Probi makes medical moves with its largest distribution deal to date
The agreement covers the license and supply of Probi’s probiotic strain Lactobacillus plantarum 299v (LP299V).
Probi will bulk supply capsules of its probiotic while Ipsen will package and market the products primarily through pharmacies.
“[The product] is expected to be launched in the first half of 2017 as a food supplement in the European markets, and then, in other key markets such as Russia and China, depending on regulatory approval,” the company said in a statement.
The LP299V strain – which the company combines with vitamin C, folic acid and iron – is also the subject of its 13.5 health claim application for increased non-heme iron absorption.
The company expects a response to the application from the European Food Safety Authority (EFSA) this year.
Yet Linda Neckmar, Probi’s director of consumer healthcare marketing and sales, told us back in November that if the claim was rejected the firm would “intensify medical marketing” and focus on exporting to the US and Asia.
Responding to our request for comment after the initial publication of this article, Probi’s CEO Peter Nählstedt told us the Ipsen agreement was not linked to its regulatory strategy in Europe.
"We believe the European markets are highly interesting and will keep on investing in developing our scientific dossier with the ambition to meet the requirements of the health claim regulation."
He said the company was investing in more studies for health claim dossiers, but not specifically for the pending iron absorption claim. "We are unsure of the timing of EFSA's response on our current application, it should be latest by end of July."
Meanwhile Ipsen – which sells more than 20 drugs in 115 countries – posted sales exceeding €1.4 billion in 2015.
A history of pharma
Ipsen specialises in areas including tumour treatment and neurosciences.
However it also has drugs in its portfolio for gastroenterology – Smecta for treatment of acute and chronic diarrhea and digestive pain and Forlax for constipation.
Marc de Garidel, Ipsen chairman and CEO, said in a statement the partnership “fully aligned” with its strategy to strengthen its gastroenterology portfolio and expand into probiotics.
Meanwhile executive vice president of the company’s primary care unit, Jean Fabre, said: “This agreement will help sustain Ipsen’s Primary Care growth and accelerate transition to the OTx [dual channel approach] model.
“The product has strong medical endorsement that will perfectly fit with our expertise and leverage our capabilities towards physicians and pharmacists in many countries.”
The company referenced the concept of ‘Rx/OTC’, whereby proven prescription drugs (Rx) are transferred to non-prescription, over-the-counter (OTC) status.
Probi’s CEO Peter Nählstedt said he expected to reach “many new markets” through the deal.
A record quarter
Today (27 April) Probi posted net sales of 87 million Swedish Kroner (€9.49m) in what it called "a new record quarter" with 26% growth compared to Q1 in 2015.
“While Probi’s growth continued in the US, other markets – including Sweden and South Korea – also contributed to the first-quarter increase. We have high expectations of our new agreement with Ipsen Pharma, and expect the partnership to generate considerable volumes in a few years’ time, since it covers a number of markets with high potential that are new for us," Nählstedt said in a financial results statement.
"The agreement is of major strategic importance to Probi and our assessment is that it could be the most comprehensive distribution agreement to date for Probi. Although we anticipate faster growth than the overall market for the full-year 2016, we do not expect to achieve the same percentage growth rate as in 2015.”
