Programs Diabetes – SGLT2 Inhibitor
Diabetes is a leading international health concern with an estimated 422 million adults or 8.5% of the population afflicted with this disease. According to theInternational Diabetes Federation, an estimated 4.9 million people died as a result of diabetes in 2014. Moreover, the cost of diabetes has risen to 825 billion dollars a year in 2016.
Most diabetics treat their disease by controlling insulin production or regulating blood sugar through the use of medication. A diabetic patient can require up to 10 different medications at a time. Despite this large number of therapeutic options many diabetics are unable to control their disease and face significant health risks.
Sirona Biochem’s SGLT2 Inhibitor
SGLT2 Inhibitors work differently from other, non-insulin, diabetes therapeutics which increase insulin production in the pancreas and/or affect metabolism. SGLT2 Inhibitors act in the kidneys to reduce the re-absorption of glucose into the bloodstream. SGLT2 Inhibitors also have the potential to be strong add-on therapies to current diabetes treatments.
Using our proprietary chemistry technology, we have developed an SGLT2 Inhibitor compound: SBM-TFC-039. Our goal is to develop a best-in-class SGLT2 Inhibitor with optimal pharmaceutical characteristics including, but not limited to, enhanced stability, bioavailability, selectivity and/or efficacy.
The first SGLT2 inhibitor to receive market approval in the U.S. was Johnson and Johnson’s SGLT inhibitor, Invokana™ (canagliflozin), which is also being considered for market approval in Europe. Forxiga™ (dapagliflozin), an SGLT2 inhibitor developed by AstraZeneca and Bristol-Myers Squibb received European market approval in November 2012 and was approved by the Food and Drug Administration (FDA) for the US market in January 2014.
SGLT2 Inhibitor Program Studies Completed
SGLT2 Inhibitor Results
Several studies have been conducted to demonstrate the effectiveness and stability of Sirona Biochem’s SGLT2 Inhibitor SBM-TFC-039.
- SBM-TFC-039 triggers glucosuria in a dose-dependent manner
- In a glucose challenge, SBM-TFC-039 reduced blood glucose excursions by 34%
- SBM-TFC-039 reduced blood glucose in obese diabetic rats to a level of lean rats within 6 hours
- In a 28-day chronic study, SBM-TFC-039 reduced blood glucose levels in obese diabetic rats by 71%
- SBM-TFC-039 reduced blood glucose by 44% in diabetic rats compared to canagliflozin at 26%
- At 36 & 48 hours after treatment, SBM-TFC-039, at a dose of 1.0mg/kg was still effective at reducing blood glucose; canagliflozin lost its effect after 36 hours.
In head-to-head preclinical studies, Sirona Biochem’s SBM-TFC-039 outperformed Johnson and Johnson’s canagliflozin
SGLT2 Inhibitor Licensing Deals By Third Parties
In March 2013, Johnson and Johnson’s canagliflozin (Invokana™) became the first SGLT Inhibitor to be approved by the U.S. Food and Drug Administration. SGLT Inhibitors are a new class of drugs bringing hope to Type 2 diabetes patients who may not be getting adequate relief from currently marketed drugs. This new SGLT Inhibitor treatment approach has resulted in significant licensing deals. Two published SGLT Inhibitor licensing deals include:
Empagliflozin, one of a two-compound licensing deal between Boehringer Ingelheim and Eli Lilly for at one time payment of €300 million and milestone payments of €625 million.
Dapagliflozin (Forxiga®), one of a two-compound licensing deal between Bristol Myers Squibb and AstraZeneca for upfront payment of US$100 million and milestone payments of up to US$1.25 billion
Bristol Myers Squibb and AstraZeneca expand licensing deal of dapagliflozin to include Japan; deal estimated to bring more than US$1 billion
Sirona’s SGLT2 Inhibitor Commercialization
In January, 2014, Sirona announced the licensing of its SGLT2 Inhibitor to Wanbang Biopharmaceuticals in China. Wanbang will develop and commercialize Sirona’s anti-diabetic SGLT2 inhibitor exclusively in the People’s Republic of China (PRC). In exchange for this license, Wanbang Biopharma has provided an upfront and will recieve milestone payments of up to US$9.5M in addition to royalty payments for product sales in the PRC.
Sirona Biochem’s SGLT2 Inhibitor remains available for ROW agreements such as:
- Licensing Agreements
- Royalty Agreements
- Acquisition of our technology
- Joint ventures
For any additional information please contact Aleksandra Kasikovic at firstname.lastname@example.org.