Hoersholm, Denmark/San Diego, California & Boulder, Colorado, June 23, 2010 — Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies and miRagen Therapeutics, Inc., a biopharmaceutical company focused on developing innovative microRNA-based therapeutics for cardiovascular and muscle disease, announced today that they have formed a strategic alliance to develop microRNA-targeted medicines for the treatment of cardiovascular disease.

Cardiovascular disease is the number one cause of death worldwide, claiming 17.1 million lives a year, or 29 percent of all deaths globally[1]. An estimated 81 million American adults – more than one in three – have one or more types of cardiovascular disease, which include high blood pressure, coronary heart disease, congenital cardiovascular defects, heart attack, chest pain, heart failure and stroke[2].

miRagen is planning to develop and commercialize single-stranded LNA-based product candidates intended for the treatment of cardiovascular disease by utilizing Santaris Pharma A/S proprietary Locked Nucleic Acid (LNA) Drug Platform. Under the terms of the agreement, Santaris Pharma A/S received a minority equity interest in miRagen, and is eligible to receive milestone payments and royalties upon achievement of certain development and regulatory milestones. Financial terms of the collaboration were not disclosed.

“We are pleased that miRagen selected Santaris Pharma A/S as its preferred partner, further validating that our LNA Drug Platform is the technology-of-choice for developing RNA-targeted medicines,” said Søren Tulstrup, President and CEO of Santaris Pharma A/S. “This collaboration is a prime example of two companies leveraging their unique capabilities in developing RNA-targeted medicines and combined expertise in cardiovascular disease to develop new medicines for life-threatening diseases. Santaris Pharma A/S looks forward to adding more alliances with biotechnology companies to its growing list of partners.”  

The unique combination of pharmaceutical properties, small size and very high affinity of LNA-based drugs developed utilizing Santaris Pharma A/S LNA Drug Platform allows this new class of drugs to potently and specifically inhibit RNA-targets in many different tissues without the need for complex delivery vehicles.

“We are very enthusiastic about our collaboration with Santaris Pharma, which provides us with what we believe is best-in-class technology to advance our mission of developing innovative microRNA-based therapies intended for the treatment of patients with cardiovascular and muscle disease,” said William S. Marshall, Ph.D., President and CEO of miRagen Therapeutics.  “Santaris Pharma’s LNA drug platform, which has produced compounds already in the clinic, can help to accelerate our development programs by providing the most effective anti-microRNA chemistry we’ve explored to date.”  

About microRNAs MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act to control the expression of sets of genes and entire pathways and are thus thought of as master regulators of gene expression. Recent studies have demonstrated that microRNAs are associated with many disease processes. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.  

About Locked Nucleic Acid (LNA) Drug Platform
The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the Company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. The LNA Drug Platform overcomes the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity, which is only achievable with LNA-based drugs, allows this new class of drugs to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. LNA-based drugs are a promising new type of therapy that enables scientists to develop drugs to attack previously inaccessible clinical pathways. The most important features of LNA-based drugs include excellent specificity, providing optimal targeting; increased affinity to targets providing improved potency; and strong pharmacology upon systemic delivery without complicated delivery vehicles.  

About Santaris Pharma A/S
Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the Company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The Company’s research and development activities focus on infectious diseases and metabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, cardiovascular disease, infectious and inflammatory diseases, and rare genetic disorders. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Pfizer, Shire plc and miRagen Therapeutics, Inc. As part of its broad patent estate, the Company holds exclusive worldwide rights to all therapeutic uses of LNA. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit www.santaris.com for more information.  

About miRagen Therapeutics
miRagen Therapeutics, Inc., was founded in 2007 to develop innovative microRNA-based therapeutics for cardiovascular and muscle disease. MicroRNAs are short, single-stranded RNA molecules encoded in the genome that regulate gene expression and are thought to play a vital role in influencing cardiovascular and muscle disease. Cardiovascular disease is the leading cause of death globally and represents an enormous burden on global healthcare systems. Principally funded through venture capital investments, miRagen combines world–class leadership in cardiovascular medicine with unprecedented in-house expertise in microRNA biology and chemistry. For more information, please visit www.miragentherapeutics.com.  

This news release contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those projected and miRagen cautions readers not to place undue reliance on the forward-looking statements contained in the release.      

Media Contacts: Santaris Pharma A/S  
Navjot Rai Director, Global Communications
Office: + 1 858 764 7064 ext. 206  
Cell: +1 619 723 5450  
e-mail: navjot.rai@santaris.com  

miRagen Therapeutics
Anna Sussman Scout Investor Relations
303-907-5358
anna@scoutir.com  

Breanna Burkart
Scout Investor Relations
303-907-5162
Breanna@scoutir.com        

[1] World Health Organization - http://www.who.int/cardiovascular_diseases/en/
[2] Heart Disease and Stroke Statistics — 2010 Update, American Heart Association  

###

“Choosing the companies with the strongest potential was by no means a small feat,” said Alex Vieux, publisher and CEO of Red Herring. “After rigorous contemplation and discussion, we narrowed our list down from hundreds of candidates from across Europe to the Top 100 Winners. We believe Santaris Pharma A/S embodies the vision, drive and innovation that define a successful entrepreneurial venture. Santaris Pharma A/S should be proud of its accomplishment, as the competition was very strong.”

Red Herring’s Top 100 Europe list has become a mark of distinction for identifying promising new companies and entrepreneurs. Red Herring editors were among the first to recognize that companies such as Facebook, Twitter, Google, Yahoo, Skype, Salesforce.com, YouTube, and eBay would change the way we live and work. 

 “We are pleased to be honored by Red Herring with this award,” said Søren Tulstrup, President and Chief Executive Officer, Santaris Pharma A/S. “Using the broad utility and versatility of our proprietary Locked Nucleic Acid Drug Platform and Drug Discovery Engine, we remain committed to discovering and developing effective RNA-targeted therapies for patients with unmet medical needs for a range of diseases including infectious diseases, inflammatory diseases, metabolic disorders, cancer and rare genetic disorders.”

Red Herring’s editorial staff evaluated the companies on both quantitative and qualitative criteria, such as financial performance, technology innovation, management quality, strategy, and market penetration. This assessment of potential is complemented by a review of the track record and standing of startups relative to their sector peers, allowing Red Herring to see past the “buzz” and make the list a valuable instrument of discovery and advocacy for the most promising new business models in Europe.

 About Santaris Pharma A/S
Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the Company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The Company’s research and development activities focus on infectious diseases and metabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, infectious and inflammatory diseases, and rare genetic disorders. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Pfizer and Shire plc. As part of its broad patent estate, the Company holds exclusive worldwide rights to all therapeutic uses of LNAs. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit www.santaris.com for more information.

 ###

Hoersholm, Denmark/San Diego, California, April 26, 2010 — Santaris Pharma A/S,  a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that it has advanced into drug development a discovery research candidate directed against PCSK9 (proprotein convertase subtilisin/kexin type 9), an important new target for the treatment of high cholesterol.  Using its proprietary Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine, Santaris Pharma A/S identified and advanced the new drug, SPC5001, in just 18 months.  

High cholesterol is a major risk factor for coronary heart disease, heart attack and stroke. According to the World Health Organization, high cholesterol is estimated to cause 18% of strokes and 56% of heart disease, globally and amounts to approximately 4.4 million deaths and 40.4 million disability-adjusted life years[1].  

Santaris Pharma A/S presented preclinical data on SPC5001 last month at the PCSK9 Conference “From gene to therapeutics” in Nantes, France where many top pharmaceutical companies gathered to discuss efforts to develop therapies aimed at inhibiting the important new target PCSK9, a protein involved in regulating LDL (low-density lipoprotein) or “bad” cholesterol in the blood.   

Data presented by Santaris Pharma A/S scientists showed that SPC5001 provided potent, specific and long-lasting inhibition of PCSK9 and lowered mean LDL cholesterol by 50% in non-human primates with a sustained reduction of 74% in the highest responder. SPC5001 did not change HDL (high-density lipoprotein) levels or the “good” cholesterol in the blood[2]. The preclinical data suggest that SPC5001 has the potential to provide patients with a new treatment option in managing their cholesterol levels.  

“There is a lot of interest in PCSK9 as an exciting new target for the treatment of high cholesterol and having demonstrated that SPC5001 effectively lowers LDL or the “bad” cholesterol in preclinical studies, we are quickly moving forward with plans to advance SPC5001 into clinical studies as a potential new treatment to help patients better manage the risks of cardiovascular diseases,” said Henrik Ørum, PhD, Vice President and Chief Scientific Officer of Santaris Pharma A/S. “SPC5001 is a testament to the efficiency of our LNA Drug Platform and Drug Discovery Engine as we discovered, optimized and advanced SPC5001 into preclinical development in just 18 months.”  

The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the Company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.   

“In addition to advancing SPC5001 into drug development for the treatment of high cholesterol, we remain on track to begin Phase 2 clinical trials of miravirsen (SPC3649) in patients with Hepatitis C in the second half of this year,” said Søren Tulstrup, President and Chief Executive Officer, Santaris Pharma A/S. “In our internal programs and partnered programs, the versatility and broad utility of Santaris Pharma A/S LNA Drug Platform and Drug Discovery Engine continues to be critical in developing effective RNA-targeted therapies with high affinity, target specificity and remarkable potency for a range of diseases.”  

SPC5001 adds to the portfolio of Santaris Pharma A/S drugs in development, including its most advanced compound miravirsen, the International Nonproprietary Name (INN) or generic name for the compound formerly known as SPC3649.  

Miravirsen, the first microRNA-targeted drug to enter human clinical trials, is a specific inhibitor of miR-122, a liver-specific microRNA that the Hepatitis C virus requires for replication. Unlike Hepatitis C therapies that directly target the virus, miravirsen works by removing a “helper” molecule (miR-122) that the virus needs in order to make new copies. Miravirsen is being studied in a Phase 1 trial multiple-ascending dose study in healthy volunteers and a Phase 2 study in patients infected with Hepatitis C is expected to begin in the second half of 2010.  

Santaris Pharma A/S also has a broad range of drug discovery and development programs with its partners: Shire plc (lead candidates against up to five targets for rare genetic disorders), Pfizer (lead candidates against up to ten targets), GlaxoSmithKline (options to drug candidates from up to four viral disease programs) and Enzon Pharmaceuticals (lead candidates against eight cancer targets successfully delivered).  

About Locked Nucleic Acid (LNA) Drug Platform
The LNA Drug Platform utilizing Santaris Pharma A/S proprietary LNA chemistry provides the key to delivering on the promise of RNA-targeted therapies today by addressing these concerns and overcoming the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity, which is only achievable with LNA-based drugs, allows this new class of drugs to potently and specifically inhibit RNA-targets in many different tissues without the need for complex delivery vehicles. LNA-based drugs are a promising new type of therapy that enables scientists to develop drugs to attack previously inaccessible clinical pathways. The most important features of LNA-based drugs include excellent specificity, providing optimal targeting; increased affinity to targets providing improved potency, and strong pharmacology upon systemic delivery without complicated delivery vehicles.  

About Santaris Pharma A/S
Santaris Pharma A/S is a privately held clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies. The Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combine the Company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The Company’s research and development activities focus on infectious diseases and metabolic disorders, while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, infectious and inflammatory diseases, and rare genetic disorders. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Pfizer and Shire plc. As part of its broad patent estate, the Company holds exclusive worldwide rights to all therapeutic uses of LNAs. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the United States. Please visit www.santaris.com for more information.      

Media Contact:
Navjot Rai  
Santaris Pharma A/S  
Office: + 1 858 764 7064 ext. 206  
Cell: +1 619 723 5450  
e-mail: navjot.rai@santaris.com    

--------------------------------------------
[1] World Health Organization - http://www.who.int/healthinfo/statistics/bod_cerebrovasculardiseasestroke.pdf
[2] Oral and poster presentation PCSK9 Conference, Locked Nucleic Acid antisense oligonucleotide inhibition of PCSK9, March 11, 2010

Hoersholm, Denmark/San Diego, California, December 3, 2009 — A study published online in this week’s Science shows that SPC3649, a breakthrough microRNA-targeted therapy developed by Santaris Pharma A/S using its proprietary Locked Nucleic Acid (LNA) technology, holds promise as a novel treatment for patients infected with the Hepatitis C virus (HCV).  

The World Health Organization estimates about 3% of the world’s population has been infected with HCV and that some 170 million are chronic carriers at risk of developing liver cirrhosis and/or liver cancer[1]. Approximately 3-4 million Americans are chronically infected with an estimated 40,000 new infections per year[2]. In Europe, there are about 4 million carriers[3].  

Santaris Pharma A/S, the first company to have advanced both mRNA and microRNA targeted drugs into clinical trials, is an international biopharmaceutical company focused on the discovery and development of RNA-targeted therapies for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.   

In this preclinical study, SPC3649 successfully inhibited miR-122, a liver-expressed microRNA important for Hepatitis C viral replication. By inhibiting miR-122, SPC3649 dramatically reduced Hepatitis C virus in the liver and in the bloodstream in chimpanzees chronically infected with the Hepatitis C virus[4]. Four HCV chronically infected chimpanzees were treated weekly with 5 or 1 mg/kg of SPC3649 for 12 weeks followed by a treatment free period of 17 weeks. The two animals that received the 5 mg/kg dose had a significant decline in viral levels in the blood and liver of approximately 2.5 orders of magnitude or approximately 350 fold[5].  

“In collaborating with Santaris Pharma, we proved that the drug worked exceptionally well in treating HCV infections in chimpanzees,” said Robert Lanford, Ph.D., a scientist at the Southwest Foundation for Biomedical Research and one of the lead authors on the study. “The current standard anti-HCV treatment, which combines pegylated interferon-alpha with ribavirin, is effective in only about 50% of patients and is often associated with severe side effects. Because of the unique mechanism of action of SPC3649 and its tolerability profile, this new therapy could have the potential to replace interferon to treat disease progression or be combined with current treatments.”   

SPC3649 provided continued efficacy in the animals up to several months after the treatment period with no adverse events and no evidence of viral rebound or resistance, an important factor that distinguishes SPC3649 from direct antiviral HCV therapeutics.  

Current antiviral therapies that target the virus directly are challenged as the HCV continually mutates to develop resistance to treatment. Because SPC3649 inhibits miR-122, an important microRNA involved in HCV replication, the HCV is blocked from replicating without the apparent selection of resistant mutants. SPC3649 has other important properties that make it attractive as a therapeutic agent for HCV. The preclinical data show changes in the expression of key genes that may help patients who do not respond to interferon treatment to become responsive.

SPC3649 is the first microRNA-targeted drug to enter human clinical trials and is currently undergoing Phase 1 clinical studies in healthy volunteers.  These preclinical data provide even greater impetus to further examine the potential of SPC3649 for treating patients infected with HCV.    

“Advancing the first microRNA-targeted therapy, SPC3649, into human clinical trials was certainly a breakthrough in science and we are very encouraged by these preclinical findings demonstrating that SPC3649 has the potential to be an effective treatment for patients infected with the Hepatitis C virus,” said Henrik Ørum, PhD, Vice President and Chief Scientific Officer of Santaris Pharma A/S. “In drug discovery and development programs internally and with our partners, we continue to demonstrate that our proprietary LNA Drug Platform is fundamental in developing effective RNA-targeted therapies with high affinity, target specificity and remarkable potency for a range of diseases.”  

Santaris Pharma A/S has a robust product pipeline based on its proprietary LNA technology including mRNA and microRNA drug discovery and development partnerships and collaborations with Shire (rare genetic disorders), Wyeth, now part of Pfizer, (delivery of lead candidates against up to ten targets), GlaxoSmithKline (four viral disease drug candidates) and Enzon Pharmaceuticals (eight cancer targets successfully delivered).  

About Locked Nucleic Acid (LNA) Drug Platform
The Locked Nucleic Acid (LNA) Drug Platform developed by Santaris Pharma A/S creates synthetically modified chemical versions of the normal nucleic acid building blocks of ribonucleic acids (RNA). These modified chemical versions called LNAs improve the drug-like qualities of resulting therapeutics (oligonucleotides) by improving affinity to their target RNA, boosting resistance to metabolism and improving tissue uptake. Upon systemic administration of these “naked” molecules, LNA-based therapeutics are delivered to many different tissues where they show potencies many-fold better than other oligonucleotide therapeutics.   

About Santaris Pharma A/S
Santaris Pharma A/S is a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies.  The Company’s proprietary Locked Nucleic Acid (LNA) drug platform, in combination with its highly specialized and targeted drug development capabilities, offers potential partners pre-screened drug candidates for commercial consideration across a multitude of disease states.  The Company’s own research and development activities focus on infectious diseases and metabolic disorders while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, rare genetic disorders and inflammatory diseases. Santaris Pharma A/S, founded in 2003, is privately-held and headquartered in Denmark with operations in the US. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Wyeth Pharmaceuticals (now part of Pfizer) and Shire plc. Please visit www.santaris.com for more information.

Media Contact:
Navjot Rai
Santaris Pharma A/S  
Office: + 1 858 764 7064 ext. 206  
Cell: +1 619 723 5450  
e-mail: navjot.rai@santaris.com   
 
[1] World Health Organization - http://www.who.int/csr/disease/hepatitis/Hepc.pdf
[2] American Association for the Study of Liver Diseases - http://www.aasld.org/patients/Pages/LiverFastFactsHepC.aspx
[3] World Health Organization - http://www.who.int/csr/disease/hepatitis/Hepc.pdf
[4] The chimpanzee is the only animal other than humans that is susceptible to HCV
[5] Lanford et al, Therapeutic silencing of microRNA-122 in primates with chronic hepatitis C virus infection, Science online 

Hoersholm, Denmark/San Diego, California, October 28, 2009 — Santaris Pharma A/S, a privately-held biopharmaceutical company focused on developing RNA drugs targeted to disease-related mRNAs and microRNAs, has expanded its executive team with the appointment of Mark Wedel, MD, FACP as Vice President and Chief Medical Officer and Stuart Mackey, JD as Vice President Strategy and Chief Business Officer. Internally and through its partners, Santaris Pharma A/S has a robust drug development pipeline including programs to treat metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.  

The newly appointed executives will hold global responsibility for advancing Santaris Pharma A/S proprietary RNA-targeted Locked Nucleic Acid (LNA) Drug Platform programs and Drug Discovery Engine capabilities. Dr. Wedel will be responsible for global clinical development programs and therapeutic portfolio management.  Mr. Mackey will lead Santaris Pharma A/S corporate strategy development, corporate communications and global business development programs.  

“I am pleased to have Dr. Wedel and Mr. Mackey join our management team,” said Søren Tulstrup, President and Chief Executive Officer of Santaris Pharma A/S. “As Santaris Pharma A/S continues to advance the development of its RNA-targeted drugs internally and with its partners, Dr. Wedel’s extensive experience in managing RNA-based clinical development programs coupled with Mr. Mackey’s experience in corporate strategy development will be valuable.”  

The newly appointed executives will be based out of the Company’s recently established US subsidiary. Increasing interest, new collaborations and breakthrough advancements led Santaris Pharma A/S, headquartered in Denmark, to establish US-based operations in San Diego, California.  

“The strong medical and business development expertise that Dr. Wedel and Mr. Mackey bring to the team further solidify the presence of Santaris Pharma A/S in the US as we continue to explore new licensing opportunities, scientific collaborations and increase visibility with capital markets,” said Dr. Arthur A. Levin, President of US operations and Vice President and Chief Development Officer of Santaris Pharma A/S.  

Dr. Wedel joins Santaris Pharma A/S from Isis Pharmaceuticals where he was Senior Vice President of Drug Development and Chief Medical Officer responsible for clinical operations, strategic therapeutic portfolio management, and overseeing Isis development programs including, cardiovascular, inflammatory, metabolic, infectious diseases, as well as oncology. Dr. Wedel received his medical degree from The Johns Hopkins School of Medicine in Baltimore, Maryland and holds board certifications in Internal Medicine,              Critical Care and Chest Medicine. He received a law degree from Thomas Jefferson School of Law, San Diego, California, and a B.A. from Valparaiso University, Valparaiso, Indiana.    

Mr. Mackey joins Santaris Pharma A/S after spending the last ten years at leading biotech company Amgen Inc. where most recently he was Managing Director of Amgen Ventures, a $100 M venture capital affiliate of Amgen Inc. with approximately 15 portfolio companies.  He had also been responsible for Amgen’s in- and outlicensing transactions group and Amgen’s Corporate Alliance Management function.  Mr. Mackey received his undergraduate degree from Harvard University and his law degree from the University of California, Berkeley’s Boalt Hall School of Law.

Recent scientific and business accomplishments at Santaris Pharma A/S include a breakthrough in medical science and new collaborations. Santaris Pharma A/S is the first company to advance a microRNA-targeted therapy into human clinical trials.  The drug SPC3649 specifically targets microRNA-122 (miR-122), a host factor for Hepatitis C virus replication. A single-dose Phase 1 trial in healthy volunteers has been completed and the drug continues to move forward in clinical trials.  

Santaris Pharma A/S recently announced a multi-year worldwide strategic alliance with Shire plc to discover and develop new RNA-targeted medicines to treat rare genetic disorders. This collaboration adds to the growing list of mRNA and microRNA drug discovery and development partnerships, which includes Wyeth (delivery of lead candidates against up to ten targets), GlaxoSmithKline (four viral disease drug candidates) and Enzon Pharmaceuticals (eight cancer targets successfully delivered).  

About Locked Nucleic Acid (LNA) Drug Platform
The Locked Nucleic Acid (LNA) Drug Platform developed by Santaris Pharma A/S creates synthetically modified chemical versions of the normal nucleic acid building blocks of ribonucleic acids (RNA). These modified chemical versions called LNAs improve the drug-like qualities of resulting therapeutics (oligonucleotides) by boosting resistance to metabolism, increasing half-life and improving tissue uptake.  LNA-based therapeutics demonstrate improved binding affinity to their target RNA, which increases potency many-fold over other nucleotide therapeutics. 

The greater potency of LNA in binding complementary RNA sequences also allows for the use of significantly shorter LNA oligonucleotide drugs which can be more effective than previous antisense or siRNA drugs.  

About Santaris Pharma A/S
Santaris Pharma A/S is a privately-held biopharmaceutical company focused on developing RNA medicines targeted to disease-related mRNAs and microRNAs. Utilizing the Company’s proprietary Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine, Santaris Pharma A/S provides fast and efficient generation of lead LNA drug candidates. 

The Company’s own research and development activities focus on infectious diseases and metabolic disorders while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, rare genetic disorders and inflammatory diseases. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the US. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Wyeth Pharmaceuticals and Shire plc. Please visit www.santaris.com for more information.  

Media Contacts:

Navjot Rai Santaris Pharma A/S USA Office + 1 858 764 7066 ext. 206 Cell: +1 619 723 5450 e-mail: nra@santaris.com

Randi Krogsgaard Santaris Pharma A/S, Denmark Office: +45 45179879  Cell: +45 20488384  e-mail: rmk@santaris.com

Hoersholm, Denmark/San Diego, California, September 16, 2009 — Santaris Pharma A/S, a privately-held biopharmaceutical company focused on developing RNA-based drugs targeted to  disease-related mRNAs and microRNAs, today announced it has established operations in the United States. Internally and through its partners, the Company has a robust drug development pipeline including programs to treat metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders.  

Increasing interest, new collaborations and breakthrough advancements utilizing the Company’s proprietary RNA-based Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine led Santaris Pharma A/S, headquartered in Denmark, to establish US-based operations in San Diego, California.  

To spearhead the US expansion, Santaris Pharma A/S has appointed leading RNA industry expert Arthur A. Levin, PhD, as President of its US operations.  In addition, Dr. Levin will hold global responsibility as Vice President and Chief Development Officer of Santaris Pharma A/S.   Dr. Levin has 15 years of experience in RNA-based research and more than 25 years of experience in the pharmaceutical industry. Prior to joining Santaris Pharma A/S, Dr. Levin was Senior Vice President of Drug Development at Isis Pharmaceuticals where he was instrumental in advancing more than a dozen RNA-based antisense drugs from basic research to clinical development.    

“We are pleased that Dr. Levin has joined our management team to establish operations in the US and oversee global development programs for Santaris Pharma A/S,” said Søren Tulstrup, President and Chief Executive Officer, Santaris Pharma A/S. “His wealth of RNA-based research and development experience  and industry knowledge will be instrumental in leveraging the Company’s proprietary Locked Nucleic Acid chemistry and Drug Discovery Engine to explore new licensing opportunities and scientific collaborations, increase visibility with capital markets and attract leading scientists.”  

Santaris Pharma A/S recently achieved a breakthrough in medical science as the first company to advance a microRNA-targeted therapy into human clinical trials.  A single-dose Phase 1 trial in healthy volunteers has now been completed and an additional Phase 1 multiple ascending-dose study is planned. The drug SPC3649 specifically targets microRNA-122 (miR-122), a host factor for Hepatitis C virus replication. In 2008, Santaris Pharma A/S published the results of successful microRNA silencing with SPC3649 in non-human primates in Nature[1].  

“Advancing the first microRNA therapy into human clinical trials is a testament to Santaris Pharma A/S leadership in the field,” said Henrik Ørum, Vice President and Chief Scientific Officer at Santaris Pharma A/S. “Our proprietary LNA Drug Platform incorporating short single-stranded LNAs offers higher affinity, greater specificity and remarkable potency compared to other RNA-based oligonucleotides. With a growing list of pharmaceutical partners and LNA rapidly becoming the chemistry-of-choice in RNA-targeted therapeutics, we are pleased to have Dr. Levin join our team to progress important new therapies into drug development.”

Last month, Santaris Pharma A/S announced a multi-year worldwide strategic alliance with Shire plc to discover and develop new RNA-based medicines to treat rare genetic disorders utilizing Santaris Pharma’s proprietary LNA Drug Platform. This collaboration adds to the growing list of mRNA and microRNA drug discovery and development partnerships, which includes Wyeth (delivery of lead candidates against up to ten targets), GlaxoSmithKline (four viral disease drug candidates) and Enzon Pharmaceuticals (eight cancer targets successfully delivered). Operations in the US aim to support existing relationships and generate new licensing and partnership opportunities.  

About Locked Nucleic Acid (LNA) Drug Platform
The Locked Nucleic Acid (LNA) Drug Platform developed by Santaris Pharma A/S creates synthetic chemical versions of the normal nucleic acid building blocks of ribonucleic acids (RNA). These synthetic chemical versions called LNAs improve the drug-like qualities of resulting therapeutics (oligonucleotides) by boosting resistance to metabolism, increasing half-life and improving tissue uptake.  LNA-based therapeutics demonstrate improved binding affinity to their target RNA, which increases potency many-fold over other nucleotide therapeutics.  The greater potency of LNA in binding complementary RNA sequences also allows for the use of significantly shorter LNA oligonucleotide drugs which can be more effective than previous antisense or siRNA drugs.  

About Santaris Pharma A/S
Santaris Pharma A/S is a privately-held biopharmaceutical company focused on developing RNA-based drugs targeted to disease-related mRNAs and microRNAs. Utilizing the Company’s proprietary Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine, Santaris Pharma A/S provides fast and efficient generation of lead LNA drug candidates.  The Company’s own research and development activities focus on infectious diseases and metabolic disorders while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, rare genetic disorders and inflammatory diseases. Santaris Pharma A/S, founded in 2003, is headquartered in Denmark with operations in the US. The Company has strategic partnerships with Enzon Pharmaceuticals, GlaxoSmithKline, Wyeth Pharmaceuticals and Shire plc. Please visit www.santaris.com for more information.  

Media Contacts:

Navjot Rai	Randi Krogsgaard
Santaris Pharma A/S, USA	Santaris Pharma A/S, Denmark
Office: + 1 858 764 7066 ext. 206	Office: +45 45179879
Cell: +1 619 723 5450	Cell: +45 20488384
e-mail: nra@santaris.com	e-mail: rmk@santaris.com

    
[1] Elmén et al. LNA-mediated microRNA silencing in non-human primates. Nature 2008, 452, 896-899