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The USFDA has finally announced the draft guidance for the development of generic version of GSK’s Asthma / COPD drug – Advair (Fluticasone propionate + Salmeterol Xinafoate).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".