New Phase of Mab biosimilar knocks the door Biosimilar Opportunities In Japan

The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than the U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (started in 2006 by launching various benefits for GE use at Pharmacy, hospital level) – now in 2014, Generic penetration of small molecules is changing the trend line and moving towards faster market penetration. While for…

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Newer Oral Anti Androgens – Expanding Role in the Treatment Paradigm of Prostate Cancer

XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry 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, we expect this to repeat in early stage prostate cancer treatment (nmCRPC,…

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Emergence of Biogenerics Era in Japan – It’s Time To Welcome Antibody Biosimilars of Foreign Origins Soon

With three products and eight players already in market – 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. ~ ¥200b worth of biologic products is going off patent by 2015…

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Moderate to Severe Pain: Novel Abuse Deterrent Formulation Technologies and Emergence of Novel Mechanisms in the Management of Pain

Pain is the leading cause of disability in the US, affecting more than cancer, diabetes and heart disease combined. Current analgesics for persistent pain are relatively ineffective, are associated with significant adverse effects or abuse liability, and do not reduce pain in all treated individuals. Opioids (e.g., morphine, codeine, oxycodone) are currently one of the most potent groups of analgesics used clinically, with prescriptions increasing by 50% over the past 10 years for chronic, non-cancer pain. However, there is clear…

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New Avatars of Microbes Super Bugs A Growing Threat Worldwide

Novel approaches to treat infection is growing as the need is urgent! Misuse/overuse of antibiotics accelerated antimicrobial resistance (AMR) and has resulted in the emergence of “super bugs” which are posing life threatening challenges world wide. Many of the advances in medical treatment like cancer therapy; organ transplants etc. would go waste if the ability to fight infections during the treatment were not available. If that fails, the gains made in life-improving modern medical advantages will be lost creating a…

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Dietary Supplements: World of Opportunities In the Indian Healthcare Market

The increasing rate of chronic diseases has emphasized the need for Prevention over Intervention. These proactive health solutions include nutritional supplements which promise medical or health benefits and fall between the food and pharma chain – ‘Nutraceuticals’. Over the years, the nutraceutical market has experienced robust growth fueled by high consumer demand, product innovation, and low regulatory hurdles. The nutraceutical industry is already facing intense competitive pressure wherein companies are seeking new opportunities or geography expansion in functional food, beverage,…

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Global Pharmaceutical and Biotechnology Outlook 2014: Rising Stars

Innovations have contributed to the availability of a range of new treatments for diseases resulting in improvement in the length and quality of life and reduced disease burden for individuals and society. However, the need for innovative therapies for unmet needs /challenging diseases continues to grow, accelerating the pace of drug development directly or through partnership/ in-licensing. We expect innovation and improved drugs therapies through novel target discovery and technology platforms to continue to flow from the backyards of small…

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Global Pharmaceutical and Biotechnology Outlook 2014: India Pharma

Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2014-16 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in the forefront of…

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Global Pharmaceutical and Biotechnology Outlook 2014: Japan Pharma

2014 will be marked as a transition year for the Japanese Pharma industry - the year is bound to be painful both for innovators and generic companies due to the new regulations. We find these regulations to be 'decisive' in spurring generic penetration significantly, with the main beneficiary being the Japanese government (or society) and not the generic companies. The implications of new price-reversions are going to have many facets and will change conventional business models. We expect many support…

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Takeda, Challenges Ahead for its New European Presiden

Post Nycomed and Millenium acquisition, the new leadership of non-Japanese CEO/President Mr. Weber will transform Takeda in a truly global Japanese company in the coming years. It is however important to see how he fulfills the Japanese expectation from these acquisitions and fills the gap for Takeda due to the recent failure of its key late stage pipeline candidates (TAK-875, TAK-700 in chemo experienced Prostate Cancer). From its remaining late stage pipeline candidates (Table 2) Vedolizumab, Contrave (Naltoxone + buproprion,…

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