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Biogen Idec – Poised to Grow Beyond MS
US$ 140BIIB’s efforts towards diversification are finally taking going to take shape from this year onwards with approvals of drugs in indications other than Multiple Sclerosis (MS) while BIIB’s supremacy in MS to remain. Positive new data from ELOCTATE (long-acting rec. Fact VIIIFc, hemophilia A) and ALPROLIX (long-acting rec. Fact IXFc, hemophilia B – Hemo B) presented at the XXIV ISTH Congress reinforces their advantages/potential safety, efficacy, and pharmacokinetic profile.
07-22 2015 Pages: 7Merck -Suvorexant delayed but no additional studies required is a sigh of relief
US$ 90DA recently issued a complete response letter to MRK’s Suvorexant. As per the complete response letter, the USFDA will need manufacturing data on the 10mg dose and clinical data for the 5mg dose. Due to safety concerns; the higher doses (30mg and 40mg) would not be approved.
07-22 2015 Pages: 1Merck -Suvorexant delayed but no additional studies required is a sigh of relief
US$ 800TAK-700 – No competitive edge against Zytiga Generics; while in early setting competition is also heating up! In the recent past, treatment paradigm of metastatic prostate cancer (mPC) has witnessed
07-22 2015 Pages: 14NATCO, Dismissal of Litigation over “Gad Patents” is Positive, Potential Launch Timing Still Contingent on Federal Circuit Outcome
US$ 90“US district court (NY Southern) granted a motion by Mylan and Sandoz to dismiss the litigation over 4 non OB patents (‘938, ‘802, ‘359 – expiring in Sept, 2019 and ‘580 – expiring in Feb – 2020). Together these patents are referred to as Gad Patents. The patents in suit claim polypeptide “markers” and methods of using such markers. Markers are polypeptides, when used with certain equipment, can measure the molecular weight of a sample of Glatiramer Acetate. The litigation has been dismissed as Mylan and Sandoz agreed not to use certain polypeptide markers to measure the weight of samples of Glatiramer Acetate.
07-22 2015 Pages: 1Merck – One timers and Forex weigh on Merck’s guidance
US$ 90MRK reported its 2Q 2013 results: the net sales decline by 11% ($11.0b) including negative foreign exchange impact by 3% compared to last year. Company reiterated its 2013 non-GAAP EPS guidance ($3.45 and $3.55) while revised its GAAP EPS to be between $1.84 and $2.05 (previous $1.92-2.16).
07-22 2015 Pages: 1TAKEDA, Vortioxetine (Brintellix) – US Approval for MDD Likely in October – Competitive Enough Against Genericized MDD Market, Yet Maturing Late Stage Pipeline Candidates Warrant A Close Watch!
US$ 140Takeda’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: 4TAEKDA, TAK-700 – Unable to demonstrate OS benefit in chemo experienced patients- What to expect in chemo naïve pool and in earlier setting?
US$ 90On 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: 5NOVARTIS – String of Pearls- LDK378, Serelaxin followed by breakthrough designation for BYM338 (bimagrumab)
US$ 90Novartis 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: 2CIPLA , We reiterate our market perform rating on Cipla with a price target of Rs.415 (20x FY-15 earnings) as we expect
US$ 140We 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
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$ 140We 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
