Monthly Archives: July 2020

The story so far: On July 11, pharma major Biocon announced that it had received the approval of the Drugs Controller General of India (DCGI) to market Itolizumab for treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome patients due to COVID-19. Itolizumab is a monoclonal antibody which is used to treat acute psoriasis.

Monoclonal antibodies are proteins cloned in the lab to mimic antibodies produced by the immune system to counter an infection. They have their genesis in serum, the colourless constituent of blood that contains antibodies. These proteins bind to an antigen, the fragment of an infectious virus in the case of SARS-CoV-2, and either destroy it or block its action. In the case of COVID-19, there are yet no proven drugs to treat moderate or severe manifestations of the disease. Among the therapies being tested is convalescent plasma, which is a constituent of blood and recovered from those who have successfully fought the disease. This blood contains antibodies produced within a week or two of being infected. While plasma therapy involves injecting this entire antibody-soup into another sick patient, a monoclonal antibody can be made by isolating specific antibodies and multiplying them via various techniques. Isolating plasma and serum is laborious and time-consuming when it must be administered to every patient. However, since 1975, several techniques have been perfected that allow antibodies once isolated to be easily replicated. These are stored in vials and can be injected into patients.

Also read | Biocons COVID-19 drug tested on too few patients to reliably conclude on benefits, say experts

While eight in 10 of those infected by the disease recover with little more than a few days of cough and fever, about one in 10 can manifest severe systems of the disease irrespective of their age and medical history. Experts are not sure why, but have observed that many who died were victims of a cytokine storm when the immune system goes into overdrive to flush out the virus. Pro-inflammatory cytokines recruit a host of specialised immune system cells to neutralise antigens. However, these cytokines can aggravate inflammation and injury in lung cells as well as in several other organs. A challenge in treatment is how to prevent this over-reaction. One method is to use antibodies that can block a particular protein, called CD6. They are found on the surface of T-cells, a class of cells that are a central prong in the bodys defence system.

Experts say if this CD-6 is suppressed, it will prevent the T-cells from releasing a cytokine cascade and thus better regulate the immune system. There is also a lot of research going on in using such antibodies to prevent the replication of the virus. Since last month there have been reports from laboratories from nearly everywhere, reporting the presence of one or more antibodies that could be used to block the spike protein, the key the coronavirus uses to infiltrate lung cells and proliferate. Before monoclonal antibodies were roped into discussions surrounding COVID-19, research has focused on deriving the right kind of antibodies that specifically bind onto regions of interest. These underpin the design of cancer therapies or fixes for autoimmune diseases, rheumatoid arthritis or acute psoriasis.

Sometimes antibodies are known to help viral entry and replication in target cells which can worsen the disease. This is why they need careful evaluation.

Also read | No evidence yet that itolizumab, tocilizumab reduces deaths: ICMR head

Itolizumab is an approved drug for acute psoriasis since 2013 and has passed safety and efficacy trials for that disease in over 500 patients. However, independent experts have pointed out that the efficacy of the drug in treating COVID-caused Acute Respiratory Disease Syndrome has not been conclusively demonstrated because it has, as part of a clinical trial, only been tested on 30 patients. However, the drug has been approved by the DCGI for emergency use in the treatment of moderate to severely-ill patients as per the discretion of physicians. The DCGI also directed Biocon to conduct a phase-4 study it must monitor it for adverse reactions or side-effects after it has been administered in large groups of patients and report back to the authorities. Experts pointed out that the normal process for approving a drug includes a phase-3 trial, where the drugs safety and efficacy are first evaluated in the wider population. Officials at Biocon claim they plan to test the drug in the United States, Canada, Australia and New Zealand. Several doctors, at a press conference organised by Biocon, said their patients had benefitted from the drug but mostly when they were yet to reach a stage before requiring ventilators or external oxygen support. The drug cost a little under 8,000 for every vial. Generally, four vials are necessary for treatment, company officials said.

You have reached your limit for free articles this month.

To get full access, please subscribe.

Already have an account ? Sign in

Show Less Plan

Find mobile-friendly version of articles from the day's newspaper in one easy-to-read list.

Move smoothly between articles as our pages load instantly.

Enjoy reading as many articles as you wish without any limitations.

A one-stop-shop for seeing the latest updates, and managing your preferences.

A select list of articles that match your interests and tastes.

We brief you on the latest and most important developments, three times a day.

*Our Digital Subscription plans do not currently include the e-paper ,crossword, iPhone, iPad mobile applications and print. Our plans enhance your reading experience.

See the original post here:
The Hindu Explains | Why is a psoriasis drug being used to treat COVID-19 patients? - The Hindu

HELLERUP, Denmark, July 21, 2020 /PRNewswire/ -- UNION therapeutics A/S ("UNION") today announced the completion of a transaction with LEO Pharma A/S (LEO Pharma) to acquire the global rights for the LEO PDE4 inhibitor compound series to be re-named UNI500.

UNI500 is a series of phosphodiesterase type 4 (PDE4) inhibitors that were discovered by LEO Pharma. LEO Pharma has been developing candidates from this series from discovery into Phase 2 in psoriasis (orismilast, oral) and atopic dermatitis (orismilast, topical) and in both indications demonstrated superior effect over placebo in randomized, double-blinded, placebo-controlled clinical studies.

"The acquisition of the PDE4 inhibitor compound series is perfectly aligned with UNION's vision to build a sustainable pharmaceutical company and it complements our current clinical activities in immuno-dermatology. The acquisition substantially accelerates our growth trajectory and enables synergies at organizational, financial, and commercial levels. Above and beyond that, UNION considers compounds from the PDE4 inhibitor compound series to have best-in-class potential for the treatment of psoriasis and other immune-dermatological disorders, with an overarching aim to address unmet medical needs", said Rasmus Toft-Kehler, Chief Executive Officer of UNION.

Morten Sommer, Chief Scientific Officer, of UNION explains "Orismilast has demonstrated promising effects in clinical studies suggesting that it could become an attractive oral treatment option for patients with psoriasis and other immune-dermatological disorders. Our ambition, based on demonstrated potency levels, is to develop orismilast as a best-in-class PDE4 inhibitor across multiple immune-related diseases. As a next step, UNION will finalize formulation efforts with orismilast and simultaneously evaluate priority indications for clinical advancement".

Thorsten Thormann, Vice President, Global Research at LEO Pharma added "LEO Pharma has been working very closely with the UNION team and have been impressed with their approach and professionalism in dermatological drug development. Accordingly, when the strategic decision was taken to divest the LEO PDE4 inhibitor compound series and orismilast, UNION was an obvious partner of choice for LEO Pharma. We look forward to seeing the program moving forward for the benefit of patients in need of new treatment options".

Under the agreement, UNION will pay upfront, development and commercial milestones of up to 200 million USD, plus low single-digit royalties on sales. As part of the transaction, LEO Pharma also becomes a minority shareholder in UNION therapeutics.

About UNION therapeutics A/SUNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. The company is working on two complementary chemistry classes spanning immunology and microbiology and has three candidates in clinical development. UNION is headquartered in Hellerup (Denmark) and managed by an experienced team across Europe and USA.

About LEO Pharma A/SThe company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries.

ContactsMorten BoesenChief Financial OfficerTel: +45 2381 5487Email: info@uniontherapeutics.com

JW CommunicationsJulia WilsonTel: +44 781 8430877Email: communications@uniontherapeutics.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/union-therapeutics/r/union-therapeutics-announces-acquisition-of-pde4i-compound-class-from-leo-pharma-with-oral-lead-cand,c3157569

The following files are available for download:

View original content:http://www.prnewswire.com/news-releases/union-therapeutics-announces-acquisition-of-pde4i-compound-class-from-leo-pharma-with-oral-lead-candidate-orismilast-in-phase-2-301096733.html

SOURCE UNION therapeutics

Read more from the original source:
UNION therapeutics announces acquisition of PDE4i compound class from LEO Pharma with oral lead candidate (orismilast) in Phase 2 - BioSpace

This article was originally published here

Dermatol Ther. 2020 Jun 17:e13858. doi: 10.1111/dth.13858. Online ahead of print.

ABSTRACT

Coronavirus disease (COVID-19) is a highly contagious respiratory infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 outbreak has been declared a pandemic by the World Health Organization on March 2020. The pandemic has affected the management of psoriasis not only for those who are under treatment but also for those who are about to begin a new therapy to control their disease. An increasing number of studies in the current literature have focused on the relationship between psoriasis and COVID-19 from different perspectives. This narrative review includes searching the PubMed and Web of Science databases using the keywords psoriasis, psoriatic arthritis, coronavirus, COVID-19, and SARS-CoV-2. The search was supplemented by manual searching of reference lists of included articles. A total of 11 relevant original investigations and 6 case studies was identified. The search was updated in May 2019. Due to the absence of randomized controlled trials, it is not likely to have a robust evidence-based approach to psoriasis management in the era of COVID-19. However, the current literature may provide some clues for safety considerations. Conventional immunosuppressive therapies such as methotrexate and cyclosporine, and anti-tumor necrosis factor agents should not be preferred due to increased risk of infection, especially in high-risk areas. The use of cyclosporine may pose additional risk due to the side effect of hypertension, which has been reported to be associated with susceptibility to severe COVID-19. Considering that the current literature has provided no conclusive evidence that biologics increase the risk of COVID-19, withdrawal of these agents should be reserved for patients with COVID-19 symptoms. The treatment approach should be personalized, considering the advantages and disadvantages for each case separately.

PMID:32686245 | DOI:10.1111/dth.13858

See the rest here:
Psoriasis and COVID-19: A narrative review with treatment considerations - DocWire News

Written by Anuradha Mascarenhas | Pune | Updated: July 21, 2020 7:33:30 am The approval from the DCGI is based on the results from the conclusion of a randomised, controlled clinical trial at hospitals in Mumbai and New Delhi. (Express Photo/Praveen Khanna)

A repurposed drug, Itolizumab, is one of the newest treatments for Covid-19 approved in India. The Drug Controller General of India recently approved it as a novel biologic therapy for restricted emergency use. The decision has also sparked controversy because of the small size of the clinical trials, and because exemption has been granted from phase-III trials.

Itolizumab is an existing drug used for psoriasis, a chronic skin disease involving unregulated growth of some skin cells that develop into red patches mostly on knees and elbows, but also on some other parts of the body. The drug, developed by Bengaluru-based Biocon, was approved in 2013. It is considered safe and effective for the treatment of psoriasis.

Why was it approved for emergency use in Covid treatment?

The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, multi-organ failure and even death.

The approval from the DCGI is based on the results from the conclusion of a randomised, controlled clinical trial at hospitals in Mumbai and New Delhi. The study focused on the safety and efficacy of Itolizumab in preventing cardio-renal complications in Covid-19 patients who also have acute respiratory distress. The drug has been found to reduce these complications in such patients.

Also in Explained | Why community transmission no longer matters at this stage

Basically, the drug controls the hyper-activation of the immune system in response to SARS-CoV-2 virus and prevents morbidity and mortality related to the cytokine storm. The clinical trial showed that the drug is best administered in the pulmonary phase of the Covid-19 infection when the cytokine build up is starting and the patient is experiencing shortness of breath and exhibiting abnormal chest images. It prevents progression to the hyperinflammation phase (cytokine storm) and other complications like coagulation and organ failure, according to Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics.

The drug has been used over 80 patients in Cuba and off-label in over 150 cases. According to Dr Shashank Joshi, Dean, Indian College of Physicians, the most critical part is to know when to use the drug and it must be reserved for moderate to severe Covid cases with cytokine storm where oxygen requirements are rapidly going up. usually between the 8th day onwards of Covid infection.

What were the results of the trial?

The trial results showed a statistically significant advantage over the control group of patients, in one-month mortality rate. All the patients who were administered Itolizumab were weaned off oxygen by Day 30, and none needed ventilator support unlike the control group that did not get the drug. Some other inflammations commonly found in such patients were also suppressed, and these correlated well with clinical improvement in symptoms. Overall, the drug was found well-tolerated.

Express Explainedis now onTelegram. Clickhere to join our channel (@ieexplained)and stay updated with the latest

How large was the trial?

The trial had 20 participants given the drug along with supportive care and 10 others given only supportive care. All 20 patients on Itolizumab recovered while three of the other 10 patients died.

Public health experts and some doctors have used social media to question the sample size of the trial. When journalists raised this question at a virtual press conference, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said Itolizumab has been approved in India and since the country is in a medical emergency, it was decided to go ahead with a clinical trial involving a cohort of 30 patients. She said the regulatory process was extremely robust and the scientific discussions on the trial was of a very high order.

The DCGI has also exempted the drug from phase III clinical trials and allowed phase IV trials (post-marketing surveillance). Itolizumab is not a new drug and was approved in India since 2013. We had done phase II and III trials, and got the approval. In the past seven years, its been used in psoriasis and we know how the mechanism works Biocon Biologics CMO Dr Athalye said. Company officials said they plan phase IV trials soon.

How much does it cost?

Each injection is presented as a 25mg/5ml solution, which costs Rs 7,950 per vial. Based on an average body weight of 60 kg, the therapy cost of a single dose comprising four vials is estimated at Rs 32,000 (MRP).

The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines

For all the latest Explained News, download Indian Express App.

The Indian Express (P) Ltd

Link:
Explained: What is Itolizumab, newly cleared for Covid-19? - The Indian Express

Most recent report on the global Psoriasis Drugs market

A recent market study reveals that the global Psoriasis Drugs market is likely to grow at a CAGR of ~XX% over the forecast period (2019-2029) largely driven by factors including, factor 1, factor 2, factor 3, and factor 4. The value of the global Psoriasis Drugs market is estimated to reach ~US$ XX Bn/Mn by the end of 2029 owing to consistent focus on research and development activities in the Psoriasis Drugs field.

Valuable Data included in the report:

Competitive Outlook

The presented business intelligence report includes a SWOT analysis for the leading market players along with vital information including, revenue analysis, market share, pricing strategy of each market players.

Some of the top tier players profiled in the report include:

Product adoption Analysis

A complete assessment of the market share, consumption patterns, and supply-demand ratio of each product is provided backed by insightful tables, figures, and graphs. The products covered in the report include:

The resourceful market study outlines the overall prospects of the Psoriasis Drugs market in the major geographies including region 1, region 2, region 3, and region 4. The most prominent market players, observable trends, opportunities, and challenges in each region is enclosed in the report.

Important Queries Addressed in the report:

Why Our Clients Trust Psoriasis Drugs Market Report?

With a systematic and methodic approach, our analysts collect data from credible primary and secondary sources. In addition, we offer the most efficient after sales services to our customers and address their problems without any delay.

Originally posted here:
Psoriasis Drugs Market: Information, Figures and Analytical Insights 2019-2026 - Cole of Duty

Global Psoriatic Arthritis Therapeutics Market Research Report 2020 to 2025 provides details of recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, strategic market growth analysis, and market size. The report also offers insightful and detailed information regarding the various key players operating in the global Psoriatic Arthritis Therapeutics market, and their financials, apart from strategies, acquisitions & mergers, and market footprint. The global Psoriatic Arthritis Therapeutics market is segmented on the basis of component, application, and region.

Companies Mentioned are:-

Pfizer, Bayer, Novartis, Abbott Laboratories, Sanofi, Bristol-Myers Squibb, Janssen Biotech, Amgen, UCB, AbbVie And Others.

Get a Sample Copy/Inquire at: https://www.theresearchinsights.com/request_sample.php?id=124848

This report segments the Global Psoriatic Arthritis Therapeutics market on the basis of types:-

Nonsteroidal Anti-Inflammatory Drug, Disease-Modifying Antirheumatic Drug, Biologic Drug, Enzyme Inhibitor And Others

On the Basis of Application (BOA) the Global Psoriatic Arthritis Therapeutics market is segmented into:-

Hospitals, Clinics, Research Labs And Others

Further in the Psoriatic Arthritis Therapeutics Market research reports, following points are included along with in-depth study of each point :-

Production Analysis Production of the Psoriatic Arthritis Therapeutics is analyzed with respect to different regions, types, and applications. Here, price analysis of various Psoriatic Arthritis Therapeutics Market key players is also covered.

Sales and Revenue Analysis Both, sales and revenue are studied for the different regions of the Psoriatic Arthritis Therapeutics Market. Another major aspect, price, which plays an important part in revenue generation, is also assessed in this section for the various regions.

Supply and Consumption In continuation with sales, this section studies supply and consumption for the Psoriatic Arthritis Therapeutics Market. This part also sheds light on the gap between supply and consumption. Import and export figures are also given in this part.

Competitors In this section, various Psoriatic Arthritis Therapeutics Market-leading players are studied with respect to their company profile, product portfolio, capacity, price, cost, and revenue.

Other analyses Apart from the aforementioned information, trade and distribution analysis for the Psoriatic Arthritis Therapeutics Market, the contact information of major manufacturers, suppliers and key consumers is also given. Also, SWOT analysis for new projects and feasibility analysis for new investment are included.

Browse Full Information/Report at:

https://www.theresearchinsights.com/life-science/Global-Psoriatic-Arthritis-Therapeutics-Industry-Market-Research-2019-124848

Geographically, this report is segmented into several key Regions, with production, consumption, revenue (million USD), and market share and growth rate of High-Frequency Spindle in these regions, from 2014 to 2026 (forecast), covering North America, Europe, China, Japan, Southeast Asia, India.

Here are 15 Chapters to deeply display the global Psoriatic Arthritis Therapeutics market:

Chapter 1: To describe Psoriatic Arthritis Therapeutics Introduction, product scope, market overview, market opportunities, market risk, market driving force.

Chapter 2: To analyze the top manufacturers of Psoriatic Arthritis Therapeutics, with sales, revenue, and price of Psoriatic Arthritis Therapeutics, in 2018 and 2020.

Chapter 3: To display the competitive situation among the top manufacturers, with sales, revenue and market share in 2018 and 2020.

Chapter 4: To show the global market by regions, with sales, revenue and market share of Psoriatic Arthritis Therapeutics, for each region, from 2015 to 2020.

More

About us:

The Research Insights A global leader in analytics, research and advisory that can assist you to renovate your business and modify your approach. With us, you will learn to take decisions intrepidly. We make sense of drawbacks, opportunities, circumstances, estimations and information using our experienced skills and verified methodologies. Our research reports will give you an exceptional experience of innovative solutions and outcomes. We have effectively steered businesses all over the world with our market research reports and are outstandingly positioned to lead digital transformations. Thus, we craft greater value for clients by presenting advanced opportunities in the global market.

Contact us :

Robin

Sales manager

Contact number: +91-996-067-0000 || [emailprotected]

https://www.theresearchinsights.com

Read more from the original source:
Psoriatic Arthritis Therapeutics Market 2020 By New Treatment Methodology and Clinical Review 2025 - 3rd Watch News