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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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

For complete information about the report, please visit our website

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.