Novartis Reports Encouraging Data on Biosimilar of Neupogen
Novartis (NVS) announced that its generic arm, Sandoz, reported encouraging data from a phase III study, PIONEER.
The study (n=218) is being conducted to compare the efficacy and safety of the biosimilar version of Amgen’s (AMGN) Neupogen (filgrastim).
Neupogen is approved for the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy.
Data from the study reported that the candidate showed similarity to Neupogen. The data also showed that repeated switching at each cycle between the investigational biosimilar and Neupogen had no impact on efficacy, safety or immunogenicity.
We remind investors that the FDA accepted Sandoz’s application for the biosimilar version of Neupogen, which makes it the first company to have a filing accepted under the new U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act of 2009 (:BPCIA). Sandoz’s application was supported by the results from the PIONEER study.
Biosimilars are the growth engine of Sandoz, generating double-digit sales in the third quarter driven by continued momentum in its three in-market products – Omnitrope (human growth hormone), Binocrit (epoetin alfa) and Zarzio (filgrastim).
Novartis also presented six-year results from the randomized phase III study, ENESTnd, on Tasigna at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco. The study showed continued superiority of Tasigna over Glivec in achieving higher rates of early, deep and sustained molecular responses in patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.
Moreover, Novartis announced data on oncology drug Jakavi at the ASH from the JUMP study, which showed that 69% myelofibrosis patients achieved above 50% reduction in spleen size from baseline when treated with Jakavi. These patients also experienced a clinically meaningful improvement in the myelofibrosis symptom score.
We remind investors that Novartis has a collaborative agreement with Incyte Corp. (INCY) for the commercialization of Jakavi in the ex-U.S. markets.
Jakavi (known as Jakafi in the U.S.) recently gained FDA approval for the treatment of patients with polycythemia vera, who had an inadequate response or are intolerant to hydroxyurea.
We cautiously watch Novartis' efforts to realign its portfolio in order to focus on its core portfolio of pharmaceuticals, eye care and generics. Successful development and commercialization of its pipeline is important at this stage as Novartis faces generic competition for several of its key drugs such as Gleevec, Zometa and Diovan.
Novartis, a large-cap pharma, currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the health care sector may consider Allergan (AGN), carrying a Zacks Rank #1 (Strong Buy).
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