BIOSTEM TECHNOLOGIES, INC. OTC:BSEM
IS A WORLD-CLASS BIOTECHNOLOGY PROVIDER THAT COULD SOON BE IN THE SPOTLIGHT ON WALL STREET!
BioStem Technologies, Inc., (OTC: BSEM), a biopharmaceutical company dedicated to commercializing regenerative biologics, stem cells, pharmaceutical products and the reformulation of niche drugs that improve, extend, and transform the quality of life for our patients. BioStem Technologies is built upon 3 distinct divisions, regenerative medicines, pharmaceutical API chemical supplies, and drug reformulation. Each division operates as a separate private entity with financial reporting that rolls up to the public parent company of BioStem Technologies.
With a focus on Active Pharmaceutical Repackaging, Pharmaceutical Reformulation, Stem Cells and Regenerative Medicine, BioStem Technologies is positioning itself to become one of the most recognized biopharmaceutical companies in today's rapidly changing medical landscape!
BioStem Technologies, Inc. (OTC PINK: BSEM), is pleased to announce the asset purchase of multiple new drug compounds from CCM Pharma Solutions establishing the beginning of a joint venture.
Nesvik Pharmaceuticals and CCM Pharma Solutions have agreed to work together to reformulate four new drug compounds using the accelerated 505(b)(2) pathway. CCM Pharma Solutions has a proven track record of successfully identifying and bringing new drug compounds to the market. Upon FDA approval of these drug compounds, Nesvik Pharmaceuticals will obtain either NDA, ANDA or Orphan drug status adding valuable assets to the company balance sheet. The projected revenues of these products upon approval will also support the company valuation in the future. CCM Pharma Solutions has a veritable history of working with Joseph Esposito, president of BSEM’s pharmaceutical division, to bring new formulations to the market via the 505(b)(2) pathway.
Andrew Van Vurst, Chief Operating Officer at BSEM stated,
“The team is very keen on moving these products into formulation development and have already made great progress in preparation of the Pre-IND application packages. We believe that the established and successful working relationship between CCM Pharma and Joseph Esposito will allow for rapid acceptance through the FDA 505(b)(2) approval process.”
Through this acquisition, BSEM will:
Acquire and fully possess four drugs identified for reformulation (BSEM 120, 125, 130, 135).
Receive royalties from new chemical entities developed (INV-220, 301, 401, and CAR-208, CCM-508, 509, and 510).
BSEM’s Initial Launch: Qualified Pharma Ingredients
BioStem's initial primary focus will be on Active Pharmaceutical repackaging under its subsidiary Qualified Pharma Ingredients. Qualified Pharma Ingredients, “(QPI)”, is the premier supplier of high quality active pharmaceutical ingredients and other pharmaceutical supplies. Using our pharmaceutical manufacturing experience, QPI continues to raise the bar of the current pharmacy supply industry. This business model reduces pharmacy risk, creates cost savings, and generates revenue opportunities, all while establishing the highest level of patient safety
The FDA has issued mandatory guidance requiring all 50 states to meet new federal guidelines for Quality, Traceability, and Transparency of chemical source. These new guidelines go into full effect Jan 2020. Other than QPI, none of the none of the current compounding pharmacies suppliers meet these new guidelines. This fact positions QPI ahead of the market giving it a unique opportunity to capture market share from existing providers. QPI will be able to meet the new standards today and offer its product at the same retail price of its competitors.
The QPI Product Example
QPI will carry in excess of 60+ unique chemicals. Below is an example of a typical product Cost - Margin - and Revenue.
QPI is currently licensed in 5 states, initial launch will be FL, TN, NC, TX, AZ.
Additional states will be phased in rapidly as revenue opportunity allows.
Leverage channel partner relationships
A scalable professional direct sales organization trained in Pharma.
Establish regional sales teams (feet on the street).
BioStem Pharmaceuticals Goal
BioStem Pharmaceuticals (OTC: BSEM) is working at the forefront the pharmaceutical industry to reformulate traditional solid dosage drugs into liquid delivery methods for niche patient groups using the FDA’s 502(b)(2) accelerated pathway to the market.
There are many challenges when trying to treat the pediatric and geriatric segments of the population with solid dosage drugs. Children and the elderly often experience difficulties in swallowing solid dosage drug forms. In both patient groups, small sized particulates or liquid dosage forms are superior to classic tablets or capsules. This creates a niche market for drug manufacturers like BioStem Pharmaceuticals to take advantage of and commercialize.
The 505(b)(2) Accelerated Development Path
In order to assist companies to develop and deploy liquid form drugs quickly, the FDA has created an accelerated approval process called 505(b)(2) process. This process allows reformulation companies to leverage prior drug data and trial information from the original drug manufacturer of the solid form. This new pathway alleviates additional lengthy, expensive trials. From beginning to end a drug candidate can fast track into the market in approximately 24 to 30 months.
Targeted for Reformulation
Currently, BioStem Pharma (OTC: BSEM) has chosen 4 initial drugs for reformulation development in 2018. Three of these drugs are in the Cardiovascular sector, and one drug in the Schizophrenia area of medicine.
Cost of Development
Each drug will require approximately $2.5M in development cost and 2.5M in FDA Fees. Once completed and deployed each drug is projected to yield top-line revenue in the realm of $30M-$40M annually in the US Market. Additionally the FDA provides exclusivity on each drug released for approximately 4 to 6 years.
BioStem Pharmaceuticals Market Advantage
Diverse, high-margin product pipeline focused on limited competition markets
Focused on the development and marketing of finished dosage forms that are inherently difficult to manufacture
Our portfolio provides multiple opportunities for future growth
Rapid development of 4 products with FDA approvals expected by 2021
Product regulatory filings expected by Q4 2019
Utilizing three highly-vetted contract manufactures located in the United States, Canada, and China
Experienced Executive Team: 100+ years of combined industry experience
State of the art FDA approved lab located in Pompano Florida
Extremely efficient, semi-virtual business model
Favorable fee for service or partnership terms on all development products
Attractive economics on diverse product pipeline will enable margin expansion
Specialty pharmaceutical business focused on the development and marketing of products with finished dosage forms that are inherently difficult to manufacture
Distribution performed by partner(s)
Outsourced manufacturing performed by FDA inspected facilities in the United States, Canada
Continued clinical Pharma research in conjunction with established pharmaceutical companies
Ongoing drug studies through existing facilities
The BioStem Regenerative Medicine Focus
BioStem is focused on harnessing the power of regenerative biologics by creating cellular medicine as a new paradigm of healthcare using breakthrough therapies that treat patients who otherwise are without effective treatment options. Our emphases will be advancing ethical regenerative medical treatments for muscular, joint, neurodegenerative and autoimmune diseases that benefit our society.
The Benefits of Regenerative Medicine
Regenerative Biologics contain the ability to generate replacements for cells that are lost through normal wear and tear, injury, or disease. As a multi-potent cell, they have the potential to develop into different cell types in the body. When a stem cell divides, each new cell can remain a multi-potent stem cell, or develop into a more differentiated type of cell, such as a muscle cell, red blood cell, or a brain cell. They have also been shown to produce a signal to induce changes in nearby cells further promoting repair and regeneration in surrounding tissue. Regenerative biologic research continues to advance exponentially each year and is one of the most fascinating and investable areas of medicine today.
Having exhausted all current treatment options, many of our patients come to us seeking alternative options. Educating them on the remarkable potential of the body’s own natural repair mechanisms, and the demonstrated effectiveness of adult stem cell therapy, we grant our patients access to treatment for certain chronic conditions.
Certain of the statements and materials set forth in this presentation constitute “Forward Looking Statements.”
Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will likely,” “should,” “could,” “would,” “may” or words or expressions of similar meaning. All such forward- looking statements involve risks and uncertainties, including, but not limited to, those risks described herein and in the private placement memorandum related to this offering. Therefore, prospective investors are cautioned that there also can be no assurance that the forward-looking statements included in this presentation will prove to be accurate. In light of the significant uncertainties inherent to the forward- looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by BioStem Technologies or any other person that the objectives and plans of BioStem Technologies will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, BioStem Technologies does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.