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United States Patent & Trademark Office Allows Patent Claims for CBM BioPharma, Inc.’s Patent Application for Pancreatic Cancer Treatment

CBM Bolsters Intellectual Property Asset Portfolio

NEW YORK, June 26, 2019 /PRNewswire/ — CBM BioPharma Inc. (“CBM”) today announced that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance and Issue Fee Due in CBM’s patent application related to the treatment of pancreatic cancer.

CBM has received from the USPTO a Notice of Allowance for patent application 15/115,393.  This application is licensed from the University of Texas by CBM.  Once the patent issue fee is paid, the new patent will protect one of CBM’s lead drug candidates, Gem-DHA, a novel gemcitabine derivative intended for the treatment of pancreatic cancer.  Preliminary data indicates that Gem-DHA is more effective than gemcitabine in mice pancreatic cancer models.  This asset is to be sold to Spherix Inc. (NASDAQ: SPEX) as part of the previously announced Asset Purchase Agreement between CBM and Spherix.  The transaction is subject to shareholder approval by Spherix shareholders and other customary closing conditions.

Anthony Hayes, Spherix CEO, stated, “I am very excited by the potential of this drug and especially by the data showing that Gem-DHA works better in reducing the growth of pancreatic tumors than the first-line chemotherapy drug gemcitabine.  The data indicates that Gem-DHA preferentially concentrates itself in the pancreas relative to other organs, suggesting it may be a promising candidate for further trials in pancreatic cancer.  We are constantly working to return value to our shareholders and this news is another data point that establishes the value of the CBM assets.”

About CBM

CBM is a private biotechnology company with a drug portfolio that focuses on the treatment of three cancers, acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and pancreatic cancer. CBM’s AML drug is a next generation targeted therapeutic designed to overcome multiple resistance mechanisms observed with the current standard of care.

Support for PR Statements:

—Gem-DHA is a novel gemcitabine derivative intended for the treatment of pancreatic cancer.
“The disclosed compounds have a nucleobase moiety and an omega-3 polyunsaturated fatty acid moiety, including pharmaceutically acceptable salt or prodrug thereof. Methods of using these compounds for the treatment of cancers such as pancreatic cancer are also disclosed.” (App. 15/115,393 at Abstract)

—Preliminary data indicate that Gem-DHA is more effective than gemcitabine in mice pancreatic cancer models.
“The results showed that Gem-DHA was more effective than the molar equivalent dose of gemcitabine HCl in inhibiting the growth of Panc-1-Luc tumors, but gemcitabine HCl at the dosing regimen used did not significantly inhibit the growth of the Panc-1-Luc tumors (FIG. 10A-C). In fact, by the end of the study, the average weight of tumors in mice that were treated with gemcitabine HCl was not significantly different from that in mice that were left untreated (FIG. 10B).” (App. 15/115,393 at Example 4)

—Gem-DHA works better in reducing the growth of pancreatic tumors than the first-line chemotherapy drug gemcitabine.
Repeating: “The results showed that Gem-DHA was more effective than the molar equivalent dose of gemcitabine HCl in inhibiting the growth of Panc-1-Luc tumors, but gemcitabine HCl at the dosing regimen used did not significantly inhibit the growth of the Panc-1-Luc tumors (FIG. 10A-C). In fact, by the end of the study, the average weight of tumors in mice that were treated with gemcitabine HCl was not significantly different from that in mice that were left untreated (FIG. 10B).” (App. 15/115,393 at Example 4)

—Gem-DHA preferentially concentrates itself in the pancreas relative to other organs.
“Similar to what was observed in tumor-bearing C.sub.57BL/6 mice (FIG. 16C), in healthy BALB/c mice, the highest percent of the injected Gem-DHA was detected in mouse pancreas (among the organs tested, FIG. 16D). Therefore, it appeared that Gem-DHA preferred to distribute in pancreatic tissues.” (App. 15/115,393 at Example 5)

Contact:
Investor Relations
hbehrmann@cbmbiopharmainc.com

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SOURCE CBM BioPharma, Inc.

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AbbVie Receives Positive Recommendation from the Institut national d’excellence en santé et en services sociaux (INESSS) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

  • INESSS recommends the reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL).i
  • Adult patients with CLL taking VENCLEXTA in combination with rituximab can stop their therapy

 

 

Montreal, QC, June 25, 2019 –AbbVie (NYSE: ABBV), a global

biopharmaceutical company, today announced that the Institut national d’excellence en santé et en services sociaux (INESSS) recommends that the Minister include Venclexta, in combination with rituximab, on the Lists of Medications for the treatment of chronic lymphocytic leukemia (CLL), if the following conditions are met: exceptional medication and lessening of the economic burden.i VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients are able to stop their therapy after two years of treatment.

INESSS concludes that the evaluation of venetoclax’s efficacy and safety in combination with rituximab is

based on a good-quality study. The outcomes of that study demonstrated that venetoclax delays disease progression compared to intravenous chemotherapy. Although intravenous chemotherapy is not included on the Lists of Medications, INESSS has recognized its efficacy.i The most common adverse reactions with venetoclax in combination with rituximab were related to white blood cells. Furthermore, there is an unmet clinical need in CLL. The reimbursement of venetoclax in combination with rituximab would be beneficial in the care pathway of CLL patients. i

“The INESSS recommendation for VENCLEXTA plus rituximab is positive news for people living with CLL

in Quebec,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are highly effective treatments available provides reassurance to people facing this uncertain journey.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iii The goal of treatment is to delay progression of the disease and improve quality of life.

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases.

 

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

-30-

Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

 

i Institut national d’excellence en santé et en services sociaux (INESSS). Avis à la Ministre. www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Mai_2019/Venclexta_2019_05.pdf. Accessed June 2019.

ii Lymphoma Canada. Chronic lymphocytic leukemia. Available at www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed June 2019.

iii Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed June 2019.

iv VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed June 2019.

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Vireo Health to Present at MJ Micro Conference in New York on June 25

MINNEAPOLIS, June 24, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced its participation at the MJ Micro Conference in New York City on June 25, 2019.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

Chief Executive Officer Kyle Kingsley, M.D., will present to investors at 2:00 p.m. ET on Tuesday, June 25, 2019. Dr. Kingsley will also meet with investors during one-on-one meetings at the conference.

MJ Micro is an invitational forum that unites publicly traded cannabis companies led by seasoned executives with institutional and high net worth investors. MJ Micro selects established companies to present at MJ Micro that have proof of concept, revenue streams, audited financials, and valuations justified by public markets. MJ Micro is a production of MJLink.com Inc., a wholly owned subsidiary of Social Life Networks, Inc.

About Vireo Health International, Inc.

Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 350 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company is currently licensed in eleven states and territories: Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico and Rhode Island. For more information about the company, please visit www.vireohealth.com.

Contact Information 

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com   
(267) 221-4800

 

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SOURCE Vireo Health International, Inc.

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Vireo Health Expands into Puerto Rico’s Rapidly Growing Medical Cannabis Market

Company plans cultivation and processing facility in San Juan area and six dispensaries throughout island

MINNEAPOLIS, June 20, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading physician-led, science-focused multi-state cannabis company, today announced the acquisition of medical cannabis licenses in the Commonwealth of Puerto Rico. The acquisition is comprised of pre-approvals for licenses to cultivate, process, and sell cannabis products and operate up to six dispensaries. This transaction marks the eleventh market in which Vireo is licensed to grow, manufacture, or sell cannabis products.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“Vireo continues to seek unique opportunities to drive our science-focused approach into larger markets. We are thrilled to expand into the Commonwealth of Puerto Rico, one of the largest pharmaceutical hubs in the world,” said Chief Executive Officer, Kyle Kingsley, M.D. “This expansion will give us access to the island’s deep pool of talented professionals, create a wide variety of jobs, and allow us to help many more patients.”

Vireo has leased a 40,000 square-foot former Pfizer facility in the Cruce Dávila Business Park, located in Barceloneta, Puerto Rico to house its cultivation and processing operations. The Company also plans to launch six “Green Goods” dispensaries throughout the island in Arecibo, Bayamón, Caguas, Guaynabo, Guayama, and Hormigueros.

Vireo Health of Puerto Rico will be led by Christian Gonzalez, a native of the island with a degree in mechanical engineering from the University of Puerto Rico Mayagüez, who brings more than 15 years of experience in cannabis, medical device, pharmaceutical, and aerospace/defense manufacturing. Gonzalez currently serves as the general manager of Vireo Health of Pennsylvania, where he oversees the company’s state-of-the art cultivation and processing facility.

“It is an honor to lead Vireo’s efforts here in Puerto Rico,” said Mr. Gonzalez. “The island has faced many challenges since Hurricane Maria. I am humbled by the opportunity to return home and contribute to rebuilding the local economy.”

On July 9, 2017, Puerto Rico passed the MEDICINAL Act, which created the Medical Cannabis Regulatory Board and allowed for only medical use of cannabis. In Puerto Rico’s medical cannabis program there are 27 qualifying conditions for which an authorized physician can prescribe cannabis. There are currently 72,000 patients enrolled in the program and the Department of Health set a goal of adding 100,000 more new patients by the end of the year.

This transaction, the agreement for which was previously disclosed in the Company’s CSE listing statement, represents Vireo Health’s fifth acquisition since it began trading on the Canadian Securities Exchange under the ticker symbol “VREO.” Vireo Health now has more than 300 employees in Puerto Rico and ten U.S. states: Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island.

About Vireo Health International, Inc.

Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company currently is licensed in eleven markets including Arizona, Maryland, Massachusetts, Minnesota, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, and Rhode Island. For more information about the company, please visit www.vireohealth.com.

Contact Information 

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Forward-Looking Statement Disclosure

This news release contains forward-looking information within the meaning of applicable securities laws, based on current expectations. Generally, any statements that are not historical facts may contain forward-looking information, and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “look forward to”, “budget” “scheduled”, “estimates”, “forecasts”, “will continue”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or indicates that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, “occur” or “be achieved.” Forward looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, future developments, the future operations, potential market opportunities, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. These statements are based upon certain material factors, assumptions and analyses that were applied in drawing a conclusion or making a forecast or projection, including Vireo’s experience and perceptions of historical trends, current conditions and expected future developments, as well as other factors that are believed to be reasonable in the circumstances.

Examples of the assumptions underlying the forward-looking statements contained herein include, but are not limited to those related to: the achievement of goals, the closing of acquisitions, obtaining of necessary permits and governmental approvals, future market positioning, as well as expectations regarding availability of equipment, skilled labor and services needed for cannabis operations, intellectual property rights,  development, operating or regulatory risks, trends and developments in the cannabis industry, business strategy and outlook, expansion and growth of business and operations, the timing and amount of capital expenditures; future exchange rates; the impact of increasing competition; conditions in general economic and financial markets; access to capital; future operating costs; government regulations, including future legislative and regulatory developments involving medical and recreational marijuana and the timing thereto; receipt of appropriate and necessary licenses in a timely manner; the effects of regulation by governmental agencies; the anticipated changes to laws regarding the recreational use of cannabis; the demand for cannabis products and corresponding forecasted increase in revenues; and the size of the medical marijuana market and the recreational marijuana market.

Although such statements are based on management’s reasonable assumptions at the date such statements are made, there can be no assurance that it will be completed on the terms described above and that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking information. Accordingly, readers should not place undue reliance on the forward-looking information. Vireo assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by applicable law.

By its nature, forward-looking information is subject to risks and uncertainties, and there are a variety of material factors, many of which are beyond the control of the Company and that may cause actual outcomes to differ materially from those discussed in the forward-looking statements. These factors include, but are not limited to: denial or delayed receipt of all necessary consents and approvals; need for additional capital expenditures; increased costs and timing of operations; unexpected costs associated with environmental liabilities; requirements for additional capital; reduced future prices of cannabis; failure of plant, equipment or processes to operate as anticipated; accidents, labor disputes and other risks of the cannabis industry; delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities; title disputes; claims limitations on insurance coverage; risks related to the integration of acquisitions; fluctuations in the spot and forward price of certain commodities (such as diesel fuel and electricity); changes in national and local government legislation, taxation, controls, regulations and political or economic developments in the countries where the Company may carry on business in the future;  liabilities inherent in cannabis operations;  risks relating to medical and recreational cannabis; cultivation, extraction and distribution problems; competition for, among other things, capital, licenses and skilled personnel;  risks relating to the timing of legalization of recreational cannabis; changes in laws relating to the cannabis industry; and management’s success in anticipating and managing the foregoing factors.

 

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SOURCE Vireo Health International, Inc.

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Spherix Files Preliminary Proxy Statement Advancing the Planned Acquisition of Assets of CBM BioPharma, Inc.

NEW YORK, June 19, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that it has filed a Preliminary Proxy Statement with the Securities and Exchange Commission and announced a Special Meeting of Stockholders related to approving various items related to the proposed and previously announced acquisition of substantially all of the assets of CBM BioPharma, Inc. (“CBM”).

Spherix Logo. (PRNewsFoto/Spherix Incorporated)

The acquisition of the CBM assets constitutes another step in Spherix’s continued transformation into an innovative pharmaceutical company with pioneering drugs and treatments focused on the development and commercialization of oncology therapeutics. CBM is a privately held pharmaceutical company with exclusive drug development rights from world renowned partners like Wake Forest University and University of Texas. CBM has a team of leading drug development scientists who will be joining the Spherix Advisory Board. The CBM platform focuses on the treatment of numerous cancers, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and pancreatic cancer.

Spherix recently acquired a 20% ownership interest in CBM. That 20% ownership stake puts Spherix in a position to benefit from any dividend distribution made by CBM from any potential sale of Spherix stock that CBM receives from the transaction.

Mr. Anthony Hayes, CEO of Spherix stated, “We are moving methodically and expeditiously to complete this transformative merger, wherein we will become a diversified biopharmaceutical company with a compelling portfolio of potential compounds to develop and commercialize. The deal is structured in a way as to minimize the cash outlay and create a structure that we hope will allow Spherix to be paid back a portion of its CBM investment. As a 20% owner of CBM, Spherix will be in a position to receive 20% of all dividends that CBM may make if CBM sells any portion of its Spherix stock. These dividends can be used to further advance the newly purchased CBM technology, without any additional dilution to shareholders.”

About Spherix Incorporated

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company. Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development. Recently, the Company has consummated strategic investments with Hoth Therapeutics, Inc. and DatChat, Inc. and recently agreed to acquire substantially all of the assets of CBM BioPharma, Inc.

About CBM BioPharma, Inc.

CBM BioPharma, Inc. (www.cbmbiopharmainc.com) is a privately held pharmaceutical company with exclusive drug development rights from world renowned partners like Wake Forest University and University of Texas. The Company has a team of leading drug development scientists who help advance their technology. The CBM platform focuses on the treatment of numerous cancers, including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) and pancreatic cancer.

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction or that the approval of the stockholders of Spherix are not obtained; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC, in the preliminary proxy statement and, when available, the definitive proxy statement filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward-looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

Additional Information

In connection with the proposed transaction between Spherix Incorporated (“Spherix” or the “Company”) and CBM BioPharma, Inc., a Delaware corporation (“CBM”) (the “Proposed Transaction”), has filed a preliminary proxy statement of Spherix with the Securities and Exchange Commission (the “SEC”). When available, Spherix will mail a definitive proxy statement and other relevant documents to its stockholders. Investors and security holders of Spherix are advised to read, when available, the preliminary proxy statement, and amendments thereto, and the definitive proxy statement in connection with Spherix’s solicitation of proxies for its special meeting of stockholders to be held to approve the Proposed Transaction because the proxy statement will contain important information about the Proposed Transaction and the parties to the Proposed Transaction. The definitive proxy statement will be mailed to stockholders of Spherix as of a record date to be established for voting on the Proposed Transaction. Shareholders will also be able to obtain copies of the proxy statement, without charge, once available, at the SEC’s website at www.sec.gov or by directing a request to: Spherix Incorporated, One Rockefeller Plaza, 11th Floor, New York, NY 10020.

Participants in the Solicitation

Spherix and CBM and their respective directors, executive officers, other members of management, and employees, under SEC rules, may be deemed to be participants in the solicitation of proxies of Spherix’s stockholders in connection with the Proposed Transaction. Investors and security holders may obtain more detailed information regarding the names and interests in the Proposed Transaction of Spherix’s directors and officers in Spherix’s filings with the SEC, including Spherix’s Annual Report on Form 10-K for the year-ended December 31, 2018, which was filed with the SEC on March 14, 2019, Spherix’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, which was filed with the SEC on May 15, 2019, and in the preliminary proxy statement for the Proposed Transaction filed with the SEC on June 18, 2019.

Disclaimer

This release shall neither constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Contact:

Investor Relations:

Hayden IR

Brett Maas, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com  

www.haydenir.com

Spherix:

Phone: 212-745-1373

Email: investorrelations@spherix.com

www.spherix.com

 

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SOURCE Spherix Incorporated

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How one dose of psilocybin healed decades of depression

‘They broke my mental shackles’: could magic mushrooms be the answer to depression?

A 56-year-old web developer named Michael was at one of the lowest points in his life after losing his mom to cancer and his friend to suicide. He had battled depression for over 30 years and was still in search of relief after trying several antidepressants and therapies.

He decided to participate in a psilocybin medical trial at Imperial College London, where he went on a five-hour psychedelic journey that turned his life around. The psilocybin-assisted therapy allowed him to relive childhood memories and confront his griefs.

“I became a different person,” Michael said. “I couldn’t wait to get dressed, get into the outside world, see people. I was supremely confident – more like I was when I was younger, before the depression started and got to its worst.”

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AbbVie’s MAVIRETTM now listed on the Nova Scotia and Manitoba formularies

  • MAVIRET is the first and only 8-week, pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to *1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease (CKD).

 

MONTREAL (Quebec), June 10, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed on the Nova Scotia Formulary and on the Manitoba Drug Benefits and Interchangeability Formulary, both effective since May 31, 2019. MAVIRET is a once-daily ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major HCV genotypes (GT1-6).2 It is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“In Nova Scotia, it is possible to reach the World Health Organization’s target of eliminating viral hepatitis as a major public threat by 2030. But in order to be successful, we need to implement strategies that include prevention, screening, timely and rapid testing, effective treatment and patient centred care for everyone living with hepatitis C,” says Dr. Lisa Barrett, MD, PhD, FRCPC, Assistant professor, Division of Infectious Diseases , Department of Medicine , Department of Microbiology & Immunology, Dalhousie University. “Today, with treatments including MAVIRET, we should be able to treat almost all people living with hepatitis C infection regardless of their background. This is very important for each individual person but also for elimination because treatment helps prevent the spread of HCV.”

 

MAVIRET is listed on the                                          for treatment-naive or treatment-experienced adult

patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.3

 

“At the Hepatitis Outreach Society of Nova Scotia (HepNS), we’ve worked over the last decade to

promote healthy living through information and support for people living with hepatitis C. But more

importantly, we’ve been committed to reducing the transmission rates. We are hopeful that with newer medications like MAVIRET being available in Nova Scotia and New Brunswick, our members will be able to seek the appropriate treatment and finally shed the stigma associated with this disease,” explains Alex MacDonnell, Acting Executive Director of HepNS.

 

MAVIRET is listed on the                                                                                                                                for treatment-naive

or treatment-experienced adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.4

 

“Hepatitis C is a serious health concern. When left untreated it leads to complications including liver cancer,” explains Dr. Kelly Kaita, Hepatologist, Director, Viral Hepatitis Investigative Unit at the

University of Manitoba. “Today, we have the knowledge and the expertise to test, diagnose and treat Canadians living with this deadly disease. Moreover, we have the right treatments, such as MAVIRET,

 

that can cure the disease in as little as eight weeks. Now is the time to act, especially as we are working

towards eradicating this virus by 2030.”

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

About Hepatitis C

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.5 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.6 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

About MAVIRET

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults across all major genotypes (GT1-6).7 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is taken once daily as three oral tablets.7

 

MAVIRET is an 8-week, pan-genotypic treatment that makes a virologic cure** possible in patients without cirrhosis who are new to treatment.*,1 These patients represent the majority of people infected with HCV. MAVIRET is also approved in patients with specific treatment challenges, including those with compensated cirrhosis, who are carriers of one of the major genotypes, and those who previously had limited treatment options, such as patients with severe CKD, post-liver and post-renal transplant recipients*** and those patients with genotype 3 HCV infection.7 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.7

 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and

Enanta Pharmaceuticals (NASDAQ: ENTA) to develop HCV protease inhibitors and therapeutic regimens that include protease inhibitors.

 

* Patients without cirrhosis and new to treatment with direct-acting antivirals (DDAs), (i.e., either treatment-naive or did not respond to previous interferon-based treatments (pegylated interferon [peg IFN] +/- ribavirin or sofosbuvir–ribavirin +/-peg IFN).

** Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4, -5 or -6 PRS (IFN or peg IFN, ribavirin and/or sofosbuvir)-treatment experienced. A 16-week treatment duration should be considered in transplant patients who are HCV GT-1 NS5A inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS- treatment experienced.

 

About AbbVie Care

Canadians prescribed MAVIRET will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout the treatment.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

Media:

Muriel Haraoui AbbVie Canada 514-717-3764

muriel.haraoui@abbvie.com

 

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final. www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed June 2019. 3 Nova Scotia Pharmacare. Nova Scotia Formulary.

https://novascotia.ca/dhw/pharmacare/pharmacists_bulletins/Pharmacists_Bulletin_May_19-04.pdf. Accessed June 2019. 4 Manitoba Pharmacare Program. Manitoba Drug Benefits and Interchangeability Formulary. www.gov.mb.ca/health/mdbif/bulletin104.pdf. Accessed June 2019.

5 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed June 2019.

6 The Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed June 2019.

7 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: November 28, 2018. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf . Accessed June 2019.

Posted on

Wuhan Closes Acquisition of Biodelta Nutraceuticals Assets

Wuhan General Group (China), Inc. (OTC PINK: WUHN) (the “Company” and “Wuhan”), is pleased to announce the closing of our previously announced Letter of Intent to acquire 49% of Biodelta Nutraceuticals, Ltd. assets which includes the land, the buildings, and the infrastructure as well as the specialized greenhouse and drying ovens. These assets will be part of our new operational facility located near Cape Town, South Africa (“Acquisition”). Total consideration for the Acquisition is US$1.567 million paid in cash.

This transaction enables Wuhan to produce 36,000 kg of marijuana in phase one (300k sq. ft), and 175,000 kg (1.3M sq. ft) in phase 2. In addition, the facility will permit Wuhan to produce a very high-end organic CBD, eliminating market shortage risk and guaranteeing supply.

About Biodelta Nutraceuticals

Biodelta Nutraceuticals (ISO 22000 and organic certified) is a Cape Town-based manufacturer and merchandiser of premium health products to all pharmacy & health shop chains across South Africa. For the past 12 years, Biodelta has developed, designed and produced more than 1,000 products for these customers and is now strategically positioned to launch CBD products through these channels. In addition, Biodelta has license applications in process for growing, extracting and product development as well as dossiers for various CBD based products.

For further information contact:

Website: https://biodelta.net

Public Relations E-mail: info@biodelta.net

About Wuhan General Group (China), Inc.

Wuhan General Group (China), Inc. through its wholly-owned subsidiary MJ MedTech is a nutraceutical biotechnology company that researches, develops and commercializes a range of CBD-based products under the Dr. AnnaRx brand. In addition, its new division, M2BIO aims to explore and develop additional indications for psilocybin new therapies that will help patients who suffer from mental illness. Our mission is to advance botanical-based medicine to the forefront by deploying best practice science and medicine, clinical research and emerging technologies.

For further information contact:

Publicly traded company (OTC Pink: WUHN)

Website: www.wuhn.org

Public Relations E-mail: info@wuhn.org

Forward-Looking Statements:

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

 

 

Contacts

Wuhan General Group (China), Inc.
Ramy Kamaneh
514 781 7368
info@wuhn.org

Posted on

AbbVie Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia

  • pERC conditionally recommends reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.i
  • Adult patients with CLL taking VENCLEXTA in combination with rituximab

 

 

Montreal, QC, June 6, 2019 –AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) conditionally recommends reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, irrespective of their 17p deletion status, only if the following condition is met: cost-effectiveness being improved to an acceptable level.i VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients can able to stop their therapy after two years of treatment.

“The pCODR recommendation for VENCLEXTA plus rituximab is positive news for Canadians living with

CLL,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are highly effective treatments available provides reassurance to people facing this uncertain journey.”

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodii, is one of the most

common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iii The goal of treatment is to delay progression of the disease and improve quality of life.

 

“This is another tremendous milestone in our efforts to bring VENCLEXTA plus rituximab to Canadians living with CLL. This is a much needed treatment option as it is the first chemotherapy-free combination in CLL that allows patients a 24-month treatment duration,” says Stéphane Lassignardie, General Manager of Abbvie Canada.

 

 

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

-30-

Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

 

ii Lymphoma Canada. Chronic lymphocytic leukemia. Available at www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed June 2019.

iii Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed June 2019.

iv VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed June 2019.

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Vireo Health to Present at Upcoming Conference Events

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