Rehovot-based biopharmaceutical firm Peptor today announced the development of a drug for the treatment of juvenile diabetes, or type 1 diabetes.
Dr. Dana Elias, VP Research and Development at Peptor, estimates that sales could reach between $1 billion to $2 billion a year by 2007 or 2008.
Approval of the commercial sale and distribution of the drug in the U.S. and Europe is expected in 2004.
Peptor's treatment helps to preserve insulin-producing cells and reduces the frequency of injected insulin supplements. Elias claims Peptor's treatment is at least two years ahead of competing medications.
Peptor is negotiating partnerships with leading international drug manufacturers for clinical trials it wants to hold in Europe and the U.S. The partnerships could lead to strategic investments, Elias says.
World Health Organization figures show that diabetes is the seventh most prevalent cause of mortality in humans. Over 150 million people worldwide suffer from the disease.
The number of diabetes patients has increased substantially in the last 25 years, possibly due to changes in diet. There are now over 50 million diabetes patients in North America, Japan and Europe, of whom 10 million could benefit from the new Peptor development.
The company plans to begin the second phase of the clinical trials of the DiaPep2777 in the U.S. in early 2002, once it receives the OK from the FDA. Third-phase trials will begin in mid-2002.
Peptor plans to apply for FDA approval of the drug in 2004, and to launch the commercial distribution of it in 2005. A similar schedule is planned for the drug in Europe.
Positive test results in Jerusalem hospital
Peptor announced today that a clinical trial conducted by professor Itamar Raz at the Ein Kerem Hadassah hospital in Jerusalem proved that the DiaPep277 drug inhibits the progression of type 1 diabetes, known as juvenile diabetes, prevents the destruction of pancreatic cells that produce insulin, and reduces the need to inject insulin to newly diagnosed patients.
The results of the research conducted and financed by Peptor were published in the November 24 issue of the medical journal De Lancet.
Elias, who acted as chief researcher in the study, said the study proved it is possible to control the activity of the immune system, and to prevent or stop altogether the attacks on the insulin producing cells.
"The DiaPep277 promises a breakthrough in the treatment of patients diagnosed with autoimmune diabetes. It may even act as immunization of individuals with a high risk of getting the disease. We may improve their lives by significantly diminishing their insulin dependence. We may also be able to inhibit or delay complications related to the disease, and even increase their life expectancy," Elias said.
In juvenile diabetes, the immune system attacks and destroys insulin-producing beta cells in the pancreas. The body loses its ability to produce insulin, which controls blood sugar levels.
Sufferers of type 1 diabetes must inject insulin several times a day to survive. Complications related to the disease include heart disease, strokes, high blood pressure, blindness, kidney conditions, harm to the nervous system, amputations, dental diseases and pregnancy complications. Sufferers' life expectancy is usually 15 years below the norm.
Delayed issueSince its establishment in 1993 Peptor has raised a total of $65 million. Its last funding round was in November 1999, when it secured $15 million at a post-money company value of $70 million.
The company planned to go public in Europe during 2000, at a company value of $115 million to $300 million. It shelved its plan after the market crash.
Peptor, founded by Yoram Karmon, PhD, now its president and CEO, employs 41 people at its R&D center in Rehovot and seven in Germany.