Generex Announces USFDA Approval of Use of Company's Flagship Buccal Insulin Product, Generex Oral-lyn™, Under the USFDA'S Treatment Investigational New Drug (IND) Program

* Press Release
* Source: Generex Biotechnology Corp.
* On Thursday September 10, 2009, 9:00 am EDT


WORCESTER, Mass., Sept. 10, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (:: Generex Biotechnology Corporation ::), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn™ under the FDA's Treatment Investigational New Drug (IND) program.


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.

Under a structured Treatment IND protocol, Generex Oral-lyn™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's ongoing global Phase III pivotal clinical trial.

This Treatment IND will be open to eligible patients that comply with the inclusion/exclusion criteria of the protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.

In order to learn more about the availability of Generex Oral-lyn™ under the IND Treatment program, as per FDA requirements, the Company will be providing information within the Home - ClinicalTrials.gov website. Details will include study design and participating sites and/or physicians. Please note that the drug will be available only through physicians who are registered in the Treatment IND program.

"We are excited about having the opportunity to meet the needs of American patients living with diabetes who have no satisfactory alternative treatment and have contacted the Company, based on their special needs, about possible access to Generex Oral-lyn™," stated Anna Gluskin, Generex's President and Chief Executive Officer. "This opportunity to provide those in critical need of Generex Oral-lyn™ will continue while the pivotal Phase III study concludes and the Company prepares for its New Drug Submission with the USFDA and other major health authorities in key markets."

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at :: Generex Biotechnology Corporation :: or the Antigen Express website at Antigen Express Inc. - biopharmaceutical company developing novel immunotherapy products -.

The Generex Biotechnology Corp. logo is available at GlobeNewswire, Inc.

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact:

American Capital Ventures, Inc.
Investor Relations Contact:
Howard Gostfrand
1-877-918-0774
Beckerman Public Relations
Media Contact:
Jerry Schranz
201-465-8020

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Full Disclosure

Looks like it could make a move soon.

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Generex Announces USFDA Price Approval for Generex Oral-lyn(TM) in the Treatment IND Program

Press Release
Source: Generex Biotechnology Corp.
On 9:30 am EDT, Wednesday October 14, 2009

Companies: Generex Biotechnology Corp.
WORCESTER, Mass., Oct. 14, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT - News) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that the U.S. Food and Drug Administration (FDA) has granted price approval in respect of the use of Generex Oral-lyn(TM) under the FDA's Treatment Investigational New Drug (IND) program.

Generex previously announced that the FDA has granted approval for the treatment use of Generex Oral-lyn(TM) in patients with Type 1 or Type 2 diabetes mellitus under the FDA's "Treatment IND" rules.

This latest FDA approval will permit the Company to charge for the product to recover costs.

The FDA's Treatment IND regulation was established in 1987 to make promising new drugs available to patients with life-threatening or otherwise serious medical conditions as early in the drug development process as possible. Preliminary evidence of drug efficacy is a condition precedent to the approval of a Treatment IND. Treatment INDs are made available to patients before general marketing begins, typically during Phase 3 studies.

Under the Treatment IND protocol, Generex Oral-lyn (TM) will be provided to patients with life-threatening or otherwise serious Type 1 or Type 2 diabetes mellitus where there is no satisfactory alternative therapy available to treat the condition.

This Treatment IND is open to persons meeting the protocol's inclusion criteria, including those who are taking currently approved anti-diabetic medications.

Generex will be providing information on the www.ClinicalTrials.gov website in respect of the availability of Generex Oral-lyn(TM) under the Treatment IND. Details will include the protocol's inclusion and exclusion criteria, study design and participating sites and/or physicians. Please note that the drug will be available only through physicians who are registered in the Treatment IND program.

Dropped instead.
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Form 8-K for GENEREX BIOTECHNOLOGY CORP

15-Oct-2009

Entry into a Material Definitive Agreement, Financial Statements and E


Item 1.01 Entry Into a Material Definitive Agreement.
On October 14, 2009, Generex Biotechnology Corporation (the "Company") entered into an At Market Issuance Sales Agreement (the "Agreement"), with Wm Smith & Co. ("Wm Smith"), under which the Company may sell an aggregate of $20,000,000 in gross proceeds of the Company's common stock from time to time through Wm Smith, as the agent for the offer and sale of the common stock. Wm Smith may sell the common stock by any method permitted by law, including sales deemed to be an "at the market" offering as defined in Rule 415 of the Securities Act, including without limitation sales made directly on NASDAQ Capital Market, on any other existing trading market for the common stock or to or through a market maker. Wm Smith may also sell the common stock in privately negotiated transactions, subject to the Company's prior approval. The Company will pay Wm Smith a commission not to exceed 3% of the gross proceeds of the sales price of all common stock sold through it as sales agent under the Agreement.

The Agreement will terminate on the earliest of (1) the sale of all of the common stock subject to the Agreement, or (2) termination of the Agreement by the Company or Wm Smith. Wm Smith may terminate the sales agreement at any time in certain circumstances, including the occurrence of a material adverse change that, in Wm Smith's reasonable judgment, may impair its ability to sell the common stock, the Company's failure to satisfy any condition under of the Agreement or a suspension or limitation of trading of the Company's common stock on NASDAQ. The Company may terminate the Agreement at any time upon 10 days prior notice, and Wm Smith may terminate the Agreement at any time upon 10 days prior notice.

The summary of the terms of the Agreement is qualified in its entirety by the text of the Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1.



Item 9.01 Financial Statements and Exhibits.

It seems to me that the new thing with these biotechs is to add a dilution cycle immediately upon release of positive news to generate revenue. This is very frustrating for us little investors as we expect an immediate pop in pps and instead endure a dilution run for a couple weeks. How are we to make any cash with this lol

Long term it's still good news for the company

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It's only money----but try not to lose it, OK?

Yep, never ending little games these guys play, especially in the penny catagory. Guess they figure they'll wait till right after the positive news they'll drop the bomb on us to supposedly soften the effect or whatever, lol. Who knows. Anyway, not a big drop, and yeah the good news should be long term. I was looking for a possible setup on the chart to move up some..but not today. I'm not in it yet. Still watching.

GNBT has a small symetrical triangle pattern. It will break one way or the other soon.

GNBT Chart

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