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BiomedtrackerPharma intelligence HEALTHCARE CONFERENCE:DAY 1
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1SUMMARYThe 34th annual JP Morgan Healthcare Conference is being held in San Francisco, CA from January 1114, 2016. A list of events and catalysts that were announced or updated at the conference today isincluded in this report. Additionally, below are some key points from today’s company presentations.ABOUT THE AUTHORSBioMedTracker is an independent research service that offers proprietary clinical assessments andpatient-based revenue forecasts of developmental drugs within a comprehensive and intuitive druginformation database. Clients from the pharmaceutical, biotech, and investment industries rely onBioMedTracker for its insight on the likelihood of approval, commercial potential, and future data andregulatory catalysts for drugs within the competitive landscape of every important disease andindication. Over the last several years, BioMedTracker has become the leader in providing objectiveinformation alongside evidence based clinical assessments and investment research on pipeline drugsworldwide. For more information on getting direct access to BioMedTracker, please acker is an all new medtech intelligence platform that provides clients with real-time dataand analysis on medical devices and diagnostics. From the people behind BioMedTracker, comes anevent-driven research service for the medical device and diagnostic marketplace. For access toMedDeviceTracker please contact your sales representative or right 2016 Sagient ResearchThis report is published by Sagient Research (the Publisher). This report contains information fromreputable sources and although reasonable efforts have been made to publish accurate information,you assume sole responsibility for the selection, suitability and use of this report and acknowledge thatthe Publisher makes no warranties (either express or implied) as to, nor accepts liability for, theaccuracy or fitness for a particular purpose of the information or advice contained herein. The Publisherwishes to make it clear that any views or opinions expressed in this report by individual authors orcontributors are their personal views and opinions and do not necessarily reflect the views/opinions ofthe Publisher.QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS1BiomedtrackerPharma intelligence August 2016 / 2
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1KEY POINTS – DAY 1 Drug pricing has received a lot of negative press, so at the opening luncheon, it wasinteresting to hear JPM Chairman and CEO, Jaime Dimon suggest that nothing wouldreally change with a new administration. He did add, however, that a newadministration could address tax policy that would affect acquisitions that effectivelymove companies overseas like the recent Pfizer-Allergan deal. Medivation (MDVN) disclosed a new SREBP inhibitor, MDV4463, which has reachedclinical development. The SREBP inhibitor is still being evaluated for safety but couldeventually be developed for NASH, hyperlipidemia, diabetes, obesity, and metabolicsyndrome. MDVN also suggested that its PD-1 inhibitor pidilizumab (which wasacquired from Curetech) is likely not primarily a PD-1 inhibitor. Its MOA for efficacy isin fact not fully understood by the company, although the company is fully pursuingDLBCL as its fastest path towards regulatory approval. Finally, look forward tocontinued evaluation of Medivation’s lead drug, Xtandi (enzalutamide), as it expandsits potential therapeutic use including data from PLATO evaluating treatment throughrising PSA levels in 2H2016. Incyte (INCY) announced a collaboration to evaluate the combination of INCB39110, aJAK1 inhibitor, with Tagrisso (osimertinib), AZN’s recently-approved EGFR inhibitor.The company also indicated that it was moving both an anti-GITR and ANTI-LSD1 druginto clinical development in 1H2016. The company also reiterated that it was movingforward with its INCB50465 PI3K-delta inhibitor instead of its similar INCB40093 drug. Biomarin (BMRN) reported numerically positive, albeit preliminary, data from anuncontrolled Phase II trial of reveglucosidase alfa in late-onset Pompe's disease. Thecompany needs to meet with regulators to discuss what will be needed for PhaseIII/registration. The Medicines Company (MDCO) announced initiation of its Phase II ORION-1 study,as expected, evaluating quarterly and bi-annual dosing in patients with elevated LDL-cand atherosclerotic cardiovascular disease (ASCVD) or risk equivalents. Completion isexpected by the end of 2016. If successful, the regimens would be more convenientthan biweekly and monthly dosing for current competitors. The company has alsostarted dosing its proof-of-concept intravascular ultrasound (IVUS) study, MILANOPILOT, for MDCO-216, a synthetic HDL. The first interim analysis is projected for thefirst half of 2016.QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS2BiomedtrackerPharma intelligence August 2016 / 3
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1 Vertex (VRTX) recently began clinical development of two next generation correctors,VX-152 and VX-440, being studied in triple combination with VX-661 and ivacaftor forup to 14 days in Phase I. Safety results are expected mid-2016, such that Phase IIstudies could start in the second half of 2016. Based on preclinical results, these drugsare expected to substantially improve treatment and provide treatment forheterozygous F508del patients, as well. Ionis (IONS) presented a new analysis of data from its trial of nusinersen in infantswith SMA, showing markedly improved ventilation-free survival compared to amatched natural history cohort. Officials noted the number of patients over 2 years ofage with nusinersen, with a couple at least 3 years old, was unprecedented. Officialsalso pointed to improvements in children with SMA, with 3 non-ambulatory patientswho were able to walk with treatment. Phase III trials are underway, with resultsexpected early 2017, but officials noted they are in discussions with regulators onbringing the drug to market as quickly as possible for infants. Coherus BioSciences (CHRS) and Baxalta (BXLT) announced positive top-line resultsfor its etanercept biosimilar, CHS-0214, in rheumatoid arthritis, though details werenot provided. The data follows on the heels of similar top-line data for psoriasis lastNovember. An MAA filing is expected in the second half of 2016, but the company didnot give an update on US plans. United Therapeutics (UTHR) noted Medtronic had answered questions from the FDAregarding their Synchromed II implantable pump for Remodulin, and has a PMAapproval expected in March. As a result, UTHR filed a sNDA for Remodulin inDecember, with a 10-month time frame, though UTHR is working to accelerate that.The pump has significant convenience advantage over current pumps, which are wornexternally.QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS3BiomedtrackerPharma intelligence August 2016 / 4
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1CONTENTSAcorda Therapeutics, Inc. (ACOR) . 6Ampyra for Ischemic Stroke . 6BioMarin Pharmaceutical Inc. (BMRN). 6BMN-701 for Pompe Disease . 6BMN 111 for Achondroplasia . 9BMN-270 for Hemophilia A . 10Kyndrisa for Muscular Dystrophy . 10Kuvan for Phenylketonuria (PKU) . 11Coherus BioSciences, Inc. (CHRS) . 12Biosimilar Bevacizumab (Coherus) for Cancer. 12Biosimilar Etanercept (Coherus) for Rheumatoid Arthritis (RA). 12Biosimilar Ranibizumab (Coherus) for Wet Age-Related Macular Degeneration (Wet AMD)(Ophthalmology) . 14Eagle Pharmaceuticals, Inc. (EGRX). 14Ryanodex for Neurology - Other . 14Emergent BioSolutions, Inc. (EBS) . 16Ixinity for Hemophilia B. 16VAX161 for Pandemic Influenza Vaccines . 16Endo International plc (ENDP) . 17Xiaflex for Cellulite . 17Gilead Sciences, Inc. (GILD) . 17TAF/emtricitabine/rilpivirine for HIV / AIDS . 17Harvoni for Hepatitis C (HCV) (Antiviral) . 18GS-9674 for Non-alcoholic Steatohepatitis (NASH) . 18GlaxoSmithKline (GSK) . 19IONIS-TTRrx for Transthyretin-related Hereditary Amyloidosis (Familial AmyloidPolyneuropathy) . 19IONIS-TTRrx for Transthyretin-related Hereditary Amyloidosis (Familial AmyloidPolyneuropathy) . 19HeartWare International, Inc. (HTWR) . 20MVAD System for Congestive Heart Failure (CHF) . 20HeartWare Ventricular Assist System for Congestive Heart Failure (CHF) . 21Incyte (INCY) . 22Jakafi for Pancreatic Cancer . 22INCB52793 for Hematologic Cancer . 22Epacadostat for Solid Tumors . 23Epacadostat for Solid Tumors . 23Epacadostat for Non-Small Cell Lung Cancer (NSCLC) . 24INCB40093 for Non-Hodgkin's Lymphoma (NHL) . 24QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS4BiomedtrackerPharma intelligence August 2016 / 5
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1INCB50465 for Hematologic Cancer . 25INCB59872 for Solid Tumors . 25INCAGN1876 for Cancer . 26Ionis Pharmaceuticals, Inc. (IONS) . 27IONIS-SMNRx for Spinal Muscular Atrophy. 27IONIS-SMNRx for Spinal Muscular Atrophy. 27Ironwood Pharmaceuticals, Inc. (IRWD) . 28Linzess for Irritable Bowel Syndrome (IBS) . 28Jazz Pharmaceuticals plc (JAZZ) . 29JZP-416 for Acute Lymphocytic Leukemia (ALL) . 29Medivation, Inc. (MDVN) . 29MDV4463 for Undisclosed. 29Medtronic, plc (MDT) . 30Synchromed for Pulmonary Arterial Hypertension (PAH) . 30Merck & Co., Inc. (MRK) . 31Keytruda for Non-Small Cell Lung Cancer (NSCLC) . 31TDO/IDO Inhibitors for Cancer . 31Ophthotech Corp. (OPHT). 32Zimura for Dry Age-Related Macular Degeneration (Dry AMD) (Ophthalmology) . 32Fovista for Wet Age-Related Macular Degeneration (Wet AMD) (Ophthalmology) . 32OptiNose AS . 33OPN-375 for Nasal Polyposis . 33Radius Health, Inc. (RDUS) . 34RAD1901 for Menopause (including Hormone Replacement Therapy [HRT]) . 34SAGE Therapeutics (SAGE). 34SAGE-105 for Neurology - Other . 34SAGE-324 for Neurology - Other . 35Seattle Genetics, Inc. (SGEN) . 35Adcetris for Diffuse Large B-Cell Lymphoma (DLBCL) - NHL. 35SEA-CD40 for Solid Tumors . 36SGN-LIV1A for Breast Cancer . 37Spark Therapeutics, LLC (ONCE) . 37SPK-RPE65 for Leber's Congenital Amaurosis (Ophthalmology) . 37SPK-FVIII for Hemophilia A . 38United Therapeutics Corporation (UTHR) . 39Remodulin (injection) for Pulmonary Arterial Hypertension (PAH) . 39List of New BioMedTracker Catalysts .41List of Updated BioMedTracker Catalyts . .46List of MedDeviceTracker Catalysts .48QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS5BiomedtrackerPharma intelligence August 2016 / 6
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1ACORDA THERAPEUTICS, INC. (ACOR)Ampyra for Ischemic StrokeEvent Date:01/11/2016Event Type:Trial Announcement - Initiation (Clinical Analysis)Trial Name:Phase I - QD FormulationMarket Group:NeurologyLead Company:Acorda Therapeutics, Inc. (ACOR)Alkermes (ALKS)Biogen (BIIB)UCB (UCB:BB)DRI CapitalPartner Companies:Phase:IIIChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:55% (3% Above Avg.)52%Analysis: Acorda announced that three prototypes of its QD formulation of dalfampridine is inPhase I PK studies. Data from this study is expected in the first quarter of 2016.Source: J.P. Morgan Healthcare Conference 01/11/2016 (ACOR, Slide 20)BIOMARIN PHARMACEUTICAL INC. (BMRN)BMN-701 for Pompe DiseaseEvent Date:01/11/2016Event Type:Trial Data - Top-Line Results (Clinical Analysis)Trial Name:Phase II - INSPIRE (Switchover Study)Market Group:MetabolicLead Company:BioMarin Pharmaceutical Inc. (BMRN)Partner Companies:Phase:N/AIIChange to Likelihood of Approval: -37%Likelihood of Approval:Average Approval:29% (5% Above Avg.)24%QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS6BiomedtrackerPharma intelligence August 2016 / 7
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1Treatment DescriptionNumber of PatientsNumber of EvaluablePatientsMean MIP(Endpoint Primary)Mean MEP(Endpoint Secondary)Mean 6MWT(Endpoint Secondary)Mean FVCupright(Endpoint tmentReveglucosidaseAlfaWeek 24N/AN/AN/AN/ATreatmentReveglucosidaseAlfaBaseline to Week24N/AN/A50.000 %52.100 %2.200 %38.900 %42.000 %3.100 %345.800 m371.900 m26.100 m60.700 %56.900 %-3.700 %Analysis: BioMarin announced interim results from INSPIRE, a Phase II trial for reveglucosidasealfa being studied for the treatment of late-onset Pompe disease (LOPD).ContextBioMarin will present these data at an upcoming medical meeting.DesignThe INSPIRE clinical trial is a Phase II single-arm, open-label, switchover study ofreveglucosidase alfa in patients with late-onset Pompe disease (LOPD) who havebeen receiving treatment with recombinant human acid alpha glucosidase (rhGAA)for 48 weeks or longer. This study was changed from a Phase II/III to a Phase II studyto allow use of drug employing a new purification process, which could be used in ananticipated Phase III registration-enabling trial. All patients in the study have beentransferred to the new material, and all future patients will be treated with the newmaterial.Ambulatory patients who have mild to moderate respiratory impairment will switchdirectly to receive reveglucosidase alfa 20 mg/kg by IV infusion every other week.The change in value in primary endpoint, Maximum Inspiratory Pressure (MIP), andsecondary endpoint, Maximum Expiratory Pressure (MEP), Forced Vital Capacity(FVC) Upright and Six-Minute Walk Test (6MWT) will be measured as the differencebetween the Baseline value and the Week 24 value within each individual subject.The study has a 24-week treatment period followed by an extension period of up toQUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDSBiomedtrackerPharma intelligence 7August 2016 / 8
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1240 weeks.The interim efficacy and safety analysis is based on 24 patients who previously hadbeen on treatment with the enzyme replacement therapy, alglucosidase alfa, andwere switched to reveglucosidase alfa. Baseline characteristics can be seen in the linkbelow.EndpointsThe primary endpoint of the study is the change in value (from baseline to Week 24)of Maximum Inspiratory Pressure (MIP). Secondary endpoints include change in value(from baseline to Week 24) of Maximum Expiratory Pressure (MEP), Forced VitalCapacity (FVC) Upright and Six-Minute Walk Test (6MWT).ResultsInvestigators indicated that, while on treatment with alglucosidase alfa, the majorityof the patient population were considered to have worsening of their Pompe diseaseover the last 12 months. At week 24, the 18 patients on treatment withreveglucosidase alfa and who completed the study demonstrated respiratory muscleimprovements with a mean increase of 2.2 points from baseline in percent predictedMaximal Inspiratory Pressure (MIP) and a mean increase of 3.1 points from baselinein percent predicted Maximal Expiratory Pressure (MEP). Patients completing thestudy also experienced a mean improvement of 26.1 meters in 6 Minute Walk Test(6MWT).In the 14 patients who met eligibility at both screening and baseline and completedthe study, a mean increase of 3.8 points from baseline in percent predicted MIP alsowas observed. The 18 patients completing the study showed a mean decrease of 3.7points from baseline in percent predicted Forced Vital Capacity (FVC), but wereconsidered relatively unchanged from screening at -0.7 points in percent predicted.Results from patients with baseline and week 24 results can be seen in the tableabove.Most Common Adverse EventsSix patients discontinued treatment early, and two patients experienced seriousadverse events. Hypoglycemia was generally similar in frequency and severity as inthe previous study, and the overall pattern of safety was otherwise consistent withexperience using other enzyme replacement therapy.QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS8BiomedtrackerPharma intelligence August 2016 / 9
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1CommentInterim II data for a Phase II switch study from approved Myozyme toreveglucosidase alfa, in patients with late-onset Pompe disease, showed positivenumerical improvements in several measures, though the trial was uncontrolled, sothe data is tentative.The interim analysis was done and the study changed from Phase II/III to Phase II,because of a new purification process, which is being used for subsequent treatmentof these and future patients (like the anticipated Phase III study). Patients in thecurrent study had been on Myozyme an average of 5.5 years, and about 61% ofpatients had overall worsening in their disease status in the past 12 months, albeitwith 52.2% only having minimal worsening.While preliminary, maximal inspiratory pressure (MIP) improved 2.2% (absolutepercent predicted, 3.8% in the per protocol analysis) and maximal expiratorypressure (MEP) 3.1%. 6MWT also improved 26.1 m. The company also noted thatMIP in untreated patients typically declines by 3.2% annually, though without acontrol in such a small trial, it is difficult to draw conclusions based on suchcomparisons.On the negative side, FVC declined by 3.7%, but the presentation noted the changefrom screening was only -0.7%, so there could have been some chance variation (itwould be useful to know the screening values for the other parameters to see howmuch variation they had, as well).Overall, while preliminary, the data are encouraging and support further testing. Weare increasing our likelihood of approval another 1%. The next step is for thecompany to meet with regulatory agencies and see what is required for Phase III.They will give an update at their R&D day in April 2016.Source: Press Release 01/11/2016 (BMRN)Sagient AnalysisJ.P. Morgan Healthcare Conference 01/11/2016 (BMRN, Slides 15-19)BMN 111 for AchondroplasiaEvent Date:01/11/2016Event Type:Trial Announcement - Trial Progressing (Clinical Analysis)Trial Name:Phase II - 202 (Pediatric)QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS9BiomedtrackerPharma intelligence August 2016 / 10
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1Market Group:EndocrineLead Company:BioMarin Pharmaceutical Inc. (BMRN)Partner Companies:Phase:N/AIIChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:25% (1% Above Avg.)24%Analysis: BioMarin announced that the fourth cohort in the Phase II study of BMN 111 for thetreatment of achondroplasia is enrolled at the 30 µg/kg/QD dose. All 15 µg/kg dosesubjects are currently in the 18 month extension.Source: J.P. Morgan Healthcare Conference 01/11/2016 (BMRN, Slide 35)BMN-270 for Hemophilia AEvent Date:01/11/2016Event Type:Trial Announcement - Trial Progressing (Clinical Analysis)Trial Name:Phase I/II - PoCMarket Group:HematologyLead Company:BioMarin Pharmaceutical Inc. (BMRN)Partner Companies:Phase:St. JudeUCLIIChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:30% (Same As Avg.)30%Analysis: BioMarin announced that safety data support treating patients at the third dose levelin the Phase I/II study of BMN 270 for the treatment of hemophilia A.Source: J.P. Morgan Healthcare Conference 01/11/2016 (BMRN, Slide 38)Kyndrisa for Muscular DystrophyEvent Date:01/11/2016Event Type:Regulatory - Progress Update (Clinical Analysis)Trial Name:N/AQUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS10BiomedtrackerPharma intelligence August 2016 / 11
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1Market Group:MetabolicLead Company:BioMarin Pharmaceutical Inc. (BMRN)Partner Companies:Phase:N/ANDA/BLAChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:79% (10% Below Avg.)89%Analysis: BioMarin provided updated information regarding regulatory filings of Kyndrisa forthe treatment of Duchenne Muscular Dystrophy (exon 51). The Company continuesto pursue FDA approval in this indication, after they were notified in December 2015that an extension would be necessary in order to reach a decision. A decision is nowanticipated in January 2016.Regarding European filings, BioMarin anticipates filing day 120 questions to the EMAin March 2016. In addition, a CHMP opinion regarding Kyndrisa in this indication isexpected in the second quarter of 2016, putting expected approval roughly in thesecond half of 2016.Source: J.P. Morgan Healthcare Conference 01/11/2016 (BMRN, Slide 11)Kuvan for Phenylketonuria (PKU)Event Date:01/11/2016Event Type:Patent - Extension (Clinical Analysis)Trial Name:N/AMarket Group:MetabolicLead Company:BioMarin Pharmaceutical Inc. (BMRN)Partner Companies:Phase:Merck KGaA (MKGAY)Daiichi Sankyo (DSKYF)ApprovedChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:100% (Same As Avg.)100%Analysis: BioMarin announced that the EU patent protection for Kuvan has been extended 4additional years through 2024.Source: J.P. Morgan Healthcare Conference 01/11/2016 (BMRN, Slide 30)QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS11BiomedtrackerPharma intelligence August 2016 / 12
Healthcare Conference: Day 1JP Morgan Healthcare Conference: Day 1COHERUS BIOSCIENCES, INC. (CHRS)Biosimilar Bevacizumab (Coherus) for CancerEvent Date:01/11/2016Event Type:Progress Update (Clinical Analysis)Trial Name:N/AMarket Group:OncologyLead Company:Coherus BioSciences, Inc. (CHRS)Partner Companies:N/APhase:PreclinicalChange to Likelihood of Approval: N/ALikelihood of Approval:0% (Same As Avg.)Average Approval:N/AAnalysis: Coherus announced that CHS-5217 is in preclinical development as a biosimilarAvastin for oncology.Source: J.P. Morgan Healthcare Conference 01/11/2016 (CHRS, Slide 28)Biosimilar Etanercept (Coherus) for Rheumatoid Arthritis (RA)Event Date:01/11/2016Event Type:Trial Data - Top-Line Results (Clinical Analysis)Trial Name:Phase III - vs. EnbrelMarket Group:Autoimmune/ immunologyLead Company:Coherus BioSciences, Inc. (CHRS)Partner Companies:Phase:Daiichi Sankyo (DSKYF)Baxalta (BXLT)IIIChange to Likelihood of Approval: 0%Likelihood of Approval:Average Approval:59% (Same As Avg.)59%Difference Between Treatment and ComparatorTreatment Description CHS-0214 vs. EnbrelACR20 At 24 WeeksN/A(Endpoint Primary)(P 0.0500)QUESTIONS? EMAIL BIOMEDSUBSCRIBE@SAGIENTRESEARCH.COMFOR OUR DISCLOSURES, PLEASE SEE BIOMEDTRACKER’s RESEARCH STANDARDS12BiomedtrackerPharma intelligence August 2016 / 13
JP Morgan Healthcare Conference: Day 1HealthcareConference: Day 1Analysis: Coherus BioSciences and Baxalta announced that CHS-0214, a proposed biosimilar ofEnbrel (etanercept), met its primary endpoint in a confirmatory, double-blind,randomized, controlled, two-part clinical study.ContextThis rheumatoid arthritis study is the second of two, large, Phase III confirmatorytrials intended for inclusion in global marketing applications for CHS-0214. Results forthe first Phas
Mean MIP (Endpoint Primary) 50.000 % 52.100 % 2.200 % Mean MEP (Endpoint Secondary) 38.900 % 42.000 % 3.100 % Mean 6MWT (Endpoint Secondary) 345.800 m 371.900 m 26.100 m Mean FVC upright (Endpoint Secondary) 60.700 % 56.900 % -3.700 % Analysis: BioMarin announced interim results from INSPIRE, a Phase II trial for reveglucosidase
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