MP Advisors: Market Research Reports

... /Target Patient Population Invokana – Market Model SGLT2 Pipeline (Japan and Global Status) Companies mentioned Mitsubishi Tanabe, Johnson & Johnson, Eli Lilly, Lexicon

Vertex Pharma’s (VRTX) stock has moved up ~30% in this year mostly based on the ... detail, please read our report released on 9th March, 2013 on Vertex titled “Dependence on Success of its CF Pipeline = Risk!” Companies mentioned Vertex Pharma

We upgrade Cadila Healthcare to Outperform and increase price target from `815 to `1050, ... years as we forecast $250m in risk adjusted incremental profits for Cadila from launch of generic mesalamine ($1.3b in brand sales), Transdermal patches ... competition for a longer term Companies mentioned Cadila Healthcare

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. ... , please read our report released on April 5, 2013, titled, “SyK Inhibition Not Good Enough - Limited Market Potential!” Companies mentioned Rigel

... EPS estimate from $4.7 per share to $4.6 per share. Companies mentioned AstraZeneca

... -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 ... our report released on 28th March, 2013 on BIIB titled, “Hold On - After TECFIDERA Array of Approvals Yet to Come!” Companies mentioned BIIB, BIOGEN IDEC

... and Skin Structure Infections – ABSSSI; PhII, CAP/HAP/Bacteremia, partnered with Bayer for Asian, LA and ME rights) from 2nd pivotal ... , please read our initiation report released on 26th March, 2013 on Trius (TSRX) titled “Partnering or Buy Out = Upside” Companies mentioned Trius Therapeutics

... 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 ...

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 ...

Pfizer’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 ...

... expectations from the compounds in pipeline of other companies with similar technology platforms. Highly differentiated, 2nd Generation DNA/RNA-based drugs ... of the SRPT’s Phosphorodiamidate Morpholino Oligomer (PMO) and Exon-Skipping technology platform. Key Points described in the report, are: SRPT: Valuation ...

Amgen (AMGN) began 2013 on a positive note outlining long-term (post-2015) growth strategies through new product launches, global expansion, and ... , please read our report released on 26th Feb. 2013, titled, “Amgen - Dynamic Strategies in Place for Global Expansion of Innovative Drugs and Biosimilars = Growth ...

... FY13 (¥1,927m de-growth of 1.4%) and discontinuation of TREAKISYM for refractory/relapsed aggressive non-Hodgkin’s Lymphoma (NHL) brought down SymBio pharma (4582 ... , please read our report released on 22nd February 2013 on SymBio titled “Growth Driver: PI3K Inhibitor’s Rigosertib & Cash to In-license More!”

We maintain our outperform rating on Natco Pharma as we expect robust growth in FY 14 driven by important new high potential launches ( ... should be invalidated. We retain our Target Price `781 and reiterate Outperform rating on Natco. We have accounted upside due to Copaxone in the Target Price

Acorda Therapeutics (ACOR) reported 4Q/FY12 results with a decent growth in sales ... label expansion of AMPYRA (POC data in 2Q13) and pipeline beyond AMPYRA could lead to the next driver to the stock. Successful ... our report released on 15th February 2013 on ACOR titled “Building Confidence Beyond AMPYRA!”

Dr Reddy’s Q3FY13 result was below our estimates as ... XL, ramp up of Fondaparinux (hospital segment) and Amoxil. We expect Dr. Reddy may participate in Vidaza opportunity which is due any time as an API ... US and Russia. We reiterate our market perform rating on Dr Reddy’s and retain out target price of Rs.1929.

... both hematologic malignancies and inflammation indication has sparked interest in Infinity Pharma (INFI). Despite limited clinical data in hand, PC and in vitro ... read our report released on 13th February 2013 on INFI titled “IPI-145, Unpartnered, Potent PI3K Inhibitor = Larger Opportunity!”

... GLP-1 secretion in glucose depended manner is the key trait of this class. Through this, GPR agonist controls hyperglycemia without hypoglycemia, and ...

Hemophilia is an inherited (X-linked recessive trait), lifelong bleeding disorder that prevents blood from clotting due to insufficient or lack of adequate amount of clotting factors – Factor VIII (FVIII) and Factor IX (proteins in blood that control bleeding). Plasma-derived FVIII and FIX proteins were used ...

The growth in the biosimilar opportunity will be driven by several patent expiries of mega-blockbuster biologics in the next 5 years. Between 2012 and 2017, over $60b worth of sales of biologics in the US/EU will lose patent protection. Out of them, Roche’s/Biogen Idec’s Rituxan/MabThera (rituximab), Merck ...

... betting on vaccines could bring a sea of change in the HCV therapy class area in the future. Roche set the trend with the ...

... to bring a change in treatment paradigm of hematological malignancies (CLL, iNHL, ALL). Curis’s (CRIS) pipeline consists of a marketed drug Erivedge (L in US, R in EU/other, vismodegib, HedgeHog ... read our report released on 11th February. 2013 on CRIS titled “Time to Assess Value Beyond Erivedge!”

... (CELG) 2. M&A in Kinase Inhibitors in the last 5 years 3. Related Milestones/catalysts in 2013-14 4. Combination Studies – PI3K, BTK inhibitors with Rituxan, Bendamustine in hematological ...

... MEK inhibitor) as monotherapy and in combination with dabrafenib (BRAF inhibitor) as combo therapy for the treatment of metastatic melanoma with a BRAF V600 mutation ... days. The accelerated assessment and early filing of the combination therapy is based on extraordinary efficacy shown in PhII study which doubled ...

Post complete response letter issued by the USFDA to NOVOB for Tresiba and Ryzodeg, we reduce our PT for NOVOB from DKK 1000 to DKK 950. Considering the US constitutes the biggest long acting insulin market (Lantus-US sales: $4b; Western EU: $1.0b; RoW: $400m; Emerg mkt: $1.0b), the CRL has clouded the ...

... test that all antisense/ RNAi focused companies have to pass. ISIS has a robust cash position, valuable IP assets, and success of a few ... in the current pipeline could accelerate the transformation from a discovery to a pharma company and help it to grow beyond KYNAMRO.

Biogen Idec (BIIB) has acquired full rights to Tysabri from Elan for an ...

AZN reported its 4Q-2102 financial results, revenue declined by 15% while core EPS was up by 1% driven by one time tax benefits and lower operating costs. For 2013, the company has guided mid to high single digit decline in revenue, while core EPS should decline faster than revenue due to higher operating ...

With our conservative view on Revlimid – opportunity in EU (no approval in NDMM and Maintenance setting), reimbursement in China, and patent challenges; we expect net product sales’ CAGR (2013-17) of 17% (vs. CELG’s guidance: 19%) including risk adjusted late stage pipeline. We are positive on upcoming ...

Roche seems to be on track of delivering sustainable growth as it announced ... forward. With Perjeta and T-DM1 as well shaping up well, Roche is on a strong ground to sustain its revenues from Herceptin ... expected to reach the market in 2016, but by then, Roche would have GA101 on the market which would fend off ...

Vertex Pharma (VRTX) 4Q12/FY12 earnings and FY13 guidance (total revenue: ... is banking on success of its Cystic Fibrosis (CF) drugs in the pipeline for resurrection. VRTX endeavors could be too late in competing from ... read our report released on 31st January, 2013 on Vertex titled “Faltering Pipeline and Sales”

... visibility of free cash flow generation, we continue to remain concerned about the fate of highly levered (operating and financial) business model of Dishman. The fact ... land clearly signifies that company is not generating sufficient free cash flow to service its debt. As the proposed sale of SEZ land has ...

... (CELG) M&A in Kinase Inhibitors in the last 5 years Related Milestones/catalysts in 2013-14 Combination Studies – PI3K, BTK inhibitors with Rituxan, Bendamustine in hematological ...

nitial sales of newly added HIV products – Complera/ Eviplera (L, truvada + rilpivirine), Stribild (L in US, ... products contributed to the impressive 4Q12/FY13 results of Gilead. Positive data of Sofosbuvir (PMI, PhIII) in ... Through life cycle management of products for HIV, late stage HCV drugs and focus on ...

Lupin’s Q3FY13 result was higher than our estimates largely on account of ... are well entrenched and customers remain greatly brand loyal. Lupin’s earnings will also remain exposed to an appreciating INR. We increase our ...

... is mainly due to the potential R&D tax credit which will be realized from 1Q 2013. But beyond 2013, we see loss of Cymbalta sales to generic ... price. Despite the increasing growth of diabetes therapy, the revenues from Humulin and Humalog continued to be flat due to competition.

... that there is meaningful upside on positive PhIII data and approval of Ibrutinib (PCI-32765, PhIII, BTK inhibitor, partnered with JNJ, PhIII ... of time, and iv) Patient tolerability including lack of bone marrow damage. Ibrutinib is a best-in-class among leukemia drugs, showed durable efficacy in Tx-naïve (TN) ...

... forces as compared to generics, a number of companies aim to exploit this – Japan has seen a flood like consolidation and partnering activities in biosimilar ... , Yoshindo etc. to be amongst the key players in biogenerics business in Japan. In this piece, we attempt to evaluate the future competitive landscape of ...

... this will take time. Leveraging Balance sheet for Acquisition Consolidation of recent acquisitions (URL and DUSA) as well as management’s quest for new ... in US. Management has commented that Sun Pharma will continue to seek acquisitions in US (focus on Derma) and other emerging markets with small to medium ...

... gone up by ~185% since our initiation on September 14th 2012. SymBio’s focus on Japan and select Asia Pacific Rim countries market along with ... details, please read our report released on 16th January. 2013 on SymBio titled “Significant Upside still Remains: Bendamustine + Regosertib + Cash to In-license More!”

... is looking to acquire front end. Going forward in FY14 we expect revenue growth to remain modest (8-9%) due to (1) high base of FY13 (2) dearth of ... do not remain enthused about Cipla’s inhaler opportunity in Europe as it has lost the first mover advantage. Modest growth in revenue (8-9%), Lower EBITDA margins ...

... Value added innovation) versus regulatory pressures to contain costs. Global Biopharmaceutical Outlook 2013-Large Cap Pharma, released by MP Advisors provides ... Emerging Markets and their importance in Growth of Large Cap Pharma 6. Global Pharma -Drugs Losing Patent Protection By 2017 7. Impact of patent ...

... and PFE announced the long awaited approval of Eliquis for stroke prevention in atrial fibrillation ... US approval, for which the PDUFA data has been set for 17th March 2013. . We foresee Eliquis clearly ... demonstrated in the ROCKET-AF trial. We expect Eliquis to cannibalize Pradaxa sales initially, while extensive ...

Natco Pharma’s Q2 FY13 result was much ahead of our expectation on sales and EBITDA largely ... our expectation as Natco wrote off `61m as payment to SMS pharma over its old litigation. The company already launched Sunitinib in India, however, expects ...

ARBP Q2 FY13 result was greatly ahead of our expectation largely due to the improvement in margin and ...

... pts – GT1, Null, and Naïve seems to have become the norm. At AASLD 2012: (i) GILD presented interim data from the ongoing PhII ... , please read our report released on 20th Nov. 2012, titled, 'Hepatitis C: UPDATE Post AASLD ’12 - Progress in IFN-Free Drugs & Vaccines - Gilead and Abbott vying ...

... complex generics to drive growth. In other words, balance sheet would remain the biggest growth driver, both for ... generics are dwindling. DUSA acquisition looks very attractive for Sun Pharma due to (1) DUSA is acquired at a trailing EV / Operating ... of Rs.795 and reiterate our Outperform rating on the stock.

BMY and AstraZeneca jointly announced the approval of its First in class SGLT-2 inhibitor Forxiga ( ... will allow rapid uptake for Forxiga. A first mover advantage should allow Forxiga consolidate its ... a 7 to 8 percent market share for this class of drugs, with JNJ’s canagliflozin taking the majority share ...

... Revlimid’s label expansion in 1st line RRMM and as maintenance therapy in EU, Celgene (CELG) 3Q12 earnings highlighted growth of Revlimid globally on both a YoY ... data from ABRAXANE trials in melanoma and pancreatic cancer……please read our report released on 11th Nov. 2012, titled, 'ABRAXANE + Pipeline Drugs = ...

We reiterate our Market Perform rating on Ranbaxy post its Q3 CY12 result that was largely in line with ... (4Q-2012), Tricor (Jan-2013), and Diovan (Anytime) in the US market will help Ranbaxy reasonably compensate the loss of Lipitor Exclusivity. In the conference ...