The deal sees Ontario-based pharma firm Aralez paying AstraZeneca an initial $175m (€156) for the rights to Toprol-XL (metoprolol succinate) and its Authorized Generic (AG), a cardioselective beta-blocker indicated for the treatment of hypertension.
“The parties will enter into a supply agreement pursuant to which AstraZeneca will continue to manufacture and supply Toprol-XL and the AG for at least 10 years,” Aralez’ CEO Adrian Adams told investors during a conference call last week.
The drug was first commercialised by the Anglo-Swedish pharma giant in 1992 and lost its US exclusivity in 2007.
However, while firms such as Actavis and Dr Reddy’s produce generic versions of the drug for the US, manufacturing complexities and compliance issues have reduced the number of competitors and AstraZeneca still saw US sales close to $90m in 2015 from Toprol-XL.
This was deemed encouraging, according to Aralez CFO Scott Charles.
“A number of generic manufacturers had difficulty in terms of manufacturing these products to the right quality standard. That led to a number of those withdrawing from the market,” he told stakeholders on the call.
“We’ve assumed the possibility of some additional generics, but even with that in mind, we think this is a very strong transaction,” he continued. “But again I would point out that a number of Generics manufacturers were not able to produce the products to the necessary standards from the FDA. And again we find that as a very strong encouragement for this transaction.”
Wockhardt’s generic version, approved in 2010, is made at the Chikalthana, India facility hit by quality issues which resulted in the US FDA issuing an import alert in 2013, banning the drug from entering the US.
Meanwhile, Novartis subsidiary Sandoz recalled its generic version of the drug in 2008 following problems with validating manufacturing processes at its plant in Wilson, North Carolina, and the following year Ethex – a subsidiary of the now defunct KV Pharmaceutical Company – followed suit. Both versions have been discontinued in the US, according to the FDA's Orange Book.