Excellagen, a Potential Treatment for EDS, is Poised for Launch

Generex Biotechnology will launch a wound care gel formulation called Excellagen, a potential treatment option for patients with Ehlers-Danlos syndrome (EDS) among others disorders.

Excellagen is a highly-purified type 1 collagen-based, topical gel. According to Generex, its 3D dermal matrix favors wound healing. It activates platelets, leading to the release of growth factors such as platelet-derived growth factor, a key wound-healing molecule. The treatment also provides a structural scaffold for cellular proliferation and migration, which boosts tissue growth during the healing process.

Originally developed by Olaregen Therapeutix, Excellagen was approved by the U.S. Food and Drug Administration (FDA) as a treatment for 17 types of wounds, including pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, surgical wounds, trauma wounds, and draining wounds.

Olaregen is now seeking orphan drug approval for Excellagen in wounds in EDS patients. Of note, orphan drug designation is intended to help in the development of therapeutic products for rare diseases or conditions.

Excellagen also was recently awarded a U.S. patent that offers 17 years of exclusivity.

Generex has plans to acquire 51 percent of Olaregen Therapeutix, Excellagen’s developer. The transaction is expected to be completed in the coming weeks.

“We are enthusiastic to bring Olaregen into the Generex family of companies,” Joe Moscato, Generex’s CEO, said in a press release.

Moscato further said that Excellagen will be launched through the company’s direct-to-physician market channels. “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,” Moscato added.

“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,” Terry Thompson, Generex’s chief operating officer and president of NuGenerex Distribution Solutions, said.

Anthony J. Dolisi, Olaregen’s CEO, added: “We are proud to be joining the Generex family of companies,” as it “provides a unique opportunity to execute our commercial launch strategy to deliver products” like Excellagen.

Excellagen was designed to be topically applied through pre-filled sterile syringes, and to be used in a once-weekly dosing regimen.