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MP ADVISORS

Total 162 Reports Found - Showing Reports From 1 To 25

The rapid growth of the generic industry has come with a number of challenges, such as heavy competition, including from authorized generics and government-mandated price cuts. All contribute to diminishing prices and ever decreasing margins. In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infri

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Xtandi – Replacing competitor from Zytiga to Casodex (Bicalutamide) for a bigger pie in Prostate cancer & Finding its niche in crowded BC market Xtandi + Zytiga vs. ARN-509 + Zytiga - Who will win the race? Rising star Anti Androgens – Third generation Antiandrogens- What left for AR-V7 mutants after TOK-001 failure? Late Stage Prostate Cancer Pipeline drugs – AKT inhibitors or PARP inhibitors or a new MoA combination with Antiandrogen or IO combo - Competing to Xtandi/Zytiga or targeti

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Rescheduling of Hydrocodone combinations from Class III to Class II, clear-cut regulatory guideline for Abuse Deterrent drug formulation NDA & ANDA (solid oral) filing and CDC guideline for Prescribing Opioids for Chronic Pain (2016) are definite steps taken by FDA in last two years for creating “Abuse Deterrent Era” in a short span to stop opioid abuse and reversing opioid epidemic in USA. There were around 18,893deaths involving prescription of opioids in the United States in 2014 which was

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Major pharma companies are continue to improve the productivity by taking different approaches like focusing on selected therapy area and markets, merger and acquisition, divestment of non-core brands/segments and consolidation in animal health, vaccines and consumer health care business. Oncology segment has been the key areas of interest for large cap Pharma companies in 2014/2015. The field of immuno-oncology is currently one of the most explosive fields in biotechnology. Bristol-Myers’s w

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2016 will be a crucial for drug makers and consumers. During ‘Make-in-India’ week in Mumbai, Govt. highlighted many amendments or introduction of new policies with an aim to make India as a major hub for end to end drug discovery. To boost drug discovery, to promote manufacturing of certain drugs against life threatening diseases like AIDS, and to reduce our dependence on China, the Govt. has promised to offer many incentives (exemption from excise duty or tax) and also plans to setup ventur

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JP Giants leaning in for becoming a Speciality Global Pharma Sakigake designation – A Push from government to “Innovate”! “Essential drugs” exemption from Z2 rule- Balancing long listed pricing pressure! Authorized Generics, Biosimilars, and Patent Litigations - Avenues to grow in JP Generic market! Increasing decline in long listed products sales, and a few success in R & D in the last decade had put JP giants under pressure to refocus on Innovation with specialty therapy area to strengt

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Non-Alcoholic SteatoHepatitis (NASH) is an unmet medical need and is becoming the leading cause of liver transplant. No FDA-approved therapies and a meager diagnosis, it poses a unique challenge in the design of studies for NASH. Therefore, there is a worldwide need for new therapies to treat the global epidemic of NASH and the cost to society will be huge if it is not addressed in the upcoming years! Besides, scarcity of treatment options, there is also an urgent unmet need to develop biomar

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BIIB’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. Last month, FDA ap

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FDA 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. We see the launch timelines delayed by atleast 12 to 18 months. In case of the 10mg dose Merck would have to conduct an additional stability study, which would take atleast 6 months. For the 5mg dose, there would be addit

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TAK-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

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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 dismi

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MRK 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). MRK expects its 2013 revenue to be approximately 5 to 6% lower than last year with foreign exchange accounting for approximately 3% points of the decline. The revenue decline was mainly due to loss of exclusi

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Sanofi reported lower than expected 2Q-2013 financial results due to greater than anticipated impact of genericization, foreign exchange and write-off related to excessive inventory in Brazil. SAN has reduced its guidance and now assumes 7-10 percent decline in EPS as compared to 0-5 percent earlier. The genericization pressure and Brazil write off’s were to an extent managed by impressive growth in Lantus and Genzyme. We see the Brazil write-off as an adverse issue associated with an aggres

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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. We see the revision in guidance as inadequate and not reflective of the gains due to delayed Diovan generic entry. Despite the higher than expected sales base in 2013, the com

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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). Increasing prevalence, high unmet need (poor tolerability, moderate efficac

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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

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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. We see the revision in guidance as inadequate and not reflective of the gains due to delayed Diovan generic entry. Despite the higher than expected sales base in 2013, the com

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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 One offs like inventory push up in domestic market

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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, management guided that company is expected to receive only 5-8 USFDA approvals during the year which was significantly lower than the earlier guidance of 22 approvals. Earlier we expected some low competition

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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. EBITDA margin at 9.8%, has improved by 220 bps on sequential basis mainly due to high margin sales of Isotretinoin and INR depreciation. Forex loss of Rs.5403m and impairment of goodwill of

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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, UK and Branded Formulations (Africa, CIS). Strong US sales post approval of Indore Facility and sustained momentum in Institutional Business will be the key growth driver in FY15.

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Tivicay (Dolutegravir) US Approval Comes with an Encouraging Broad Label. Focus Shifts on Data from FLEMINGO Study and Approval of Trii FDC! ViiVhealthcare today announced US approval of Tivicay (Dolutegravir) - it is approved both for treatment naïve and treatment experienced HIV patients and also in INSTI (integrase strand transfer inhibitor) resistance patients (except in patients where INSTI-resistance is due to Q148 substitution plus two or more additional INSTI resistance substitution).

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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. The hazard ratio for overall survival in the intent-to-treat (ITT) population was 0.79, and in a pre-specified subgroup analysis (pts identified prospectively as most likely to

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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. Key advantage with Flutiform is its faster onset of action which gives rapid relief from wheeziness and waking to a

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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

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