Do-Coop Technologies Ltd., a privately held corporation based in
Israel, announced today that it has reached two significant milestones
for Neowater(TM), its proprietary water-based nanotechnology. A Type
IV Drug Master File has been submitted to the US Food and Drug
Administration (FDA) for Neowater. In addition, the first Current Good
Manufacturing Practice (cGMP) Neowater manufacturing plant is
operational in Israel.
About Neowater
Neowater is an enabling technology that is based on breakthrough
water-based nanotechnology. Unlike traditional, dry nanotechnology,
which focuses on a nanoparticle end product, Neowater builds upon the
unique properties of nanoparticles to modify the physical properties
of water molecules around them.
Each nanoparticle within Neowater, with its huge surface, creates
an effect known as the "surface effect," and in turn organizes the
water molecules surrounding it. This is similar to the surface effect
of organelles within living cells. Both the organelles and the
nanoparticles use this unique mechanism to create intracellular water.
While the former is within cells and organs and cannot be harnessed
nor used in a lab bench, the latter one, which is branded as Neowater,
can.
This technology, developed in Israel, produces water whose
physical properties mimic that of intracellular water using inorganic,
insoluble crystals introduced in water in a patented process.
Neowater, with its stable system of largely hydrated nanoparticles,
like non-ionic detergent derived micelles, reduces the entropy of
aqueous solutions. In addition, by design, since it exhibits both
hydrophilic and hydrophobic properties it can be used as a unique
solvent replacement.
Neowater DMF (for WFI) and cGMP production
Biotech and pharmaceutical companies have within their portfolios
a significant amount of compounds and drugs which have been proven
effective in vitro, yet they are very insoluble and thus unusable,
such as novel cancer therapeutic drugs. Other compounds which are good
drug candidates are too soluble, or they are prone to hydrolysis, both
rendering them ineffective. While these companies are experts at
screening and finding effective compounds, and they have invested
millions in this effort, they often lack the expertise to overcome
these challenging technological barriers and release these compounds
to the market. Neowater technology allows such companies to capture
the real value of otherwise valueless portfolios.
"Using Neowater, biotech and pharma companies can solvate their
valuable compounds, enhancing both their stability and
bioavailability, and thus can extend and protect their intellectual
property and investments. We have packaged our enabling technology
capabilities into a unique, simple-to-use service that can enable
companies to reduce or replace polar solvents such as detergents and
surfactants, alcohols and other broadly used solvents like DMSO, as
well as to replace regular water and even lyophilization. Our
customers have validated the performance of their Neowater-solvated
compounds in their own laboratory and in pre-clinical tests, and have
returned to us to license this unique capability," said Eran Gabbai,
founder, President and CTO of Do-Coop Technologies, and the inventor
of Neowater technology.
"Our customers have asked us to submit Neowater to the regulatory
bodies, such as the US FDA, so clinical trials with the re-formulated
compounds could begin as soon as their pre-clinical studies were
completed. The submission of a Type IV DMF for Neowater to the FDA
allows a convenient way for companies to cross-reference our filing in
their regulatory submissions. In parallel to the regulatory review of
Neowater, we have also designed, built and approved the first
cGMP-compliant Neowater manufacturing plant, which is located in
Israel. These milestones mean that our pharma customers can now start
clinical studies for their compounds formulated with Neowater, and
also avoid the need for a separate Neowater control in their studies,"
added Mr. Gabbai.
Do-Coop Technologies will present Neowater technology at the
Business Forum (May 9th, 11:15 a.m., Room B, Drug Delivery Session)
and also exhibit during the Bio 2007 Annual International Convention
in Boston, MA, May 6-9, 2007 (Booth #2087).
More details can be found in Do-Coop's web site www.docoop.com or
by sending an email to info@docoop.com .
