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BioCentury Extra
As published Friday, February 05, 2016 5:10 PM PST

  • FDA review: Remicade biosimilar extrapolation "reasonable"

    On Friday, FDA posted briefing documents ahead of the Feb. 9 meeting of its Arthritis Advisory Committee to discuss a BLA from Celltrion Inc. (KOSDAQ:068270) for its CT-P13, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ).

    Celltrion conducted clinical studies of CT-P13 in rheumatoid arthritis and ankylosing spondylitis, and is seeking extrapolation of CT-P13 across all seven of Remicade's approved indications including Crohn's disease, pediatric Crohn's disease, ulcerative colitis (UC), pediatric UC, psoriatic arthritis and plaque psoriasis.

    In the briefing documents, FDA reviewers said the preclinical, clinical and manufacturing data submitted by Celltrion suggest that it is "highly similar" to Remicade, a chimeric mAb against TNF alpha.

    FDA officials noted that while there were differences in the binding of the Fc regions between Remicade and CT-P13, "it is reasonable to extrapolate conclusions regarding the similar efficacy and safety of CT-P13 and U.S.-licensed Remicade to IBD."

    Panel members will be asked to discuss the similarity of CT-P13 to Remicade, whether there are clinically meaningful differences between the two mAbs, and whether there are sufficient data to support extrapolation to the approved indications beyond those studied in clinical trials.

    The panel will vote on whether CT-P13 should be approved as a biosimilar of Remicade for each of the seven indications.

    On Friday, Celltrion slipped W1,200 to W119,400. The documents were posted after market close in Korea.

    J&J fell $3.63 to $100.24 on the day. The pharma's 3.5% drop was steeper than the 1.4% decline by the NYSE Arca Biotechnology Index (BTK).

    AbbVie Inc. (NYSE:ABBV) was off $3.87 to $52.89 on the day, reflecting investor concerns about FDA's apparent increased comfort level with extrapolation. The 6.8% drop was about double the 3.7% decline on the BioCentury 100 index. AbbVie markets the TNF alpha inhibitor Humira adalimumab. Last month, FDA accepted a BLA for a biosimilar version of Humira from Amgen Inc. (NASDAQ:AMGN), which is also seeking extrapolation.

  • SciClone seeking alternatives

    SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) gained $0.65 to $8.76 on Friday after reporting late Thursday that it settled an investigation with the SEC and hired Lazard to help the company seek strategic alternatives.

    According to SciClone, the SEC and U.S. Department of Justice were investigating whether historical sales and marketing activities in SciClone's China operations violated the Foreign Corrupt Practices Act. SciClone agreed to pay the SEC $12.8 million to settle the investigation, but "neither admits nor denies it engaged in any wrongdoing." The DoJ declined to pursue any action against SciClone. Both agencies have been investigating SciClone since 2010.

    One possibility for the company could include following in the footsteps of other commercial-stage Chinese life science companies that have been taken private in management-led buyouts.

    These include Simcere Pharmaceutical Group (Nanjing, China) and 3SBio Inc. (HKSE:1530). Last year, 3SBio reemerged as a public company when it raised HK$4.4 billion ($569.2 million) in an IPO on the Hong Kong Stock Exchange.

    "These investigations have required a significant commitment of management time and resources, and we are pleased with the resolution," CFO and SVP of Finance Wilson Cheung told BioCentury. "The full strategic review we are undertaking is in an early stage, and is designed to consider a range of strategic alternatives available to us with a view to enhancing stockholder value. We do not plan to comment further on the strategic review or potential outcome until the process has been completed."

    In January, SciClone reported preliminary 2015 sales of $157-$158 million. The company will report 4Q15 and 2015 financial results in March.

  • FDA issues CRL for Kalydeco

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) fell $5.11 to $86.61 on Friday after FDA issued a complete response letter for an sNDA seeking to expand the label of cystic fibrosis drug Kalydeco ivacaftor to include patients two and older with one of 23 residual function mutations in the CF transmembrane conductance regulator (CFTR) gene. Vertex markets the small molecule CFTR potentiator in the U.S. to treat CF in patients two and older who have one of 10 other mutations.

    The sNDA was based in part on preclinical data for Kalydeco in the 23 mutations and data from an exploratory Phase IIa trial in 24 patients with eight of the 23 mutations. According to Vertex, there are more than 1,500 U.S. CF patients two and older with 1 of the 23 mutations.

    In January, Vertex reiterated 2016 Kalydeco sales guidance of $670-$690 million. The guidance did not incorporate sales from the population covered by the sNDA.

  • Gilead's Mansuri joining Sanofi

    Sanofi (Euronext:SAN; NYSE:SNY) hired Muzammil Mansuri as EVP of strategy and business development, effective Feb. 22. In the role, he also will be responsible for the pharma's Sanofi-Genzyme BioVentures corporate venture fund. Mansuri was SVP of R&D strategy and corporate development at Gilead Sciences Inc. (NASDAQ:GILD).

  • Amgen's Blincyto improves OS in ALL Phase III

    Amgen Inc. (NASDAQ:AMGN) said an interim analysis showed Blincyto blinatumomab met the primary overall survival (OS) endpoint vs. standard of care chemotherapy in the open-label Phase III TOWER trial to treat Philadelphia chromosome-negative (Ph-), relapsed or refractory precursor B cell acute lymphoblastic leukemia (ALL). The biotech stopped the study early on the recommendation of the independent DMC.

    Blincyto has accelerated approval for the indication based on data from a Phase II trial in which 41.6% of 185 evaluable patients achieved complete remission or complete remission with partial hematologic recovery within two Blincyto treatment cycles. The European Commission granted conditional approval to Blincyto in November.

    According to Amgen, TOWER is the first study to show an OS benefit with an immunotherapy in ALL. The biotech said it plans to present the data and work with regulatory authorities to obtain full approval of Blincyto, a bispecific T cell engager (BiTE) that binds to CD19 expressed on B cells and CD3 expressed on T cells.

    Amgen was off $4.87 to $145.04 on Friday.

  • Cellular Biomedicine secures $43.1M from Dangdai

    Cell therapy company Cellular Biomedicine Group Inc. (NASDAQ:CBMG) is raising $43.1 million through the sale of 2.3 million shares at $19 to Wuhan Dangdai Science and Technology Industries Group. The purchase price is a 10% premium over Cellular Biomedicine's Wednesday close of $17.21, before the deal was announced, and gives Dangdai a 19.4% stake. Cellular Biomedicine said it would use the funds to support development of its chimeric antigen receptor (CAR) T cell therapies.

    Cellular Biomedicine was off $0.70 to $17.80 on Friday.

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