Ektapharm, LLC.
Executive
Overview
Ektapharm is developing
novel drug delivery technology that:
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Addresses large unmet bio-pharmaceutical industry needs
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$8.8B and growing market segment
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Experienced scientific team
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Strong patent IP portfolio
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Active partnership interest
¨
Capital efficient pathway
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Ektapharm,
LLC. is a bio-pharmaceutical development company that is commercializing
technology to address clear challenges in the $8.8B segment of the drug
delivery market encompassing injectable/implantable [PLGA] polymers.
Developed
around proprietary microencapsulation technology invented by Steven Schwendeman,
Ph.D., Chair of Pharmaceutical Sciences at the University of Michigan,
Ektapharm has assembled a technical team of senior drug delivery experts with
extensive industry experience. Ektapharm’s technology addresses recognized
pharmacokinetic, processing and controlled drug delivery issues with existing PLGA-polymer
drug delivery technologies, that currently are the basis for several
billion-dollar drug products from companies such as Abbott, AstraZeneca and
Novartis.
Ektapharm
has drawn active licensing interest from large biopharmaceutical companies, and
is following a capital efficient development pathway that promises to generate
significant returns for investors with clearly defined early stage investor exit opportunities as
early as 2015/16.
The Market
Poly(lactic-co-glycolic
acid) (PLGA) is a well-characterized, FDA-approved, polymer that is currently an
essential component of several widely-prescribed therapeutics such as
Sandostatin LAR® (Novartis), leuprolide acetate (Abbott, Sanofi-Aventis, TAP),
and Zoladex® (AstraZeneca) which had 2010 sales of over $1B (US), $2B
(worldwide) and $1B (worldwide), respectively.
With
20+ years in commercial use, PLGA enables in
vivo controlled (sustained-LAR) release of a variety of therapeutics, including
biotherapeutic macromolecules, with predictable in vivo degradation (Figure 1). This allows for superior dosing,
compliance, and delivery of sensitive therapeutic compounds. Despite its commercial use, PLGA systems have
several major shortcomings that prevent more cost-effective manufacturing and
extension of use to other therapies and indications.
By
overcoming key challenges with current methods of PLGA manufacturing and drug
encapsulation, Ektapharm’s proprietary microencapsulation and processing
technologies hold the potential to:
·
Improve
in vivo pharmacokinetics by
eliminating the initial “burst” of drug release common to current PLGA systems;
·
Transform
PLGA manufacturing from expensive, large-scale aseptic processes to lower cost,
terminal sterilization;
·
Avoid
biochemical protein degradation and use of protein-denaturing organic solvents;
·
Enable
extension of patent-life on drugs at the cusp of expiration and/or use of PLGA
in new indications.
In
total, the US injectable/implantable drug delivery market consists of
therapeutics (APIs) and the improved delivery technologies with which they are
packaged. This market is projected to reach $8.8 billion in 2011 with an annual
growth rate of 7.9%.
Business
Strategy
Ektapharm
will seek to leverage its scientific team’s industry relationships and current
interest from two global, large-cap biopharmaceutical companies into commercial
partnerships and licensing deals. As a prerequisite to these partnerships,
Ektapharm will initially focus on fully characterizing its drug delivery system
according to commercially relevant specifications. To do so, Ektapharm has set up a laboratory
in Michigan and will hire one FTE (candidate identified) to complete these
studies. Upon completion, Ektapharm will
be in a position to re-initiate partnership/licensing discussions with
currently interested parties and identify additional licensing opportunities. Analyses of comparable licenses suggests that such deals could be valued from $40 to
$200 Million.
In
parallel with partnership efforts, Ektapharm’s team will assess potential lead
therapeutic applications for which Ektapharm’s technology would be uniquely
suited to create clinical value for therapeutic agents/drugs that cannot be
effectively delivered with current modalities. Should worthy therapeutic candidate[s] be
identified, Ektapharm plans to expand its operations and acquire/recruit additional
technical and management personnel to develop this candidate for clinical
testing and likely acquisition by a major biopharma upon successful completion
of Phase II trials.
Progress
to Date
In addition to
company and team formation, Ektapharm has made significant scientific progress
to date. In vivo efficacy and release studies were conducted with leuprolide
demonstrating reduced initial drug burst. Also, in vitro studies have been conducted to characterize micropores,
loading, release kinetics, protein stability, and encapsulation efficiency. In
total, 7 patents have been filed and two have issued (US 6,743,446 &
8,017,155) on Ektapharm’s technology. Finally, the company through expert
Pharma marketing consulting resources conducted a survey of several senior
biopharma executives in R&D and business development that validated the
market need for improved PLGA-related pharmacokinetics, processing, and
delivery and Ektapharm’s corresponding value proposition.
Team
Ektapharm’s team has
significant experience developing and managing drug delivery technologies
combining in depth knowledge of the science with extensive industry track
records (see
CV’s):
Management
Frederick Foley, Chief Executive
Officer. Fred has continuing interests in biomedical and drug delivery
technologies with a number of leading researchers. He is a seasoned
entrepreneur with a background in division line management, operations, business
development, mergers and acquisitions, innovative technology programs with
large (Fortune100) and start-up entities. He was CEO/co-founder of a number of
early stage technology-based enterprises where he led successful fund raisings and
numerous multi-million dollar bio-medical product development programs.
He
has completed a number of advanced business programs at the Harvard Business
School, Franklin Pierce Law and conducted research [industry fellow] at UC
Berkeley and remains an active participant in numerous continuing life science
medical educational org programs and holds numerous medical technology patents.
Chief Science Officer TBNamed - 2014
Scientific
Advisory Board
Professor Steven Schwendeman, Chair
Department of Pharmaceutical Sciences, University of Michigan. Principal inventor of
EktaPharm’s technology,
Dr. Schwendeman’s research focus involves all aspects of
poly(lactic-co-glycolic acid) delivery systems, including: microencapsulation,
stabilization and controlled release of PLGA-encapsulated therapeutics. He has numerous awards, publications and
patents. Steve received a B.S.E. in Chemical Engineering and his Ph.D. in
Pharmaceutics from the University of Michigan. He completed postdoctoral
training at MIT with Professor Robert Langer.
Larry
Brown, Sc.D.,
Former CTO/VP Research, Baxter Healthcare. Larry has conducted early stage
research and directed further development of a number of successful widely used
biopharmaceutical products. In addition to his tenure at Baxter he held
senior research leadership positions at Enzytech, Inc. (now Alkermes), Transderm
Diagnostics, Inc. (founder) and Epic Therapeutics, Inc. Larry received his doctorate with Professor
Robert Langer at MIT.
Mark
Tracy, Ph.D.,
Tracy Bio-Consulting Dr. Tracy has been a
product development executive with over 20 years of scientific, managerial,
business, experience focused on transforming advances in new drug delivery
technology and medicinal research for a number of leading drug delivery and pharmaceutical
companies. He is the Past President of
the Controlled Release Society (CRS) and currently provides consulting services
to the biopharmaceutical industry. Dr Tracy received his PhD in Chemistry from
Stanford University.
Tacey
Viegas, Ph.D.,
COO Serina Therapeutics, Inc. Dr. Viegas has many years of
pharmaceutical industrial experience in drug discovery, drug delivery and
pharmacokinetics. He held a number of scientific development positions at R.P.
Scherer Corporation (now Catalent), MDV Technologies, BioCryst Pharmaceuticals and
Nektar Therapeutics. Dr. Vieges has numerous patents and publications in the
area of polymer therapeutics [PEG] and pharmaceutics. He has developed numerous
multi-million dollar biopharma product technologies. He has a B.S. in
Chemistry and Pharmacy, M.S. and doctorate in Pharmaceutical Sciences
from the University of Mississippi.
Seed Funding Milestones:
¨ System
Characterization
¨ Partnership
discussions
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As a
near virtual company, Ektapharm is advancing its technology studies aided by the company’s advisory board along with well
known established commercial GMP partnered resources
Upon completion of
these studies, Ektapharm expects to be in a position to enter licensing partnerships.
For more information, please contact:
