Research Desk Line-up: Amarin Post Earnings Coverage
LONDON, UK / ACCESSWIRE / August 14, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) ("Ionis"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=IONS. The RNA-targeted drug discovery and development Company announced on August 11, 2017, that as part of the strategic review and reprioritization of its drug pipeline in the Rare Diseases unit, GlaxoSmithKline PLC (NYSE: GSK) ("GSK") has declined licensing options on inotersen and IONIS-FB-LRx. After GSK's decision, Ionis will retain all the rights pertaining to both these drugs and the Company has plans to continue with development and commercialization of the drugs independently. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Sharing his plans for about the two drugs, B. Lynne Parshall, COO of Ionis, stated:
"We are pleased to move forward these two important drugs ourselves. We are prepared to independently advance inotersen and remain on track to file for marketing approval of inotersen in the US and EU this year."
Commenting on the development, Stanley T. Crooke, Chairman and CEO of Ionis, said:
"We are deeply committed to the TTR amyloidosis patient community. Patients with TTR amyloidosis, their families and healthcare providers are desperately seeking improved therapeutic options for this devastating, progressive, fatal disease."
Sarah Boyce, Chief Business Officer of Ionis, added:
"Our goals for inotersen are to maximize its commercial success and optimize our commercial participation. To achieve these goals, we are actively considering forming a commercial subsidiary to commercialize or co-commercialize inotersen in North America, as well as other options. Our recent experience building a commercial subsidiary has prepared us for this opportunity. We have substantial interest from potential partners and are in discussions with several parties."
About Inotersen
Inotersen is an antisense drug designed to reduce the production of transthyretin, or TTR, to treat TTR amyloidosis, a severe, rare, and fatal disease. Amyloidosis is a rare disease caused by the build-up of abnormal material called amyloid within the tissues of the body like peripheral nerves, heart, gastrointestinal system, eyes, kidneys, central nervous system, thyroid, and bone marrow. These deposits cause illness by damaging the structure and the function of the organs where they are found. In patients with familial amyloid polyneuropathy (FAP), TTR amyloid deposits cause nerve disease (neuropathy). FAP is the most commonly diagnosed form of hereditary systemic amyloidosis. Inotersen, which is identified for the treatment of patients with FAP, has received Orphan Drug Designation and Fast Track Status from the US Food and Drug Administration (FDA). The European Medicines Agency (EMA) has also granted Orphan Drug Designation to inotersen for the treatment of patients with TTR amyloidosis.
Ionis and GSK had partnered in March 2010 for the development and commercialization of inotersen. As per the agreement, Ionis was responsible for all the clinical trials and GSK had the right to exercise the option. For the license option, GSK had agreed to pay a licensing fee and the complete responsibility for getting regulatory approvals and commercialization of inotersen. GSK had agreed to pay an upfront fee at the start of the partnership with further milestone payments based on progress. If GSK exercised its option to license inotersen, Ionis was eligible for receiving royalties from GSK.
In May 2017, Ionis has completed the Phase-3 NEURO-TTR study of inotersen in patients with FAP and the data showed that the study met both its endpoints. This was followed by new top-line data from the Phase-3 NEURO-TTR study of inotersen in patients with FAP which was presented by Ionis in July 2017 at the 2017 Peripheral Nerve Society Meeting. The study met its primary endpoints and the results were in-line with the benefit-risk profile for inotersen in patients with FAP.
Given the positive outlook Ionis plans to approach FDA and EMA for marketing authorization for inotersen in FY17 based on which it will apply for the commercial launch in FY18. Ionis has also indicated that it may either go solo or partner with an interested party to commercialize inotersen in North America and other markets.
About IONIS-FB-LRx
FB-LRx is a Generation 2+ ligand conjugated antisense (LICA) drug designed by Ionis to reduce the production of complement factor B (FB) for the treatment of dry age-related macular degeneration (AMD). Genetic association studies have shown that overactivation of an innate immunogenic cascade has been associated with the development of dry AMD. AMD is the leading cause of central vision loss in developed countries. It is estimated that more than three million people in the United States will be affected by the disease by 2020. Dry AMD accounts for 85% of all cases of AMD.
Ionis has completed that Phase-1 study evaluating IONIS-FB-LRx in healthy volunteers and in May 2017 presented the results. The Phase-1 study indicated that healthy volunteers treated with a single dose of IONIS-FB-LRx achieved dose dependent reductions in plasma FB of up to a 50%. In the six - week period, when these volunteers were treated with multiple doses of IONIS-FB-LRx, greater reductions in circulating FB levels were recorded. The Company is currently working on starting the Phase-2 study in patients with dry AMD.
GSK and Ionis partnered for the development of this drug in March 2010. Ionis was responsible for the clinical studies up to Phase-2 proof-of-concept after which GSK would have the exclusive option to licence the drug. GSK had offered to pay double-digit royalties on sales of IONIS-FB-LRx.
Commenting on the potential of the drug, Brett P. Monia, Senior Vice President of Drug Discovery and Franchise Leader for Oncology and Rare Diseases at Ionis, said:
"IONIS-FB-LRx represents a unique opportunity to develop a treatment for underserved rare and broad patient populations affected by a variety of complement-mediated diseases. IONIS-FB-LRx takes advantage of our LICA technology, which can potentially provide greater patient convenience by allowing for significantly lower doses and less frequent administration."
Ionis/GSK partnership
Ionis and GSK have also partnered with each other for the development of other drugs for the treatments for infectious diseases. These are IONIS-HBVRx and IONIS-HBV-LRx, both aimed at treatment for hepatitis B virus (HBV). Both the drugs are in the Phase-2 clinical trials which are being conducted by GSK. The current decision of GSK to decline the licensing options on inotersen and IONIS-FB-LRx will not impact the Ionis/GSK partnership on the two drugs aimed at treating infectious diseases.
On July 22, 2017, Emma Walmsley the new CEO of GSK shared plans of completely overhauling the Company to give it a business edge, fast track development of blockbuster drugs, and prioritize growth in the US. Part of this plan included the strengthening the Company's R&D which included the decision to terminate or divest out of more than 30 pre-clinical and clinical programs that were not financially attractive. The decision also included looking at strategic options for its Rare Diseases unit and the pipeline of drugs under the unit.
Last Close Stock Review
On Friday, August 11, 2017, the stock closed the trading session at $46.76, rising 2.63% from its previous closing price of $45.56. A total volume of 2.63 million shares have exchanged hands, which was higher than the 3-month average volume of 1.39 million shares. Ionis Pharma's stock price soared 2.95% in the past six months and 30.25% in the previous twelve months. At Friday's closing price, the stock's net capitalization stands at $5.80 billion.
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