Therapeutic Class

Over the last decades, therapeutic options for Plaque Psoriasis (PsO) and Psoriatic Arthritis (PsA) have expanded considerably and improved patients’ pain, function, and quality of life. Approved biologics fill in a critical unmet need of limited efficacy of DMARDs; however, as in most cases one drug does not fit the bill for all the patients. The lack of targeted immune therapies other than TNF-α inhibitors in Psoriasis signals opportunities for drug developers to bring agents to market that offer treatment…

Targeting unmet needs in the treatment of cancer/ hematological malignancies through innovative drug development strategies have witnessed favorable outcomes. Over the past decade, Proteasome inhibitor, Velcade (bortezomib) and the immunomodulatory drugs – Thalomid (thalidomide) and Revlimid (lenalidomide) have become the cornerstone of treatment for patients with Multiple Myeloma (MM) resulting in improved survival. However, eventually all patients relapse and new treatment options for Relapsed/ Refractory Multiple Myeloma (RRMM) are required to further improve survival and quality of life of this…

XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. In coming years, we expect this to repeat in early stage prostate cancer treatment (nmCRPC,…

With three products and eight players already in market – Japan biosimilar market will enter new phase of biosimilars with first ‘mab’ approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because – 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data. ~ ¥200b worth of biologic products is going off patent by 2015…

Pain is the leading cause of disability in the US, affecting more than cancer, diabetes and heart disease combined. Current analgesics for persistent pain are relatively ineffective, are associated with significant adverse effects or abuse liability, and do not reduce pain in all treated individuals. Opioids (e.g., morphine, codeine, oxycodone) are currently one of the most potent groups of analgesics used clinically, with prescriptions increasing by 50% over the past 10 years for chronic, non-cancer pain. However, there is clear…

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…

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…

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,…

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…

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).…