BOSTON and Aliso Viejo, Calif., July 16, 2019 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. AKCA, an affiliate of Ionis Pharmaceuticals, Inc., and Ambry Genetics Corporation ("Ambry"), a Konica Minolta company, announced an expansion of their collaboration as the two companies mark the one-year anniversary of the hATTR Compass™ program. hATTR Compass is a no-cost, confidential genetic testing and genetic counseling program for people with suspected hereditary (hATTR) amyloidosis that enables faster diagnosis and earlier treatment of this rare, progressive and fatal disease.
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To date, over 700 physicians across the United States, Canada and Puerto Rico have utilized hATTR Compass to help hundreds of people learn if they carry any of the TTR gene mutations associated with hATTR amyloidosis. hATTR Compass screens for up to 81 genes that cause hereditary polyneuropathies and up to 92 genes associated with hereditary cardiomyopathies, including hATTR amyloidosis. The hATTR Compass program helps accelerate or confirm the diagnosis of hATTR amyloidosis while providing support and resources to people and healthcare professionals throughout the genetic testing process.
hATTR amyloidosis is an autosomal dominant genetic disease, which means every first-degree relative of an affected patient has a 50 percent chance of having the same gene mutation. Because of this, those living with hATTR amyloidosis often suffer the dual burden of watching older loved ones suffer with the disease, while also fearing what the future could hold for their children or grandchildren.
"We now know that if you have hATTR, the sooner you can start treatment, the better, underscoring the importance of early diagnosis through genetic testing. With hATTR Compass and the help of our family's physician, we were able to test 27 family members for the genetic variants that cause hATTR amyloidosis in one day," said Angel Male, an hATTR Compass participant and family caregiver. "Each person's individual results – positive or negative – have helped us proactively take control of our futures. We know who is at risk, what symptoms to look for and are empowered to begin seeking treatment that will slow the disease down and allow us to maintain our independence for as long as possible."
As hATTR amyloidosis progresses, patients may experience symptoms that initially present as tingling, numbness or pain of neuropathy. These symptoms can progress to include carpal tunnel syndrome caused by amyloid depositions, chronic nausea and gastrointestinal distress. Due to the historic absence of treatment options, and the disparate nature of these symptoms, hATTR amyloidosis is often not suspected or diagnosed, leading to multiple specialist visits, years of searching for answers and, often times, inappropriate treatment for a misdiagnosed condition.
"hATTR amyloidosis is a zebra with many different stripes," said Andrew Darlington, DO, Piedmont Healthcare. "Up until recently, patients – especially those located in local communities further away from specialized amyloidosis treatment centers - have been slipping through our fingers. hATTR Compass gives local neurologists and cardiologists a tool to correctly diagnose patients early in the disease course and begin treatment as soon as possible close to home, eliminating delays associated with travel to and from treatment centers, logistics and appointment availability."
Akcea and Ambry recently expanded their hATTR Compass partnership which includes increasing their salesforce and marketing efforts to drive additional awareness and education for patients and physicians.
"hATTR Compass has helped enable early diagnosis and treatment for people who are suffering from this rapidly progressive disease and it allows them to get answers about their disease from their own local physician," said Sarah Boyce, President at Akcea Therapeutics. " As a result of hATTR Compass, as well as a new treatment that can be administered by the patient or caregiver, Akcea is helping patients receive the answers they seek, obtain the life-changing treatment they need and maintain the independence they cherish in the comfort of their own communities."
"hATTR amyloidosis is a complex disease that requires the kind of sophisticated tool offered by Ambry Genetics for proper diagnosis. We are pleased to expand our partnership with Akcea to further our commitment to supporting physicians, patients and their families through offering access to our high-quality and comprehensive genetic testing that can identify at-risk patients," said Tom Schoenherr, Chief Commercial Officer of Ambry Genetics.
ABOUT hATTR COMPASS™
hATTR Compass is a no-cost, confidential genetic testing and genetic counseling program for people with suspected hereditary (hATTR) amyloidosis. hATTR Compass screens for up to 81 genes that cause hereditary polyneuropathies and up to 92 genes associated with hereditary cardiomyopathies, including hATTR amyloidosis. The hATTR Compass program helps accelerate or confirm the diagnosis of hATTR amyloidosis while providing support and resources to people and healthcare professionals throughout the genetic testing process.
To be eligible for hATTR Compass, people must be in the U.S., Canada and Puerto Rico, 18 years or older, and are either experiencing red flag symptoms of hATTR amyloidosis or are aware of a family history of hATTR amyloidosis, including polyneuropathies and cardiomyopathies.
Confidential genetic counseling is part of the hATTR Compass program, which enables confidential access to diagnostic testing, treatment and professional guidance. Genetic testing results will only be provided to people and their healthcare providers to ensure the protection of confidential patient information.
Akcea has also partnered with Backpack Health to provide an additional resource for people and their families. As part of hATTR Compass, Backpack Health, a mobile and web-based app that helps people keep track of their symptoms, procedures, diagnostic tests and ongoing treatment for hATTR amyloidosis, will be available at no-cost for hATTR Compass participants and their families. The tool also makes it easy for individuals and families navigating the hATTR amyloidosis journey to share important medical information with healthcare professionals.
To learn more about hATTR Compass and the testing process, please visit www.hattrcompass.com.
ABOUT HEREDITARY TRANSTHYRETIN (hATTR) AMYLOIDOSIS
Hereditary ATTR amyloidosis is a severe, progressive, and life-threatening disease caused by the abnormal formation of the TTR protein and aggregation of TTR amyloid deposits in various tissues and organs throughout the body, including in peripheral nerves, the heart and intestinal tract. The progressive accumulation of TTR amyloid deposits in these organs often leads to intractable peripheral sensorimotor neuropathy, autonomic neuropathy, and/or cardiomyopathy, as well as other disease manifestations. Hereditary ATTR amyloidosis causes significant morbidity and progressive decline in quality of life, severely impacting activities of daily living. The disease often progresses rapidly and can lead to premature death. The median survival is 4.7 years following diagnosis. Additional information on hereditary ATTR amyloidosis, including a full list of organizations supporting the hATTR amyloidosis community worldwide, is available at www.hattrchangethecourse.com or by visiting www.hATTRGuide.com.
ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc. IONS, is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious and rare diseases. Akcea is commercializing TEGSEDI® (inotersen) and advancing a mature pipeline of novel drugs, including WAYLIVRA® (volanesorsen), AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, with the potential to treat multiple diseases. All six drugs were discovered by and are being co-developed with Ionis, a leader in antisense therapeutics, and are based on Ionis' proprietary antisense technology. TEGSEDI is approved in the U.S., E.U. and Canada. WAYLIVRA is approved in the E.U. and is currently in Phase 3 clinical development for the treatment of people with familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally. Akcea is a global company headquartered in Boston, Massachusetts. Additional information about Akcea is available at www.akceatx.com and you can follow us on twitter at @akceatx.
ABOUT AMBRY GENETICS CORPORATION
Ambry Genetics, as part of Konica Minolta Precision Medicine, excels at translating scientific research into clinically actionable test results based upon a deep understanding of the human genome and the biology behind genetic disease. Our unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate and pharmaceutical partners, means we are first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions. We care about what happens to real people, their families, and the people they love, and remain dedicated to providing them and their clinicians with deeper knowledge and fresh insights, so together they can make informed, potentially life-altering healthcare decisions. For more information, please visit www.ambrygen.com.
AKCEA'S FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the business of Akcea Therapeutics, Inc. Any statement describing Akcea's goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Akcea's forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Akcea's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Akcea. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Akcea's programs are described in additional detail in Akcea's annual report on Form 10-K, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Ionis", "Akcea," "Company," "Companies" "we," "our," and "us" refers to Ionis Pharmaceuticals and/or Akcea Therapeutics.
Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics®, TEGSEDI® and WAYLIVRA® are trademarks of Akcea Therapeutics, Inc.
Akcea Media and Investor Contact:
Kathleen Gallagher
Head of Communications and Investor Relations
(617) 207-8509
kgallagher@akceatx.com
Ambry Media Contact:
June Fujimoto
949 301 2454
press@ambrygen.com
Videos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/5263caff-8e87-4d65-9057-b8c3fa946d12
https://www.globenewswire.com/NewsRoom/AttachmentNg/6a39392c-ed65-4fcc-b548-a2bfae92ad2c
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