Emergent’s Narcan opioid overdose nasal spray is getting first generic competition from Teva and Sandoz (via Emergent Biosolutions)
Teva and Novartis’ Sandoz recently launched generic versions of Narcan on the same day, but it likely wasn’t a coincidence. Both first-to-market generics for Narcan, an opioid overdose rescue nasal spray, are FDA approved, but only Sandoz’ version is authorized by Narcan’s brand marketer Emergent BioSolutions.
Emergent, which acquired Adapt Pharma and the Narcan nasal spray in 2018, has been in a protracted patent litigation with Teva over its generic version. The FDA approved Teva’s naloxone hydrochloride nasal spray in April 2019 as the first Narcan generic, but Emergent filed a lawsuit alleging Teva infringed on Adapt patents. A decision in 2020 ruled in favor of Teva, but Emergent appealed. This past summer a three-judge US Court of Appeals panel heard Emergent’s case but had yet to render a final decision.
Teva didn’t answer questions about the launch timing, but Emergent released a statement noting Teva’s launch ‘prior to resolution of the related patent litigation.’
Emergent’s statement also pointed out its long history working with public health officials to ‘educate and safeguard people who may be at risk of an opioid overdose,’ and said it welcomes additional solutions to help fight the opioid epidemic. Emergent said it will update any 2022 financial effect when it presents year-end results. In response to follow-up questioning, an Emergent spokesperson said the company is not planning any legal action in response to the Teva launch.
Meanwhile, Sandoz announced the debut of its Emergent-authorized generic Narcan on the same day as Teva in December. When asked about timing, a spokesperson said in an email that the launch was ‘based on our agreement with Emergent.’
The authorized generic from Sandoz means it is the exact same product as the branded Narcan with a different label and sold at a generic price. The deal with Emergent also ensures the brand licensor a portion of those sales. Emergent in turn pays royalties to the originator of the Narcan nasal spray, Opiant Pharmaceuticals.
Along with the new Narcan generics, other drugmakers have entered the naloxone hydrochloride nasal spray market through different dosing mechanisms. Narcan is a 4-mg spray dose, but Hikma Pharmaceuticals got its FDA approval for Kloxxado in April for an 8-mg intranasal dose while Adamis Pharmaceuticals’ FDA nod for Zimhi in October is a 5-mg injectable dose. On the horizon is potentially even more competition from Opiant itself. Its nasal nalmefene, another investigational treatment for opioid overdose, secured an FDA fast track designation in November.
What they’re all pursing is a slice of the unfortunately growing opioid overdose treatment market. Opioid overdose deaths increased 40% during the pandemic from May 2019 through June 2020 — but even as pandemic panic eases, the opioid epidemic is still raging. The CDC reported more than 75,000 opioid overdose deaths from April 2020-2021, an increase of 35%. Emergent sales of Narcan have increased in tandem. Its most recent third quarter sales of $133 million notched a 50% increase year-over-year. Sales through nine months were almost $314 million, already topping its full 2020 revenue of $311 million. Emergent has delivered 26 million Narcan devices in the US since its 2016 debut.
In 2018, Adapt did some regional TV testing of a Narcan ad encouraging concerned parents of young people on pain meds to stock the med at home in case of accidental overdose. However, marketing of naloxone in general has been limited to direct appeals to public health officials in communities, first responder organizations and hospitals. Most states have adopted laws that allow direct sales to consumers at pharmacies.
Still neither Teva nor Sandoz have plans to market the Narcan generics to consumers.
A Teva spokesperson said in an email, ‘We don’t market/promote generic products; they are prescribed as name-brand and then supplemented by doctors or pharmacies.’
Sandoz simply said its Narcan generic is available ‘to people in the US via retail pharmacies and institutions, including hospitals,’ and added that its product website will feature resources for pharmacists.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
All the big R&D trends are on display in this new list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 60 new drug approvals for last year, topping the 59 in 2020. That’s a close second to the 64 OKs that came out of the FDA in 2018. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.
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A third former GlaxoSmithKline scientist caught in an alleged plot to steal trade secrets and sell the work in China pleaded guilty to conspiracy on Monday.
Lucy Xi, a 44-year-old scientist, was accused of feeding her former husband, Yan Mei, confidential information on GSK’s research into monoclonal antibodies for his work on a new Chinese biotech company called Renopharma, according to the charges.
The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.
The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.
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Susan Sweeney, Amgen SVP of global marketing, access and capabilities
Susan Sweeney spent more than two decades in drug commercialization at Bristol Myers Squibb before moving to Amgen in September 2019, just a few months before the Covid-19 pandemic.
Sweeney, now Amgen’s senior VP of global marketing, access and capabilities, didn’t know of course what was about to happen any more than anyone else, but her longtime drug launch expertise – which included blockbusters like Opdivo and Eliquis – meant she’d weathered more ups and downs in pharma commercialization than most.
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Pfizer pitched some early New Year’s resolutions with Covid-related rules in LinkedIn and Facebook video posts just before the end of the year. Resolution rule number one was a suggestion for those who didn’t have a promise yet for 2022 to take the vow: ‘I will do my part to stop the pandemic.’
Its second rule suggestion? ‘Please do not make it your 2022 goal to learn more of the Greek alphabet’ in a reference to the naming convention of Covid-19 variants selected by the World Health Organization. Lastly, the Covid-19 mRNA vaccine maker, along with partner BioNTech, offered suggestions for a good toast: ‘Here’s to a great 2022!’ along with a bad idea for a toast: ‘It can’t get any worse!’
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