On October 23, 2017 AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) reported that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018 (Press release, AstraZeneca, OCT 23, 2017, View Source [SID1234521078]).

The Japan NDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine.

This is the second NDA for Lynparza in Japan where the medicine is currently under review for use in ovarian cancer, with a PMDA decision for this indication anticipated in the first half of 2018.

Lynparza tablets are currently being tested in a range of tumour types in addition to ovarian and breast, including prostate and pancreatic cancers.

NOTES TO EDITORS

About OlympiAD

OlympiAD is a randomised, open-label, multicenter Phase III trial assessing the efficacy and safety of Lynparza tablets (300mg twice daily) compared to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international trial was conducted in 19 countries across Europe, Asia, North America and South America.

About Lynparza (olaparib)
Lynparza was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR)-pathway deficiencies to potentially kill cancer cells. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.

Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

About Germline BRCA mutations

BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein is either not made or is faulty, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.1

About Breast Cancer in Japan

In Japan, breast cancer is the fifth leading cause of death among women.[2] In Japanese women, breast cancer incidence peaks in the late forties, whereas in the US and Europe the peak incidence is in women over 60 years of age [3, 4, 5]. Despite more treatment options becoming available during the past three decades, there is currently no cure for patients diagnosed with metastatic (Stage IV) breast cancer. In Japan, 5- and 10-year relative survival rates for patients with Stage IV breast cancer are as low as 32.6% and 15.6%, respectively.[6] Therefore, the primary aim of treatment is to slow progression of the disease for as long as possible and improving or maintaining a patient’s quality of life.[7]

About the AstraZeneca and MSD Strategic Oncology Collaboration

On 27 July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US announced a global strategic oncology collaboration to jointly develop and commercialise AstraZeneca’s Lynparza, the world’s first and leading PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. The collaboration is based on increasing evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumour types and is aimed at maximising the potential of Lynparza to become the preferred backbone of combination therapies. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our majority investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On October 23, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its third quarter 2017 financial results on Wednesday, November 1, 2017, after the close of the U.S. financial markets (Press release, Clovis Oncology, OCT 23, 2017, View Source [SID1234521085]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET that day to discuss the company’s results in greater detail.

The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss third quarter 2017 results on November 1 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 7792319.

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.