GlobeNewswire

Akcea and Ionis Complete Licensing Transaction to Commercialize Inotersen for hATTR

Dela

Akcea shareholders approved the transaction on April 16 at a Special Meeting of Stockholders

Ionis licenses Akcea worldwide rights to inotersen and AKCEA-TTR-LRx        
      

CAMBRIDGE, Mass. and CARLSBAD, Calif., April  17, 2018  (GLOBE NEWSWIRE) --  Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced the two companies have completed a previously announced transaction licensing the exclusive, worldwide rights from Ionis to Akcea for inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx.

Inotersen is under regulatory review in the U.S. and EU with approvals planned for mid-2018 for the treatment of hereditary transthyretin amyloidosis, or hATTR. hATTR is a systemic, progressive and fatal disease. Akcea and Ionis are also developing AKCEA-TTR-LRx for hereditary and wild-type forms of ATTR and plan to commence clinical studies for AKCEA-TTR-LR in 2018.

In addition, following the close of the transaction, today, Sarah Boyce joined Akcea as president and a member of the Akcea board of directors reporting to Paula Soteropoulos, Akcea's chief executive officer. Ms. Boyce was formerly the chief business officer at Ionis.

The transaction was subject to certain closing conditions, including a non-waivable condition that the stock purchase agreement, the license agreement and related agreements and the transaction be approved by the affirmative vote of holders representing a majority of the issued and outstanding shares of common stock other than Ionis and its affiliates, which excluded a vote of Akcea's directors and officers. This affirmative vote was obtained at a special meeting of Akcea stockholders on April 16, 2018.

TRANSACTION TERMS
Under the agreement, Akcea paid Ionis an upfront licensing fee of $150 million through the issuance of 8,000,000 shares of common stock priced at $18.75 per share. Akcea obtained rights to commercialize inotersen and AKCEA-TTR-LRx globally. To support the incremental resources required for the launch of inotersen and to progress the clinical development program for ACKEA-TTR-LRx, Ionis purchased $200 million of Akcea common stock, or 10,666,666 shares, priced at $18.75 per share. Upon closing this transaction, Ionis' ownership in Akcea increased by 7%, from 68% to 75%, totaling 64,114,545 shares. Regulatory approval of inotersen and AKCEA-TTR-LRx in the U.S. and EU will trigger milestone payments to Ionis of $50 million and $40 million, respectively, for each drug, with additional milestone payments due upon approval of both programs in various other geographies. The initial milestone payments may be payable in Akcea common stock at fair market value. Commercial profits and losses from inotersen will be split 60% to Ionis and 40% to Akcea until the first commercial sale of AKCEA-TTR-LRx, after which the profits and losses will be shared 50/50. The costs of the development of AKCEA-TTR-LRx and the profits from its commercialization will be shared 50/50. The license for the two drugs also includes various sales milestone payments of up to nearly $1.3 billion. For this transaction, Ionis was advised by Stifel, Nicolaus & Company, Incorporated and Akcea was advised by Cowen and Company, LLC.

ABOUT INOTERSEN
Inotersen is an antisense drug designed to reduce the production of transthyretin, or TTR protein, to treat TTR amyloidosis (ATTR), a systemic, progressive and fatal disease.

Inotersen is currently under regulatory review for marketing authorization in the U.S. and EU. The U.S. Food and Drug Administration has granted Orphan Drug Designation and Fast Track Status to inotersen and the European Medicines Agency has granted Orphan Drug Designation to inotersen.

ABOUT HEREDITARY TRANSTHYRETIN AMYLOIDOSIS (hATTR)
hATTR is a progressive, systemic, and fatal genetic disease caused by the inappropriate formation and aggregation of TTR amyloid deposits in various tissues and organs throughout the body, including in peripheral nerves, heart, intestinal tract, eyes, kidneys, central nervous system, thyroid and bone marrow. 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. Patients with hATTR often present with a mixed phenotype and experience overlapping symptoms of polyneuropathy and cardiomyopathy.

Ultimately, hATTR results in death within three to fifteen years of symptom onset. Therapeutic options for the treatment of patients with hATTR are limited and there are currently no disease-modifying drugs approved for hATTR. There are an estimated 50,000 patients with hATTR worldwide.

ABOUT IONIS PHARMACEUTICALS, INC.
Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases. Using its proprietary antisense technology, Ionis has created a large pipeline of first-in-class or best-in-class drugs, with over 40 drugs in development. SPINRAZA® (nusinersen) has been approved in global markets for the treatment of spinal muscular atrophy (SMA). Biogen is responsible for commercializing SPINRAZA. Inotersen and volanesorsen are two antisense drugs that Ionis discovered and successfully advanced through Phase 3 studies.  Inotersen is under regulatory review for marketing approval in the U.S. and EU for the treatment of patients with hereditary ATTR amyloidosis. Volanesorsen is under regulatory review for marketing approval in the U.S., EU and Canada for the treatment of patients with familial chylomicronemia syndrome, or FCS. Volanesorsen is also in a Phase 3 study in patients with familial partial lipodystrophy, or FPL. Akcea, an affiliate of Ionis focused on developing and commercializing drugs to treat patients with serious and rare diseases, will commercialize inotersen and volanesorsen, if approved. Ionis' patents provide strong and extensive protection for its drugs and technology. Additional information about Ionis is available at www.ionispharma.com.

ABOUT AKCEA THERAPEUTICS
Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious and rare diseases. Akcea is advancing a mature pipeline of six novel drugs, including inotersen, volanesorsen, AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, all 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. Inotersen is under regulatory review in the U.S. and EU for the treatment of hereditary transthyretin amyloidosis (hATTR). Volanesorsen is under regulatory review in the U.S., EU and Canada for the treatment of familial chylomicronemia syndrome, or FCS, and is currently in Phase 3 clinical development for the treatment of familial partial lipodystrophy, or FPL. Akcea is building the infrastructure to commercialize its drugs globally. Akcea is a global company headquartered in Cambridge, Massachusetts. Additional information about Akcea is available at www.akceatx.com.

IONIS' AND AKCEA'S FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the recently announced transaction between Ionis and Akcea, Ionis' and Akcea's business and the therapeutic and commercial potential of inotersen, AKCEA-TTR-LRx and other products in development. Any statement describing Ionis' or Akcea's goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of inotersen, volanesorsen or other of Ionis' or Akcea's drugs 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 drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Ionis' and 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 Ionis' and 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 Ionis and Akcea.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Ionis' and Akcea's programs are described in additional detail in Ionis' and Akcea's annual reports on Form 10-K for the year ended December 31, 2017, which are on file with the SEC.  Copies of these and other documents are available from each 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(TM) is a trademark of Ionis Pharmaceuticals, Inc. Akcea Therapeutics(TM) is a trademark of Akcea Therapeutics, Inc.

Akcea Media and Investor Contact:
Kathleen Gallagher
Head of Communications and Investor Relations
(617)-207-8509
kgallagher@akceatx.com

Ionis Media and Investor Contact:
D. Wade Walke, Ph.D.
Vice President, Corporate Communications and Investor Relations
760-603-2741




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Akcea Therapeutics, Inc. via Globenewswire

Om

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Iconovo: kundprojekt blir framflyttat tre till sex månader8.11.2018 15:45Pressmeddelande

Fortsatt arbete med ett av Iconovos pågående kundprojekt kommer att flyttas fram tre till sex månader. Projektet avser utveckling av produkt anpassad för kund som ska svara för produktion och marknadslansering. Det aktuella arbetet var planerat att ske under fjärde kvartalet men beräknas ske under nästa år, och detta påverkar Iconovos omsättning under 2018 negativt med cirka 2 miljoner kronor. Orsaken är att kunden har beslutat att genomföra en mindre klinisk studie för att verifiera produkten innan nästa steg tas vilken omfattar investeringar i betydande mångmiljonbelopp i produktionskapacitet, baserat på Iconovos utveckling. Studien görs för kundens egna räkning och är inte villkorad av tillsynsmyndigheter. "Detta påverkar vårt resultat på kort sikt, men det faktum att kunden har beslutat att göra en betydande investering i faktisk produktion betyder att vi med stor säkerhet kan se fram emot licensintäkter under en lång tidsrymd framöver i samband med att produkten lanseras på markna

Stillfront Group AB: Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 20187.11.2018 14:34Pressmeddelande

PRESSMEDDELANDE 7 november 2018 Inbjudan till Stillfront Groups kvartalsrapport för tredje kvartalet 2018 Stillfront Groups kvartalsrapport för det tredje kvartalet 2018 kommer att publiceras klockan 07.00 den 22 november 2018. En webbsänd telefonkonferens kommer att hållas klockan 10.00 samma dag där Jörgen Larsson, VD och Sten Wranne, CFO, kommenterar resultatet. Presentationen och rapporten kommer efter presentationen att finnas tillgänglig på www.stillfront.com Webbsändningen nås på adressen: https://tv.streamfabriken.com/stillfront-q3-2018 För att delta via telefon, vänligen ring: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FÖR YTTERLIGARE INFORMATION, VÄNLIGEN KONTAKTA: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com OM STILLFRONT Stillfront är en oberoende utvecklare, förläggare och distributör av digitala spel - med visionen att bli en ledande indie-spelutvecklare och förläggare. Stillfront är verksamt genom tio näst intill självständiga dotte

Stillfront Group AB: Invitation to Stillfront Group Q3 presentation7.11.2018 14:34Pressmeddelande

Invitation to Stillfront Group Q3 presentation Stillfront Group interim report for the third quarter 2018 will be published at 07.00 CET on 22 November 2018. A presentation of the report will be held the same day at 10.00 CET via telephone conference or audiocast where Jörgen Larsson, CEO and CFO Sten Wranne are to comment on the report. The presentation can be viewed live at https://tv.streamfabriken.com/stillfront-q3-2018 To participate via phone please call: SE: +46 8 566 426 63 UK: +44 20 300 898 01 US: +1 8 557 532 235 FOR FURTHER INFORMATION, PLEASE CONTACT: Sofia Wretman, IR Phone: +46 708 11 64 30 sofia@stillfront.com ABOUT STILLFRONT Stillfront is a group of independent creators, publishers and distributors of digital games - with a vision to become the leading group of indie game creators and publishers. Stillfront operates through ten near-autonomous subsidiaries: Bytro Labs in Germany, Coldwood Interactive in Sweden, Power Challenge in the UK and Sweden, Dorado Online Games

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

Modus Therapeutics announces FDA Acceptance of Sevuparin IND for the treatment of sickle cell disease7.11.2018 08:30Pressmeddelande

STOCKHOLM, November 7, 2018. Karolinska Development's portfolio company Modus Therapeutics announces today that the U.S Food & Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to initiate a Phase I clinical trial with subcutaneous sevuparin for the treatment of sickle cell disease (SCD) FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD. At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, t

Oboya participates in China International Import Expo1.11.2018 15:00Pressmeddelande

Newsletter Lerum, 1th November 2018 Oboya Horticulture Industries AB (publ) ("Oboya"), a global manufacturer and supplier of products and services for the cultivation industry, will participate in China International Import Expo in Shanghai, China. China International Import Expo (CIIE) is a six-day fair held from November 5 to November 10, 2018 at the National Convention & Exhibition Center in Shanghai, China. This fair brings together companies, exhibitors and professional buyers from all over the world. The fair creates new channels for companies from different countries and regions and provides the opportunity to do business, strengthen cooperation and promote trade. Oboya's strategy is to work globally in the various markets in the cultivation and flower industry, which it's important for Oboya to participate in the major trade shows. Oboya has its own booth at the fair and will show/marketing the European cultivation products and technology to the Chinese market. The purpose of t

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum