Prime Standard | Paion AG is making progress: Remimazolam in fourth country for sale. In South Korea via licensees


PAION AG (ISIN: DE000A0B65S3) and Remimazolam is becoming more and more of a success story. The approvals for various applications in various countries are increasing. And the 5 approvals available so far are just the beginning – of which 4 market launches have taken place ..

It’s all a question of patience. Remimazolam is approved in the USA, the EU / EEA and China for short sedation and in Japan and South Korea for general anesthesia. And even if a 10% share in sales for the future sales of Remimozalam in general anesthesia in South Korea will probably not reach the potential earnings in Europe or the USA, it is still a further step:

Hana Pharm, Remimazolam licensee for South Korea, informed PAION about the launch of ByfavoTM (Remimazolam) for use in general anesthesia in South Korea. Remimazolam was approved for general anesthesia in South Korea in January 2021 and is sold under the trade name ByfavoTM expelled.

Dr. Jim Phillips, CEO of PAION AG, explained: “The launch in South Korea is great news and proof of the strong commitment of our partner Hana Pharm. PAION is entitled to royalties of 10% of net sales in South Korea. We look forward to a successful launch in what is already the fourth country and to announcing further commercial news about the South Korean market as soon as we receive it. “

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On March 27, 2021 1:43 p.m., Paion reported an approval that is even more important for sales and the future of the company:

„... announces today that the European Commission (EC) Byfavo(R) (Remimazolam) for procedural sedation (brief sedation) in adult patients. Byfavo(R) is an ultra-short-acting, intravenous benzodiazepine sedative and anesthetic. “

And Dr. Jim Phillips, CEO of PAION AG, commented on 02/27/2021: “We are very pleased that the European Commission Byfavo(R) approved and would like to thank all healthcare professionals, patients, and partners who helped develop Remimazolam. This approval marks one of the most important steps on PAION’s path to becoming a specialty pharmaceutical company bringing novel products for anesthesia and intensive care medicine to hospitals. We look forward to using our recently acquired GIAPREZA(R) and XERAVA(R) to launch three products at different times in selected European countries from the second half of 2021. We estimate the annual peak sales potential in short sedation in Europe currently at around EUR 50 million to EUR 60 million “

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While the share price has got into a tailspin since the capital increase that was actually announced and expected on March 19, 2021, the success reported today should bring a little more confidence back to the share price. At least the board delivered everything as it promised.

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Opportunities – now EMA approval for general anesthesia is still missing – applied for, but still pending

While general anesthesia is likely to be the larger market, the approval announced today already gives more imagination to the stock. And rather from a scientific point of view expresses itself Professor James East, Senior Consultant Gastroenterology and Endoscopy, John Radcliffe Hospital, Oxford: “The approval of Byfavo(R) is of great interest to gastroenterologists as no new sedation medication has been added to our tools of the trade in this area for a decade. The substance performed well in the clinical trials and enabled an efficient sedation process from start to finish. The safety profile was promising, even in patients with severe systemic diseases, and the entire process was optimized for the patient by the rapid onset / waning of the sedative effect. “

It makes even more sense to build up your own sales in Europe with purchased active ingredient licenses as supplementary products

On January 12th An important course in 2021: Paion will use almost all of its cash and cash equivalents to enter into a license agreement for GIAPREZA (TM) (angiotensin II) and XERAVA (TM) (eravacycline) with La Jolla Pharmaceutical Company and certain wholly owned subsidiaries (together La Jolla) . The agreement grants PAION an exclusive license to market these two approved products in the European Economic Area, Great Britain and Switzerland (the Territories).

And this step makes sense if you can

build up a separate sales structure for Remimozalam in Europe after approval

want. Then additional products in the “sample case” can help finance the fixed costs and amortize the structural costs more quickly. Looking ahead. And at the same time shows how confident you are of receiving approval in Europe.

This is how the promise of the Paion CEO is based: … These products have the potential to double PAION’s annual sales in each of the next 5 years from 2022 onwards.“ These are the licenses that were acquired in order not to have to restrict sales in Europe to just Remimozolam. So exciting times ahead. Paion is obviously not licensing out in Europe and is building up its own sales department. ANNUAL DOUBLING … and on the way there, the message from the USA fit. There they consciously use a strong licensing partner for their market presence:

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And in the USA, marketing by the licensee in the field of short sedation starts

BYFAVO (TM), under this name Remimazolam is sold in the USA, has been launched. And BYFAVO (TM) is available immediately through leading wholesalers and specialty distributors for ordering and delivery to customers. So reported the licensee Acacia Pharma.

On July 2, 2020, the US Food and Drug Administration (FDA) granted marketing authorization for BYFAVO (TM) for the initiation and maintenance of brief sedation in adults who are undergoing a procedure of up to 30 minutes. On October 6, 2020, the US Drug Enforcement Administration (DEA) classified it as a Group IV drug, completing the approval process. And final packaging and shipping to the US were made possible.

Now the sales force also decides on success

To this end, Acacia has built important sales, marketing, medical training and operational support teams over the past two years to support both BYFAVO (TM) and BARHEMSYS(R) to market in the United States directly through its own sales channels. And the beginning is difficult: The Acacia sales team is focused on exploiting the great market opportunities in the US hospital market for brief sedation and the prevention and treatment of post-operative nausea and vomiting (PONV), BYFAVO (TM) and BARHEMSYS(R) address, use. Get Listed First: For the first year after commercialization, the commercial team will initially focus on ensuring that BYFAVO (TM) is on the drug listings based on the unmet needs it can address and the health economic benefits it can offer Hospitals is included.

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And so commented Dr. Jim Phillips, CEO of PAION AG: „We are delighted to be able to support Acacia in commercializing it, and we are delighted with our US partner’s strong commitment to BYFAVO (TM). As sales grow over the next few months and years, PAION will receive royalties of 20-25% in the US. We look forward to a successful launch of this unique new product.“

Added to this Mike Bolinder, CEO of Acacia Pharma: „We are excited to make BYFAVO (TM) available to anesthesia providers and the millions of patients in the United States who require moderate sedation for medical procedures each year. BYFAVO (TM) and BARHEMSYS(R) have a clear and shared value proposition focused on mobilizing patients safely and quickly after such procedures, which is correspondingly driving revenue for hospitals and surgical centers in the United States.

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The launches come at a time when Covid-19 has already had a significant impact on these centers, creating significant patient backlogs and impacting ongoing sales. (…)“

BYFAVO (TM) can be ordered in the US through leading wholesalers and select specialty distributors including Cardinal Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris and Dickson, and Curascript.

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Paion – Specialty pharmaceutical company

And the company sees itself like this: “PAION AG is a listed specialty pharmaceutical company that develops innovative active ingredients for use in outpatient and hospital sedation, anesthesia and intensive care medicine with the aim of later marketing. PAION’s lead compound is Remimazolam, an intravenously administered, ultra-short-acting and easily controllable benzodiazepine sedative and anesthetic. Remimazolam is partnered in several markets outside of Europe. Remimazolam was approved for brief sedation in the United States in July 2020 and was approved for general anesthesia in Japan in January 2020. In China, licensee Yichang Humanwell filed for approval for Remimazolam in brief sedation in November 2018, and in South Korea, licensee Hana Pharm filed for approval for Remimazolam in general anesthesia in December 2019.

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“In Europe, PAION is seeking approval for Remimazolam in the indications of general anesthesia and brief sedation (To be considered fulfilled since the end of March.) on. A marketing authorization application for brief sedation was submitted in November 2019. Results of a phase III study in general anesthesia are expected in the second half of 2020.

PAION’s mission is to be a leading specialty pharma company in the fields of anesthesia and critical care medicine by bringing novel products to market that benefit patients, physicians and healthcare stakeholders. PAION is headquartered in Aachen and has another location in Cambridge (United Kingdom). “

Currently (April 7th, 2021 / 09:07 a.m.) the shares of Paion AG are listed in Frankfurt trading with a plus of 3.13% (+0.07 EUR) at 2.14 EUR.

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