Industry Themes

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…

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,…

¥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…

The coming years will see Japan pharma regaining its status as innovator driven with Edoxaban for Daiichi Sankyo, Canagliflozin for Mitsubishi Tanabe, and Dolutegravir for Shionogi bringing the good times back for the respective companies in 2013 and carrying enough potential to change global market dynamics in the anticoagulant, diabetes and HIV space resp. We think that the massive ~$45b poured in acquiring innovation by Japanese companies does not justify its value as we find that the key catalysts from…

India pharma rode on the wave of bunched up patent expires in the US with many Para IV launches in 2012. In addition, it also benefited from the continuing high teen growth of Indian pharma market. With patent expires in the US dwindling from $30b in 2012 to $10b in 2013 (small molecules), Indian generic companies will now need to focus on complex generics that offer sustainability of earnings. Locally acting drugs and targeted drug delivery products make up for…

Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long. 2012 saw new drugs approvals for unmet needs, first in class drugs for Anti-obesity, Myelofibrosis, cancers and better drug options for HCV, RA, MS, psoriasis, HCC, dyslipidemia etc. We…

Macro Analysis Performance of the Mature Biotech companies recommended by MP Advisors in 2012 -report card is very impressive and we expect the positive sentiments to prevail in 2013 and beyondValuation Multiples and Fundamentals- Drivers of Growth.MP Advisors’ Proprietary Sum-of-The-Parts Valuation and Top Picks for 2013Drug Approvals 2012-15Key Milestones During 2013/14Impact on revenue 2012-2017 from Patent Expiry and Strategies deployed to meet the challenges.Pipeline of Biosimilar mAbsJoint Ventures between innovators and biosimilar playersMerger & Acquisitions Forecast- 2013-2020 In-depth Company Analysis…

Over the next five years, we will witness surge in approval of new drugs that would deliver a major improvement in the standard of care. Therapy areas - Oncology, Diabetes, Ophthalmology HCV, Atrial Fibrillation, Multiple Sclerosis, Dyslipidemia, Alzheimer’s and Melanoma are few select areas where newer therapies that are safer and more efficacious will reach the market. Many of these innovations promise a paradigm shift in the standard of care. The year 2012 has marked the beginning of this trend…