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Biosimilar Drugs Loom Large on Amgen’s Radar

Between patent lawsuits and purchasing drugs like Celgene Corp.’s Otezla, Amgen Inc. is looking to bring its biosimilar business to the bottom line. Recently, the Thousand Oaks biotech challenged the patents of Alexion Pharmaceutical’s blockbuster drug, Soliris, which treats rare diseases of the blood, muscles, spinal cord and optic nerve, according to an Investor’s Business Daily article on Aug. 30. Amgen initially filed the lawsuits in February. The U.S. Patent Trial and Appeal Board agreed to a requested review at the end of last month. Amgen’s ABP 959, currently in the company’s pipeline, is a biosimilar that treats hemoglobinuria, which is also what Soliris treats. Another patent dispute with Paris-based Sanofi and New York’s Regeneron Pharmaceuticals has been a back-and-forth battle since 2014; the lawsuit stalled in a setback for Amgen, with U.S. District Judge Richard Andrews on Aug. 28 setting aside a jury verdict that Amgen’s patents were valid. Amgen originally brought the lawsuit to stop Sanofi and Regeneron from selling Praulent, a cholesterol medication. The drug is in direct competition with Amgen’s Repatha, which also treats cholesterol. Andrews ruled that Amgen’s patent claims were invalid because they didn’t provide sufficient information regarding the drug’s innovations. “Today, the United States District Court in Delaware granted a motion in part reversing the jury verdict from February which had upheld the validity of Amgen’s patents. The court denied the motions on written description and for a new trial,” Amgen said in a statement. “We disagree with the court’s decision in reversing the jury verdict on enablement and will seek review by the appellate court.” Amgen is set to acquire Otezla, a Celgene Corp. psoriasis drug, for $13.4 billion in cash, the Thousand Oaks company said at the end of last month. Its agreement with Celgene assumes an expected merger between Celgene and New York’s Bristol-Myers Squibb Co. Otezla is the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, Amgen said in a statement. Last year Otezla had sales of $1.6 billion. Amgen expects to grow sales through global expansion and new indications, “with expectations for Otezla to realize at least low double-digit sales growth, on average, over the next five years,” the company said in a statement. “The acquisition of Otezla offers a unique opportunity for Amgen to provide patients an innovative oral therapy for psoriasis and psoriatic arthritis that fits squarely within our portfolio and complements our Enbrel and Amgevita brands,” Robert Bradway, chief executive at Amgen, said in a statement. “We will take advantage of our 20 years of experience in inflammatory disease to realize the full global potential of Otezla as an affordable option for patients with these serious, chronic inflammatory conditions.” Amgen’s Enbrel treats varying types of arthritis, while Amgevita treats psoriasis.

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