Sanofi to supply insulin to Generex

By Nick Taylor

- Last updated on GMT

Related tags Insulin

Sanofi-Aventis will manufacture and supply recombinant human insulin crystals to Generex Biotechnology for use in Oral-lyn commercial production and clinical trials.

Oral-lyn, Generex’s liquid formulation of regular human insulin delivered to the buccal mucosa, is commercially available in India, Lebanon, Algeria and Ecuador and Phase III type 1 diabetes trials are ongoing at several sites.

To support attempts to gain regulatory approval in major markets, including the US and Canada, Generex has entered into an active pharmaceutical ingredient (API) supply agreement with Sanofi.

"We are very pleased to have entered into this long-term supply agreement for insulin crystal​," said Anna Gluskin, Generex's president and CEO.

Gluskin added: "It solidifies one of our key product components which will assist in the smooth transition into commercialisation of our flagship product, Generex Oral-lyn, into major markets​.”

The insulin will be manufactured at Sanofi’s site in Frankfurt, Germany. Since the end of the 1990s the site has developed pilot and commercial scale production of human recombinant insulin from a genetically modified Escherichia coli​ strain.

In addition to gaining an API supply Generex will also receive quality and regulatory support from Sanofi. Generex’s regulatory team will now begin updating current regulatory submissions to include Sanofi’s insulin crystal.

“A new paradigm”

Gluskin explained that Generex is seeking “to establish a new paradigm for the treatment of diabetes​” by gaining regulatory approval for Oral-lyn in major pharmaceutical markets.

The company believes its product “is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin​” which, unlike inhaled insulin products, has no pulmonary deposition.

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