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Enanta lawsuit claims Pfizer’s Paxlovid infringes its patent

US biotech Enanta Pharma has filed a lawsuit against Pfizer, claiming that its oral antiviral for COVID-19 Paxlovid
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US biotech Enanta Pharma has filed a lawsuit against Pfizer, claiming that its oral antiviral for COVID-19 Paxlovid infringes one of its patents and seeking damages from the pharma giant.

The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and was awarded earlier this month.

If the complaint is upheld, Enanta could be in line for a share of Pfizer’s revenues from Paxlovid, expected to make a colossal $22 billion in sales this year, after launching in December 2021.

Enanta has a long heritage in the development of antiviral compounds, working with AbbVie on therapies for hepatitis C virus (HCV) infection including Viekira Pak (paritaprevir/ritonavir/ombitasvir/dasabuvir) and Mavyret/Maviret (glecaprevir/pibrentasvir).

It is also developing its own therapies for respiratory syncytial virus (RSV), human metapneumovirus (hMPV) and chronic hepatitis B virus (HBV), and started work on COVID-19 early in in the pandemic focusing on 3CL protease – the same target as nirmatrelvir.

It has since advanced a lead candidate (EDP-235) into phase 1 clinical testing and claimed a fast-track designation for the drug from the FDA, according to court documents.

Enanta’s suit is asking for a judgment that Pfizer has infringed the ‘953 patent plus damages to compensate for that infringement and costs, with any award trebled because it claims the big pharma has done so wilfully.

The company said it “recognises the importance of Paxlovid’s availability to patients and does not intend to seek an injunction or take other action in this litigation that would impede the production, sale or distribution of Paxlovid.”

However, it “seeks fair compensation for Pfizer’s use of a coronavirus 3CL protease inhibitor claimed in the ‘953 patent.”

There’s a potential third wheel in the dispute, according to SVB Securities analyst Rosanna Ruiz, who said in a research note that Pardes Biosciences filed a patent on its 3CL protease inhibitor PBI-0451 earlier than Enanta, according to an Investors Business Daily report.

The legal challenge carries a risk as well, as it could cupper the development of Enanta’s drug – and possibly Pardes’ – if Pfizer can prove it was the first to develop a drug candidate targeting the protease. Either way, the legal wrangling is likely to take years to be resolved.

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Aging-US | Time makes histone H3 modifications drift in mouse liver

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone…

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BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone H3 modifications drift in mouse liver.”

Credit: Hillje et al.

BUFFALO, NY- June 30, 2022 – A new research paper was published in Aging (Aging-US) on the cover of Volume 14, Issue 12, entitled, “Time makes histone H3 modifications drift in mouse liver.”

Aging is known to involve epigenetic histone modifications, which are associated with transcriptional changes, occurring throughout the entire lifespan of an individual.

“So far, no study discloses any drift of histone marks in mammals which is time-dependent or influenced by pro-longevity caloric restriction treatment.”

To detect the epigenetic drift of time passing, researchers—from Istituto di Ricovero e Cura a Carattere Scientifico, University of Urbino ‘Carlo Bo’, University of Milan, and University of Padua—determined the genome-wide distributions of mono- and tri-methylated lysine 4 and acetylated and tri-methylated lysine 27 of histone H3 in the livers of healthy 3, 6 and 12 months old C57BL/6 mice. 

“In this study, we used chromatin immunoprecipitation sequencing technology to acquire 108 high-resolution profiles of H3K4me3, H3K4me1, H3K27me3 and H3K27ac from the livers of mice aged between 3 months and 12 months and fed 30% caloric restriction diet (CR) or standard diet (SD).”

The comparison of different age profiles of histone H3 marks revealed global redistribution of histone H3 modifications with time, in particular in intergenic regions and near transcription start sites, as well as altered correlation between the profiles of different histone modifications. Moreover, feeding mice with caloric restriction diet, a treatment known to retard aging, reduced the extent of changes occurring during the first year of life in these genomic regions.

“In conclusion, while our data do not establish that the observed changes in H3 modification are causally involved in aging, they indicate age, buffered by caloric restriction, releases the histone H3 marking process of transcriptional suppression in gene desert regions of mouse liver genome most of which remain to be functionally understood.”

DOI: https://doi.org/10.18632/aging.204107 

Corresponding Author: Marco Giorgio – marco.giorgio@unipd.it 

Keywords: epigenetics, aging, histones, ChIP-seq, diet

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About Aging-US:

Launched in 2009, Aging (Aging-US) publishes papers of general interest and biological significance in all fields of aging research and age-related diseases, including cancer—and now, with a special focus on COVID-19 vulnerability as an age-dependent syndrome. Topics in Aging go beyond traditional gerontology, including, but not limited to, cellular and molecular biology, human age-related diseases, pathology in model organisms, signal transduction pathways (e.g., p53, sirtuins, and PI-3K/AKT/mTOR, among others), and approaches to modulating these signaling pathways.

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FDA asks for COVID boosters to fight Omicron’s BA.4, BA.5 subvariants

The U.S. Food and Drug Administration on Thursday recommended booster doses of COVID-19 vaccines be modified beginning this fall to include components…

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FDA asks for COVID boosters to fight Omicron’s BA.4, BA.5 subvariants

By Michael Erman

June 30 (Reuters) – The U.S. Food and Drug Administration on Thursday recommended booster doses of COVID-19 vaccines be modified beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus.

The FDA said manufacturers would not need to change the vaccine for the primary vaccination series, saying the coming year will be “a transitional period when this modified booster vaccine may be introduced.”

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The new booster shots would be bivalent vaccines, meaning doses would target both the original virus as well as the Omicron subvariants.

The decision follows a recommendation by the agency’s outside advisers to change the design of the shots this fall in order to combat more prevalent versions of the coronavirus. read more

BA.4 and BA.5 are now estimated to account for more than 50% of U.S. infections, according the U.S. Centers for Disease Control and Prevention, and have also become dominant elsewhere.

The FDA said in a statement on Thursday that it hoped the modified vaccines could be used in early to mid-fall.

Pfizer Inc (PFE.N) with partner BioNTech SE (22UAy.DE) and Moderna Inc (MRNA.O) have been testing versions of their vaccines modified to combat the BA.1 Omicron variant that caused the massive surge in cases last winter.

Although they have said those vaccines worked against BA.1 and the more recently circulating variants, they did see a lower immune response against BA.4 and BA.5.

The companies had already been manufacturing their BA.1 vaccines, and said on Tuesday that swapping to a BA.4/BA.5 version could slow the rollout.

Pfizer/BioNTech, which on Wednesday announced a $3.2 billion contract to supply more COVID vaccine doses to the United States, said they would have a substantial amount of BA.4/BA.5 vaccine ready for distribution by the first week of October. read more

Moderna said it would be late October or early November before it would have the newly modified vaccine ready.

Reporting by Michael Erman in New Jersey and Leroy Leo in Bengaluru; Editing by Jonathan Oatis and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters

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Marketing automation startup Retail Rocket nabs $24M for expansion

Retail Rocket, a retention management platform for brands, today announced that it raised $24 million in a Series A round led by Cyprus-based private equity…

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Retail Rocket, a retention management platform for brands, today announced that it raised $24 million in a Series A round led by Cyprus-based private equity fund Flintera. In addition to the fundraising, Retail Rocket revealed that it acquired SailPlay, a startup developing software to help retailers build loyalty programs and send mass message campaigns.

New York-based SailPlay had raised $3.3 million prior to the acquisition. Founded in 2013 by Leonid Shangin and Yakov Filippenko, the company offered services to collect customer data and leverage it to create games, texts, and tasks designed to encourage repeat business.

As for Retail Rocket, it launched in 2012 headed by Moscow Business School of Management classmates, Nick Khlebinsky and Andrey Chizh, who’d attempted but failed to gain traction with several startups. The learnings from their previous efforts were the springboard for Retail Rocket, which after multiple pivots eventually grew its customer base to over 1,000 companies including Nintendo, Puma, and Decathlon.

“The digital marketing world is growing very fast and the demand for highly-skilled professionals is constantly increasing,” CEO Khlebinsky said. “The complexity of digital marketing tools is booming too — just several years ago we couldn’t imagine the technologies we use today.”

According to Khlebinsky, Retail Rocket uses a mathematical model to segment first-time buyers of a company’s product. By analyzing their actions — for example, the links they click on — the platform attempts to figure out their wants and preferences.

Image Credits: Retail Rocket

Retail Rocket also offers tools for campaign management like email marketing and web-based push notifications, as well as an engine that attempts to identify the best timing and communication channel (e.g., SMS) to make personalized offers. The goal is to create a “system of loyalty and retention management” for both online and offline customers, Khlebinsky said, that ultimately boosts business.

“We work with ecommerce on a performance-based pricing model,” Khlebinsky explained. “In most countries, the pandemic lockdowns spiked online sales, thus we experienced a temporary revenue increase. After the lockdown ended, there was a decrease, but to levels exceeding the pre-lockdown months, because a lot of people were forced to change their buying habits towards online shoppings.”

Absent independent reviews of Retail Rocket’s platform, it’s unclear whether its approach might beat out rivals like SalesForce, SAP, Bloomreach, and Dynamic Yield. But the promise of software that predictably drives repeat business is alluring. According to HubSpot, a mere 5% increase in customer retention can boost profits by 25% to 95%.

Retail Rocket has around 150 employees spread across offices in the Netherlands, Germany, Spain, Italy, and Chile, and it plans to double down on mergers and purchases in the coming months. Sources close to the company tell TechCrunch that Retail Rocket has $50 million set aside for acquisitions alone.

“Retail Rocket popped on our radars thanks to their international expansion and ability to set up sales teams in Europe and Latin America,” Flintera partner Sergey Vasin said in a statement. “We were impressed with the company’s results given the limited amount of investment they raised. The company was bootstrapping its growth after the seed round. Despite that, the efficiency of Retail Rocket products surpasses those of international competitors. We expect that the global e-commerce market will continue its growth at more than 10% per annum, with Latin America leading the race.”

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