Haha! Team Humira still going strong!!!

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anonymous

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NO BIOSIMILAR FOR YOU!!!! ENBREL IS DYING AS WE ARE KILLING YOU IN CONTRACTING WITH MORE INDICATIONS


U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine.

In June, Amgen, the world's biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion.

In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."

Amgen said it still plans to challenge the legality of the patents.

"Although we are disappointed by the PTO's decision, we continue to question the validity of the patents," the company said in a statement. "We look forward to presenting our position in court."

Amgen in November became the first company to file with U.S. health regulators seeking approval to sell a less expensive biosimilar version of the blockbuster medicine. Several companies are also developing biosimilar versions of Humira.

Amgen has said it expects the first of its several biosimilars in development to reach the market between 2017 and 2019.

AbbVie this week said it sees Humira sales reaching $18 billion by 2020. Based on its various patents, AbbVie said it does not expect competition from biosimilars until 2022.
 












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However, based on sales projections offered up by the company this week at J.P. Morgan's conference, investors might be wrong to worry about Humira's revenue run rate, at least for now. That's because AbbVie seems to believe that generic interlopers will be kept at bay by other patents covering Humira, including those related to the method of treatment for various indications. AbbVie thinks that those Humira patents will allow its sales to grow, rather than shrink, to $18 billion in 2020.

That's a bold prediction given that the companies developing Humira biosimilars are among the biggest and most successful biopharma companies in the world. Amgen(NASDAQ:AMGN) and Merck & Co. (NYSE:MRK), which is working with Samsung and Biogen (NASDAQ:BIIB)on a Humira biosimilar, already have phase 3 trial data in hand showing their look-alikes work as well as Humira, and those companies have significant experience and resources available to them that could allow them to skirt Humira's remaining patents.

If Humira's patents do hold up, then it will buy AbbVie time to boost demand for its recently acquired (and fast-growing) oncology drug, Imbruvica.

AbbVie forked over $21 billion last year to get its hands on Imbruvica and management thinks the drug's revenue can climb from its current $1.2 billion pace to $5 billion over the coming few years.

Meeting that sales target will require Imbruvica to succeed in a slate of ongoing trials that could expand its addressable market. Imbruvica's use as a monotherapy in the first-line treatment of chronic lymphocytic leukemia (CLL) and its use as a treatment for multiple myeloma, a multibillion dollar indication, are among some of the most intriguing studies under way.

Additionally, AbbVie plans to leverage Imbruvica's sales and marketing know-how to build up revenue for its other hematology drugs, too. Those drugs include venetoclax, a CLL therapy; elotozumab, a treatment for relapsing multiple myeloma; and duvelisib, a late clinical stage CLL and indolent non-Hodgkins lymphoma medicine. If it can do that, then AbbVie will become one of the biggest cancer drugmakers in the next five years.

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Abbvie will compete against Kyprolis and we will kill you in oncology!
 
















Novartis is coming!

The FDA approves Novartis' (NYSE:NVS) IL-17A inhibitor, Cosentyx(secukinumab), for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis, both life-long painful and debilitating inflammatory diseases that affect the joints and/or spine.

The European Commission approved the two new indications in November.

In January 2015, Cosentyx was cleared in the U.S. and EU for the treatment of adults with moderate-to-severe plaque psoriasis.

Cosentyx is one of the company's anticipated blockbusters that is expected to generate peak sales of $1B+. Through Q3, it has posted $140M in sales.
 








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