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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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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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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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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New Technologies Initiative: Gateway to Treating Genetic Diseases – Sarepta Therapeutics – Skipping Makes Sense – Restoring Muscle Function in Duchenne Muscular Dystrophy

Approval of KYNAMRO (ISIS/Sanofi, HoFH), a first systemic Oligonucleotide Antisense (ASO) based therapy has raised expectations from the compounds in pipeline of other companies with similar technology platforms. Highly differentiated, 2nd Generation DNA/RNA-based drugs that work at the fundamental level of gene and protein expression have the potential to bring a paradigm change in treating diseases esp. rare genetic disorders like – Familial Hypercholesterolemia (FH), Duchenne Muscular Dystrophy (DMD), TTR (Transthyretin amyloidosis), SMN (spinal muscular atrophy) etc. Noteworthy, amongst them…

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Drivers of M&A in 2013-2016: PI3Ks and BTK Inhibitors

Targeting kinases have been on the agenda of most drug developers/ researchers as they hold the key path to signaling, development and growth of the cell. Tumors/cancer biology indicates that this balance is disturbed and inhibiting the aberrant pathways in a balanced way is an approach to developing drugs against cancer. Resistance to existing therapies develops as cancer cells bypass these efforts and their remains an evergreen search for new targets to meet these challenges. Large global pharma are constantly…

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