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Pharma news – 8 June, 2020

Sun pharma starts phase 2 clinical trials of a plant-derived drug for Covid-19

The phytopharmaceutical (plant-derived) drug, Aquilegia chrysantha (AQCH) is currently being tested for its efficacy against Covid-19. This drug was initially developed for dengue. Owing to its broad antiviral activity, it is now being considered as a possible treatment option for Covid-19.

Plants Profile for Aquilegia chrysantha (golden columbine)
AQCH Plant- image Courtesy USDA

Sun Pharma has already completed the human safety study of AQCH. This comprises the first phase of the clinical trial. Following this, it has received the approval from the DCGI[1] for conducting phase 2 trials.

As per the reports, this was received in April,2020. AQCH is also the first phytopharmaceutical drug that is approved by the DCGI as a potential treatment option for Covid-19.

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The drug firm has stated that the trial will be conducted on 210 patients in 12 centers across India. The patients will be treated with AQCH for 10 days. The company believes that the results will be out by October,2020.

Sun pharma had earlier collaborated with ICGEB[2], Italy for conducting in-vitro studies on AQCH. This study proved that AQCH has anti-SARS-CoV-2[3] effects. To further validate this, preclinical trials on small animals were performed. These animal studies also showed promising results and paved the way for its study in humans.

File:SARS-CoV-2 (yellow).jpg - Wikimedia Commons

DBT[3]-ICGEB, CSIR-IIIM[4] and Sun pharma have been working together since 2016 for the development of a phytopharmaceutical drug for dengue.

In 2007, the DBT’sTask Force on Medicinal and Aromatic Plants began to evaluate plant-derived drugs for treating dengue. The secretary of DBT also claimed that their team is actively involved in the development of a drug against Covid-19.

Abbreviation: 1. Drugs Controller General of India

  • International Center for Genetic Engineering and Biotechnology
  • Department of Biotechnology
  • Council of Scientific and Industrial Research – Indian Institute of Integrative Medicine

CMA bans Indian-origin pharma industry chief for price-fixing in the UK

The Competition and Markets Authority (CMA) has banned and taken strict action against Amit Patel for breaking the competition law. Patel was the former director of Auden McKenzie and Amilco and has been involved in the price-fixing of essential drugs in the past.

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Patel was the director of Auden McKenzie between September,2014 to May,2015. During this time, Auden McKenzie and King Pharmaceutical Ltd. had come up with an agreement regarding the sales of drug nortriptyline. According to this, King would supply 25mg tablets of the drug and Auden would supply only 10mg tablets to the large pharmaceutical wholesaler. The price and quantities of this drug were predetermined by the companies. Hence, the competition was limited and the drug was sold at prices higher than the market value.

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He also made another illegal agreement to protect Aspen’s monopoly in the market from 1 March 2016 to 19 October 2016. During this period, he ensured that both his company and the pharma company, Tiofarma, stayed out of the UK[1] fludrocortisone market. As a result of this, Aspen became the sole supplier of Fludrocortisone at that time and increased the prices charged to the NHS[2] by about 1,800%.

Patel also made sure that Aspen gave about 30% of the prices it charged to Amilco. This was done to keep Amilco away from the market during that period.

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Patel had accepted his wrongdoings and voluntarily given undertakings to hasten the conclusion of this case. The CMA had decided to reduce the regular 6 years ban to 5 years on behalf of his cooperative and compliant nature. It has stated that as a part of the Company Directors Disqualification Act, Patel is banned from holding a director role in any company for 5 years in England, Scotland and Wales. He is also banned from being involved in any management role during this period.

Nortriptyline is an anti-depressant drug used by thousands of patients to relieve the symptoms of depression. Fludrocortisone is a prescription-only drug that is used to treat Addison’s disease. Patients with Addison’s disease usually suffer from primary or secondary renal insufficiency.

Abbreviation: 1. United Kingdom

                             2. National Health Service

AstraZeneca’s anticancer drug may be a potential treatment option for severe Covid-19 patients

The British-Swedish pharmaceutical company, AstraZeneca has been proactive in its search to find a potential cure for Covid-19. This drug firm has recently tested its anticancer drug, Calquence in severe Covid-19 patients.

File:Astra Zeneca Mölndal IMG 2892.JPG - Wikimedia Commons

This preliminary test was conducted on 19 Covid-19 patients between 20 March 2020 and 10 April 2020. 11 patients of this cohort were receiving supplemental oxygen. The remaining 8 patients were on a ventilator. In this study, steroids and hydroxychloroquine were taken by all the patients surviving on a ventilator. Around 5 patients who were on oxygen supply were also concomitantly administered with either one of these medications.

Post-treatment with Calquence, 9 out of the 11 patients of the oxygen supply group were discharged. One patient died and the other remained hospitalized. In the ventilator cohort, three patients were discharged and one patient was sent to rehabilitation. However, the remaining four patients died.

File:Doctor with Patient Cartoon.svg - Wikimedia Commons

About 12 of the 19 patients recovered using this treatment and there was no relapse in any of them. As per reports, AstraZeneca is now planning to launch a phase 2 trial for this drug. Around 200 patients are expected to take part in this.

Calquence suppresses a protein that is responsible for the production of the cytokine storm in Covid-19 patients. This protein is called interleukin-6 (IL-6). Studies have shown that Calquence targets the Bruton’s tyrosine kinase enzyme to control the excess production of IL-6.

The generic name of Calquence is Acalabrutinib. It is a USFDA[1] approved drug that acts by inhibition of a group of enzymes called kinases. Some kinases are active in cancer cells and hence it is effective in treating cancer. It is commonly used to treat mantle cell lymphoma, small lymphocytic lymphoma and chronic lymphocytic leukemia. The adverse effects produced by this drug include arrhythmia, headache and diarrhea among others.

Abbreviation: 1. United States Food and Drug Administration

AstraZeneca is all set to supply Covid-19 vaccines from September,2020

AstraZeneca has been conducting clinical trials of its Covid-19 vaccine. These trials are ongoing and the firm plans to get the final approval from the drug regulatory authority after the results are out. The results are expected in August,2020.

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However, the company has begun to manufacture the Covid-19 vaccines pioneered by its partner, Oxford University. It plans to manufacture around 2 billion doses of the vaccine by September,2020. The drug firm justifies that the results obtained so far have been promising and hence it has gone ahead with the manufacturing even before getting the approval from the regulator.

To ensure the mass production, it has roped in many institutes like the CEPI[1], Gavi the Vaccine Alliance and the Serum Institute of India. These partnerships are believed to assist in supplying the vaccine to low- and middle-income countries.

File:Patient Logo 2018.svg - Wikimedia Commons

The company has separate supply chains in the USA, Europe and India and is now planning to establish production in China. It also claimed that the financial risk would be shared along with CEPI if the ongoing trial fails.

Oxford University began the trial of its vaccine in April 2020 with hundreds of volunteers. The trial is now expanded to include around 10,000 volunteers. The tests will also be conducted in Brazil starting mid-June.

Abbreviation: 1. Coalition for Epidemic Preparedness Innovations

References:

[1] Sun Pharma Initiative– The Hindu – 5 June 2020

[2]price fixing case– Economic times- 5 June 2020

[3]astrazeneca cancer drug– The Print – 6 June 2020

[4]astazeneca vaccine for covid-19 The New Indian Express – 6 June 2020

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