Merck & Co. confirms $3bn takeover of EyeBio

 MSD has confirmed a $3 billion takeover deal for ophthalmology biotech EyeBio and its drug candidate for diabetic macular oedema (DME) and neovascular age-related macular degeneration (AMD).

The transaction – which includes an upfront cash payment of $1.3 billion and another $1.7 billion in milestones – was first reported by the Wall Street Journal this morning. MSD, known as Merck & Co in the US and Canada, said it expects to close the purchase of the US and UK-based biotech in the third quarter.

EyeBio’s main asset is Restoret, an intravitreally delivered trispecific antibody that acts as an agonist of the Wnt signalling pathway and is in the phase 1b/2a AMARONE study in DME and neovascular or ‘wet’ AMD – both major causes of sight loss. MSD said that it expects the drug to start a pivotal phase 2b/3 study in DME before the end of the year. 

Restoret is designed to resolve the leakage in retinal fluid that is seen in these diseases and often persists, despite treatment with standard anti-VEGF therapies, which while effective can produce unpredictable results and often don’t resolve leakage fully, meaning vision will continue to deteriorate.

Last November, EyeBio completed an upscaled Series A financing, raising $130 million for the future development of Restoret, shortly after completing the initial multiple ascending dose (MAD) part of the AMARONE study focusing on safety. The second part – a dose-finding stage that will look at safety, as well as preliminary efficacy, measures – is now underway.

VEGF-directed drugs like Bayer and Regeneron’s Eylea (aflibercept) generate billions of dollars in sales every year from their use in AMD, DME, and other retinal disorders, and EyeBio reckons a drug that addresses residual fluid could have big sales potential.

To give an idea of the size and potential of the opportunity, Eylea is the top-selling drug in the ophthalmic anti-VEGF category, with sales of around $9.5 billion last year, but could see biosimilar competition within the next few years. Meanwhile, Roche’s newer VEGFxAng-2 bispecific antibody Vabysmo (faricimab) – first approved in 2022 – is also gaining ground at a phenomenal pace, with sales reaching $2.7 billion last year and almost $930 million in the first quarter of 2024 alone.

With those sorts of numbers, it is unsurprising that MSD is interested in making a wager on Restoret and accelerating its clinical development, particularly as it looks ahead to the end of patent protection for its $25 billion-a-year cancer blockbuster Keytruda (pembrolizumab) from 2028.

The pharma group has been steadily bolting on acquisitions to boost its pipeline and product portfolio, notably buying Acceleron for $11.5 billion in 2021 and Prometheus for $10.8 billion a year later, along with several smaller-scale deals.

In its 2023 financial update, chief executive Rob Davis said the company was still interested in deals in the $1 billion to $15 billion range. The company all-but exited the ophthalmology sector a decade ago, but has retained an interest – licensing a drug for geographic atrophy from NGM Bio in 2015, for example – although, that failed a phase 2 trial in 2022 and the alliance was dissolved.

https://pharmaphorum.com/news/update-msd-confirms-3bn-takeover-eyebio

Viridian Details Phase 3 Program for Thyroid Eye Disease

 

• On track to initiate two phase 3 clinical trials of VRDN-003 in August 2024
• REVEAL-1 and REVEAL-2, will evaluate two active dosing regimens of subcutaneously (SC) administered VRDN-003 in active and chronic thyroid eye disease (TED), with topline readout anticipated in the first half of 2026 for both trials
• VRDN-003 Biologics License Application (BLA) submission anticipated by year-end 2026
• VRDN-003 is the only half-life extended anti-IGF-1R antibody in clinical development with the potential for convenient SC dosing as infrequently as every 8 weeks, for a total of 3 administrations

https://www.biospace.com/article/releases/viridian-therapeutics-announces-details-of-subcutaneous-vrdn-003-phase-3-clinical-program-for-patients-with-active-and-chronic-moderate-to-severe-thyroid-eye-disease/

NanoViricides Antiviral Results in Ideal Flat Blood Concentration for Sustained Antiviral Effect

 A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More

NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports that its clinical stage lead nanoviricide broad-spectrum antiviral drug candidate, NV-387, results in an ideal flat blood concentration profile for an extended time period upon oral administration in two different animal models.

This unusual but highly desirable, extended flat time profile of blood concentration of orally given NV-387 enables sustained antiviral effect over a long period of time, allowing infrequent dosing regimens.

The blood concentration of NV-387 increased to a peak in approximately the first hour, and then remained almost constant for eight hours or longer, thereafter, the concentration declined to reach baseline at about twelve hours; upon oral administration of a first dose of NV-387. This was found to be the case in studies involving two different animal models, namely, rats and dogs.

After repeated dosings, the plateau of the sixth dose lasted for at least 24 hours, thereafter declining to baseline at about 36 hours, in both the rat and dog animal models.

The same plateau profile phenomenon was observed in both male and female animals, as well as in both species of animals, namely, rat and dog.

The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoir of the drug in the host that releases the drug at a regular rate into the bloodstream.

The Company has recently reported that NV-387, when given as a slow bolus intravenous infusion, was found to result in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model.

https://www.biospace.com/article/releases/orally-administered-nv-387-results-in-ideal-flat-blood-concentration-profile-for-sustained-antiviral-effect-/

Capricor Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne

 --FDA Grants Pre-BLA Meeting Request and Rolling BLA Submission after Review of HOPE-2 and HOPE-2 OLE 3-Year Results--

https://www.biospace.com/article/releases/capricor-therapeutics-announces-positive-type-b-meeting-with-fda-for-cap-1002-program-for-duchenne-muscular-dystrophy-with-an-aim-to-expedite-bla-pathway/

GSK Appeals Delaware Court’s Decision in Zantac Cases as Plaintiff Drops Lawsuit

 GSK on Monday provided two updates on the legal cases surrounding its heartburn drug Zantac (ranitidine), including a voluntary plaintiff dismissal and an appeal of a recent decision by the Delaware State Court.

The company announced that the plaintiff Eugenia Kasza has voluntarily dropped her case against the pharma, which would otherwise have started trials in an Illinois state court on Monday. GSK said it did not settle Kasza’s claim “and has not paid anything in exchange for the voluntary dismissal.”

In her lawsuit, Kasza alleged that Zantac caused her breast cancer. However, GSK contends that 16 epidemiological studies of human data—taken together—show “no consistent or reliable evidence” that Zantac aggravates the risk of any cancer.

“GSK will continue to vigorously defend itself and manage this litigation in the best interests of the company and shareholders,” the company said in its statement.

As part of its defense efforts, GSK on Monday also announced that it has taken the first step to appeal the recent ruling by the Delaware State Court, which allowed plaintiff expert witnesses to testify in the Zantac cases. The ruling, released last week, sent GSK’s stocks tumbling 10%.

On Monday, the pharma said that it “strongly disagrees” with the court’s ruling, noting that it is “inconsistent with how the Daubert standard has been applied previously in Delaware and federal courts.” The Daubert standard helps courts determine whether expert testimony is admissible at a trial. It can be brought about by either the plaintiffs or defendants.

In its appeal of the court’s decision, GSK has asked for an interlocutory review which is typically granted only in exceptional situations. “GSK believes such circumstances are present here and that it is important to raise these matters now to the Delaware Supreme Court.” Pfizer, Sanofi and Boehringer Ingelheim are all part of the application.

First developed by Glaxo Holdings, which is now part of GSK, Zantac is a histamine 2-receptor antagonist that tempers the secretion of gastric acid, the main driver of heartburn. In 2019, the FDA said that it had found several samples of ranitidine to be contaminated with NDMA, an environmental impurity that the regulator classifies as a probable human carcinogen.

In April 2020, the FDA asked ranitidine manufacturers to withdraw their products as the NDMA contaminations could build over time and may expose patients to unacceptable levels of toxicity. There are still some 70,000 Zantac cases in the Delaware Superior Court, according to Reuters.

https://www.biospace.com/article/gsk-readies-appeal-of-delaware-court-s-decision-in-zantac-cases-as-plaintiff-drops-lawsuit/

Sage’s Dalzanemdor Shows Effect in Huntington’s Study, Analysts Say Results ‘Underwhelming’

 Sage Therapeutics announced Tuesday that its oral NMDA receptor dalzanemdor showed a slight numerical improvement in a small Phase II Huntington’s disease trial, while acknowledging the study was not designed to demonstrate a statistically significant difference between the drug candidate and placebo.

The Phase II SURVEYOR study, which included 40 patients with Huntington’s Disease (HD), was designed to investigate the magnitude of cognitive impairment compared to 29 healthy participants, as well as evaluate the safety of dalzanemdor.

Sage said the study met its primary endpoint of showing a statistically significant difference, as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score, at baseline between healthy participants and those with HD prior to treatment with dalzanemdor or placebo.

While Sage noted a “small numerical difference” between dalzanemdor and the placebo, using the HD-CAB score on day 28, no complex data was provided. At the same time, the company said other “prespecified analyses” showed potential positive signals and additional work is ongoing to analyze the data.

In addition, Sage reported that dalzanemdor was generally well-tolerated and no new safety signals were observed, though 11 participants with HD experienced treatment-emergent adverse events which were mostly mild to moderate in severity.

William Blair analysts in a Tuesday note to investors called the results “underwhelming” and said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive” based on the SURVEYOR results.

“While we agree that this finding is critical for advancing the understanding of the HD-CAB and for the design of studies of cognitive impairments in HD, it does not provide much data on the activity of dalzanemdor,” the analysts wrote.

Sage is also waiting to report topline data for the drug in another HD study as well as treatment with dalzanemdor in Alzheimer’s disease.

It’s been a rocky road for dalzanemdor which hit significant stumbling blocks in April. A Phase II trial in Parkinson’s disease did not demonstrate a substantial difference in the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score compared to placebo. The drug candidate also did not reach any exploratory endpoints, with Sage deciding to halt any further development for dalzanemdor in Parkinson’s.

https://www.biospace.com/article/sage-s-dalzanemdor-shows-some-effect-in-phase-ii-huntington-s-study-analysts-say-results-underwhelming-/

Target Hospitality Craters as Biden Admin Will Shutter ICE Facility In Dilley, Texas

 Shares of Target Hospitality were rocked on Tuesday morning, falling more than 35% during the cash session, after news broke that the government was planning on terminating a services agreement with the company's migrant programming partner.

The company offering rental accommodations with catering and hospitality services revealed that the U.S. government plans to end its contract with Target's partner for the current South Texas Family Residential Center situated in Dilley, Texas.

This termination is expected to take effect within 60 days, around August 9, MarketWatch reported.

Their report followed earlier reporting from The Wall Street Journal, stating that the Biden administration is shutting down an Immigration and Customs Enforcement detention facility in Dilley, which has historically housed migrant families apprehended for illegal border crossings.

The report said Biden was closing the center because "it is far more expensive to operate than other ICE facilities". In other words, we've got plenty of cash to send overseas and squander on foreign aid - but not enough to keep ICE facilities open.

Officials state that without new funding from Congress, Biden's ability to deport more migrants under the revised policy hinges on increasing detention space for those awaiting removal. Closing the Dilley facility would free up resources for approximately 1,600 extra detention beds elsewhere. 

Since 2021, Dilley has only housed single adults after Biden ceased detaining families there. Shutting it down entirely would hinder any attempt by a potential second-term President Trump to repurpose it for family detention, the report said.

The Journal notes that immigration advocates view Dilley as emblematic of harsh immigration policies, with children enduring prolonged stays. Lawyers and students nationwide represented families there, contesting deportations and seeking release.

Trump has pledged a massive deportation effort if re-elected, yet such action, especially against families, depends on available detention space. 

Dilley's layout, initially for oil workers, suited family detention with its cottages and separate areas, unlike typical centers designed for adults.

Opened under Obama to deter illegal crossings, Biden discontinued family detention in 2021, favoring release with monitoring. 

Biden's recent executive action subjects migrant families to swift deportation if ineligible for asylum, detaining some briefly before deportation flights, limited by a 2015 court ruling to about 20 days.

Meanwhile Target said it will provide updates on the operational and financial impact of this termination before June 30.

https://www.zerohedge.com/markets/target-hospitality-shares-crater-35-news-biden-admin-will-shutter-ice-facility-dilley-texas