TAK-700 - No competitive edge against Zytiga Generics; while in early setting competition is also heating up! In the recent past, treatment paradigm of metastatic prostate cancer (mPC) has witnessed
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…
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…
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…
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).…
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…
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…
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…
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,…
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.…