Lilly to Buy European ADC Player Emergence Therapeutics

 To further boost its oncology business, Eli Lilly made its first move Thursday to acquire European startup Emergence Therapeutics, which is focused on developing novel antibody-drug conjugates for cancers with high unmet need.

The acquisition was first revealed in a short press announcement from Heidelberg Pharma, indicating that Lilly had purchased all of the German biotech’s shares in Emergence. Heidelberg Pharma is a founding investor in Emergence and will receive around $7 million this year from the transaction. The company may also see an additional $5 million payment depending on certain guarantees and clinical and regulatory milestones.

Lilly confirmed the news of the buyout to BioPharma Dive, but declined to provide further details regarding its ADC development pipeline.

Emergence’s most mature candidate is ETx-22, which targets Nectin-4, a surface protein commonly found on malignant cells but rarely expressed by healthy cells. According to Emergence’s website, the antigen has recently been clinically validated by the approval of Astellas and Seagen’s Padcev (enfortumab vedotin), another antibody-drug conjugate (ADC) that targets Nectin-4 for urothelial cancer.

Using a proprietary linker and payload technology, Emergence is developing ETx-22 to be a next-generation, Nectin-4-targeting ADC that can deconjugate from tumor cells. This technology is designed to reduce side effects such as skin toxicities, which is particularly dose-limiting for Padcev.

The tech also allows for higher doses of ETx-22, thereby increasing its efficacy without triggering more safety concerns, according to the company. To support the candidate’s development, Emergence secured around $94 million in Series A backing in December 2021.

Emergence is initially developing ETx-22 for bladder and triple-negative breast cancer, as well as malignancies with moderate and low Nectin-4 expression levels such as lung and ovarian cancer.

The startup is Lilly’s latest investment to deepen its cancer portfolio. In January 2019, Lilly bought Loxo Oncology for $8 billion, adding Loxo’s pipeline of oral inhibitors for various cancer types.

In February 2022, Lilly inked an ADC collaboration with ImmunoGen valued at up to $1.7 billion. Through the partnership, the pharma giant gains access to ImmunoGen’s camptothecin technology to develop anti-cancer treatments that target Type I topoisomerase.

Aside from the Emergence buyout, Lilly has also signed two other acquisition agreements this month alone. On Thursday, the pharma company announced a deal potentially worth $300 million to buy its diabetes partner Sigilon Therapeutics, with which it has been developing a Type 1 diabetes treatment.

Last week, Lilly acquired DICE Therapeutics for around $2.4 billion. The deal will give Lilly DICE’s proprietary platform to produce small molecules drugs that disrupt protein-protein interactions to address autoimmune and inflammatory diseases.

https://www.biospace.com/article/lilly-to-buy-european-adc-player-emergence-therapeutics/

Madrigal starts rolling submission for FDA approval of NASH treatment

 Madrigal Pharmaceuticals Inc.'s stock (MDGL) rose 5% Friday after the company said it has started a rolling submission of a New Drug Application to the U.S. Food and Drug Administration seeking accelerated approval of its resmetirom as a treatment for, nonalcoholic steatohepatitis, or NASH, with liver fibrosis. NASH is a more severe version of nonalcoholic fatty liver disease, or NAFLD, a range of conditions that occurs when excess fat builds up in liver cells. An estimated 25% of Americans have NAFLD, while about 20% of those patients end up developing NASH, in which the inflammation and cell damage caused by the fat buildup can cause cirrhosis and liver failure. The disease is one of the main reasons patients require liver transplants. Resmetirom was granted FDA Breakthrough Therapy designation in April for the treatment of NASH patients with liver fibrosis. Conshohocken, Pa.-based Madrigal is currently conducting a Phase 3 trial of the therapy. The company expects the NDA to be completed by July. For more, see: Inside the NASH drug boom: New drugs for a 'silent' liver disease that affects millions near FDA approval

https://www.morningstar.com/news/marketwatch/20230630500/madrigal-pharmaceuticals-stock-up-5-as-company-starts-rolling-submission-for-fda-approval-of-nash-treatment

Toxic Wildfire Smoke Blankets Ten States As Independence Day Weekend Begins

 As the Fourth of July weekend approaches, tens of millions of Americans are heading off today to either sandy beaches or resort communities in the mountains. Some folks are staying home or traveling short distances because 'Bidenomics' has miserably failed and bankrupted mid/low-tier households who can no longer afford an Airbnb or hotel in a resort area. But the one thing in common that millions across the Mid-Atlantic and up and down the Northeast regions are all experiencing into the holiday weekend is the lingering wildfire smoke from Canada. 

The National Weather Service issued air quality alerts over parts of the Midwest, Great Lakes, central Appalachians, Northeast, and Mid-Atlantic through the weekend. 

"Canadian wildfire smoke is expected to continue impacting portions of the northeastern quadrant of the U.S. over the next few days," NWS wrote in a Friday morning update. 

NWS had some good news: "However, air quality is expected to slowly improve due to a combination of thunderstorm activity and dispersion of the smoke as we head into the weekend." 

Still, toxic air quality alerts stretch from Michigan to Ohio, West Virginia to Pennsvyina to Maryland, Washington, DC, Virginia, Delaware, New Jersey, New York, and into the lower New England area. 

The unhealthy air is terrible for people with heart or lung disease, older adults, children, and teens. Pittsburgh had the worst air quality this morning. 

Instead of blaming 'climate change' for everything... Maybe Canada's 500 raging wildfires have resulted from bad fire management over the last few decades. Plus, it's an El Nino year... 

https://www.zerohedge.com/weather/toxic-wildfire-smoke-blankets-ten-states-independence-day-weekend-begins

Planned Parenthood Declares Virginity "A Social Construct"

 by Steve Watson via Summit News,

Planned Parenthood has received backlash after posting a tweet declaring that virginity is “outdated” and “hurts everyone.”

The post featured a billboard with a further declaration “Virginity is a social construct,” and claiming that the concept of virginity is a “patriarchal’ way of thinking:

The idea of virginity comes from outdated — let's be real, patriarchal— ways of thinking that hurts everyone. 📢 pic.twitter.com/QYmNbEZzbw

— Planned Parenthood (@PPFA) June 29, 2023

The organisation has pushed this idea for a while now…

Idk who needs to hear this but virginity is a made-up social construct, and it has absolutely nothing to do with your hymen.

— Planned Parenthood (@PPFA) November 6, 2019

Twitter, do your thing...

Groomers

— Lady Lisa ♥️🇺🇸♥️ (@SumSol44) June 29, 2023

Either you’ve had sex or you haven’t. How is that a “social construct”?

— Alexis K (@AlexisKat6) June 29, 2023

Unethical behavior is so much easier to justify when everything's a social construct!

— Alex Schirmer (@alexschcom) June 30, 2023

We know you need promiscuity to make money. It’s gross.

— Jessica O’Donnell 🏈 (@heckyessica) June 29, 2023

Same people

https://www.zerohedge.com/political/outrage-planned-parenthood-declares-virginity-social-construct

Arcutis up 15% on growth in prescriptions for Zoryve cream

 Arcutis Biotherapeutics (ARQT) is up 15% Friday as the Street applauded new prescription data for the company's psoriasis cream Zoryve.

https://seekingalpha.com/news/3984664-arcutis-up-15-growth-prescriptions-zoryve-psoriasis-cream

Abcam Receives Multiple Takeover Approaches Amidst Growing Polyclonal Antibodies Market

 On June 30, 2023, Abcam, a renowned biotechnology supplier based in the UK, found itself at the center of attention as it received multiple takeover approaches from various companies. Among the interested parties were Danaher, Agilent Technologies, and Germany’s Merck KGaA. This news caused a significant surge in Abcam’s ADRs, with a 4% increase. It is worth mentioning that Danaher had previously abandoned a takeover pursuit of another company called Catalent.

The growing global polyclonal antibodies market, which is projected to witness a 4% compound annual growth rate (CAGR) by 2029, could potentially contribute to the heightened interest in Abcam.

https://beststocks.com/abcam-receives-multiple-takeover-approaches-a/

Biden moves ahead with Medicare drug price negotiations amid industry lawsuits

 Undeterred by a growing number of lawsuits, the Biden administration on Friday released revised guidance for Medicare’s new drug price negotiation program.

The latest guidance outlines how the Centers for Medicare and Medicaid Services will negotiate with drugmakers to reach agreement on a maximum fair price for a selected medicine, the agency said. It was informed by public input on the initial guidance the agency released in March, which explained how it will select the drugs and how the negotiations will be conducted.

The program, which was authorized by the Inflation Reduction Act that congressional Democrats passed last year, has prompted a fierce backlash from the pharmaceutical industry. Two drug manufacturers and two industry groups have filed lawsuits, arguing the measure is unconstitutional.

But the administration is not backing down from implementing its historic new power. It intends to keep its timeline of announcing the first 10 drugs that will be selected for negotiation by September 1. CMS and the drugmakers will negotiate during 2023 and 2024. The prices will be effective starting in 2026.

“The Biden-Harris Administration isn’t letting anything get in our way of delivering lower drug costs for Americans,” Secretary of Health and Human Services Xavier Becerra said in a statement. “Pharmaceutical companies have made record profits for decades. Now they’re lining up to block this Administration’s work to negotiate for better drug prices for our families. We won’t be deterred.”

The initial set of drugs will be chosen from the top 50 Part D drugs that are eligible for negotiation that have the highest total expenditures in Medicare. CMS will consider multiple factors when developing its initial offer, including the drugs’ clinical benefits, the price of alternatives, research and development costs and patent protection, among others.

If drugmakers don’t comply with the process, they will have to pay an excise tax of up to 95% of the medications’ US sales or pull all their drugs from the Medicare and Medicaid markets. The pharmaceutical industry contends that the true penalty can be as high as 1,900% of sales.

Changes to the process

CMS said it received more than 7,500 comments on its initial guidance from patient groups, drug companies, pharmacies and others.

The changes it is making are aimed at improving transparency and fostering “an effective negotiation process,” the agency said.

They include revising the confidentiality process to state that CMS will release information about the negotiations when it publishes the explanations of the prices. Also, drug companies may publicly discuss the negotiations – the prior secrecy requirement had been a point of contention among manufacturers that was mentioned in the lawsuits.

In addition, CMS will hold patient-focused listening sessions to provide drug companies and the public more opportunities to engage with the agency. The sessions – which will give patients, caregivers and others the chance to share input on how a medication addresses unmet needs, how it impacts specific populations and what therapeutic alternatives exist – will be held in the fall for the first round of drugs.

Mounting lawsuits

Merck, Bristol Myers Squibb, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, and the US Chamber of Commerce have all recently filed lawsuits in federal courts across the US. They each argue the program is unconstitutional in various ways.

The challengers also say that the negotiation provision will harm innovation and patients’ access to new drugs.

Among the arguments are that the program violates the Fifth Amendment’s “takings” clause because it allows Medicare to obtain manufacturers’ patented drugs, which are private property, without paying fair market value under the threat of serious penalties.

Plus, the negotiations process violates the First Amendment, the challengers say, because it coerces manufacturers into saying that they agree to the price that the government has dictated and that it’s fair.

Another argument is that the process violates the Eighth Amendment by levying an excessive fine if drugmakers refuse to negotiate and continue selling their products to the Medicare market.

Merck expects its diabetes drug Januvia to be among the drugs named in September and its blockbuster cancer treatment Keytruda and diabetes drug Janumet to be subject to negotiation in the future. Bristol Myers Squibb believes its blood thinning medication, Eliquis, will be subject to negotiations this year, and its cancer medication, Opdivo, will be selected in a subsequent round.

“The price setting provisions in the IRA are bad policy,” PhRMA CEO Stephen Ubl said in a press conference last week. “They threaten our industry’s ability to research and develop new treatments and cures. They put access to innovative medicines at risk for Americans today and in the future. And they jeopardize providers’ ability to prescribe the treatments they believe are in the best interest of their patients.”

https://www.cnn.com/2023/06/30/politics/medicare-drug-price-negotiations-new-guidance/index.html