Epanova: Will the New Drug Save Struggling Pharma Giant AstraZeneca?
Hit by a stagnant pipeline, job cuts, Phase III failures, generics competition and looming patent cliffs, AstraZeneca has seen better days; but a new drug could potentially put the ailing company back on its feet, says an analyst with research and consulting firm GlobalData.
On 18 September 2013, AstraZeneca announced that the new drug application (NDA) for Epanova (omefas), a fish oil-based treatment for hypertriglyceridemia, was accepted by FDA. Epanova, a product developed by Omthera Pharmaceuticals, caught the attention of AstraZeneca during the last year, leading to the latter company’s $437 million take-over of Omthera in July.
According to the current NDA, Epanova would be indicated to treat severe high blood levels of triglycerides, a condition that is marked by triglyceride levels equal to or exceeding 500 mg/dL, and which afflicts some four million patients in the US, increasing their risk of heart disease and strokes.
Eric J. Dimise, PhD, GlobalData’s Analyst covering Cardiovascular and Metabolic Disorders, says: “If approved, Epanova would come into head-to-head competition with GlaxoSmithKline’s (GSK) Lovaza (omega-3-acid ethyl esters) and Amarin’s Vascepa (icosapent ethyl), both omega-3-acid ethyl ester fish oil-derived treatments for hypertriglyceridemia.”
Dimise says that even though Epanova is also prepared from fish oil omega-3s, it boasts two key innovations that Omthera and AstraZeneca believe will give it a leg up over the competition.
First, unlike the esterified GSK and Amarin compounds, Epanova consists of the omega-3 oils in their free acid form. Second, Omthera claims that a patent-protected capsule will further improve the delivery and the effect of the product’s active ingredients.
However, according to Dimise, AstraZeneca has been clear about where its sights are set for the long-term future of this drug: a Crestor-Epanova combination therapy.
“Statins are the true giants of the drug market, and AstraZeneca would very much like to prevent Crestor from drowning in the flood waters of the generic Lipitor (atorvastatin) deluge.
“Furthermore, if the acquisition of smaller companies and promising compounds during the last year turn out to be smart moves — as may well be the case with Epanova — AstraZeneca will be able to tout a short-term success whilst having crystalised a longer-term vision,” concludes Dimise.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance