Generex stated that it has paid an initial payment of $400,000 on 27 November 2018 to secure the agreement and it plans to close the transaction in the coming weeks.
Olaregen is all set to launch its first product Excellagen, a flowable dermal matrix device which has secured 510(K) clearance from the US Food and Drug Administration (FDA).
The medical device is claimed to be useful in a range of wound types and it was recently awarded a US patent with a 17 year right of exclusivity.
Excellagen is claimed to be a highly-purified Type 1 collagen-based, flowable gel formulation approved for 17 indications. It is useful in 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.
Generex stated that Olaregen’s Excellagen can activate platelets which trigger the release of essential growth factors and offers a structural scaffold for cellular infiltration and migration. This process is said to significantly accelerate the growth of granulation tissue.
Excellagen’s flowable fibrillar collagen formulation is topically applied through pre-filled sterile syringes and is designed to be applied once a week.
Generex CEO Joe Moscato said: “We are enthusiastic to bring Olaregen into the Generex family of companies. 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.”
Furthermore, Excellagen can act as an Enabling Delivery Platform to deliver peptides, small molecule drugs, DNA biologics, antimicrobials, stem cell and exosomes. Exosomes are extracellular vesicles are the residual components of stem cells responsible for cell-to-cell signaling, which is an important aspect of a cell’s function.
Generex stated that that Olaregen’s pipeline will focus on the development of Excellagen for bone, joints and cartilage regeneration. R&D will also look into the use of the product in treating osteo and rheumatoid arthritis, cartilage repair and plantar fasciitis.
