Novo Nordisk to acquire biopharmaceutical company Dicerna for $3.3bn
19 November | vaccines
Novo Nordisk has signed a definitive agreement for the acquisition of Dicerna Pharmaceuticals, including its ribonucleic acid interference (RNAi) platform, for a total equity price of nearly $3.3bn in cash. Under the deal, Novo Nordisk will initiate a tender offer for the purchase of complete Dicerna common stock outstanding shares for $38.25 per share.
Dicerna leverages GalXC and GalXC-Plus RNAi technologies to develop RNAi-based treatments that are claimed to specifically silence disease-causing genes. Its RNAi technology platform provides access to intracellular disease targets in hepatic, as well as extrahepatic cell and tissue types.
With the takeover, Novo Nordisk will gain rights to Dicerna’s RNAi platform, an addition to the former’s current research technology platforms. Novo Nordisk plans to debt finance the takeover, which will lead to a rise in expenses related to research and development.
10 november | opioids
OKLAHOMA SUPREME COURT OVERTURNS RULING AGAINST J&J IN $465M OPIOID LAWSUIT
The Oklahoma State Supreme Court in the US has overturned a 2019 judgement that had ruled Johnson & Johnson (J&J) and its Janssen Pharmaceutical Companies were accountable for contributing to the opioid crisis.
The ruling was overturned after concluding that a lower court incorrectly interpreted the public nuisance law of Oklahoma.
This is the first case of its type to reach this stage of a trial in the US.
In the latest release, justice James Winchester noted: “We hold that the district court’s expansion of public nuisance law went too far.
“Oklahoma public nuisance law does not extend to the manufacturing, marketing, and selling of prescription opioids.”
10 november | regulation
BIOHAVEN AND PFIZER PARTNER TO MARKET MIGRAINE DRUGS OUTSIDE THE US
Pfizer has signed a collaboration and licence agreement to obtain rights to market Biohaven Pharmaceutical’s migraine drugs, rimegepant and zavegepant, outside the US.
An oral calcitonin gene-related peptide receptor antagonist (CGRP), rimegepant is marketed as Nurtec ODT in the US region.
The drug is also indicated as preventive therapy in adults with episodic migraine.
The EMA and other regulatory agencies outside the US are currently reviewing applications seeking approval for rimegepant.
An increased affinity small molecule CGRP receptor antagonist, zavegepant is being analysed in an intranasal delivery and a soft-gel formulation in Phase III trials for treating migraine.
10 november | deals
US TO PROCURE 1.4 MILLION COURSES OF MOLNUPIRAVIR FOR $1BN
The US Government will buy 1.4 million courses of Merck and Ridgeback Biotherapeutics’ molnupiravir for nearly $1bn.
This purchase is pursuant to obtaining emergency use authorisation or approval from the US Food and Drug Administration for the experimental antiviral pill to treat Covid-19.
An oral form of a potent ribonucleoside analogue, molnupiravir hinders SARS-CoV-2 virus replication.
With the latest option exercised, the US Government has committed to buy a total of 3.1 million courses for approximately $2.2bn. The courses will be supplied between receipt of authorisation and early next year.
09 november | approvals
FDA APPROVES ETON-AZURITY’S EPRONTIA ORAL SOLUTION FOR SEIZURES AND MIGRAINES
The US FDA has granted approval to Eton Pharmaceuticals and Azurity Pharmaceuticals’ Eprontia (topiramate) oral solution to treat seizures and migraines.
A liquid formulation of topiramate, Eprontia is now indicated as a single agent to treat partial-onset or primary generalised tonic-clonic seizures in individuals aged two years and above.
The oral solution is also approved as an adjunctive treatment for partial-onset seizures, primary generalised tonic-clonic seizures or seizures linked with Lennox-Gastaut syndrome in people aged two years and above.
Eton noted that Eprontia can be used as a preventive therapy for migraine in patients aged 12 years and above.
09 november | vaccines
UK TO ADD WHO EUL-LISTED COVID-19 SHOTS TO APPROVED VACCINES LIST
The UK Government has issued guidance to include the Covid-19 vaccines of Bharat Biotech, Sinovac and Sinopharm Beijing on the approved list of shots for travellers entering the country.
From 22 November, travellers who are fully inoculated with a Covid-19 vaccine listed on the World Health Organization’s emergency use listing (WHO EUL) will not be required to self-isolate.
A government statement said: “From 4am on Monday 22 November, we will recognise the following vaccines: Pfizer BioNTech, Oxford AstraZeneca (including Covishield), Moderna and Janssen (Johnson and Johnson), and WHO EUL including Sinovac, Sinopharm Beijing and Covaxin.
AstraZeneca and Ionis partner to develop antisense therapy eplontersen
AstraZeneca and Ionis Pharmaceuticals have signed an agreement to develop and market experimental therapy, eplontersen, wherein AstraZeneca will oversee the development and marketing of the treatment globally.
Eplontersen is a ligand-conjugated antisense treatment that can potentially lower transthyretin (TTR protein) production for treating TTR amyloidosis’ (ATTR) hereditary and non-hereditary forms.
Gritstone bio and CEPI extend deal to develop Omicron vaccine candidate
Gritstone bio and the Coalition for Epidemic Preparedness Innovations (CEPI) expanded their agreement to develop a self-amplifying mRNA (SAM) vaccine against the Omicron variant of the SARS-CoV-2 virus. Gritstone has already begun production of the vaccine. CEPI will provide up to $5m for a Phase I trial in South Africa.
EMA CHMP recommends granting approval for Roche’s therapy to treat Covid-19
The advice is based on data from trials where Actemra/RoActemra lowered death risk in severe or critical Covid-19 patients. If approved, the anti-interleukin 6 (IL-6) receptor biologic is intended for patients who are taking systemic corticosteroids and need supplemental oxygen. These individuals also require mechanical ventilation.
Canada enters deals to procure Merck and Pfizer’s Covid-19 antiviral pills
Pfizer anticipates supplying one million courses of its oral pill Paxlovid through 2022. Additionally, according to an agreement with Merck, Canada will obtain 500,000 courses of the company’s oral antiviral, molnupiravir, on obtaining authorisation from Health Canada. The government also holds options to procure upto 500,000 additional courses of molnupiravir.
EUCB and Novartis to co-develop two drug candidates for Parkinson’s Disease
Belgian pharmaceutical firm UCB has signed an agreement with Novartis to develop disease-modifying treatments for Parkinson’s Disease (PD) patients. Under the partnership deal, the companies will co-develop and market UCB0599, along with an opt-in to develop an anti-alpha-synuclein antibody, UCB7853, after the completion of a Phase I programme.
26 november | Vaccines
EMA RECOMMENDS PFIZER-BIONTECH’S COVID-19 VACCINE FOR CHILDREN
The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on the use of Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, in children aged five to 12 years.
Data from the trial showed that the vaccine had an efficacy of 90.7% in subjects seven days after the second dose was administered. The vaccine had a favourable safety profile, and offered strong immune responses.
23 November | DEALS
ARROWHEAD AND GSK SIGN DEAL FOR RNAI THERAPEUTIC ARO-HSD
Under the agreement, GSK will develop and market Arrowhead’s ARO-HSD for nonalcoholic steatohepatitis (NASH) treatment. A ribonucleic acid interference (RNAi) therapeutic, ARO-HSD acts on the HSD17B13 as a potential therapy for individuals with alcohol-related and nonalcohol associated liver diseases such as NASH.
Arrowhead is entitled to $120m in upfront payment from GSK, which will also make further payments of $30m on commencing a Phase II trial.
ICR researchers find drug combination to treat brain cancer in children
Researchers from the Institute of Cancer Research, UK, have identified a new combination of two approved cancer drugs that can be used to treat children suffering from incurable brain cancer.
Ocugen seeks FDA EUA for Covid-19 vaccine use in children
Ocugen has sought EUA from the US FDA for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.
Developed by Ocugen’s partner, India-based Bharat Biotech, and the Indian Council of Medical Research – National Institute of Virology, the whole-virion, inactivated vaccine is called Covaxin.
FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients
The US FDA has declined to grant an EUA for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.
In a letter to the company, the agency noted that its decision comes due to inadequate evidence on the known and possible benefits of the treatment and its risks in critical Covid-19 patients with respiratory failure.
Novartis and Dunad sign deal to develop protein degrader drugs
Novartis and UK-based company Dunad Therapeutics have signed a strategic partnership and licence agreement to develop oral targeted protein degrader small molecule therapies.
EMA stops rolling review of Lilly’s antibodies for Covid-19
The EMA has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.