Generex Biotechnology Makes
Major Advance On $22 Billion
Wound Care Market Announcing Milestone
Agreement
Generex
Biotechnology
Partner Olaregen Therapeutix Inc. Signs Manufacturing
Agreements for Excellagen Wound Healing Collagen
Matrix
Collagen
Solutions & Berkshire Sterile Manufacturing to Supply
Excellagen
for Q1
Launch
MIRAMAR, FL --
January 3,
2019 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation
(GNBT) today announced that its
partially, soon to be fully-owned subsidiary, Olaregen Therapeutix, Inc. has signed critical
manufacturing agreements for Excellagen with Collagen Solutions, a
highly-regarded supplier of medical grade collagen biomaterials for
use in research, medical devices, and regenerative medicine
applications, and with Berkshire Sterile Manufacturing (BSM), a
state-of-the art, GMP fill/finish manufacturer providing
formulation and sterile filling as well as analytical development
and stability services to the biotech and pharmaceutical
industries. The two contract manufacturers
will produce and package Excellagen in two dose formulations for
the initial product launch in the first quarter of 2019, with a
third dosage option for large wounds to follow shortly
thereafter.
The wound care market is
expected to reach $22.8 billion by 2023 from roughly $19 billion in
2018 at a compounded annual growth rate of 3.7%, according to a
report from Markets & Markets. Advanced wound care
products are designed to cure and treat
a variety of complex wounds, such as diabetic foot ulcers, venous
ulcers, and pressure ulcers, burn, trauma and other types all of
which Excellagen are cleared for use. The rising
incidence of difficult to treat wounds are driving the growth of
advanced wound healing products resulting from Increasing
prevalence of diabetes, a rapidly aging population as well as
developments and innovations in enhanced wound care products such
as Excellagen.
In the United States, it is
estimated that as many as 4.5 million people have chronic wounds,
resulting in substantial economic and psychosocial costs. Various
pathologic states result in chronic wound development, including
arterial or venous insufficiency, diabetes, undue skin pressure,
presence of a foreign body, and infection.
Anthony J. Dolisi, CEO of Olaregen Therapeutix commented: "We are extremely
pleased to announce the initiation of production of
Excellagen
and our partnership
with Collagen Solutions and BSM. These premier manufacturing
companies have the scale and flexibility to ensure that
Olaregen
is prepared for
commercial introduction with multiple dosing options for
Excellagen. We now have access to vast
resources and customer/support networks with a common goal of
reducing waste and allowing vertical markets to select the optimal,
cost-effective Excellagen dose based on the patients'
needs. Wound healing is clearly a market that needs to address
these issues. With a comprehensive understanding of the needs of
physicians and patients, combined with a strategy that embraces
improved product offerings along with a competitive economic
advantage we are confident is our roadmap to success."
Joe Moscato, CEO of Generex said, "We are excited
that Olaregen has begun its commercialization
efforts for Excellagen in 17 FDA-cleared treatment
indications, especially in surgical applications and in
areas of high unmet medical need like Mohs surgery (for skin
cancer) and diabetic foot ulcers. As we advance the aims of
Generex
in building a
best-in-class regenerative medicine company, I am pleased to
announce that Generex has signed a term sheet for a
$15 million equity line to make our obligatory payments to fund the
manufacturing and commercial launch of Excellagen, and to ultimately close the
full acquisition of Olaregen. The equity line, once
complete, will also be available to fund the clinical development
of Regentys Extra-Cellular Matrix Hydrogel
(ECMH) that will culminate in FDA submission and approval. The
equity line enables Generex to manage its financials by
making payments to our subsidiaries based on value-driven
milestones rather than through immediate shareholder dilution. We
plan to provide details of this equity financing agreement in the
coming days as we finalize the closing documents and receive
Generex
board approval on
the full transaction". Mr. Moscato continued, "The closing
documents for Regentys are complete and in attorney
review, and that closing should take place in the coming days,
followed shortly thereafter by Olagregen. In addition, we will be
announcing plans to add two new acquisitions to the
NuGenerex
family of companies
that will add significant revenues to NuGenerex Distribution
Solutions."
About Generex Biotechnology
Generex Biotechnology is a strategic,
diversified healthcare holdings company with offerings in a variety
of services, diagnostics, medical devices, and pharmaceutical
development. The mission of the company is to provide physicians,
hospitals, and all healthcare providers with an end-to-end solution
for patient centric care from rapid diagnosis through delivery of
personalized therapies, streamlining care processes, minimizing
expenses, and delivering transparency for payers.
About Olaregen Therapeutics
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. Excellagen is a FDA 510K cleared device
for a broad array of dermal wounds, 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, enabling Olaregen to market Excellagen in multiple vertical markets.
Additionally, Excellagen can serve as an Enabling
Delivery Platform for pluripotent stem cells, antimicrobial agents,
small molecule drugs, DNA-Based Biologics, conditioned cell media
and peptides. Olaregen's initial focus will be in
advanced 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 our Service-Disabled
Veteran-Owned Small Business (SDVOSB)
This a Service-Disabled
Veteran-Owned Small Business (SDVOSB) that specializes in the sale,
marketing, and distribution of innovative medical products through
a nationwide network of veteran owned distribution
services.
About Cannabis Therapies US
Cannabis Health LOI
Generex Biotechnology has also stepped
forward in the rapidly evolving and growing cannabis based
therapies sector entering into an LOI with US Cannabis Health, a JV
between Puration, inc. (PURA),
Kali-Extracts, Inc. (KALY)
and Nouveau Life Pharmaceuticals, Inc. (NOUV).
The LOI includes an agreement for KALY to produce specialized CBD
extracts for infusion into a bottled water to be produced by PURA
under a private label for Generex.
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.
Contact:
Generex Biotechnology
Corporation
Joseph
Moscato
646-599-6222
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