On July 3, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") reported that an additional patent has been issued related to BENDEKA by the United States Patent and Trademark Office (USPTO) (Press release, Eagle Pharmaceuticals, JUL 3, 2018, View Source [SID1234527546]). Patent number 10,010,533 will expire January 2031. The USPTO has now issued or allowed a total of 15 patents in the BENDEKA family of patents expiring from 2026 to 2033.

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The newly issued patent will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing Eagle’s total Orange Book listed patents for BENDEKA to thirteen1. Furthermore, as a result of a Court decision issued on June 8, 2018, BENDEKA now has Orphan Drug Exclusivity (ODE). The FDA will not be able to approve any drug applications referencing BENDEKA until the ODE expires in December 2022. Moreover, the Company now does not expect generic TREANDA entrants into the market until December 2022, rather than November 2019.

"We believe that with the recent positive ODE decision and the strength of our intellectual property portfolio, BENDEKA has longevity well beyond 2022," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Under a February 2015 exclusive license agreement for BENDEKA, Teva Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial activities for the product including promotion and distribution.

On July 3, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical stage oncology drug development company reported that it has granted to Y-mAbs Therapeutics, Inc., a privately held clinical stage biopharmaceutical company, an exclusive sublicense to a bi-valent ganglioside based vaccine intended to treat neuroblastoma, a rare pediatric cancer (Press release, MabVax, JUL 3, 2018, View Source [SID1234527551]). A third of neuroblastoma patients are diagnosed as infants; and ninety percent are younger than five years of age at time of diagnosis. Neuroblastoma is responsible for twelve percent of all cancer deaths in children less than 15 years of age.

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The neuroblastoma vaccine was originally developed by Dr. Philip Livingston and colleagues at Memorial Sloan Kettering Cancer Center (MSK) and licensed as part of a broader portfolio of anti-cancer vaccines to MabVax. MabVax filed for and was granted an Orphan Drug Designation for the neuroblastoma vaccine and has manufactured Phase II clinical supplies for a planned but not initiated clinical trial to be conducted with the consortium New Advances in Neuroblastoma Therapy (NANT). NANT is the only consortium of academic medical centers in the world solely dedicated to developing novel treatments and biomarkers for children with Neuroblastoma. Over the last several years MabVax has shifted its focus and resources to the Company’s human antibody discovery and development programs that are currently in early stage clinical trials and have attracted partner interest.

Y-mAbs Therapeutics, Inc ("Y-mAbs") is a clinical-stage biopharmaceutical company developing novel antibody therapeutics for oncology targets based on a range of technologies licensed from MSK under an exclusive worldwide license and research collaboration agreement. The Company has two antibody based products in advanced clinical trials for the treatment of neuroblastoma and other cancers.

Total value of the transaction to MabVax is $1.3 million plus a share of a Pediatric Disease Voucher if granted by the U.S. Food and Drug Administration ("FDA") to Y-mAbs on approval of the vaccine and the Pediatric Disease Voucher is subsequently sold. Additionally, Y-mAbs will be responsible for all further development of the product as well as any downstream payment obligations related to this specific vaccine to MSK that were specified in the original MabVax-MSK license agreement. If Y-mAbs successfully develops and receives FDA approval for the Neuroblastoma vaccine, it is obligated to file with the FDA for a Pediatric Disease Voucher. If the voucher is granted to Y-mAbs and subsequently sold, then MabVax will receive a percentage of the proceeds from the sale of the voucher by Y-mAbs.

David Hansen, President and CEO of MabVax Therapeutics, explained, "Y-mAbs is ideally positioned to continue the development of the Neuroblastoma vaccine because of their experience in immunotherapy generally and neuroblastoma specifically. If Y-mAbs is successful in development of this product, MabVax will see a greater financial benefit through participation in the sale of the Pediatric Disease Voucher."

On July 2, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) (Press release, AstraZeneca, JUL 2, 2018, View Source [SID1234527536]).

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Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit said: "Non-small cell lung cancer is a leading cause of death in Japan, and we are dedicated to bringing new treatment options to patients as quickly as possible. As the only immunotherapy approved in the curative-intent, Stage III lung cancer setting, Imfinzi has the potential to change the treatment paradigm for patients diagnosed with this disease."

The approval of Imfinzi is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial in unresectable Stage III NSCLC. In the trial, Imfinzi demonstrated an improvement in median PFS of 11.2 months compared to placebo. Imfinzi improved other meaningful outcomes such as time to distant metastasis or death and overall response rates. Detailed results of the PACIFIC trial were published in the New England Journal of Medicine (NEJM).

1 Blinded Independent Central Review (BICR).

2 Among the ITT population, 7% in the Imfinzi arm and 10% in the placebo arm had non-measurable disease as assessed by BICR according to RECIST v1.1.

3 Stratified by sex, age, and smoking history.

4 Pike estimator.

5 Compared with allocated α of 0.0104 (Lan DeMets spending function approximating O’Brien Fleming boundary) for interim analysis.

The incidence and severity of adverse events were comparable for patients receiving Imfinzi vs. patients receiving placebo. The most frequent adverse reactions were rash which occurred in 73 subjects (15.4%), hypothyroidism which occurred in 50 subjects (10.5%), diarrhoea which occurred in 46 subjects (9.7%) and interstitial lung disease which occurred in 46 subjects (9.7%).

In May 2018, AstraZeneca announced that the PACIFIC trial met its second primary endpoint, showing statistically-significant and clinically-meaningful overall survival (OS) in patients receiving Imfinzi compared to placebo. Full results will be presented at a forthcoming medical meeting.

Imfinzi is also approved in the US, Canada, Switzerland and India based on the Phase III PACIFIC trial. Regulatory reviews in the EU and other jurisdictions are ongoing with an EU decision expected in the second half of 2018.

About Stage III NSCLC

Stage III (locally-advanced) NSCLC is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasised) to distant organs, as Stage III is currently treated with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017. The majority of Stage III NSCLC patients are diagnosed with unresectable tumours. Before the PACIFIC trial, the standard of care was chemotherapy and radiation therapy, followed by active surveillance to monitor for progression.

About PACIFIC

The PACIFIC trial is a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi as treatment in patients with Stage III unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

The trial has been conducted in 235 centres across 26 countries involving 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark PFS and OS, objective response rate, and duration of response.

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a 1st-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

On July 2, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that U.S. researchers published scientific findings recommending development of anti-Liver Cancer Drugs based on a mechanism of action utilized by Namodenoson (Press release, Can-Fite BioPharma, JUL 2, 2018, View Source [SID1234527537]).

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Can-Fite extensively published that its anti-cancer drug candidate, Namodenoson, inhibits a specific molecular signaling pathway in the liver cancer cells, designated as the Wnt/β-catenin, and is responsible for the development and progression of hepatocellular carcinoma (HCC). The scientific article published on June 28, 2018 by key opinion leaders from the University of Texas MD Anderson Cancer Center, Houston, TX, USA, recommends that targeting and inhibiting the very same Wnt/β-catenin pathway leads to an anti-cancer effect against hepatocellular carcinoma (Role of Wnt/β catenin signaling in hepatocellular carcinoma pathogenesis and clinical significance; Authors: Khalaf AM, Fuentes D, Morshid AI, Burke MR, Kaseb AO, Hassan M, Hazle JD, Elsayes KM. View Source)

"We are very excited to read the MD Anderson group article which we consider as important validation of Can-Fite’s scientific approach to the development of Namodenoson for the treatment of liver cancer. We’re proud to be working in the forefront of research of HCC with our orally available drug Namodenoson with its unique mechanism of action as an anti-cancer agent and its favorable safety profile. We look forward to data release from our ongoing Phase II advanced liver cancer trial," stated Can-Fite CEO Dr. Pnina Fishman.

The currently ongoing global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

Can-Fite received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for HCC.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On July 2, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516)reported that Chugai obtained approval from the Ministry of Health, Labour and Welfare (MHLW), for glycoengineered type II anti-CD20 monoclonal antibody GAZYVA Intravenous Infusion 1000 mg [generic name; obinutuzumab (genetical recombination)], which was co-developed by the two companies for the treatment of "CD20-positive follicular lymphoma" in Japan (Press release, Chugai, JUL 2, 2018, View Source [SID1234527538]).

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"This approval of GAZYVA will add a new treatment option for CD20-positive follicular lymphoma" said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "GAZYVA has been confirmed to be more efficacious than RITUXAN in combination with chemotherapy which is the standard therapy. Based on our experiences in the field of blood cancer cultivated over many years, we will prepare a system for providing information of proper use so that GAZYVA will be prescribed appropriately."

Shouzou Sano, Nippon Shinyaku’s Director, General Manager of Sales and Marketing Div. said "I am very glad that manufacturing and marketing approval for our co-developed product, GAZYVA, was granted. By adding this new product to our lineup in the area of hematologic malignancies, on which we are focusing, we will make utmost efforts to meet the demands in the clinical setting and contribute to the treatment of patients."

Identical to RITUXAN which is recommended as a treatment of non-Hodgkin’s lymphoma in treatment guidelines in Japan and overseas, GAZYVA is a glycoengineered type II anti-CD20 monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. GAZYVA is designed to attack and destroy targeted B cells both directly and together with the body’s immune system.

Follicular lymphoma is a type of non-Hodgkin’s lymphoma, and the number of patients are seven to fifteen percent of non-Hodgkin’s lymphoma1). In Japan, the prevalence of malignant lymphoma was reported to be approximately 27,000 and the number of deaths due to the disease was reported to be approximately 11,000, both in 20122, 3). Since the cases of Hodgkin’s lymphoma is reported to account for approximately eight to ten percent of the cases of malignant lymphoma in Japan1), the prevalence of non-Hodgkin’s lymphoma is estimated to be approximately 24,000 and the number of deaths from this condition is estimated to be approximately 10,000. The prevalence and deaths from malignant lymphoma tend to increase in recent years2, 3), and a same tendency is seen in patients with non-Hodgkin’s lymphoma.

Chugai and Nippon Shinyaku will work closely to make GAZYVA contribute to the treatment of CD20-positive follicular lymphoma.

1. Japanese Society of Hematology. Guidelines on Treatment of Hematopoietic Tumors (2013) Version 1.2. (View Source, Japanese only)
2. Center for Cancer Control and Information Services, National Cancer Center. National estimates of cancer incidence based on cancer registries in Japan (1975-2012) (View Source)
3. Center for Cancer Control and Information Services, National Cancer Center. Cancer mortality from Vital Statistics in Japan (1958-2015) (View Source)