Pipeline

January 29, 2018

Company	Drug/Device	Medical Condition	Status
Apexian Pharmaceuticals	APX3330	advanced solid tumors	Phase I trials initiated
Bavarian Nordic	BN-Brachyury	cancer metastasis	Phase I trials initiated enrolling 10 subjects
Protalex	PRTX-100 (PRTX-100-203 Study)	persistent/chronic Immune Thrombocytopenia	Phase Ib trials initiated enrolling 30 subjects in Europe
IntelGenx	Montelukast VersaFilm	Alzheimer’s disease	Phase IIa trials initiated
Biomarck Pharmaceutical	BIO-11006	non-small cell lung cancer	Phase II trials initiated in India
Melinta Therapeutics	radezolid	bacterial vaginosis	Phase II trials initiated
TrovaGene	PCM-075 + Zytiga	metastatic castration-resistant prostate cancer	Phase II trials initiated enrolling 25 subjects
Evofem Biosciences	Amphora	prevention of urogenital chlamydia and gonorrhea in women	Phase IIb/III trials initiated enrolling 850 subjects in the U.S.
GC Pharma	GC1102	hepatitis B virus infection following liver transplantation	Phase II/III trials planned
Swedish Orphan Biovitrum	SOBI003	mucopolysaccharidosis type IIIA	Fast Track designation granted by the FDA
Astellas Pharma	gilteritinib	acute myeloid leukemia	Orphan Drug designation granted by the EC
BERG	BPM31510	pancreatic cancer	Orphan Drug designation granted by the FDA
Enzychem Lifesciences	EC-18	acute radiation syndrome	Orphan Drug designation granted by the FDA
Nohla Therapeutics	NLA101	hematopoietic stem cell transplantation	Orphan Drug designation granted by the EC
Omeros	OMS721	primary Immunoglobulin A nephropathy	Orphan Drug designation granted by the EMA
Orphazyme	arimoclomol	Niemann-Pick disease Type C	Rare Pediatric Disease designation granted by the FDA
Genmab	daratumumab (Darzalex) + bortezomib, melphalan and prednisone	newly diagnosed multiple myeloma	Priority Review granted by the FDA
Baxter International	Bivalirudin	anticoagulant in patients undergoing percutaneous coronary intervention	FDA approved
Bristol-Myers Squibb	Yervoy (ipilimumab)	advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older	EC expanded indication approved
Takeda Pharmaceutical	Adcetris (brentuximab vedotin)	CD30-positive cutaneous T-cell lymphoma	EC extended current conditional marketing authorization