RSVP (répondez, s’il vous plaît) in Medwatch – Thea Olesen.

by HOBBES on 7TH AUGUST 2012 · a translation of the article by

KRESTEN MORTEN Munksgaard Published 07.08.12 pm. 16:06

The Champagne bottles may remain in the  refrigerator at BioPorto’s Headquarters for just a little longer. Although it was widely expected during the first six months of 2012, the company failed to secure a global distribution agreement for the AKI kidney injury test, called the NGAL-Test.

It was otherwise the expectation among investors and other stakeholders, that such an agreement would fall into place in the first half of 2012, primarily because the company’s CEO Thea Olesen in the annual report for 2011 declared that “The first of this type of Agreement is expected to be concluded in the first half of 2012 “.

Of course it is still interesting to get Agreements with the large players  and make a global distribution Agreement. We are working at full speed, and I expect, that they will be signed- at least with some of them (The large players) – during this year.  It’s basically our primary task for the time being, “says Thea Olesen to Medwatch.

Regional Agreement in place

Instead of a global Agreement, BioPorto entered a Regional Agreement  with Wienerlab who can distribute the NGAL test in Latin America. Therefore the Thea Olesen also concludes that BioPorto lived up to its promises, although she does not hide the fact that she would have liked a global deal also.

We are still negotiating with large corporations, contracts that are not geographically limited, and it looks as we are relatively close to signing such Agreements. But it’s hard to put an exact time on when such a partnership is established, ” says Thea Olesen, “ However I would expect that at least one such global deal is finally closed by end of the year.

Further Thea explains that negotiations with the big pharmaceutical companies are more complicated than the smaller, which means that the negotiation process takes longer than with the Agreements the company has already concluded.

Tests on analyzers

When you have to make a deal with Large Global Companies, it simply requires just a little more. They must ensure that it has just the right quality, and that they can provide it at a price-level that corresponds to their portfolio of other Tests, and that they have the technical knowledge to help their customers. In addition, the test must fit seemlessly with their instruments, and they will have to verify it in all of their various machines. “

Have BioPorto come so far in the negotiations, that the NGAL-Test is being validated their machines?

Yes … It is clear that the checks take a little extra time, and they are some slightly more demanding, and those checks are being carried out right now, and we are naturally discussing and negotiating. They (the companies) will have to be absolutely sure that what when they accredit the Test, that it is indeed a good test for their machines, and that is  something they can vouch for.”

Lawsuits are still lurking

Earlier this year BioPorto won a patent case against the Swedish company Phadia in the Maritime and Commercial Court. The case was initiated by the Swedish company, who believed that the NGAL-Test violated their patent, but the claim by Phadia was rejected.

However, Phadia has appealed the verdict to the Supreme Court, and there is also the case at EPO where the American company Abbott is pursuing a patent case against BioPorto under EU auspices, because the Americans believe that BioPorto patent is invalid. BioPorto lost the case at the Opposition Division in february 2012, but the company has also appealed the decision.

Thea Olesen recognizes that the many lawsuits put the company in a weaker bargaining position than if they were not there, but she believes time is on BioPorto’s side and  that its actually working to BioPorto benefit.

“Actually the appeal proceedings at EPO means that it will take several years before it is the case is settled, but it is in our favor, because the more time that passes, the more we can get NGAL-Test included as a routine Test in hospitals. IP rights will always create a risk for everyone in this business, no matter who you enter into an agreement with, but I do not believe that the Large Companies do not feel that they have the time to wait several years to see the results of the Appeal before acting. “

Who are you negotiating with at the moment?

I can only say that it is majority of the more substantial players, when you look at figures, size, presence and so on.”

Amongst the Major players are: Roche, Abbott, Siemens, Ortho Clinical Diagnostics and Beckman Coulter.

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