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Dec 6 (Reuters) – Contract drugmaker Emergent Biosolutions said on Tuesday its over-the-counter nasal spray as generic clomid without a prescription treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator.
Emergent is seeking the U.S. Food and Drug Administration’s approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country.
The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said.
Emergent’s announcement comes generic clomid without a prescription few weeks after the FDA said naloxone might be safe and effective for over-the-counter use in some forms, potentially paving the way for its use federally.
There are legal barriers limiting access to naloxone in some states, and even in others the drug is not always available to those most at risk of an overdose.
The worsening opioid crisis has prompted U.S. President Joe Biden’s administration to develop newer strategies, including the use of naloxone.
If approved, Narcan could face competition from generic clomid without a prescription versions of the drug, pressuring margins for Emergent, Cowen analyst Boris Peaker said.
Rival Opiant Pharmaceuticals’ drug nalmafene is also under the FDA’s review and could pose additional risk to Narcan sales, as it provides better protection against an opioid overdose, Peaker added.
Government data estimates that there were more than 100,000 drug-related overdose deaths in the country during 2021, a near 15% increase from the year earlier.
The Maryland-based company said its application to the health regulator includes data that supports safe and effective use of Narcan based on usability and more than five years of post-marketing studies. (Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Anil D’Silva and Maju Samuel)
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Medical advances recently have forced a re-think of the ‘one-drug-fits-all’ approach to therapy.
Something that works for some patients might not work for others or even be dangerous.
Identifying an individual’s biological indicators or biomarkers, therefore, is critical in the precise diagnosis of a patient’s disease and treatment.
It’s known as precision or personalised medicine and helping pharmaceutical companies identify these key genetic traits is the skillset of recent AIM-listee Diaceutics.
Diaceutics is involved in precision medicine testing
In fact, its ticker symbol – DXRX – tells you all you need to know about the business.
DX is the industry abbreviation for testing and RX the shorthand for treatment, and bringing the two together is what the company is all about.
‘Some drugs only work in certain patient types and you find those patients through genetic testing,’ says Peter Keeling, Diaceutics’ chief executive.
To build a dataset, Diaceutics acquires anonymous patient data directly from testing in laboratories, which is then overlaid with information from insurance claims.
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clomid no prescription one dataset ever gives all the answers, says Keeling, and it this layering of information that is the key for its drug developer customers.
The group has been collecting information since it was set up in 2005 and has now amassed a ‘deep data lake’.
That includes 3.5million tests from more than 2,500 laboratories, a US database of 51million patient records, and results from over 53million ‘testing events’ outside the US.
This week, the company added to its database with the acquisition of 16million records for £1million, something it promised when it listed in March.
Data protection rules are strict in both the US and Europe, but the pharma industry itself has a zero tolerance for mistakes in data handling and Diaceutics is keenly aware of its need for security.
The ambition is to be the global market leader in patient test data for a variety of new types of precision drugs.
Oncology/cancer testing is a core market for the company alongside multiple sclerosis and rheumatoid arthritis.
Today, precision medicine is all focused on the therapy, but the amount of value in improving patient testing is at least the equivalent to the introduction of a new drug, the company believes.
Industry estimates suggest it can cost between $1billion -$2billion to develop a new drug and Keeling wants to highlight the value ‘in the first half of the drug development equation’ ie. the testing beforehand.
That means demonstrating just how much money can be released into the healthcare system or to the pharma or clinical groups just by fixing the testing ecosystem. ‘Pharmaceutical groups are good at launching the drugs, but struggle to manage the testing,’ says Keeling.
Oncology/cancer testing is a core market for the company alongside multiple sclerosis and rheumatoid arthritis
It is a growing market. Big pharma already spends around $1billion a year on testing, but Keeling believes this total will double or more over the next 4-5 years. That makes a big target to go for and with the funds available from its listing Diaceutics plans to be in a position to take advantage.
The fact that it is one of only a handful of companies to brave the Brexit uncertainty and float this year underlines its confidence. It has been well-rewarded for its endeavour with the share price rising handily since the float.
A placing that preceded the listing and raised £17million at 76p was also heavily over-subscribed. The cash raised was earmarked for patient data acquisitions and to put infrastructure on the ground for a push into Asia and Latin America.
A new software platform, Nexus, that does everything quicker and more efficiently is also under development.
Revenues have grown 40-50 per cent annually over the past five years and brokers expect that the trend of good sales growth will continue helped by the investments made with the placing money.
Sales last year jumped to £10.4million from £7.4million, with profits rising 82 per cent on an underlying basis to £1.9million.
Keeling noted that the business has been profitable from day one, but the group’s listing indicates a step-up in ambition and scale.
The shares now trade at 85.5p each, which values the group at a shade under £60million.
That might look punchy on current yardsticks but if Keeling is right about the direction of the pharma industry towards precision medicine testing this is a company that has a lot further to travel.
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