Pipeline

August 13, 2018

Company	Drug/Device	Medical Condition	Status
OncoPep, Inc.	PVX-410, investigational multi-peptide cancer vaccine	Smoldering multiple myeloma (SMM)	Phase Ib trial initiated
SW Safety Solutions, Inc.	Nitrile Exam Gloves with Low Dermatitis Potential Claim	Skin irritation or sensitization	Initial – Looking for Principal Investigator to head clinical study
Kyowa Kirin, Inc.	Poteligo (mogamulizumabkpkc) injection	Relapsed or refractory mycosis fungoides (MF) or Sezary syndrome after at least one prior systemic therapy	Approval granted by FDA
Celltrion, Inc.	Bevacizumab biosimilar ‘CT-P16’	Metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma	Phase III trial initiated
Apotex Inc.	New generic potassium chloride oral solution	Hypokalemia (low potassium blood levels) in patients who are on diuretics	Approval granted by the FDA under a novel term called the Competitive Generic Therapy designation
Alector, LLC	AL001, a human recombinant monoclonal antibody	Frontotemporal dementia (FTD)	Granted Orphan Drug Designation by the FDA
Pliant Therapeutics, Inc.	PLN-74809	Idiopathic pulmonary fibrosis (IPF)	Granted Orphan Drug designation by the FDA
Castle Creek Pharmaceuticals, LLC	Diacerein 1% ointment (CCP-020)	Epidermolysis bullosa simplex (EBS)	Fast Track Designation granted by the FDA
Elite Pharmaceuticals, Inc.	Generic methadone hydrochloride 5 mg and 10 mg tablets	Severe pain, maintenance treatment of opioid addiction (heroin or other morphine-like drugs)	Approval granted by the FDA
Alteogen Inc.	ALT-P7, an antibody-drug conjugate (ADC) using a Trastuzumab variant form of antibody	Gastric cancer	Granted Orphan Drug Designation by the FDA
Vertex Pharmaceuticals Inc.	Orkambi (lumacaftor/ ivacaftor)	Underlying cause of cystic fibrosis in children ages 2 to 5 with the most common form of the disease	Approval granted by the FDA
BioCryst Pharmaceuticals, Inc.	BCX7353	Prevention of angioedema attacks in patients with hereditary angioedema	Fast Track Designation granted by the FDA
PharmaMar	Lurbinectedin	Small cell lung cancer	Granted Orphan Drug Designation by the FDA
Sensus Healthcare, Inc.	SRT-100+, the next-generation Superficial Radiation Therapy solution	Non-melanoma skin cancers (NMSC) and keloids	Granted 501(k) clearance by the FDA
Armagen Inc.	GT-184, an investigational enzyme replacement therapy (ERT)	Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA)	Granted Orphan Drug Designation by the FDA
Shionogi & Co., Ltd	Mulpleta®(lusutrom-bopag)	Thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure	Approval granted by the FDA