Summary

• Page properties (1 modified, 0 added, 0 removed)

Details

Page properties

Content

...	...	@@ -6,7 +6,7 @@
6	6
7	7	Anthera Pharmaceuticals, Inc. (ANTH) is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The company currently have two compounds in development, Sollpura and blisibimod. The company licensed Sollpura from Eli Lilly & Co (“Eli Lilly”) in July 2014. Sollpura is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. The company licensed blisibimod from Amgen, Inc. (“Amgen”) in December 2007. Blisibimod targets B-cell activating factor, or BAFF, which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including Immunoglobulin A nephropathy, or IgA nephropathy.
8	8
9		-**Sollpura**
	9	+== **Sollpura** ==
10	10
11	11	The exocrine pancreas is responsible for synthesis and secretion of digestive enzymes, including lipase, protease, and amylase. In addition, the pancreas secretes bicarbonate into the duodenum to neutralize the very high acidity of stomach contents. EPI occurs when diseases such as cystic fibrosis (“CF”) and chronic pancreatitis (“CP”) impede or destroy the exocrine function of the pancreas. A reduction in, or absence of, the normally secreted pancreatic digestive enzymes causes lipids, proteins, and carbohydrates to enter the distal gastrointestinal (“GI”) tract in un-absorbable forms, leading to GI pain and distention, mal-digestion, and steatorrhea. Without appropriate therapy, patients with EPI may experience malnutrition, poor growth, weight loss, reduced quality of life, and, in severe cases, increased morbidity and early death.
12	12
...	...	@@ -45,7 +45,7 @@
45	45	* lack of enteric coating allows for potentially fewer and smaller, easy to swallow capsules and adequate storage stability compared with porcine PERTs of an equivalent unit dose strength; and
46	46	* a sachet formulation containing Sollpura powder for oral solution which can be easily dissolved into water, and finally provides patients, especially young pediatric patients, with an easy-to-swallow dosing option.
47	47
48		-**Blisibimod**
	48	+== **Blisibimod** ==
49	49
50	50	BAFF, or B-cell Activating Factor (also known as B lymphocyte stimulator or BLyS), is a member of a tumor necrosis family of natural human proteins and is critical to the development, maintenance and survival of multiple B-cell lineages as well as plasma cells – all of which are critical to the human immune response. B-cells and plasma cells are a vital part of the human immune system, producing natural antibody responses to invading pathogens such as viruses, bacteria and other dangerous antigens. Abnormally high elevations of BAFF, B-cells and plasma cells have been associated with several autoimmune diseases, including lupus and IgA nephropathy. BAFF is primarily expressed by macrophages, monocytes and dendritic cells and interacts with three different receptors on B-cells and plasma cells including BAFF receptor, or BAFF-R, B-cell maturation antigen, or BCMA, and transmembrane activator and cyclophilin ligand interactor, or TACI. The potential role of BAFF inhibition and associated reductions in B-cell and plasma cell numbers in lupus and rheumatoid arthritis has been validated in multiple clinical studies with blisibimod and other BAFF antagonists.
51	51
...	...	@@ -111,11 +111,11 @@
111	111
112	112	The company's objective is to develop and commercialize its product candidates to treat serious diseases associated with inflammation, including enzyme replacement therapies and renal disease. To achieve these objectives, the company intend to initially focus on the following activities.
113	113
114		-**Advance Clinical Development of Sollpura**
	114	+=== **Advance Clinical Development of Sollpura** ===
115	115
116	116	Anthera Pharmaceuticals is advancing the development of Sollpura in a Phase 3 registration program in patients with cystic fibrosis-related EPI. If its Phase 3 clinical study is successful, the company intend to commercialize Sollpura in the U.S. and seek strategic corporate partners whose capabilities complement ours to launch Sollpura outside of U.S.
117	117
118		-**Seek Collaborative Corporate Partner for Blisibimod**
	118	+=== **Seek Collaborative Corporate Partner for Blisibimod** ===
119	119
120	120	Anthera Pharmaceuticals has received orphan drug designation for blisibimod for the treatment of IgA nephropathy. The company plan to opportunistically enter into collaborations with third parties for the development of blisibimod in renal disease and other B-cell associated glomerulonephritides.
121	121