There’s nothing new, Sanofi has done everything it can in order to launch on time, and anything short of that is very unlikely, says Zealand Pharma CEO Britt Meelby Jensen after the company had to go out and officially defuse market speculation last week.

The speculation relates to an ongoing patent trial between Sanofi and AstraZeneca pertaining to the Zealand-discovered substance lixisenatide, to which Sanofi holds the rights. The substance is marketed as Lyxumia and will also be part of the potential blockbuster combination drug LixiLan, which could earn the Danish company billions, if approved for the market.

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“Stepping back for one moment, there’s nothing new in this, but one might wonder why it surfaces right now. This case has been underway since last summer and no new information has been presented in the past month to change things. The reason it gets attention now is that Novo Nordisk mentioned this case between AstraZeneca and Sanofi last Wednesday at a conference for analysts in connection with their annual results,” Britt Meelby Jensen tells MedWatch, adding:

“It’s very common that companies try to target each other through patent litigation, when you are dealing with products with huge potential. It’s normal practice in the industry.”

Initiated by Sanofi

AstraZeneca holds a number of patents because they own the rights to the first generation GLP-1 drugs Byetta and Bydureon. These drugs are based on the substance exanetide, and lixisenatide from Zealand is also based on this substance in a modified version. AZ holds patents for the substance itself as well as a formulation patent that might clash with Lyxumia and LixiLan – that is what a court has to decide in the ongoing trial.

“It's a case that was brought before the court by Sanofi, because they feel they have such strong patent protection that they wanted a court to make it official before launch. AstraZeneca then instantly launched a patent case in response. It happens all the time,” Britt Meelby Jensen says and continues:

“We are not a party in this case, but have merely shared the relevant patent material and have an ongoing dialogue with Sanofi and their US patent attorneys who are experts in this area.”

Crucial voucher

But why would Novo bring that up?

Novo Nordisk and Sanofi are currently racing to become the first company to launch a product pairing a long-acting basal insulin with a GLP-1 analogue in the US. Novo was one step ahead of its French rival before Sanofi opted to make use of a priority voucher when it submitted its application to the FDA in December – a voucher it spent USD 245 million to buy from the company retrophin.

“Sanofi submitted the official documents in the case in July. They subsequently chose to use this voucher that they spent DKK 1.7 billion on, which cuts four months from the evaluation process. With all the insight the company has into the matter, why on earth would they use this voucher if they didn’t believe they could launch on time? These cases usually end with a settlement,” Britt Meelby Jensen explains.

Sanofi’s actions and the CEO’s own talks with patent attorneys make her believe Sanofi will launch on time, provided they win approval of the product.

“We get a lot of questions. These IP cases crop up all the time in our industry and they are extremely complex. Our private investors might become a bit uncertain. That uncertainty relates to the actual launch of the product,” she says and adds:

“If I ask a patent expert in the US whether there’s a chance launch will be postponed due to these cases, he would say it’s a remote possibility. Looking back over the past decade, I cannot recollect any major product for which launch has been delayed due to a case at this stage.”

 Zealand's lead drug involved in patent dispute 

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- translated by Martin Havtorn Petersen

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