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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Hemophilia

Hemophilia is an inherited (X-linked recessive trait), lifelong bleeding disorder that prevents blood from clotting due to insufficient or lack of adequate amount of clotting factors – Factor VIII (FVIII) and Factor IX (proteins in blood that control bleeding). Plasma-derived FVIII and FIX proteins were used in the 70’s for treating these disorders but transmission of contaminating viruses reduced its use. In 1999, recombinant FVIIIs and FIX, free of viral, animal, or human proteins became the standard of care (SoC).…

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Rituxan Biosimilar

The growth in the biosimilar opportunity will be driven by several patent expiries of mega-blockbuster biologics in the next 5 years. Between 2012 and 2017, over $60b worth of sales of biologics in the US/EU will lose patent protection. Out of them, Roche’s/Biogen Idec’s Rituxan/MabThera (rituximab), Merck and JNJ’s Remicade (infliximab), and Amgen and Pfizer’s Enbrel (etanercept) had WW sales of ~$23b in 2011 and have patents expiring in EU and ROW in 2013/14. Biosimilar version of Rituxan was launched…

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

New targets/drugs remain an evergreen medical need to address the unmet need of drug resistance in the treatment of cancer. Large global pharma are constantly on the hunt for drugs with label expansion potential = Longevity and Blockbuster Potential! About $10b+ has already been invested in licensing /acquisition of PI3K and other kinase inhibitors/companies since the last five years. Scientific data on the role of PI3K, BTK kinase in cancer and clinical Proof of Concept (PoC) data of the PI3K,…

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Future Of GPR Agonist

Despite about half a dozen distinct targets having been innovated and introduced in the market for the oral treatment of Type 2 diabetes, ~60% of diabetics still exhibit progressive worsening of glycemic control and ~half of them end up with daily insulin. Increasing epidemiology of Type 2 diabetes due to genetic/lifestyle changes, as well as micro/macrovascular (CV) complication associated with diabetes, demands the researcher to find newer options for treating diabetes which can address other consequences along with HbA1c reduction.…

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Hepatitis C Virus Infection

The launch of Protease inhibitors’ (PIs) created a wave in 2011-12 and accelerated the pace of innovation and impressive Sustained Virologic Response (SVR) rates by oral IFN free drug combinations have raised the bar and the expectations of pts, physicians and investors. Freedom from IFN, treating all genotypes and betting on vaccines could bring a sea of change in the HCV therapy class area in the future. Roche set the trend with the acquisition of Anadys for total of $230m…

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Japan Biosimilars

¥200b worth of biologic products is going off patent by 2015 and this value exceeds ~ ¥500b if we include products that will see their patent expiries by 2021 in Japan. There are a 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…

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