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ENANTA PHARMA – Debut of a Star- 2nd in the Oral IFN free HCV Drug Race!

US$ 140

Gilead entered the HCV race with the acquisition of Pharmasset in 2011 and ABBV through its alliance with Enanta (ENTA) in 2006. Gilead’s Sofosbuvir (PhIII, PMI) in combination with RBV and GS-5885 (PhIII, NS5A inhibitor) is all set to enter the market by 2014 but ENTA/ABBV’s DAAs (ABT-450, PI/r + ABT-333, PMI + ABT-267, NS5AI) will not be too far behind.

07-21 2015   Pages: 8

MITSUBISHI TANABE , Outperform – Invokana: Nice to Have A Clean Label, Yet A Long Way To Go Before Gaining Full Confidence!

US$ 500

“Invokana clean label thrills many on the street rising hopes that Invokana sales could cross $2.5b+ at peak. However we think that CV issues (dose dependent increase in LDL, CV events observed in first 30 days in CANVAS study), associated genital/UTI infections, compromised efficacy in renally impaired patients and long term safety study requirements by FDA (Table 1), should be seen in conjunction with the ‘clean label’.

07-21 2015   Pages: 9

VERTEX PHARMA – Dependence on Success of its CF Pipeline = Risk

US$ 140

Vertex Pharma’s (VRTX) stock has moved up ~30% in this year mostly based on the positive expectation building on Lumacaftor/KALYDECO (CFTR corrector/ CFTR potentiator, PhIII, homozygous del508 mutation Cystic fibrosis/CF), after it received breakthrough therapy designation from the FDA.

07-21 2015   Pages: 4

RIGEL – SyK Inhibition Not Good Enough – Limited Market Potential!

US$ 140

RIGL/AZN’s Fostamatinib (FosD, syk inhibitor, PhIII) has again disappointed by not demonstrating better or at par efficacy with approved or competing RA drugs. Despite achieving a statistically significant ACR20 improvement at 24 weeks in a PhIII, OSKIRA-I trial, it failed to demonstrate any statistical significance in its second primary endpoint – change from baseline in mTSS (mTSS = radiographic modified total Sharp score).

07-21 2015   Pages: 5

AstraZeneca – On the verge of a breakdown – Respiratory portfolio (Symbicort and Pulmicort) threatened by Generics

US$ 90

he respiratory portfolio of AZN which so far has withstood generics attack, is now giving away. Yesterday’s court ruling invalidating pulmicort respule patent and Teva filing a MAA in Europe for a generic equivalent of Symbicort has really shaken AZN base business. In addition recently Apotex announced invalidation of AZN Crestor patent in the Australia ($350m annual sales in 2012). We revise our 2013 core EPS estimate from $4.7 per share to $4.6 per share.

07-21 2015   Pages: 2

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: 10

BIOGEN IDEC – Hold On – After TECFIDERA Array of Approvals Yet to Come!

US$ 140

Most 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: 6

TRIUS THERAPEUTICS – Partnering or Buy Out = Upside

US$ 90

Positive 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: 4

Astellas, Acofide: Japanese Approval Raises Global Hopes!

US$ 90

Astellas 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: 3

Dolutegravir – SAILING data confirms best in class integrase inhibitor – More threat to Elvitegravir than Raltegravir

US$ 90

Dolutegravir – 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.

07-21 2015   Pages: 3
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