Medgenics' Orphan Drug Approval For Hepatitis Therapy @ Seeking Alpha - $MDGN

"Big Pharma Target"

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) is a clinical-stage biopharmaceutical company developing an innovative and proprietary platform technology - a biological "Biopump" - which allows patients to produce, within their bodies and on a long-term basis, their own natural human protein therapy for the treatment of a range of chronic diseases, such as anemia and hepatitis C.

Over on Seeking Alpha, drugs to treat the hepatitis virus are seen as "becoming the hottest area of medicine." The article goes on to state:

"No wonder that large biotechs are looking to buy - hepatitis viruses, grouped as A, B, C, and D, are considered a worldwide epidemic and highly contagious. The World Health Organization (WHO) puts the number of those infected at 550 million, or nearly 8% of the entire human population. Almost 70% of people advance to a chronic state. It is the number one reason for liver cancer. There is no cure.

Which brings us to - Medgenics (MDGN) announcing an Orphan Drug Designation for its INFRADURE for the treatment of hepatitis D. Orphan Drug Designation means smaller clinical trials and faster approval time.

This announcement follows an astounding run of good news for Medgenics including FDA approval of an Investigational New Drug (IND) application for its EPODURE device for anemia and the launch of a US-based manufacturing facility for its Biopump, the company, making good on our prediction of a highly-favorable relationship with the FDA.

Also, good results would pave the way for hepatitis C trials in the US and for final approval for hepatitis D in Israel. Hepatitis D affects 15 million people worldwide. Hepatitis C is a larger market at 180 million, and we envision INFRADURE serving as a platform technology to launch all versions of treatment for the hepatitis virus."

Medgenics was also featured on the Seeking Alpha's Bio Pharma Movers List.

Medgenics, Inc. Raises $9.5 Million in Private Placement (MDGN)

Medgenics (NYSE AMEX: MDGN) 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.

The Company announced that it has "raised gross proceeds of approximately $9.5 million (approximately $8.4 million net) through the sale of 1,944,734 units (the “Units”), with each Unit consisting of one share of the Company’s Common Stock, $0.0001 par value per share (the “Common Stock”), and a warrant to purchase 0.75 of one share of Common Stock (the “Warrants”). Each Unit was sold for a purchase price of $4.90 to institutional and other accredited investors in a private placement transaction. The Warrants expire in five years, have an initial exercise price of $8.34 per full share and become first exercisable on December 15, 2012."

Medgenics plans to use these proceeds "to further its clinical trial programs for its EPODURE™ Biopump producing erythropoietin for the treatment of anemia, and its INFRADURE™ Biopump producing interferon-alpha for the treatment of hepatitis, as well as for other research and development, patent maintenance and other intellectual property support and general corporate purposes."

Maxim Group LLC acted as the exclusive placement agent for the private placement.

President and Chief Executive Officer of Medgenics Andrew L. Pearlman, Ph.D, stated,

"To date in 2012 we have achieved several regulatory milestones towards launching new clinical trials in the U.S. and in Israel. The capital we raised will be applied towards funding key studies in anemia and hepatitis, as well as advancing our technologies along the path towards commercialization."

Read the full release at Reuters.com. 

Orphan Drug Designation Biotechs For Investment Consideration @ Seeking Alpha (MDGN)

Medgenics (NYSE AMEX: MDGN) 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.

At Seeking Alpha, contributor Chemistfrog wrote an article explaining the background of the "Orphan Drug" designation, and listing some "some biotechs for investor consideration that have or are candidates for Orphan Drug designation therapies."

About Medgenics, he writes, 

"Medgenics, Inc. (MDGN) chart has been on a tear since December 29th's low of $2.49 and is now trading above $6.70 per share, up over 170%. The chart remains bullish and shows no signs of abatement except for some possible resistance at $7.00. The company filed for Orphan Drug designation on April 23rd this year and expects to hear back from the FDA by the end of June for its INFRADURE treatment for Hepatitis D, a serious liver disease caused by the hepatitis D RNA virus. Although rare in the United States, the disease affects about 15 million people worldwide. INFRADURE is based on the company's proprietary Biopump platform which utilizes the patients' own tissue samples to manufacture and then re-implant back into their bodies the modified cells (biological pump) to produce their own human protein therapy for a sustained period of time."

He continues,

"[This] technology has a broad range of possibilities with treatments possible for anemia, hepatitis C &D, multiple sclerosis, arthritis, obesity, chronic pain, cancer recovery, and more. INFRADURE is the company's lead product and is in Phase I/II for Hepatitis C utilizing the same technology and protein therapy, interferon-alpha. Proof-of-concept trials in mice and humans created therapeutic levels of interferon-alpha and other protein therapies in blood serum. If safety and efficacy data are promising early, the chart growth for this emerging biotech could continue on its uptrend; the current market capitalization of $66 million would be dramatically undervalued if interim data proves to be promising."

Read more at Seeking Alpha. 

Medgenics Initiates U.S. Biopump Processing Site (MDGN)

Medgenics, Inc. (NYSE AMEX: MDGN; Stock Twits: $MDGN) is developing and commercializing Biopump, a proprietary tissue-based implantable platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy, for the treatment of a wide range of chronic diseases starting with anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which require the patient to endure years of costly injections of therapeutic proteins.

The Company announced that it has initiated its first U.S. Biopump processing facility in Davis, California, a good manufacturing practice (GMP) certified facility. The Company’s contract manufacturing organization (CMO) processes EPODURE Biopumps here for the treatment of anemia. This marks the first Biopump processing site outside of Israel, and provides Medgenics (MDGN) with a significant ability to scale-up its clinical and commercial capabilities to address global therapeutic areas such as anemia and hemophilia.

In a key dry run test of the production system, "tissue micro-organs were obtained and loaded into individual closed processing chambers in Israel, and then shipped to the U.S. CMO Biopump processing center in California. There, the micro-organs were processed in their closed systems into fully functioning EPODURE Biopumps, meeting the release criteria for use in human clinical trials in the U.S. This demonstrates Medgenics capability to support the treatment of patients at remote clinical sites, transporting their Biopumps to and from strategically located processing facilities, thereby allowing for multicenter clinical trials and practical commercial implementation."

Medgenics recently announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a Phase IIb study of EPODURE for the treatment of anemia in dialysis patients in the U.S.

Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, stated,

"The launch of this U.S. processing facility is another important step for advancing our U.S. clinical trials and product commercialization. The initial processing of Biopumps in the GMP facility of our U.S. CMO resulted in product that meets all quality requirements for use in human clinical trials. We plan to continue with processing additional lots of product to ensure consistency and reliability before the U.S. clinical trial commences. Importantly, this U.S. GMP processing center has been launched through an existing facility, which is much less capital intensive and simpler to establish than typical protein production facilities. As Medgenics grows and expands, we believe that similar Biopump processing facilities can be easily set up in other sites around the world."

Reading more at Seeking Alpha. 

Medgenics Moving In Record Time @ Seeking Alpha (MDGN)

Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG) is a clinical-stage biopharmaceutical company developing an innovative and proprietary platform technology - a biological "Biopump" - which allows patients to produce, within their bodies and on a long-term basis, their own natural human protein therapy for the treatment of a range of chronic diseases, such as anemia and hepatitis C.

At Seeking Alpha, contributor Ray Dirks wrote an article highlighting the Medgenics' recent news that "the FDA approved its filing to start clinical trials using its Biopump platform technology to treat anemia in kidney dialysis patients" in record time.

He writes, 

"As we've said in the past, EPODURE, one of MDGN's three proprietary Biopumps in development, looks to eliminate frequent, costly and inconvenient injections of erythropoietin (EPO). Amgen Inc. (AMGN) has owned this space for years and medicine is ready for a change.

Our FDA, known for its sluggishness and bad management, moved quickly to allow Medgenics to commence Phase IIb trials in the US, giving us their endorsement of a valuable technology that even the agency can't ignore. EPODURE works, and the FDA recognizes that our overburdened healthcare system can only benefit from the economics that Medgenics offers."

He continues,

"When MDGN announces the enrollment of its first subjects, we expect a leap in MDGN shares. The kidney dialysis market is more than 100,000 people start dialysis each year in the U.S., and last year there were 500,000 patients receiving dialysis, an estimated industry of $42.5 billion...

With more therapeutic areas targeted, a better platform technology, and progress achieved faster than we've seen with other biopharmaceuticals, do not miss out on this time to buy."

Read more at Seeking Alpha.