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C h a i n D r u g s t o r e D a i l y Tu e s d a y, A u g u s t 9 , 2 0 1 6 6 6 STRONGBRIDGE BIOPHARMA PLC PROVIDES UPDATE ON CORPORATE PROGRESS Strongbridge Biopharma plc, a global rare disease biopharmaceutical company focused on the development and com- mercialization of novel therapeutic options, has announced an update on cor- porate progress. "We believe that our rare endocrine disease assets, COR-003 and COR-005, have the potential to be innovative new treatment options for Cushing's syn- drome and acromegaly, respectively, where there is considerable unmet need. We look forward to reaching critical near-term development milestones for each asset, including the reporting of top- line data from the COR-003 SONICS trial during the first half of 2017 and finalizing the technology to be utilized for a long-acting formulation of COR- 005 later this year. As part of our portfo- lio prioritization efforts, we have decided to initiate the return of COR-004 to Antisense Therapeutics. We also contin- ue to evaluate opportunities to maximize Strongbridge's growth potential, and believe that the company's current cash resources are sufficient to fund planned operations into the fourth quarter of 2017," said Matthew Pauls, President and Chief Executive Officer of Strongbridge Biopharma. Strongbridge has prioritized its rare endocrine disease portfolio and will con- tinue to advance clinical development of COR-003 (levoketoconazole), the com- pany's lead product candidate, which is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing's syndrome. The company will also contin- ue to advance development of COR-005, a next-generation somatostatin analog (SSA) with a unique receptor binding profile, being investigated for the treat- ment of acromegaly, with potential addi- tional applications in Cushing's disease and neuroendocrine tumors. SONICS clinical trial enrollment continues to progress as planned, and the company expects to report top-line data during the first half of 2017. For addition- al information about the SONICS trial, visit www.cushingssyndromestudy.com. The company expects to select and finalize the technology to be utilized for a proprietary long-acting formulation of COR-005 in 2016. Additional COR-005 development activities will be sequenced to ensure that the company's existing cash resources are sufficient to fund planned operations through the receipt of data from the COR-003 SONICS trial. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. As part of Strongbridge's prioriti- zation of its rare endocrine disease port- folio and following receipt of feedback from regulatory authorities on COR- 004, the company has initiated the return of COR-004, a second-genera- tion antisense compound for the poten- tial treatment of acromegaly, to Antisense Therapeutics. Following the return of COR-004, all rights to develop and commercialize COR-004 will revert to, and be the responsibility of Antisense Therapeutics. Further, given Strongbridge's core strategic focus on the development and commercialization of novel therapeutic options for the treatment of rare diseases, the company has decided not to invest fur- ther in the development of BP-2002, a gene-modified probiotic in pre-clinical development for the potential treatment of type 1 and 2 diabetes. The Company is cur- rently exploring potential partnership and out-licensing opportunities for BP-2002. As of December 31, 2015, Strongbridge had cash and cash equiva- lents of $51.4 million and no outstanding debt. The company believes it has suffi- cient existing cash and cash equivalents to fund planned operations into the fourth quarter of 2017, which is after the expected receipt of data from the COR- 003 SONICS trial. About Strongbridge Biopharma Strongbridge Biopharma is a global rare disease biopharmaceutical company focused on the development and com- mercialization of novel therapeutic options. Strongbridge's lead product can- didate, COR-003 (levoketoconazole), is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing's syndrome. Strongbridge's rare endocrine disease franchise also includes COR-005, a next-generation somatostatin analog (SSA) being investigated for the treat- ment of acromegaly, with potential addi- tional applications in Cushing's disease and neuroendocrine tumors. Both COR- 003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strong bridgebio.com. IMMUNOMEDICS DEVELOPS NOVEL ANTIBODY-BASED PRODUCTS FOR AUTOIMMUNE DISEASE AND CANCER THERAPY Immunomedics, Inc. has announced the issuance of U.S. patent no. 9,278,129 for the company's new patent family "Methods of Treating Rapidly Progressive Glomerulonephritis Using Chimeric and Humanized Anti-Histone Antibodies," which will expire in February 2034. This new patent concerns methods of use of the company's proprietary anti- histone antibody. This antibody has potential use in a variety of autoimmune, septic and inflammatory diseases. The issued claims cover use in rapidly pro- gressing glomerulonephritis, a kidney autoimmune disease that is rapidly fatal if left untreated. Histones are important proteins that function as structure components of chromatin. Besides having nuclear func- tions, histones can also be released into circulation by both damaged and activat- ed cells. Recent studies have indicated that circulating histones play a crucial role in sepsis and acute respiratory dis- tress syndrome, thus suggesting that his- tones could serve as promising therapeu- tic targets for infectious and inflammato- ry disorders. Earlier this month, two additional U.S. patents were issued to the company. Patent no. 9,272,029 relates to the company's new patent f amily "Interferon-Lambda Antibody Complexes," which was assigned to IBC Pharmaceuticals, Inc., the Company's majority-owned sub- sidiary, and has an expiration date of April 8, 2030. This patent concerns methods and compositions for creating antibody complexes of interferon- lambdas (IFN-λs) using the company's proprietary DOCK-AND-LOCK™ protein conjugation platform technolo- gy. IFN-λs are a group of cytokines that, in animal models, induce both tumor cell death and destruction through innate and adaptive immune responses, suggesting that local deliv- ery of the cytokine might be an adjunc- tive strategy in the treatment of human malignancies. The other patent, 9,272,057, relates to additional claims under the patent family "Combining Radioimmunotherapy and Antibody- drug Conjugates (ADCs) for Improved Cancer Therapy." This new patent con- cerns compositions and methods of treating pancreatic cancer using radiola- beled antibodies combined with ADCs. The allowed claims cover sacituzumab govitecan (IMMU-132), the company's lead ADC that has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease, and clivatuzumab tetraxetan, which is being evaluated in a Phase 3 (PANCRIT-1) registration trial as a radiolabeled antibody in patients with advanced pancreatic cancer. "These new patents are the results of our continuing innovative efforts to develop new agents and treatment regi- mens to improve the management of patients with cancer, autoimmune dis- eases and other serious diseases," com- mented Cynthia L. Sullivan, President and Chief Executive Officer. "We believe that they enhance our commercial assets and rich pipeline." For more information, visit www.immunomedics.com.