Miramar, FL -- November 28, 2018 --
InvestorsHub NewsWire -- Announces Commercial Launch of FDA
Approved Excellagen® , Proprietary, Patented
Wound Care Product Focused on the Treatment of Complicated Wounds
including Diabetic Ulcers and 16 Other FDA Approved Indications
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Generex Biotechnology Corporation (GNBT) announced today the signing of
a Letter of Intent to acquire 51 percent of Olaregen Therapeutix
Inc., a New York based regenerative medicine company. Generex made
an initial payment of $400,000 on November 27, 2018 to secure the
agreement, and the company is in the process of completing the
legal documents with a plan to close the transaction in the coming
weeks.
Olaregen will introduce its first product, Excellagen®, a
flowable dermal matrix that is a 510K FDA cleared medical device
for utilization for a variety of wound types that has recently been
awarded a U.S. patent with a 17 year right of exclusivity.
Excellagen® is a highly-purified Type 1 collagen-based, flowable
gel formulation approved for 17 indications , including partial and
full thickness wounds, pressure ulcers, venous ulcers, diabetic
ulcers, chronic vascular ulcers, tunneled/undermined wounds,
surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser
surgery, podiatric, wound dehiscence), trauma wounds (abrasions,
lacerations, second- degree burns, and skin tears) and draining
wounds.
Excellagen® activates platelets, triggering the release of
essential growth factors and providing a structural scaffold for
cellular infiltration and migration, this process significantly
accelerates the growth of granulation tissue. Excellagen's® unique
flowable fibrillar collagen formulation is topically applied
through easy-to-control, pre-filled sterile syringes, and is
designed for application at once weekly intervals.
Additionally, Excellagen® can serve as an Enabling
Delivery Platform delivering peptides, small molecule drugs, DNA
biologics, antimicrobials, stem cell and exosomes. Exosomes,
commonly referred to as extracellular vesicles are the residual
components of stem cells responsible for cell-to-cell signaling,
the most significant aspect of a cell’s function. Combined with
certain tissue types, Excellasome® can provide a significant
advance in regenerative medicine.
Olaregen’s pipeline will focus on developing Excellasome®
for the regeneration of bones, joints and cartilage. R&D
efforts will address the use of Excellasome® in the treatment Osteo
and Rheumatoid Arthritis, cartilage repair and plantar
fasciitis.
Excellagen® also offers an innovative opportunity in the
treatment of the rare disease Ehlers-Danlos Syndrome, consisting of
13 subtypes. The Ehlers-Danlos syndromes are a group of connective
tissue disorders that can be inherited and are varied both in how
they affect the body and in their genetic causes. They are
generally characterized by joint hypermobility (joints that stretch
further than normal), skin hyperextensibility (skin that can be
stretched further than normal), and tissue fragility. Research
statistics of the Ehlers-Danlos syndromes show the total prevalence
as 1 in 2,500 to 1 in 5,000 people. Olaregen will seek Orphan Drug
approval for the use of Excellagen® in this rare disorder with
limited therapeutic options at this time.
Excellagen® has a reimbursement code by the
Healthcare Common Procedure Coding System that has a unique Q Code
designation 4149 referred to as a skin substitute.
“We are enthusiastic to bring Olaregen into the Generex
family of companies,” stated Joe Moscato, CEO of Generex. “This
acquisition perfectly illustrates our corporate strategy as we
build a new pharmaceutical company
model. Excellagen® is FDA cleared and ready to
launch using our investment, which is directed at building sales
and commercial value almost immediately. We are
launching Excellagen® through our direct to
physician market channels established with our recently announced
acquisitions in pharmacy and management services. As we have stated
all along, Generex is focused on building an “end-to-end” solution
to improve healthcare for doctors and patients, and the acquisition
of Olaregen is a clear demonstration of this model. All of their
pieces fit together beautifully in our current structure and in our
plans for the future.”
Terry Thompson, COO of Generex and President of NuGenerex
Distribution Solutions, added, “We are actively pursuing new
products to support our MSO network of physicians and surgeons.
Excellagen will be a game changer for our physician networks and
their patients in providing a cutting-edge regenerative medicine
solution to promote healing and tissue repair of difficult to treat
diabetic foot ulcers and tunneling wounds. This acquisition clearly
advances our overall mission to solidify the doctor patient
relationship by providing innovative medicines that improve health
outcomes.”
Anthony J. Dolisi, CEO of Olaregen, continued, “We are
proud to be joining the Generex family of companies with this new
venture. This is an exciting time for the team at Olaregen, which
was established with the primary purpose of
commercializing Excellagen®, a proprietary, patented,
advanced wound healing product that has been FDA cleared based on
excellent clinical results and has a 17 year patent protection. The
Generex family of companies provides a unique opportunity to
execute our commercial launch strategy to deliver product through
surgical centers, department of defense, operating rooms, VA
system, wound care centers, as well as podiatrists’ offices on the
front line in the diagnosis and treatment of patients with wounds
and ulcers resulting from diabetes and cardiovascular
complications. Collectively Olaregen and Generex have a dedication
to clinical excellence and patients and their families stand at the
center of all we do.”
About Excellagen
Excellagen is an FDA-cleared
aseptically-manufactured, syringe-based, ready to use, topical,
flowable, 3-dimensional dermal matrix that supports a favorable
wound healing environment. Excellagen activates
platelets triggering release of Platelet-Derived Growth Factor
(PDGF), key wound healing growth factors. It is designed to
accelerate granulation tissue growth by providing a structural
scaffold for cellular migration and proliferation, and activates
platelets, triggering the localized release of endogenous growth
factors including PDGF. Upon contact with small amounts of
blood, Excellagen immediately activates the
expression of PDGF and activates the healing
process. Excellagen is an FDA-approved medical
device, a highly-purified Type 1 collagen-based gel extra-cellular
matrix and delivery system approved for 17 indications in wound
care, including partial and full thickness wounds, pressure ulcers,
venous ulcers, diabetic ulcers, chronic vascular ulcers,
tunneled/undermined wounds, surgical wounds (donor sites/grafts,
post-Mohs surgery, post-laser surgery, podiatric, wound
dehiscence), trauma wounds (abrasions, lacerations, second- degree
burns, and skin tears) and draining
wounds. Excellagen can also serve as an Enabling
Delivery Platform for pluripotent stem cells, antimicrobial agents,
small molecule drugs, DNA-Based Biologics, conditioned cell media
and peptides. Excellagen is intended for use by
healthcare professionals in the United States.
About Olaregen Therapeutix
Olaregen Therapeutix, Inc. is a regenerative medicine
company focused on the development, manufacturing and
commercialization of products that fill unmet needs in the current
wound care market. The company aims to provide advanced healing
solutions that substantially improve medical outcomes while
lowering the overall cost of care. Olaregen's first product
introduction, Excellagen (flowable dermal
matrix) is a topically applied product for dermal wounds and other
indications. The company is focused in advancing wound care
including diabetic foot ulcers (DFU), venous leg ulcers and
pressure ulcers. Future products focusing on innovative therapies
in bone and joint regeneration comprise the current pipeline. The
company's mission is to become a significant force in regenerative
medicine and advance the science of healing.
About Generex Biotechnology
Generex is a strategic, diversified healthcare holdings
company with offerings in a variety of services, diagnostics,
medical devices, and pharmaceutical development. The Company’s
direct-to-patient services support its strategy of all-inclusive
access to doctors, diagnostics, therapeutics, and additional
health-related services to greatly improve the patient experience
in receiving care. On the provider side, Generex’s management
services remove administrative burdens in multiple provider
settings, including private practice and hospital, allowing doctors
to devote more time to patient care. Revenue from the Company’s
subsidiaries will support clinical advancement of its wholly owned
therapeutic products with a focus in immunotherapeutics based on
stimulating critical members of the immune response, known as T
helper cells, and its proprietary buccal administration of
insulin.
Cautionary Note Regarding Forward-Looking
Statements
This release and oral statements made from time to
time by Generex representatives in respect of the same subject
matter may contain "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995. These
statements can be identified by introductory words such as
"expects," "plan," "believes," "will," "achieve," "anticipate,"
"would," "should," "subject to" or words of similar meaning, and by
the fact that they do not relate strictly to historical or current
facts. Forward-looking statements frequently are used in discussing
potential product applications, potential collaborations, product
development activities, clinical studies, regulatory submissions
and approvals, and similar operating matters. Many factors may
cause actual results to differ from forward-looking statements,
including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not.
Known risks and uncertainties include those identified from time to
time in the reports filed by Generex with the Securities and
Exchange Commission, which should be considered together with any
forward-looking statement. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing
undue reliance on such statements. Generex undertakes no obligation
to update publicly any forward-looking statements, whether as a
result of new information, future events or
otherwise. Generex claims the protection of the safe
harbor for forward-looking statements that is contained in the
Private Securities Litigation Reform Act.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181128005244/en/
Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222
Todd Falls
800-391-6755 Extension 222
investor@generex.com
Russo Partners
Investor / Media Contacts:
Alex Fudukidis
(646) 942-5632
alex.fudukidis@russopartnersllc.com
Caroline Cunningham
(212) 845-4292
Caroline.Cunningham@russopartnersllc.com
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