Alvogen Targets Esmya With First European Rival
Executive Summary
Alvogen has gained multiple European approvals for a rival to Gedeon Richter’s Esmya through the decentralized procedure.
Alvogen says it has become the first company to register a European generic rival to Gedeon Richter’s uterine fibroids therapy, Esmya (ulipristal), having received regulatory clearance in “multiple European countries” after successfully concluding 16 parallel registration procedures.
Sales of Esmya fell by almost 75% in 2018 after EU regulators imposed restrictions on the use of the product due to a potential association between the drug and liver damage. Gedeon Rochter has since been been able to relaunch the product, which is used to treat abnormal uterine bleeding in women with uterine fibroids.
“Alvogen and its business partners have filed for marketing authorization in 16 European countries using 16 decentralized procedures,” the company confirmed, pointing out that the ulipristal 5mg tablets were “fully developed in-house by Lotus Pharmaceuticals, an Alvogen subsidiary.”
Faysal Kalmoua, executive vice-president of Alvogen’s global portfolio, said the US firm was “pleased with the approval for generic ulipristal tablets, and we look forward, with our business partners, to leading the commercialization of this important product in Europe.”
Gedeon Richter said a generic competitor to Esmya could not be marketed until after 20 May 2020.
Acknowledging that Gedeon Richter had already registered its own authorized generic – via the informed consent procedure – a spokesperson for Alvogen insisted that “Alvogen is the first company with a true generic” that was not a duplicate registration.
“For a small molecule [drug], regulations allow filing of both a DCP, a centralized procedure and nationally in Europe,” the Alvogen spokesperson noted. “After a thorough assessment on each of those three regulatory paths, we opted for the DCP regulatory pathway.”
DCP Allows Flexibility With Partners
Commenting on the decision to pursue approval through the decentralized procedure (DCP), the Alvogen spokesperson said “we make decisions on a product-by-product basis, and for ulipristal, the DCP was the best regulatory path. As we have a significant amount of business partners – 16 – for this product, the decentralized path was much more effective in securing the right flexibility for each partner.”
While Alvogen did not indicate an anticipated launch date, the firm said its ulipristal “will be launched at the earliest possible timing, taking into account all potential exclusivities, including relevant and valid patents in each jurisdiction”.
Responding to Alvogen’s announcement, a Gedeon Richter spokesperson pointed out that “the original product’s protection expires on 20 May 2020,” meaning “generic Esmya products cannot be launched in the market before this date.”
The Gedeon Richter spokesperson noted that the informed consent authorization received in 2018 “provides a theoretic opportunity for us to manufacture the generic version of Esmya, but for the time being we cannot comment [on] a potential launch of the generic product”.
“The usage of the ‘informed consent’ procedure is an internationally accepted approach that is legally compliant with all relevant regulations,” the Hungarian company added. “We have chosen this approach in line with our commercial business strategy applied for Esmya.”
Restrictions On Use/Sales Slump
Earlier this year, Richter reported that Esmya sales plummeting by 72.2% to €25.9m ($29.3m) dragged the company to a 3.0% pharmaceutical sales decline in 2018. (Also see "Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings" - Generics Bulletin, 14 Feb, 2019.)
The slump in sales for Esmya came after the European Medicines Agency's pharmacovigilance committe, PRAC, in 2018 implemented temporary measures that included stopping new patients being started on Esmya and halting new courses of therapy being given. The PRAC review followed concerns about drug-induced liver injury potentially associated with Esmya that included several cases that resulted in liver transplants. (Also see "Liver Damage Worries Lead To Further EU Restrictions On Richter’s Esmya " - Pink Sheet, 21 May, 2018.)
Richter began to relaunch Esmya across EU markets in August and September last year. (Also see "Esmya Review Held Back Gedeon Richter in First Half" - Scrip, 2 Aug, 2018.)
The original version of this article was published on 16 April 2019 on the website of Generics Bulletin, a sister publication to the Pink Sheet.