Pharma News

Mylan, a global pharmaceutical company announced the commercial launch of its Remdesivir under the brand name DESREM™ in India to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The company also launched a 24/7 helpline where patients and healthcare practitioners can access information about Mylan’s Remdesivir and its availability.

Mylan released the first batch of its generic Remdesivir (DESREM™) and will continue to increase its supply across the country in the wake of the rising demand for the drug.

Mylan will manufacture DESREM™ in its state-of-the-art injectable facility in Bangalore, which will work to service the demand in India and other export markets where Mylan has received a license from Gilead for the commercialization of Remdesivir. The previously announced agreement between Mylan and Gilead is part of a long-standing history between the two organizations to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID-19 treatments.

President, India and Emerging Markets, Rakesh Bamzai said: “In the wake of increasing cases of COVID-19 across India, Mylan remains committed to continue its efforts in the fight against the pandemic. With the launch of DESREM™ and our national 24/7 COVID-19 helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of Covid-19. At Mylan, we believe we have a responsibility to help make the world a better place and the entire team at Mylan has stepped up in this time of need to serve patients and deliver better health for a better world.”

Mylan is committed to continue doing its part in support of public health needs as the situation around COVID-19 continues to evolve. Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

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Indian institute of Technology (IIT) Madras researchers have shown that the active principle from turmeric that is curcumin can enhance cancer cell death caused by a protein called ‘TRAIL.’ They performed studies using isolated leukaemia cells from cancer patients and found that non-toxic concentrations of curcumin can significantly increase the efficiency of TRAIL-induced cell death.

There have been considerable efforts in developing therapeutic agents that trigger self-death of cells that malfunction. Apoptotic death or programmed death such destruction of cancer cells could prevent the spread of the disease. One such agent that can trigger self-destruction that has been found promising is a protein called ‘TNF-Related Apoptosis-Inducing Ligand’ (TRAIL). Its ability to selectively kill cancer cells by ‘apoptosis’ has resulted in a number of preclinical studies being carried out all over the world.

In cancer treatment, it is important to induce death of the cancer cells preferentially without extensive damage to healthy cells in the body. Apoptosis is generally preferred over the more aggressive and premature ‘necrosis’ for killing cancer cells because it releases fewer cellular components that trigger inflammation than the latter.

Elaborating on this research and its impact, Prof. Rama Shanker Verma, Bhupat and Jyoti Mehta School of Biosciences, Department of Biotechnology, IIT Madras, said, “Despite strong anti-tumor activity of TRAIL in pre-clinical studies, clinical trials results have hitherto been unsatisfactory because cancer cells seem to acquire resistance against TRAIL upon long-term exposure. Thus, the next round of research has been to find chemicals that can reverse resistance and increase sensitivity of cancer cells to TRAIL.”

Several studies have focused on natural compounds that could significantly enhance TRAIL-mediated apoptosis at non-toxic concentrations. The IIT Madras team chose curcumin, the yellow part of the common turmeric that is used in daily cooking, as a sensitizer of TRAIL-resistant cancer cells to apoptosis.

Curcumin is already known to be a potent anti-cancer agent because of its ability to inhibit carcinogenesis and induce apoptosis in various cancer cells. Its function as a sensitizer to TRAIL has been shown in cases of prostate cancer, breast cancer, colon cancer and malignant glioma.

Curcumin is already known to be a potent anti-cancer agent because of its ability to inhibit carcinogenesis and induce apoptosis in various cancer cells.

The IIT Madras Research Team showed that treating leukaemia (blood/bone-marrow cancer) cells with curcumin sensitises the cells to TRAIL and results in more efficient cell death.

“Our findings clearly show that even small concentration of curcumin could potentially enhance the sensitiveness of leukemic cells to TRAIL,” said the researchers.

The IIT Madras Researchers are, however, cautious in extrapolating the results. While the reactions have been carried out in vitro, i.e., with isolated cells outside the human body, ‘in a test tube’, it is unclear if the same results can be obtained in vivo, i.e., inside the body. This doubt arises because curcumin is known to be poorly absorbed into the blood from the gut and its bioavailability for therapeutic purposes is generally poor. Bioavailability is basically the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect.

But the researchers are hopeful that this difficulty will be circumvented soon. There are many studies ongoing around the world to increase the bioavailability of curcumin.

“Compounds such as quercetin found in onions, green tea etc., and piperazine, found in black and green pepper, have been shown by a few researchers to enhance absorption of curcumin by the body,” added Prof Verma.

There are no confirmatory evidences yet, but such research, combined with observations made by the IIT Madras team, can unleash newer effective and safe therapies for cancer.

This research was led by Prof. Rama Shanker Verma, Bhupat and Jyoti Mehta School of Biosciences, Department of Biotechnology, IIT Madras. The paper was co-authored by Ms. Sridevi Surapally, Ms. Madhumathi Jayaprakasam and Prof. Verma. The results of this work were recently published in the journal Pharmacological Reports.

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Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, has announced that it has commenced a Post Marketing Surveillance (PMS) study on FabiFlu® to closely monitor the efficacy and safety of the drug in 1000 patients that are prescribed with the oral antiviral, as part of an open label, multicenter, single arm study.

Further, Glenmark has announced a price reduction of 27% for FabiFlu®. The new MRP is INR 75 per tab from the earlier INR 103 per tab. The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.

Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team within the country, ensuring self-reliance with regard to longterm production and manufacturing. The API is manufactured at the Gujarat production facility which is USFDA & MHRA–UK approved. The formulation product is manufactured at the facility in Himachal Pradesh, which is also USFDA and MHRA-UK approved.

Commenting on these developments, Mr. Alok Malik, Senior Vice President & Head – India business, Glenmark Pharmaceuticals Ltd., said, “We expect this post marketing surveillance study to shed more light on the drug’s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu®. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses. Our internal research shows us that we launched FabiFlu® in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country.”

Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu®(API and formulations), Glenmark has managed to keep the pricing of FabiFlu® lower as compared to its price in other countries. FabiFlu® in India was originally launched at INR 103/tab, while, its price as INR is higher in the remaining countries. (INR 600/tab in Russia, INR 378/tab in Japan, INR 350/tab in Bangladesh and INR 215/tab in China). *Based on trade data available for 200mg /tab from the respective countries and currency rates in respective countries equivalent to INR recorded.

On June 20th, Glenmark announced that it received manufacturing and marketing approval from India’s drug regulator for FabiFlu®, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The manufacturing and marketing approval was granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. Glenmark has also completed the phase 3 clinical trial with Favipiravir (FabiFlu®) in mild to moderate COVID-19 patients in India. The trial results will be available shortly.

Glenmark is also conducting another Phase 3 clinical trial to evaluate the efficacy of two antivirals drugs Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India. The combination study which is called the FAITH trial is looking to enroll 158 hospitalized patients of moderate COVID-19 in India. Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, facilitating early clinical cure and discharge of patients.

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Biocon Ltd an innovation-led global biopharmaceuticals company, announced that it has received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab  (ALZUMAb®) Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe  ARDS (acute respiratory distress syndrome) patients due to COVID-19.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb® for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.

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 of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.  The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19. The data is compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country.

“This positions India amongst the leading global innovators in their effort to overcome the COVID-19 pandemic. The randomized control trial indicated that all the patients treated with Itolizumab (ALZUMAb®) responded positively and recovered. The control arm that did not receive Itolizumab unfortunately had deaths. Itolizumab is now approved for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19. We plan to take this therapy to other parts of the world impacted by the pandemic.

“Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in COVID-19 patients. I am pleased that our R&D and clinical teams delivered on this promising hypothesis in such a short period of time. It is a proud moment for all of us at Biocon and we would like more and more patients to benefit from this therapy. I also thank the investigators and the regulators for the sense of urgency that they displayed in this study.

“ALZUMAb®  has a seven-year proven track record of safety as doctors in India have been prescribing this biologic to treat acute psoriasis and ensure a better quality of life for patients and now we will be able to save many critically ill COVID-19 patients with our drug.”

Dr Suresh Kumar, Medical Director, Lok Nayak Hospital, Delhi said: “At the time of this COVID-19 pandemic, we do not have any specific treatment for patients who are losing the fight against the disease in spite of best supportive care. Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80% and would have  been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged. I sincerely believe Itolizumab will not only help in reducing morbidity and mortality of COVID-19 patients but will also help us in judiciously managing healthcare resources like ICUs and ventilators for critically ill patients.

Dr Mohan Joshi, Dean, BYL Nair Hospital, Mumbai, said: “In our hospital, we have tried Itolizumab in many COVID-19 patients with moderate to severe ARDS and found significant improvement in clinical, radiological and inflammatory markers after administering Itolizumab. These outcomes were quite evident with one dose of Itolizumab when administered before the ‘cytokine storm’ set in. Most of the patients have well tolerated the drug. Given the growing surge of COVID-19 cases, I would recommend use of Itolizumab in moderate to severe complications in COVID-19.

Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: “We are delighted with the results of the clinical trial for Itolizumab in India. Itolizumab demonstrated statistically significant advantage over the control arm, in one month mortality rate. Key efficacy parameters such as PaO2 and SpO2 (oxygen saturation) improvement without increasing FiO2 (oxygen flow) also showed statistically significant advantage for Itolizumab arm over the control arm. All the patients on Itolizumab arm were weaned off oxygen by Day 30, and none needed ventilator support unlike the control arm. Key secondary endpoints of clinical markers of inflammation such as IL-6, TNF-α, serum ferritin, d-dimer, LDH and CRP showed clinically significant suppression post dose and correlated well with clinical improvement in symptoms and chest x-ray images. Itolizumab was overall well tolerated and was found to be safe. Itolizumab when administered to patients with moderate to severe ARDS due to COVID-19, prevents morbidity and mortality due to cytokine storm.

India currently has more than 283,400* documented active coronavirus infections and over 22,100* deaths

Itolizumab’s unique mechanism of action of immunomodulation involves binding to the CD6 receptor and blocking the activation of T lymphocytes, which in turn suppresses the pro-inflammatory cytokines, thus reducing the cytokine storm and deadly inflammatory response.

Biocon launched ALZUMAb® (Itolizumab) in India in 2013 for the treatment of chronic plaque psoriasis. Many patients have benefitted from this novel therapy.

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Strides Pharma Science Limited (Strides) announced that its step down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA).

The product is a generic version of Fioricet® with Codeine Capsules, 50 mg/325 mg/40 mg/30 mg, of Teva Branded Pharmaceutical Product R&D, Inc.

According to IQVIA MAT May 2020 data, the US market for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg is approximately US$ 10 Mn. The product will be marketed by Strides Pharma Inc. in the US market.

The company has 124 cumulative ANDA filings with USFDA of which 87 ANDAs have been approved and 37 are pending approval.

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Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name DESREM™ in India and will be available to patients in July at a price of INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.

Mylan will manufacture remdesivir in India at its world-class injectables facilities, which also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration (FDA) for compliance with good manufacturing practices. The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO). The approval by DCGI in India represents the first for Mylan in these 127 markets.

Mylan President Rajiv Malik said: “Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India.

Malik continued: “Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic. Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time. We are proud to continue our work in support of public health in partnership with governments and other stakeholders as we work together in the fight against COVID-19.”

Rakesh Bamzai, President, India and Emerging Markets, said: “The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan is cognizant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities including R&D, regulatory, manufacturing and supply chain, while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, including India. Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID19 treatments. Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.

As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs. As the situation around COVID-19 continues to evolve, Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

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WHO accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms. The Solidarity Trial was established by WHO to find an effective COVID-19 treatment for hospitalized patients.

The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the 1-2 July WHO Summit on COVID-19 research and innovation.

These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect.

For each of the drugs, the interim results do not provide solid evidence of increased mortality. There were, however, some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial. These will also be reported in the peer-reviewed publication.

This decision applies only to the conduct of the Solidarity trial in hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19. The interim Solidarity results are now being readied for peer-reviewed publication.

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Warning that thermal cameras and other such “temperature screening” products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus.

The Agency is telling manufacturers and suppliers of thermal cameras that they should not make claims which directly relate to COVID-19 diagnosis, and is reminding businesses to follow Government advice on safe working during COVID-19.

Graeme Tunbridge, MHRA Director of Devices, said:
1. Many thermal cameras and temperature screening products were originally designed for non-medical purposes, such as for building or site security. Businesses and organisations need to know that using these products for temperature screening could put people’s health at risk.
2. These products should only be used in line with the manufacturer’s original intended use, and not to screen people for COVID-19 symptoms. They do not perform to the level required to accurately support a medical diagnosis.
3. We are reminding anyone selling these products not to make claims which directly relate to COVID-19 diagnosis. If they fail to comply, we will take formal enforcement action.

Products which the manufacturer claims are intended for screening for COVID-19, or fever-like symptoms, would be regarded as medical devices and regulated by the MHRA.

There is little scientific evidence to support temperature screening as a reliable method for detection of COVID-19 or other febrile illness, especially if used as the main method of testing.

Temperature readings from temperature screening systems will measure skin temperature rather than core body temperature. In either case, natural fluctuations in temperature can occur among healthy individuals. These readings are therefore an unreliable measure for detection of COVID-19 or other diseases which may cause fever. Furthermore, infected people who do not develop a fever or who do not show any symptoms would not be detected by a temperature reading and could be more likely to unknowingly spread the virus.

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Zydus an innovation-driven, global pharmaceutical company, announced that it’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India.

In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.

Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.

With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).

The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

Company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

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