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CADILA HEALTHCARE LTD, Upgrade to Outperform – Best Poised beyond Patent Cliff – Complex Generics launches on the horizon
US$ 140“We upgrade Cadila Healthcare to Outperform and increase price target from `815 to `1050, as we build into our model forecasts for its high margin / low competition opportunities (Mesalamine franchise, Trasnsdermal patches and Urokinase).
07-21 2015 Pages: 10BIOGEN IDEC – Hold On – After TECFIDERA Array of Approvals Yet to Come!
US$ 140Most awaited approval of TECFIDERA (BG-12, delayed-release capsule of dimethyl fumerate) with a ‘clean’ label should seal Biogen Idec (BIIB)’s supremacy in the MS space. We expect TECFIDERA to become the first choice among oral MS drugs in the first line setting based on its robust efficacy and favorable safety profile compared to its oral MS peers – Novartis’ Gilenya (L, fingolimod) and Sanofi’s Aubagio (L, teriflunomide).
07-21 2015 Pages: 6TRIUS THERAPEUTICS – Partnering or Buy Out = Upside
US$ 90Positive top line data of Tedizolid (oral/IV, 2nd-generation oxazolidinone, PhIII, Acute Bacterial Skin and Skin Structure Infections – ABSSSI; PhII, CAP/HAP/Bacteremia, partnered with Bayer for Asian, LA and ME rights) from 2nd pivotal PhIII study (ESTABLISH 2, Table 1A/1B) increases the probability of approval by 1H14 in US in ABSSSI indication.
07-21 2015 Pages: 4Astellas, Acofide: Japanese Approval Raises Global Hopes!
US$ 90Astellas and Zeria announced today that they received approval for Acofide in Japan (Acotiamide /Z-338, functional dyspepsia, jointly developed by Astellas and Zeria in Japan). Acofide is the first drug to be approved for Functional Dyspepsia (under Rome III criteria) and addresses a huge unmet need – it is estimated that over a quarter of Japanese adults suffer functional dyspepsia (~25m people).
07-21 2015 Pages: 3Dolutegravir – SAILING data confirms best in class integrase inhibitor – More threat to Elvitegravir than Raltegravir
US$ 90Dolutegravir – SAILING data confirms best in class integrase inhibitor – More threat to Elvitegravir than Raltegravir
Clinical data from PhIII SAILING study announced yesterday demonstrated dolutegravir’s statistically significant superiority as compared to Isentress in treatment experienced HIV patients.
Competition for Pristiq – Earlier than Expected – A Substantial Opportunity for Alembic and Ranbaxy
US$ 90Pfizer’s Pristiq will now witness competition as today the USFDA approved Alembic’s 505 (b) (2) application for Extended release Desvenlafaxine base tablets, which is bioequivalent to Pfizer’s Pristiq (Desvenlafaxine Succinate).
07-21 2015 Pages:New Technologies Initiative: Gateway to Treating Genetic Diseases – Sarepta Therapeutics – Skipping Makes Sense – Restoring Muscle Function in Duchenne Muscular Dystrophy
US$ 500“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.
07-21 2015 Pages: 18AMGEN – Dynamic Strategies in Place for Global Expansion of Innovative Drugs and Biosimilars = Growth Drivers
US$ 140Amgen (AMGN) began 2013 on a positive note outlining long-term (post-2015) growth strategies through new product launches, global expansion, and entering the global biosimilar space with new partners and ventures.
07-21 2015 Pages: 6NATCO PHARMA, Outperform – Major New Product Launches to strengthen growth Trajectory
US$ 140“We maintain our outperform rating on Natco Pharma as we expect robust growth in FY 14 driven by important new high potential launches (oncology space) in the domestic market. We are particularly excited about Everolimus launch (May 2013) in the domestic market, which we believe is a big opportunity. Lansoprazole Rx and OTC in US will drive the export formulation business in FY14. The company also continues to make good progress in creating new growth avenues in the US, as they are also expected to file an ANDA for Vidaza shortly.
07-21 2015 Pages: 8ASTELLAS , TAKEDA – ASCO-GU 2013 Review: Prostate Cancer – Xtandi Confirms Its Superiority In Early Setting, ARN-509 Is Emerging Threat To Xtandi, While TAK-700 Lags Behind!
US$ 90Clinical data presented at ASCO-GU 2013 confirms Xtandi (Enzalutamide, Astellas/Medivation) to be the next standard of care antiandrogen therapy across the treatment progression of prostate cancer amongst new treatment options (Zytiga, Provenge, Jevtana).
07-21 2015 Pages: 3