Emergent acquires global rights for oral smallpox antiviral from Chimerix

27 September | DEALS

Emergent BioSolutions has acquired exclusive global rights for oral smallpox antiviral, Tembexa (brincidofovir), from Chimerix. Chimerix entered a ten-year contract worth up to $680m with the US Government in August this year for delivering up to 1.7 million courses of the tablet and suspension formulations of Tembexa.

This deal comprises an initial product procurement of nearly $115m as well as an option for further procurement worth up to nearly $551m, exercisable at the Biomedical Advanced Research and Development Authority’s (BARDA) discretion.

The drug has two formulations, a 100mg tablet form and 10mg/mL oral suspension, indicated to be administered once a week for two weeks.

27 September | COVID-19

Pfizer and BioNTech seek EUA for Omicron-based Covid-19 booster in children

Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US FDA for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children. The companies sought authorisation for booster vaccine usage in children aged five to 11 years.

Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/BA.5-adapted vaccine, as well as Omicron BA.4/BA.5-adapted vaccine’s pre-clinical findings. A Phase I/II/III clinical trial of the Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine was initiated recently in children aged six months to 11 years.

7 October | DEALS

Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US FDA is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk. A decision on the approval of the Biologics License Application (BLA) is anticipated on 17 November.

As per the deal, Sanofi will extend commercial resources in the US and Provention will pay for the former’s field force-associated expenses linked to teplizumab’s commercialisation.  Retaining all rights to teplizumab, Provention will be responsible for its commercialisation approach.

3 October | DEALS

Myovant rejects Sumitovant and Sumitomo’s $2.5bn acquisition offer

Myovant Sciences has rejected an acquisition offer worth $2.5bn from Sumitovant Biopharma and its wholly-owned subsidiary Sumitomo Pharma, citing it ‘significantly undervalues’ the company.

Sumitovant and Sumitomo submitted a non-binding proposal to the audit committee of the board of directors of Myovant for the acquisition of all outstanding shares of the company that are not currently held by Sumitovant for $22.75 for each share in cash. At present, Sumitovant owns nearly 52% of Myovant’s outstanding shares. The proposed acquisition had valued Myovant at an equity price of $2.4bn and a $2.5bn enterprise price.

5 October | R&D

miRecule and Sanofi partner to develop muscular dystrophy therapy

miRecule and Sanofi have entered a strategic partnership and exclusive licence agreement for the development and commercialisation of an antibody-RNA conjugate (ARC) to treat facioscapulohumeral muscular dystrophy (FSHD). The anti-DUX4 RNA therapy was discovered using the DREAmiR platform of miRecule. Under the partnership, the anti-DUX4 RNA therapy of miRecule will be merged with the muscle-targeted NANOBODY technology of Sanofi to fuse the two molecules into an ARC using the NAVIgGator conjugation and formulation chemistry of the former.

The anti-DUX4 RNA therapy was discovered using the DREAmiR platform of miRecule. The resultant therapy could become a disease-modifying treatment that selectively acts on and reduces FSHD’s underlying cause in muscle tissue.

6 October | R&D

Intravacc gets NIAID contract for intranasal gonorrhoea vaccine development

Intravacc has received a contract worth $14.6m from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.

Named NGoXIM, the NG vaccine is based on gonococcal OMVs merged with sustained-release microspheres comprising recombinant human IL-12. Intended for intranasal administration, NGoXIM was demonstrated to be effective in animal models and elicited a durable and cross-protective immune response in proof-of-concept (PoC) studies.

In Brief

Avrobio receives FDA rare pediatric disease status for cystinosis therapy

Avrobio has received rare pediatric disease designation from the US FDA for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. AVR-RD-04 works by genetically modifying a patient’s hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein.

Merck obtains favourable US court ruling on sitagliptin patent lawsuit

Merck (MSD outside of North America) has reported that it received a ruling in favour of the company from the US District Court for the Northern District of West Virginia in a patent infringement suit against Viatris linked to sitagliptin. The court determined that both of the Merck patents at issue were legitimate and infringed.

Abpro and Celltrion partner to develop antibody for cancer

Abpro has entered a strategic collaboration with Celltrion for the global development and commercialisation of the former’s antibody therapy, a t-cell engager known as ABP 102. Once Abpro completes in vitro studies, Celltrion will oversee the development of ABP 102.

Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring vital elements to bolster health systems.

7 October | REGULATORY

US FDA grants Fast Track status for Lilly’s tirzepatide to treat obesity

The US FDA has granted Fast Track designation for Eli Lilly and Company’s tirzepatide to treat adults with obesity or overweight with weight-associated comorbidities. The company intends to commence a rolling submission of a new drug application (NDA) for tirzepatide in adults for this indication this year.

A once-weekly glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide is a single new molecule. In May, the FDA granted approval for tirzepatide as Mounjaro for use as an adjunct to diet and exercise to boost glycemic control in adults with type 2 diabetes mellitus.

13 October | DEALS

Inceptor Bio and Avectas partner for CAR-T cell therapies development

Inceptor Bio has partnered with cell engineering technology company Avectas to improve CAR-T cell therapies’ development and manufacturing to treat solid tumours. Under the collaboration deal, Inceptor Bio will use the Solupore technology from Avectas instead of electroporation for engineering T cells to yield a healthier T cell.

This non-viral technology aims to increase the engineered T cells’ quality as well as their durability in the tumour microenvironment. The combination of Solupore delivery with Inceptor’s CAR-T platform is expected to boost performance and efficacy.

In brief

Avrobio receives FDA rare pediatric disease status for cystinosis therapy

Avrobio has received rare pediatric disease designation from the US FDA for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. AVR-RD-04 works by genetically modifying a patient’s hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein.

Merck obtains favourable US court ruling on sitagliptin patent lawsuit

Merck (MSD outside of North America) has reported that it received a ruling in favour of the company from the US District Court for the Northern District of West Virginia in a patent infringement suit against Viatris linked to sitagliptin. The court determined that both of the Merck patents at issue were legitimate and infringed.

Abpro and Celltrion partner to develop antibody for cancer

Abpro has entered a strategic collaboration with Celltrion for the global development and commercialisation of the former’s antibody therapy, a t-cell engager known as ABP 102. Once Abpro completes in vitro studies, Celltrion will oversee the development of ABP 102.

Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring vital elements to bolster health systems.