OTTAWA, May 13, 2020 /CNW/ - Akcea Therapeutics Canada, Inc., a subsidiary of Akcea Therapeutics, Inc. (NASDAQ: AKCA), today announced that it has concluded its negotiation with the pan-Canadian Pharmaceutical Alliance (pCPA) with a Letter of Intent regarding TEGSEDI™ (inoterson) for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR)1. Akcea Therapeutics, Inc. is a majority-owned affiliate of Ionis Pharmaceuticals, Inc.
"We're very pleased to have achieved this important milestone in our efforts to secure coverage of TEGSEDI for those living with the polyneuropathy of hATTR in Canada," said Jared Rhines, senior vice president, Americas, and general manager at Akcea Therapeutics Canada. "This achievement underscores the data supporting TEGSEDI and the critical unmet need for these patients living with this progressive disease. We appreciate the pCPA team's thorough review and response, which lays the path forward for our discussions with the provinces, territories and federal agencies. We understand that these are challenging times with COVID-19 and we look forward to productive discussions at the earliest, appropriate, time."
Approved in October 2018, following a priority review by Health Canada, TEGSEDI is an RNA-targeted therapeutic and was the first treatment approved for Canadians living with hATTR, which is caused by the inappropriate formation and aggregation of TTR amyloid deposits in various tissues and organs throughout the body. The progressive accumulation of TTR amyloid deposits in these tissues and organs leads to sensory, motor and autonomic dysfunction often having debilitating effects on multiple aspects of a patient's life.2,3,4
hATTR amyloidosis is an under-recognized, debilitating and progressive disease that is caused by the buildup of TTR proteins that misfold due to inherited mutations. It is characterized by the deposition of amyloid fibrils throughout the body including in nervous tissue and can have a devastating impact on patients' quality of life. TEGSEDI is a once-weekly, at-home subcutaneous injection that targets the polyneuropathy of hATTR amyloidosis at its source by reducing production of the TTR protein.
Special Warnings and Precautions TEGSEDI is associated with reductions in platelet count, which may result in thrombocytopenia. Platelet count should be monitored at least every 2 weeks during treatment with TEGSEDI and for 8 weeks following discontinuation of treatment. Glomerulonephritis has occurred in patients treated with TEGSEDI. Careful monitoring of UPCR and eGFR is important during treatment with TEGSEDI. The most common adverse reactions that occurred in at least 20% of TEGSEDI-treated patients and that occurred more frequently than on placebo were injection site erythema, nausea, fatigue, diarrhea, headache and injection site pain.
For more important safety information for TEGSEDI, including method of administration, drug interactions and adverse drug reactions, please see the Health Canada approved product monograph at www.akceatx.ca.
About Akcea Therapeutics Canada Akcea Therapeutics Canada, based in Ottawa, Ontario, is the Canadian subsidiary of Akcea Therapeutics, Inc. Akcea is a biopharmaceutical company focused on developing and commercializing medicines to treat patients with serious and rare diseases. Akcea Therapeutics Canada is a member of Innovative Medicines Canada, the industry association representing Canada's research-based pharmaceutical companies.
About Akcea Therapeutics Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), is a biopharmaceutical company focused on developing and commercializing medicines to treat patients with serious and rare diseases, all of which are based on Ionis' proprietary antisense technology platform. Akcea is headquartered in Boston, Massachusetts, and is building the infrastructure to commercialize its medicines globally. Additional information about Akcea is available at www.akceatx.com and you can follow the Company on Twitter at @akceatx.
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, including the commercial potential of Akcea's medicines in development 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 medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. 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 quarterly reports on Form 10-Q and annual reports on Form 10-K, 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® and TEGSEDI™ are trademarks of Akcea Therapeutics, Inc.
1 TEGSEDI™ Product Monograph
2 Gertz MA. Am J Manag Care. 2017;23(7 suppl):S107-S112
3 Hawkins P et al. Ann Med. 2015; 47:625-638 3. Suhr O et al. J Int Med. 1994;235:479-485 4. Saraiva M. FEBS Letter. 2001;498:201-203
4 Amyloidosis Foundation. Understanding the patient voice in hereditary transthyretin-mediated amyloidosis (ATTR amyloidosis)
SOURCE Akcea Therapeutics Canada
For further information: Akcea Investor Contact: Angelyn Lowe, Executive Director, Corporate Communications & Investor Relations, 442-287-0470, [email protected]; Akcea Canada Media Contact: Sheila McEachen, Aggregate Communications, 416-319-6557, [email protected]