higher EPODURE doses to confirm that haemoglobin will be safely maintained or elevated over the period of the trial using these higher dosage levels of EPO delivery, and to show evidence of dose-dependence: greater administered EPODURE dose should generally result in greater haemoglobin response. Biopumps produced from the two new patients who entered this phase of the study were administered to them on 17 June 2010. Only 3-4 Biopumps were needed in each patient to deliver a total of 40 IU/kg/day. As noted, this has now been followed at 4 weeks post-treatment by greater haemoglobin response in these patients than has been seen in the previous patients. These results are a significant step towards demonstrating sustained dose-dependent haemoglobin response, and in the Company's development of EPODURE Biopump. Dr. Andrew Pearlman, CEO of Medgenics commented: "We are pleased with the strong response of these first patients treated in the new part of our study. We are particularly gratified by the greater rise in haemoglobin in these patients compared to the lower dose counterparts, a finding that supports our belief that EPODURE is a dosable treatment. We are confident that the coming weeks and months will confirm for the mid-dose what we have shown at lower dose: that a single administration of Biopumps can provide many months of effective anaemia therapy in these patients replacing scores of EPO injections. We now look forward to following these patients, while recruiting additional patients to the trial in the coming months." |
Posted at 05/7/2010 08:22 by sicilian_kan Statement re: Share Price DiscrepancyTIDMMEDG Medgenics Inc 05 July 2010 ? Medgenics, Inc. ('Medgenics' or the 'Company') Statement Regarding Share Price Discrepancy Medgenics (AIM: MEDG and MEDU), the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, has noted the widening discrepancy between the mid-market price of the MEDU and MEDG quotes for common shares of par value US $0.0001 each in the Company ("Common Shares"). The Company would like to confirm that all of its issued and outstanding Common Shares, whether trading on the MEDU line or the MEDG line, rank pari passu in all respects and carry equal voting rights and equal rights to dividends. The only difference between the two quotes (MEDU and MEDG) is that the Common Shares trading on the MEDG line were when issued and remain subject to restrictions on transfer under the US Securities Act of 1933 (as amended) (the "US Securities Act"). The MEDG line of Common Shares cannot be settled electronically in the CREST system and, instead, settle in CREST only on a cash basis, with the buyer being responsible for re-registering the certificated holding. Buyers and sellers of the MEDG line of stock are both required to complete a representation letter in connection with a dealing in Common Shares trading on the MEDG line in order to assure compliance with the transfer restrictions and for settlement to be facilitated. A significant number of the Common Shares trading on the MEDG line may now qualify to have the restrictions lifted and for migration to the MEDU line of Common Shares. Other than the transfer restrictions, the Company confirms that there are no differences in rights between the Common Shares quoted on the MEDU line and those quoted on the MEDG line. For further information regarding the applicable restrictions on transfer on MEDG quoted Common Shares, the ability to transfer Common Shares from the MEDG line onto the MEDU line, participation in the depository interest arrangements that have been established by the Company and the transfer of Common Shares within CREST, shareholders should refer to the announcement made by the Company on 12 November 2008 or contact the Company directly at investor-relations@m |
Posted at 07/12/2009 08:21 by sicilian_kan First class news out today. This is basically the number 1 guy in the world that they have recruited. Astonishing that an AIM microcap can recruit him and a real thumbs up validation for medgenics tech. Will be really good to have him on board for the trials too as he will carry great weight with the regulatory bodies.--- RNS Number : 6537D Medgenics Inc 07 December 2009 WORLD EXPERT ON LIVER DISEASE JOINS THE SCIENTIFIC ADVISORY BOARD OF MEDGENICS DR BRUCE BACON TO SUPPORT DEVELOPMENT OF COMPANY'S INNOVATIVE HEPATITIS-C TREATMENT Misgav, Israel and London, UK - 07 December 2009 - Medgenics (AIM: MEDG and MEDU), the biopharmaceutical company that creates implantable therapeutic protein producing Biopumps announced today that Dr. Bruce R. Bacon was appointed to the Scientific Advisory Board of the Company. Dr. Bacon is a former President of the American Association for the Study of Liver Diseases (AASLD) and a recognised World expert on Hepatitis. Dr. Bacon is the James F. King, MD Endowed Chair in Gastroenterology, Professor of Internal Medicine, and Director of the Division of Gastroenterology and Hepatology at Saint Louis University School of Medicine in St. Louis, Missouri. The potential treatment of Hepatitis using the Company's patented INFRADURE technology is one of the core projects that the Company is seeking to commercialise. Medgenics reported consistently promising and unprecedented results from the safety and efficacy clinical trial of its EPODURE Biopumps for sustained anaemia treatment from a single administration, in progress since September 2008. Biopumps are made from tissue taken by needle biopsy taken from under the patient's own skin and processed to become implantable biofactories to provide the required therapeutic protein for many months. The INFRADURE technology has been similarly used to create implantable Biopumps that produce Interferon Alpha for months and will offer a significant addition to the physician's Hepatitis armamentarium to treat this scourge of a disease. Dr. Eugene Bauer, Chairman of Medgenics commented: "We are delighted to welcome Dr. Bacon to Medgenics. As one of the world's top experts in Hepatitis C, he brings a wealth of experience and influence to the company. Hepatitis is one of the core areas of treatment that we are seeking to commercialise. Having an expert of Dr. Bacon's calibre is essential as we move into the clinic with the exciting new approach to treatment that our INFRADURE technology offers. Our ability to attract leading figures such as Dr. Bacon demonstrates the growing stature of Medgenics in the global market for therapeutic protein delivery. I and the rest of the Board look forward to working with him as we continue to develop Medgenics." Dr. Andrew Pearlman, CEO of Medgenics commented: "The appointment of Dr. Bacon is another important addition to the senior team at Medgenics. Coming in the wake of the signing of a hemophilia development agreement with a major international biopharmaceutical company, Dr. Bacon's appointment is a further strong vote of confidence for Medgenics and our INFRADURE approach to interferon alpha therapy in the treatment of Hepatitis C." |
Posted at 30/10/2009 08:25 by sicilian_kan (Disclaimer: no information on this thread is intended as investment advice, do your own Research)(A) Introduction Medgenics is targetting a $95bn (2010) global market for protein therapy, including lead candidates for anemia, hemophilia. Its technology is the Biopump, which are made from 30 mm long tissue samples taken by needle biopsies from the lower layer of the patient's skin under local anaesthetic, and are processed during 10-14 days to become "biofactories" producing the required protein. The requisite number of Biopumps are then injected back under the patient's skin to provide sustained protein production and delivery for many months. (B) The Pipeline (1) EPODURE (EPO / Anemia - Mid Phase 1) At present, injections are required 1-3x/week for EPO injections (anemia etc). These form a $9.6bn global market (2009) that Medgenics can target. The revenue per patient is USD $15,000 to $25,000 per year in a typical anemia patient. EPODURE from Medgenics is currently blowing this need out of water through clinical trials of its BioPump technology. Open phase I trials are taking place allowing for regular updates on their success (rather than the results being at the end of the trial). At the lowest dose, Medgenics smashed its primary end-points of 3-6 months elevated hemoglobin (primary endpoint) within the target range (secondary endpoint). The majority of the 7 patients treated had sustained levels of haemoglobin over 6-12 months and one formerly EPO dependent patient has gone 2 years without injections. The low dose was not expected to be sufficient for a sustained period. Compare this to other EPO alternatives or treatments in clinical trials. The next best thing (hoped to knock Amgen's EPO treatments off top spot) was Hematide from Affymax and Takeda (13th biggest Pharma worldwide). This published some Phase III results in June 2010. They aimed at needing injections once a month (a target far inferior to Medgenics'). Though the endpoints were met, the drug stumbled on safety grounds an further analysis of the results is taking place before they discuss the matter / registration with the FDA. Other treatments in Phase II, such as Lipoxen's ErepoXen saw an increase in haemoglobin levels when compared to baseline and these effects lasted "up to 28 days after dosing". One more point of note, Medgenics's Biopump technology is designed to maintain blood protein levels without peaks and troughs, as occur with traditional injections. The green line below is Medgenics's aim. The red line is traditional therapy. In summary, Medgenics EPO results are best in class by a long, long way and if the results are confirmed in later trial results, Amgen and others have a lot to be worried about. Medgenics have said that "To the best of the Directors' knowledge, nothing approaching EPODURE'S length of sustained anemia relief in patients has been shown from a single treatment of any other kind". The patient who has gone 24 months without injections said "For me the treatment has been and continues to be successful, without complications or discomfort. At 72 years old, I continue to do physical work in the citrus groves several hours a day, but unlike in the previous year, I have not needed injections. The treatment has improved my quality of life". Medgenics have also just started to show that EPODURE can generate dose dependent results. In other words, by implanting more than one Biopump, they can increase the therapeutic response. Only 3-4 Biopumps were needed in each patient to deliver a total of 40 IU/kg/day, double the target response for the low dose. This has now been followed at 4 weeks post-treatment by nearly double the haemoglobin response in these patients than was seen with the low dose patients. Showing that EPODURE is a dosable treatment will be key to its success. One patient on the lower dose has now also been given further Biopumps, to show that the treatment can be adjusted if need be. Of the $9.6bn EPO market, Amgen's drugs have a $5.2bn share, with their at least weekly injections. This shows the potential and there is a huge opportunity here for Medgenics. The latest Phase I/IIa results of the clinical trial are to be presented at the annual convention of the American Society of Nephrology, one of the largest meetings of nephrologists in the world, on November 19th. The presentation will be given by, Prof. Anatole Besarab, of Ford Hospital, Detroit MI - a member of the Company's Strategic Advisory Board and a leading authority in renal anaemia. Assuming continued positive results in the Phase I/IIa trial, Medgenics has said that it intends to seek a strategic partner for the license of the EPODURE Biopump. So far as safety is concerned, "As of the end of October 2010, 12 patients had been treated...No related adverse events have been reported for any of the treated patients, with the exception of minor, local subcutaneous hematoma (bleeding) seen at the harvest and implantation sites, as can be expected for any invasive procedures dealing with the skin. The hematoma was generally seen to clear up within several weeks for all patients treated. In addition, no immune response to the implanted Biopumps was reported. Because the protein secreted by the implanted Biopumps is the patient's own naturally-produced human EPO and not a foreign substance, no adverse reaction was expected, and none has been noted. Evidence that the Biopumps were not rejected by the patients' immune system is seen in the sustained elevation and maintenance of hemoglobin levels in most of the patients. All of the patient procedures have been well tolerated and no complaints of discomfort have been received". Megenics believe that the planned "phase IIb clinical trial would likely involve 60 to 120 patients...in multiple centers...Initial discussions with our regulatory advisers indicate it is possible that following successful demonstration of these points in 60-120 patients in the phase IIb clinical trial, such trial could be converted into a broader pivotal phase III clinical trial for product approval. More than one major U.S. clinical site has asked to take part in the planned phase IIb clinical trial, with costs estimated in the $6-10m range. With sufficient funding, we could perform the phase IIb clinical trial on our own, or alternatively, if agreement is reached with an appropriate strategic partner as more of the Phase I/II data comes in, the phase IIb clinical trial could be conducted with such partner under that agreement". (2) INFRADURE (IFN-a / Hepatitus C and Cancer - Entering Phase I) Essentially, this is similar Biopump technology to the above, but releasing a different protein (IFN-a) aimed at treating Hepatitus C and some forms of cancer. In 2009, the IFN-a market was worth $2.6bn and there is an unmet need for an IFN-a therapy with greatly reduced side effects, which the Biopump promises. Medgenics explains that "The current standard of care in treating hepatitis C involves weekly bolus IFN-α injections that are usually accompanied by mild to severe side effects in the great majority of patients...Experts believe the side effects are in large part due to the short-term substantial overdose of each injection. The overdose is deliberate to try to overcome the inherently short half life of the IFN-α (5.5 hours) and keep the concentration above the minimum effective level for sufficient time after each injection". The biopump would offer continuous delivery at the right dosing level. Medgenics believes that based on their preclinical work and on the EPODURE trials that "a few biopumps may deliver the required IFN-α dose for six months or more in typical patients with hepatitis C". In April 2010, Medgenics introduced in vivo and in vitro pre-clinical data on the Infradure Biopumps at a major European Liver conference (EASL, Vienna April 2010), drawing interest from experts and pharmaceutical companies in the major potential advantages that INFRADURE could provide in the treatment of hepatitis-C. The results paralleled those found with EPODURE which is now working in Phase I clinical trials. Medgenics hopes to bring INFRADURE to clinical trials in the near future and has now raised the funds required to do so. What is important here is that if Medgenics can shortly show that the Biopump also works in clinical trials on IFN-a then they will be able to open up the whole $95bn protein market, rather than just the $11.9bn EPO market. This will have a radical effect on the share price and on partnering negotiations. Medgenics will be launching INFRADURE into clinical trials in Q4 2011, with results available in 2012. (3) (Factor 8 / Hemophilia - Preclinical) Essentially, this is similar Biopump technology to the above, but releasing a different protein (Factor VIII) aimed at treating hemophilia. In 2009, the Factor VIII market was recorded as being worth $4bn. I note that the current cost of IFN-a injections typically exceeds $100,000 per year per patient. Though preclinical, this is a very exciting technology for Medgenics. On 23 October 2009, Medgenics signed a development agreement with a major international biopharmaceutical company that is a market leader in the field of hemophilia. This has garnered further interest from other companies in the biopump. This market leader paid Medgenics $4m USD to work exclusively with them on a preclinical basis for a period of one year. It has recently been confirmed that "Biopumps are now successfully producing active clotting factor VIII protein: considered by many to be the most challenging of proteins to produce in vitro. The Company views this as a further confirmation of the Biopump Platform, with Factor VIII now joining EPO and Interferon alpha as proteins continuously produced by Biopumps. The Company is continuing development of its FVIII Biopump to further increase FVIII output per Biopump to bring it to target levels thought sufficient to improve blood clotting if they were administered to patients with haemophilia. If successful, this would provide a unique and exciting new therapeutic option for haemophilic patients which could make a major difference in their lives". In addition, it was said that "Medgenics is in advanced discussions with its pharmaceutical partner regarding continuation of collaboration in development of Factor VIII Biopumps for the treatment of haemophilia and will update the market as this moves forward". The CEO stated that "we are proud to announce that we have shown we can make Biopumps producing clotting factor VIII for haemophilia, and look forward to further improvements in output with continued collaboration with our pharmaceutical partner." All things considered, it looks very promising that a new agreement will be signed up to in the near future. (C) Anticipated Newsflow 19 November 2010 - Phase I/IIa EPODURE results (mid dose) released 19 November 2010 - Presentation of Phase I/IIa (mid dose) results at American Society of Nephrology conference Q4 2010 - Factor VIII collaboration contract extension with market leader in field Q4 2010 - US IPO Q1 2011 - Phase I/IIa high dose to be trialed Q2 2011 - INFRADURE approval to start clinical trials H2 2011 - EPODURE licencing deal to be structH2 2011 - EPODURE to enter Phase IIb H2 2011 - INFRADURE enters Phase I/IIa (D) Some Strengths and Weaknesses (1) Strengths You are buying into the technology, i.e. the fact that it works in the EPO trials and that the preclinical trials are showing similar success, shows that the Biopump has a good chance of success in releasing other proteins too. The patents should go across all medical conditions that might use the technology, which makes the patent process much easier. Biopumps are expected to have increased efficacy, improved safety, be reversable treatment, have reduced side effects, lower costs, eliminate frequent injections and is hoped to extend treatment to those who are not treated at present due to side effects. This is not like cancer, where a patient may have got better for a number of reasons or treatments. If these patients have sustained improvements, then this is almost certainly down to the Biopump. There is a huge market for protein therapies. The trial results are stunning. Exisiting EPO treatments require weekly injections. Companies are struggling to get both safe and successful Phase III trials with EPO lasting a month. EPODURE has shown the majority of patients at 6 months or other with no significant side effects and one patient has lasted a year. Deal talks re Factor VIII are advanced and further deal talks for EPO are expected once the Phase I/IIa trial has finished. A US IPO is planned and the initial forms are now filed with the US SEC. This should increase interest in the Biopump and the share price too. Realistically, bios are better valued in the US than in the UK. This dual listing must be of benefit. On Medgenics advisory board are three world renowned former Presidents of major US organisations, the American Society of Gene Therapy, the Renal Physicians Association, the American Association for the Study of Liver Diseases. They also have a world renowned vet on board, who writes the "must-have text" that "remains the only encyclopedic resource for veterinary internal medical problems. The internationally acclaimed 'gold standard'" book as described by Waterstones. These people have the pick of all the companies in the world to work for and all three choose to be with Medgenics. Ask yourself why this might be... Medgenics Board of Directors is an experienced one and with the Kanter family, have people connected to the company who are willing to fairly fund it through any difficult patches. That the directors hold lots of shares (30%) and warrants will protect the value of the share price as their interests are alligned with ours. Low market cap considering what it has achieved. Few shareholders, so when this catches on, there should be serious spikes in the share price. After a RHPS tip, MEDU shot up to 30p intraday before falling slowly back to 12p. Further spikes should happen on key news / tips. US IPO will mean funding secured to start of Phase IIb, by when an EPODURE deal should be signed. (2) Weaknesses If the Biopump technology fails, then it is likely it will fail for multiple treatments, i.e. the pipeline. There are a large number of warrants outstanding. Liquidity is not the best and fill and kills rather than live online quotes appear to be the best way to trade Lord Steinberg passed away a year ago and his shares could be sold though they have not been yet. There could be patent challenges (E) US IPO SEC Registration Form If you want to know about Medgenics, this document is a comprehensive overview as to the current state of play. I suggest reading it all: You are buying into the technology, i.e. the fact that it works in the EPO trials and that the preclinical trials are showing similar success, shows that the Biopump has a good chance of success in releasing other proteins too. (F) MEDG OR MEDU? The company has two tickers, MEDG and MEDU. This is for historical reasons. All shares used to be MEDG shares, but since November 2008, there have been MEDU (unrestricted) shares on the market. MEDG, not MEDU, shareholders who are US persons have additional requirements to comply with and the shares are marked as restricted. This does not affect my UK rights to buy and sell MEDG shares on AIM as I am selling those shares to a UK broker, not a US citizen. So from a day to day point of view, holing MEDG shares does not affect me. Both MEDG and MEDU have the same nominal value so dividends will be the same as will be any takeover sum due per share. MEDG shares can have their restrictions removed if held for one year, so you can convert MEDG to MEDU with time. At differing times, MEDG and MEDU have been the ticker with the higher share price . You may need to complete a Form W-8BEN before you can trade. About which ticker you should buy, forms, restrictions etc., you should of course speak to you broker. There have been two main RNS's re the different tickers, I put the links below for assistance: |
Posted at 23/10/2009 07:42 by eggbird I wonder who the major Pharma company is? Looks very good for a company with a £8.5 million Mark CapAIMVHO RNS Number : 2665B Medgenics Inc 23 October 2009 ? Medgenics, Inc. ('Medgenics' or the 'Company') MEDGENICS SIGNS DEVELOPMENT AGREEMENT WITH MAJOR INTERNATIONAL PHARMA COMPANY Marks first step towards commercialization of Medgenics' Biopump tissue protein therapy technology Focus on sustained treatment of Hemophilia * Feasibility agreement worth up to $7 million (including preclinical development funding and an option to proceed to commercial agreement) * Medgenics' first Biopump agreement with a major healthcare corporation * Uses Biopump in a new application to produce blood clotting Factor VIII * Deal expected to enhance Medgenics' ongoing efforts towards commercial agreements for other applications of the Biopump platform technology Misgav, Israel; London, UK and Vienna, VA, - 23 October 2009 - Medgenics (AIM: MEDG and MEDU) is pleased to announce that it has signed a preclinical development and option agreement with a major international biopharmaceutical company that is a market leader in the field of hemophilia. This groundbreaking feasibility agreement is worth up to $7 million in payments that will include funding for preclinical development of Medgenics' Biopump protein technology to produce and deliver clotting protein Factor VIII for the sustained treatment of hemophilia. Under the terms of the agreement, Medgenics will receive $4 million to work exclusively with this partner for one year to develop a Biopump to test the feasibility of continuous production and delivery of this clotting protein. Additional payments totaling $3 million are payable upon Medgenics meeting certain technical milestones and upon the partner's exercise of an option to extend the exclusivity through an additional period to negotiate terms to commercialize the Biopump technology for Factor VIII. This is a new application of the Biopump tissue protein therapeutic platform, which has previously demonstrated success in the production of erythropoietin ("EPO") in treating renal anemia and interferon alpha for use in treating hepatitis-C. The market for Factor VIII is greater than $3.2 billion per year (La Marie 2008), and according to the World Federation of Hemophilia, some 400,000 people in the world have hemophilia. Dr. Andrew Pearlman, Chief Executive Officer of Medgenics, said: "We are very excited to have reached this key milestone toward commercialization of our technology. The fact that this agreement is for a new therapeutic application of our Biopump demonstrates the versatility of our platform technology. It further validates the belief that our platform can be applied to help treat many chronic diseases and will attract further interest from other major partners.The fact that a market leader in hemophilia has entered such an agreement at this early stage testifies to the promise of the Biopump technology for use in treating hemophilia. It reflects our mutual expectation that this feasibility program will be successful and will lead to a definitive agreement to complete the development and to commercialize this unique and exciting new therapeutic option which could make a major difference in the lives of hemophilic patients." "Medgenics' Biopump platform technology has already achieved unprecedented results in the sustained treatment of anemia; the only indication that we have tested in patients to date. In a Phase I/II clinical study using our EPODURE Biopumps to produce and deliver EPO in patients with chronic kidney disease, a single administration of EPODURE Biopumps has been shown to provide effective anemia treatment for up to 12 months without any need for additional EPO injections. We believe our Biopump technology will address many of the current challenges in healthcare and provide an important advance for the treatment of chronic disease." "While this first agreement is directed to the treatment of hemophilia, Medgenics is continuing its discussions with other potential partners with a view to signing additional agreements for other indications using different therapeutic proteins." |
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