Pipeline

February 12, 2018

Company	Drug/Device	Medical Condition	Status
Fibrocell Science	FCX-013	moderate to severe localized scleroderma	IND submitted to the FDA
Daiichi Sankyo	U3-1402	metastatic or unresectable epidermal growth factor receptor-mutated non-small cell lung cancer	Phase I trials initiated enrolling 60 subjects globally
Palatin Technologies	PL-8177	ulcerative colitis and other inflammatory bowel diseases	Phase I trials initiated enrolling 52 subjects
Phosplatin Therapeutics	PT-112	relapsed or refractory multiple myeloma	Phase I/II trials initiated
Gemphire	gemcabene	pediatric nonalcoholic fatty liver disease	Phase IIa trials initiated enrolling 40 adolescent children between the ages of 12 and 17
OncBioMune Pharmaceuticals	ProscaVax	advanced prostate cancer	Phase II trials initiated
Xcovery	ensartinib (X-396)	advanced malignant melanoma harboring alterations in ALK	Phase II trials initiated
Endo International	collagenase clostridium histolyticum	cellulite	Phase III trials initiated enrolling 840 women in the U.S.
Pharma Two B	P2B001	early Parkinson's disease	Phase III trials initiated enrolling 525 subjects
Tessa Therapeutics	T cell immunotherapy	nasopharyngeal cancer	Phase III trials initiated enrolling 35 subjects
GlaxoSmithKline	Bexsero	meningitis B vaccine	Breakthrough Therapy designation granted by the FDA
Sage Therapeutics	SAGE-217	major depressive disorder	Breakthrough Therapy designation granted by the FDA
Zogenix	ZX008 (low-dose fenfluramine)	seizures associated with Dravet syndrome	Breakthrough Therapy designation granted by the FDA
MeiraGTx	AAV2/8-hCARp.hCNGB3 (A002)	achromatopsia due to mutations in the CNGB3 gene	Rare Pediatric Disease designation granted by the FDA
Adhesys Medical	VIVO	surgical sealant	Expedited Access Pathway designation granted by the FDA
Alnylam Pharmaceuticals	patisiran	hereditary ATTR amyloidosis	NDA accepted and Priority Review granted by the FDA
Allergan	Avycaz (ceftazidime and avibactam)	hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia	Expanded use approved by the FDA
Ferring Pharmaceuticals	Zomacton (somatropin)	human growth hormone deficiency	FDA approved