Summary

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	5	+= Overview =
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9		-==== Overview ====
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11	11	Anthera Pharmaceuticals, Inc. 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.
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13	13	**Sollpura**
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64	64	[[image:https://www.sec.gov/Archives/edgar/data/1316175/000121465918001789/img3.jpg]]
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66		-==== Market Opportunity ====
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68	68	Sollpura for the treatment of Exocrine Pancreatic Insufficiency (EPI)
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74	74	According to the National Organization for Rare Diseases, primary IgA nephropathy occurs at any age, most commonly with clinical onset in the second and third decades of life and a large number of cases eventually progress to renal failure. There is also a striking geographic variation in the prevalence of IgA nephropathy throughout the world. In the United States, IgA nephropathy is considered an orphan disease as it is believed to affect approximately 130,000 people annually. In August 2017, the FDA granted orphan drug designation for blisibimod for the treatment of IgA. The prevalence of IgA nephropathy varies throughout the world, with the highest prevalence in Asia (Singapore, Japan and China), Australia, Finland and southern Europe (20 to 40% of all glomerulonephritis). In Asia, routine urinalyses are performed for school children and renal biopsies for patients with asymptomatic hematuria, and the reported prevalence of the disease is much higher. For example, in Japan, IgA nephropathy is estimated to affect over 350,000 people annually. According to the National Kidney and Urologic Diseases Information Clearinghouse, 25% of adults with IgA nephropathy eventually develop total kidney failure.
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76		-==== Manufacturing Strategy ====
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78	78	**Sollpura**
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108	108	In the CHABLIS-SC1 study, the primary endpoint compared the effects of blisibimod and placebo at Week 52 using the SLE Responder Index-6 (SRI-6): ≥6-point improvement in SELENA-SLEDAI, no new BILAG 1A or 2B domain scores, and <0.3-point increase in Physician’s Global Assessment. Compared with placebo, a higher proportion of subjects on blisibimod met the SRI-6 criteria from Week 16 through Week 52. However, this effect was not statistically significant at the primary endpoint analysis at Week 52. There was a statistically-significant steroid sparing effect among subjects randomized to blisibimod wherein 17.2% of subjects in the blisibimod group achieved corticosteroid dose of less than or equivalent to 7.5 mg prednisone compared with 8.9% in the control group (p=0.019). In subjects with baseline urinary protein:creatinine ratio (UPCR) ≥0.5 g/g, significantly higher proportions of blisibimod subjects achieved >50% reduction in UPCR, and/or UPCR <0.5 g/g. Reductions in SLE autoantibodies and B cells, and increases in complement C3 and C4 were observed with blisibimod. The company believe that these data support the further research with blisibimod patients with B-cell associated glomerulonephritides including IgA nephropathy, lupus with renal manifestations, and membranous glomerulonephritis. As a result of the outcomes of the CHABLIS-SC1 trial, at the end of 2016 the company elected to discontinue the Phase 3 CHABLIS-7.5 study, which was initiated in June 2016.
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110		-==== Research and Development ====
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112	112	Since its inception in 2004, Anthera Pharmaceuticals has focused primarily on developing its product candidates, which currently include Sollpura for EPI and blisibimod for IgA nephropathy and potentially other glomerulonephritides. In the years ended December 31, 2017, 2016, and 2015, the company incurred $28.6 million, $46.5 million and $33.5 million, respectively, of research and development expense.
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114		-==== Strategy ====
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116	116	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.
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128	128	The company's product candidates are focused on highly-specialized physician segments, such as cystic fibrosis specialists and nephrologists. The company believe that the company can build a small, focused sales force capable of marketing its products effectively in acute care and orphan indications.
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130		-==== Competition ====
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132	132	The company's industry is highly competitive and subject to rapid and significant technological change. The company's potential competitors include large pharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions. The company's primary competitors who market PERTs approved in the U.S. or are developing PERTs in the U.S. are described in further detail below. The company believe that key competitive factors that will affect the development and commercial success of its product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.
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139	139	|Pertzye|Approved|Chiesi|EPI, CF|Ÿ Porcine, enteric coated
140	140	|MS1819|Phase 2a |AzurRx|EPI, CP|Ÿ Lipase only
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142		-==== Intellectual Property ====
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144	144	The company's policy is to pursue, maintain and defend patent rights, developed internally and licensed from third parties, to protect the technology, inventions and improvements that are commercially important to the development of its business. The company also rely on trade secrets that may be important to the development of its business.
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185	185	Anthera Pharmaceuticals is aware of two third-party issued U.S. patents that contain broad claims related to BLyS or BAFF binding polypeptides. Based on its analyses, if these patents were asserted against it, the company do not believe that blisibimod would be found to infringe any valid claim of these patents. If the company were to challenge the validity of either of these issued U.S. patents in court, the company would need to overcome the presumption of validity that attaches to every U.S. patent by presenting clear and convincing evidence as to the invalidity of the patent’s claims. There is no assurance that a court would find in its favor on questions of infringement or validity, and the company could incur substantial costs in litigation if Anthera Pharmaceuticals is required to defend against patent suits brought by third parties or if the company initiate these suits. If third-party patents are determined to be valid and construed to cover blisibimod, the development and commercialization of this program could be affected, subjecting it to potential liability for damages and possibly requiring it to obtain a license to continue marketing the affected product. Such a license may not be available on commercially acceptable terms, if at all.
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187		-==== Current License Agreements ====
	183	+== Current License Agreements ==
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189	189	**Eli Lilly and Company**
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201	201	In connection with a collaborative arrangement with Zenyaku Kogyo Co., Ltd (“Zenyaku”) for the development of IgA nephropathy that was executed in December 2014 and terminated in January 2016, the company amended the Amgen Agreement in November 2014 to (i) adjust certain royalty and milestone payment obligations payable to Amgen in light of its collaboration with Zenyaku and (ii) provide that the sublicense granted by it to Zenyaku shall survive the termination of the Amgen Agreement. Under this amendment, the company also agreed to grant Amgen that number of shares of its common stock equal to $1.0 million divided by the volume weighted average price of its common stock for 20 trading days prior to issuance. The company issued 420,751 shares of common stock to Amgen at $2.3767 per share on January 28, 2015 pursuant to a subscription agreement with Amgen, with the consideration paid by Amgen in the form of a waiver of a fee otherwise payable to Amgen under the Amgen Agreement.
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203		-==== Manufacturing and Supply ====
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205	205	The company currently rely on contract manufacturers to produce drug substances and drug products required for its clinical studies under current GMP with oversight by its internal managers. The company plan to continue to rely upon contract manufacturers and, potentially, collaboration partners to manufacture commercial quantities of its product candidates if and when approved for marketing by the FDA. The company's contract manufacturers obtain the raw materials for the drug substances and drug products required for its clinical studies from a variety of sources. The company believe that this will provide a sufficient supply of these raw materials and drug product to meet its needs for the foreseeable future. The company do not have in place long term supply agreements with respect to all of the components of any of its pharmaceutical systems, however, and are subject to the risk that the company may not be able to procure all required components in adequate quantities with acceptable quality, within acceptable time frames or at reasonable cost.
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207	207	The company's research and development activities involve the controlled use of potentially hazardous substances, including toxic chemical and biological materials. Accordingly, Anthera Pharmaceuticals is subject to federal, state and local laws governing the use, handling and disposal of these materials. The company believe that its safety procedures for handling and disposing of these materials comply in all material respects with the standards prescribed by local, state and federal regulations.
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209		-==== Sales and Marketing ====
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211	211	Given its stage of development, Anthera Pharmaceuticals has not developed a commercial organization or distribution capabilities. The company expect that the company would develop these capabilities once the company receive Phase 3 data in contemplation of FDA approval and the commercial launch of its product candidates. In order to commercialize its product candidates, the company plan to develop these capabilities internally or through collaboration with third parties. In selected therapeutic areas where the company feel that any approved products can be commercialized by a specialty sales force that calls on a limited and focused group of physicians, the company may seek to commercialize the product candidates alone. The company also plan to seek commercialization partners for products in international markets.
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