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Accord Healthcare has secured commercial rights to Adienne’s novel lyophilized formulation of thiotepa in Europe, extending its portfolio of cancer treatments.





Accord Healthcare has entered into an exclusive licensing and distribution agreement to commercialize Adienne Pharma & Biotech’s Tepadina (thiotepa) 15mg and 100mg lyophilized powder for injections.

Intas’ European operation will begin selling Tepadina across select markets in Europe, such as Italy, Spain, UK, Ireland, Benelux and Portugal. “Additional markets will be included in 2020, with the aim of Accord becoming the sole distributor across all European markets by early 2021,” the partners stated.

Adienne will continue to be the marketing authorization holder for the oncology vials in the territories and will be responsible for manufacturing and supplying the freeze-dried product, which is indicated in the conditioning regimens before autologous and allogeneic hematopoietic stem cell transplantation to treat hematological diseases and solid tumors both in adult and pediatric population. It has been granted orphan-drug designations by both the European Medicines Agency and the US Food and Drug Administration.

Orphan Designation Granted In Europe
Noting that thiotepa had been used to prepare patients for transplantation of blood-making cells in the European Union since the late 1980s, the EMA said Adienne had presented published literature that included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumors. Having given an orphan designation in January 2007, the European Commission issued a pan-European centralized authorization for Tepadina in March 2010.

“With this new partnership,” the firms commented, “Accord secures exclusive rights to market, commercialize and sell Adienne’s novel chemotherapy brand Tepadina which will be supported by an expert sales force, and a seasoned marketing team that has successfully launched multiple oncology products in Europe.”

Accord has also gained commercial rights in Europe and India to new delivery presentations of thiotepa and other oncology and cytotoxic drugs that the Switzerland-based rare and severe disease specialist is developing “to improve and enhance the healthcare professional and patient experience.”

“We are committed to bringing complex, added value products to improve the lives of cancer patients,” commented James Burt, Accord’s executive vice-president for Europe, the Middle East and North Africa. “This agreement builds on our oncology platform adding to our extensive oncology experience in Europe, where we supply more than 35 oncology products across the region. We are excited to take over the commercialization of this product, which will provide tangible advantages to patients and healthcare providers, and we look forward to a mutually beneficial and successful collaboration with Adienne.”

Adienne’s founder, owner and president, Antonio Francesco Di Naro, remarked: “We are very pleased to have established this collaboration with Accord, whose established track record of successful marketing of complex oncology and specialty products gives us confidence that they are the best partner for our Tepadina product. Accord has a remarkable commercial team and infrastructure in place, and we are highly confident in their ability to successfully leverage that platform with us.”

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