MP Advisors: Market Research Reports

... top line data of TC-5214 from European PhIII study ( ... , reported adverse events were similar to what it was observed in PhIIb trial (Constipation, Asthenia). A negative outcome ... in PhIII EU studies (Chart 1- Geography wise market size MDD, EU – 22%) comes as a blow for Targacept/AstraZeneca ...

Biogen Idec (BIIB) is closing 2011 with a positive note and ... Copaxone (L, RRMS) share of the MS market. Moreover, PhIIb data readouts from SELECT trial of Daclizumab HYP (PhII, IL-2 alpha subunit ... read our report, released on Nov. 8, 2011 on “Biogen Idec - Data of BG-12 + Sales Growth Brighten 2012 Prospects”

... more details, please read our report, released on Nov. 8, 2011 on “Onyx Pharma - Carfilzomib Approval – Now or Later?”

We close our positive investment alert on Bayer - post approval of Xarelto in SPAF by the USFDA. The stock has given a stellar ~27% returns (From €36.5 to ... FDA briefing documents leading to ~13% crash in Bayer’s stock price). Xarelto is approved with broad label to use in all NVAF patients, however without ...

Astellas released solid interim data from AFFIRM trial on MDV-3100 ... this solid data, we find a limited bottom line impact on Astellas due to its commercialization agreement with Medivation. Under the agreement, Medivation will ... receive upto $650m milestone payment which leaves a little for Astellas’s investor.

In this note we summarize the 3Q earnings of Mature Biotech – ALXN, AMGN, BIIB, CELG, GILD, and ONXX. We continue to reiterate ... PhIII data in mCRC). For more details, please read our 3Q11 earnings’ summary report released on 4th Nov, 2011 on “Mature Biotech: 3Q11 Earnings Summary”.

FDA endocrinologic and metabolic drugs advisory committee unanimously (14-0) recommended approval for Vytorin for reduction of CV risk in pre-dialysis chronic kidney disease patients. The committee’s vote was mixed (10-6 not in favor) for approval in ESRD (end stage renal disease) patients. The USFDA verdict ...

... same levels before generic entry happened and helped the results. Genzyme grew by a lackluster 7% as Cerezyme sales were impacted by a temporary ... to release Cerezyme. In case of Plavix patent infringement, the US Court of Appeals upheld the damages award granted to Sanofi and BMS in the amount of $442m ...

... we strongly believe IPCA would be able to retrieve its high teen’s growth rate. Besides these, growth will be driven by (1) anti malarial tender sales of generic Coartem ...

... our estimates on account of – 1) Better than expected improvement in margins after divesting chemical business, 2) Growth in pharma business backed by addition of a new subsidiary ...

... to moderate RA pts population where biologics have not made a dent. At ACR 2011 (Nov. 5-9, 2011, Chicago), key data on safety and efficacy ... read our meeting preview report released on 1st Nov, 2011 on “Rheumatoid Arthritis: Battlefield at ACR ’11 - Next Wave: Innovative Oral Drugs for RA”.

... Study of Liver Diseases (AASLD) 2011 (Nov. 4 - Nov. 8, San Francisco) will unveil - Data and new approaches to treat Hepatitis C Viral Infection (HCV ... our Therapeutic Class Overview report released on 31st October, 2011 on Hepatitis C: AASLD 2011 titled “Next Wave: IFN-Free Drugs with Safety ...

As expected, Sun Pharma received the final approval for generic Cardizem CD (annual sales of $300m) for all the strengths, viz. 120 mg, ... the patented price. All the current generic companies including Sun pharma has settled the Para IV litigation with Valeant (erstwhile Biovail ...

... Growth, API Saves Margin Dr Reddy’s Q2 FY12 result that was slightly higher than our sales ...

... read our report released on 25th October, 2011 on BIIB titled “Dominating Multiple Sclerosis Market for Long Term!”

NVS reported third quarter results today delivering robust sales growth ... cutting initiatives (2000 jobs cuts in the US and Switzerland), growth from recently launched products (Gilenya, Lucentis, ... INC424, AG0178, SOM230, QVA149, AIN457) will allow NVS growth to continue unscathed by the looming patent expiries ( ...

Vertex (VRTX) next target is to capture the HCV/HIV co-infected patients ... related to Earnings, Rheumatoid Arthritis (RA), Cystic Fibrosis (CF), etc. programs to have a positive impact on the stock price. For more details, please read ...

NVS recently presented impressive PhII data for Secukinumab (AIN457, IL-17A inhibitor) in Plaque Psoriasis at annual European Academy of ... Dermatology and Venereology (EADV) congress. Data from three PhII studies ...

... ) wave to treat HCV the race to offer the first “IFN free all oral option” seems to have begun. Preliminary data from Abbott’s PhII trial ... ’11 is challenging Pharmasset (VRUS) multiprong approach. For more details, please read our report released on Oct. 24th, 2011 on VRUS titled “IFN-free Oral Option” for ...

... ’s less encouraging PhIII data. We thus reiterate our market Perform on Biocon with target price of Rs. 324

... need along with approved indication… For more details, please read our report released on October 21, 2011 on Alexion (ALXN), titled “Meeting Expectations with Steady Growth- Trend ...

... in Multiple Sclerosis (ECTRIMS) 2011, Roche today announced the long term (96 weeks) safety and efficacy data from a PhII study on ocrelizumab in Relapsing Remitting Multiple Sclerosis ...

... of $1b) under 180-day exclusivity starting 14 March 2012. Cipla remained an active partner to Ivax (now Teva) by developing ... -day exclusivity. Thus Cipla too will share the upsides from the exclusivity. We expect Cipla to gain $50m ... will start accruing immediately after the upside from Zyprexa API supply to Teva ...

... in cash, which expands its existing Hepatitis C virus franchise. Anadys brings two pipeline candidates, ANA598 -non-nucleoside direct acting antiviral inhibitors ...

... landscape of Hepatic cancer drugs under development in China with an objective to figure out the market potential and positioning of China Medical System’s lead drug candidate – CMS ...

AstraZeneca today announced that it has settled paragraph IV litigation for Seroquel XR with Handa pharmaceuticals, who has the first to filer status ... settlement Handa will launch Seroquel XR generics only after November 2016. While litigation is ongoing with other Para-IV filers and a court decision ...

We reiterate our positive investment alert on Bayer post announcement of positive top line data of Xarelto in Ph III study ... in ACS patients in absolute term in PhIII ATLAS TIMI ACS study. Bayer plans to file for approval by YE 2011, and post Plavix patent ...

Recent failures of Edoxaban’s key competitor factor-Xa inhibitors from Japan - YM 150 (Astellas) and TAK-442 (Takeda), the closest candidate in Japan now is Xarelto ... years away from hitting the market. Edoxaban is the first and only approved factor-Xa inhibitor in Japan for prevention of VTE, though Japanese ...

... candidates and overseas business. Overall, we find R&D has potential to bring drivers in long term; however we prefer to stay sideline until we get a better ...

... months compared to Herceptin + docetaxel (14.2 m vs. 9.2 m- Table 1). The safety data as well, is very convincing as T-DM1 cut Grade 3 or more adverse effects ... 50% (46.4% vs. 89.4%). With T-DM1 and pertuzumab arrows in its quiver, Roche is well poised to sustain its breast cancer franchise beyond Herceptin ...

... therapy area is heating up, Vertex (VRTX) will continue to have the edge for at least 3yrs. We expect most of the near term milestones related for ... read our report released on 23th September, 2011 on VRTX titled “Near Term Positive Long Term Neutral”.

... daily NS5A inhibitor (BMS-790052) +Peg-IFN/RBV. Efficacy data of BMS-790052 raises ... NS5A inhibitor) - Once daily w/o IFN. PSI-7977+ Peg-IFN/RBV have shown advantage over the ... IFN-free combinations. For more details, please read our report released on 21th September, 2011 on VRUS titled “Tapping Both IFN and IFN ...

We have a positive expectation for the approval of Eculizumab (L, Soliris, Paroxysmal Nocturnal Hemoglobinuria) in Atypical ... more details, please read our report released on September 16, 2011 on Alexion (ALXN), titled “Great Expectations From Label Expansion”.

Turn of The Decade: Novel Glp-1’s To Emerge as the New Leader in Diabetes Class Bydureon – A near term growth driver of the class Novel delivery platforms and fixed ... in cumulative peak sales for this class of drugs by the turn of this decade as we see innovation efforts around this class will result in ...

... . It is an attractive acquisition target due to…. For more details, please read our report released on 13th September, 2011 on ARQL titled “Read-Out Only in 2013”.

Pharmasset (VRUS) announced top line data of PSI-7977 PhIIb, PROTON ... read our report released on 13th September, 2011 on VRUS titled “Another Step Towards Success”.

After a long wait, Ardea (RDEA) reached an agreement with the FDA on the proposed PhIII ... in the report released on 12th September, 2011 on RDEA titled “Entering the Pivotal Phase”. For more details please ask for our initiation ...

Based on a planned interim review of early data from ALTTO (Adjuvant lapatinib and/or Trastuzumab Treatment Optimization trial), a Phase III, four arm study of adjuvant ... hence has recommended patients assigned to Tykerb alone arm of the trial should discontinue. While DSMB has asked patients on the rest ...

On September 8, FDA advisory committee will meet to discuss approval of Xarelto in SPAF, while ...

Today, AstraZeneca announced mixed top line results from most awaited SATURN (Study of Coronary Atheroma by InTravascular ...

... read our report released on 2nd September, 2011 on ONXX titled “Testing Time Ahead in the Hematological Cancer Space”.

... August at ESC, BMY announced the much awaited data from ARISTOTLE study. The data is convincing and warrants an approval for Eliquis ...

... TREATMENT IN THE ERA OF NEXT GENERATION ORAL ANTICOAGULANTS Pradaxa: With first mover advantage, Will it be the Leader ... which will have wide ranging impact on the treatment paradigm in several therapeutic areas encompassing ... Acute coronary syndrome. This therapy class report analyses the practical issues in the ...

DETAILED DATA FROM ARISTOTLE STUDY AT ESC – AUGUST 28th. BMY is likely to announce detailed data on Eliquis in SPAF from the ARISTOTLE study. The data on Eliquis from ARISTOTLE will be compared to the data on Pradaxa from RELY trial and not Xarelto- ROCKET AF, as there are major differences in trial design. ...

... Nov-10 and May-13 respectively); together they contributed ~56% of revenue in FY 03/11. Eisai solely depends on catalysts coming out of its pipeline. Following Halaven approval ... , Eisai has three late stage candidates E-2007/ perampanel ...

The USFDA approval of Zelboraf (Vemurafenib) for inoperable metastatic melanoma, well in advance of the PDUFA date is encouraging. USFDA has also approved the cobas BRAF mutation diagnostic test. This will reduce YERVOY uptake directly as ~50% of Metastatic Melanoma patients are B-RAF positive and Zelboraf ...

Approval of Complera (GILD’s Truvada + Tibotec’s Edurant) reiterates GILD’s ... HIV infection. With the current economic turmoil, approval of once-daily Complera (formerly Fixed Dose Combination drug) impact may ... report released on 12th August, 2011, titled – “Complera Approval - Positive Long Term Impact”

We reiterate our Underperform rating on Aurobindo after Q1 FY12 result that remained ... (up by 39% and 20% of total sales) that included a Government of India tender where ARBP did not earn any profit. As expected ... API and formulations) remain at the core of ‘India advantage’. We reduce our target price to Rs.120

Kyowa Hakko Kirin announced to initiate Ph III JP trial for ARQ-197 (Ph II, c-Met inhibitor, advance or metastatic NSCLC, oral). JP Ph III ... & ESMO suggest favorable outcome in Ph III. ARQ-197, if reaches market, will be targeting ~ 30,000 patients in Japan and expecting a generous 10% discounted launch price ...

We reiterate our Market Perform rating on Ranbaxy after the Q2 CY11 result that was in line with our ... about a possible timely launch. Longer term potential of Ranbaxy seems promising with Daiichi-Ranbaxy likely to become the largest generic company in Japan ...