Generex Oral-lyn: First Oral Mouth Insulin Medication for Diabetics

Around the world diabetics survive each day by injectable insulin medication: pens, injectors and pumps. 1 Estimated 7.8% of the United States population has diabetes. 6 United States Food and Drug Administration (FDA) approve methods to administer insulin to diabetics safely. 1 When the pancreas produces (islet cells 7) little or no insulin or the cells do not respond appropriately to insulin, necessary to move glucose ( After food is eaten, broken down to produce glucose as the main source of energy for the human body) from the blood to cells, the metabolic disorder is diabetes. 2 When insulin is not present in the human body, calories contained in glucose to furnish life - sustaining energy for the human body will not be provided, no matter how much food is eaten. 7 Four major types of diabetes. 6 Generex Biotechnology developed insulin spray Generex Oral-lyn (For the inside oral cavity of the mouth) for the treatment of Type 1 and Type 2 diabetes: Similar to an asthma inhaler medication device. 3 In Asian countries and India Generex Oral-lyn successfully treats diabetics. 4 During a phase three pivotal evaluation in the United States, Generex Oral-lyn demonstrated positive results for seeking FDA approval. 5

The American Diabetes Association advises diagnose for pre-diabetes or diabetes, Oral Glucose Tolerance Test (OGTT) or Plasma Glucose Test (FPG) provided by health care professionals. Results of the FPG 100 - 125 mg/dl: Signals pre - diabetes, and higher than 126 mg/dl test positive for diabetes. Results of the OGTT measured two hours after drinking glucose - rich beverage: 140 -199 mg/dl test positive for pre - diabetes and level above 200 mg/dl test positive for diabetes. Four classifications for diabetes: Type one and two diabetes occurs when the body fails to produce insulin (or resistance - "a condition in which the body fails to properly use insulin") and insulin deficiency. Five to ten percent of women after pregnancy develop gestational diabetes. In the United States, 57 million people diagnosed with pre-diabetes, glucose level is high but less than for type Two diabetes. About one in four people do not know they have diabetes. Factors linked to cause diabetes include genetics, obesity, lack of exercise and environmental factors. 6

Traditionally diabetics use injections to administer insulin, one of more than twenty types sold in the United States. Common for many people to feel uncomfortable or nervous, especially injecting for the first time insulin. 8 Generx Biotechnology Corporation (public traded company - symbol GNBT) specialize, developing medication to be administered through inner lining of the mouth, such as Generex Oral-lyn tm: Insulin medication for diabetics. 9 Through an asthma inhaler device, Generx Oral-lyn is administered in the mouth and none of the medication goes into the lungs. 10 Previously, Generex Biotechnology had an agreement with Eli Lilly (pharmaceutical company) for developing Oral-lyn buccal insulin spray. In 2003, mutual agreement between Eli Lilly and Generex Biotechnology ended their previous arrangement.

Subsequentially, management of Generex Biotechnology pursued independently investigating and through own financing, sought the merits of Oral-lyn mouth insulin spray. 2004 - 2005 Generex Biotechnology persevered avoiding bankruptcy and presented positive accumulated data, regarding the safety and efficacy of Generex Oral-lyn. 14

In April 2008, Generex Biotechnology signed an agreement with SciGen (scigenltd.com) for distribution, marketing and securing Government approvals from Asia countries including People's Republic of China, Hong Kong, South Korea, Malaysia, Philippines, Thailand, Vietnam and Indonesia for the sale of Generex Oral-lyn. In October 2007, Generx Oral-lyn approved for sale in India (product marketed and sold by Shreya Life Sciences Pvt. Ltd. 10). 9: In India brand name is Oral Recosulin(tm) for diabetics. 11

In March 2009, Generex Biotechnology reported during a Phase - Three evaluation (300 subjects), Generex Oral-lyn proved to be safe for diabetics, without no significant adverse side effects reported.12 The Food and Drug Administration did not have objections for long - term multi-center (74 clinical sites around the world) Phase Three study of Generex Oral-lyn. 13 The Data collected during the Phase Three evaluation, support evidence to seek regulatory approval for the sale of Generex Oral-lyn, including U.S. Food and Drug Administration endorsement. 12 Generex Oral-lyn approved for sale in Canada and awaiting FDA approval process for sale in the United States. 15

References:

1.) Insulin - http://www.fda.gov/diabetes/insulin.html

2.) Diabetes Overview - http://diabetes.niddk.nih.gov/dm/pubs/overview/

3.) Generex Oral-Lyn - http://www.generex.com/products.php?prod_id=Nzk

4.) Generex Biotechnology and SciGen, Ltd Enter Into Distribution Agreement for Generex Oral-lyn in China - http://biz.yahoo.com/pz/080401/139265.html

5.) Generex Biotechnology Announces Successful Phase Three Study Data for Generex Oral-lyn(tm) - http://biz.yahoo.com/pz/090310/161017.html

6.) All About Diabetes - http://www.diabetes.org/about-diabetes.jsp

7.) Diabetes: What is Insulin? - http://www.endocrineweb.com/diabetes/2insulin.html

8.) Insulin: Who Needs It and Who Doesn't? - http://diabetes.about.com/od/doctorsandspecialists/a/whoinsulin.htm

9.) Generex-Biotechnology and SciGen, Litd. Enter Into Distribution Agreement for Generex Oral-lyn in China - http://biz.yahoo.com/pz/080401/139265.html

10.) Generx Biotechnology Provides Update on Generex Oral-lyn in India - http://newsblaze.com/story/20090311095527zzzz.nb/topstory.html

11.) Generex Biotechnology Provides Update On Generex Oral-lyn(tm) in India - http://biz.yahoo.com/pz/090311/161127.html

12.) Generex Biotechnology Announces Successful Phase Three Study Data for Generex Oral-lyn(tm) - http://biz.yahoo.com/pz/090310/161017.html

13.) Form 10-K GENEREX BIOTECHNOLOGY CORP - http://biz.yahoo.com/e/081010/gnbt10-k.html

14.) Generex Biotechnology: Oral-lyn Buccal Insulin Takes Center Stage - http://seekingalpha.com/article/71819-generex-biotechnology-oral-lyn-buccal-insulin-takes-center-stage?source

15.) Gnerex Biotech Oral-lyn Granted Special Access Authorization by Health Canada - http://seekingalpha.com/article/75652-generex-biotech-s-oral-lyn-granted-special-access-authorization-by-health-canada