Pipeline

April 1, 2019

Company	Drug/Device	Medical Condition	Status
International AIDS Vaccine Initiative (IAVI)	BG505 SOSIP.664 gp140	HIV	Phase I trial initiated enrolling 60 healthy adult subjects in Seattle, Boston and Nairobi
Aerie Pharmaceuticals, Inc.	netarsudil ophthalmic solution	open-angle glaucoma or ocular hypertension	Phase II trial initiated enrolling 208 subjects in Japan
DURECT Corporation	DUR-928 (topical)	mild to moderate plaque psoriasis	Phase IIa trial initiated enrolling 20 subjects at multiple sites across the U.S.
Modra Pharmaceuticals B.V.	ModraDoc006/r	recurrent or metastatic HER-2 negative breast cancer	Phase IIa trial initiated enrolling 24 subjects
Urovant Sciences	vibegron	overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH)	Phase III trial initiated enrolling 1,000 male subjects with BPH who are also taking BPH medications but continue experiencing OAB symptoms
Breath Therapeutics	L CsA i	Bronchiolitis Obliterans Syndrome (BOS)	Phase III trial initiated enrolling 110 subjects with BOS following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation at leading lung transplant specialty centers in eight countries
Novocure	Tumor Treating Fields combined with paclitaxel	recurrent, platinum-resistant ovarian cancer	Phase III trial initiated enrolling 540 subjects
Eisai Co., Ltd.	BAN2401	Alzheimer's disease	Phase III trial initiated enrolling 1,566 subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia (collectively known as early AD) with confirmed amyloid pathology in the brain
Zimmer Biomet, Inc.	ROSA ONE Spine System	minimally invasive and complex spine surgeries	510(k) clearance granted by the FDA
Genetesis, Inc.	CardioFlux	cardiac imaging	510(k) clearance granted by the FDA
Beckman Coulter	DxH 520 hematology analyzer	neonate, pediatric and critical care	510(k) clearance granted by the FDA
Enzyvant	RVT-801	Farber disease	Rare Pediatric Disease designation granted by the FDA
Promedior, Inc.	PRM-151	Idiopathic Pulmonary Fibrosis (IPF)	Breakthrough Therapy designation granted by the FDA
Impulse Dynamics	Optimizer Smart System for delivering CCM therapy	heart failure	Breakthrough Device designation granted by the FDA
Lipella Pharmaceuticals, Inc.	LP-10	cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy	IND approval granted by the FDA
Slayback Pharma LLC	Hydroxyprogesterone Ca-proate Injection, USP 250 mg/ 1 ml	preterm birth prevention	ANDA approval granted by the FDA
Enzyvant	RVT-801	Farber disease	Fast Track approval granted by the FDA
Novartis	Mayzent (siponimod)	multiple sclerosis (MS)	Fast Track approval granted by the FDA
BrightWater Medical, Inc.	ConvertX Biliary Stent System	biliary obstructions	Approval granted by the FDA
Jazz Pharmaceuticals	Sunosi	narcolepsy	Approval granted by the FDA