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Anti-CD20 Monoclonal Antibody â€œRITUXAN®,â€ Application for Approval of Additional Indication of CD20-Positive Chronic Lymphocytic Leukemia

On August 3, 2018 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku filed an application for approval with the Ministry of Health, Labour and Welfare for the anti-CD20 monoclonal antibody RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the treatment of "CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, AUG 3, 2018, View Source [SID1234528819]). RITUXIAN is co-marketed by the two companies in Japan.

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Zenyaku received a request from the MHLW to develop RITUXAN for the treatment of CD20-positive CLL issued on April 6, 2012, as a result of the evaluation by the "11th Review Committee on Unapproved Drugs and Indications with High Medical Needs" held on March 23, 2012, and has been preparing to file for the addition of this indication. On March 20, 2018, the orphan drug designation was granted for RITUXAN for CD20-positive CLL as the estimated number of newly diagnosed CLL patient per year is about 400.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of females to males is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work for the early approval of the product to provide RITUXAN for CLL patients and medical professionals who are waiting for a new treatment option.

vTv Therapeutics Announces Second Quarter 2018 Results and Update

On August 3, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter that ended June 30, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361982 [SID1234528671]).

"Since our announcement regarding the topline results from Part B of the STEADFAST Study, we have continued to analyze the results from Parts A and B and are encouraged by our findings," said Steve Holcombe, chief executive officer, vTv Therapeutics. "In addition, our other programs, including our glucokinase activator currently in clinical development for type 1 diabetes and our GLP-1R program that is being developed in partnership with Huadong Medicine for type 2 diabetes, continue to make steady progress."

Recent Achievements and Outlook

Azeliragon data analysis continues in order to move development of the therapy forward in consultation with our scientific advisory board and the FDA.
SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study has begun dosing patients with type 1 diabetes in a 12 week study to evaluate TTP399 as an add-on to insulin therapy. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Advancing PDE4 program with Newsoara. During the second quarter, vTv licensed rights to its PDE4 program to Newsoara Biopharma Co., Ltd. to further its development and potential commercialization in China and other Pacific Rim countries. Newsoara is developing vTv’s PDE4 compounds as a potential therapeutic for COPD, a chronic illness affecting nearly 100 million people in China.
Additional Investment by MacAndrews & Forbes Incorporated. MacAndrews & Forbes provided vTv an additional $10 million capital line.
Upcoming Events

vTv will participate in the following upcoming investor conferences:

H.C. Wainwright Annual Healthcare Conference, September 4-6, New York.
vTv will also participate in the following upcoming scientific conferences:

11th Clinical Trials on Alzheimer’s Disease (CTAD), October 24-27, Barcelona.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2018, were $1.2 million compared to $6.5 million as of March 31, 2018.
R&D Expenses: Research and development expenses were $8.6 million in the second quarter of 2018, compared to $8.9 million in the first quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of fiscal 2018.
G&A Expenses: General and administrative expenses were $2.7 million and $2.3 million, for the second quarter of 2018 and the first quarter of 2018, respectively. The change in general and administrative cost was driven by lower incentive compensation costs in the first quarter of 2018 related to a reduction in the expected probability of payment of the remaining amount of fiscal 2017 incentive bonuses.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.6 million for the second quarter of 2018 compared to net loss before non-controlling interest of $10.0 million for the first quarter of 2018.
Net Loss per Share: GAAP net loss per share was $0.31 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on weighted-average shares of 10.0 million and 9.7 million for the three month periods ended June 30, 2018 and March 31, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.29 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 33.1 million and 32.8 million for the three months ended June 30, 2018 and March 31, 2018, respectively.

Athenex, Inc. to Report Second Quarter Earnings Results on August 14, 2018

On August 3, 2018 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release second quarter 2018 and six months ended June 30, 2018 earnings results on August 14, 2018 before the market opens (Press release, Athenex, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361991 [SID1234528634]). The Company will host a conference call and live audio webcast on Tuesday, August 14, 2018 at 9:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13682063. A replay of the call will be accessible two hours after its completion through August 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13682063. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com.

Entry into a Material Definitive Agreement

On August 3, 2018, the registrant and Maxim Group LLC further amended their July 23, 2012 Equity Distribution Agreement solely for the purpose of adding the registrant’s new registration statement on Form 3 (File No 333-226059) to the definition of "registration statement" as the old registration statement expired (Filing, 8-K, Hemispherx Biopharma, AUG 3, 2018, View Source [SID1234528630]).

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to PharmaMar’s lurbinectedin

On August 3, 2018 PharmaMar (PHM:MSE) reported that lurbinectedin has been granted orphan drug status by the FDA for the treatment of small cell lung cancer (Press release, PharmaMar, AUG 3, 2018, View Source [SID1234528444]).

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan Drug designation may provide certain benefits, including a 7-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials, and an exemption from FDA application fees.

"We are delighted to receive this orphan drug designation as it underscores the great need for innovative, effective treatments for this cancer, and recognizes the potential benefits that lurbinectedin may provide for patients with small cell lung cancer," said Luis Mora, Managing Director of the Oncology Business Unit of PharmaMar. "Receiving orphan drug designation for the treatment of small cell lung cancer (SCLC) is a significant regulatory milestone in the development of lurbinectedin", has added.