It is already facing offences from AbbVie’s Humira, Johnson & Johnson’s Remicade and Novartis’ Cosentyx. AbbVie’s Humira generated $14 billion in 2015 and has contributed more than 60% of its total revenue.Īmgen’s Enbrel has fallen under the spotlight after the FDA Advisory panel recommended approval of its biosimilar, which Novartis and Sandoz manufactured together. The panelists voted 26-0 in favor of the use of Amgen’s ABP-501 for the treatment of seven chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis. The company recently gained recommendation for approval for its biosimilar of AbbVie’s Humira from the FDA’s Advisory Committee. According to Wall Street analysts, Xgeva will touch $1.6 billion in revenue in 2016, recording a year-over-year (YoY) rise of approximately 12.3%.Īfter the patents for Neulasta and Neupogen expired, revenue from those drugs have recorded a gradual decline. Wall Street analysts predict Neupogen's sales to slump 18.6% in 2016.Īmgen wants to tackle the challenge from biosimilars with its own copycats. Xgeva, Neulasta and Neupogen witnessed stagnant growth due to fierce competition and patent expiries. The program completed its enrollment in June 2015, and results from 27,500-patient trial are expected to be delivered in the first quarter of 2017. The FOURIER outcomes trial is managed for the evaluation of Repatha in combination with statin therapy, compared to placebo plus statin therapy in order to reduce the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease. Physicians are eagerly waiting for results from the FOURIER trial. Repatha, indicated for the treatment of hypercholesterolemia and dyslipidemia, has witnessed slow but steady growth in the US. The company’s secondary hyperparathyroidism investigational drug Parsabiv is expected to gain FDA approval in 2016. In addition to mature brands including Xgeva, Prolia and Enbrel, Sensipar - a hyperparathyroidism molecule that generated $5.1 billion in 2015 - is considered to be crucial. Imlygic on the other hand is yet to secure traction in the oncology market. Amgen says it can utilize data from the Endeavor trial to secure favorable reimbursement terms from European regulators. Compared to 2015, cost management initiatives have yielded an added $400 million in gross savings this year.ĭata from the Aspire and Endeavor trials has fortified Kyprolis’ position in the multiple myeloma (MM) market. The company is working to optimize its cost structure to invest more in R&D. Amgen is working on speedy product launches and improving its global reach. It has plans to strengthen the bone health, nephrology, neuroscience, anti-inflammation and biosimilar businesses through 2016.Ĭost management also remains a priority. 7:22-bk-22549, 7/18/23.Since the launch of Kyprolis and Repatha in the US this year, analysts have focused on Amgen’s oncology and cardiovascular portfolios. This case is Endo International plc and Par Sterile Products, LLC, Bankr. The Canadian government, public school districts and the DOJ’s bankruptcy watchdog have also objected to the proposed sale.Įndo didn’t immediately respond to a request for comment. The bid includes all of Endo’s assets in exchange for wiping out $6 billion of debt owed. Williams also asked the court to appoint a Chapter 11 trustee to oversee and investigate the company’s bankruptcy.Įndo last month agreed to proceed with the “stalking horse” bid submitted by Tensor Limited, formed by a group of Endo’s first-lien lenders. “The United States and certain other unsecured creditors have been singled out to recover nothing,” he said. The company filed for bankruptcy last year to resolve allegations that it profited from the national opioid crisis. It would leave the government’s claims “completely unsatisfied,” Williams said in his objection, filed on behalf of the Department of Justice, Department of Health and Human Services, Department of Veterans Affairs, and the Internal Revenue Service.Įndo owes nearly $3.5 billion in priority, unsecured tax claims and hundreds of millions of dollars in claims stemming from federal law enforcement and healthcare liabilities, Williams said. The deal, in which lenders would take over the pharmaceutical maker by applying the debt they’re owed, would improperly distribute some sale proceeds to certain favored creditors, US Attorney for the Southern District of New York Damian Williams said in court papers filed Tuesday. The Justice Department and other federal agencies objected to Endo International Plc’s proposed sale to lenders, arguing the $6 billion deal is “discriminatory” to the US government and other creditors.
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