FDA issues complete response letter for Merck’s chronic cough treatment
25 January | FDA
The US FDA has issued a complete response letter (CRL) to Merck’s (MSD) New Drug Application (NDA) for gefapixant to treat adults with refractory chronic cough (RCC) or unexplained chronic cough (UCC). Gefapixant is an investigational, oral, non-narcotic, selective P2X3 receptor antagonist.
In the CRL, the regulatory agency sought further data linked to the measurement of efficacy. Merck noted that the CRL issued by the FDA was not related to gefapixant’s safety. The company is currently reviewing the CRL and will hold discussions with the FDA for further steps. In September 2020, Merck reported positive data from Phase III COUGH-1 and COUGH-2 trials of gefapixant for treating refractory or unexplained chronic cough, with a statistically significant decline in 24-hour cough frequency versus placebo. The studies evaluated a twice-daily dose of 45mg gefapixant in adults for 12 weeks in COUGH-1 and 24 weeks in COUGH-2.
2 February | HIV
GSK’S VIIV HEALTHCARE ENTERS PATENT DISPUTE SETTLEMENT AGREEMENT WITH GILEAD
GlaxoSmithKline (GSK) has announced a settlement of a patent dispute between ViiV Healthcare and Gilead Sciences. ViiV agreed to the settlement of the worldwide patent infringement litigation between GSK, Shionogi and Gilead over its patents linked to an antiretroviral therapy, dolutegravir, used for the treatment of human immunodeficiency virus (HIV), along with other medicines. ViiV Healthcare, GSK and Shionogi claimed Gilead’s Biktarvy infringed some of the patents linked to dolutegravir. Biktarvy combines three HIV therapies namely an inhibitor of HIV integrase bictegravir, tenofovir alafenamide and emtricitabine. Patent infringement lawsuits in the US, the UK, Ireland, France, Japan, Germany, Korea, Canada and Australia will be dropped as a result of the latest agreement.
20 January | M&A
UCB TO BUY RARE DISEASE THERAPIES DEVELOPER ZOGENIX FOR $1.9BN
The company’s subsidiary will be merged into Zogenix and the remaining shares of Zogenix common stock will be cancelled. Under the deal, the company will initiate a tender offer through its subsidiary Zinc Merger Sub to buy all Zogenix’s outstanding shares for $26 per share in cash. The deal value also includes a contingent value right (CVR) for a $2 cash payment after receiving EU approval of Fintepla as an orphan medicine by 31 December 2023. Fintepla (fenfluramine) C-IV oral solution has received approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to treat seizures associated with Dravet syndrome in patients aged two years and above.
4 February | COVID-19
FDA CLEARS PARDES’ IND APPLICATION FOR ORAL COVID-19 ANTIVIRAL DRUG
The US Food and Drug Administration (FDA) has granted clearance to Pardes Biosciences’ Investigational New Drug (IND) application for its oral antiviral drug candidate, PBI-0451, to treat and prevent Covid-19.
At present, PBI-0451 is being analysed in a Phase I dose-escalation clinical trial in New Zealand. The blinded, placebo-controlled, randomised trial is designed to assess PBI-0451’s safety, tolerability and pharmacokinetics following single and multiple ascending dose administration. The company expects trial results in the current quarter of this year.
An orally bioavailable direct-acting antiviral (DAA) main protease (Mpro) inhibitor, PBI-0451 is under development for preventing and treating Covid-19 infection caused by the SARS-CoV-2 virus as well as associated ailments. Mpro is an essential protein needed for coronaviruses replication.
19 January | M&A
PROKIDNEY SIGNS SPAC MERGER DEAL WITH SOCIAL CAPITAL SUVRETTA
ProKidney has signed a definitive agreement for a business combination with special purpose acquisition company (SPAC) Social Capital Suvretta Holdings Corp. III (SCS), according to an announcement. The deal, which will make ProKidney a publicly-traded company, values the combined entity at $2.64bn. It is anticipated to offer gross cash proceeds of up to $825m, comprising up to $250m of cash in the trust account of SCS and a $575m fully committed private investment in public equity (PIPE). The PIPE is led by investment from Social Capital, Suvretta Capital’s Averill strategy, current investors of ProKidney, institutional investors and family offices.
14 January | R&D
BENEVOLENTAI AND ASTRAZENECA EXPAND DRUG DISCOVERY PARTNERSHIP
BenevolentAI and AstraZeneca have announced the expansion of their artificial intelligence (AI)-powered drug discovery partnership to include disease areas, systemic lupus erythematosus (SLE) and heart failure (HF). The three-year collaboration extension comprises an upfront payment, funding for research, payments on meeting development milestones and tiered royalty payments on revenues in the future. The latest expansion builds on the long-term partnership entered in 2019.During that year, the companies collaborated to leverage AI and machine learning to discover and develop new therapies for the treatment of chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).
Cocrystal Pharma to develop two antiviral drugs as oral Covid-19 therapies
Cocrystal Pharma has announced the selection of two investigational antiviral drug candidates, CDI-988 and CDI-873, to further develop them as oral therapies to treat Covid-19.
Novavax and Israel enter Covid-19 vaccine supply deal
In the initial stage, Novavax will supply five million doses of the protein-based Covid-19 vaccine to Israel. With the latest development, Novavax’s vaccine will become the first protein-based substitute to be offered in Israel.
FDA grants full approval for Moderna’s Covid-19 vaccine
The Spikevax vaccine is currently approved by regulatory agencies in over 70 countries. It is given as an initial two-dose regimen administered at a gap of one month.
Zydus starts Covid-19 vaccine supplies to Indian Government
Zydus commenced the delivery of the first consignment of its Covid-19 deoxyribonucleic acid (DNA) Plasmid vaccine, ZyCoV-D, to the Government of India. The vaccine supplies are made from the company’s recently commissioned Zydus Vaccine Technology Excellence Centre.
University of Oxford to evaluate repurposed antiviral drugs for Covid-19
The $2.16m project will assess 138 drugs with antiviral activity against the SARS-CoV-2 virus. As part of the project, the team will quickly detect new combinations of drugs that could effectively treat Covid-19 by using a data-guided approach.
8 February | OPIOIDS
TEVA TO PAY $225M TO SETTLE OPIOID CLAIMS IN TEXAS
According to the contract, the company will make a $150m payment to the state for a period of 15 years. Teva will also offer supplies of Narcan a lifesaving generic, to reverse opioid overdoses for more than ten years at a wholesale acquisition cost of $75m. In May 2019, the company agreed to pay $85m to Oklahoma to resolve allegations that the illegal marketing of its pain medication contributed to the opioid epidemic in the US.
3 February | RARE DISEASE
FDA GRANTS ORPHAN DRUG STATUS TO SYROS’ MYELODYSPLASTIC SYNDROME THERAPY
The US FDA has granted orphan drug designation (ODD) to Syros Pharmaceuticals’ oral therapy, tamibarotene, to treat myelodysplastic syndrome (MDS). Tamibarotene is a selective retinoic acid receptor alpha (RARα) agonist. At present, oral therapy is being analysed along with azacitidine in the Phase III SELECT-MDS-1 clinical trial to treat RARA-positive individuals with recently detected higher-risk MDS (HR-MDS). This ongoing trial is assessing the safety and efficacy of the combination treatment.
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.