Avanzanite Bioscience looks to commercialize innovative medicines for rare diseases in Europe

November 15, 2022 - 3 minutes
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Avanzanite Bioscience B.V. has officially launched its commercial-stage enterprise, to expand patient access to medicines for rare diseases in Europe while unlocking revenue and growth potential for emerging research-based biopharmaceutical originators. 

Avanzanite, a fully authorized distributor of medicinal products, partners with biopharmaceutical collaborators through flexible, bespoke licensing and distribution partnerships across Europe. The company’s business model enables the global commercialization of promising medicines and addresses the unsustainable inequities in access to innovative orphan drugs across Europe.

Avanzanite was established to address a market need in the European orphan drug landscape due to the complexity and cost of streamlining business operations across more than 30 countries given a limited number of patients and an increasingly challenging market access environment. 

The company said most European launches of orphan drugs – as high as 80% – fail to meet their commercial and revenue goals and do not reach patients in need. The result of these unique market dynamics leaves emerging biopharmaceutical companies unmotivated or ill-equipped to establish European operations or enter certain countries. 

Patients missing out

As a result, an increasing number of biopharmaceutical companies either opt not to launch their new orphan medicines in Europe or exit the market altogether. These dynamics are particularly damaging to emerging biopharmaceutical originators that are the driving force of global pharmaceutical innovation, especially for rare diseases. Ultimately, the patients are the ones paying the price by missing out on promising therapies.

Avanzanite founder and CEO, Adam Plich, said: “We are providing a market-driven solution for the issue of access to orphan medicines in Europe.

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“Our inspiration and the initial validation of our unique business model stems from our collaboration and an exclusive license agreement with SIFI S.p.A. a leading international ophthalmic company headquartered in Italy. SIFI partnered with Avanzanite to commercialize and distribute its investigational ultra-orphan medicine for the treatment of Acanthamoeba keratitis (AK) – a devastating, highly resistant eye infection that accounts for 50% of blindness among contact lens users – across 26 countries within the European Economic Area and Switzerland.” 

After more than 15 years of R&D efforts, the European Medicines Agency (EMA) is currently reviewing the product for marketing approval.

Broadest market access

“When evaluating commercialization options for our orphan medicine in multiple European territories, Avanzanite made a compelling case as to why it would be best positioned to commercialize and, in fact, provide the broadest market access through its unique business model,” said Fabrizio Chines, SIFI chairman and CEO. 

“Mr. Plich and his team demonstrated an impressive track record of managing the complexities of product launches across the fragmented European marketplace, particularly regarding pricing & reimbursement, physician engagement and technical operations.”

Avanzanite is advancing discussions with several biopharmaceutical companies seeking to enter the European market in order to expand portfolio breadth. Avanzanite said it sees significant opportunities to expand patient access and optimize value creation for originators. 

Plich said: “We’ve cracked the code in deciphering this tricky landscape, and now, with our initial strategic partnership with SIFI, we are ready to take our transformational model to the next level by bringing new medicines to patients with rare diseases.”

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