Unilife CEO on Fox Business: "We Embraced U.S. Regulations" (Video) (UNIS)

A new trend is underway that is bringing jobs back to the US. But one company was ahead of the curve: Unilife Corporation, a developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania.

In a Fox Business interview, Unilife CEO Alan Shortall explains that the company had outsourced its manufacturing operation to China around 2004-2005, but decided to move it back to the United States for a variety of reasons, not all of them intuitive. For example, the US's well-known and very stringent safety regulations, which make most businesses look elsewhere for manufacturing opportunities, were exactly what Unilife Corp was looking for.

As Mr. Shortall explains, "The US has a wonderful reputation for high quality medical devices, and the reason for that is because the regulations in the US are so stringent. Now I know we all complain about regulations, but this is one time when we actually embrace them, because it makes us better. And consequently, we can sell our products anywhere in the world because they're recognized as the best."

View the full interview below:

About Unilife Corporation

Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a U.S. based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs.

Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a U.S. based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. 

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. 

Type 1 Diabetes on Rise Among Youth @ WSJ (ISLT)

Islet Sciences, Inc. (OTCBB: ISLT) is a development-stage biotechnology company with patented technologies focused on transplantation therapy for people with insulin-dependent diabetes. The Company's transplantation technology includes methods for the culturing, isolation, maturation, and immuno-protection (microencapsulation) of islet cells. Islet Sciences’ mission includes the introduction of commercial products with applications to cell-based replacement therapy in the healthcare marketplace.

In the Wall Street Journal, Kate Linebaugh writes about a new study from the CDC showing that there has been a 23% jump in the prevalance of Type 1 diabetes among American youth. 

She writes,

"The growth in Type 1 stumps researchers who haven't been able to identify what triggers the autoimmune response or explain why an increasing number of people are afflicted. About 80% of Type 1 diabetics don't have a close relative with the disease.

'We don't know yet what is triggering diabetes or why it is increasing,' said Dana Dabelea, professor of epidemiology and pediatrics at the University of Colorado, Denver."

Researchers have several theories about the reasons behind the suddent jump:

"A leading theory known as the accelerator hypothesis suggests that greater weight gain and growth early in life puts stress on insulin-producing cells in the pancreas that sets off the autoimmune attack.

Another explanation is the so-called hygiene hypothesis, which is also linked to the rise of asthma and food allergies. Children in a modern society contend with fewer parasitic, viral and bacterial illnesses than previous generations, so the underchallenged immune system begins reacting to other stimuli in ways that are harmful." Read more at The Wall Street Journal. 

While it is undoubtedly important to try to research the possible causes of this trend, it is also important to develop new, more effective treatments for the growing population of Type 1 diabetes patients in the US. There are over 200 million diabetes sufferers in the US, and 5-10% of these patients are Type I insulin-dependent. Current treatments for Type I diabetes are palliative and require constant glucose monitoring and repeated daily insulin injections. This is a difficult regimen for responsible adults, and can be much worse for less mature patients, such as teenagers.

By contract, Islet Sciences' approach involves the transplantation of glucose-producing pancreatic islet cells, which could allow patients to become independent of injected insulin and eliminate the need for constant monitoring of their blood glucose levels. This would be especially beneficial to adolescents, who are much less likely to take their health and their treatments seriously. Read more at www.isletsciences.com. 

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. 

Crystal Research Releases Executive Overview of AtheroNova (AHRO)

AtheroNova (OTCBB: AHRO) is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits. The Company's focus on compounds to reduce or eliminate atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention.

Crystal Research Associates has released an executive overview of the company. The report includes investment highlights, executive overview, corporate growth strategy, intellectual property, company leadership, core story (Atherosclerosis, AtheroNova's AHRO-001, Corporate Agreements), competition, milestones, historical financial results, risks, recent events, and glossary. 

See the full report below.  

Crystal Research AtheroNova Executive Overview June 2012

View more documents from DailyDoseEquities

Zacks.com initiates coverage of CytoSorbents Corporation, gives Outperform rating (CTSO)

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to modulate the immune system and fight organ failure in life-threatening illnesses such as sepsis, burn injury, trauma, lung injury and pancreatitis. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and absorption.

Zacks Investment Research has initiated coverage of CytoSorbents Corporation and assigned it an "Outperform" rating.

Senior Medical Device Analyst Brian Marckx writes,

"CytoSorbents' novel blood purification technology aims to revolutionize the treatment of life-threatening illnesses in the ICU.  Patients with critical care illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome and pancreatitis are some of the most seriously-ill and difficult to treat patients in the hospital.  Their CytoSorb device was CE Marked in March 2011 and subsequently commenced its initial commercialization. Near-term game-plan is to build awareness to facilitate broader roll-out in Europe.  FDA approval is a longer-term goal, the quest for which is now in the planning stage."

He continues,

"Despite certain risks, we feel the shares trade cheaper than warranted and are initiating coverage with an Outperform rating."

Read the full report at Zacks.com.  

Law Targeting Counterfeit Electronics Will Have Global Implications, Study Finds

Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators.

A recent company blog post discusses Section 818 of the U.S. National Defense Authorization Act for Fiscal Year 2012, a new Federal anti-counterfeiting law that is expected to have "broad international implications for hundreds of overseas companies that have supplied billions of dollars’ worth of items to the U.S. government."

An assessment by research and data supplier IHS iSupply reveals that Europe is "the largest supplier of electronics to the U.S., placing the region squarely in the sights of the new law. Europe accounts for 51% of all foreign electronics sales to the U.S. military; 47% comes from the Middle East and 2% comes from Asia."

Chairman, President, and CEO of Applied DNA Dr. James A. Hayward explains,

"Not only will the impact of Section 818 be felt worldwide, but also it is bound to cross from the public to the private sector. This is because many of the same facilities that supply the U.S. military also produce global electronic components for commercial applications. As a result, it is vital that the suppliers have new technological tools to identify components at risk of counterfeits."

Dr. Hayward's company is developing one potential way to help meet these challenges: DNA marking, a process in which botanical DNA is isolated, segmented, shuffled and reassembled to form an encrypted, unique and secure DNA marker which can be applied anywhere on a product to guarantee its authenticity. 

DNA marking can be integrated into existing processes and procedures with minimal, if any, change in process. DNA is the "gold standard" of forensic evidence and is trusted and depended upon by law enforcement around the world. It is used by the FBI, Interpol and forensic labs worldwide; it is an accepted form of legal, forensic evidence that is accepted by courts globally. 

Read more at adnas.com. 

Binghamton University S3IP Center and Applied DNA Sciences Partner on DNA Authenticity Technologies for Microelectronics (APDN)

Applied DNA Sciences, Inc. (OTCBB:APDN) is a provider of botanical-DNA based security and authentication solutions that can help protect products, brands and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA and smartDNA®, our principal anti-counterfeiting and product authentication solutions that essentially cannot be copied, provide a forensic chain of evidence and can be used to prosecute perpetrators.

Applied DNA, together with The New York State Center of Excellence in Small Scale Systems Integration and Packaging at Binghamton University (S3IP), New York, has announced "the signing of a Memorandum of Understanding calling for collaboration on microelectronics research and commercialization, and other projects. The two organizations aim to embark on various projects, including further advancements in Applied DNA Sciences' forensic authentication and security technologies."

The partnership utilizes the skilled staff and advanced facilities at S3IP, in combination with the technology, business experience and product lines of APDN. This new relationship comes as the defense industry searches for new ways to battle the incoming flood of counterfeit electronics that have plagued both consumer and the military markets. Applied DNA and S3IP will work "to commercialize the resulting applications, with the potential to impact the estimated $3.1 billion annual flow of semiconductors to the U.S. military(1) and a global commercial market in semiconductors valued well in excess of $300 billion."

United States Senator Kirsten Gillibrand (D-NY) welcomed the new partnership, commenting,

"New York is poised to lead in the high-tech economy of the future. When we partner our world class universities and research laboratories with cutting-edge businesses like S3IP in Binghamton and Applied DNA Sciences on Long Island, we can spark new innovation with the power to protect our defense technology, keep our country safe, and attract new businesses and new jobs to help grow our economy."

The partners will develop a joint research program to develop "new ways to embed and authenticate DNA on various substrates. The advances are aimed at extending the company's botanically derived DNA technology to new verticals and to future needs. According to the Memorandum of Understanding signed by The Research Foundation for the State University of New York, whose office is located at Binghamton University Office of Sponsored Programs, and by APDN, the partners will aim to scale up new methods for SigNature DNA incorporation into and onto a variety of materials."

Additionally, the program may involve "testing of marked packaging of microchips in coordination with APDN partners, and explore advances in rapid reading solutions for screening chips in varying scenarios." 

Bahgat Sammakia, interim vice president for research, and director of S3IP at Binghamton University, commented,

"S3IP works in partnership with government, academia and industry to enable new electronics applications for energy, healthcare, telecommunications and consumer applications, and defense industries. We are excited about this partnership with Applied DNA Sciences, which will enable new research opportunities for our faculty, staff and students. This program is just one example of the benefits of working in collaboration with industry, the results of which will bridge our expertise in biotechnology and information technology to enable new opportunities for ensuring the security of our nation's electronic systems."

Said Dr. James A. Hayward, President and CEO of Applied DNA Sciences,

"Our collaboration with Binghamton University extends our commitments to collaborative research with NYS universities, including our current work with Stony Brook University, and the College of Nanotechnology Science and Engineering at the University of Albany. Combined with Long Island's heritage in DNA science and in the defense industry, we could not be in a better strategic location to extend our biotechnologies for microelectronics."

Read the full article at adnas.com.