Visiongain http://www.marketresearch.com/Visiongain -v1531/ Publisher Sample
Phone: 800.298.5699 (US) or +1.240.747.3093 or +1.240.747.3093 (Int'l) Hours: Monday - Thursday: 5:30am - 6:30pm EST Fridays: 5:30am - 5:30pm EST
Email: [email protected] MarketResearch.com
Epigenetic R&D, Therapies and Diagnostics:
Industry and Market Prospects 2014-2024 of $143m by the middle of the forecast period (Table 4.5 and Figure 4.7). By 2024, the market will be worth $257m, having grown with a CAGR of 11.3% since 2013.
Table 4.5 Epigenetic Therapies, Technologies and Diagnostics: Canadian Market Size ($m) Forecast, 2013-2024 2013 2014 2015 2016 2017 2018 Canadian Market Size ($m) 79 85 93 107 123 143 Annual Growth (%) 7 9 15 15 16 CAGR (%) 2013-2018 12.5 2019 2020 2021 2022 2023 2024 Canadian Market Size ($m) 163 184 210 231 245 257 Annual Growth (%) 14 13 14 10 6 5 CAGR (%) 2018-2024 10.2 CAGR (%) 2013-2024 11.3 Source: visiongain 2014
Figure 4.7 Epigenetic Therapies, Technologies and Diagnostics: Canadian Market Size ($m) Forecast, 2013-2024
300
250
200
150
Market Size Market Size ($m) 100
50
0 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Year
Source: visiongain 2014 4.4 European Union (EU) Epigenetics Market: Revenues 2013
Europe - for the purposes of this reported considered to be the EU - was the second largest region in the world epigenetic therapies and technologies market in 2013, behind North America. In that
www.visiongain.com Page 83
Epigenetic R&D, Therapies and Diagnostics:
Industry and Market Prospects 2014-2024
A MAA was submitted to the EMA in November 2007 for this indication. However, in October 2008, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on Zolinza, stating that data provided by Merck was not sufficient to approve the drug. In February 2009, Merck announced that it was withdrawing its application based on the opinion of the CHMP. In July 2011, Zolinza was approved for use in CTCL in by the Ministry of Health, Labour and Welfare (MHLW) in Japan, where it will be marketed by Taiho Pharmaceutical part of Otsuka Holdings Co., Ltd. The drug is currently approved in the US, Canada, Japan and Australia for similar indication. The patent expiry of Zolinza is scheduled for July 2015.
5.4.1 Zolinza for Multiple Myeloma Treatment
Revenue growth for Zolinza during the period 2014-2024 will be driven by approvals in new regions, including the EU, and in new indications, such as multiple myeloma. In the US, 21,000 people were reported with multiple myeloma in 2013 (Table 5.10). Zolinza was granted orphan drug status for that indication in the EU in April 2011. Orphan status has also been granted for treating multiple myeloma in the US. Zolinza has already been shown to be effective in combination with Velcade, with phase III results being released in December 2011. Patients in the trial treated with a combination of Velcade and Zolinza were found to have a 23% lower risk of disease progression than patients treated with Velcade on its own. Interim results from a phase II trial had previously shown that Zolinza is effective in treating patients who are unresponsive to treatment with Velcade. Currently, there are three phase III clinical trials investigating the efficacy of vorinostat in treating multiple myeloma via combination therapy (Table 5.11).
The success in multiple myeloma contrasts with failures in other indications, visiongain notes. In September 2011, Merck announced that a trial of the drug in mesothelioma had failed to meet its primary endpoint of improving overall survival, for example. Beyond cancer, Zolinza has shown efficacy in treating other diseases. Researchers from the University of North Carolina found that the drug was effective in clearing latent HIV from patients receiving other treatments. The study found that the HDAC inhibitor activates the disease within patients, which is then cleared by regular HIV therapies. The researchers deduced that the vorinostat forces the virus to become active, allowing the antiretroviral therapy the participants were already taking to do their job and destroy the virus. They are continuing to investigate the study which is now in phase II and is expected to finish in 2016. Merck & Co. and National Institute of Allergy and Infectious Disease (NIAID) are collaborating with the researchers from the University of North Carolina in the study.
www.visiongain.com Page 114
Epigenetic R&D, Therapies and Diagnostics:
Industry and Market Prospects 2014-2024
Figure 5.16 HDAC Inhibitor Expected Approvals, 2015-2020
Source: visiongain 2014 5.6.1 Beleodaq (TopoTarget/ Spectrum Pharmaceuticals): A Novel Pan- HDAC Inhibitor
Beleodaq (belinostat, PXD-101) is a novel pan-HDAC inhibitor developed by TopoTarget. The drug is primarily being developed for PTCL, although clinical trials are underway for many other cancer indications. For a number of these TopoTarget is partnered with the US National Cancer Institute (Table 5.17). In October 2012, Beleodaq was awarded orphan drug status in the EU for its primary indication, guaranteeing it 10 years market exclusivity upon approval. Orphan drug designation has also been granted in the US. The pivotal study of Beleodaq for the treatment of relapsed or refractory (R/R) PTCL was closed for recruitment in September 2011 after the inclusion of 129 patients. Final data presented at the American Society for Clinical Oncology (ASCO) annual meeting in 2013 showed an objective response rate (ORR) of 26% in all PTCL patients, 28% in PTCL patients with platelet counts above 100,000/µL and 45.5% in patients with the PTCL subtype angioimmunoblastic T-cell lymphoma (AITL). Safety data presented at the T-Cell Lymphoma Forum in 2013 showed a favourable safety profile of Beleodaq when compared to the approved treatments for patients with PTCL and it was emphasized that combining Beleodaq with cytotoxic regimens is likely feasible. Beleodaq appears to have low myelosuppression and even patients
www.visiongain.com Page 126