Zydus Cadila | Business Upturn

Zydus Cadila to apply for COVID-19 vaccine trial on kids below 12 years of age

Vandana Nampoothiri — Mon, 23 Aug 2021 07:57:05 +0000

Zydus Cadila is planning to apply for the COVID-19 vaccine trial for children of age group 3-12, the company’s MD Dr Sharvil Patel said on Saturday.

“The vaccine development journey starts by first trying it in adults, then adolescents, and then children. We will now file for a trial in children of the age group of 3-12 in the next 7-10 days.” Patel told India Today.

Speaking about the side effects of the ZyCoV-D vaccine, Patel said, “We have done the trials on 1,400 adolescents of 12-18 years. In all the trials, we have not seen any severe side effects related to the vaccine.” The trials were conducted in 2,800 adults and 1400 adolescents across 50 centres.

Labelled as one of the largest vaccine trials in the country, ZyCoV-D vaccine trials were conducted on 28,000 volunteers. Interim results from Phase-III Clinical Trials showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases.

Patel in a press conference said that the pharma company is looking to supply the vaccine from September. “In the next one or two weeks we will have better clarity on the pricing,” he further added.

Zydus Cadila’s ZyCoV-D vaccine received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) on August 20. The vaccine is said to be the world’s first indigenously developed DNA-based vaccine for COVID-19. ZyCoV-D will be administered to adolescents of the age group 12-18 along with adults.

DCGI to soon release recommendations on Zydus Cadila vaccine: Dr VK Paul

Bhomik Mathur — Fri, 09 Jul 2021 12:55:44 +0000

The central drugs regulator DCGI will soon come out with its recommendations on the application filed for the ZyCoV-D COVID-19 vaccine, according to Dr VK Paul who heads the National Task Force on COVID19 and is a member of the NITI Aayog. ZyCoV-D is a three-dose, DNA plasmid vaccine produced by Ahmedabad based pharma company Zydus Cadila. If approved for use, it would be the first DNA- based COVID-19 vaccine in the world.

Dr Paul said on Friday that the vaccine will be approved for those above the age of 12 years if the scientific data indicates that the vaccine is safe. Zydus has claimed that its vaccine can be administered to children in the age group of 12-18 years. On vaccine efficacy, the company has said that ZyCoV-D provides 66.6% efficacy against symptomatic Covid-19 cases and 100% protection against mild cases of COVID-19.

Currently, four COVID-19 vaccines have been approved in India – Covishield, Covaxin, Sputnik V and Moderna. If ZyCoV-D receives a nod from the DCGI, it would be the country’s second indigenously developed vaccine.

Zydus Cadila has further informed that it has also examined the possibility of using 2 doses and immunogenicity results it found were close to that observed with three doses. On new mutations of the virus like the Delta variant, the company said that its vaccine trial was carried out during the second wave of COVID-19 infections in India when Delta was the dominant variant in the country.

The newly appointed health minister of the country, Mansukh Mandviya, had recently made a visit to the pharma company’s manufacturing plant.

We were honoured to welcome Shri @mansukhmandviya , Hon'ble Minister of State (Independent Charge) for Ministry of Ports,Shipping and Waterways and Minister of State for Chemical & Fertilizers, Government of India, at the Zydus Vaccine Technology Excellence Centre, Ahmedabad. pic.twitter.com/ew2DDYC6An

— Zydus Lifesciences Ltd. (@ZydusUniverse) July 4, 2021

Cadila Healthcare Q3 results: Profit increased by 41%

Sanah Shah — Fri, 05 Feb 2021 11:31:03 +0000

Cadila Health, Indian multinational pharmaceutical company on Friday 5th February 2021 announced a 41% increase in its consolidated net profit to Rs 527.2 crore for the quarter ended December 2020 due to robust sales in all segments.

The company had reported a net profit of Rs 373.9 crore for the corresponding period of the fiscal last year, Cadila Healthcare said in a filing to BSE. Consolidated revenue of the company stood at Rs 3,795.6 crore for the quarter under review as against Rs 3,6381.1 for the previous year.

The filing stated, “The company’s business in India geography which comprises human health formulations business, Consumer wellness business and Animal health business posted strong growth during the quarter as it grew by 20 per cent on a year-on-year basis and registered revenues of Rs 1,643 crore.” It continued to say that US formulations business registered revenues of Rs 1,603 crore during the quarter.

The company filed 10 additional abbreviated new drug applications (ANDAs) with the United States Food and Drug Administration (USFDA) making the total number of filings to 410 and received 9 new product approvals (including 4 probable approvals) from the USFDA, according to the filing.

As the fight against COVID-19 rages on, the company was given approvals to begin phase-III clinical trials of Pegylated Interferon Alpha-2b in India and the approval to start phase III clinical trials of its vaccine ZyCoV-D, it added.

The trials for the vaccine are ongoing and will be tested across 60 locations in 30,000 healthy adult volunteers in India.

During the quarter period, the company commenced the oral anti-diabetic agent, Dapaglyn (Dapagliflozin) in India for patients suffering from Chronic Obstructive Pulmonary Disorder (COPD).

In a separate filing, Cadila Healthcare said its board has approved the reappointment of Apurva S Diwanji as an Independent Director of the company for the second term of five consecutive years, starting from May 13, 2021, to May 12, 2026.

Shares of Cadila Healthcare, the listed entity of Zydus Group, were trading at Rs 481.30 per scrip on BSE, up 0.45% from its last close.

Zydus Cadila receives DCGI nod for Phase-I trial of ZYIL1

Sarthak Yadav — Mon, 07 Dec 2020 08:12:24 +0000

On Monday, Drugs Controller General of India (DCGI) granted Zydus Cadila the permission from to initiate Phase-1 clinical trial of its novel molecule ZYIL1, indicated for use as an inhibitor for inflammation condition ”NLRP3”.

“It has received permission to initiate the Phase-1 clinical trial of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. NLRP3 inflammasomes are involved in the inflammation process,” said Zydus Cadila.

This harmful inflammation within the body leads to the onset and development of various kinds of diseases, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, Gastro-intestinal diseases (inflammatory bowel disease), renal diseases and CNS diseases, the company added.

“We will study the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYIL1 in this Phase I clinical trial in healthy human volunteers. We are committed to developing these pioneering novel treatments to the clinic for the patients in need,” says Chairman of Zydus Cadila Healthcare Pankaj R Patel.

Last month, Zydus Cadila had filed the investigational new drug application for ZYIL1, positioned for management of critically ill COVID-19 patients.

Shares of Cadila Healthcare were trading 1.85 per cent higher at Rs 479.70 apiece on BSE

Zydus Cadila completes Phase II trials of its Alpha-2b

Chittesh Dalmia — Thu, 12 Nov 2020 04:45:42 +0000

Zydus Cadila on Thursday announced that it has successfully completed Phase II clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’.

The Pharmaceutical stated in its BSE regulatory filing. “In this open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative. In the test arm 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc.”

“The study established the early safety, efficacy and tolerability of PegiHepTM in moderate COVID-19 patients. The study so far has indicated that Pegylated Interferon alpha-2b could have a beneficial impact on the patient suffering from moderate COVID 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients.”

Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “We continue to look at possible treatment options that are safe and efficacious in the treatment and management
of COVID 19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID 19.”

“Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List. Zydus Cadila’s Pegylated Interferon alpha-2b,
PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients.”

Remdac: India’s cheapest Remdesivir version launched by Zydus Cadila to fight COVID-19

News Desk — Thu, 13 Aug 2020 07:54:22 +0000

Indian pharmaceutical company, Zydus Cadila launched the cheapest generic version of antiviral drug remdesivir on Thursday, 13 August priced at Rs.2800 for a 100 mg lyophilized injection. As India continues to battle COVID-19 being the third-worst hit nation, ‘Remdac’ is the most economical treatment for the virus currently.

The company has assured that the drug will be made available across India through the group’s strong distribution chain reaching out to government and private hospitals treating COVID patients.

“Remdac is the most affordable drug as we would like to enable patients to have access to this critical drug in the treatment of COVID-19″, said Dr. Sharvil Patel, the Managing Director of Cadila Healthcare Limited. “Through the course of this pandemic, our efforts have been focused on supporting people in this healthcare crisis, whether it is through developing vaccines, ramping up production and distribution of critical drugs and therapies, making diagnostic tests available, or exploring new treatment options”, he added.

Gilead Sciences Inc’s Remdeivir is an investigational drug that was issued an emergency use authorization by the U.S. Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of COVID-19. In June 2020, Zydus entered into a non-exclusive agreement with the company to manufacture and sell the drug. The API for the drug has been developed and manufactured at the group’s API manufacturing facilities in Gujarat.

Zydus is the fifth company to launch a copy of the antiviral in India, while their plasmid DNA vaccine ZyCov-D is now in Phase II of the Adaptive Phase I&II clinical trials. Shares of Cadila Healthcare, the listed entity of the group, were trading at ₹387 apiece on BSE, 0.44% higher against their previous close.

Gilead has also entered into licensing agreements with Dr.Reddy’s Laboratories Ltd and Syngene International Ltd to make remdesivir for distribution in 127 countries, including India.