On October 20, 2017 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the European Medicines Agency (EMA) has designated ofranergene obadenovec (VB-111) as an “orphan medicinal product” for the treatment of ovarian cancer, adding to the orphan status already granted for glioblastoma in US and Europe (Press release, VBL Therapeutics, OCT 20, 2017, View Source [SID1234521052]). VB-111 is the Company’s lead product candidate currently being studied in a Phase 3 pivotal trial for recurrent glioblastoma, with launch of a Phase 3 in platinum-resistant ovarian cancer expected by the end of the year.

“The receipt of an Orphan Drug Designation is a key regulatory milestone that is designed to provide a number of important benefits, including the potential for conditional marketing authorization and ten years of market exclusivity for VB-111,” said Prof. Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics.

Orphan Drug Designation is granted by the EMA to drugs that are intended for the treatment of life-threatening or chronically debilitating rare diseases, where no satisfactory treatment of the condition concerned is authorized. If such a treatment exists, then the medicine must be of significant benefit to those affected by the condition. Rare diseases are those defined as having a prevalence of not more than five per 10,000 persons in Europe. The Orphan Drug Designation provides potential incentives for the sponsor from the European Union to develop a medicine for a rare disease, such as protocol assistance, reduced fees, funding from the EC for clinical trials and protection from competition once the medicine is placed on the market, including ten years of market exclusivity.

On October 20, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted MESUPRON (upamostat) Orphan Drug designation for the adjuvant treatment of pancreatic cancer (Press release, RedHill Biopharma, OCT 20, 2017, View Source [SID1234521043]).

The Orphan Drug designation allows RedHill to benefit from various development incentives to develop MESUPRON for this indication, including tax credits for qualified clinical testing, waiver of a prescription drug user fee (PDUFA fee) upon submission of a potential marketing application and, if approved, a seven-year marketing exclusivity period.

MESUPRON is a proprietary, first-in-class, orally-administered protease inhibitor, with several potential mechanisms of action to inhibit tumor invasion and metastasis. MESUPRON presents a new, non-cytotoxic approach to cancer therapy. MESUPRON has undergone several Phase I studies and two Phase II proof-of-concept studies.

RedHill recently announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of MESUPRON and RedHill’s Phase II-stage investigational compound, YELIVA, in combination with a known antibiotic, for hard-to-treat cancers.

Pancreatic cancer is the third leading cause of cancer mortality in the U.S.1 and is characterized as a disease with a very high unmet medical need. The overall five-year survival rate for the disease is only 8.2% in the U.S.2, representing one of the poorest prognoses across all cancers. The majority of pancreatic cancer cases are diagnosed late, at which point the disease is already locally advanced or metastatic3. Furthermore, pancreatic cancer is predominately a cancer of the elderly, with the median age of diagnosis being 71 years in the U.S.4 It is estimated that 53,670 new cases5 will be diagnosed in 2017 in the U.S. The 2017 worldwide sales of pancreatic cancer therapies are estimated to reach approximately $1.6 billion6.

RedHill has an ongoing research collaboration agreement with the Department of Molecular Biology and Genetics of Aarhus University in Denmark for the evaluation of MESUPRON. With the recent identification of human trypsin-3 and human trypsin-2 as high-affinity molecular targets, RedHill is also evaluating utilization of MESUPRON in several inflammatory gastrointestinal indications.

About MESUPRON:
MESUPRON is a proprietary, first-in-class, orally-administered potent inhibitor of several proteases targeting cancer and inflammatory gastrointestinal diseases. Protease inhibitors have been shown to play key roles in tumor invasion and the metastasis process. High levels of certain proteases are associated with poor prognosis in various solid tumor cancers, such as pancreatic, gastric, breast and prostate cancers. MESUPRON presents a promising new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit both tumor metastasis and growth. MESUPRON has undergone several Phase I studies and two Phase II proof-of-concept studies. The first Phase II study was in locally-advanced, unresectable pancreatic cancer and the second study in metastatic breast cancer in combination with first-line chemotherapeutic agents. RedHill recently announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of MESUPRON and RedHill’s Phase II-stage investigational compound, YELIVA, in combination with a known antibiotic, for hard-to-treat cancers. RedHill acquired the exclusive worldwide rights to MESUPRON, excluding China, Hong Kong, Taiwan and Macao, from Germany’s WILEX AG for all indications.

On October 20, 2017 Amgen (NASDAQ:AMGN) reported that it will report its third quarter financial results on Wednesday, Oct. 25, 2017, after the close of the U.S. financial markets (Press release, Amgen, OCT 20, 2017, View Source [SID1234521062]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 20, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, November 3, 2017 to discuss its third quarter 2017 financial results. Management also will provide a brief update on the business (Press release, ImmunoGen, OCT 20, 2017, View Source [SID1234521055]).

To access the live call by phone, dial 719-325-4907; the conference ID is 6498153. The call also may be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through November 17, 2017.