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Re: None

Friday, 05/26/2017 3:21:42 PM

Friday, May 26, 2017 3:21:42 PM

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The future playing field/market potential for Rolontis. An article by EP Vantage discusses sales of Neulasta and Coherus' biosim by 2022. Here's part of the article

It could become the first Neulasta biosimilar on the market early next year, but could be launched sooner if the US Supreme Court overturns a 180-day notification period; a decision could also come in June.

To try and stave off entry Amgen recently sued Coherus over an infringement of its '707 patent, which covers purification of the drug and expires in 2024; a couple of months ago Amgen also filed a trade secrets lawsuit. The complaint links former Amgen employees now working at Coherus with alleged breaches in confidentiality agreements regarding Amgen's pipeline. Coherus rejected the claims.

Coherus reported a positive bioequivalence study with '1701 last July, comparing 6mg of CHS-1701 versus 6mg of Neulasta. This met all of its co-primary endpoints in healthy subjects, and '1701 had a similar safety profile to Neulasta. Efficacy was not a requirement of the trial.

Neulasta had sales of $4.8bn last year, but this is expected to almost halve by 2022 to $2.8bn, according to sellside consensus from EvaluatePharma. Sales of CHS-1701 are forecast to reach $648m by 2022, at which point it will be Coherus's top-selling product.

On the competitor front Mylan's own biosimilar, MYL-1401H, is closest behind Coherus, with an FDA decision due in October. Meanwhile, Apotex was recently granted an inter partes review over a patent regarding protein folding. Novartis' (NYSE:NVS) Sandoz unit received a complete response letter for its biosimilar last July, and pulled a European application earlier this year.

I've stated multiple times that I'd be happy as a clam if Rolontis attained 200M in sales basically doubling the revenue of Spectrum. EvaluatePharma is saying Coherus' biosim could take in 648M by then. Heck, if the biosim can do it wouldn't you think that Rolontis could take home something similar?

https://seekingalpha.com/article/4076836-renal-cancer-data-accelerons-coherus-biosimilars-date-fda?auth_param=mqj99:1cigjpj:a731befa24141425574de779fe9c00fe&uprof=44&dr=1