Oramed Pharmaceuticals Announces That Dr. Michael Berelowitz, Senior Vice President at Pfizer, Joins its Board of Directors JERUSALEM, May 18, 2010
announced that Dr. Michael Berelowitz, MD, joins Oramed Pharmaceuticals' Board of Directors. Dr. Berelowitz is currently Senior Vice President and Head of Clinical Development and Medical Affairs in the Specialty Care Business Unit at Pfizer, Inc., the world's largest research-based pharmaceutical company.
Dr. Berelowitz joined Pfizer in 1996, after a number of years in academia, as a Medical Director in the Diabetes Clinical Research team. Since then he has assumed positions of increasing responsibility until being appointed to his present role in 2009. 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.
"Dr. Michael Berelowitz joins our board and Oramed gains a renowned industry leader in the study of diabetes. His extensive experience should help us bring our insulin capsule ORMD-0801 through trials and to market. We are delighted to have him as part of our team," states Nadav Kidron, Oramed Chief Executive Officer.
"I have been closely following Oramed's progress and am impressed with the significant advances that the company has made in developing its novel oral insulin capsule, ORMD-0801," said Dr. Berelowitz. "I am very pleased to join Oramed's Board of Directors and look forward to working with the leadership team to enhance the development of therapeutic applications of the company's oral drug delivery technology and in the further maturation of ORMD-0801."
Oramed Pharmaceuticals was established in 2006, and is based on over 25 years of medical research at the world-renowned Hadassah University Medical Center in Jerusalem, Israel.
For over two decades, scientists at Hadassah Hospital's Diabetes Unit, led by Professor Hanoch Bar-On, worked to develop a technology designed to enable the oral administration of insulin to diabetics. A medical breakthrough in 2005 laid the foundation for the founding of Oramed Pharmaceuticals, of which Hadassah remains a part owner of the company. Professor Bar-On helped found Oramed, together with Dr. Miriam Kidron, and served as a director until his untimely death in 2006.
Over the past two years, Oramed has successfully conducted various animal studies with its oral insulin product, ORMD 0801. The positive outcome set the stage for Phase 1a Phase 1b clinical trials that tested the research on healthy human volunteers, again culminating in successful results.
In August 2008, Oramed completed Phase 2a clinical trials of ORMD 0801. The goal of these trials was to evaluate the safety and efficacy of oral insulin on individuals diagnosed with diabetes. These trials proved, for the first time, that Oramed's oral insulin capsule can be effectively delivered to people diagnosed with diabetes. The trial demonstrated that the product had a good safety profile, was well tolerated and effective in lowering blood glucose levels in patients with type 2 diabetes. By administering oral insulin to these patients as an earlier form of treatment, patients will be better able to control and balance their diabetes, leading to a healthier condition and better quality of life.
In May 2009, Oramed commenced Phase 2b clinical trials in South Africa. These trials will test Oramed's first indication on Type 2 Diabetic patients.
Oramed's pipeline currently consists of an insulin suppository (ORMD-0802) and an oral method for delivery of GLP1 analog (ORMD-0901) and the influenza vaccine (ORMD-1001). Oramed's unique oral delivery technology serves as a platform for other vaccines and medications currently available exclusively in injection form.
Oramed Pharmaceuticals Announces Completion of Patient Enrollment for Pivotal Phase 2B Clinical Trials of ORMD-0801
January 19 announced today the completion of patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801. The last of the thirty Type II diabetes patients was enrolled for a study in which subjects will be administered the insulin-based capsule for a period of six weeks.
The randomized, double-blind, placebo-controlled, multi-centered study will evaluate the safety, tolerability, and efficacy of Oramed's oral insulin delivery technology. The study is taking place in five locations throughout South Africa and is being monitored by OnQ Consulting, a clinical research organization (CRO) based in Johannesburg, South Africa. Study results are expected by the end of first quarter of 2010.
This trial marks an important milestone in ORMD-0801 safety testing, assessing the first indication of ORMD-0801 on a large group of volunteers over an extended treatment period.
"The closing of enrollment for the Phase 2B trial is an exciting accomplishment for us, as it moves us closer to completing this trial and receiving the results. In the upcoming months, we look forward to being able to share the results from the trial, which will mark a major milestone in the development of oral insulin," explained Nadav Kidron, CEO of Oramed Pharmaceuticals.
Oramed Pharmaceuticals Expands Scientific Advisory Board With the Appointment of John Amatruda, M.D.
Oramed Pharmaceuticals a developer of oral delivery systems, announced today that John M. Amatruda, M.D. has joined Oramed's Scientific Advisory Board, enhancing Oramed's talented and experienced scientific team.
Dr. Amatruda was 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.
In joining the Scientific Advisory Board, Dr. Amatruda will provide Oramed access to his extensive successful pharmaceutical industry experience in the development and approval of novel drugs. Additionally, his experience in licensing, structuring agreements and managing collaborations will prove invaluable to the Company.
"Dr. Amatruda is a very highly respected pharmaceutical executive and we are honored that he is joining our Scientific Advisory Board," said Nadav Kidron, Chief Executive Officer of Oramed. "His expertise and knowledge in the diabetes field will assist us in moving forward with the development of our product pipeline."
Dr. Amatruda commented that "it is a pleasure to join the Scientific Advisory Board of Oramed. Oramed's development of proprietary technology for the oral delivery of peptide pharmaceuticals will be an important advance in the treatment of many chronic diseases that require injectables, including diabetes."
Dr. Amatruda is joined on the Scientific Advisory Board by the following existing members: Derek LeRoith, Ph.D.; Nir Brazilai, M.D.; Ele Ferrannini, M.D., Ph.D.; and Avram Hershko, M.D., Ph.D.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 1
As filed with the Securities and Exchange Commission on February 24, 2010
ORMD 0801 - Oral Insulin Capsule
Oral Insulin Capsule
In August 2008, Oramed successfully completed Phase 2A clinical trials of its oral insulin capsule. This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients. ORMD 0801 was well tolerated by all patients and had a good safety profile; no serious adverse events were encountered throughout the study. In two thirds of the subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.
Oramed also conducted another Phase 2a study with Type 1 diabetic patients and positive results were reported in July of 2009. The oral insulin capsule was safe, tolerable, and was not vulnerable to food effects.
Phase 1B trials were completed in March 2008 and were intended to find the optimal dosage of ORMD 0801. These trials were conducted with healthy volunteers.
In August 2007, Phase 1A clinical trials were completed, the goal of which was to assess both the safety/tolerability and absorption properties of Oramed's proprietary delivery technology. The trials examined changes in insulin, glucose and C-peptide plasma concentrations over time in healthy volunteers under several differing oral dosing scenarios.
Phase 2B clinical trials have commenced in the first quarter of 2009 in South Africa.
ORMD 0901 - GLP1 Analog
In September 2009, Oramed received approval from the Instututional Reveiw Board to commence human clinical trials of ORMD 0901, a GLP1-analog. This approval was granted after suuccesful pre-clinical results were reported. The trials on healthy volunteers will take place at Hadassah University Medical Center.
Glucagon-like peptide-1 (GLP-1) is an incretin hormone - a type of gastrointestinal hormone that stimulates the secretion of insulin from the pancreas. The incretin concept was hypothesized when it was noted surprisingly that glucose ingested by mouth (oral) stimulated two to three times more insulin release than the same amount of glucose administered intravenously. GLP-1 was found in addition to stimulates insulin release, to suppress glucagon release (hormone involved in regulation of glucose) from the pancreas, it slows gastric emptying to reduce the rate of absorption of nutrients into the blood stream, and it increases satiety. Other important beneficial attributes of GLP-1 are its effects of increasing the number of beta cells (cells that manufacture and release insulin) in the pancreas and possibly to be hormone that protects the heart.
At least two of GLP-1's attributes are unique and particularly important among the available antidiabetic drugs. While there are other drugs available which stimulate insulin release, none however enhances glucose dependent release. The implication of glucose dependency is that insulin will only be released if glucose levels are increased so that the risk of hypoglycemia due to excess insulin release is considerably reduced. One other distinguishing attribute of GLP-1 is the increase in satiety it causes, which results in reduces food intake and consequently lead to weight loss. GLP-1 is only the second among the available antidiabetic drugs associated with weight loss, which is of utmost importance for people with diabetes.
Of note is that GLP-1 is rapidly inactivated by an enzyme (dipeptidyl peptidase 4) as soon as it reaches the blood circulation. This implies that to develop an exact copy of GLP-1 as a drug, is not practical because it will require administration by continuous infusion. Consequently several long-lasting analogs with the same activity as GLP-1 have been developed and have either been approved for clinical use in the US or are in various stages of clinical studies.
Management Team http://www.oramed.com/index.php?page=7&fltr=1
cash: 1mln dollars
total asset 3 mln
total liabilities: 411.000
key trial for oral insulin with expected results at the end Q1 for 2010
October 20, 2009
Interview with Nadav Kidron, CEO
Oramed Announces Completion of Pivotal Phase 2b Clinical Trials of it's Oral Insulin Capsule, ORMD-0801 for Type 2 Diabetes
The Phase 2b trial is a randomized, double-blind, placebo-controlled, multi-centered study, that primary evaluated the safety, and tolerability of Oramed's oral insulin delivery technology. The study took place in five locations throughout South Africa and was monitored by OnQ Consulting, a clinical research organization (CRO) based in Johannesburg, South Africa.
"The completion of the Phase 2b clinical trial for ORMD-0801 is a significant milestone for Oramed," said Nadav Kidron, Chief Executive Officer of the Company, who continued, "We are especially thankful for the dedication of all the investigators who participated in the study."
Oramed Pharmaceuticals and sanofi-aventis Enter Into an Agreement for the Insulin Supply of Oramed's Oral Insulin Capsules
Oramed Pharmaceuticals Inc.(http://www.oramed.com), a developer of oral delivery systems, today announced that Oramed entered into a Manufacturing Supply Agreement (MSA) with sanofi-aventis. According to the MSA, sanofi-aventis will supply Oramed with specified quantities of recombinant human insulin to be used by Oramed for its clinical trials in the USA.
The MSA is managed by the Commercial and External Partnership within Industrial Affairs (CEPiA) at sanofi-aventis, which will allow Oramed to leverage sanofi-aventis' ability and expertise regarding quality and regulatory support.
"Oramed's oral delivery technology together with sanofi-aventis capabilities to produce insulin on a large scale supports Oramed's efforts to conduct clinical development of Oramed's oral insulin capsule in the growing diabetes market in the US.", says Nadav Kidron, Oramed's CEO. "It is very satisfying to work with such a professional company and their dedicated staff."
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines presently delivered via injection. Oramed is seeking to revolutionize the treatment of diabetes through its patented flagship product, an orally ingestible insulin capsule currently in phase 2 clinical trials. Established in 2006, Oramed's technology is based on over 25 years of research by top research scientists at Jerusalem's Hadassah Medical Center. The Company's corporate and R&D headquarters are based in Jerusalem.
For more information, please visit http://www.oramed.com.