Mission
Augment Therapeutics is an early-stage pharmaceutical research and development company and its mission is to “Revitalizing Old Medicines” and strives to invent “better and/or safer” or “super generic” versions of many widely used existing generic drugs that have some drawbacks or limitations by using our proprietary platform linker technologies. So far, we have invented potential “safer or super generic” versions of widely used generic drugs such as omeprazole, naproxen and aspirin. Interestingly, these novel versions exhibit a few competitively advantageous properties over their generic counter parts and they can therefore qualify as ideal candidates for development through 505(b)(2) NDA pathway, which is the least expensive and shortest route to new drug approval by US FDA.
THE COMPANY AND TEAM
Augment Therapeutics is headquartered in the city of Hyderabad and incorporated in Telangana State, India. The company is co-founded by Mrs. Veeraveni Baddireddy (An Indian citizen, 51% shareholding) and Mr. Apparao Satyam (A US citizen and OCI/U Visa holder, 49% shareholding).
Scientific Team – Responsible of preclinical and clinical research work
Scientific Advisors – Responsible for dealings with US FDA on regulatory issues
Dr. Somesh Sharma, PhD
(A US citizen)
35+ Years of drug discovery experience in both Indian and US Pharma industry
Dr. Larry Kauvar, PhD
(A US citizen)
35+ Years of experience of drug discovery experience in US Pharma industry
A Regulatory Consultant, who is an expert in 505(b)(2) NDA submissions – to be hired.
Administrative Team – Responsible for managing Admin & Finance Departments
Mrs. Veeraveni Baddireddi, MMS
(Finance)
Co-founder and Managing Director at Augment Therapeutics
Auditor: Mrs. Radhika Vunnam, Chartered Accountant, Hyderabad.
CURRENT PROJECT OBJECTIVE: DEVELOPMENT OF A POTENTIALLY “SUPER GENERIC” VERSION OF OMEPRAZOLE THROUGH 505(b)(2) NDA ROUTE
OMEPREZOLE USES
Generic omeprazole is the most widely used anti-ulcer medicine and it is the only proton pump inhibitors (PPIs)-based anti-ulcer drug included in the WHO’s List of Essential Medicines. Omeprazole is widely used for the treatment of duodenal and gastric ulcers, gastro-oesophageal reflux disease (GERD), dyspepsia and Zollinger-Ellison syndrome. It is also used in combination with NSAID-based pain medicines such as naproxen, diclofenac, aspirin (which is also widely used for prevention of cardiovascular disease), etc., and with antibiotics amoxicillin (or metronidazole) and clarithromycin in triple therapy for effective eradication of Helicobacter pylori infection.
OMEPRAZOLE PROBLEMS
Unfortunately, omeprazole suffers from the following drawbacks or problems: 1) it decomposes under acidic conditions of stomach; 2) it shows very poor bioavailability; 3) it must be enteric coated, which not only increases the cost of drug but also delays onset of therapeutic action due to delayed absorption; 4) it must be dosed early morning before breakfast, which is very inconvenient to patients; 5) higher doses and/or long-term use of omeprazole (or any other approved PPI) has shown many side effects such as Clostridium difficile-associated diarrhoea, pneumonia, osteoporotic fractures, etc.; 6) poor profit margins as it has no exclusivity and faces stiff competition among hundreds of omeprazole manufacturers and sellers.
Hence there is an immediate medical as well as commercial need for development of “better or super generic” versions of anti-ulcer drugs that do not show any or most of the above-mentioned drawbacks or problems of omeprazole and other proton pump inhibitors.
OUR SOLUTION
As a solution, we have now invented a potentially “super generic” version of omeprazole, which does not exhibit most of the above-stated drawbacks or problems of omeprazole. Thus, our potentially “super generic” version of omeprazole (is/shows):
- Stable in acidic conditions of stomach;
- Statistically significant improvement in bioavailability over omeprazole (See the PK data showing comparison of oral bioavailabilities of omeprazole prodrug, omeprazole and esomeprazole (included for comparison). Please access the said PK data by using the URL: http://www.mediafire.com/file/pnrz3qox2w7vka0/Bioavailability_data.pdf/file);
- May not need enteric coating which not only reduces cost of the drug but also helps in faster onset of therapeutic action;
- May be dosed anytime a patient needs it – can lead to patient convenience and better compliance;
- May reduce (or even eliminate) side effects that are believed to be dose-dependent;
- A novel patentable molecule – can offer 5 years exclusivity when it is developed via 505(b)(2) NDA route and even 20 years exclusivity when it is patented.
- Moderate to high profit margins can be expected as our compound is an improved version of generic omeprazole.
Zegerid, due to presence of sodium bicarbonate, is not recommended for patients with:
- Respiratory alkalosis
- High blood pressure
- Chronic heart failure
- Renal failure
- and those patients who are on salt-restricted diet
Other Known adverse reactions with NaHCO3 include:
- Headache, abdominal pain, flatulence, gas formation, metabolic alkalosis, diarrhoea, hypernatremia, peripheral edema, seizures, tetany and tremor
- There were many instances of stomach rapture on consumption of sodium bicarbonate immediately after a heavy meal
OUR COMPETITIVE ADVANTAGES
Initially, several hundred omeprazole manufacturers and sellers around the world may be our competitors but our potentially “super generic” version of omeprazole is expected to prevail due to its competitively advantageous properties over generic omeprazole. However, the following are a few other competitors:
SANTARUS, INC., USA [https://www.linkedin.com/company/santarus-inc./]
Santarus developed Zegerid, which is a combination product containing immediate release non-enteric coated omeprazole (20 mg or 40 mg) and sodium bicarbonate (1000 mg). Zegerid was also approved through 505(b)(2) NDA route in 2006 and achieved peak sales of $307 Million in 2017, which is about 11.4% share of omeprazole market.
DR. REDDY’S LABS
Dr. Reddy’s Labs recently launched generic version of Zegerid in the US Market and this generic Zegerid also suffers from the same above-mentioned drawbacks of sodium bicarbonate.
Hence, Zegerid or its generic version could not disrupt the omeprazole market significantly due to the drawbacks associated with sodium bicarbonate.
We therefore believe that our super generic version of omeprazole, due to the above-mentioned competitive advantages over Zegerid and generic omeprazole, has the highest potential to become the “anti-ulcer drug of choice” among proton pump inhibitor-based anti-ulcer drugs.
OMEPRAZOLE MARKET
Omeprazole is currently the 7th largest prescribed drug with >70 million prescriptions and its current global market is at $2.67 billion and it is projected to grow to $4.00 billion by 2026.
Hence, our potentially “super generic” version of omeprazole, because of its competitively advantageous properties over generic omeprazole and Zegerid, has the highest potential to grab significant market share from omeprazole market and can become a “Blockbuster” drug within a short period of its introduction to the US Market.
STARTUP FINANCIAL NEEDS
NEAR TERM NEED (12-18 months): We are seeking $0.60 – 1.00 million equity seed funding to complete/reach the following tasks/milestones:
- Hire a professional regulatory consultant from USA, who is an expert in 505(b)(2) NDA process.
- BY taking help of the said regulatory consultant, complete Pre-IND meeting with US FDA and get advice/minutes of pre-IND meeting from USFDA for the development of this promising prodrug of omeprazole through 505(b)(2) NDA route within 6 months from the date of Pre-IND meeting request.
- File a provisional patent application in India within 4 months of initiation of this project.
- Synthesis of new prodrugs of other approved PPIs and determine and compare their acid-stability and oral bioavailability with their respective parent PPIs.
- Develop a process and make 50-100 g of NCE for the preclinical and stability studies.
- Complete a few essential preclinical toxicity studies such as Ames test, Micronucleus test and Chromosomal Aberration test.
- Complete either or both of the following two efficacy tests (which is/are essential to overcome the possible rejection based on Section 3(d) of Indian Patent Act in order to get a patent in India): i). Determine and compare efficacies of omeprazole prodrug and omeprazole in rats with acute gastritis induced by NSAID such as aspirin or diclofenac. ii). Determine and compare efficacies of omeprazole prodrug and omeprazole in rats with gastritis induced via Pylori infection.
- Complete stability studies on the NCE as per ICH guidelines for a duration of 12 months initially, which may be extended up to 18 months or 24 months if it is necessary.
- File a non-provisional, PCT and US patent applications within 12 months from the provisional filing date.
- Draft and submit a manuscript for publication to an international peer reviewed medicinal chemistry journal within a few months of filing PCT and non-provisional patent applications.
LONG-TERM NEED (12-18 Months):
We will seek $4.00 – 6.00 million Series A funding as soon as we reach the anticipated significant milestone (i.e., US FDA qualifying our molecule for development through 505(b)(2) NDA route) and complete the required preclinical & clinical development of NCE as per FDA guidelines and submit 505(b)(2) NDA to US FDA.