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PIPELINE WATCH: Phase III Trials Start In Atypical HUS, Fabry Disease And Colorectal Cancer

Executive Summary

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

The table records clinical developments using data from Informa Pharma Intelligence’s Biomedtracker. It lists drugs for which an important event was recorded between October 21 and October 27, 2016, divided by event type.

Events can include Phase II and Phase III trial initiations, development discontinuations, and the release of top-line and full clinical trial results. A brief summary of product approvals is also included.

A companion resource, The Pink Sheet’s regulatory-focused FDA Performance Tracker, follows regulatory milestones such as new submissions and user fee calculations, complete response letters and breakthrough therapy designations.

PIPELINE WATCH – October 21 to October 27, 2016

Lead company/partner

Compound

Indication

Comments

Phase III Suspended

Dipexium Pharmaceuticals Inc.

Locilex (pexiganan) cream

diabetic foot ulcer infections

OneStep-1 and -2; did not meet primary endpoint.

Inovio Pharmaceuticals Inc.

VGX-3100

cervical dysplasia

FDA clinical hold on proposed trial due to concerns about delivery device.

AstraZeneca PLC

durvalumab

head and neck cancer

FDA partial clinical hold due to bleeding events. New patient enrolment halted.

Phase III Results

Janssen Pharmaceutical Cos. /Bayer AG

Xarelto (rivaroxaban)

treating and preventing venous thromboembolism

Real world data confirms safety and efficacy.

Sunovion Pharmaceuticals Inc.

Latuda (lurasidone)

schizophrenia in adolescents

Safe and effective, supplemental NDA submitted.

Vertex Pharmaceuticals Inc.

Okambi (lumacaftor,ivacaftor) and Kalydeco (invacaftor)

cystic fibrosis

They modify progression in long-term data.

Chimerix Inc.

brincidofovir

adenovirus infection

AdVise; viremia declined in blood cell transplant patients.

Gilead Sciences Inc.

Descovy (emtricitabine and tenofovir alafenamide)

HIVAIDS

Switching from Truvada (emtricitabine and tenofovir disoproxil fumarate)

Phase III Interim/Top-line Results

Merck & Co. Inc.

Keytruda (pembrolizumab)

advanced bladder cancer

KeyNote-045; improved overall survival.

AstraZeneca PLC

Lynparza (olaparib)

ovarian cancer

SOLO-2, Significant improvement in PFS.

Boehringer Ingelheim GMBH

biosimilar adalimumab (BI 695501)

rheumatoid arthritis

Pivotal study, showed equivalence to AbbVie’s Humira.

ProMetic Life Sciences Inc. /Hematech Biotherapeutics Inc.

plasma-derived plasminogen

plasminogen deficiency

US BLA filing to start within weeks.

Eli Lilly & Co.

Taltz (ixekizumab)

psoriatic arthritis

SPIRIT-P2; positive results, 2017 supplemental filings.

Roche /Genentech Inc.

Lucentis (ranibizumab)

polypoidal choroidal vasculopathy

EVEREST II; an additional indication.

Daiichi Sankyo Co. Ltd./Eli Lilly & Co.

Effient (prasugrel)

ischemic stroke

PRASTO-1 and 2; an additional indication in Japanese patients.

Aerie Pharmaceuticals Inc.

Rhopressa (netarsudil) ophthalmic solution

glaucoma, ocular hypertension

Rocket 4; achieves endpoint, NDA to be resubmitted.

GlaxoSmithKline PLC

Shingrix vaccine

shingles

ZOSTER-004; supports flexible dosing, and using with flu vaccine.

Gilead Sciences Inc.

sofosbuvir, velpatasvir and voxilaprevir

hepatitis C

POLARIS-1,2,3,4; once daily single tablet.

Theravance Biopharma Inc. /Mylan NV

revefenacin

chronic obstructive pulmonary disease

Met primary endpoint and well tolerated.

Phase III Initiated

Alexion Pharmaceuticals Inc.

ALXN1210

atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria

A longer-acting anti-C5 antibody, given every eight weeks.

Maruishi Pharmaceutical Co. Ltd./Faron Pharmaceuticals Oy

Traumakine (FP-1201-lyo)

acute respiratory distress syndrome

A European study is already underway.

Ultragenyx Pharmaceutical Inc. /Kyowa Hakko Kirin Co. Ltd.

KRN23

pediatric X-linked hypophosphatemia

A fully human IgG1 Mab.

Protalix BioTherapeutics Inc.

PRX-102

Fabry disease

A modified human alpha-GAL-A protein.

Sumitomo Dainippon Pharma Co. Ltd.

napabucasin

colorectal cancer

The CanStem303C study.

Phase II Suspended

Aduro Biotech Inc.

CRS-207, ADU-623

ovarian, brain, and pancreatic cancer

FDA partial clinical hold due to Listeria infection.

GlaxoSmithKline PLC

losmapimod

chronic obstructive pulmonary disease

Development stopped by company.

Phase II Results

Minerva Neurosciences Inc. /Mitsubishi Tanabe Pharma Corp.

MIN-101

schizophrenia, negative symptoms

Six-month extension study; improved symptoms.

ChemoCentryx Inc.

avacopan (CCX168), a complement inhibitor

C3 glomerulopathy

A patient with this rare disease responded.

Shire PLC

maribavir

CMV infection

Reduced viremia in transplant patients.

Trevena Inc.

oliceridine

pain

Safe and effective.

Bristol-Myers Squibb Co.

Opdivo (nivolumab)

heavily pretreated classical Hodgkin’s lymphoma

CheckMate-205; safe and effective in an expanded cohort.

Phase II Completed

Samumed

SM04554

androgenetic alopecia

Safe and effective.

Phase II Interim/top-Line Results

OncoGenex Pharmaceuticals Inc./Ionis Pharmaceuticals Inc.

apatorsen; an antisense heat shock protein 27 production inhibitor

metastatic bladder cancer

Borealis-2; positive survival results.

Sanofi/Lexicon Pharmaceuticals Inc.

sotagliflozin

type 1 diabetes

inTandem4; confirms Phase III dose.

Windtree Therapeutics Inc.

Aerosurf (lucinactant)

respiratory distress syndrome

In premature infants.

ObsEva SA

nolasiban (OBE001); oral oxytocin antagonist

in vitro fertilization

IMPLANT; proceeding to Phase III in Europe.

Galapagos NV/AbbVie Inc.

GLPG1837

cystic fibrosis

SAPHIRA 2; well tolerated

Allergan PLC /Motus Therapeutics Inc.

relamorelin, a ghrelin agonist

diabetic gastroparesis

Safe and effective, in diabetes patients.

Advaxis Inc.

axalimogene filolisbac

cervical cancer

Increased overall survival rate

DBV Technologies SA

Viaskin Peanut

peanut allergy

OLFUS-VIPES; two year follow-up showed durable responses.

Gilead Sciences Inc.

selonsertib (GS-4997)

non-alcoholic steatohepatitis (NASH), pulmonary arterial hypertension, diabetic kidney disease

Showed antifibrotic activity.

Phase II Initiation

Targovax ASA

ONCOS-102/GM-CSF gene therapy

malignant mesothelioma

Increases tumor infiltrating lymphocytes.

Selecta Biosciences Inc.

SEL-212

gout

In refractory patients.

Stealth BioTherapeutics

elamipretide

congestive heart failure

The IDDEA-HF study.

Actelion Pharmaceuticals Ltd.

ACT-541468

insomnia

In adult patients.

Theranexus

THN102

narcolepsy

Being compared with modafinil.

Sanifit

SNF472

calciphylaxis

An orphan disease.

Source: Informa Pharma Intelligence’s Biomedtracker.

Marketing Approvals – October 21 to October 27, 2016

Lead Company

Partner Company

Drug

Indication

Market

Comments

REGULATORY APPROVAL

Merck & Co

-

Zinplava (bezolotoxumab)

recurrence of Clostridium difficile-associated diarrhea

US

In patients receiving antibacterial drugs.

Recordati Industria Chimica & Farmaceutica SPA

Apricus Biosciences Inc.

Vitaros (alprostadil) cream

erectile dysfunction

Greece

Launch expected in first half of 2017.

SUPPLEMENTAL REGULATORY APPROVAL

Merck & Co

-

Keytruda (pembrolizumab)

first line non-small cell lung cancer

US

For tumors with a high PD-L1 expression and no EGFR or ALK tumor aberrations.

Novartis AG

-

Cosentyx (secukinumab)

psoriatic arthritis, ankylosing spondylitis

Switzerland

Targets IL-17.

Source: Biomedtracker.

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