Changes for page Redhill Biopharma

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--= Paragraph 1 =
++= History and Development of the Company =
--==== History and Development of the Company ====
++RedHill Biopharma Ltd. (RDHL) was incorporated on August 3, 2009, and was registered as a private company limited by shares under the laws of the State of Israel. The company's principal executive offices are located at 21 Ha’arba’a Street, Tel Aviv, Israel.
--The company's legal and commercial name is RedHill Biopharma Ltd. The company's company was incorporated on August 3, 2009, and was registered as a private company limited by shares under the laws of the State of Israel. The company's principal executive offices are located at 21 Ha’arba’a Street, Tel Aviv, Israel.
--
  In February 2011, the company completed its initial public offering in Israel, pursuant to which the company issued 14,302,300 Ordinary Shares, and 7,151,150 tradable Series 1 Warrants to purchase 7,151,150 Ordinary Shares for aggregate gross proceeds of approximately $14 million. On December 27, 2012, the company completed the listing of its ADSs on the NASDAQ Capital Market. The company's Ordinary Shares are traded on the Tel-Aviv Stock Exchange under the symbol “RDHL,” and its ADSs are traded on the NASDAQ Capital Market under the same symbol "RDHL".
  The company's capital expenditures for the years ended December 31, 2017, 2016 and 2015 were approximately $146,000, $85,000 and $14,000, respectively. The company's current capital expenditures involve equipment and leasehold improvements.
--==== Business Overview ====
++= Business Overview =
  Redhill Biopharma is a specialty biopharmaceutical company primarily focused on late-clinical development stage and commercialization of proprietary drugs for gastrointestinal ("GI") diseases and cancer. From inception to the end of the period covered by this Annual Report, the company invested a total of $6.2 million on in-licensing and acquisitions of therapeutic candidates and related technologies.
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  In addition to its primary focus on the development of clinical-stage GI products, Redhill Biopharma has established commercial presence and capabilities in the U.S., intended primarily to support potential future launch of its GI-related therapeutic candidates currently under development in the U.S. The company pursue its commercial activities in the U.S. through RedHill Biopharma Inc., a wholly-owned subsidiary the company formed in Delaware in January 2017. Through this subsidiary, the company currently commercialize in the U.S., EnteraGam® and promote Donnatal® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg.
--==== The company's Strategy ====
++= Strategy =
  The company's goal is to become a significant player in the development and commercialization of pharmaceuticals for the treatment of GI diseases and cancer.
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  * where applicable, utilize the FDA’s 505(b)(2) regulatory pathway to potentially obtain more timely and efficient approval of its formulations of previously approved products. Under the 505(b)(2) process, Redhill Biopharma is able to seek FDA approval of a new dosage form, strength, route of administration, formulation, dosage regimen, or indication of a pharmaceutical product that has previously been approved by the FDA. This process enables it to partially rely on the FDA findings of safety or efficacy for previously approved drugs, thus avoiding the duplication of costly and time-consuming preclinical and various human studies. See “Item 4. Information on the Company – B. Business Overview – Government Regulations and Funding – Section 505(b)(2) New Drug Applications”; and
  * cooperate with third parties to develop or commercialize therapeutic candidates in order to share costs and leverage the expertise of others.
--==== The company's Therapeutic Candidates ====
++= Therapeutic Candidates =
  **Summary**
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  |RHB-107 (MESUPRON)|Gastrointestinal and other solid tumors|An orally-dosed small molecule compound with an established clinical safety profile; first-in-class specific inhibitor of five human serine proteases|Completed two Phase II studies; pre-clinical studies ongoing|Worldwide exclusive license; excludes China, Hong Kong, Taiwan and Macao
  |Combination against Ebola virus|Ebola virus disease|Unmet medical need|The first part of a pre-clinical research collaboration with a U.S. government agency completed; the second part has not yet been initiated|We filed our own IP directed to the use of a new combination therapy for treating an individual infected with or exposed to a filovirus
--**TALICIA®**
++== TALICIA® ==
  ALICIA® is intended for the eradication of H. pylori bacterial infection in the GI tract. TALICIA® is a combination of three approved drug products – omeprazole, which is a proton pump inhibitor (prevents the secretion of hydrogen ions necessary for digestion of food in the stomach), amoxicillin and rifabutin, which are antibiotics. TALICIA® is administered to patients orally.
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  |-|Comparative Bioavailability|Comparing the bioavailability of TALICIA®in fed and fasted state and to the bioavailability of the active comparator for the confirmatory Phase III study|Algorithme Pharma, Canada|18|Completed|Completed in 2017
  |ERADICATE Hp2|Phase III|Assess the safety and efficacy of TALICIA® as compared to active comparator|Up to 65 sites in the U.S.|444|Ongoing|Top-line results expected in H2/2018
--**RHB-104**
++== RHB-104 ==
  Crohn’s Disease
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  |-|Phase II|Randomized double-blind placebo-controlled Phase II study in IBS-D|16 sites in the U.S.|126|Evaluating the safety and efficacy of BEKINDA® 12 mg in IBS-D|Completed 2018
  |TBD|Phase III|Randomized double-blind placebo-controlled Phase III study in IBS-D|TBD|TBD|TBD|TBD
--**RHB-106**
++== RHB-106 ==
  RHB-106 is a tablet intended for the preparation and cleansing of the GI tract prior to the performance of abdominal procedures, including diagnostic tests such as colonoscopy, barium enema or virtual colonoscopy, as well as surgical interventions, such as a laparotomy.
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  | |clinical trial| | |the trial|the trial|
  |-|Phase IIa|Comparison of the product’s effectiveness and safety with an existing product|Center for Digestive Disease, Australia|60|Completed|Completed in 2005
--**YELIVA® (ABC294640)**
++== YELIVA® (ABC294640) ==
  YELIVA® is a proprietary, first-in-class, orally-administered SK2 selective inhibitor, with anti-inflammatory and anti-cancer activities, targeting multiple oncology, inflammatory and GI indications.
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  Hepatocellular carcinoma is the most dominant form of liver cancer, accounting for approximately 85% of liver cancer cases, according to GlobalData. According to the World Health Organization (WHO) International Agency for Research on Cancer GLOBOCAN 2012 report, liver cancer is the second and most common cause of cancer-related deaths worldwide. The annual worldwide incidence of liver cancer was estimated in such report to have reached 782,000 cases in 2012, with a mortality rate of 95%; the corresponding U.S. numbers are 30,000 and 80%, respectively. Most patients with HCC suffer from liver cirrhosis, which develops following long periods of chronic liver disease. According to this report, the majority of HCC cases are associated with hepatitis B and hepatitis C virus infections. Few treatment options exist for patients diagnosed at an advanced stage, representing the majority of HCC patients. Sorafenib (Nexavar®) is a targeted drug approved for the treatment of HCC in patients who are not candidates for surgery and do not have severe cirrhosis. According to GlobalData, the market for the treatment of HCC in the seven major markets is estimated to exceed $615 million in 2018 and reach approximately $780 million in 2020. There are several drugs in late-stage clinical development for HCC.
  Radiation therapy can cause both acute and chronic side effects. The side effects that develop depend on, among other things, the area of the body being treated, the dose given per day, the total dose given, the patient’s general medical condition, and other treatments given at the same time. Acute side effects may include skin irritation or damage at regions exposed to the radiation beams. The oral cavity is highly susceptible to direct and indirect toxic effects of cancer chemotherapy and ionizing radiation. The American Cancer Society estimated that more than 65,000 people in the U.S.
++
++= References =