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TAKEDA, Vortioxetine (Brintellix) – US Approval for MDD Likely in October – Competitive Enough Against Genericized MDD Market, Yet Maturing Late Stage Pipeline Candidates Warrant A Close Watch!

US$ 140

Takeda’s late stage pipeline candidate – Vortioxetine (Filed, Partnered with Lundbeck, US PDUFA on October 2nd) is expected to get FDA approval for the treatment of Major Depressive Disorder (MDD). Despite the fact that antidepressant market will be ~fully genericized by 2013 (when Cymbalta will go off patent in Dec 2013), there are ~dozen of compounds in mid-late stage development for the treatment of MDD (Table-1).

07-22 2015   Pages: 4

TAEKDA, TAK-700 – Unable to demonstrate OS benefit in chemo experienced patients- What to expect in chemo naïve pool and in earlier setting?

US$ 90

On Friday 26th July ‘13, Takeda announced interim analysis results from the ELM-PC 5 Phase 3 study of Orteronel (TAK-700) plus prednisone in chemo experienced prostate cancer patients. The interim analysis of the study indicated that it was likely that orteronel plus prednisone would not meet the primary endpoint of improved OS when compared to the control arm (HR- 0.894), though the study did meet the secondary endpoint of improving rPFS (HR- 0.755). On the safety front, there were no major concerns.

07-22 2015   Pages: 5

NOVARTIS – String of Pearls- LDK378, Serelaxin followed by breakthrough designation for BYM338 (bimagrumab)

US$ 90

Novartis reported strong 2Q-2013 financial results due to the absence of Diovan generics in the US. For the same reason, Novartis has revised its earning guidance for the full year 2013. It now expects group net sales to grow at a low-single digit and the group core operating income to decline at a low-single digit rate.

07-22 2015   Pages: 2

CIPLA , We reiterate our market perform rating on Cipla with a price target of Rs.415 (20x FY-15 earnings) as we expect

US$ 140

We reiterate our market perform rating on Cipla with a price target of Rs.415 (20x FY-15 earnings) as we expect
1) Sales growth to slow down in the upcoming quarters FY-2014. The 1Q-FY 14 sales and profit growth were primarily led by one-offs.
2) Margins may be adversely impacted – Higher R&D, overheads and recent drug pricing policy
3) Medpro acquisition may at best be 2-3% accretive to earnings
Q1-FY 14 Earning Led by One Offs

07-22 2015   Pages: 5

CADILA HEALTHCARE, We reiterate our outperform rating on Cadila; however, revise our price target down to Rs.950 (20x of FY15 earnings), owing to the delay in the approval of ANDA’s.

US$ 140

We reiterate our outperform rating on Cadila; however, revise our price target down to Rs.950 (20x of FY15 earnings), owing to the delay in the approval of ANDA’s. We lower our revenue and EBITDA estimates of FY14 by 5% and 8% respectively as during the Q1- FY14 earnings conference call,

07-22 2015   Pages: 10

RANBAXY – Stretched Balance Sheet, a Weak Product Pipeline, and Uncertainty around Monetizing Exclusivities

US$ 140

“Q2 CY-13 Result in Line: Sales grew by 8% QoQ primarily on account of higher Absorica (Isotretinoin) sales in US. US sales grew by 29% sequentially as company now has 14% share in Isotretinion (~$400m market). Excluding US, revenue across the geographies remained muted and grew by 1% sequentially and 2% yoy.

07-22 2015   Pages: 6

IPCA – We reiterate our market perform rating for IPCA and increase price target to Rs.740 by valuing the company at 18x of FY15 earnings. We expect revenue and earnings to grow by 16 -17% in next two

US$ 140

We reiterate our market perform rating for IPCA and increase price target to Rs.740 by valuing the company at 18x of FY15 earnings. We expect revenue and earnings to grow by 16 -17% in next two years (FY14 and FY15). In FY14, growth will primarily come from Institutional Anti-Malarial Business

07-22 2015   Pages: 5

SHIONOGI – Tivicay (Dolutegravir) US Approval Comes with an Encouraging Broad Label. Focus Shifts on Data from FLEMINGO Study and Approval of Trii FDC!

US$ 300

Tivicay (Dolutegravir) US Approval Comes with an Encouraging Broad Label. Focus Shifts on Data from FLEMINGO Study and Approval of Trii FDC!

07-22 2015   Pages: 3

INCYTE – JAKAFI’s Label Expansion in Ref. Metastatic Pancreatic Cancer = Multi-Billion Potential!

US$ 140

Positive interim Overall Survival analysis data from the PhII, RECAP trial of Ruxolitinib (L – JAKAFI for MF, oral JAK 1/2 inhibitor, PhII/III in PV/ET, partnered with Novartis for Ex-US rights) in combination with capecitabine in recurrent or treatment-refractory metastatic pancreatic cancer pts is a pleasant surprise.

07-22 2015   Pages: 3

KYORIN, Flutiform Will Make its Japanese Debut Soon – A game changer for Kyorin!

US$ 200

“Following the second PAFSC committee recommendation, Flutiform (Fluticasone propionate + formoterol) fixed dose combination is likely to get Japanese approval in September. It will be the third LABA + ICS entering Japanese market for the treatment of Asthma. In Global studies, Flutiform has demonstrated non-inferiority to Seretide Evohaler MDI (Chart 1) and Symbicort Trubohaler.

07-22 2015   Pages: 5
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