Home / 2020 / July / 02

Daily Archives: July 2, 2020

Novavax Announces Updates to Leadership Team

Frank Czworka appointed SVP, Global Sales

Brian Webb promoted to SVP, Manufacturing

GAITHERSBURG, Md., July 02, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Frank Czworka as Senior Vice President, Global Sales, with responsibility for leading sales planning and distribution. Novavax also announced the promotion of Brian Webb to Senior Vice President, Manufacturing, with responsibility for overseeing antigen manufacturing and supply activities in support of Novavax’ vaccine candidates.

“Frank’s extensive commercial and sales expertise will be invaluable to Novavax’ transformation into a commercial stage organization,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Brian has been instrumental in the recent expansion and alignment of our manufacturing capabilities and supply partnerships. I am confident that the company will benefit greatly from their mutual expertise as we advance our efforts to bring NVX‑CoV2373 and NanoFlu to market.”

Mr. Czworka brings more than two decades of biopharmaceutical experience to Novavax, most recently serving as Vice President, Global Customer Engagement at U.S. Pharmacopeia. In sales and marketing leadership positions at Osiris Therapeutics, Auxilium Pharmaceuticals, MedImmune and TAP Pharmaceuticals, Mr. Czworka has assembled, developed, deployed and directed award-winning global sales and marketing teams to achieve business objectives. He has launched multiple medications across a variety of therapeutic areas while increasing patient access to vital treatments. Mr. Czworka received a bachelor of science degree in business administration – marketing from the University of Central Florida.

“This is an exciting time to join Novavax, with much to be accomplished as we advance our COVID-19 candidate and prepare the regulatory submission for NanoFlu,” said Mr. Czworka. “I’m excited to contribute to the team so that we can positively impact the lives of patients and reduce the global burden of these infectious diseases.”

Mr. Webb joined Novavax in May 2014 with responsibility for internal and external manufacturing. Prior to joining Novavax, Mr. Webb held numerous operational leadership roles at GlaxoSmithKline and Human Genome Sciences where he had the opportunity to take multiple products from early clinical stage through licensure and launch. He received a bachelor of science degree in biology from Salisbury University and a master of science degree in biotechnology from Johns Hopkins University.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products, including statements regarding the manufacturing of vaccine antigen dose amounts and timing, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission (SEC) and updated by any Quarterly Report on Form 10-Q, particularly the risks inherent to developing novel vaccines. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors
Novavax, Inc.
Silvia Taylor and Erika Trahan
ir@novavax.com
240-268-2022

Media
Brandzone/KOGS Communication
Edna Kaplan
kaplan@kogspr.com
617-974-8659

Imperial Capital Hires Distressed Debt Trading Veteran, Simon Mullaly, to Head New European Private Credit Group

LOS ANGELES, July 02, 2020 (GLOBE NEWSWIRE) — Imperial Capital Group, LLC (“Imperial Capital”), announced today that Simon Mullaly has returned to the markets to launch a European Private Credit Group in which he will serve as Head Trader.  The European Private Credit Group will source private European credit investment opportunities for Imperial Capital’s institutional investors in both Europe and the US.

“We believe that Simon is rejoining the market at the opportune time when there is an increasing appetite for special situations trading in both Europe and the US,” said Tim Sullivan, President of Imperial Capital, LLC. “The addition of Simon to head a dedicated European Private Credit effort affirms the Company’s vision to expand our existing credit sales & trading franchise into non-cusip trading solutions for our clients.”

Simon Mullaly joins Imperial Capital as a Managing Director and Head of the European Private Credit Trading Group.  He will be based in Stamford, CT.  Previously, Mr. Mullaly was the founder and CEO of Yorvik Partners, a European based credit brokerage firm that specialized in distressed debt before being acquired by Sterne Agee in late 2013.  Prior to founding Yorvik, Mr. Mullaly managed trading desks for Deutsche Bank, AG and Lehman Brothers in London.  Mr. Mullaly earned an MBA from The Wharton School at the University of Pennsylvania and a BSc at Nottingham Trent University.

“I am excited to join Imperial Capital’s well-established fixed income platform that includes bespoke research,” said Simon Mullaly.  “I believe that we can leverage Imperial Capital’s platform to grow a Private European Credit group that complements the growth of private debt in Europe as a credible asset class that is systemically changing and here to stay.”

About Imperial Capital, LLC

Imperial Capital, LLC is a full-service investment bank offering a uniquely integrated platform of comprehensive services to institutional investors and middle market companies. We offer sophisticated sales and trading services to institutional investors and a wide range of investment banking advisory, capital markets and restructuring services to middle market corporate clients. Paired with our proprietary research and sales & trading desk analysis, we provide investment analysis across an issuer’s capital structure, including bank loans, debt securities, the hybrid/bank capital marketplace (through our ELP Framework), post-reorganization equities, special situations claims and listed and unlisted equities. Our comprehensive and integrated service platform, expertise across the global capital structure, and deep industry sector knowledge enable us to provide clients with research driven ideas, superior advisory services, and trade execution. We are quick to identify opportunities under any market conditions and we have a proven track record of offering creative, proprietary solutions to our clients. Imperial Capital, LLC has three principal businesses: Investment Banking, Institutional Sales & Trading and Institutional Research. More information about Imperial Capital, LLC can be found at www.imperialcapital.com.

For more information regarding Imperial Capital, please contact:
Mark Martis
+1 310 246 3674
mmartis@imperialcapital.com

About Imperial Capital (International), LLP

Imperial Capital International, founded in 2011, is an affiliate of Imperial Capital, LLC with an office in central London.  Complementing Imperial Capital’s existing corporate credit sales and trading franchise, Imperial Capital International expanded the Imperial Capital franchise into the EEA.  The company focuses on the entire credit spectrum and takes a full capital structure research approach to supplement sales and trading services to its European institutional clients.

For more information regarding Imperial Capital (International), LLP, please contact:
Emma McClintock
+ 44 (0) 207 650 5429
emcclintock@imperialcapital.com

Helsinn Group and MEI Pharma Discontinue the Phase 3 Study with Pracinostat in AML after Completing Interim Analysis

Helsinn Group and MEI Pharma Discontinue the Phase 3 Study with Pracinostat in AML after Completing Interim Analysis

Lugano, Switzerland and San Diego, USA, July 2, 2020 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, and MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing potential new therapies for cancer, today announce that an interim futility analysis of the ongoing Phase 3 study of pracinostat in combination with azacitidine in patients with AML who are unfit to receive standard intensive chemotherapy, undertaken by the study Independent Data Monitoring Committee (“IDMC”), has demonstrated it was unlikely to meet the primary endpoint of overall survival compared to the control group. Based on the outcome of the interim analysis, the decision was made to discontinue the recruitment of patients and end the study. The decision was based on a lack of efficacy and not on safety concerns. Pending further evaluation, patients currently enrolled in other pracinostat studies will continue treatment.

About AML

Acute Myeloid Leukemia (AML) is a disorder of the blood and bone marrow caused by the uncontrolled proliferation of an abnormal hematopoietic cell of myeloid lineage. This results in a high circulating number of immature blood cells and replacement of normal bone marrow by malignant cells. AML has various subtypes, which are based on the type of cell from which the leukemia developed. It is typically a disease of older patients, with a median age at diagnosis of 67 years. Whilst the cure rate with intensive chemotherapy for AML patients who are 60 or younger is 35 to 40%, the rate is poor in older patients, typically not exceeding 15%.

About Pracinostat

Pracinostat is an oral histone deacetylase (“HDAC”) inhibitor that is being investigated in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (“AML”) who are unfit for standard intensive chemotherapy. It is also being evaluated in a Phase II study in patients with high or very high-risk myelodysplastic syndromes (“MDS”). The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation for pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy. In addition, the FDA has granted Breakthrough Therapy Designation to the combination treatment.

In August 2016, Helsinn and MEI Pharma entered an exclusive license, development and commercialization agreement for pracinostat in AML and other potential indications. The agreement provides that Helsinn is primarily responsible for development and commercialization costs for pracinostat in AML and other indications, including MDS.

Pracinostat is an investigational agent and is not approved for commercial use in the U.S. or any other country worldwide.

About the Helsinn Group

Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisition to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with over 80 long-standing partners in 190 countries, who share our values. The Group’s pharmaceutical business, (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn Investment Fund was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

About MEI Pharma

MEI Pharma, Inc. (Nasdaq: MEIP) is a late-stage pharmaceutical company focused on developing potential new therapies for cancer. MEI Pharma’s portfolio of drug candidates contains four clinical-stage assets, including ME-401, currently in an ongoing Phase 2 clinical trial which may support an accelerated approval marketing application with the U.S. Food and Drug Administration. Each of MEI Pharma’s pipeline candidates leverages a different mechanism of action with the objective of developing therapeutic options that are: (1) differentiated, (2) address unmet medical needs and (3) deliver improved benefit to patients either as standalone treatments or in combination with other therapeutic options. For more information, please visit www.meipharma.com.

Forward-Looking Statements

Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; the impact of the COVID-19 pandemic on our industry and individual companies, including on our counterparties, the supply chain, the execution of our clinical development programs, our access to financing and the allocation of government resources; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

For more information:

Helsinn Group Media Contact:
Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
Email: Info-hhc@helsinn.com
For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo

MEI Pharma

David A. Walsey
VP of IR and Corporate Communications
Tel: 858-369-7104
investor@meipharma.com

Jason I. Spark
Canale Communications for MEI
Tel: 619-849-6005
jason@canalecomm.com

COVID-19: Active cases dip below 100 – Health DG

KUALA LUMPUR The number of COVID-19 active cases in the country dipped under 100 today, with the recovery rate now standing at 97.6 per cent.

 

Health director-general Datuk Dr Noor Hisham Abdullah said 85 active cases were recorded today, while 62 patients have recovered and discharged, bringing cumulative recoveries to 8,437 cases.

 

“Three new cases were recorded today, bringing the total COVID-19 positive cases to 8,643. One is an imported case involving a Malaysian citizen, while another two were local transmissions involving non-Malaysians,” he said in a statement today.

 

 

 

Elaborating on the local transmissions, he said one of them was from the Bukit Bintang cluster here, which was detected in a second screening during quarantine, and another one was detected from screening upon entering a lock-up in Kota Kinabalu, Sabah.

 

Dr Noor Hisham said the total positive cases for the Bukit Bintang cluster was 11, comprising 10 Bangladeshis and one local citizen.

 

“So far, some 304 people have been screened, involving 204 foreigners and 100 Malaysians, of which 293 people were found to be negative. The cause of infection in this cluster is being investigated,” he explained.

 

 

Meanwhile, Dr Noor Hisham said no additional COVID-19-related fatalities were reported overnight, keeping the cumulative death toll at 121 or 1.4 per cent of the total cases.

 

“There are two patients being treated at the Intensive Care Unit (ICU) and both need ventilator support,” he said.

 

In a related development, he said 620 out of 5,804 individuals who were placed under the home surveillance order (HSO) must undergo a second screening for COVID-19 on the 13th day of their quarantine.

 

Therefore, Dr Noor Hisham said the district health offices together with the police were actively tracing the respective individuals.

 

“The Health Ministry wishes to remind that action can be taken against any individuals who violate regulations under this order. They can be fined or sent to jail or both,” he added.

 

He urged all travellers who returned to Malaysia to cooperate with the Health Ministery and comply with the regulations under the HSO.

 

 

 

Source: BERNAMA News Agency

 

 

COVID-19: 620 returnees who dodged 2nd screening under police radar

KUALA LUMPUR Police have obtained the complete list of 620 people who were placed under home supervision and observation for 14 days upon returning from abroad but have yet to undergo the second screening for COVID-19.

 

Bukit Aman Criminal Investigation Department director Datuk Huzir Mohamed said the police would be tracking those people soon.

 

“We advised them to come forward and give full cooperation to the Health Ministry to undergo the second screening. If they failed to do so, police will not hesitate to take any action against them,” he told Bernama when contacted today.

 

 

 

Huzir said action could be taken against them under Section 22(b) of the Prevention and Control of Infectious Diseases Act 1988 (Act 342) and Regulation 10 of the Prevention and Control of Infectious Diseases (Measures within the Infected Local Areas) (No 7) Regulations 2020.

 

Senior Minister (Security Cluster) Datuk Seri Ismail Sabri Yaakob in his statement on the Recovery Movement Control Order today urged all 620 people who were placed under home quarantine but have yet undergo their second screening on the 13th day, to do so or be prepared to face action.

 

 

Source: BERNAMA News Agency

 

 

National committee on rural water supply projects

PUTRAJAYA A national-level committee for rural water supply projects will be set up to coordinate and regulate implementation of the projects nationwide, including in Sabah and Sarawak.

 

Environment and Water Minister Datuk Tuan Ibrahim Tuan Man said the committee would be chaired jointly by the the ministry and Rural Development Ministry.

 

He said the committee would focus on improving the quality of services through infrastructure development and water supply systems in compliance with guidelines by the  National Water Services Commission as provided in the National Water Services Commission Act 2006 (Act 655).

 

 

 

The committee, he said, would also focus on improving the operation and system of alternative rural water supply projects.

 

“The ministry is committed to ensuring that the desired results are achieved through coordination between ministries and other agencies to achieve the target of 98 per cent coverage of rural water supply by 2025,” he said in a press statement today.

 

Tuan Ibrahim said two agencies under his ministry, namely the Water Supply Division and the Department of Irrigation and Drainage, are  actively involved in the planning and implementation of the rural water supply projects.

 

 

The implementation of the projects also involves various ministries and agencies including the Ministry of Health (MOH), Ministry of Energy and Natural Resources, the Orang Asli Development Department (JAKOA), FELDA and the regional development authorities.

 

The rural water supply project was first implemented under the Accelerated Rural Water Supply scheme in the Second Malaysia Plan (1971) (1971 to 1975) and continued until the 11th Malaysia Plan. Among the main goals and objectives of the project are to provide and expand the coverage of clean and treated water supply so that the health and quality of life of the rural community can be improved.

 

 

 

Source: BERNAMA News Agency

 

Police to use AMLA to combat migrant smuggling activities

 

KOTA TINGGI Police will act more aggressively in combating smuggling of migrants into the country by diversifying the scope of the investigation that will include their assets which are believed to have been obtained from such activities.

 

Johor police chief Datuk Ayob Khan Mydin Pitchay said that the investigation would also include the use of Section 4 of the Anti-Money Laundering, Anti-Terrrorism Financing and Proceeds of Unlawful Activities Act (AMLA) 2001, that would cover accounts of the suspects’ family members.

 

“I also warn the local people against getting involved in any migrant smuggling activities because the punishment is harsh, imprisonment of not more than 20 years and we are also considering actions under the AMLA.

 

 

 

 

“All accounts (and assets) of individuals suspected to be involved in smuggling of migrants as well as those belonging to their family members will be frozen. The consequences is not just on the suspects but also their family members. So don’t get involved!” he said this to reporters at the Kota Tinggi district police headquarters, here, today.

 

Also present was Bukit Aman’s CID Organised Crime Investigation (D14) assistant director ACP Azman Ali.

 

Earlier, 51 individuals were charged in the Kota Tinggi Sessions Court with being part of an organised crime group dubbed ‘ Geng Otong’, which has been actively involved in smuggling of migrants since 2014.

 

 

Ayob Khan described the case as the biggest in history and the first of such case in Malaysia where those arrested have been involved in migrant smuggling, and investigated for organised crime.

 

“They are members of organised crime groups that include syndicate’s masterminds, agents and transporter, who are in the same network”, he said, adding that all of them were detained under the Security Offences (Special Prevention Measures) Act 2012 (SOSMA).

 

He said that the success was the result of cooperation with the Johor Criminal Investigation Department (CID) led by its chief SAC Md Yusuf Ahmad, together with his deputy (Intelligence and Operations) ACP Hoo Chuan Huat, and assisted by several teams from Bukit Aman.

 

He said police would also focus on migrant smuggling activities on the west coast of Johor after 95 per cent of such activities on the east coast were successfully eradicated.

 

He said for the remaining 19 suspects, involving officers and law enforcement personnel, they will be charged in connection with the migrant smuggling cases.

 

“We have completed the investigation papers to be submitted to the Attorney-General’s Chambers. ‘Insya Allah’ (God willing), next week we will obtain the decision to charge them.

 

“Meanwhile, the remaining members of the ‘Geng Otong’  are believed to be in Indonesia and we are monitoring their movements”, he said, adding that operations against migrant smuggling activities to continue.

 

 

 

Source: BERNAMA News Agency