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These 3 Big Biotechs Could Have New Blockbuster Drugs Very Soon



4/10/2017 5:59:04 AM

These 3 Big Biotechs Could Have New Blockbuster Drugs Very Soon April 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff

NEW YORK – Three of the world’s largest biotech companies are unleashing new drugs that could prove to be potential game-changers when it comes to treatments and also have the opportunity to deliver huge returns for Regeneron, Amgen and Celgene.


Todd Campbell, an analyst writing in The Motley Fool, dove into the possibilities that face each of these companies.

1. Regeneron

In late March, the U.S. Food and Drug Administration approved severe atopic dermatitis injectable Dupixent, which was co-developed by long-time partner Sanofi. Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis (AD), the company said in its March 29 announcement. AD, the most common form of eczema, has a wide-market. Regeneron estimated there are about 300,000 people in the United States who have been diagnosed with uncontrolled moderate-to-severe AD and are in need of new treatment options. Phase III trials showed the drug showed was successful in clearing the rashes associated with AD. While Dupixent might have a steep price tag at $37,000, Campbell noted that insurers are not likely to balk at paying for the treatment due to the difficulty in treating autoimmune disorders–unlike the high price tag of its high cholesterol drug, Praluent, which is more expensive than traditional statins. Dupixent is also being evaluated as a potential treatment for other allergic diseases including asthma, eosinophilic esophagitis and nasal polyposis, which could lead to additional revenue streams.

2. Amgen

Although Amgen is facing a number of patent expirations for revenue drivers such as Enbrel and Neupogen, Campbell said the company’s biosimilar pipeline “could propel this company's stock higher.” He noted that Amgen’s Humira biosimilar, Amjevita, will soon be available in Europe and if the company overcomes legal challenges in the United States from AbbVie, Humira’s maker, the company could have a blockbuster. Amjevita was approved by the FDA in 2016. It was the first approved biosimilar for Amgen. The litigation, if successful, could protect Humira’s $8 billion annual revenue stream from biosimilar threats until 2022. Amgen is also developing biosimilars for cancer drugs Avastin and Herceptin. The FDA is expected to rule on the Avastin biosimilar later this year and Amgen is expected to file for approval of the Herceptin biosimilar soon, Campbell said. Although biosimilars have been slower to catch on in the United States, Campbell said “the odds are good that these drugs will win a lot of prescription volume over time.”
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3. Celgene

New Jersey-based Celgene could knock out a Novartis multiple sclerosis drug, if the FDA approves Ozanimod, a selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator. Campbell said that the market for oral MS drugs is about $8 billion annually. The company is looking to seek regulatory approval soon and if the FDA gives the nod, Campbell said Ozanimod could displace Novartis’ Gilenya, which is used in newly diagnosed MS patients. Part of Gilenya’s issue is a sudden drop-off in heart rate, Campbell said. Ozanimod has not shown that problem in clinical trials. With a more attractive safety profile, Campbell said doctors may prefer it to the established drug. Ozanimod also has a chance of taking a bite out of revenues generated by Biogen’s Tecfidera, which has shown some safety issues concerning a rare and life-threatening brain disease called progressive multifocal leukoencephalopathy. Tecfidera and Gilenya generated more than $3 billion last year.


Read at BioSpace.com


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