Vedolizumab, MLN0002, Ulcerative colitis, Crhon's disease, integrin inhibitor, Remicade, Humira, Simponi, Tysabri, Etrolizumab, Tofacitinib, GEMINI 1 2, STELARA, GSK-1605786, Vercirnon, Traficet-EN - Reports Corner

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https://www.reportscorner.com/reports/28651/-Vedolizumab,-MLN0002,-Ulcerative-colitis,-Crhons-disease,-integrin-inhibitor,-Remicade,-Humira,-Simponi,-Tysabri,-Etrolizumab,-Tofacitinib,-GEMINI-1,2,-STELARA,-GSK-1605786,-Vercirnon,-Traficet-EN--/

Takeda received priority review status from US FDA for its late stage candidate Vedolizumab (filed for UC and Crhon’s disease (CD), a4ß7 integrin inhibitor) to treat ulcerative colitis indication. Vedolizumab targets the disease by preventing leukocyte extravasations through inhibiting a4ß7 integrin in the gut which is different from currently used second line options, mainly anti-TNFs (Remicade, Humira, Simponi). The key limitations with these drugs are their low response rate (~40% do not respond) and lost of response over time (~30%-40%). We understand that dose escalation and switch to a second anti-TNF recapture the response in 40-80% of patients but after 12 months the response rate drops significantly. This creates a huge unmet need for a drug which ..............On pipeline front..............The report discuss in details unmet need, late stage pipeline drugs and competitive landscape of ulcerative colitis and crohn's disease treatment options.

CADILA HEALTHCARE , Lipaglyn Launched in India – Survey suggests quick market acceptance, if priced appropriately - Reports Corner

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https://www.reportscorner.com/reports/28650/CADILA-HEALTHCARE-,--Lipaglyn-Launched-in-India-%E2%80%93-Survey-suggests-quick-market-acceptance,-if-priced-appropriately/

Zydus today announced the launch of its novel dual PPAR agonist Lipaglyn (saroglitazar) for treatment of diabetic dyslipidemia patients not controlled by statin alone. Based on our physician survey / assessment of the drug profile / market analysis, we expect Lipaglyn to garner around INR 650 million in peak sales in India by 2016. We see the need of a fixed dose combination of Lipaglyn with statin as important for the quick ramp up for this novel compound.

Treating Refractory Hematological Malignancies – Multiple Myeloma (MM): New Treatment Options Driving In-Licensing and M&A - Reports Corner

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https://www.reportscorner.com/reports/28652/Treating-Refractory-Hematological-Malignancies-%E2%80%93-Multiple-Myeloma-(MM):-New-Treatment-Options-Driving-In-Licensing-and-M&A/

The report (ToC) provides an overview of the therapies for Multiple Myeloma (Newly diagnosed - NDMM and relapsed/ refractory - RRMM), unmet need, and limitations of the current standard of care (SoC) for relapsed and refractory MM 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 this field for this indication – Celgene, Amgen (post-acquisition of Onyx pharma), and MorphoSys are available within this full report. Key M&A activities that have taken place in this area in the last 5 years and a list of products in early /late-stages of development available for in-licensing are highlighted in the report. This report is built using primary and secondary research data and in-house proprietary database.

MORPHOSYS (MOR) - MOR103/ MOR202 – Partnering is the Beginning of a New Phase of Growth - Reports Corner

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https://www.reportscorner.com/reports/28653/MORPHOSYS-(MOR)---MOR103/-MOR202-%E2%80%93-Partnering-is-the-Beginning-of-a-New-Phase-of-Growth-/

Alliances with GSK and Celgene in 2013 propelled MorphoSys (MOR) in the limelight. This could well be the inflection point in MorphoSys's evolution into a successful mature biotech company on the strength of its innovative platforms to develop biologics. Licensing of un-partnered early programs and the clinical data of its maturing therapeutic antibody pipeline are the future drivers. MOR enter into out-licensing deal with CELG for jointly development of MOR-202 (HuCAL antibody targeting CD38) for a total value of €698.8m. CELG strong presence in hematological malignancy further enhances the value with possible expansion in other leukemia’s....... For more detail, please read our report released on September 12, 2013, titled, “MOR103/ MOR202 – Partnering is the Beginning of a New Phase of Growth ”.

Amgen (AMGN) - Onyx Acquisition - Maturing Pipeline - Biosimilar Opportunity - Better Poised Than Large Pharma - Reports Corner

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https://www.reportscorner.com/reports/28662/Amgen-(AMGN)---Onyx-Acquisition---Maturing-Pipeline---Biosimilar-Opportunity---Better-Poised-Than-Large-Pharma/

Amgen (AMGN) announced the acquisition of Onyx pharma at $125/sh or $10.4b ($9.7b net of est. Onyx cash) in net cash, strengthening its Oncology/ Hematology drug portfolio ($7b in 2012, 42% of total sales) by adding Onyx’s marketed products – Kyprolis (L in US, RRMM, proteasome inhibitor, ex-JP rights), Nexavar (sorafenib, RCC, HCC, profit-sharing ex.JP) and Stivarga (regorafenib, mCRC, GIST, 20% royalties on WW sales). For Nexavar and Stivarga, Amgen has co-promotion agreement with Bayer in the US. This merger is synergistic and will be accretive to adj. EPS aided by cost savings from 2015. Amgen changed its approach to increase... For more detail, please read our report on AMGN released on 12th Sept. 2013, titled, "Onyx Acquisition + Maturing Pipeline + Biosimilar Opportunity = Better Poised Than Large Pharma!"

Generic Advair – 3 years to go, but which generic companies are better poised - Reports Corner

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https://www.reportscorner.com/reports/28663/Generic-Advair-%E2%80%93-3-years-to-go,-but-which-generic-companies-are-better-poised/

The USFDA has finally announced the draft guidance for the development of generic version of GSK’s Asthma / COPD drug – Advair (Fluticasone propionate + Salmeterol Xinafoate). The guidelines pave the way for generic companies to launch a substitutable and interchangeable version of Advair in the US market, which should allow easy and larger penetration for generic copies. Apart from ANDA filings, we should also see a few companies which are developing an improved formulation or using a different device file through the 505(b) (2) route. We see Mylan and Sandoz are well positioned to enter the market in 2016 with a fully substitutable version, while we are not sure if Cipla could also do the same. Sun Pharma also has access to dry powder inhaler technology (starhaler), but the efficacy profile of its formulation is quite different from Advair, hence it may have to come through the 505(b) (2) route. Teva has recently acquired Microdose therapeutx, which gives it access to DPI technology, hence there is a chance that Teva could also accelerate development of a fully substitutable version of Advair.

GSK – FDA Advisory committee positive on Anoro Ellipta – First once daily dual bronchodilator for US COPD patients - Reports Corner

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https://www.reportscorner.com/reports/28656/GSK-%E2%80%93-FDA-Advisory-committee-positive-on-Anoro-Ellipta-%E2%80%93-First-once-daily-dual-bronchodilator-for-US-COPD-patients/

GSK and Theravance jointly announced that the FDA pulmonary allergy Drugs Advisory Committee recommended in favor of approval (11-2) for the once daily, lower dose regimen (Vilanterol-62.5 mcg/ Umeclidinium 25 mcg). The committee unanimously voted in favor of efficacy, while safety votes were divided (10-3). The higher dose (125/25 mcg) of Anoro was not considered by USFDA for voting. The PDUFA date of Anoro is Dec 18, 2013 and a timely approval will make Anoro the first dual bronchodilator to be launched in the US. We expect Anoro to garner global peak sales of $ 1.5b. Anoro once launched will cannibalize the market of twice daily LABA’s (formoterol and Salmeterol) and Spiriva. LABA’s are primarily co-prescribed as second line treatment agents in COPD patients and about 25-30% of Spiriva prescriptions have LABA’s as coprescribed drugs. We see the market for Spiriva getting impacted to that extent. The MAA (Europe) for Anoro has already been filed in Europe and expected to receive approval by the end of this year. The submission of the regulatory application to the Japanese ministry has been done in Apr 2013.GSK and Theravance jointly announced that the FDA pulmonary allergy Drugs Advisory Committee recommended in favor of approval (11-2) for the once daily, lower dose regimen (Vilanterol-62.5 mcg/ Umeclidinium 25 mcg). The committee unanimously voted in favor of efficacy, while safety votes were divided (10-3). The higher dose (125/25 mcg) of Anoro was not considered by USFDA for voting. The PDUFA date of Anoro is Dec 18, 2013 and a timely approval will make Anoro the first dual bronchodilator to be launched in the US. We expect Anoro to garner global peak sales of $ 1.5b. Anoro once launched will cannibalize the market of twice daily LABA’s (formoterol and Salmeterol) and Spiriva. LABA’s are primarily co-prescribed as second line treatment agents in COPD patients and about 25-30% of Spiriva prescriptions have LABA’s as coprescribed drugs. We see the market for Spiriva getting impacted to that extent. The MAA (Europe) for Anoro has already been filed in Europe and expected to receive approval by the end of this year. The submission of the regulatory application to the Japanese ministry has been done in Apr 2013.

Edoxaban – HOTSUKAI VTE STUDY Results at ESC-13- Well differentiated and should carve its niche in VTE patients with PE/Renal impairment - Reports Corner

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https://www.reportscorner.com/reports/28657/Edoxaban-%E2%80%93-HOTSUKAI-VTE-STUDY-Results-at-ESC-13--Well-differentiated-and-should-carve-its-niche-in-VTE-patients-with-PE/Renal-impairment-/

On 1st Sep, at ESC, Daiichi-Sankyo presented positive results from the PhIII HOKUSAI-VTE study on Edoxaban in VTE (Venous thromboembolism) treatment. Edoxaban demonstrated non-inferiority in terms of efficacy and superiority in terms of safety compared to warfarin in the trial. The results are on the same lines as Eliquis and better than Xarelto and Pradaxa. Based on this data and subgroup analysis, we believe Edoxaban would be preferred primarily in those patients who present with a Pulmonary embolism (with or without DVT) and also those with renal impairment. We expect the market size for VTE treatment to be.....................
HOKUSAI –VTE Implications for ENGAGE-AF.........................

SymBio pharma - TREAKISYM Label Expansion - Rigosertib’s Potential in MDS market - Cash to In-license More - Reports Corner

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https://www.reportscorner.com/reports/28664/SymBio-pharma---TREAKISYM-Label-Expansion---Rigosertib%E2%80%99s-Potential-in-MDS-market---Cash-to-In-license-More/

SymBio (4582) licensed Onconova’s Rigosertib (SyB L-1101, PhI, RRMDS, Dual inhibitor of PI-3 and PL-1 Kinase Inhibitor) and gained Japan/Korea rights in 2011. Onconova Therapeutics (ONTX) debut in NASDAQ has been very encouraging and should percolate into SymBio especially in light of the upcoming PhIII data in US of Rigosertib IV (Rig. IV) in RRMDS by YE13. Disappointing guidance of TREAKISYM (bendamustine hydrochloride, L, rrNHL, MCL) sales for FY13 (¥1,563m, lowered down by ~¥365m) hit the stock, but future potential of its product portfolio remains intact with... For more detail please read our report on SymBio released on 3rd Sept. 2013, titled, "TREAKISYM’s Label Expansion + Rigosertib’s Potential in MDS market + Cash to In-license More!"

Celgene (CELG) - Label Expansion of Marketed Product and Newly Drug launches - Maturing Pipeline - Long Term Gain - Reports Corner

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https://www.reportscorner.com/reports/28665/-Celgene-(CELG)---Label-Expansion-of-Marketed-Product-and-Newly-Drug-launches---Maturing-Pipeline---Long-Term-Gain/

CELG’s Maturing pipeline through its own proprietary compounds and acquisition/in-licensing should keep the momentum positively in coming years. New launches – POMALYST (L, Pomalidomide, RRMM), Apremilast (PR, Psoriasis, PsA), and label and geographic expansion of marketed products – Revlimid, Vidaza, and ABRAXANE (L, mBC, NSCLC; R – pancreatic cancer, PDUFA: Sept. 21, 2013) should sustain the growth for long term. CELG has recently raised $1.5b in senior notes strengthening its balance sheet and continues it buyback plans ($3b announced in June 2013). We expect ... For more detail please read our report on Celgene released on 2nd Sept. 2013, titled, "Label Expansion of Marketed Product and Newly Drug launches + Maturing Pipeline = Long Term Gain".

Onconova Therapeutics (ONTX) -Near-Term Catalysts = Upside Still! - Reports Corner

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https://www.reportscorner.com/reports/28660/Onconova-Therapeutics-(ONTX)--Near-Term-Catalysts-=-Upside-Still!/

Onconova Therapeutics (ONTX) debut on NASDAQ (IPO: 5.9m share offering @ $15 July 25, 2013) has been impressive (30% up since IPO), raising the inevitable question – Is this the upper limit or is there still room for upside? Estybon is targeting a niche patient pool, where unmet medical needs remain due to lack of effective treatment or no approved therapies. Rig. IV showed median overall survival of 35 weeks in four early-stage PhI/II trials in pts with 2nd-line Higher Risk MDS vs. less than six months offered by current standard of care (as per historic peer-reviewed published reports). Our risk reward analysis indicates that ONTX's lead drug, Estybon (Rigosertib/ ON 01910.Na, PhIII, PI3K-PLK inhibitor, partnered with Baxter for EU rights and SymBio pharma for Japan & Korean rights) is ... For more detail please read our report on Onconova released on 30th August 2013, titled, "Near-Term Catalysts = Upside Still!"

Ambit Biosciences (AMBI) - Early Approval of Quizartinib in RR-AML = A Risk Worth Taking - Reports Corner

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https://www.reportscorner.com/reports/28661/Ambit-Biosciences-(AMBI)---Early-Approval-of-Quizartinib-in-RR-AML-=-A-Risk-Worth-Taking/

Regaining WW rights to Quizartinib (PhII/III, a selective oral potent FLT3, FMS like tyrosine kinase-3 inhibitor for acute myeloid leukemia, AML) from Astellas in 2013 armed AMBI to tap the unmet need in refractory/ relapsed AML (RR AML) and related hematological disorders. In the PhIIb study pts, FLT3 positive AML patients relapsed/refractory to one or more prior therapies treated with quizartinib achieved CRc rates of 46% vs.3-4% seen with other tyrosine kinase inhibitors. FDA is reviewing the data, new endpoints and is likely to announce its decision by Nov 2013. The drug has a fast track in orphan status and the company is on track to start the PhIII trial in 2014 in rrAML irrespective of the FDA’s decision. Even if the drug does not get approved in ... For more detail please read our report on Ambit released on 30th August 2013, titled, "Early Approval of Quizartinib in RR-AML = A Risk Worth Taking".