Game Changer: Medgenics’ FDA Fast Track Application for Hepititis
Medgenics (MDGN) April 24, 2012 by Ray Dirks
By Ray Dirks
There are five different varieties of hepatitis, A, B, C, D, and E. I’ve recently written about the biotech deals that have been transacted around companies developing a hepatitis C treatment. I made the point that the space is ‘hot’ and that big pharma is paying billions for such acquisitions. I’ve also mentioned that Medgenics, which currently has a hepatitis C treatment in clinical trials, is currently valued at only $53 million, with the stock at $5.45 per share. I recommended when it was at $3.50 per share on February. That’s a 56% increase in about two months. That rise may be nothing compared to what I believe will happen with Medgenics based on its recent Orphan Drug Application for hepatitis D.
Medgenics just announced on April 23rd that is has filed for Orphan Drug Designation with the FDA for INFRADURE™ in the treatment of hepatitis D. INFRADURE is based on Medgenics’ proprietary, platform tissue-based Biopump™ technology which uses the patient’s own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis. This application is supported by safety and efficacy data already being collected for INFRADURE’s treatment of hepatitis C because INFRADURE uses the same treatment for both!
The hepatitis D opportunity is not available to the companies in the hepatitis C space who are developing direct antiviral agents (DAAs) because those agents are specifically targeted to the hepatitis C virus, and are not effective against the hepatitis D virus.
However Medgenics’ INFRADURE is a game-changer because it treats hepatitis C, D, or B and may also be effective with A and E. INFRADURE specifically aims to provide the same interferon-alpha but in a plug-and-play manner which basically is designed to guarantee patient compliance, reduces side effects and maximizes efficacy by providing many months of treatment in the physiologically effective range while avoiding the major discomfort and risks of the peak overdoses of the injections, and without the dropout of interferon treatment between injections.
This would apply not only to hepatitis D and to hepatitis C. It would also apply to hepatitis B, where it has recently been shown that long term interferon therapy of a year or more can provide actual “cure” of the disease – seroconversion – in contrast to just keeping it in check with oral antiviral agents, which can’t eradicate the virus because it is integrated into the patient’s DNA.
Medgenics has the one treatment in development, in the market, that can treat hepatitis across the board AND Medgenics just applied for Orphan Drug Designation for its INFRADURE for hepatitis D because the number of U.S. patients with hepatitis D is estimated to be considerably lower than 200,000. If Orphan Designation is approved, it could help INFRADURE attain an expedited regulatory approval route for hepatitis D. Safety, efficacy, and approval of INFRADURE for hepatitis D would certainly help it move along in approval for hepatitis D and B. What is that worth? Although in the U.S. there are under 200,000 people with hepatitis D, the disease effects an estimated 15 million people worldwide.
Let’s revisit the recent hepatitis C deals to put into perspective what a treatment for D, C, and B might be worth.
In November, Gilead Sciences (GILD ) bought Princeton, NJ-based Pharmasset for $11 billion for the next generation of hepatitis-C treatments. Vertex Pharmaceuticals, working with Merck, is offering a pill for hepatitis-C, but it has to be taken three times a day though stands the chance to make $2 billion in a couple of years, when approved. Bristol-Myers Squibb (BMY ) acquired Inhibitex for $2.5 billion and Roche’s (RHHBY.PK ) purchased Anadys Pharmaceuticals for $230 million.
INFRADURE will go into human clinical trials in the first half of this year for hepatitis C in Israel. Based on laboratory and animal data that reported up to six months of consistent delivery of interferon-alpha, Phase I clinical trial results should show efficacy based on results seen with EPODURE. Orphan Drug Designation for hepatitis D could put INFRADURE on track for approval within 12 months. This could blow the doors open for all of Medgenics other drugs on the same Biopump delivery platform.
Once again, we draw your attention to the value of Medgenic’s platform technology. In addition to hepatitis D, C, B and potentially A and E, Medgenic’s product is being designed for use in hemophilia, multiple sclerosis, arthritis, obesity and diabetes.
We strongly advise our readers to watch this company going forward as we continue to expect even more bullish developments and positive news flow going forward and that this is a multibillion dollar opportunity.
Disclosure:
The information contained in this Report contains forward-looking statements relating to the developments of the featured company’s products, services and future operating results or the future of the market. Statements contained in writing or in interviews are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected.
The words “believe,”, “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could affect performance include, but are not limited to, those factors that are discussed in each Company’s most recent reports and/or registration statements filed with the Securities and Exchange Commission. Visitors to this Internet Site are cautioned not to place undue reliance on these forward-looking statements. These statements have not been independently verified by the officers, directors or employees of Corporate Profile, LLC .com.
The information on this Internet Site has been submitted by journalists and analysts or provided by the companies contained herein or other sources believed to be reliable. Corporate Profile, LLC has not independently verified the information provided to it by third parties. Each individual should perform his or her own independent analysis before investing. The information contained herein is neither an offer nor a solicitation to buy any of the securities of the companies contained herein. Investing in securities is speculative and contains a high element of risk.
Game Changer: Medgenics’ FDA Fast Track Application for Hepititis
Medgenics (MDGN) April 24, 2012 by Ray Dirks
By Ray Dirks
There are five different varieties of hepatitis, A, B, C, D, and E. I’ve recently written about the biotech deals that have been transacted around companies developing a hepatitis C treatment. I made the point that the space is ‘hot’ and that big pharma is paying billions for such acquisitions. I’ve also mentioned that Medgenics, which currently has a hepatitis C treatment in clinical trials, is currently valued at only $53 million, with the stock at $5.45 per share. I recommended when it was at $3.50 per share on February. That’s a 56% increase in about two months. That rise may be nothing compared to what I believe will happen with Medgenics based on its recent Orphan Drug Application for hepatitis D.
Medgenics just announced on April 23rd that is has filed for Orphan Drug Designation with the FDA for INFRADURE™ in the treatment of hepatitis D. INFRADURE is based on Medgenics’ proprietary, platform tissue-based Biopump™ technology which uses the patient’s own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis. This application is supported by safety and efficacy data already being collected for INFRADURE’s treatment of hepatitis C because INFRADURE uses the same treatment for both!
The hepatitis D opportunity is not available to the companies in the hepatitis C space who are developing direct antiviral agents (DAAs) because those agents are specifically targeted to the hepatitis C virus, and are not effective against the hepatitis D virus.
However Medgenics’ INFRADURE is a game-changer because it treats hepatitis C, D, or B and may also be effective with A and E. INFRADURE specifically aims to provide the same interferon-alpha but in a plug-and-play manner which basically is designed to guarantee patient compliance, reduces side effects and maximizes efficacy by providing many months of treatment in the physiologically effective range while avoiding the major discomfort and risks of the peak overdoses of the injections, and without the dropout of interferon treatment between injections.
This would apply not only to hepatitis D and to hepatitis C. It would also apply to hepatitis B, where it has recently been shown that long term interferon therapy of a year or more can provide actual “cure” of the disease – seroconversion – in contrast to just keeping it in check with oral antiviral agents, which can’t eradicate the virus because it is integrated into the patient’s DNA.
Medgenics has the one treatment in development, in the market, that can treat hepatitis across the board AND Medgenics just applied for Orphan Drug Designation for its INFRADURE for hepatitis D because the number of U.S. patients with hepatitis D is estimated to be considerably lower than 200,000. If Orphan Designation is approved, it could help INFRADURE attain an expedited regulatory approval route for hepatitis D. Safety, efficacy, and approval of INFRADURE for hepatitis D would certainly help it move along in approval for hepatitis D and B. What is that worth? Although in the U.S. there are under 200,000 people with hepatitis D, the disease effects an estimated 15 million people worldwide.
Let’s revisit the recent hepatitis C deals to put into perspective what a treatment for D, C, and B might be worth.
In November, Gilead Sciences (GILD ) bought Princeton, NJ-based Pharmasset for $11 billion for the next generation of hepatitis-C treatments. Vertex Pharmaceuticals, working with Merck, is offering a pill for hepatitis-C, but it has to be taken three times a day though stands the chance to make $2 billion in a couple of years, when approved. Bristol-Myers Squibb (BMY ) acquired Inhibitex for $2.5 billion and Roche’s (RHHBY.PK ) purchased Anadys Pharmaceuticals for $230 million.
INFRADURE will go into human clinical trials in the first half of this year for hepatitis C in Israel. Based on laboratory and animal data that reported up to six months of consistent delivery of interferon-alpha, Phase I clinical trial results should show efficacy based on results seen with EPODURE. Orphan Drug Designation for hepatitis D could put INFRADURE on track for approval within 12 months. This could blow the doors open for all of Medgenics other drugs on the same Biopump delivery platform.
Once again, we draw your attention to the value of Medgenic’s platform technology. In addition to hepatitis D, C, B and potentially A and E, Medgenic’s product is being designed for use in hemophilia, multiple sclerosis, arthritis, obesity and diabetes.
We strongly advise our readers to watch this company going forward as we continue to expect even more bullish developments and positive news flow going forward and that this is a multibillion dollar opportunity.
Disclosure:
The information contained in this Report contains forward-looking statements relating to the developments of the featured company’s products, services and future operating results or the future of the market. Statements contained in writing or in interviews are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected.
The words “believe,”, “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could affect performance include, but are not limited to, those factors that are discussed in each Company’s most recent reports and/or registration statements filed with the Securities and Exchange Commission. Visitors to this Internet Site are cautioned not to place undue reliance on these forward-looking statements. These statements have not been independently verified by the officers, directors or employees of Corporate Profile, LLC .com.
The information on this Internet Site has been submitted by journalists and analysts or provided by the companies contained herein or other sources believed to be reliable. Corporate Profile, LLC has not independently verified the information provided to it by third parties. Each individual should perform his or her own independent analysis before investing. The information contained herein is neither an offer nor a solicitation to buy any of the securities of the companies contained herein. Investing in securities is speculative and contains a high element of risk.