Dainippon Sumitomo Pharma – Expectation From BBI-608 To Achieve FY2017 MTP Target Looks Unachievable!

Dainippon Sumitomo (DSP) is one of those Japanese pharma companies which has changed its orbit by successful US launch of Latuda (Lurasidone, dopamine-2, serotonin-2 and serotonin-7 receptors agonist schizophrenia/bipolar disorder) in the last two years. But DSP’s expectation to generate $650m by FY2017 from its lead compound BBI-608 from mCRC is way unachievable. Pipeline Cancer Stem Cell Inhibitors- from OncoMed/Celgene (OMP-21M18, OMP-52M51) And Bionomics (BNC-101) also need a close watch. On M & A front (Table 11), DSP’s R &…

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Global Pharmaceutical & Biotechnology Outlook 2014: Major US and EU

Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisition In recent years' several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma, and breast cancer from major pharmaceutical companies. Many of them are expected to reach multi-billion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1, anti-PCSK9,…

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Global Pharmaceutical & Biotechnology Outlook 2014: Mature Biotech

Positive sentiments for the biotech sector have prevailed in the last two to three years, and we expect this trend to continue for the next year too. Our optimism is based on the continuity in the flow of innovative products from their pipeline, implementation of strategic decisions to improve cost efficiency, strengthen therapeutic leadership, and hedge against generic threats – which all lend stability to the business model of the company. Focus and interest in Orphan diseases remain and Alexion…

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Hepatitis C Virus Infection

Freedom from injecting Interferon (IFN), treating major HCV genotypes WW and betting on vaccines could bring a sea of change in the treatment of HCV infection in the future. This year the first IFN-free drug options for HCV Genotype 2/3- Gilead’s Sofosbuvir/RBV (GS-7977, PDUFA Dec. 8, 2013) is expected to be approved and launched! By 2015 launch of Gilead’s Sofosbuvir/Ledipasvir (PhIII) and AbbVie/ Enanta’s (ABT-450r/ABT-472/ABT-333) should remove the need of IFN for GT1 genotype HCV patients as well! Tapping the…

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Rituximab biosimilar

Approval of Inflectra/Remsima, the first biosimilar Monoclonal antibody (Mab) from Celltrion and Hospira in EU in 2013 is a trend setter! Inflectra is a biosimilar of Johnson & Johnson's Remicade, which is approved for RA, Crohn's disease and several other conditions and had $2 billion in sales in Europe last year. This approval has further increase the optimism of companies developing and marketing biosimilars and the wait for the launch of others in queue Rituxan, Herecptin, Enbrel etc may not…

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Treating Refractory Hematological Malignancies – Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML): Emerging Therapeutics

The report provides an overview of the approved therapies for AML, MDS, unmet need and limitations of the current SOC for relapsed and refractory pts. The report highlights the competition and commercial opportunity in pursuing this therapy area – Comprehensive list of the early and late stage drugs in the clinic, their MoA and the companies developing them. Detailed financial and competitive analysis of the companies leading in the race to launch new therapies for this indication – Ambit Biosciences,…

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Innovative Drug Delivery Systems: Novel Product and Formulation Technology Licensing Opportunities for Generic Pharmaceutical Companies

There are more than 1400 sustained or controlled release drugs approved all over the world. Revenues within the global generics market reached an estimated value of $265b in 2012, showing a growth of 9.3% throughout the year. The contribution of generics is approximately 20% of the overall international pharmaceutical market. Utilization of generic in terms of volume is higher in the US and lower in Japan, 89% and 24% respectively. The oral drug delivery market remains the largest slice of…

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Risk – Reward of Developing a Herceptin Biosimilar – A Thorough Assessment

Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprises about 15% of its cumulative Pharma sales. While eying for this potentially lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report – “Risk-Reward of Developing a Herceptin biosimilar – A thorough assessment” looks into several aspects of…

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Xtandi- The Real Potential and the Astellas Part!

Xtandi- The Real Potential and the Astellas Part! Expectations that Xtandi (Enzalutamide, Approved, Prostate Cancer) is going to bring a paradigm shift to treat prostate cancer as an ideal antiandrogen therapy (includes positive expectation from interim analysis of PREVAIL expected at ESMO-13/ early 4Q 2013 study in pre-chemo setting) has recently resulted in a rally in Astellas’ price. Although, the clinical profile of Xtandi (steroid free regimen, better safety and efficacy than Zytiga) carries potential to compete with Casodex/Zytiga generics…

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