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Fortress Biotech Announces Rare Pediatric Disease Designation for CUTX-101 for the Treatment of Menkes Disease

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NEW YORK, Jan. 16, 2020 — Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease Designation to Cyprium Therapeutics’ (“Cyprium”) Copper Histidinate, also referred to as CUTX-101, for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by genetic mutations of the copper transporter, ATP7A. The FDA previously granted Orphan Drug and Fast Track Designations to CUTX-101 for the treatment of Menkes disease.

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States. If Cyprium’s new drug application (“NDA”) is approved, the company may be eligible to receive a priority review voucher, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred. This program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.

“The FDA’s Rare Pediatric Disease Designation of CUTX-101 for the treatment of Menkes disease, after granting Orphan Drug and Fast Track Designations to CUTX-101 previously, highlights the significant unmet medical needs for patients with this devastating and life-threatening disease. Currently, there is no FDA-approved treatment for Menkes disease,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium. “The entire Cyprium team is encouraged by this designation and will continue to work diligently toward submitting the NDA for CUTX-101.”

About Menkes Disease and Related Copper Metabolism Disorders Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A, which affects approximately one in 100,000 newborns per year. Biochemically, Menkes patients have low levels of copper in their blood and brain, as well as abnormal levels of certain neurochemicals. Definitive diagnosis is typically made by sequencing the ATP7A gene. The condition is characterized by distinctive clinical features, including sparse and depigmented hair (“kinky hair”), connective tissue problems, and severe neurological symptoms such as seizures, hypotonia, and failure to thrive. Mortality is high, with many patients dying before the age of three years, if untreated. Milder versions of ATP7A mutations are associated with other conditions, including Occipital Horn Syndrome and ATP7A-related Distal Motor Neuropathy. Currently, there is no FDA-approved treatment for Menkes disease and its variants.

About CUTX-101 (Copper Histidinate) CUTX-101 is in clinical development to supplement blood and brain copper levels in patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression. CUTX-101 is a subcutaneous injectable formulation of Copper Histidinate manufactured under cGMP that is intended to improve tolerability due to physiological pH and to bypass the oral absorption of copper, which is impaired in patients with Menkes disease. In a Phase 1/2 clinical trial conducted at the National Institutes of Health (NIH), early treatment of patients with Menkes disease with CUTX-101 led to an improvement in neurodevelopmental outcomes and survival. A Phase 3 trial of CUTX-101 in patients with Menkes disease is ongoing at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

About Cyprium Therapeutics Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement (“CRADA”) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the National Institutes of Health (NIH), to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In addition, Cyprium and NICHD entered into a worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in Menkes patients, and to be used in combination with CUTX-101. CUTX-101 was granted U.S. Food and Drug Administration (“FDA”) Fast Track and Rare Pediatric Disease Designations, and both CUTX-101 and AAV-ATP7A have received FDA Orphan Drug Designation previously. Cyprium was founded by Fortress Biotech, Inc. (Nasdaq: FBIO) and is based in New York City. For more information, visit www.cypriumtx.com

About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was recently ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentage of fiscal year revenue growth over a three-year period. Fortress is focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market therapeutic areas, including oncology, rare diseases and gene therapy, which allow it to create value while mitigating risk for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital, and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contacts: Jaclyn Jaffe and William Begien Fortress Biotech, Inc. (781) 652-4500 [email protected]

Lung Yam, M.D., Ph.D. Cyprium Therapeutics, Inc. [email protected]

Investor Relations Contact: Daniel Ferry LifeSci Advisors, LLC (617) 430-7576 [email protected]

Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 [email protected]

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Suncity Group Named Title Sponsor for Local Arts Events

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Fully Supports Macau’s Cultural Industry and the Recovery of Macau

 

MACAU, CHINA – Media OutReach – 20 September 2020 – To revitalize the development of Macau’s cultural industry, Suncity Group fully supports the local arts event, rooting for Macau citizens and local artists through series of astonishing and diversified music entertaining events. ‘Suncity Group Rooting for Macau – SIM! Music Festival 2020’ is the first musical performance of series events title sponsored by Suncity Group, ended perfectly at the Cotai Arena, Venetian Macau on September 19.

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Maria Helena de Senna Fernandes, Director of Macau Government Tourist Office, Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd. attended the event 

‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau

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Local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival

 

With the purpose of ‘reigniting the local performing arts power’, a group of outstanding local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival. A total of 12 units did their utmost to compete in the same stage with singing and dancing. There was no cessation to the excitement and the symphony of applause and cheers in the whole night.

 

The organisers have specially invited Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd., Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association to serve as adjudicators and presenters, witnessing and supporting this diversified music festival that belongs to Macau with the other officiating guests. It shot in the arm of Macau’s cultural industry which has been gradually recovering after the pandemic. After a series of stiff competitions and wonderful performances by the participating units, the ‘Best Styling Award’ went to Walk with Scamper, the ‘Best Teamwork Award’ was awarded to Girls Rock, the ‘Best Positive Energy’ was given to Bacalhau Talkshow & Band, and finally the ‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau.

 

Mr. Chau said, ‘2020 is the year full of difficulties. With the impact of the pandemic, performing arts and cultural industries in mainland China and Macau have been hard hit. Most of the large-scale musical performances have also been suspended. “Suncity Group Rooting for Macau – SIM! Music Festival 2020” as the first music festival of this year, it undoubtedly brings more positive energy to Macau society as well as the cultural industry, pro-actively supporting the development of Macau’s industrial diversification.’

 

As the first extraordinary music feast of series events ended, ‘Suncity Group Rooting for Macau – SIM! Full Band festival 2020’, also title sponsored by Suncity Group, comes immediately thereafter and will be held on September 26. 13 teams of local rock bands will spare no effort to inspire local Macau citizens and awaken their rocking soul. There are also DJ performances, cold beer and snacks at that night, creating a diversified and dynamic rock music festival with hyper performances and mouth-watering delicacies. It once again roots for the recovery of Macau’s economy.

 

As an enterprise rooted in Macau, Suncity Group is committed to the motherland and Macau. With actively fulfilling its social responsibilities, the Group strives to support the recovery of cultural industry in mainland China and Macau as well as the diversified development of Macau in cooperating to national policies and long-term development of China. Through the title sponsorship of the series arts events, Suncity Group hopes to bring more positive energy and get the uptick of confidence to the Macau society.

 

High-resolution images can be downloaded in the gallery:

https://dropbox.suncity-group.com/url/0919sim

About Suncity Group

Suncity Group was founded in 2007. Since establishment, Suncity Group has been striving to provide the extraordinary VIP entertainment service for our guests, and we then opened a number of VIP Clubs in various 6-star hotels and resorts throughout Macau with the rapid growth of our business. Meanwhile, we successively set up exclusive VIP Clubs in Manila, Seoul, Incheon, Phnom Penh and Da Nang, etc.

 

Adhering to the spirit of “Innovating With Diversity, Striving For Success”, Suncity Group spared no effort to develop high-end entertainment services and products as well as roll out global VIP loyalty program for the selected members to enjoy entertainment, travel, catering services, luxury shopping and motion picture. Today, the scope of our business covers most sectors, especially in the fields of global travel, film production, concert and event planning, catering and luxury goods.

 

As a Macau born and bred enterprise, Suncity Group is not only devoted to develop the Asian market, but also oriented to expand the global network. In the future, we will surely continue to diversify our VIP entertainment services, attract more exclusive members and make every effort to promote our business in every corner of the world.

 

Official Website | www.suncitygroup.com.mo/en

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CNOOC Limited Announces Commencement of Production at Liuhua 16-2 Oilfield / 20-2 Oilfield Joint Development Project

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HONG KONG, Sept. 20, 2020 /PRNewswire/ — CNOOC Limited (the "Company", SEHK: 00883, NYSE: CEO, TSX: CNU) announced today that Liuhua 16-2 oilfield/ 20-2 oilfield joint development project has commenced production.

Liuhua 16-2 oilfield / 20-2 oilfield joint development project is located in Eastern South China Sea. The average water depth of the joint development project is approximately 410 meters.  One 150,000 DWT FPSO and three underwater production systems are newly built. A total of 26 development wells are planned to be put into production and development. The project is expected to reach its peak production of approximately 72,800 barrels of crude oil per day in 2022.

CNOOC Limited holds 100% interest of Liuhua 16-2 oilfield/ 20-2 oilfield joint development project.

– End –

Notes to Editors:

More information about the Company is available at http://www.cnoocltd.com.

*** *** *** ***

This press release includes "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements regarding expected future events, business prospectus or financial results. The words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends" and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors the Company believes are appropriate under the circumstances. However, whether actual results and developments will meet the expectations and predictions of the Company depends on a number of risks and uncertainties which could cause the actual results, performance and financial condition to differ materially from the Company’s expectations, including but not limited to those associated with fluctuations in crude oil and natural gas prices, macro-political and economic factors, changes in the tax and fiscal regimes of the host countries in which we operate, the highly competitive nature of the oil and natural gas industry, the exploration and development activities, mergers, acquisitions and divestments activities, environmental responsibility and compliance requirements, foreign operations and cyber system attacks.  For a description of these and other risks and uncertainties, please see the documents the Company files from time to time with the United States Securities and Exchange Commission, including the Annual Report on Form 20-F filed in April of the latest fiscal year.

Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements. The Company cannot assure that the results or developments anticipated will be realised or, even if substantially realised, that they will have the expected effect on the Company, its business or operations.

*** *** *** ***

For further enquiries, please contact:

Ms. Jing Liu
Manager, Media & Public Relations
CNOOC Limited
Tel: +86-10-8452-3404
Fax: +86-10-8452-1441
E-mail: [email protected]

Ms. Ada Leung 
Hill+Knowlton Strategies Asia
Tel: +852-2894-6225
Fax: +852-2576-1990
E-mail: [email protected]

Photo – https://photos.prnasia.com/prnh/20200911/2914374-1LOGO?lang=0

 

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Odonate Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – ODT

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NEW YORK, Sept. 19, 2020 — Pomerantz LLP announces that a class action lawsuit has been filed against Odonate Therapeutics, Inc.  (“Odonate” or the “Company”) (NASDAQ: ODT) and certain of its officers.   The class action, filed in United States District Court for the Southern District of California, and docketed under 20-cv-01828, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Odonate securities between December 7, 2017, and August 21, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Odonate securities during the class period, you have until November 16, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Odonate was founded in 2013 and is based in San Diego, California.  Odonate is a pharmaceutical company that develops therapeutics for the treatment of cancer.  The Company is focused on developing tesetaxel, an orally administered chemotherapy agent. 

Tesetaxel is in Phase 3 clinical study for patients with locally advanced or metastatic breast cancer (“MBC”), called the CONTESSA trial, which is evaluating tesetaxel in combination with capecitabine in patients with MBC.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) tesetaxel was not as safe or well-tolerated as the Company had led investors to believe; (ii) consequently, tesetaxel’s commercial viability as a cancer treatment was overstated; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On August 24, 2020, during pre-market hours, Odonate issued a press release announcing top-line results from the CONTESSA trial.  Although the study met its primary endpoint, tesetaxel plus capecitabine was associated with Grade 3 or higher neutropenia (low levels of white blood cells), which occurred in 71.2% of patients with the combination treatment versus 8.3% for capecitabine alone.  Various other Grade 3 or higher treatment-emergent adverse events (“AEs”) were also associated with tesetaxel plus capecitabine versus capecitabine alone.  Further, discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy, and the overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.

On this news, Odonate’s stock price fell $15.21 per share, or 45.35%, to close at $18.33 per share on August 24, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT: Robert S. Willoughby Pomerantz LLP [email protected]

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