PFIZER AND BIONTECH REPORT POSITIVE COVID-19 VACCINE TRIAL DATA IN CHILDREN

Pfizer and BioNTech have reported positive data from a Phase II/III clinical trial in which a two-dose regimen of their Covid-19 vaccine, Comirnaty, demonstrated strong neutralising antibody responses in children aged five to 11 years.

The messenger ribonucleic acid vaccine is approved by the US FDA as a two-dose schedule to prevent Covid-19 in people aged 16 years or above.

In the initial stage, the Phase I/II/III trial enrolled up to 4,500 children aged six months to 11 years at more than 90 study centres in the US, Finland, Poland and Spain.

It assessed the safety, tolerability and immunogenicity of the two-dose series of the vaccine administered 21 days apart in three age groups, five to 11 years; two to five and six months to two years.

ORAL MOLNUPIRAVIR HAS AT LEAST 350 PATIENTS TO RECRUIT IN PHASE III COVID-19 TRIAL

The Phase III portion of an ongoing Phase II/III trial of Merck and Ridgeback Biotherapeutics’ molnupiravir in mild-to-moderate Covid-19 has enrolled around 1,100 to 1,200 patients of its 1,550-patient target, an investigator said.

The trial could complete enrolment in one to two months, assuming worldwide infection continues to spread at its current rate.

A Merck spokesperson said the trial’s enrolment is on track; November is the company’s best guess for when the trial will have enough events for a final analysis.

The placebo-controlled Phase III MOVe-OUT study has a primary endpoint of percentage of patients who are hospitalised and/or die over 29 days.

GRIFOLS AGREES TO ACQUIRE TIANCHENG PHARMACEUTICAL FOR $1.3BN 

Grifols has entered a share purchase agreement to acquire complete shares of Tiancheng (Germany) Pharmaceutical Holdings for a total of nearly $1.3bn (€1.1bn).

The Grifols and Tiancheng transaction value comprises $906m (€773m) and a loan of $367m (€313m), Grifols noted.

Tiancheng Pharmaceutical owns 89.88% of the ordinary shares and 1.08% of the preferred shares of German public listed healthcare company Biotest.

Biotest focuses on advanced haematology and clinical immunology with a pipeline of new proteins that complement Grifols’ product portfolio.

On concluding the deal, Grifols will indirectly have rights to 17,783,776 ordinary shares in Biotest, signifying nearly 89.88% of Biotest’s voting rights and 44.94% of total share capital.

KOREAN MFDS APPROVES CELLTRION’S REGDANVIMAB FOR COVID-19 TREATMENT 

The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion Group’s regdanvimab (CT-P59) for extended use in adult and elderly people aged 50 years or above with Covid-19.

Celltrion noted that regdanvimab is the first monoclonal antibody therapy for Covid-19 to obtain full approval from the Korean MFDS.

The antibody treatment is intended for adults with moderate disease symptoms.

Elderly patients with mild symptoms and a minimum of one underlying medical condition such as obesity, cardiovascular disease, chronic lung disease, diabetes, etc and those receiving immunosuppressive agents are eligible for the therapy.

Furthermore, the MFDS has lowered the administration duration for the approved dosage of single intravenous (IV) infusion of 40 mg/kg regdanvimab to 60 minutes from 90 minutes.

LILLY’S COVID-19 ANTIBODY COMBO EUA EXPANDS FOR POST-EXPOSURE PROPHYLAXIS

The US FDA has updated the EUA for Eli Lilly’s bamlanivimab plus etesevimab to include post-exposure prophylaxis in some people to prevent Covid-19.

Bamlanivimab and etesevimab are indicated to be administered together to treat mild to moderate Covid-19 in adults and children aged 12 years and above who are at high risk of progressing to severe disease.

This neutralising antibody combination is authorised for use as bamlanivimab 700mg and etesevimab 1400mg.

BIOCON BIOLOGICS ENTERS STRATEGIC COLLABORATION WITH SERUM INSTITUTE UNIT

Biocon Biologics, a Biocon subsidiary, has entered a strategic collaboration with Serum Institute of India unit Serum Institute Life Sciences (SILS) for access to and commercialisation of the latter’s vaccine portfolio.

Part of the deal is that Biocon Biologics will offer a nearly 15% stake to SILS, at a post-money valuation of approximately $4.9bn and will gain access to 100 million doses of vaccines each year for 15 years, mainly from SILS’s new vaccine plant in Pune, India.

The alliance will provide Biocon Biologics with commercialisation rights to the SILS vaccine portfolio, which includes Covid-19 vaccines, for worldwide markets.