Pipeline

October 15, 2018

Company	Drug/Device	Medical Condition	Status
Akcea Therapeutics	TEGSEDITM (inotersen)	Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults	Granted approval by the FDA
Akcea Therapeutics	AKCEA-APO(a)-LRx	Cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a)	Positive topline results from a Phase II clinical trial
Bausch Health Companies, Inc.	BRYHALI™ (halobetasol propionate) Lotion, 0.01%	Plaque psoriasis in adults	FDA tentatively approved New Drug Application; final OK pending expiration of exclusivity for related product
Eximo Medical Ltd	B-Laser™ Atherectomy System	Peripheral artery disease (PAD)	Granted 510(k) clearance by the FDA
YiSheng BioPharma Co.	PIKA® rabies vaccine	Rabies	Granted clearance by the China FDA to proceed with a clinical trial
Genentech	Hemlibra	Hemophilia A patients without factor VIII inhibitors	Granted approval by the FDA
Leadiant Biosciences, Inc.	Revcovi™ (elapegademase-lvlr) injection	Adenosine deaminase severe combined immune deficiency (ADA-SCID) in children and adults	Granted approval by the FDA
Breckenridge Pharmaceutical, Inc.	Roflumilast Tablets, 500mcg (generic for Daliresp® Tablets)	COPD	Abbreviated New Drug Application approved by the FDA
Valneva USA	XIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed)	Japanese encephalitis	Accelerated dosing regimen approved by the FDA
Eidos Therapeutics, Inc.	AG10	amyloidosis (ATTR)	Granted Orphan Drug designation by the FDA
Paratek Pharmaceuticals, Inc.	NUZYRA™ (omadacycline)	Community-acquired bacterial pneumonia; acute skin infections (ABSSSI) in adults	Granted approval by the FDA
Poxel SA	Imeglimin, an investigational therapeutic agent	Type 2 diabetes	Patient enrollment completed in the TIMES 2 trial of the Phase III registration program
Chugai Pharmaceutical Co., Ltd	HEMLIBRA® (US generic name: emicizumab-kxwh)	Hemophilia A without factor VIII inhibitors in newborns, children and adults	Granted approval by the FDA
Genentech	baloxavir marboxil	Influenza type A/H3N2 and type B	Phase III CAPSTONE-2 trial showed symptoms improved significantly faster in patients at high risk of serious flu who took the drug v. a placebo
Zealand Pharma A/S	Glepaglutide	Short bowel syndrome (SBS)	First patient enrolled in a global Phase III trial