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Ionis (IONS) Expands Licensing Deal With Otsuka for HAE Drug

Ionis Pharmaceuticals IONS has entered into a licensing agreement with Otsuka Pharmaceutical. Per the terms, Otsuka will acquire exclusive rights to market its investigational late-stage hereditary angioedema (HAE) therapy, donidalorsen, in the Asia-Pacific region.

This agreement is an expansion of the licensing deal signed last year. Per the terms, Ionis granted exclusive grants to Otsuka to market donidalorsen in Europe.

With these deals, Otsuka will be responsible for territory-specific development, regulatory filings and commercialization activities for donidalorsen across the Asia-Pacific region and Europe. Ionis will continue to maintain responsibility for the non-clinical and clinical development of the drug.

In consideration of granting the rights in the Asia-Pacific region, Ionis will receive an upfront payment of $20 million and will also be eligible for milestone payments. The company will also be eligible to receive tiered royalties on the drug’s net sales, with terms similar to the previously-signed agreement for Europe (ranging from 20-30%).

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A rare genetic disease, HAE is marked by severe and potentially fatal swelling of the arms, legs, face and throat.

Last month, Ionis reported positive data from two phase III studies — OASIS-HAE and OASISplus — evaluating donidalorsen in patients aged 12 years and older with HAE. Data from these studies showed that treatment with the drug achieved significant and sustained reductions in mean monthly HAE attack rates and continued attack rate improvement of more than 90% with one year of treatment for monthly or every two-month dosing.

Based on the above results, Ionis is making preparations to file a new drug application (NDA) for donidalorsen with the FDA later this year. Otsuka is also preparing to submit regulatory filings in Europe before this year-end seeking marketing approval for the drug.

Year to date, Ionis’ shares have lost 19.7% compared with the industry’s 8.4 % fall.

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Donidalorsen is one of Ionis’ wholly-owned pipeline candidates, which it intends to launch independently in the United States. If approved, the drug’s commercial launch is part of management's broad strategy to deliver a steady flow of wholly-owned medicines to patients.

Currently, Ionis’s pipeline consists of partnered and wholly-owned candidates. The company has partnerships with big pharma companies like AstraZeneca AZN, Biogen BIIB and Novartis NVS. The company’s collaboration with these drugmakers provides it with funds in the form of license fees, upfront payments and milestone payments to invest in its internal pipeline development.

In April, Ionis filed an NDA with the FDA seeking approval for olezarsen to treat familial chylomicronemia syndrome (FCS) based on results from the phase III BALANCE study. Data from the BALANCE study showed that treatment with olezarsen led to significant triglyceride-lowering and substantial reductions in acute pancreatitis attacks in FCS patients. If approved, olezarsen will be Ionis’ first medicine that will be launched independently. A similar regulatory filing in Europe is expected later this year.

Biogen, AstraZeneca and Novartis are Ionis’ partners for Qalsody (tofersen), Wainua (eplontersen) and pelacarsen, respectively. The FDA approved Wainua last year in December to treat adults with polyneuropathy caused by hereditary TTR amyloidosis (ATTRv-PN). Ionis and AstraZeneca are also working on expanding the drug’s label in other forms of amyloidosis. The companies are currently evaluating the drug in the phase III CARDIO-TTRANSform study to treat cardiomyopathy caused by hATTR amyloidosis (ATTR-CM). This indication has a larger market than ATTRv-PN. Data from this study is expected in first-half 2025.

Biogen and Ionis are developing advanced treatments for neurological disorders. Ionis licensed Spinraza to Biogen, which is approved for treating spinal muscular atrophy in pediatric and adult patients. While Biogen is responsible for marketing Spinraza worldwide, Ionis receives royalties on Spinraza’s sales. Both companies have also developed Qalsody, which received FDA approval last year to treat amyotrophic lateral sclerosis (ALS) with superoxide dismutase 1 (SOD1) mutations.

Ionis and Novartis are evaluating pelacarsen in the ongoing phase III cardiovascular outcome study, HORIZON, in patients with established cardiovascular disease and elevated lipoprotein(a) or Lp(a). Novartis is responsible for leading the candidate's global development and commercialization activities.

Ionis Pharmaceuticals, Inc. Price

 

Ionis Pharmaceuticals, Inc. Price
Ionis Pharmaceuticals, Inc. Price

Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote

 

Zacks Rank

Ionis currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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