Regeneron quarterly profit beats Wall Street estimates on strong drug sales

 Regeneron Pharmaceuticals on Friday reported a quarterly profit that beat analysts’ estimates, benefiting from a recovery in demand for its flagship eye drug and a jump in sales of its eczema drug.

Physician-administered macular degeneration drug Eylea sales were hurt during the height of the pandemic last year as patients were reluctant to visit doctors’ offices.

As lockdowns eased, U.S. sales of the drug rose nearly 10% to $1.34 billion for the fourth quarter.

Sales from eczema drug Dupixent, which are recorded by Regeneron partner Sanofi, were $1.17 billion, compared to $751.5 million a year earlier.

Regeneron earned $9.53 per share on an adjusted basis, beating estimates of $8.39 per share, according to Refinitiv IBES data.

https://www.cnbc.com/2021/02/05/regeneron-pharmaceuticals-regn-q4-2020-earnings.html

CureVac, UK to Collaborate on Vaccines Against SARS-CoV-2 Variants

 CureVac N.V. (NASDAQ:CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced that it has entered a collaboration with the UK Government to develop and manufacture potential vaccine candidates against SARS-CoV-2 variants. Any resulting vaccine candidates will be manufactured and distributed in the UK and its overseas and dependent territories, subject to regulatory approval. The objective of the collaboration is to mitigate the effects of the current pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.

"One of the biggest challenges we continue to face in combating COVID-19 is the emergence of multiple variants, each of which poses a potentially significant threat to public health," said Dr. Antony Blanc, Chief Business Officer and Chief Commercial Officer of CureVac. "The UK Government and its Vaccines Taskforce (VTF) has been at the forefront of surveillance, vaccine development and delivery of vaccines for deployment during this pandemic. At CureVac, we believe we have the ability to quickly adapt our mRNA technology to address current variants and prepare for the emergence of new strains. This collaboration is expected to bring to bear our significant combined forces to ensure vaccines keep winning against COVID-19."

Dr Clive Dix, Interim Chair of the UK Vaccines Task Force added : "Today's agreement will help ensure the UK is best prepared against the emergence of any significant new virus variant as mRNA vaccines can be rapidly adapted to be effective against new virus variants more easily than traditional vaccine technologies. We are constantly tracking the virus so we can identify any significant new variant as quickly as possible; therefore, as part of this agreement, CureVac and the UK Government will assess multiple virus variants and are expected to generate multiple vaccine candidates against those selected."

The research and development collaboration combines CureVac's resources and technological expertise in mRNA vaccine development with the scientific experience of the Vaccines Taskforce and the UK's network of experts and capabilities in SARS-CoV-2 vaccine research and development. As part of the collaboration, the VTF, informed by the newly-formed Variant Vaccine Expert Advisory Group, and CureVac, with its unique mRNA vaccine platform, will assess multiple SARS-CoV-2 variants and are expected to generate vaccine candidates against those selected. Clinical studies will be expedited in the UK in order to secure emergency or conditional marketing authorizations for selected vaccine candidates against the most threatening variant viruses.

CureVac will also transfer its technology to enable the manufacturing of clinical and commercial quantities of any vaccines that result from the collaboration, as well as manufacturing of CureVac's existing vaccine against SARS-CoV-2 (CVnCoV), which is currently in Phase 3 clinical trials.

https://www.biospace.com/article/releases/curevac-and-uk-government-to-collaborate-on-development-of-vaccines-against-sars-cov-2-variants/

I-Mab Advances Antibody Uliledlimab in US, China

 I-Mab (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, today announced multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors. The Company plans to present detailed clinical results at select scientific conferences this year.

https://www.biospace.com/article/releases/i-mab-announces-multiple-clinical-advancements-of-its-differentiated-cd73-antibody-uliledlimab-in-china-and-the-u-s-/

AstraZeneca's Imfinzi drug fails in head and neck cancer trial

 AstraZeneca said on Friday its Imfinzi drug did not prolong survival in a trial testing it as an initial treatment of head and neck cancer, a setback in its push to widen use of the immunotherapy beyond lung cancer.

Revenues from Imfinzi, mainly used against certain types of lung cancer, gained 42% to $1.48 billion in the first nine months of 2020, its fastest growing product.

“We will continue to build on the established benefits of Imfinzi in early lung cancer and small cell lung cancer, to bring immunotherapy treatment options to all patients who may benefit,” said Astra’s head of oncology, Dave Fredrickson.

The drug is also being tested against tumours affecting the bladder and cervix, among other cancer types.

https://www.reuters.com/article/astrazeneca-cancer/update-1-astrazenecas-imfinzi-drug-fails-in-head-and-neck-cancer-trial-idUSL4N2KB29E

Sanofi eyes mores savings, higher profitability after earnings rise

 Sanofi said on Friday it aimed to grow earnings per share this year after it posted stronger-than-expected results in the fourth quarter, and the drugmaker committed to boosting cost savings and profitability further through to 2025.

The French firm, which stunned investors last year with the delay of a COVID-19 vaccine candidate, confirmed an operating income margin target of 30% for 2022 and set itself a goal to improve it to more than 32% three years later.

The company is hosting a virtual investor day later on Friday that will largely focus upcoming drugs.

https://www.reuters.com/article/sanofi-results/sanofi-eyes-mores-savings-higher-profitability-after-earnings-rise-idUSL8N2KA6SU

Pfizer Confirms U.S. Patent Term Extension for IBRANCE tol March 2027

 Pfizer Inc. (NYSE: PFE) today announced that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE® (palbociclib). The certificate extends the term of U.S. Patent No. RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

https://www.businesswire.com/news/home/20210205005079/en/Pfizer-Confirms-U.S.-Patent-Term-Extension-for-IBRANCE%C2%AE-palbociclib-Until-March-2027

Spero Therapeutics: FDA Hold on SPR720 Phase 2a Trial

 Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant bacterial infections and rare diseases, today announced that the United States Food and Drug Administration (FDA) informed Spero that a clinical hold has been placed on its Phase 2a clinical trial of SPR720, Spero’s investigational oral antimicrobial agent being evaluated in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

Spero received verbal notification of the clinical hold for the SPR720 Phase 2a trial but has not yet received written notice from the FDA. The clinical hold follows the notification by Spero to the FDA of its decision to pause dosing in its ongoing Phase 2a clinical trial of SPR720 as a precautionary measure following events in its ongoing animal toxicology study of SPR720. The decision to implement the pause was made based on a recommendation from Spero’s Safety Review Board (SRB), following review of data from an ongoing toxicology study of SPR720 in adult non-human primates in which mortalities with inconclusive causality to treatment were observed. The animal study is being conducted to assess the potential toxicity of SPR720 over a 4-month duration. A concurrent 4-month study of SPR720 in rats is proceeding uneventfully. These studies are meant to support longer-term treatment with SPR720 beyond the 28 days currently supported by IND-enabling toxicology studies. Spero is in discussion with FDA to evaluate the findings and determine the further development pathway for the SPR720 clinical program. No serious adverse events have been observed in any human study participants.

https://www.globenewswire.com/news-release/2021/02/05/2170670/0/en/Spero-Therapeutics-Provides-Update-on-SPR720-Phase-2a-Clinical-Trial.html