Welcome to Pipeline Review

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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Monday, March 15, 2010

The Day the FDA Served Notice

The biotech world had been impatiently awaiting the FDA to deliver some type of Action Letters to Mannkind and Amylin/Eli Lilly/Alkermes regarding the NDA's for Afrezza inhalable insulin and Byetta LARS. As I blogged in previous posts, some of these new diabetes drugs have been controversial due to perceptions about their safety profiles. While original Byetta had been linked to certain serious side effects (see here), these were safety alerts and no proof currently exists that Byetta is the cause of the kidney problems. Similarly, much of the safety concern swirling around Afrezza has to do with the previous safety alert issued for Exubera, the first inhalable insulin to gain FDA approval (but not market place acceptance). That alert centered around a small amount of clinical trial patients developing lung cancer, but a direct link to Exubera has not been determined (see here.)

Complete Response Letters

Today, the FDA served notice, in the form of Complete Response Letters, resulting in a setback for both Afrezza and Byetta LARS. Currently, it is too early to tell how severe of a blow these CRLs are to both new drug candidates, and it appears more concerns plague Afrezza as opposed to Byetta LARS. In Afrezza's case, the FDA is requesting information regarding the clinical utility of Afrezza, and more information is needed to determine the thinking at the FDA. The news release regarding Afrezza is here, while the news release concerning Byetta LARS can be found here.

Clinical Utility

While thinking of Generex Oral-lyn buccal insulin spray, my thoughts center around the recent FDA approved Treatment IND which Generex secured in the Fall of 2009. A Treatment IND can only be issued if the new drug candidate is thought to be safe, and if there is no suitable alternative drug currently approved on the market to treat a segment of the population. In my opinion, that bodes well for how the FDA may view the clinical utility of Oral-lyn buccal insulin, and its safety profile. A delay in Afrezza's development may also increase the potential enrollment success for Generex Oral-lyn into the Treatment IND program.

The ultimate success for Oral-lyn will be determined in its current Phase III study for Type 1 patients, however the Treatment IND program also allows the inclusion of Type 2 patients. All of these patients have a need for a non-invasive insulin therapy that is designed to offer treatment of postprandial hyperglycemia with less risk of postprandial hypoglycemia. In a nutshell, I believe that is positively the unique clinical utility for Generex Oral-lyn.