Anglo-Swedish pharma company AstraZeneca has mobilised research efforts to advance the development of a novel coronavirus-neutralising long-acting antibody combination (LAAB) for the potential prevention and treatment of Covid-19, pharma company’s India managing director Gagandeep Singh told ET.
Separately, variant vaccine AZD2816, based on the original Covid jab, is under trials and, once initial data becomes available, will be submitted to regulators for assessment as a next-generation booster.
The LAAB vaccine, AZD7442, is being studied in a comprehensive clinical trial programme for both prevention and treatment of Covid-19 in over 9,000 participants. LAAB is a cocktail of two monoclonal antibodies working synergistically and is being developed for Covid prevention and treatment of infection. It could be administered by intramuscular injection and intravenous studies are also ongoing for treatment of critical hospitalised patients.
Serum Institute of India manufactures and distributes the AstraZeneca-Oxford vaccine Covishield in the country.
“AstraZeneca is working with governments around the world to make AZD7442 accessible to high-risk populations as another valuable option in the fight to end Covid-19, should it prove to be effective and well tolerated,” Singh said.
The company’s portfolio includes oncology, cardiovascular, gastrointestinal, respiratory and inflammation products.
Trade Margin Caps
AstraZeneca has filed a writ petition in the Delhi High Court against a National Pharmaceutical Pricing Authority (NPPA) order, which said AstraZeneca overcharged for Tagrisso 80 mg under the Trade Margin Rationalisation Notification. The order was issued February 27, 2019.
Trade margin caps are applicable under the notification for Tagrisso along with certain other anti-cancer medicines.
“AstraZeneca strongly believes that it has not violated any laws with respect to pricing and it has accordingly challenged the said order passed by the NPPA. We are confident of the merits of our case,” Singh said. “We are not in a position to comment in detail as the matter is sub judice.”
AstraZeneca has chosen to keep away from generic medicines and focus on specialty drugs.
“The Indian entity will continue to prioritise investments in its focus areas in line with its global growth platforms,” Singh said. “Globally, there is a focus on assets which reduces the burden of Covid on these patients’ lives.”
The growth platform is performing well with innovative molecules such as dapagliflozin, osimertinib and olaparib, he said.
“Partnerships with Sun Pharma and Abbott have helped boost the sales of our dapagliflozin franchise,” he said. “Also, dapagliflozin is the first and only SGLT-2 inhibitor which has been approved for treatment of patients with heart failure with reduced ejection fraction proven to significantly reduce the risk of cardiovascular death and hospitalisation due to heart failure.”
Dapagliflozin has also been approved for treatment of patients with chronic kidney disease.
The company’s portfolio is going to be bolstered by the company’s recent acquisition of Alexion and continued industry leading investments in R&D, he said.
AstraZeneca has switched the packing of dapagliflozin, metformin and ticagrelor to India and supplies have started. “Accelerating new products remains a key priority and we are committed to maintaining timelines of key regulatory milestones to align with the global pipeline,” he said. “The Indian entity achieved remarkable pipeline and regulatory performances in 2020, with 10 approvals of new medicines or lifecycle management indications in major markets.”
