Global Pharma US & EU Outlook 2015

CONNAUGHT PLACE, India - Aug. 28, 2015 - PRLog -- FDA approved more number of drugs (44) in 2014 and out of that 38% (17) are first –in-class. AstraZeneca tops the list with four drug approvals in the US. Infectious disease area received more than 25% of total approval and oncology therapy follows with 18% approval. First – in-class mechanisms like anti-PD1, anti-PCSK9 and CDK inhibitors continue to get attraction by large cap pharma companies. Nivolumab, Pembrolizumab have received approval in metastatic melanoma and currently explored in multiple large oncology segments like NSCLC, RCC, Hodgkin’s lymphoma would decide the potential of the company in the near term. Intense competition is on-going between Amgen and Sanofi/Regeneron in bringing up novel PCSK9 inhibitors: evolocumab and alirocumab in the US market respectively in the treatment of elevated LDL-C (lowering of LDL). Amgen was the first to file in the US for approval of evolocumab and Sanofi leveled that playing field by buying a priority review voucher that could speed up the FDA review. The first CDK inhibitor Ibrance (palbociclib) has also got the approval in the US for post-menopausal women with estrogen receptor positive (ER-positive), human epidermal growth factor receptor 2 negative (HER2) metastatic breast cancer who have not received an endocrine therapy and several follow up molecules are coming up from Eli lilly (LY2835219) and Novartis (LEE011) are two years behind palbociclib in this segment.

Major pharma companies are continue to improve the productivity by taking different approaches like focusing on selected therapy area and markets, merger and acquisition, divestment of non-core brands/segments and consolidation in animal health, vaccines and consumer health care business. Cardiovascular and metabolic segments remains attractive and major pharma companies are focusing on bringing newer products options with better patients compliances and economics through SGLT2+DPP4 combo pills, biosimilar Insulin (LY2963016), once daily GLP-1 agonist (dulaglutide, Trulicity) and Injectable device compliance (new Bydureon pen).

Global Biopharmaceutical Outlook 2015-Global Pharma, released by MP Advisors provides analyses of individual large cap companies, promising drug candidates in their late stage pipelines, competitive landscape, and important therapy areas where new innovation will create leadership, forecast for major marketed drugs where competition/ regulatory scenario will change the dynamics, and the potential impact of several important upcoming milestones on the industry

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