Apotex Mystery: Why Has Accord BioPharma Taken Its Place In Pegfilgrastim Biosimilar Litigation?
Executive Summary
Court grants request to substitute Accord BioPharma for Apotex in Amgen infringement suit. Apotex says it has no plans to exit the biosimilar business.
In an unusual move, Apotex Inc. asked to have Accord BioPharma take its place in Amgen Inc.'s infringement suit challenging Apotex's Neulasta (pegfilgrastim) and Neupogen (filgrastim) biosimilars. The court issued an order granting the substitution on 26 August, raising questions about what is happening at Apotex.
Apotex had asked the court to permit it to file the motion for substitution under seal. In a 22 August filing, it said the motion "contains highly confidential and commercially sensitive business information which, if disclosed to the public, would likely result in significant economic and competitive injury to Apotex." Amgen did not oppose the motion for substitution or the request that it be kept under seal.
The suit, Amgen v. Apotex, was renamed Amgen v. Accord BioPharma. The change is surprising for although Apotex developed the biosimilars in partnership with Accord parent Intas Biopharmaceuticals Ltd., only Apotex was named as a defendant in the complaint. Apotex gained the North American and European development rights to Intas' filgrastim, marketed in India as Neukine, in 2008. [See Deal]
Apotex spokesperson Jordan Berman declined to comment on the substitution. "Out of respect for the judicial process, we do not comment on litigation matters," he said. Asked if Apotex plans to leave the biosimilar space, he said "we have a highly successful biosimilar business in a key growth market, and no plans to exit that business at this time."
Amgen's complaint alleges that Apotex's manufacturing process for its pegfilgrastim biosimilar Lapelga and filgrastim biosimilar Grastofil infringes Amgen patent No. 9,856,287, which covers refolding proteins using a chemically controlled redox state. Apotex won a suit over a related manufacturing process patent, No. 8,952,138, in November 2017 when the US Court of Appeals for the Federal Circuit affirmed a district court ruling of noninfringement.
However, the Canadian company has been unable to get its biosimilars through the US Food and Drug Administration. Both drugs are used to decrease the incidence of infection by treating neutropenia, a decrease in white blood cells caused by chemotherapy.
Sell Off Of Some Businesses
The mysterious switch in defendants comes as Apotex is grappling with manufacturing problems and selling off some of its businesses. In July, Apotex voluntarily withdrew 31 abbreviated new drug applications after FDA inspections found data integrity and quality unit failures at two of its plants in India. (Also see "Apotex Withdraws 31 ANDAs After Failing To Ensure Data Integrity At Two Indian Manufacturing Plants" - Pink Sheet, 9 Jul, 2019.)
Last year, Apotex sold its business in five European countries to Aurobindo. (Also see "Aurobindo buys Europe operations from Apotex" - Generics Bulletin, 27 Jul, 2018.) And its Australian business recently merged with former Strides unit Arrow Pharmaceuticals. (Also see "Arrotex Formed As Strides-Apotex Merger Completes In Australia" - Generics Bulletin, 10 Jul, 2019.)
In April, Bloomberg reported that Apotex was exploring a sale of the entire company. The children of Apotex founder Barry Sherman and his wife Honey took control of the company after their parents were found murdered at their home in late 2017. (Also see "Apotex Rumored To Be Weighing $3bn Sale" - Generics Bulletin, 9 Apr, 2019.) Asked about the prospects of such a sale, Apotex's Berman said that "as a privately held company, we do not discuss the company's strategy."
Apotex was a leader in filing biosimilar applications at FDA. It submitted an application for the pegfilgrastim biosimilar in December 2014 and a filgrastim biosimilar application in October or November 2014. The company is believed to have received complete response letters from FDA but has declined to comment on the cause of the delay.
Meanwhile, Mylan NV and Coherus BioSciences Inc. have launched their pegfilgrastim biosimilars in the US. Mylan and its partner Biocon Ltd. launched Fulphila (pegfilgrastim-jmdb) in July 2018 and Coherus' Udenyca (pegfilgrastim-cbqv) entered the US market in January.
Apotex's two biosimilars have been approved in Canada, the European Union and Australia. Health Canada approved Grastofil (filgrastim) in March 2016 and Lapelga (pegfilgrastim) in April 2018. The company's Apobiologix division launched Lapelga in Canada in February.