V1 and other fearless biotech researchers, I wanted to call the thread's attention to another interesting company, called TheraTech. Theratech is already profitable and has various projects with several big pharms. They already have on the market a transdermal androgen patch (perfect material for the thread humorists) and a transdermal estrogen patch. In addition they are working on a dry powder inhaler delivery technology as well as a transmucosal delivery technology. Interested in any comments, observations, etc.
Last yearly summary can be found at:
biz.yahoo.com
Perhaps most interesting of all, they are developing a new oral delivery mechanism for isulin. I believe the date is 1996. Apparently still has not made it into P1.
SALT LAKE CITY--August 5, 199-- A report published in the August issue of Diabetes Care(a), details a new way to deliver peptide drugs through the mucosal surfaces of the mouth, a method that eventually may eliminate the need for injections.
Reporting on a recently completed human feasibility trial conducted by a team of doctors in Sweden, Dr. Mark Gutniak of Stockholm's Valling by Medical Center, stated that therapeutic plasma levels of glucagon-like insulinotropic peptide (GLP-1), a natural peptide hormone that influences insulin secretion and glucose metabolism, can be achieved by applying a small tablet between the lip and gum.
The delivery system is a proprietary formulation developed by TheraTech Inc. (NASDAQ:THRT).
GLP-1, which previously could only be administered by injection, is being evaluated for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). NIDDM is the form of the disease affecting approximately 80 percent of all diabetics.
Presently these patients are commonly treated with diet, orally administered blood-sugar reducing drugs, such as sulfonylureas, and insulin administered by injection.
Recent studies have suggested that GLP-1 may be a promising alternative antidiabetic agent. "It is known," Gutniak pointed out, "that GLP-1 stimulates insulin secretion through a glucose-dependent action. At the same time, it inhibits both glucagon secretion and gastric emptying.
"The peptide," Gutniak continued, "combines the effects of many other drugs currently used for the treatment of diabetes by acting on the gut, pancreas and glucose production from the liver."
In all previous experiments, GLP-1 has been administered by injection. Consequently, the study Gutniak and his associates conducted in collaboration with TheraTech represents a significant breakthrough. It demonstrated the feasibility of delivering GLP-1 using an adhesive-backed tablet that is placed in the mouth between the gum and either the cheek or lip.
Because the mucous membranes of the mouth are highly permeable and the surrounding tissues have an abundant blood supply, the drug is readily absorbed directly into the blood stream.
The tablets used in the study are a proprietary TheraTech-developed, permeation-enhanced oral transmucosal delivery system. The tablets are less than a centimeter in diameter and totally dissolve in the mouth.
The study involved eight healthy volunteers. Each volunteer received activeand placebo tablets in a randomized, double-blind, crossover comparison. Blood samples were drawn at regular intervals during each test period and carefully analyzed for changes in glucose, insulin, glucagon and GLP-concentrations.
The results were very impressive. Peak GLP-1 levels, reached at 30 minutes after tablet administration, were 16 times higher than baseline levels measured prior to administration of the tablets.
In response to the elevated GLP-1 levels, plasma insulin levels rose significantly, causing blood glucose and glucagon concentrations to begin dropping within 15 minutes, and to decline to their lowest levels within 50 minutes following administration of the tablets.
Significantly, the action of the peptide given transmucosally was almost identical to that achieved after subcutaneous injections, as reported in other studies.
According to Dr. Dinesh C. Patel, TheraTech's president and chief executive officer, the company is extremely excited with the results of Gutniak's study.
"In addition to demonstrating the feasibility of delivering GLP-1 and its potential applications for treating NIDDM," Patel stated, "Dr. Gutniak and his colleagues demonstrated that TheraTech's transmucosal delivery system can effectively deliver peptide drugs in general.
"Currently," Patel continued, "we are discussing worldwide development and distribution agreements for GLP-1 with several major pharmaceutical companies.
"Furthermore," Patel concluded, "TheraTech is exploring other peptide and related large-molecule drugs that may be delivered transmucosally instead of by injections, thus making them more patient-friendly."
TheraTech Inc., headquartered in Salt Lake City, is a leader in the development of innovative products based on controlled release drug delivery technologies, developing products independently as well as with corporate partners.
These products include transdermal patches, oral transmucosal products for the delivery of peptide drugs, oral controlled release products and topical preparations. TheraTech's development pipeline holds over 20 products spanning a wide variety of delivery technologies and therapeutic areas. (a) Diabetes Care is a professional journal published by American Diabetes Association for endocrinologists and other medical professionals specializing in the treatment of diabetes. >> |
