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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Saturday, October 17, 2009

A N.I.C.E. Development for Generex Oral-lyn in the U.K.

The United Kingdom's National Institute for Health and Clinical Excellence (NICE) has begun the draft scope for Generex's novel buccal insulin for the management of type 1 diabetes. Oral-lyn is currently in Phase III trials for patients with Type 1 diabetes and Generex is moving closer towards submission to the Medicines and Healthcare products Regulatory Agency MHRA. At present, over 350 patients have been enrolled in the program in 70 clinical sites around the world.

NICE recently entered the first stage to "appraise the clinical and cost effectiveness of buccal insulin within its licensed indication for the management of type 1 diabetes". They began consultation on suggested remit, draft scope and provisional matrix of consultees and commentators on September 21st and this process continues until October 19th. A scoping workshop in scheduled on November 11th in London.

This is not the first time that a needle free insulin delivery system has been appraised ny NICE. Early in 2006, NICE ruled that Pfizer's inhalable insulin, Exubera, not be prescribed to UK patients at all. However, after appeal from Pfizer NICE altered final guidance. They remained sceptical, saying that Exubera should not be used as routine treatment. They ruled that diabetic patients in the United Kingdom must prove "needle phobia" before they can be prescribed Exubera. The decision caused a storm of controversy, since patients would first have to be diagnosed with the phobia by a psychologist or psychiatrist.

Exubera offered an uncompetitive healthcare value proposition, priced at a premium while lacking dosing flexibility combined with significant safety concerns. The negative edict from doomed Pfizer's launch of Exubera in the UK, and the negative publicity played a major role in Exubera's subsequent failure in the US. In 2007, Pfizer chose to abandon Exubera and took a $2.8 billion pretax hit by discontinuing their marketing efforts in one of the drug industry's costliest failures.

One inhalable insulin system remains in development, Mannkind's Afresa, and while it appears to be a more effective and convenient in comparison to Exubera, questions regarding the safety of inhaling a growth agent like insulin into the lungs persist. Oral-lyn is a new alternative to subcutaneous injections of prandial insulin and is conveniently delivered to the membranes of the oral cavity by a four inch metered device with no pulmonary (lung) deposition. Oral-lyn fully avoids the potential risks of chronic lung tissue exposure and in Oral-lyn's clinical trials to date there has never been a serious adverse event reported to usage of buccal insulin.

In the NICE's draft scope of the Health Technology Appraisal for Oral-lyn, they state they will evaluate the cost effectiveness in terms of incremental cost per quality-adjusted life year. They add that the time horizon for estimating clinical and cost effectiveness should be sufficiently long to reflect any differences in costs or outcomes between the technologies being compared. Costs will be considered from an NHS and Personal Social Services perspective. Quality-adjusted life-year represents the morbidity of diseases by a scale of 0 to 1.0, representing the extremes of death and full health. For instance, if you have diabetes and a foot amputation due to diabetic complications, your quality of life will be reduced by 35%. In other words, your quality-adjusted life-year would be only 0.65.

Evaluating the cost effectiveness of Oral-lyn over a long time horizon should be favorable to Generex. The cost per unit of buccal insulin vs regular injected insulin is higher, but overall health care savings may be seen when an insulin hesitant diabetic leads a more compliant regimen. Further, NICE states in the draft proposal that they intend to appraise Oral-lyn through its Single Technology Appraisal (STA) Process. In November 2005, NICE launched the Single Technology Appraisal process, which is designed to enable assessment of single drugs and devices close to when they are first licensed, allowing NICE’s existing system to be reserved for more complex issues. This shortens the process and final guidance will come quicker.

There are approximately 2.5 million people in England and Wales with diabetes, approximately 10% of whom have type 1 diabetes. Generex's website states that Oral-lyn has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes. Generex recently announced that the FDA has granted approval for the treatment use of Oral-lyn in patients with Type 1 or Type 2 diabetes mellitus under the FDA's "Treatment IND" rules. The FDA's Treatment IND program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.

NICE's Proposed Technology Appraisals can be found here.