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Pharmaceutical companies focus on getting vaccines and COVID drugs to countries with high cases (Source:Alamy)

Aspen Global Inc. and Johnson & Johnson have announced that they will provide 300,000 doses of J&J’s COVID-19 vaccine for South African teachers and support vaccination programmes in South Africa and elsewhere in Africa, after facing a production setback.

The vaccination support was announced by Aspen after learning that specific batches of the J&J COVID-19 vaccine manufactured at Aspen’s Gqeberha production site and designated for the South African market had to be destroyed due to a good manufacturing practice risk linked to isolated material in the drug substance supplied to Aspen by J&J from Emergent, their contract manufacturing partner in the US. 

“This is not only a setback to both the Aspen and Johnson & Johnson teams who have worked tirelessly to ensure the manufacture of these batches, but more importantly, has the potential to negatively impact the vaccine rollout across South Africa and Africa,” said Aspen. The company noted that the batches manufactured had been retained in storage awaiting the outcome of a US Food and Drug Administration assessment of Emergent.  

But Aspen said that over the next few weeks J&J was expected to “deliver substantial quantities of compliant finished vaccines to South Africa to replace the lost stock, thereby ensuring the momentum in the South African vaccine initiative is maintained.”

Aspen said that it expects imminently to release J&J vaccines manufactured from drug substance that has not been impacted by the Emergent contamination, adding that its further doses of the vaccine in production will become available in July.

Strides Partners With Ennaid For Oral COVID Drug

Strides Pharma Science Limited has announced that its Singapore affiliate has entered into an exclusive partnership with Ennaid Therapeutics to develop an undisclosed oral, repurposed medication to treat mild, moderate and asymptomatic cases of COVID‐19. Strides noted that it would be the exclusive manufacturing in partner to Ennaid for the product. 

Commenting on the partnership, R Ananthanarayanan, managing director and group CEO of Strides, said “at Strides we are committed in our fight against COVID‐19 and are working on creating a portfolio of products to aid COVID treatment and supportive care. Partnership with Ennaid is part of our initiative to provide quality and affordable treatment to the global patient pool impacted by COVID‐19.”

Ennaid’s CEO, Darnisha Harrison, said “the magnitude of human loss in India due to COVID‐19 compelled Ennaid India Private Limited to partner with Strides Pharma extending critical resources to aid its government.” Harrison added, “we are honored to join forces with an India‐based company to bring hope and healing at a time when it’s critically needed.”

Ennaid said that it would be seeking emergency authorization from the FDA – as well as an approval for compassionate use in India – for its therapy using artificial intelligence drug discovery platforms, in partnership with discovery scientists at Universidad Católica de Murcia.

Harrison added, “Since the drug was previously approved by the FDA for other indications, it has already been proven safe in humans. What we have will not only bring much needed relief to India but to patients around the world.”

Dr Reddy’s, Lupin, Cipla And Sun Pharma Partner With Eli Lilly For Baricitinib In India

Dr. Reddy's Laboratories Ltd. has announced entering a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly for the manufacture and commercialization of the drug, baricitinib, which has received the restricted emergency use approval from the Central Drugs Standard Control Organization, Ministry of Health, in India.

The drug baricitinib has received the Indian nod for use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.

The drug was earlier registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients. However, with a rapid increase in active COVID-19 cases in India, the timely restricted emergency use of baricitinib is expected to become an important life-saving treatment for patients with moderate to severe symptoms of COVID-19.

Commenting on the partnership, Deepak Sapra, CEO of API and services at Dr Reddy’s said, “From the start, we have been determined to explore every possible avenue against COVID-19. Our collaboration with Lilly will help us make yet another treatment option available to patients in India.”

Furthermore, Dr Reddy’s said that “this partnership comes at a critical juncture in the fight against the pandemic in India, and adds to the company’s existing range of COVID-19 therapeutics covering the full spectrum from mild to moderate and severe conditions of the disease and a vaccine.”

Separately,Lupin Limited has also signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly for manufacturing and selling of baricitinib in India, “in order to expand access for COVID-19 treatment in India.”

Signing a similar agreement with Eli Lilly,Cipla Limited said, “this collaboration is a step further in Cipla’s efforts to enhance access to critical treatments for patients affected by the pandemic.” The company said that it will leverage its extensive distribution footprint to make this therapy accessible to more patients and markets.

Commenting on the partnership, Umang Vohra, managing director and global CEO of Cipla said, “Through the pandemic, Cipla has been at the forefront of COVID care and our partnership with Lilly is a demonstration of our unwavering commitment to care towards patients impacted by COVID-19.”

As India’s Sun Pharmaceutical Industries Ltd. also entered into a partnership with Eli Lilly for baricitinib, Kirti Ganorkar, CEO of India business at Sun Pharma said, “Through this collaboration, we aim to join our forces with Lilly to accelerate access to baricitinib in India at a time when it is most needed. This is another step by Sun Pharma towards making more treatment options available to patients in India for dealing with the pandemic.”

Lilly has also granted a voluntary license to challenger Natco Pharma Limited for baricitinib in India, ending what could have escalated into a tussle over access and availability of the therapy for the treatment of COVID-19 (see sidebar).

Celltrion’s Regdanvimab Demonstrates Neutralising Effect Against South African Variant

South Korea’sCelltrion, Inc. has announced that its anti-COVID-19 monoclonal antibody treatment, regdanvimab (CT-P59), has a neutralizing effect against the South African coronavirus variant in an in vivo model.

HoUng Kim, head of the medical and marketing division at Celltrion Healthcare, said “we are encouraged by the new data, which reinforces that Celltrion’s CT-P59 treatment could be effective against the South African variant and variant mutations.”

According to Celltrion, CT-P59 demonstrated reduction in the binding affinity against the receptor binding domain in the three mutations (K417N, E484K and N501Y substitutions) of the South African variant. In addition, CT-P59 showed a reduced susceptibility against the South African variant in a live virus and pseudo-virus assay in vitro study.

However, Celltrion noted that there was no significant difference observed in the respiratory viral infection in the upper and lower respiratory tracts when exposed with SARS-CoV-2 wild type and the South African variants in the study.

“Taken together,” said Celltrion, “the reduced effect in in vitro neutralisation of CT-P59 is unlikely to compromise the in vivo therapeutic potency against the variant in the respiratory tract, especially at a clinical dose.”

Kim added, “We have commenced the development of a neutralizing antibody cocktail with CT-P59 against new emerging strains in the UK and South Africa and we will continue to further investigate the neutralizing antibodies and other responses to protect against current SARS-CoV-2 strains and emerging variants.”

Furthermore, Celltrion said that its global Phase III clinical trial to further evaluate the efficacy and safety of CT-P59 is ongoing in 13 countries including the US, Spain and Romania.

Formycon Receives Approval For Early Action For Its COVID-19 Drug

Formycon AG has received an approval for early action for its COVID-19 drug, FYB207, by the Bavarian Ministry of Economic Affairs, Regional Development and Energy.

“The requested grant is expected to support the further development of FYB207 until the completion of clinical phase II and has an anticipated volume of approximately €11m ($13m),” said Formycon, as the company noted that the amount of funding would be determined upon receipt of the formal notice of approval.

Formycon received the fund as the Free State of Bavaria created the conditions for funding development and innovation projects aimed at opening up new therapy options for treating the infectious disease induced by the SARS-CoV-2 coronavirus, called “BayTherapie 2020” with a provision of a total of up to €50m.

Commenting on the approval, Nicolas Combé, chief financial officer of Formycon, said “we are pleased that the Bavarian State Ministry of Economic Affairs, Regional Development and Energy has granted an early start to our funding application. Our project prevailed in a highly competitive process and, in addition to the associated scientific and technological recognition of our development approach by renowned reviewers, the support of public funding is a key component of project financing.”

Formycon’s FYB207 is expected to move into Phase I/IIa clinical testing in the fourth quarter of 2021. “FYB207 also has inherent enzymatic activity that may provide patients with additional lung and cardiovascular protection,” said Formycon. “In addition, FYB207 can potentially be used for all coronaviruses that use ACE2 as a port of entry.”

Combé added, “We want FYB207 to be an important treatment option for COVID-19 patients that saves lives. At the same time, we also want to contribute to the prevention of outbreaks of new coronaviruses in the future.”

Formycon, together with its academic partners Ulrike Protzer, chair of virology and Johannes Buchner, chair of biotechnology at the Technical University of Munich, recently published new results on the in vitro neutralization of SARS-CoV-2 variants by FYB207. “These showed that FYB207 had an even stronger effect against the B.1.1.7 mutant of the virus, which is considered particularly infectious, than against earlier variants,” stated Formycon.

As the SARS-CoV-2 and other Coronaviruses use the protein ACE2 on the surface of human cells as a portal of entry for respiratory infections, Formycon said that it has therefore fused the human ACE2 protein to the constant part of human immunoglobulin G4 (IgG4) using computational structural design to create FYB207, “a highly effective SARS-CoV-2 blocker that completely prevents cell infection in vitro.”

“Compared to vaccines and therapeutic antibodies, the ACE2-IgG4-Fc fusion protein is maximally protected against viral escape by mutation. The risk of infection amplification by vaccines and IgG1 antibodies described for coronaviruses is minimized by using the IgG4 portion in the fusion,” Formycon stated.

Beximco Revisits Supply Schedule For Vaccines In Bangladesh

After having received the first 7 million doses of the Oxford University/AstraZeneca SARS-CoV-2 vaccine from partner Serum Institute of India Alvogen Companies Donate To Support COVID Vaccines, Bangladesh’s Beximco has announced that the company is collaborating with SII to provide a revised supply schedule of vaccine export to Bangladesh, as the company expects delay in vaccine supplies.

After the recent surge of COVID-19 cases in India, the Indian Government has put temporary controls on vaccine exports. Hence, Beximco does not anticipate that SII will be able to supply the all of the remaining 23 million doses before the planned date at the end of June 2021.

In addition, Beximco said that its previously announced plan to distribute one million doses for the private pay market in Bangladesh is on hold, as the company is reviewing whether to resume the plan once vaccine supplies stabilize.

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