Oramed Pharmaceuticals, Inc.
Oramed Pharmaceuticals, Inc.

Oramed Pharmaceuticals, Inc.


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Key Executives:
Nadav Kidron Esq, MBANadav Kidron Esq, MBA
CEO & Director 
Miriam Kidron, Ph.DMiriam Kidron, Ph.D
Chief Scientific Officer & Director 
Investor Relations:Aviva Sherman   Phone: 972-2-566-0001  
Web Site:http://www.oramed.com/
Email:aviva@oramed.com
Exchange:
OTC BB Symbol: ORMP Year Listed: 2006 
Industry:Biotechnology, Drug Delivery, Healthcare, Pharmaceuticals
Year Established:2006
# of Employees:10
Auditor:Kesselman & Kesselman (member of PricewaterhouseCoopers)
Law Firm:ZAG S&W
Main Subsidiaries:Oramed Ltd.
Office Address:2/5 Kefar Hi-Tech, Jerusalem 91390
Telephone:972-2-566-0001
Fax:972-2-566-0004
     Oramed Pharmaceuticals is a pioneer in the field of oral delivery solutions for drugs currently administered via injection. Orameds technology, based on more than 25 years of research at Hadassah Medical Center in Jerusalem, is an innovative platform that allows peptides to safely maneuver through the gastrointestinal tract and enter the bloodstream. This technology stands to change the face of medicine as we know it by revolutionizing the treatment of diabetes, administration of vaccinations, and other current injection-only treatments. 
     Orameds flagship product is an oral insulin capsule which has produced significant results on diabetic patients in clinical trials. The advantages of Orameds oral insulin include increased patient compliance and an earlier intervention solution which treats the disease while simultaneously curbing further disease deterioration.   
     In addition to developing oral insulin, Phase 1a clinical trials are currently in progress on Orameds GLP-1 analog, another crucial drug in the treatment of diabetes, after successful pre-clinical trials.                
     Today diabetes is considered a global epidemic - the number of diabetics worldwide has already exceeded the 300 million mark and continues to climb at a rate of 7 million people per year. The market is currently estimated at $400 billion. Through its oral drug delivery platform, Oramed hopes to establish a new paradigm for the treatment of diabetes and help enrich the lives of diabetics across the globe. 
     Oramed is endorsed and directed by prominent leaders in the field of research and development, including: Professor Avram Hershko, recipient of the 2004 Nobel Prize in Chemistry; Professor John Amatruda, former Senior Vice President of Merck and Co., Inc.; and Dr. Michael Berelowitz, former Senior Vice President at Pfizer, Inc., and currently the Chairman of the Oramed Scientific Advisory Board. 
     Orameds plans for 2012 include submission of an IND (Investigational New Drug) application to the USFDA on its oral insulin, to be followed by initiation of Phase 2 FDA-approved clinical trials, for which it is currently raising funds.   
     Strategy    
     The company plans to ultimately seek a strategic commercial partner, with experience in development, commercialization, and marketing. Oramed anticipates such a
partner would be responsible for, or substantially support, late stage clinical trials (Phase III) to ensure regulatory approvals and registrations in the appropriate markets in
a timely manner. The company further anticipates that such a partner would also be responsible for sales and marketing of its oral insulin capsule in these markets.

Management
CEO & Director: Nadav Kidron Esq, MBA
Nadav Kidron Esq, MBAMr. Nadav Kidron has served the CEO of Oramed Pharmaceuticals since founding the company in 2006. He is an entrepreneur whose career has included managerial roles in a variety of companies and organizations. Mr. Kidron is a Board Member for Entera Bio. He is also an Advisory Board Member for The Trendlines Group, a group that invests in and develops innovation-based businesses. More Info

Chief Scientific Officer & Director: Miriam Kidron, Ph.D
Miriam Kidron, Ph.DDr. Miriam Kidron was appointed Chief Medical and Technology Officer and director in March 2006. Dr. Kidron is a pharmacologist and a biochemist with a PhD in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the Diabetes Unit at Hadassah University Hospital in Jerusalem, Israel. During 2003 and 2004, Dr. Kidron served as a consultant to Emisphere Technologies Inc., a company that specializes in developing broad-based proprietary drug delivery platforms. Dr. Kidron was formerly a visiting professor at the Medical School at the University of Toronto (Canada), and is a member of the American, European and Israeli Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger Award. More Info

CFO: Yifat Zommer, CPA
Yifat  Zommer, CPAMs. Yifat Zommer was appointed Chief Financial Officer, Treasurer and Secretary in April 2009. From April 2007 to October 2008, Ms. Zommer served as Chief Financial Officer of Witech Communications Ltd., a subsidiary of IIS Intelligence Information Systems Ltd, a company operating in the field of video transmission using wireless communications. From April 2006 to April 2007, Ms. Zommer acted as Chief Financial Officer for CTWARE Ltd., a telecommunication company. Prior to that she was an audit manager in PricewaterhouseCoopers (PwC), where she served for five years. Ms. Zommer holds a Bachelor of Accounting and Economics degree from the Hebrew University and Business Administration (MBA) from Tel-Aviv University. Ms. Zommer is a certified public accountant in Israel. More Info

Director of Research and Development: Ehud Arbit, M.D.
Ehud  Arbit, M.D.Dr. Arbit joined the company in mid-2008, having previously served as the vice president of Medical Research at Emisphere Technologies, where he was a co-inventor of six patents related to drug delivery technology. Previously, Dr. Arbit has held distinguished academic positions as Professor at Cornell University Medical College, Member of the Sloan Kettering Cancer Center (MSKCC) and as Division Director at Memorial Sloan Kettering Cancer Institute in New York. Dr. Arbit has numerous publications in peer reviewed journals and had served on the editorial boards of several medical journals. More Info

Medical Affairs: Roy Eldor, M.D.
Roy  Eldor, M.D.Dr. Eldor joined Oramed in 2008 and is the Principal Investigator for all of the company's clinical trials conducted at Hadassah Medical Center. He is an Endocrinologist in the Diabetes unit and Endocrinology Department of Hadassah Medical Center. Dr. Eldor graduated from Hadassah - Hebrew University Medical School. and is currently pursuing post-doctoral work in the Division f Diabetes Unit in the Department of Medicine at the University of Texas, San Antonio. More Info

Scientific Advisory Board: John Amatruda, M.D.
John  Amatruda, M.D.Professor Amatruda was formerly the Senior Vice President and Franchise Head, Diabetes and Obesity at Merck Research Laboratories. He is board certified in internal medicine, endocrinology and metabolism and has a proven track record in academics and pharmaceutical discovery research and development, including several novel candidate compounds, INDs, translational studies, development programs and four NDAs. More Info

Scientific Advisory Board: Nir Brazilai, M.D.
Nir  Brazilai, M.D.Professor Brazilai is the Director of the Institute for Aging Research at the Albert Einstein College of Medicine. He is a Chaired Professor of Medicine and Molecular Genetics and a member of the Diabetes Research Center, the Divisions of Endocrinology and Geriatrics. He is the Director of the Diabetes Research and Training Center Physiology core, and also the co-Director of the Montefiore Hospital Diabetes Clinic. More Info

Scientific Advisory Board: Ele Ferrannini, M.D. Ph.D.
Ele  Ferrannini, M.D. Ph.D. Professor Ele Ferrannini has published over 350 original papers and 50 book chapters, and is amongst the "highly cited scientists." (ISIhighlycited.com). One of many great honors achieved by Professor Ferrannini includes being elected a past President to the EASD, European Association for the Study of Diabetes. The Association is based on individual membership and embraces scientists, physicians, laboratory workers, nurses and students from all over the world who are interested in diabetes and related subjects in Europe, such as the ADA, American Diabetes Association does in America. Professor Ferrannini has worked with various institutions including the Department of Internal Medicine, University of Pisa School of Medicine, and CNR (National Research Council) Institute of Clinical Physiology, Pisa, Italy; Diabetes Division, Department of Medicine, University of Texas Health Science Center at San Antonio, Texas, USA. He has also had extensive training focused on microbiology, immunology, endocrinology, and specializing in diabetes studies. More Info

Scientific Advisory Board: Avram Hershko, M.D. Ph.D
Avram  Hershko, M.D. Ph.DProfessor Hershko joined the Oramed Scientific Advisory Board in July 2008. In 2004, he received the Nobel Prize in Chemistry. He earned his M.D. (1965) and PhD (1969) from the Hebrew University - Hadassah Medical School of Jerusalem, a period which included service as a physician in the Israel Defense Forces (1965-67). After a post-doctoral fellowship with Gordon Tomkins at the University of San Francisco (1969-72), he joined the faculty of the Haifa Technion becoming professor in 1980. He is now Distinguished Professor in the Unit of Biochemistry in the B. Rappaport Faculty of Medicine of the Technion. More Info

Scientific Advisory Board: Derek LeRoith, M.D. Ph.D
Derek LeRoith, M.D. Ph.DProfessor LeRoith has been a member of Oramed's scientific advisory board since 2006 and is currently the Chief of the Division of Endocrinology, Diabetes and Bone Diseases at Mt. Sinai School of Medicine, NY. He has worked at the NIH since 1979 in the field of Endocrinology and Diabetes and rose to be head of the Diabetes Branch at the National Institutes of Health in Bethesda M.D., a position he held until 2005. More Info


Directors
Director and Chairman of the Scientific Advisory Board : Michael Berelowitz, M.D.
Michael  Berelowitz, M.D.Dr. Michael Berelowitz was appointed as a director on June 1, 2010 and in 2011 also became the Chairman of the Scientific Advisory Board. Dr. Berelowitz is the former Senior Vice President and Head of Clinical Development and Medical Affairs in the Specialty Care Business Unit at Pfizer, Inc. From 1996 to 2009 he served in various roles at Pfizer, Inc., beginning as a Medical Director in the Diabetes Clinical Research team and then assuming positions of increasing responsibility until being appointed to his present role. Prior to that, Dr. Berelowitz spent a number of years in academia. Among his public activities, Dr. Berelowitz has served on the board of directors of the American Diabetes Association, the Clinical Initiatives Committee of the Endocrine Society, and has chaired the Task Force on Research of the New York State Council on Diabetes. He has also served on several editorial boards, including the Journal of Clinical Endocrinology and Metabolism and Endocrinology, Reviews in Endocrine and Metabolic Disorders and Clinical Diabetes. Dr. Berelowitz has authored and co-authored more than 100 peer-reviewed journal articles and book chapters in the areas of pituitary growth hormone regulation, diabetes and metabolic disorders. More Info

Director : Leonard Sank
Mr. Leonard Sank was appointed as a director in October 2007. Mr. Sank is a South African entrepreneur and business man who is devoted to entrepreneurial endeavors and initiatives. He has over 20 years of experience playing important leadership roles in developing businesses. He was a director in Eastvaal Motor Group, a diversified retail motor business. He was also director in Vecto Finance, a credit lending business. He has also served as a director of Macsteel Service Centres SA Pty Ltd., South Africa’s largest private company. He also serves on the board of local non-profit charity organizations in Cape Town, where he resides. More Info
Director : Harold Jacob, M.D.
Dr. Harold Jacob was appointed as a director in July 2008. Since 1998, Dr. Jacob has served as the president of Medical Instrument, a company which provides a range of support and consulting services to start-up and early stage companies as well as patenting its own proprietary medical devices. Dr. Jacob has advised a spectrum of companies in the past and served as a consultant and then as the Director of Medical Affairs at Given Imaging Ltd., during 1997 to 2003, a company that developed the first swallowable wireless pill camera for inspection of the intestine. He has licensed patents to a number of companies including Kimberly Clark Ballard. Since 2003, Dr. Jacob has served as the CEO of NanoVibronix, a medical device company using surface acoustics to prevent catheter acquired infection as well as other applications. He practiced clinical gastroenterology in New York and served as Chief of Gastroenterology at St. Johns Episcopal Hospital and South Nassau Communities Hospital in 1986-1995, and was a Clinical Assistant Professor of Medicine at SUNY during 1983-1990. Dr. Jacob founded and served as Editor in Chief of Endoscopy Review and has authored numerous publications in the field of gastroenterology. More Info
Year Ended August 31
Income Statement Data ($K)
2011
2010
2009
Total Revenues 
0.0
0.0
0.0
Operating Loss
 2,435.3
 2,972.6
 2,784.1
Financial Income (Expense), net
14.5
10.1
 21.0
Gain on Sale of Investment
1,033.0
0.0
0.0
Pretax Loss (Income)
 1,585.2
 2,962.4
 2,763.1
Net Loss (Income)
 1,561.2
 2,977.4
 2,760.5
Diluted Loss (Earnings) Per Share ($)
 0.02
 0.05
 0.05
Fiscal year ending August 31     
 
 
 


Balance Sheet Data ($K)
8/31/11
8/31/10
Total Cash & ST Investments
1,513.4
1,199.6
Current Assets
 4,284.1
1,396.8
Total Assets
 4,325.9
1,450.9
Current Liabilities
 441.3
458.6
Total Equity
 3,723.9
830.3
   
 
 

 
Key Financial Ratios
8/31/11
8/31/10
Current Ratio
9.7x
3.0x
L-T Debt/Equity
NA
NA
  
 
 

 
Dividend Policy
Company does not currently pay dividends.
 


Main Shareholders (August 31, 2011)
 
Nadav Kidron
15%
Zeev Bronfeld
9%
Attara Fund
9%
Hadasit Medical Research Services & Development Ltd.
6%
Leonard Sank
5%
Other private investors
21%
 
 
 

ORMD 0801 - Oral Insulin Capsule
  ORMD 0801 - Oral Insulin Capsule
Oramed’s Oral Insulin has the potential to create a new paradigm in the treatment of diabetes by allowing insulin to be given at an earlier stage of treatment, and by potentially slowing disease progression. Early intervention is expected to spare beta cells and to improve pancreatic stability. The mechanism of insulin delivery is one that mimics the body’s physiological process, thus decreasing instances of hypoglycemia and other injection-related side effects. The company is now working on an IND submission to the FDA which will be followed by a Phase 2 clinical trial in the US in early 2013.
ORMD 0901 - GLP1 Analog
  ORMD 0901 - GLP1 Analog
Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. In addition, GLP-1 was found to suppress glucagon release from the pancreas, slow gastric emptying to reduce the rate of absorption of nutrients into the bloodstream, and increase satiety. The current market for injectable GLP-1 analog is close to $1 billion and, to-date, they are available only as parenteral dosage forms. With Oramed’s oral delivery of GLP-1 analog, compliance will increase and the side effect of nausea will be reduced. Oramed has conducted pre-clinical and clinical studies with an oral GLP-1 Analog and results showed that it is absorbed from the gastrointestinal tract and can effectively curb glucose excursion post-glucose loading. Further clinical trial are expected in Q3 2012.

Announcements
16/5/2012
Oramed Pharmaceuticals Granted Israeli Patent for its Core Technology in Oral Delivery of Proteins More Info

8/5/2012
Oramed Pharmaceuticals Awarded Grant by the Office of the Chief Scientist of Israel More Info

20/3/2012
Oramed Pharmaceuticals Chosen to Present at the XVI International Symposium on Atherosclerosis (ISA2012), (March 25-29, 2012; Sydney, Australia) More Info

7/2/2012
Oramed Pharmaceuticals Announces Educational Lecture at the National University Hospital in Singapore More Info

24/2/2012
Oramed Pharmaceuticals Granted Australian Patent for Important Part of the Company's Core Technology in Oral Delivery of Proteins More Info

10/1/2012
Oramed Pharmaceuticals Files US Patent Application for Combination Oral Treatment of Diabetes More Info

12/12/2011
Corporate Profile's CPReports.com Publishes Goldman Small Cap Research's Article on Oramed Pharmaceuticals More Info

25/10/2011
Oramed Pharmaceuticals Chosen to Present at the Diabetes Technology Meeting (October 27-29, 2011; San Francisco, CA) More Info

4/10/2011
Corporate Profile's CPReports.com Publishes Report by RAY DIRKS of RAY DIRKS Research on Oramed Pharmaceuticals More Info


All Announcements

News
Globes - 24/11/2011 - Oramed mulls dual listing on TASE, upgrading to AMEX
Oramed Pharmaceuticals is developing an insulin capsule, which is undergoing a Phase IIb clinical trial under FDA protocols. More Info

Oramed Pharmaceuticals
Milestones in Developing Oral Insulin
Oramed Pharmaceuticals
Company Introduction
Oramed Pharmaceuticals
Breaking News


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