MP Advisors: Market Research Reports

Amylin, Acquisition, BMY, AZN, Bydureon, Byetta, GLP-1 agonists, Type 2 Diabetes, Dulaglutide

We continue with our Underperform rating on Eisai following approval of Belviq (lorcaserin, 5 HT 2C agonist, partnered with Arena) in the US. Despite ... (Qnexa has PDUFA date on 26th July 2012; we are expecting approval). Belviq administration is to be discontinued if 5% weight loss is not achieved within 12 ...

We are skeptical if the FDA will approve Mirabegron (first in class β3-AR agonist, overactive bladder ... the fact that CV risk concerns raised with Mirabegron are mild in nature and the FDA’s ... seems to be more common view of street - we expect mirabegron to generate $300m revenue by 2016 from USA; our WW peak ...

The complete response letter to Eliquis, was entirely unexpected, and should impact sentiments. We see a ~10% negative stock price reaction as BMY’s valuations have been stretched, and ...

... events – cardiovascular toxicities and deaths associated with Kyprolis as expected. ONXX has finally succeeded in ... Nexavar (L, RCC, HCC, partnered with Bayer), Kyprolis, and Regorafenib (R, oral multi-kinase inhibitor, GIST ... on Jun 21, 2012 on Onyx Pharma titled “Onyx Pharma - Kyprolis to Accelerate Growth”

... a closer look at the situation, examine the possibilities and rationale of Roche increasing its stake in Chugai, and the possible course of action to attain this under Japanese ...

... , please read our report, released on June 18, 2012 and titled, “RIGEL - Oral RA Market - Room for Syk Also.

... continue in 2012. In this report, we highlight the investment opportunities in the mid-small cap Rising Star companies: ARQL: Key Driver is Tivantinib (c-MET inhibitor) in PhIII for ... of the risk reward please read our report titled, “Rising Stars (Small-Mid Cap) Biotech/Biopharma: Investment Opportunities”.

A relative assessment of new clinical data published on SGLT2 inhibitors at ADA 2012, suggests that JNJ/Mitsubishi Tanabe’s canagliflozin is all set to ... pipeline candidates with a differentiated clinical profile include Lexicon’s dual SGLT2/1 inhibitor – LX4211 - Superior post prandial glucose reduction, ...

... flat growth of Revlimid (L, RRMM, MDS), reported in its 1Q12, we expect Celgene (CELG) to meet its FY12 guidance (Total rev.: $5.4-$5.6b and EPS ... , please read our report, released on 12th June on CELG, titled “Long-Term Prospects Intact but Competition Emerging!”

Dainippon Sumitomo Pharma (DSP) has help R&D day recently and kew take away was that Latuda (lurasidone) ...

Merck reported data from the two pivotal PhIII study of Suvorexant (Orexin receptor antagonist, Insomnia) at Sleep 2012 meeting. First in class ... in US and Japan by YE 2012, and data from another two pivotal studies will be out by YE 2012. We estimate worldwide peak sales of $750m for Suvorexant

The ORIGIN trial was intended to expand Lantus use in the ... existing use in the late stage setting. In the trial, Lantus did delay the progression of pre-diabetes to diabetes ... disadvantage. The only positive implication for Lantus from the ORIGIN trial is that it completely removes the cancer risk overhang on ...

Among all oral options for the treatment of Rheumatoid Arthritis (RA), JAK inhibitors are ready to reach the market but the debate will continue – whether targeting specific JAK-1, 2, &3 or a multipronged approach like JAK 1/2, 1/3 is better? JAK1 may be the most suitable target as an anti-inflammatory drug ...

... REMS program for PML risk have driven and anchored Elan Corp.'s (ELN), but future growth is highly dependant on the success ... , Please read our report released on June 11, 2012 on ELN, titled “A Tale of Two: Tysabri = Support; Bapineuzumab = Upside”.

Vertex (VRTX) has evolved from an innovator to a profitable Biotech but at the ... detail, please read our report released on 11th June, 2012 on Vertex titled “Time to Book Profits….!”

... crucial aspects of growth strategy for a generic company or an Active Pharmaceutical Ingredient manufacturing ... recently approved or are in late stage development / Filed but with significantly success probability ... / therapeutic value compared to marketed drugs Anticipated competition in the therapy and ...

Novartis today reported positive Phase 3 data on ACZ885 (canakinumab) in SJIA. The data is impressive but commercial opportunity would be limited as SJIA is a rare disease, while ... 20000 or less depending on the weight. While if NVS chose to price ACZ885 at its existing annual cost ($100,000), it may not be able ...

Top-line data from PhIII trial, TOWER of Sanofi’s Aubagio (teriflunomide, R, RRMS, PDUFA: 3Q12) reaffirms our take on BG-12 (Dimethyl fumerate, R, Est. ... details, please read our report released on June 1st , 2012 on Biogen (BIIB), titled “Teriflunomide Does Not TOWER Over BG-12”

We reiterate Sun Pharma as our Top Pick in the Indian pharma space after its higher ... growth like (1) continuing sales of Doxil generic after Sun gets ANDA approval (2) launch of Prandin, Comtan ... In addition to the near term drivers, we see Sun Pharma positioning itself to become a leader in global generics with ...

IPCA’s Q4 FY12 result was slightly below our ... on Q-o-Q basis mainly due to the reduction in production as IPCA implemented the track and trace system in its manufacturing facility ... margin of 5%) too impacted the business. We remain enthused about Ipca’s 18-20% growth guidance for domestic pharma in FY13. We rate ...

... read our report released on May 31st, 2012 on ONXX, titled “ASCO ’12: Kyprolis’ Data enough to obtain an ‘Accelerate Approval’?”

Vertex (VRTX) evoked an uproar when it corrected the data of its KLAYDECO/VX- ... detail, please read our report released on 31th May, 2012 on Vertex titled “KALYDECO + VX-809 Analysis – PhIII Should be Successful in CF patients with Homozygous ...

... diagnosed multiple myeloma (NDMM) will take center stage in this ASCO. These include Celgene’s Pomalidomide (PhIII), Onyx’s Carfilzomib (PhIII), ... more details, please read our report released on May 30th, 2012 on ASCO 2012, titled “Promise Of Drugs for Relapsed/ Refractory Multiple Myeloma (RR MM) To Unfold”.

... review will be due within 60 days from the filing date, i.e. May 23rd. Enzalutamide is the first in class androgen receptor signaling inhibitor ... data is better for enzalutamide - 4.8 months vs. 3.9 months for Zytiga. Despite enzalutamide’s solid data, we find a limited bottom line impact on Astellas due to its ...

... , please read our report released on May 29, 2012 on VVUS, titled “Which one First to the Market – Qnexa/Lorcaserin or both?”

... boosted Amgen’s (AMGN) pipeline, while Mustafa Nevzat pharma (MN pharma, pvt., Turkey) is a strategic move to increase its presence in the growing emerging/ international markets ... read our report released on May 29th, 2012 on AMGN, titled “Innovation + Emerging Market – A Balanced Approach”

... (100% ownership), and Beijing Continent (51% ownership). China’s market for IPF is GNI’s focus and at the current valuation (if convinced about the ... market size) it could present an investment opportunity. China regulatory approval of ...

... expected to unfold favorably for Mitsubishi Tanabe (MT) - 1) Upcoming Catalysts From Diabetes Franchise: Canagliflozin is showing promise of better safety and ... our talk with MT. Launch of MT’s teneligliptin, though it will be fifth DPP-4 in Japan, it will have its share backed by two of the strongest marketing ...

... ‘rationalization’ of various partnerships in different geographies. Launch of Dymista and Vancomycin by Cipla’s partners in US too may not fetch any meaningful upside in the ... near term. We reiterate our Market Perform on Cipla but change our target price to `341 as we rollover to FY13 ...

Despite the setback in the pipeline – negative recommendation from FDA advisory committee on ... franchise should be able to buffer some setbacks in the pipeline. The FDA advisory panel voted 11-0 against approval of the ... , released on May 14, 2012 on REGN, titled “Diversified Pipeline can Buffer the Setback”.

Cadila’s Q4 FY12 result was much higher than our estimates owing to ... declined by 4.5% due to forex loss. FY12 remained a year of consolidation after Cadila acquired Nesher, Bremer and Biochem. Going forward, the company ...

... details, please read our report released on 9th May, 2012 on Halozyme titled “HyQvia’s Delay – Percolation to Other Drugs in the Pipeline?”

Vertex (VRTX) released positive PhII data from KALYDECO in combination with VX-809 for CF pts with delF508 mutation. Low ... detail, please read our report released on 8th May, 2012 on Vertex titled “KALYDECO + VX-809/VX-661 (CF), INCIVEK (HCV) + Pipeline –Value Loaded ...

Novartis today presented the pasireotide LAR PhIII study data in treatment naïve ... LAR SOM 230 is also being explored in another Phase 3 study head to head with open label Sandostatin and Lanreotide ATG in patients with ...

Roche announced discontinuation of DAL-OUTCOME study today due to no meaningful clinical efficacy benefit. Our PT remains unchanged as we ...

Gilead’s supremacy in the HIV space in 2012-18 should remain intact with the successful launch of ... , please read our report released on 3rd May, 2012 on Gilead titled “After HIV -Poised to Deliver the Best Anti-Viral Treatment Options for HCV!”

Incyte (INCY) reported net revenues of $19.3m of the only approved drug for Myelofribrosis (MF), JAKAFI / JAKAVI (ruxolitinib, JAK 1/2 inhibitor, PhII/III in PV/ET; partnered with Novartis for ... , please read our report released on May 2, 2012 on INCY, titled “JAKAFI / JAKAVI to Drive Sustainable Profitability”

The recent two year safety findings from the CATT study in conjunction ... the safety benefits translating into market share gains for either of the drugs. The rate of adverse events at two years, ... are similar to that observed at the end of first year, which shows that there has ...

... , please read our report, released on May 1, 2012 on REGN, titled “A Myriad of Opportunities – EYLEA (AMD, CRVO) + ZALTRAP (mCRC) + ARCALYST (Gout ...

Vertex (VRTX) 1Q12 earnings highlighted robust KALYDECO sales (L in US, CF pts with ... also plans to begin three additional pivotal studies of KALYDECO to target CF pts with R117H mutation and in ... on 1st May, 2012 on Vertex titled “KALYDECO Uptake Balances INCIVEK Disappointment - 2012 Guidance Achievable!”

The increase in sales is because of high growth in Insulin sales in India (probably due to Pfizer’s marketing) and also growth in immunosuppressant sales. ...

Though Q1’12 earnings were disappointing (flat growth of Revlimid), we expect Celgene (CELG) should able to meet its FY12 guidance (Total rev.: $5.4-$5.6b ... read our report released on 27th April, 2012 on CELG titled, “Revlimid Sales Disappoints, but Long Term Prospects Intact!”

Daiichi Sankyo’s (DS) announcement to take over Shanghai Xinshengyuan Pharmaceutical Group in China thru its Chinese subsidiary Daiichi Sankyo (China) Holdings Co., Ltd. came as a surprise last week. Xinshengyuan is largely ...

Sanofi Q1-2012 results shines on Lantus outperformance, but we remain concerned on their medium term guidance SAN posted Q1-2012 results, with sales and business EPS growing 7% and ... guidance, We see potential risk to Lovenox sales growth in Europe from Xarelto / generic copies, slowdown in Lantus sales with ...

... Hemolytic Uremic Syndrome (aHUS) indication, and label expansion in other rare and high unmet need indications of Soliris; we expect the growth trajectory continues ... , please read our report released on April 25, 2012 on ALXN, titled “Soliris’ Label Expansion & Diversification to Perk ALXN Up!”

Top line data from PREVAIL I & II trials announced on 24 April, 2012, show Latuda (lurasidone, already approved for ... line data suggests that safety was found to be consistence in all trials and in acceptable range. This report analysis key findings from PREVAIL I & II studies ...

... of Ardea Biosciences (RDEA) by AstraZeneca (AZN) for $32/s or ~$1.26b is the second deal in this month in the gout space, after Takeda (TYO: 4502) acquired privately ...

... me-too ARB Azilva (Azilsartan) in Japan in May-12; Azilva aims to retain revenue of Takeda’s best selling ARB Blopress that is soon going off patent. Takeda highlights the ...

... Chouzai (leading drug chain in Japan), which suggests that 25% of Rx received from general practitioners (GP’s) contained generic names. From April, 2012, a two-point ... amongst several other regulatory changes and we expect the revised incentive system for GPs will have ~similar magnitude of impact on other ...