Mike Havrilla's  Instablog

On 11/23/09, Transcept Pharma (NASDAQ: TSPT) announced that it is scheduled to meet with the FDA on 1/20/10 to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). As previously announced, the CRL, received by TSPT on 10/28/09, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects.

Following the receipt of official FDA minutes of the meeting, TSPT plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo NDA resubmission. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million.

Advantages of the Epinex Quantitative Immunoassay System for Point-of-Care Testing include the following:

1.) Rapid:  Results within minutes.

2.) Quantitative:  Yields a precise value, not just "yes" or "no".

3.) Easy to use:  No training required.

4.) Cost effective:  Point-of-care testing reduces overall cost to the healthcare system.

5.) High Sensitivity:  Results comparable to the "gold standard" ELISA test.

The Epinex G1A^TM (glycated albumin, which is a measure of average blood sugar control over the previous month) Test is the first of a series of diagnostic monitoring tests based on the Company's proprietary detection platform technology and dual-mode test reader. Future rapid tests under development by Epinex include infectious diseases, other metabolic disorders, coronary artery disease, rheumatoid arthritis, Down Syndrome, and neonatal HIV.

Albumin is a protein found in the blood that can be measured with precision and has a turnover or replacement time of 2-3 weeks. Like many proteins in the body, albumin can become altered or glycated. High levels of glycated albumin have been directly linked to major complications of diabetes such as retinopathy (blindness) and nephropathy (kidney failure) through the damage caused to small blood vessels by the altered protein. It is also a marker for other types of diabetes complications. More than 25 years of clinical research has proven that monthly measurement of glycated albumin is a superior technology to monitor and control glycation.

The Epinex G1A^TM Rapid Diabetes Monitoring Index Test is a monthly test for the control of glycation. The test is composed of the G1A^TM reader and a proprietary dual-channel test cassette, which is able to simultaneously test for glycated albumin and total albumin. A drop of whole blood is placed on the sample well of the cassette and the cassette is inserted into the reader device. Based on the Company's platform technology, the G1A^TM reader automatically quantifies the analyte concentrations on the cassette and gives the G1A^TM Index, the ratio of glycated albumin to total albumin in serum.

The G1A^TM Index shows how well the patients have controlled their level of glycation over the previous month. Simple to operate, the G1A^TM test system can be performed at the point of care without the need for highly trained laboratory technicians. It allows for immediate feedback between healthcare provider and patients, thus facilitating timely therapeutic interventions. The results are stored on the device, providing trend analysis as well as displaying immediate results. The results can be transmitted by means of a computer or wireless connection to a doctor's office or other central data location.

The global diabetes epidemic affects an estimated 300 million people worldwide and this number is expected to double by 2030 with an estimated cost of $232 billion. Diabetes is the fifth leading cause of death in the U.S. and fourth leading cause of death on a global basis. Complications of diabetes may include heart disease, blindness, kidney failure, extremity amputations / circulation problems, and neuropathies.

The market for all diabetes monitoring products is the largest medical diagnostics market in the world at $12.4 billion in 2000 and estimated to grow to a level of $27 billion by 2010, representing a 12% CAGR (compound annual growth rate). The diabetes testing market is dominated by global, diversified healthcare giants such as Johnson & Johnson (NYSE: JNJ) (LifeScan - One Touch), Abbott Labs (NYSE: ABT) (FreeStyle), Roche (OTC: RHHBY.PK) (Accu-Chek), and Bayer (OTC: BAYRY.PK) (Ascenscia).

Glycation (binding of excess sugar to proteins such as albumin and hemoglobin) is a major cause of the long-term complications of diabetes and an indicator of the risk of developing those complications. The goal of diabetes monitoring is to control glycation and to avoid the complications of diabetes. This allows diabetics and their health care providers to determine a treatment regimen, to monitor its effectiveness, and to alter it as needed for better overall glucose control. Current diabetes monitoring methods may include periodic doctor visits (e.g. every six months) in addition to multiple tests for monitoring blood sugar levels.

Blood glucose monitoring is the most common and frequent means of measuring blood sugar levels on a real-time basis and may be conducted up to four times daily or more via finger prick or alternate site (e.g. forearm) testing by patients. While blood glucose machines are often subsidized or given away free, the test strips are expensive and represent an ongoing cost along with poor patient compliance due to the high frequency of testing and finger pricks that are involved with this method. Glycated hemoglobin (HbA1c) is typically conducted 2-3 times per year and provides a measure of average blood sugar control over the previous 90 days.

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