January 2017

Allergan plc and Assembly Biosciences, Inc. announced that Allergan has entered into a research, development, collaboration and license agreement for the worldwide rights to Assembly's microbiome gastrointestinal (GI) development programs. The agreement provides Allergan with worldwide rights to preclinical compounds ABI-M201 and ABI-M301, targeting ulcerative colitis (UC) and Crohn's disease (CD), as well as two additional compounds to be identified by Assembly for Irritable Bowel Syndromes (IBS); with Diarrhea (IBS-D), with Constipation (IBS-C) or Mixed (IBS-M).

Allergan plc, a leading global pharmaceutical company, and Lysosomal Therapeutics (LTI) announced that Allergan has purchased an exclusive option right to acquire LTI.  LTI is focused on innovative small-molecule research and development in the field of neurodegeneration, yielding new treatment options for patients with severe neurological diseases.

RedHill Biopharma Ltd.  announced that the positive final results, announced in June 2015, of the first Phase III study with RHB-105 for the treatment of H. pylori infection were presented by Ira Kalfus, MD, Medical Director at RedHill, at the Innovations in Gastroenterology 2017 Symposium, held in Israel on Friday, January 6, 2017, and received the Second Place Best Abstract Award. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.

Pluristem Therapeutics Inc. announced that the Company’s Phase III study of its PLX-PAD cells in the treatment of critical limb ischemia (CLI) was cleared by the U.S. Food and Drug Administration (FDA). Pluristem’s strategy is to use this single multinational Phase III study to support the submission of a biologics license application (BLA) to the FDA for marketing approval. Pluristem expects to begin enrolling patients in its Phase III study in both the U.S. and Europe during the first half of 2017.

Tot Biopharm Co., Ltd., a high-tech bio-pharmaceutical company, and Lee's Pharmaceutical Holdings Limited, a Hong Kong-based public biopharmaceutical company, jointly announced that Lee's Pharma, through its wholly-owned subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited has acquired the exclusive license of TAB014, the monoclonal antibody drug developed and manufactured by Tot Biopharm, within China. TAB014 is a new antibody product that can be used to treat wet age-related macular degeneration (wAMD) and other eye diseases.

Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are ineligible for cisplatin chemotherapy, and are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.