Diagnostica Stago S.A.S (Stago), a privately held Company that provides reference tests and instrumentation in hemostasis, announced today that the company has entered a joint research agreement with Bristol-Myers Squibb Company (BMY) to develop an assay for measuring the circulating blood concentration of the oral Factor Xa inhibitor ELIQUIS® (apixaban). No commercial assay is presently available to specifically measure apixaban plasma concentration. Terms of the agreement were not disclosed.
Stago is pleased to have the opportunity to develop this test, said Tristan Herve, Director of Pharmaceutical Development, These oral Factor Xa inhibitors address an important unmet need for patients requiring anticoagulant therapy.
Stago has already completed prototype development and will be applying for health authority approvals of the assay worldwide. Diagnostica Stago retains 100 percent global development and commercialization rights for the assay.
About Diagnostica Stago
Stago, created in 1945, is an IVD company which develops and markets reagents and automated systems for the investigation of blood coagulation disorders. Stago is a leading player in Haemostasis and Thrombosis. Headquarters, as well as R&D, manufacturing and logistics activities are located mainly in the Paris area (France). Stago products are available in more than 100 countries in the world. Stago Group had over 2000 employees worldwide.
For Akers Biosciences Inc (LON:AKR, NASDAQ:AKER), 2018 will be a defining year, according to chief executive John Gormally and its founder Raymond Akers.
For having secured US$6.9mln of new investment, the company is focused on becoming cash flow positive and profitable.
READ: Akers Biosciences unveils plans to raise US$6mln
The turnaround probably cant come quickly enough for shareholders in a business currently valued at less than the cash it has in the bank.
A rerating will be effected if the company can successfully deliver on its fully-funded growth strategy set out in a 21-page Powerpoint presentation the firm delivered to would-be investors ahead of its most recent fund-raiser.
Host of other products
The cornerstone of the business will continue to be the PIFA rapid assay for an allergy to the blood thinner heparin; however, theres a host of other products that it is hoped will help propel the company towards profitability.
Chief among them is a new rapid test for Chlamydia that has huge potential: the PIFA PLUSS assay, which can deliver results in five minutes rather than the days it takes for a lab test.
For women, at least, the simple blood test is far less invasive than the cervical swab currently used to collect samples.
This product, we believe, is going to be transformational for the company, says its chairman Akers.
There is nothing like it in the world. It is the first assay that gives you the results in minutes and it is also the first blood test for Chlamydia.
It aims to work with the organisation Planned Parenthood in the US where it will also target clinics, college campus medical centres alongside government care-givers.
Potential commercial partners
CEO Gormally said executives are lining up potential commercial partners who would help introduce PIFA PLUSS Chlamydia to the wider world; however, the product must first receive whats called 510(k) approval from the US Food & Drug Administration.
The process of securing this regulatory sign-off began last May and the medicines watchdog asked for more data from Akers in December.
We are nearer the end of the road with the FDA but it is very difficult to predict when it is going to happen. We think it is going to be sooner rather than later, said Akers.
The story doesnt end with Chlamydia. The companys health and wellness offering also has the potential to generate significant revenues, Gormally points out.
Akers has developed an app that helps users track their health over time, which segues nicely with a number of products that tap into huge markets.
It has breath test devices that help promote, track and encourage choices related to general health and wellbeing.
Talking to network marketing companies
It is talking to network marketing companies in a bid to open new sales channels, and the plan is to target weight loss centres, health and fitness clubs and doctors specialising in anti-aging.
Sleepers in the Akers development pipeline are the PulmoHealth breath tests that detect biomarkers associated with lung cancer, asthma and chronic obstructive pulmonary disease (COPD).
The numbers involved are mind-boggling: there are 1.6mln people diagnosed each year with lung cancer, 300mln suffer asthma, while 210mln smokers are currently being treated for COPD.
An asthma clinical trial has been highly successful and the next step is to file with the FDA for 510(k) clearance.
Cholesterol test already on sale
Already on sale is Tri-Cholesterol, the companys rapid test that measures total, HDL (good) and LDL (bad) cholesterol.
The product, the only one of its kind, is sold in major US drugstore chains under the FirstCheck brand and is another huge seam to mine for the business.
This last infusion of cash will get us across the line, says Gormally, regarding the recent fundraising.
Everyone at Akers is supremely focused on making 2018 a profitable year.
"John J. Gormally, Chief Executive Officer of Akers Bio, commented:
"Akers Bio is delighted to have signed a three-year agreement with GNYHA, one of the premier group purchasing organizations in the United States healthcare sector. Their membership includes a diverse listing of prominent and large integrated delivery networks (IDNs) and hospitals. Enhanced access to GNYHA's network has the potential to dramatically increase domestic sales of our flagship product."
"Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), (the "Company" or "Akers Bio"), a developer of rapid health information technologies, has signed a distribution agreement with First Check Diagnostics, LLC ("First Check"), the major global diagnostic device and service provider, to serve as the exclusive distributor of the Company's rapid cholesterol self-test in the United States under their "First Check" brand.
First Check products are sold through major retailers including, CVS, Rite Aid, Target, Kmart, Meijer, Giant Eagle, Stop & Shop, Giant and ShopKo.
Akers Bio's Tri-Cholesterol "Check" test is the only combined rapid test which provides an estimate of a person's Total cholesterol as well as their High Density Lipoprotein ("HDL") cholesterol levels - their 'good cholesterol'; thereby providing an estimate of a person's Low Density Lipoprotein ("LDL") levels - their 'bad cholesterol'. These features are essential to accurately differentiating between a person's 'good' and 'bad' cholesterol thereby making it a truly effective screening test for high cholesterol.
$800,000 cash in hand, with $2m due from Novatek in the next month (before 31st December), so hopefully this will run smoothly.
The concluding outlook reads extremely well - notably re profitability next year:
Akers Bio moves into the final quarter of 2016 with excellent momentum in domestic sales of our flagship rapid test for HIT and with the remaining $2,000,000 due under the Novotek order for products in China which we expect to be fulfilled in the fourth quarter. There is also evidence of further demand for Akers Wellness products which are expected to produce additional sales in the remaining months of the year. The combination of these growing product sales and a leaner cost base is expected to enable Akers Bio to trade profitably both in the final quarter and, more significantly, in 2017."
The breath test for diabetics seems like a potentially huge winner imho, backed up by the comment in the RNS:
"The technology has a large number of potential mass-market applications, including within health and wellness, but in particular, we believe the ability to help Type 1 and some Type 2 diabetics monitor their ketone levels in a non-invasive, convenient format will be a significant advancement in the management of a disease that affects hundreds of millions of people worldwide," added Dr. Akers."
"Dan DelMastro, CEO of Aero-Med added, "Aero-Med recognizes the enormous market potential for products within the health and wellness sector so we are delighted to be incorporating OxiChek into our sales offering. Having personally observed the positive customer reaction to OxiChek at conventions in recent months, I am optimistic that there is strong potential for this product."
Great RNS - the Chinese FDA have approved "for medical use throughout Mainland China the Company's flagship rapid tests for allergic reactions associated with the widely used blood-thinner, heparin."
With Novotek already in place as the distributor, this is excellent news for a mere £9m m/cap company. And Akers' test is the first and only such test of its kind in China.
Consider the size of Novotek:
"NovoTek Therapeutics Inc. is a vital part of NovoTek Group, and is in charge of all international business. To date, NovoTek Group has grown to seven subsidiary companies focused on pharmaceutical marketing, medical and IVD products marketing, and contract research services. NovoTek has its own preclinical research facility, clinical trial and regulatory teams, and more than 600 sales representatives (500 for pharmaceuticals and 100 for medical devices) across China. NovoTek has more than 800 employees and more than 10 local branches nationwide. www.novotekchina.com "
Commercializes New App-Enabled Tests for Health and Wellness Industry and Consumers
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers Bio" or the "Company"), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, announces that all development specifications have been finalized and production has commenced for its two transformational breath tests designed for the health and wellness industry and consumers.
Akers Bio is launching the BreathScan OxiChek ("OxiChek") and BreathScan KetoChek ("KetoChek") tests this week at the Supply Side West conference in Las Vegas, Nevada. The conference focuses on dietary supplements and sports nutrition, two key markets for these new products.
OxiChek is the first disposable breath test to rapidly determine levels of oxidative stress (free radicals) in the body. OxiChek measures the most abundant free radicals including superoxides, hydrogen peroxide and aldehydes - unlike some pre-existing devices which measure only one. Frequent use of OxiChek may help consumers and professional clients manage and adhere to their regimen of nutritional supplementation for management of oxidative stress, which is implicated in many diseases, including cardiac, cancer and arthritic diseases.
KetoChek, and the Company's non-quantitative version, METRON®, are the only disposable breath-based diagnostic devices that rapidly determine if the subject is in the optimal fat-burning state for weight loss, known as ketosis. Achieving a state of ketosis - as indicated by the measure of breath ketones - is a goal of many individuals following low carbohydrate diets. KetoChek is a simple, non-invasive test to identify, track and quantitatively monitor breath ketones for individuals interested in maximizing weight loss...
.."The response to the Akers Wellness products has been overwhelmingly positive," said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman. "We launched our first product, METRON®, into this market last month, including through the Amazon marketplace. Now, the Company is expanding its market reach through our efforts at Supply Side West, targeting multi-level marketing companies in the nutraceutical business, fitness and weight loss centers, chiropractors, and anti-aging medicine physicians. The Company is aggressively seeking distribution into these market segments," continued Dr. Akers.
"We believe that consumers are increasingly looking for personalized health, and that the BreathScan platform will provide the footprint for the Company to enter into the new era of digital medicine. Our new health and wellness products are poised to make an impact now as we commence production and will begin shipping this quarter....."
Raymond Akers, chief executive of Akers Biosciences (LON:AKR), reckons the global heparin-induced thrombocytopenia (HIT) test industry is not far away from being valued as a US$1bn market.
Akers is a front runner in the space and has distribution for its own HIT test in every major diagnostic market after inking agreements for India, Germany, Italy and Scandinavia.
Millions of patients are exposed to heparin around the world each year and between 1% and 5% of those patients receive a HIT diagnosis.
The test is the only US and EU cleared rapid test to detect a potentially fatal allergy to the widely used blood thinner, heparin.
That allergy reverses the effect of heparin and turns it into a clotting agent, which is clearly very dangerous."
"Akers Biosciences Introduces New Rapid Breath Ketone and Oxidative Stress Tests to the Health and Wellness Industry
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers Bio" or the "Company"), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, introduced two new breath tests to the U.S. market from the Company's Akers Wellness division at the World Congress on Anti-Aging Medicine in Hollywood, Florida, USA last week.
Brief notes from last night's presentation - apologies if anything written down/understood incorrectly:
Sales should be up to $7.2m this year, with breakeven during the period, and ending with approx.$10m cash (i.e almost 50% of the m/cap).
AKR can produce $50m of sales from their existing facilities, so there's no need for material capital expenditure.
- the price of AKR's Heparin test is to be INCREASED from May 1st, due to the huge savings for hospitals
- 10 new sales reps are each opening 3 new hospital/customer accounts per month, each selling $30k per annum, which I calculate to be $10.8m revenues per annum once a year's selling is up and running
- there should be one or two further Chinese orders this year
Cholesterol test is perfect for Australia given distances/flying doctors etcf, and has achieved $900,000 of unbudgeted sales
5 products currently on the market, growing soon to 11
Future products include (1) breath test for lung cancer, (2) test for type 1 diabetics, at 73% margins (this is AKR's lowest margin test!), (3) chlamydia test, to be perfected this summer after clinical trials.
AKR's great advantage is that clinical trials only take a few months and cost relatively little.
The diabetes test will be launched in China and USA this year. AKR already have a Chinese facility. I think he said the asthma test is this year too.
There's no competition for the heparin and other breath tests (except the alcohol test in Europe).
"Pioneering drug company boosted by marketing deal
One Alternative Investment Market company hoping to buck the general malaise on the junior market is Akers Biosciences, which will today announce a deal to begin marketing one of its flagship treatments in Britain and eight other European countries.
Akers, which has a dual Aim and Nasdaq listing, has developed a pioneering new test that can rapidly detect whether patients have a potentially fatal allergy to heparin, the blood thinning drug routinely used in hospitals around the world. The test is already in use in the US healthcare systems but Akers will now begin selling it far more widely across Europe, the Middle East and Africa.
The potential for the test is enormous while millions are prescribed heparin, as many as 5 per cent of them develop an allergy to the product. Patients undergoing serious heart surgery or major orthopaedic procedures are regarded as particularly vulnerable to such problems."
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers" or the "Company"), a medical device company focused on reducing the cost of healthcare through faster, easier diagnostics, has added six new distributors to market its rapid tests for heparin]induced thrombocytopenia ("HIT") in nine additional countries within Europe, the Middle East and Africa (EMEA).
The Company has signed multi-year distribution agreements for PIFA Heparin/PF4 Rapid Assay products with Pathway Diagnostics Ltd, covering Great Britain; ACCUSCIENCE Ireland Ltd, covering Ireland and Northern Ireland; Tokra Medikal Tic Ltd Sti, covering Turkey; LabPro d.o.o, covering Serbia, Montenegro, Macedonia, Bosnia and Herzegovina; AVL Sofia Ltd, covering Bulgaria; and MASTERLAB SARL, covering Morocco.
Akers has developed the only U.S. and E.U. cleared rapid test to detect a potentially fatal allergy to the widely used blood thinner, heparin. This clinical syndrome known as HIT reverses heparin's intended therapeutic effect and transforms it into a clotting agent. Patients suffering HIT are at risk of developing limb- and life-threatening complications, so the rapid diagnosis provided by the Company's Heparin/PF4 devices is paramount to effective, clinical decision making. Millions of patients are exposed to heparin around the world each year and between 1% and 5% of those patients receive a HIT diagnosis. The largest at-risk populations are patients undergoing major cardiac or orthopedic surgical procedures.
"As sales of our rapid tests for HIT continue to rise in the U.S. we are actively seeking to roll out the marketing to other countries around the world," said Raymond F. Akers, Jr. PhD, Co-founder and Executive Chairman of the Board. "These additional distribution partnerships add to our expanding global footprint which now exposes the Company's flagship test to 20 non-U.S. markets including China," continued Dr. Akers.
"Key to growing the international footprint is partnering with distributors with the right networks and experience to drive sales - in some cases in countries where there is no established procedure for testing for HIT," added Nicolas Daurel, Vice President, Sales and Marketing for EMEA. "We are confident that our international partners have these credentials and look forward to supporting their strategies.""
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