PIPELINE WATCH: Five Approvals, Eight Filings And One Launch

This week's Pipeline Watch, a snapshot of all the late-stage R&D and regulatory events in the pharma and biotech industries, is now available to view.

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Pipeline Coming Into View

The table records clinical and regulatory developments using data from Informa Pharma Intelligence’s Biomedtracker. It lists all drugs for which an event was recorded from Aug. 19 to Aug 25, 2016, divided by event type.

Events can include latest launches, approvals, withdrawals, suspensions, regulatory filings, CHMP recommendations, Phase III clinical trial initiations, development discontinuations, and the granting of orphan drug and fast-track status.

PIPELINE WATCH – Aug. 19 to Aug. 25, 2016

Source: Informa Pharma Intelligence’s Biomedtracker.

Lead Company	Partner Company	Drug	Indication	Market	Comments
REGULATORY APPROVAL
Pfizer Inc.	-	Troxyca ER (oxycodone and naltrexone)	management of pain	US	Extended-release capsules with abuse deterrent properties.
Hemispherx Biopharma Inc.	GP Pharm	Ampligen (rintatolimod)	chronic fatigue syndrome	Argentina	Claimed to be the first drug approved for CFS.
Lupin Ltd.	-	Acofide (acotiamide)	dyspepsia	India	A GI prokinetic agent.
SUPPLEMENTAL REGULATORY APPROVAL
Gilead Sciences Inc.	-	Truvada (emtricitabine and tenofovir disoproxil)	HIV prevention	EU	First antiretroviral approved for pre-exposure prophylaxis.
ACCELERATED/CONDITIONAL APPROVAL
MolMed SPA	-	Zalmoxis (cell therapy)	graft-versus-host disease	EU	A suicide gene is inserted into transplanted stem cells.
REGULATORY FILING ACCEPTED
Clovis Oncology Inc.	-	rucaparib	ovarian cancer	US	PDUFA date is Feb. 23, 2017.
Mylan NV	Biocon Ltd.	biosimilar trastuzumab	breast and gastric cancers	EU	Originator is Roche’s Herceptin.
Cempra Inc.	-	Solithera (solithromycin)	community-acquired pneumonia	EU	An oral and iv antibiotic.
Puma Biotechnology Inc.	Pfizer Inc.	neratinib	breast cancer	EU	Extended adjuvant use in HER2-positive early-stage disease.
Portola Pharmaceuticals Inc.	Bristol-Myers Squibb Co., Pfizer	IndexXa (andexanet alfa)	reversal of anticoagulation	EU	Seeking conditional approval.
SUPPLEMENTAL REGULATORY FILING ACCEPTED
Janssen-Cilag International	Genmab AS	Darzalex (daratumumab)	multiple myeloma	EU	With only one prior therapy.
Chugai Pharmaceutical Co. Ltd.	-	Actemra (tocilizumab) subcutaneous	rheumatoid arthritis	Japan	New once-weekly regimen.
ORPHAN DRUG DESIGNATION
TG Therapeutics Inc.	-	TGR-1202	chronic lymphocytic leukemia	US	An oral PI3K delta inhibitor in Phase III.
Bristol-Myers Squibb	-	Opdivo (nivolumab)	esophageal cancer	US	Marketed in other indications.
Roche	-	MabThera (rituximab) subcutaneous	indolent non-Hodgkin’s lymphoma, chronic lymphocytic leukemia	US	Marketed in other indications.
Roche	-	etrolizumab	ulcerative colitis	US	An MAb targeting the beta-7 integrin subunit.
Scynexis Inc.	-	SCY-078	invasive Aspergillus infections	US	Already designated for Candida infections.
FAST-TRACK STATUS
Mallinckrodt PLC	-	Synacthen (tetracosactide) Depot	Duchenne muscular dystrophy	US	Phase I started.
AstraZeneca PLC	Eli Lilly & Co.	AZD3293	Alzheimer’s disease	US	An oral BACE inhibitor in Phase III.
BREAKTHROUGH THERAPY DESIGNATION
Stemline Therapeutics Inc.	-	SL-401 (IL-3 conjugated to diphtheria toxin)	blastic plasmacytoid dendritic cell neoplasma	US	Receptors to IL-3 are expressed on some cancer stem cells.
COMPLETE RESPONSE LETTER
Amgen Inc.	-	Parsabiv (etelcalcetide)	secondary hyperparathyroidism	US	In chronic kidney disease patients on dialysis.
REGULATORY FILING
Mitsubishi Tanabe Pharma Corp.	-	teneligliptin and canagliflozin	type 2 diabetes	Japan	A fixed-dose combination tablet.
PRIORITY REVIEW
Clovis Oncology Inc.	-	rucaparib	ovarian cancer	US	NDA accepted for review.
REGULATORY REVIEW EXTENSION
Sanofi	Zealand Pharma AS	IGlarLixi (lixisenatide and insulin glargine) pen device	type 2 diabetes	US	PDUFA date extended to Nov. 2016.
PHASE III TRIAL INITIATION
NeuroDerm Ltd.	-	ND0612L	Parkinson’s disease	-	Levodopa/carbidopa sc liquid formulation.
Daiichi Sankyo Co. Ltd.	-	Savaysa (edoxaban) low dose	stroke prevention	-	ELDERCARE-AF study, in the elderly.
Mezzion Pharma	-	udenafil	congenital single ventricle heart disease	-	The FUEL study in adolescents.
Gilead Sciences	Galapagos NV	filgotinib	rheumatoid arthritis	-	The FINCH program of three studies.
Pharmacosmos AS	-	Monofer (iron isomaltoside)	iron deficiency anemia, non-dialysis dependent chronic kidney disease	US	Designed to obtain US approval while searching for a partner.
PRODUCT LAUNCH
Cumberland Pharmaceuticals Inc.	Clinigen Group PLC	Ethyol (amifostine)	radiotherapy-associated xerostomia, cisplatin-related renal toxicity	US	Its first oncology support product.