This was the first news piece of 2019, about a year ago. It sounded so promising at the time:
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/PRNewswire/ Generex Biotechnology Corporation (OTCMKTS: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 Excellegen 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
marketsto 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.”
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/PRNewswire/ Generex Biotechnology Corporation (OTCMKTS: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 Excellegen 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
marketsto 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.”
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