Spherix Announces the Addition of Dr. Rana Quraishi to Company’s Advisory Board

NEW YORKOct. 29, 2018 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that it has added Dr. Rana Quraishi to the Company’s Advisory Board to assist the Company in evaluating potential opportunities in the biopharmaceutical area.

Spherix Logo. (PRNewsFoto/Spherix Incorporated)

Dr. Rana Quraishi is the Director of New Ventures, at UM Ventures University of Maryland, Baltimore.  UM Ventures is a joint initiative bringing the University of Maryland, Baltimore and University of Maryland, College Park together to commercialize discoveries and create economic impact by engaging partners in industry and social ventures.  Dr. Quraishi has a Ph.D. in Molecular Biology and Biochemistry from Columbia University where she was also an undergraduate and an M.S. from Harvard University.

Dr. Quraishi has spent much of her career working in life science directed finance, investment and consulting organizations.

At the TCG Group, a premiere private equity firm, she focused on business development opportunities for its life science companies. Prior to this, she was a Principal at Conning Capital Partners/SwissRe an early stage private equity fund providing growth capital for entrepreneurial companies where she served on Boards of several portfolio companies.

Dr. Quraishi also served as CFO/Senior Advisor for Helicon Therapeutics, a start-up with assets contributed by Cold Spring Harbor and OSI Pharmaceuticals. She developed the company’s business plan and made investor presentations leading to initial funding. Helicon was subsequently acquired.

Earlier in her career Dr. Quraishi worked for Standard and Poor’s, GE Capital where she was Commercial Quality Leader for GE Capital and prior to that headed the Business Development Group at its FGIC subsidiary, J.E. Seagram and American Express where she led treasury and acquisitions and divestitures groups.

She has served on several for-profit and not for-profit boards and has also authored the widely read “Market Demand Study for Commercial Biotechnology, Biomedical, and Bioinformatics Facilities in New York City” for the New York City Partnership and Investment Fund.

Dr. Quraishi stated, “I’m committed to moving pioneering technologies toward commercialization and delighted to join the Spherix Advisory Board to advance that effort.”

Anthony Hayes, the Chief Executive Officer of Spherix stated, “We continue to make strategic investments in both biotechnology and human capital. Dr. Quraishi is another checkmark to assist us in our transformation into a biotech company. We are confident her experience and industry knowledge will assist Spherix through these exciting times. All of the pieces are coming together with the recently announced proposed merger with CBM and its ground breaking drug research.

About Spherix Incorporated

Spherix Incorporated was launched in 1967 as a scientific research company. Spherix is committed to advancing innovation by participation in the development of new technology. Spherix draws on portfolios of pioneering technology to support product innovation.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. We are a small company with limited financial resources and our scientific background and abilities to implement a commercialization strategy is subject to ever-changing market conditions and rapidly-advancing technologies over which we have no control. While we believe that these forward-looking statements are reasonable, market conditions and competition in the marketplace is ever-changing and we have no control over these influences. As a result, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”) including, but not limited to, the Risk Factors relating to the Company’s patent business and other aspects of the Company’s business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

 

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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Spherix Provides Video Demonstration of CBM Drug Reversing Paralysis in Preclinical Study

NEW YORKOct. 17, 2018 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today provided shareholders with a video demonstration on its website of the potential effectiveness of CBM BioPharma, Inc.’s (“CBM) innovative drug platform.   As previously disclosed on October 11, 2018, Spherix entered into a merger agreement with CBM, a privately held innovative pharmaceutical company focused on the development of drugs in the multibillion-dollar oncology therapeutics market.  The notable video, which was recorded at Wake Forest University, visually demonstrates the potential effectiveness of one of CBM’s primary drug candidates known as KPC34.  Researchers at Wake Forest have been testing whether KPC34 can be used on mouse subjects to treat Acute Lymphoblastic Leukemia (ALL) that has spread to the nervous system.  Once recurrent ALL spreads to the nervous system, patients often experience paralysis.

In the video, a mouse which suffers from hind leg paralysis as a result of recurrent late staged ALL is shown to improve dramatically from the paralysis within forty-eight hours of being treated with KPC34.  Within just twenty-four hours of the first injection of KPC34, the mouse could walk. Forty-eight hours later a second injection was administered and the mouse was able to move about without challenges.

Anthony Hayes, CEO of Spherix, stated, “This remarkable video demonstrates the tremendous potential for this drug to treat ALL.  The video was part of a written submission on KPC34 to PLOS OneTM a peer reviewed medical journal. We are collecting additional information to continually provide our shareholders with updates to help better educate them on these compounds and the biotechnology space generally. We anticipate further updates in the future.”

About Spherix

Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Spherix has acquired over 100 patents from Rockstar Consortium Inc., and several hundred patents issued to Harris Corporation, covering a variety of methods and components involved in switching, routing, networking, optical and telecommunication sectors.

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 at Austin.  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 in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

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

Spherix Logo. (PRNewsFoto/Spherix Incorporated)

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SOURCE Spherix Incorporated

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Health Canada Approves Label Update for AbbVie’s HUMIRA® (adalimumab) Supporting Potential For Use During Breastfeeding and Use During Pregnancy if Clearly Needed

  • Updated label provides guidance that HUMIRA use can be considered while breastfeeding and should only be used during pregnancy if clearly needed1
  • Approval is supported by postmarketing data, a prospective cohort registry analysis designed to monitor and evaluate the exposure to medication during pregnancy, as well as literature regarding lactation1

 

MONTREAL, QC, October 15, 2018 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved a label update for HUMIRA® (adalimumab) to include clinical and postmarketing safety data surrounding pregnancy and breastfeeding. This label update includes guidance that HUMIRA use can be considered while breastfeeding and should only be used during pregnancy if clearly needed.1

 

“While Abbvie continues to exercise appropriate due caution regarding the safety of its products, the recent label change for HUMIRA is reassuring for women living with inflammatory bowel disease (IBD), particularly because IBD most commonly affects individuals in their peak reproductive years,” said Dr. Cynthia Seow, Associate Professor, Division of Gastroenterology and Hepatology, University of Calgary. “While HUMIRA should be used during pregnancy only if clearly needed, this label update cites data demonstrating a lack of pattern of major birth defects with the use of HUMIRA during pregnancy, and a statement on the relative safety of HUMIRA use whilst breastfeeding.”

 

“This label update provides important, clinically meaningful information allowing women and their healthcare professionals to better understand the safety of HUMIRA during pregnancy and

breastfeeding, and to make an informed treatment decision,” said Christina Pelizon, Medical Director, AbbVie Canada. “Understanding how immune-mediated diseases impact patients at all stages of life drives the way we conduct research and generate evidence to advance the field of immunology.”

 

The Health Canada label update is based on final data from a prospective cohort pregnancy exposure registry conducted by OTIS (Organization of Teratology Information Specialists) / MotherToBaby, the leading group of maternal health experts in evaluation of drugs during pregnancy in North America, as well as literature review regarding lactation.

 

 

 

 

 

 

 

 

The registry, conducted in the U.S. and Canada between 2004 and 2016, compared the risk of major birth defects in live-born infants in 69 women with rheumatoid arthritis (RA) and 152 women with Crohn’s disease (CD) treated with adalimumab at least during the first trimester with 74 women with RA and 32 women with CD not treated with adalimumab during pregnancy. The proportion of major birth defects among live-born infants in the adalimumab-treated and untreated cohorts was 10% (8.7% RA, 10.5% CD) and 7.5% (6.8% RA, 9.4% CD), respectively.

 

The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects. This study cannot reliably establish whether there is an association between adalimumab and the risk for major birth defects because of methodological limitations of the registry, including small sample size, the voluntary nature of the study, and the non- randomized design.

 

Adalimumab may cross the placenta into the serum of infants born to women treated with HUMIRA during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for five months following the mother’s last HUMIRA injection during pregnancy.

 

Limited information from case reports in the published literature indicates the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. Published data suggest that the systemic exposure of adalimumab to a breastfed infant is expected to be low because adalimumab is a large molecule and is degraded in the gastrointestinal tract. However, the effects of local exposure in the gastrointestinal tract are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for adalimumab and any potential adverse effects on the breastfed child from adalimumab or from the underlying maternal condition.

 

 

About HUMIRA

 

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

 

HUMIRA is one of the most comprehensively studied biologics available. The overall clinical database for HUMIRA spans 20 years across 14 indications globally (10 in Canada), including more than 100 clinical trials with more than 33,000 patients. HUMIRA is approved in 90 countries and used by more than 1 million patients worldwide.

 

 

 

 

 

 

 

 

Any medicines can have side effects. Like all medicines that affect the immune system, HUMIRA can cause serious side effects.1 Before initiation of, during and after treatment with HUMIRA, patients should be evaluated for active or inactive tuberculosis infection with a tuberculin skin test. For further information, please see the HUMIRA Product Monograph1available at www.abbvie.ca.

 

About AbbVie Care

The AbbVie Care 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 journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research-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 abbvie.ca and abbvie.com. Follow @abbviecanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

Important Safety Information

HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy. People at risk of TB may be treated with medicine for TB before starting HUMIRA. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

 

For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life- threatening if treated.

 

 

 

 

 

 

 

 

Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with other biologics DMARDS (e.g. anakinra or abatacept) or other TNF antagonists is not recommended. People using HUMIRA should not receive live vaccines.

 

Common side effects of HUMIRA include injection site reactions (redness, swelling, itching, pain or bruising), cough and cold symptoms, headache, rash, nausea, pneumonia, fever and abdominal pain.

 

HUMIRA is given by injection under the skin.

 

The benefits and risks of HUMIRA should be carefully considered before starting therapy.

 

This is not a complete list of the Important Safety Information for HUMIRA. For additional important safety information, please consult the HUMIRA Product Monograph at www.abbvie.ca

 

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Media:

Julie Lepsetz AbbVie Canada (514) 832-7268

julie.lepsetz@abbvie.com

 

 

 

References:

1 HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. Last updated August 28, 2018.

Spherix to Merge with CBM BioPharma Pharmaceutical Company

Transformative Merger Creates Innovative Biopharma Platform Poised for Growth

NEW YORKOct. 11, 2018 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) today announced that it has entered into a merger agreement with CBM BioPharma, Inc. (“CBM”) that will transform Spherix into an innovative pharmaceutical company with pioneering drugs and treatments focused on the multibillion dollar oncology therapeutics market.

Spherix Logo. (PRNewsFoto/Spherix Incorporated)

CBM is a privately held pharmaceutical company with exclusive drug development rights from world-renowned partners including Wake Forest Innovations and the University of Texas at Austin. CBM has a team of leading drug development scientists who will be joining Spherix as advisors to advance the technology. The CBM platform focuses on the treatment of numerous cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and pancreatic cancer.

Two specific proprietary drugs that are currently being researched are:

KPC34 (Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Developed at Wake Forest School of Medicine, AML and ALL drug, KPC34, is a next generation treatment designed to overcome multiple resistance challenges observed with the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug.

One competitive benefit of KPC34 includes its ability to be orally administered. This is critical for patients that are unable to tolerate repeated cycles of chemotherapy. In addition, it has served to double the mean survival time of patients versus the current standard of care treatments.

DHA-dFdC (Pancreatic Cancer Drug)

Developed at the University of Texas at Austin, DHA-dFdC has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models. DHA-dFdC also overcomes tumor cell resistance to current chemotherapeutic drugs.  Pancreatic cancer is a deadly disease that affects millions of people around the world.

The following doctors will be supporting the efforts of Spherix, after the completion of the merger:

Dr. Timothy S. Pardee, MD, PhD, an Associate Professor of Internal Medicine, Section on Hematology and Oncology and Cancer Biology and Director of Leukemia Translational Research at Wake Forest School of Medicine.  Dr. Pardee stated, “I am very excited at the possibility of bringing KPC34 to the clinic in early phase clinical trials. As a physician scientist who treats acute leukemia patients, I know firsthand the clear unmet medical need for relapsed patients.”

Dr. Gregory Kucera, a Professor of Internal Medicine at the Wake Forest University School of Medicine with over 28 years of research experience on novel therapeutics for cancer treatment. His laboratory has expertise in synthesizing therapeutics, lipid biochemistry, and in vitro drug testing.  Dr. Kucera stated, “As a research scientist, the satisfaction of seeing a compound like KPC34 go from the laboratory to an early stage clinical trial is immense.  I have a great sense of pride in knowing that the work done by our research team has produced a drug that may benefit cancer patients in the very near future.”

Joining Spherix as Chief Science Officer to oversee clinical advancement of these drugs is Dr. Tom Wilkie who is an Associate Professor of Pharmacology at the University of Texas Southwestern Medical Center in Dallas. He earned both his BA at the University of California Berkeley and his PhD with Richard Palmiter at UW Seattle, in biochemistry. Wilkie has published 74 primary research papers and reviews, serves on NIH, CIRM, and AACR grant review study sections. He reviews manuscripts for multiple journals, and is Director of the first-year graduate student core course at UT Southwestern.

Dr. Wilkie stated, “I’m delighted to join Spherix as Chief Science Officer.  The agreement between Spherix Incorporated and CBM BioPharma will advance the exciting potential for improving the lives of patients, family, friends, and ultimately, all of us.  Proposals for the next phase of testing are underway.”

Dr. Robert J. Vander Zanden, Spherix’s Chairman of the Board, stated, “Spherix is extremely pleased to announce this merger with CBM, as we believe it serves as a necessary step in our transition to a diversified biopharmaceutical company.  This deal builds upon our investment in Hoth Therapeutics, which owns several exciting assets in various stages of development.”

Anthony Hayes, CEO of Spherix stated, “We are very excited to welcome CBM BioPharma and its team to Spherix.  It is an exciting and transformational time for the Company. Spherix will pay $16.5 million in stock for 100% of CBM by issuing 15 million Spherix shares to CBM at a fixed price of $1.10 per share.  I look forward to sharing more information with our shareholders about the merger in the upcoming weeks, via investor outreach and our upcoming SEC filings.”

About Spherix

Spherix is committed to advancing innovation by active participation in all areas of the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation. Spherix has acquired over 100 patents from Rockstar Consortium Inc., and several hundred patents issued to Harris Corporation, covering a variety of methods and components involved in switching, routing, networking, optical and telecommunication sectors.

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 in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

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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AbbVie Receives Health Canada Approval of ORILISSATM (elagolix) for the Treatment of Moderate to Severe Pain Associated with Endometriosis

  • Endometriosis affects up to one in 10 women of reproductive age in 1
  • 7 out of 10 women being managed for endometriosis have unresolved pain throughout the 2
  • The approval of ORILISSA is supported by data from two replicate Phase 3 studies, which evaluated nearly 1,700 women.
  • In clinical trials, ORILISSA™demonstrated sustained relief over 12 months across the two most common types of pain: dysmenorrhea and non-menstrual pelvic 3

 

 

Montreal, QC, October 5, 2018 –AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that Health Canada approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of moderate to severe pain associated with endometriosis.3

 

ORILISSA (elagolix) is a novel, orally administered, highly potent, short-acting, selective, non-peptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulation hormone (FSH) levels, leading to decreased blood levels of the ovarian sex hormones, estradiol and progesterone. LH and FSH suppression begins within hours of administration and is readily reversible upon discontinuation of ORILISSA.3

 

“Endometriosis causes a significant impact on the quality of life of women because of the debilitating and incapacitating pain. Women living with endometriosis can be sidelined by this disease,” says Dr. Nicholas A. Leyland, BASc, MD, MHCM, FRCSC, Chair of the Department of Obstetrics and Gynaecology, McMaster University. “Since there is no cure, the goal of treatment is to alleviate the symptoms and improve a woman’s quality of life. With ORILISSA, we are now able to offer our patients an additional new option that can help them resume living their lives.”

 

Endometriosis causes chronic pelvic pain and is sometimes associated with infertility. It affects up to one in 10 women of reproductive age in Canada.1 Furthermore, 7 out of 10 women being managed for endometriosis have unresolved pain throughout the month. 2

 

“Endometriosis is a complex and incurable disease. This is why early diagnosis is extremely important. Currently, on average, it takes seven to nine years of complaining about symptoms to medical professionals to receive a diagnosis of endometriosis. Therefore, earlier diagnosis and treatment can help mitigate years of unnecessary suffering,” explains Philippa Bridge-Cook, Ph.D., The Endometriosis Network Canada. “In addition, patients coping with symptoms without a diagnosis can sometimes face dismissal of their symptoms from friends, family, and even medical professionals. This can lead to feelings of isolation, anxiety, and depression.”

 

 

The approval of ORILISSA is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated ORILISSA significantly reduced the two most common types of endometriosis pain: dysmenorrhea and non-menstrual pelvic pain. A higher proportion of women treated with ORILISSA 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and non-menstrual pelvic pain compared to placebo in a dose- dependent manner at month three. Women were defined as responders if they experienced a reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain. 3

 

Both ORILISSA treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain at month six. Women in the Phase 3 studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS) and women taking ORILISSA 150 mg once daily and 200 mg twice daily reported a statistically (p <0.001) significant reduction from baseline in NRS scores compared to placebo at month three. Clinical trial data also demonstrated women taking ORILISSA 200 mg twice daily showed statistically significant greater reduction in pain during sexual intercourse from baseline to month three compared to placebo. The most frequent (≥10%) adverse reactions reported in clinical trials with ORILISSA (elagolix) were hot flush, headache and nausea. 3

 

The recommended duration of use for ORILISSA is up to 12months for the 150 mg once daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment.3

 

“The approval of ORILISSA demonstrates AbbVie’s continued commitment to women living with endometriosis. We are proud of our heritage in women’s health and strive to fill the unmet medical need by providing a safe and efficacious treatment,” says Stéphane Lassignardie, General Manager of AbbVie Canada.

 

ORILISSA is expected to be available in Canadian retail pharmacies in early November 2018.

 

About AbbVie Care

Canadian women prescribed ORILISSA 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.

 

About Neurocrine Biosciences, Inc.

Neurocrine Biosciences, a San Diego based biopharmaceutical company, is focused on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA® (valbenazine), the first FDA approved product indicated for the treatment of adults with tardive dyskinesia, a movement disorder. Discovered and developed through Phase II clinical trials by Neurocrine, ORILISSA™ (elagolix), the first FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain in over a decade, is marketed by AbbVie as part of a collaboration to develop and commercialize elagolix for women’s health. Neurocrine’s clinical development programs include opicapone as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson’s disease patients, elagolix for uterine fibroids with AbbVie, valbenazine for the treatment of Tourette syndrome, and NBI-74788 for the treatment of congenital adrenal hyperplasia (CAH). For more information and the latest updates from Neurocrine, please visit www.neurocrine.com.

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

1YourPeriod.ca – https://www.yourperiod.ca/endometriosis/what-is-endometriosis/

2De Graaff AA, D’Hooghe TM, Dunselman GAJ, Dirksen CD, Hummelshoj L, WERF EndoCost Consortium, Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013;28(10):2677-2685.

3Orilissa Product Monograph, AbbVie Corporation, October 5, 2018.

Health Literacy Still an Issue in Canada

  • 60 per cent of Canadian adults and 88 per cent of seniors are not health literate
  • ABC Life Literacy launches nine new resources as part of its ABC Health Matters program
  • Low literacy is associated with poor health outcomes

 

(Toronto, ON – September 27, 2018) October is Health Literacy Month, a time to increase understanding of health information and for Canadians to take charge of their health. According to the Public Health Agency of Canada, 60 per cent of Canadian adults and 88 per cent of seniors are not health literate.

 

In recognition of Health Literacy Month, ABC Life Literacy Canada has developed nine new resources for patients and health care providers as part of the ABC Health Matters program. Good health literacy means being able to access, understand, evaluate, communicate and use information related to your health and the health of others to make appropriate health decisions.

 

The ABC Health Matters program was created to help Canadians to manage their health more effectively by increasing their confidence when talking about and making decisions regarding health issues. ABC Life Literacy developed a workbook-led workshop, delivered at community learning and health care centres across Ontario. Through the program, adults develop a deeper understanding of how to advocate for their own health as well as the health of their family and gain a better understanding of how to access health care.

 

“It would be hard to find something more personal to someone than their health,” said ABC Executive Director Mack Rogers. “It can be frustrating and sometimes frightening to feel as if you don’t have control over your own health which is why we created the ABC Health Matters program. The program empowers Canadians to manage their health more effectively and increases their confidence in discussing their health issues with health care providers.”

 

This year, additional resources were developed for the ABC Health Matters program to help Canadians take charge of their health during Health Literacy Month. New resources available at ABCHealthMatters.ca include:

 

  • Health Passport – pocket-sized guide for patients when speaking with health care providers
  • Medical History Card – a place to keep track of medical history to keep with you
  • Tips for Your Doctor Visit – sample questions for patients when speaking with their doctor
  • You and Your Pharmacist – details of support available from your local pharmacist
  • Your Rights as a Patient – your rights and responsibilities as a patient
  • Caring for Loved ones – tips for caregivers for how to support and advocate for someone under your care

 

Tools were also created for health care providers to support communication with patients with low literacy as well as posters for placement in waiting rooms and the pharmacy with questions and information for patients.

 

“AbbVie is proud to be a founding member of the ABC Health Matters program,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “We believe that every Canadian should be an advocate for their own health. When you understand the health care system, you are better equipped to navigate its intricacies and access the right services for yourself and your family. This will result in improved health outcomes for all.”

 

 

Health Literacy Month is a great opportunity for Canadians to commit to increasing their health literacy and the new ABC Health Matters resources will give them the tools to do just that. ABC Life Literacy will also launch an awareness campaign leading up to Health Literacy Month to heighten awareness and access to the free ABC Health Matters tools and resources.

 

ABC Health Matters was created with the support of AbbVie Corporation. Two workbooks that can be used for workshop delivery or for learning at home as well as the new resources are available for free download at ABCHealthMatters.ca.

 

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About ABC Life Literacy Canada

ABC Life Literacy Canada is a non-profit organization that inspires Canadians to increase their literacy and essential skills. We mobilize business, government and communities to support lifelong learning and achieve our goals through leadership in programs, communications and partnerships. We envision a Canada where everyone has the skills they need to live a fully engaged life. For the latest news and information on adult literacy please visit www.abclifeliteracy.ca, follow us on Twitter or join our Facebook page.

 

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.

 

 

For more information, please contact:

Ana Oliveira

Director of Marketing, Communications and Development ABC Life Literacy Canada

416-218-0010 ext. 121

aoliveira@abclifeliteracy.ca

 

Muriel Haraoui Communications Manager AbbVie Canada

514-717-3764

muriel.haraoui@abbvie.com

ABBVIE RECEIVES APPROVAL FROM HEALTH CANADA FOR THE COMBINATION OF VENCLEXTA® WITH RITUXIMAB AS A TREATMENT FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

  • In the MURANO Phase 3 clinical trial, the VENCLEXTA® (venetoclax) plus rituximab combination showed a significant improvement in progression-free survival (PFS, the time on treatment without disease progression or death) for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) patients,
  • The combination of VENCLEXTA plus rituximab reduced the risk of disease progression or death by 81 percent when compared to a standard of care chemoimmunotherapy regimen, bendamustine plus rituximab.i
  • Patients receiving VENCLEXTA plus rituximab achieved a high overall response rate (ORR) of 92 i
  • With this approval, VENCLEXTA plus rituximab is the first chemotherapy-free combination with a 24-month treatment duration for
  • Approximately 2,400 cases of chronic lymphocytic leukemia (CLL) are diagnosed every year in Canadii

 

Montreal, QC, September 25, 2018 –AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced Health Canada has issued a Notice of Compliance for 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

 

“Having another effective therapy for relapsed/refractory CLL is a great benefit to patients. It is also valuable to have this new therapy be of fixed duration because most patients prefer not to have to

remain on therapy indefinitely” explains Dr. Carolyn Owen, MD, MDres(UK), FRCPC, a Hematologist and associate professor at the University of Calgary. “With venetoclax plus rituximab, I can now offer my patients an effective treatment with a clear end-date, allowing patients to plan for the future and enjoy time off therapy.”

 

The approval is based on the MURANO Phase 3 clinical trial data which demonstrated a significant improvement in progression-free survival (PFS, the time on treatment without disease progression or death) for relapsed/refractory (R/R) CLL patients, reducing the risk of disease progression or death by 81 percent when compared to bendamustine in combination with rituximab, a standard of care chemoimmunotherapy regimen.i

 

“Lymphoma Canada is pleased with the approval of VENCLEXTA in combination with rituximab for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is imperative to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Elizabeth Lye, Scientific Advisor, Lymphoma Canada.

 

Clinical trial patients who received VENCLEXTA plus rituximab achieved an overall response rate (ORR) of 92 percent and those who received the bendamustine plus rituximab regimen achieved an ORR of

 

72 percent.i The most common adverse reactions (ARs), greater than or equal to 20 percent, with a 5 percent higher frequency reported with VENCLEXTA in combination with rituximab were neutropenia, diarrhea and upper respiratory tract infection.i

 

“When my CLL relapsed for the second time, I was fortunate to have access to VENCLEXTA in

combination with rituximab,” explains Mark Silverstein of Aurora, ON. “Today, I am able to enjoy an improved quality of life, and do what brings a great deal of meaning to my life: to help others navigate through their cancer journey with confidence and dignity by encouraging them to advocate for themselves within the health care system, reflect on the potential benefits in understanding their cancer and treatment landscape, to assist in managing the emotional and spiritual effects of a diagnosis, and finally to help them find what is meaningful in their own lives.”

 

In Canada, CLL accounts for approximately 2,400 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.ii The goal of treatment is to delay progression of the disease and improve quality of life.

 

“VENCLEXTA plus rituximab is the first chemotherapy-free combination in CLL that allows patients a 24- month treatment duration,” says Stéphane Lassignardie, General Manager of Abbvie Canada. “The approval of this regimen will bring a much needed treatment option to Canadians living with CLL.”

 

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.

 

About the MURANO Study

A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized (1:1) MURANO study (NCT02005471). The study was designed to evaluate the efficacy and safety of VENCLEXTA in combination with rituximab (194 patients) compared with bendamustine in combination with rituximab (195 patients). The median age of patients in the trial was 65 years (range 22-85).i

 

About AbbVie Care

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.

 

 

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

i VENCLEXTA product monograph, AbbVie Corporation, September 21, 2018

ii Canadian Cancer Statistics, 2015 http://www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic- lymphocytic-cll/statistics/?region=on

Wuhan General Group confirms the cancelation of 60% of its outstanding common shares

MONTREAL, Sept. 14, 2018 (GLOBE NEWSWIRE) — via OTC PR WIRE — Wuhan General Group (China), Inc. (OTC PINK: WUHN) (the “Company”), a Nevada investment company focused on the industrial technology and other emerging market space, is pleased to announce its completion of the first stage in the reorganization of the Company’s share structure. This restructuring, consistent with the Company’s strategic growth plans, will serve to increase shareholder value and enhance the Company’s growth potential.

The company has reduced its outstanding common shares from 100 million to approx. 39.7 million. All canceled shares have been returned to the company treasury to be used in future acquisitions as well as to raise funds by means of private placements for present and future projects. This action will allow the Company to increase its cash flow without increasing the authorized number of shares.

“We are excited about achieving this milestone on our roadmap planned for 2018 and next year,” said CEO, Ramy Kamaneh. “As we continue evaluating our Company operations, we will continue building a strong foundation to create a successful company that benefits all shareholders. We are excited about achieving this goal and are in the process of doing so with what is to come.”

About Wuhan General Group (China) Inc

Wuhan General Group (China), Inc., based in Nevada, is an investment company focused in the areas of Cryptocurrency mining operations and infrastructure. In addition to its strong commitment in facilitating the development and adoption of cryptocurrency mining operations, Wuhan continues to pursue distinct investment decisions based on emerging markets that reflect the highest business, technical, and legal standards.

Wuhan General Group (China), Inc.
Publicly traded company (OTC Pink:WUHN)
Website: www.wuhn.org

For further information contact:
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.

Source: Wuhan General Group (China), Inc

US Defense Department Facility to be Transformed into Cryptocurrency Mining Farm

MONTREAL, Sept. 11, 2018 (GLOBE NEWSWIRE) — via OTC PR WIRE — Wuhan General Group (China), Inc. (OTC PINK: WUHN) (the “Company”), a Nevada investment company focused in cryptocurrency mining operations announced today that it’s currently negotiating a redesign of a US Defense Department data center to transform it into a Cryptocurrency mining facility. The facility will meet security and power requirements when mining cryptocurrency. It will also provide the Company with an opportunity to set new standards in cryptocurrency mining safety, stability, and security measures.

This new facility will launch at an optimal time in the market to strengthen the Company’s cryptocurrency mining division for highly scalable and flexible mining operations across all major cryptocurrencies. The Company benefits from low-cost North American power, a cool climate, and high-speed Internet, which is critical to mining success, placing it in a competitive position to maximize profitability. Ultimately, the project comes at a time that will serve in the Company’s and shareholders’ best interests.

The 55,0000 sq. ft facility has over 3MW of power ready to accommodate up to 1300 mining machines for Bitcoin, Zcash, and others with an additional 12,000 to be deployed upon successful completion of its upgrade to a 30MW facility in 2019. Once the negotiation is finalized, the first order of rigs from Asicminer is expected to arrive in late October and more in the coming months. The Company estimates this operation to bring monthly revenue in excess of $3.5M based on current cryptocurrency market prices for the initial 1300 mining machines in operation. More information will be shared regarding the progress of the project when available.

Ramy Kamaneh, CEO said: “We had planned to build this operation three months ago, but with the bearish cryptocurrency market, we took a step back to reassess our strategy. The decision to wait for market stability was a good one, especially considering many cryptocurrency machines are no longer profitable in the current market. We acted in the best interests of the Company and its shareholders and firmly believe that the market has bottomed and a bullish market is starting again.”

In addition to providing optimal cryptocurrency mining performance, the facility will adhere to strict safety and security standards. As a leader in streamlined solutions that respond to the impacts of the tech industry, the Company believes that this project will increase in value and also create opportunities for innovation within the sector.

About Wuhan General Group (china) Inc

Wuhan General Group (China), Inc., based in Nevada is an investment company focused in the areas of Cryptocurrency mining operations and infrastructure. In addition to its strong commitment in facilitating the development and adoption of cryptocurrency mining operations, Wuhan continues to pursue distinct investment decisions based on emerging markets that reflect the highest business, technical, and legal standards.

Wuhan General Group (China), Inc.
Publicly traded company (OTC Pink:WUHN)
Website www.wuhn.org

For further information contact:
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.

Source: Wuhan General Group (China), Inc