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Regeneron Pharmaceuticals, Inc. (REGN) - $25 value - yours FREE >>
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J&J (JNJ) Remicade Patent Invalid, Pfizer to Launch Inflectra?
Johnson & Johnson (JNJ - Free Report) suffered a setback in its patent infringement lawsuit against Celltrion and Pfizer, Inc.’s (PFE - Free Report) Hospira regarding the launch of a biosimilar version of its blockbuster drug, Remicade (infliximab), in the U.S.
The District of Massachusetts Federal Court ruled in favor of Celltrion and Hospira and said that U.S. Patent No. 6,284,471 for Remicade ('471 patent) is invalid. J&J intends to appeal the decision and said that it continues to expect operational sales growth of 3-4% in 2016, even if a biosimilar is launched on or after Oct 3, 2016.
Remicade brought in sales of $2.9 billion (including U.S. exports) in the U.S. in the first six months of 2016 and $4.5 billion (U.S.) in 2015. J&J was looking to delay the entry of biosimilars with the '471 patent expiring in Sep 2018.
JOHNSON & JOHNS Price
JOHNSON & JOHNS Price | JOHNSON & JOHNS Quote
We remind investors that Celltrion’s biosimilar version of Remicade, Inflectra, had gained FDA approval earlier this year in April. Inflectra is approved for use across all eligible indications of the reference product, Remicade, which include reducing the signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
Pfizer has exclusive commercialization rights to Inflectra in the U.S. and certain other territories.
Will Pfizer Go for an “At-Risk” Launch?
The big question is will Pfizer launch Inflectra before an appeals decision is out. A launch before the appeals decision would be an “at-risk” launch which means Pfizer would be liable to pay damages to J&J if the appeals decision is in J&J’s favor. Biosimilar versions of Remicade are already available in certain markets outside the U.S.
J&J and Pfizer are both Zacks Rank #3 (Hold) stocks. Some better-ranked stocks in the health care sector include Actelion Ltd. and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . While Actelion is a Zacks Rank #1 (Strong Buy) stock, Regeneron is a Zacks Rank #2 (Buy) stock.
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