J&J Inks $1.25B Deal to Buy Rights to Atopic Dermatitis Candidate from Numab

 Johnson & Johnson is continuing its buying activity in the skin disease space, announcing Tuesday plans to purchase Yellow Jersey Therapeutics, a subsidiary of Numab Therapeutics, and its bispecific antibody NM26 for $1.25 billion in cash. 

NM26, which started Phase I dosing in 2023, is ready to enter Phase II studies and targets two pathways to treat the skin disease atopic dermatitis (AD) or eczema. The pathways are the IL-4R alpha subunit (IL-4Rα) and IL-31. Il-4Rα triggers Th2-mediated skin inflammation, while Il-31 impacts skin itching and eventual scratching that worsen the condition.

“We are committed to developing differentiated bispecifics that combine the targeting of two distinct disease-driving pathways. NM26 can potentially deliver a treatment specifically for patients with inflamed skin associated with intense itching,” David Lee, the global immunology therapeutic area head at J&J Innovative Medicine, said in a statement.

J&J contends the candidate could effectively treat other inflammatory skin diseases that involve Th2 inflammation and itching. The deal is expected to close in the second half of 2024.

Earlier this month, J&J announced it purchased biotech Proteologix and its bispecific antibody for AD for $850 million in a cash deal and a preclinical antibody. The candidate PX128 targets interleukin 13 TSLP and is in a Phase I trial for AD. The preclinical asset that J&J also scooped up in the deal, PX130, targets Il-13 and Il-22 for moderate to severe AD. 

“Our goal is to deliver transformational efficacy for all patients living with immune mediated diseases like AD,” Candice Long, worldwide vice president of immunology at J&J, said in a statement. “Our investment in differentiated bispecifics is the next chapter in our impactful Immunology legacy. It reinforces our commitment to address unmet medical needs by leveraging patient insights and our deep disease expertise.”

Numab has forged partnerships with other pharmaceutical companies, such as a development and licensing agreement with Ono Pharmaceutical in March 2024 to find an immuno-oncology candidate. The Swiss biotech received CHF 258 million ($283 million) in upfront research and milestone payments in that deal. Numab has also entered into previous development agreements with Eisai and Boehringer Ingelheim.

https://www.biospace.com/article/j-and-j-inks-1-25b-deal-to-buy-rights-to-atopic-dermatitis-candidate-from-numab-therapeutics-/

Why Summit Therapeutics Stock Is Sinking

 Shares of Summit Therapeutics (NASDAQ: SMMT) were sinking 22.6% as of 11:10 a.m. ET on Tuesday. This sell-off follows a similar steep decline of 22% on Friday after Summit revealed late-stage data for its lead candidate, ivonescimab, in combination with chemotherapy in treating non-small cell lung cancer (NSCLC).

In a regulatory filing on Friday, Summit referenced top-line data included in a presentation by its Chinese partner, Akeso, at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. Patients receiving ivonescimab in combination with chemotherapy had a median progression-free survival of 7.06 months compared to 4.8 months for patients receiving only chemotherapy. However, 61.5% of patients receiving the combo experienced severe or medically significant treatment-emergent adverse events.

Some good news for Summit Therapeutics

Investors reacted negatively to the late-stage data for ivonescimab. However, there was some good news: China's National Medical Products Administration gave the drug its first regulatory approval on Friday as a second-line treatment for patients with epidermal growth factor receptor (EFGR) mutated, advanced or metastatic NSCLC.

Was there any silver lining in the safety data presented by Akeso? Perhaps: Summit noted that the most common serious adverse events were related to chemotherapy rather than ivonescimab.

Is Summit Therapeutics stock a buy on the pullback?

Some aggressive investors could view Summit Therapeutics' pullback as a buying opportunity. However, I think that most investors will be better off staying on the sidelines with this clinical-stage biotech stock. Other stocks  likely offer more attractive risk-reward propositions.

https://finance.yahoo.com/m/79594eb4-4f42-35a0-865f-4ef81fda56c4/why-summit-therapeutics-stock.html

Why Is Sharps Technology (STSS) Stock Up

 

• Sharps Technology (STSS) stock is up alongside a five-year purchase agreement.
• This covers $188.5 million of syringes made by it.
• That agreement is with Nephron.

Sharps Technology (NASDAQ:STSS) stock is rocketing higher on Tuesday after the company announced a potential five-year purchase agreement with Nephron.

This agreement has Nephron making Sharps Technology its exclusive pre-filled copolymer syringe manufacturer. That will see it purchase a minimum of $188.5 million of syringes over those five years.

The purchase agreement also includes an amendment to the cash consideration between the two companies. That includes $35 million payable in cash on closing. $1 million of that will be payable as a deposit within 14 days of approval by the seller’s senior lender.

It’s worth noting that the five-year purchase agreement with Nephron hasn’t gone into effect just yet. Instead, it will only do so after the completion of an asset purchase agreement between the two companies.

https://investorplace.com/2024/05/why-is-sharps-technology-stss-stock-up-194-today/

Nippon Shinyaku’s DMD drug fails confirmatory trial

 The future of Nippon Shinyaku’s Duchenne muscular dystrophy (DMD) therapy Viltepso has been thrown into doubt after it failed a clinical trial designed to upgrade its 2020 accelerated approval.

The Japanese group’s NS Pharma subsidiary has revealed that Viltepso (viltolarsen) missed its primary objective in the confirmatory RACER53 trial, and was unable to distinguish itself from placebo in the time taken for DMD patients to stand up from a supine position.

The exon-skipping drug was approved by the FDA for DMD patients with mutations in the dystrophin gene amenable to exon 53 skipping, a group that accounts for around 8% of the total DMD population.

It was the second exon 53-skipping drug to reach the US market after Sarepta’s rival Vyondys 53 (golodirsen), which was controversially cleared by the FDA in 2019 after a previous rejection and an appeal from the company.

NS Pharma said in a statement that “continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.”

The RACER53 Study compared Viltepso as an 80 mg/kg once weekly dose to placebo in 77 ambulatory boys with DMD over 48 weeks. There was a trend towards an increase in time to stand from supine (TSS) with NS Pharma’s drug, but the placebo group showed a similar trend, making it impossible to show a significant difference, according to the company.

NS Pharma’s president, Tsugio Tanaka, said additional analyses are being undertaken to see if other factors confounded the result, such as age, treatment period, and use of concomitant drugs like corticosteroids.

“Considering the results of prior clinical studies, we have confidence that viltolarsen can be a beneficial treatment for amenable patients with Duchenne,” he asserted.

Sales of Viltepso were around $90 million last year, while Sarepta’s Vyondys 53 and other exon-skipping DMD therapies Exondys 51 (eteplirsen) and Amondys 45 (casimersen) collectively brought in around $950 million. Vyondys 53 contributed $130 million of that total.

Exon-skipping therapies could, however, become superseded by a new generation of gene therapies for DMD, led by Sarepta’s Elevidys (delandistrogene moxeparvovec), which was cleared by the FDA for ambulatory patients aged four to five in the middle of 2023 and had generated $200 million in sales by year-end, of which $131 million came in the fourth quarter.

Sarepta recently filed for approval to extend the label for Elevidys to include all ambulatory DMD patients, despite missing its primary objective in a phase 3 trial.

https://pharmaphorum.com/news/nippon-shinyakus-dmd-drug-fails-confirmatory-trial

Asahi Kasei makes $1.1bn bid to buy Calliditas

 Asahi Kasei has offered to buy Sweden’s Calliditas Therapeutics for SEK 11.8 billion ($1.1 billion) as part of a plan to expand internationally in healthcare.

The Japanese group’s tender offer is a premium of around 83% on Calliditas’ closing share price yesterday and has been recommended by the biotech’s board, which says a takeover would enhance its ability to develop and commercialise its products.

Calliditas specialises in developing drugs for rare diseases and has one product on the market – corticosteroid-based Tarpeyo (budesonide) for IgA nephropathy (IgAN) which is also sold as Nefecon in China and Kinpeygo in Europe – and a pipeline headed by dual NADPH oxidase (NOX4/1) inhibitor setanaxib.

The Swedish company is projecting sales of Tarpeyo will reach around $150 million this year, but Asahi Kasei’s interest will also likely be driven by the potential of setanaxib, which has been described as a “pipeline-in-a-product” and has the potential to be first-in-class.

The drug is being developed for a range of fibrotic rare diseases and solid tumours, with three phase 2 readouts expected this year in primary biliary cholangitis (PBC), idiopathic pulmonary fibrosis (IPF), and squamous cell carcinoma of the head and neck (SCCHN).

Asahi Kasei is a diversified industrial group – with fingers in a lot of pies including chemicals, construction, and energy – but in recent years has made expansion in the pharma and medical device sectors a priority, for example buying critical care products developer Zoll in 2012 and transplant care specialist Veloxis in 2020. Last year, healthcare accounted for 20% of net sales and around a third of operating profit.

The company said in a statement that buying Calliditas ties in with its strategy to “expand its businesses globally through specialising in the areas of immunology, transplantation, and adjacent diseases.”

Tarpeyo fits squarely into its current areas of expertise in health and has potential as the only fully approved product shown to reduce the loss of kidney function in adults with primary IgAN who are at risk for disease progression, it added. Calliditas was recently awarded seven years of market exclusivity for the drug, giving it protection from generic competition until 2030.

Other benefits of the takeover will include a stronger presence in the US market through expanded in-house sales in the renal and autoimmune disease categories. It will also give it a presence in Europe – initially in R&D – and contribute to the company’s plan to build a global specialty pharma business.

https://pharmaphorum.com/news/asahi-kasei-makes-11bn-bid-buy-calliditas

Zelensky Signs $1BN Weapons Deal With Spain, Includes Patriot Missiles

 Ukraine and Spain have inked a new military deal worth 1 billion euros ($1.08 billion), which will see the Spanish military transfer more military equipment to Kiev over the course of this year.

The commitment calls for greater supplies of modern military equipment which prioritizes "Ukraine's key capacity needs" - especially safeguarding the country's export routes.

El Pais newspaper listed that Spain has just pledged as part of the package a dozen U.S.-made Patriot anti-aircraft missiles and 19 second-hand German-made Leopard tanks.

Spain was among countries under pressure by EU leadership to essentially give up weapons it doesn't need at this time for its own defenses, especially the Patriots.

However, the Patriot missiles are unlikely to include the full Patriot systems and batteries, according to El Pais, and thus this will be of limited advantage at a moment Kharkiv in the north, and Odessa in the south, are getting pummeled.

Spanish Prime Minister Pedro Sánchez said of the agreement with Ukraine, "It is more important than ever to redouble our support." This comes after Zelensky and his top officials have complained that Western aid has been too slow to arrive.

This also comes the day after a deadly Russian strike on a market in Kharkiv city over the weekend, per the BBC:

At least 12 people have been killed and 43 others wounded after Russian forces hit a supermarket in the northern Ukrainian city of Kharkiv with two glide bombs, local officials say.

A large fire could be seen raging at the Epicentr K home improvement store on the northern outskirts of the city.

Ukrainian President Volodymyr Zelensky said over 200 people could have been inside the supermarket when it was attacked.

With each new strike, Zelensky's lashing out at his Western backers grows louder...

"If Ukraine had sufficient air defense systems and modern combat aircraft, Russian strikes like this one would have been impossible," Zelensky stated. "And that is why we appeal to all leaders, to all states: we need a significant enhancement of air defense and sufficient capabilities to destroy Russian terrorists."

"This is a task that must be accomplished and can only be accomplished together with the world. Every day, we call on the world to provide us with air defense and to save our people," Zelensky continued. And in a veiled attack which appears aimed at Washington, he concluded with: "Every unmade decision to support us results in the loss of our people."

https://www.zerohedge.com/geopolitical/zelensky-signs-1bn-weapons-deal-spain-includes-patriot-missiles

Israeli & Egyptian Troops Clash At Rafah Border, Leaving One Dead

 In a significant escalation, an Egyptian soldier has been shot dead at the Rafah border crossing after a rare exchange of gunfire erupted between the two sides.

Israel's Channel 14 described that Egyptian security forces "fired on an Israeli truck at the Rafah crossing" and that immediately soldiers of the Israel Defense Forces (IDF) "responded to this with gunfire."

Quickly after, officials on both sides of the border agreed to cease firing, and the incident is under investigation.

International reports including in Bloomberg and the BBC say that an Egyptian soldier at the border was left dead in the shootout. Israel media sources are calling it "a violation of the peace agreement with Egypt."

The IDF subsequently confirmed: "There was a shooting incident on the Egyptian border; the [incident] is under investigation, [and] dialogue is taking place with the Egyptian side."

Times of Israel has quoted the country's Army Radio to describe current Israeli narrative of the incident:

The Ynet news site and Army Radio quoted unnamed Israeli military sources blaming Egypt for the deadly exchange of fire.

According to the reports, Egyptian forces opened fire first on Israeli troops at the Rafah Border Crossing, who responded with fire of their own.

The situation at the Rafah border crossing has been incredibly tense after Israel's military took over operations of the Gaza side. Palestinian officials had previously operated the post, but earlier this month the IDF took it over as part of the ongoing Rafah offensive.

Tensions with Egypt are also at boiling point given the concern that hundreds of thousands of refugees displaced by Israel's offensive could pour into the Sinai.

A US-backed peace treaty has guided Israel-Egypt relations since 1979...

Egypt's economy has already long been under strain and Cairo says it can't absorb mass numbers of displaced Palestinians. Large walled and enclosed 'tent cities' have been erected in the scenario where tens of thousands get across the border.

https://www.zerohedge.com/geopolitical/israeli-egyptian-troops-clash-rafah-border-leaving-one-dead