NZ firm seeks European partners to make heart drug ingredient
pharmafile | April 12, 2011 | News story | Manufacturing and Production |Â Â Photonz Corp, contract manufacturingÂ
A small New Zealand company is trying to find European contract manufacturing partners to help it scale up production of an omega-3 fatty acid ingredient derived from marine microalgae.
Photonz Corp has just signed an agreement with French technology company Separex to develop a separation process for the eicosapentaenoic acid (EPA) ingredient, which it says has been shown in trials to boost the beneficial effects of cholesterol-lowering statin drugs in patients with cardiovascular disease.
The first EPA-based pharmaceutical product reached the market in 1990 in the form of Lovaza (formerly Omacor), which contains EPA derived from fish oil and sold in Europe by Norwegian company ProNova BioPharma.
Lovaza remains the only EU- and FDA -approved omega-3 derived prescription drug, with more than $1 billion in worldwide sales in 2009, according to IMS Health data. Much of that total is accrued by GlaxoSmithKline, which licenses rights to Lovaza in the USA and Puerto Rico and says it brought in around $822 million in sales last year.
With such a lucrative market in the offing, other omega-3 fatty acid based drugs are coming through development, notably Amarin’s AMR101 which could be filed for approval in its first markets this year.
Photonz believes that as demand for EPA grows, fisheries will be unable to supply enough of the raw material.
“Fish are the only source of all EPA used in drugs”, it says, noting that EPA drug sales are exposed to the risk of not being able to source the most important ingredient.
“We plan to secure a significant share of EPA sales to drug manufacturers on the basis of product consistency and as the ‘insurance policy’ in the supply chain”, notes the company.
Photonz’s aim now is to identify a European contract manufacturer which can work with Separex and Photonz to develop a commercial-scale production platform.
The firm built a prototype industrial fermentation plant for microalgae-derived EPA last year, marking a major increase over its earlier pilot-scale operations, but said at the time that “considerable problem-solving” still had to be undertaken to make the process more reliable.
Since then, a lot of work has gone into improving yields and developing downstream purification processes so that a high-purity EPA suitable for pharmaceutical applications can be achieved.
Phil Taylor
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