Japan Biogenerics Market & Prostate Cancer Oral Anti-Androgens Analysis in New Research Reports
Japan biosimilar market will enter new phase of biosimilars with first 'mab' approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because - 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data, says the report Therapeutic Class Overview : Emergence Of Biogenerics Era In Japan - It's Time to Welcome Antibody Biosimilars of Foreign Origins Soon available at http://www.reportsnreports.com/reports/275199-therapeutic-class-overview-emergence-of-biogenerics-era-in-japan-its-time-to-welcome-antibody-biosimilars-of-foreign-origins-soon.html .
~ ¥200b worth of biologic products is going off patent by 2015 and this value exceeds ~ ¥400b if we include products that will see their patent expiries by 2021 in Japan (Table 1). There are number of reasons to believe that follow-on-biologics or biosimilars will not replicate the lethargic growth story of generic - preliminary because the much higher cost of biologic therapy brings significant burden on patients despite relatively low co-pay in Japan - and this will push individuals and DPC Hospitals to use biogeneric products to a greater extent unlike generic drugs. Secondly, the regulatory supports are going to be stringent enough to ensure quality measures and minimizing the 'not made in Japan' factor from prescriber's and user's mindsets.
Anticipating this opportunity and favorable macro forces as compared to generics, a number of companies aim to exploit this - Japan has seen a flood like consolidation and partnering activities in biosimilar space (Table 2, Annexure I). While a dozen+ companies have already laid their road map for biosimilars space, at this time we see Sandoz, JCR, Meiji Seika Pharma, Fuji Film Kyowa Kirin Biologics, Nippon Kayaku, Nichi Iko, Yoshindo etc. to be amongst the key players in biogenerics business in Japan.
It is also noteworthy that large global player, which currently look silent in Japan.
In this piece, we attempt to evaluate the future competitive landscape (Table 3) of the Biosimilars space in Japan, assess the overall attractiveness of the same, and try to identify the key determinates to succeed in this space. At this point, we do not arrive at any investment recommendations from the sector
List below is a part of table of contents for this report that shows companies discussed in it:
SELECT JAPANESE COMPANIES VENTURING INTO BIOGENERICS SPACE
JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners (Table 15)
Meiji Seika Pharma (MSP) - Ahead of Peers on Trastuzumab Race (Table16)
Fuji Film Kyowa Kirin Biologics (FF-KKH) - Looking Beyond Domestic
Opportunities (Table 17)
1. Nichi-Iko - Aspiring To Go Overseas Markets As Well (Table 18)
2. Mochida: Revving Up Collaboration Efforts (Table 19)
3. Nipro Pharma: Not Much Development Following First Success
4. Yoshindo: A 'Three Step' Approach to Build a 'Bio Company'
5. Nippon Kayaku - Pioneering 'New Age' Of Biosimilars (Table 20)
6. Mitsubishi Tanabe: Late Entrant But With Many Strengths
7. Sawai: Wait & Watch' Strategy Continues
8. Towa: May Venture the Space by 2016
9. Daiichi Sankyo - Premium Generics Business Will Prioritize Biosimilars
10. Umn Pharma - Transforming Vaccines Heritage into New Generation Biologics
11. Kissei: Intensied Efforts to Build EPO Franchise
12. Kyowa Hakko Kirin: Gearing up for Bigger Pie
13. Aska Pharmaceuticals - Barriers To Gain From Partner's Pipeline
14. Toyobo Biologics - Eying At Biosimilars CMO Business
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In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. In coming years, the report Therapeutic Class Overview: Newer Oral Anti Androgens - Expanding Role in the treatment Paradigm of Prostate Cancer (http://www.reportsnreports.com/reports/275200-therapeutic-class-overview-newer-oral-anti-androgens-expanding-role-in-the-treatment-paradigm-of-prostate-cancer.html ) expects this to repeat in early stage prostate cancer treatment (nmCRPC, before Prostectomy) due to launch of newer antiandrogens in this setting. Longer duration of therapy and high prevalence makes this earlier setting market more lucrative and bigger for newer options than late stage if they succeed.
In coming years, the research forecasts second generation antiandrogens (Androgen synthesis inhibitors/Androgen receptor inhibitors, Xtandi, ARN-509, ODM-021, Zytiga, TAK-700, TOK-001) to replace them and expand their use beyond current levels in nmCRPC (non metastatic Castrate resistance Prostate cancer) patients and also in pre-prostectomy (Chart 3). This newer agents will expand these markets atleast by $10b ($6b in pre prostectomy, $4b nmCRPC) if get success.
TAK-700 (Takeda), ARN-509 (JNJ) and Xtandi are strong candidates to get success in early stage prostate cancer and in next two years PhIII clinical data from EL-04, PROSPER and SPARTAN study, will decide who will lead this market. While TAK-700 has a first launch advantage it is important to see how ARN-509, compete to Xtandi in earlier setting and in terms of safety for penetrating in early prostate cancer market. Other than these PhIII studies, Xtandi PhII data from neoadjuvant PC and ARN-509 data in preprostectomy patients will decide their use in earlier setting. This report estimates $2.8b peak sales for Xtandi in mCRPC setting, while in earlier setting it has potential to generate atleast ~$2b if it gets success in PROSPER , STRIVE, TERRAIN and neoadjuvant study.
Other pipeline Antiandrogens discussed in this report along with analyst views include -
EPI-001
AZD3514
HE3232 (Apoptone)
BMS-641988
Androgen Synthesis inhibitors: Dthe pipeline candidates have potential treplace Zytiga?
TAK-700- How it is different from Zytiga?
TOK-001
Indirect near term key competitors tZytiga/Xtandi in Post chemsetting:
OGX-011
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