After launching its flagship oral insulin spray in Ecuador last December, Generex is finally gearing up to take on big pharma in the global non-injectable insulin arena and has picked Cardinal Health to help meet manufacturing demands.
The Canadian biotech firm stole a march on Pfizer last year, beating the pharma giant to the title of launching the world's first non-injectable insulin, Oral-lyn - an insulin spray delivered by the company's RapidMist device into the mouth of the patient.
However, Pfizer will launch its anticipated blockbuster, a pulmonary inhaled insulin device called Exubera, in the US next month and with other products from big firms such as Eli Lilly and Novo Nordisk following behind, Generex must break into the major markets of the US and EU soon if it is to have any major part in this competition.
Generex first needs to conduct large-scale Phase III clinical trials on Oral-lyn in order to get it approved by the tougher regulatory authorities of the EU and US, as the approval of the product in Ecuador was based on the results of clinical trials in Ecuador involving only 250 patients with diabetes.
With this in mind, Generex is planning to start clinical trials involving thousands of patients in Canada, Israel, Italy and the UK by the end of August and Cardinal is now ramping up production of Oral Lyn to meet this deadline, Mark Fletcher, executive vice president of Generex told Outsourcing-Pharma.com.
For previous trials Generex has made the clinical supplies of the drug at its pilot plant in Canada, and will still continue to do so, however, the firm is now also calling upon Cardinal to help boost its supplies.
"We need more product in a shorter time frame than our pilot plant can handle alone," said Fletcher.
"We circulated a request for proposals and at the end of the day, Cardinal was the best choice in terms of price and capability."
Under the terms of the contract, Cardinal will formulate and fill clinical trial batches of the drug into the pre-made drug delivery device at its manufacturing and analytical services facility in Research Triangle Park, North Carolina, US.
Cardinal is not the only beneficiary of Generex's desire to compete on a global scale.
The two firms that manufacture the drug delivery device, French firm Valois, who makes the rubber valves, and UK firm Pressport who makes the metal canisters, have also now ramped up production and business will continue to grow for these two firms if Generex achieves worldwide acceptance, particularly Valois.
"Valois is an extremely specialised company and is the only one in the world who can make these valves," said Fletcher.
The commercial production of Oral-lyn for the Ecuador market is currently being carried out by PharmaBrand, Generex's joint venture partner, at its existing manufacturing plant in Quito, Ecuador.
Generex is also preparing to file for approval of Oral-lyn in Columbia, Peru and Bolivia, and will further scale-up production in the second half of this year to produce over 2 million cans per year to service commercial sales in those additional markets.
"If Cardinal performs well under the current contract, it is entirely possible that we will partner with them for the commercial manufacturing of Oral-lyn in other parts of the world once it receives marketing approval," said Fletcher.
"We have no current plans to build a manufacturing facility of our own."