Spectrum Pharmaceuticals, the U.S. partner for clinical development of South Korean drug developer Hanmi Pharmaceutical’s Rolontis (eflapegrastim), is facing a patent infringement lawsuit from Bioverativ Therapeutics over the neutropenia drug in the U.S.

According to the South Korean pharmaceutical company on Friday, the U.S. biotech firm filed the lawsuit against Spectrum Pharmaceuticals with a Delaware court on May 28, claiming that Rolontis infringes on its patents, and is seeking unspecified damages and an injunction.

Bioverativ, which develops and produces long-acting hemophilia treatments, argues Rolontis has infringed on its long-acting drug release technology.

The production, use and commercialization of Rolontis does not infringe any patent rights, Spectrum Pharmaceuticals said in response, adding it will take strong measures to protect the development and commercialization rights of Rolontis under the contract with Hanmi Pharmaceutical.

Rolontis is a long-acting granulocyte colony-stimulating factor analog for chemotherapy-induced neutropenia, and Hanmi signed a deal to license out the therapy to Spectrum in 2012.

Rolontis is also the first-ever drug employing the Korean drug maker’s proprietary Lapscovery (Long-Acting Protein and Peptide Discovery) technology that extends the life of a peptide or protein in the body for better efficacy and potency.

Spectrum had filed a BLA for Rolontis in the U.S. based on data from phase 3 clinical trials and it is under regulatory review for marketing authorization by the U.S. FDA. It was approved by Korean health authorities in March.

Hanmi said Labscovery, the basic technology for Rolontis, is its unique technology and will cooperate with Spectrum to protect its rights over Rolontis.

By Pulse

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