Target $400
Wednesday, January 8, 2025
Johnson & Johnson MedTech halts Varipulse PFA cases due to stroke reports
Johnson & Johnson MedTech (NYSE: JNJ)
announced today that it “temporarily paused” all U.S. cases using its Varipulse pulsed field ablation (PFA) system as of Jan. 5.“Out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said in a news release. “As the U.S. External Evaluation leveraged a unique platform configuration, there is no impact to commercial activity and Varipulse cases outside of the U.S.”
The Varipulse platform treats atrial fibrillation (AFib) with a single device that combines PFA with the Carto 3 mapping system. Its variable-loop, multi-electrode Varipulse catheter uses laser-cut nitinol tubing for its loop shape, which is adjustable from 25 mm to 35 mm. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system.
J&J joined Medtronic and Boston Scientific as companies with PFA technologies approved for treating AFib when it received an FDA nod in November.
The company reported more than 130 cases with Varipulse in the U.S. since it began external evaluation. Those took place across 14 sites and 40 operators. Globally, it reported more than 3,000 commercial cases with Varipulse.
“We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation. We expect to have more information to communicate within the coming days,” the company said.
Analysts’ take on Johnson & Johnson MedTech Varipulse news
Needham analysts Michael Matson, David Saxon and Joseph Conway issued a report saying that an unnamed electrophysiologist confirmed that J&J “paused sales of its Varipulse PFA system due to reports of strokes with the device.”
They also cited a report of a stroke in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. That indicated that a patient experienced a stroke following Varipulse treatment. The analysts said at least two additional patients had strokes following Varipulse procedures in Europe.
“It is unclear how long the Varipulse sales will remain paused, but even if [Johnson & Johnson] allows sales to be resumed, we believe that the product is now likely to be tainted and that electrophysiologists are likely to be wary of using it,” the analysts wrote. noting they expect Boston Scientific and Medtronic to benefit if their systems don’t have similar issues.
Medtronic’s PulseSelect PFA system became the first to win FDA approval for AFib in 2023. Boston Scientific followed with its Farapulse system in January. Medtronic added to its offerings in October with an FDA nod for its Affera mapping and ablation system with the Sphere-9 catheter.
The analysts said they believe Boston Scientific’s Farapulse “is largely proven at this point given the large number of real-world procedures and no indications to date of elevated stroke rates.”
“This news makes us more positive on [Boston Scientific] since our recent downgrade mainly centered on the competitive risk posed by both the [Medtronic] and [Johnson & Johnson] PFA product launches.”
https://www.massdevice.com/johnson-johnson-halts-varipulse-cases-stroke/
Catalyst Settles FIRDAPSE® (amifampridine) Patent Litigation with Teva
As Part of the Settlement, Teva Receives a License to Market Generic FIRDAPSE Beginning in February 2035
China's National Medical Products Administration OKs PADCEV-KEYTRUDA combo for Bladder Cancer
- First regimen to be approved in China to demonstrate superiority to platinum-containing chemotherapy for the treatment of locally advanced or metastatic urothelial cancer, the standard of care for nearly 40 years1
- NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the treatment combination significantly improved overall survival and progression-free survival outcomes1
Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of care for nearly 40 years.
New California Law Violates 1st And 14th Amendments, Business Groups Argue In Lawsuit
by Kimberly Hayek via The Epoch Times,
Business groups in California filed a federal lawsuit on New Year’s Eve to challenge a new law that prohibits companies from firing or in any way disciplining workers who refuse to attend “captive audience” meetings, effectively undoing nearly 80 years of precedent protecting employer speech.
Senate Bill 399, which took effect on Jan. 1, adds section 1137 to the California Labor Code, prohibiting employers from taking any action against an employee who refuses to attend a meeting that addresses a company’s opinions on political or religious matters.
The California Chamber of Commerce and California Restaurant Association, which filed the suit, claim that the law violates employers’ First and 14th amendments rights by restricting employer speech and regulating their conversations with employees.
“Because of SB 399, employers in California are now subject to liability, penalties, and other administrative action when they exercise their federal constitutional and statutory rights to talk to employees about political issues,” the lawsuit said.
The bill discriminates against employers’ speech by regulating the content of employers’ communications with their employees and puts a chill on employer speech, the business organizations argued in the suit. The California Restaurant Association said it has the right to express its views on issues.
“Throughout legislative deliberations, we repeatedly underscored the fact that SB 399 was a huge overreach,” CalChamber President and CEO Jennifer Barrera said in an emailed statement to The Epoch Times.
“SB 399 is clearly viewpoint-based discrimination, which runs afoul of the First Amendment. In addition, SB 399 is preempted by the NLRA.”
“Employers have the right to express their views and opinions on many issues,” Jot Condie, CRA president and CEO, said in a statement to The Epoch Times.
“SB 399 creates restrictions that are unworkable and the unintended consequences of this new law outweigh any perceived benefit.”
The National Labor Relations Board in November 2024 said captive audience meetings—which take place during work hours, are mandatory, and often cover unionization matters—are illegal.
SB 399, authored by state Sen. Aisha Wahab, a Democrat, is geared toward stopping employers from intimidating employees who attempt to start or join a union.
It also bans employers from punishing employees who choose not to attend an employer-sponsored meeting or to not participate in communications of the employer’s opinion about religious or political matters.
Political matters refer to any communication regarding any politician, party, legislation, regulation, or labor organization. Religious matters refers to communications relating to religious affiliation and practice or support of any religious organization or association.
The new law prohibits workplaces from making those meetings mandatory. It also places new restrictions on communications about these issues between workers and their bosses.
Employers could be on the hook for a $500 civil penalty if they violate provisions. The bill also authorizes employees to bring a civil action and petition a court for injunctive relief.
The new law overrules a 1948 case, Babcock & Wilson Co., in which the National Labor Relations Board decision permitted employers to hold captive audience meetings during work hours to share the company’s views on unionization.
'Big Pharma Rushes to China for Deal Prospecting Despite Regulatory Uncertainty'
China is adapting its Life Sciences policy to bolster innovation and data transparency. Big Pharma is taking note.
In the final weeks of 2024, pharmaceutical companies struck a handful of deals with China-based biotechs, with antibody-drug conjugates high on the wish list. The flurry of activity reflects a potential gold mine for Western companies as China’s data become more trustworthy, experts told BioSpace.
“What you’re seeing is, as the U.S. is doing things to make its environment less hospitable to biopharma, China is making its environment more hospitable to biopharma,” said Kirsten Axelsen, a nonresident fellow at the American Enterprise Institute and senior policy advisor at DLA Piper, in an interview with BioSpace.
China is revamping Life Sciences policy to bolster its intellectual property system, investing in R&D, allowing smoother technology transfer between universities and companies and, most importantly, allowing universities to make money from the IP protecting those innovations. China joined the International Council for Harmonisation in 2017, launching its integration into the global drug regulatory system.
The fruits of that labor are now apparent in rising deal activity—and value. These deals have been larger than the average over 2024 and at least three to four have involved partnerships or whole new companies forming around a China-developed asset, according to Jefferies. A Chinese company is involved in at least a fifth of development programs across the entire industry’s total clinical pipeline, according to a 2025 preview report from Evaluate Pharma.
This uptick in U.S.-based companies licensing drugs from China in 2023 and 2024 is occurring despite “geopolitical hiccups,” Jefferies analysts said in a recent note. The hiccup, of course, is the BIOSECURE Act, which directed biopharma to move away from using certain Chinese firms, such as CDMO WuXi Biologics. The legislation was not included in an end-of-year defense budget bill, however, leaving the issue unresolved.
Venture capital firms like Bain Capital Life Sciences, Atlas Venture and RTW Investments have been looking to China to launch new companies, too. Kailera Therapeutics launched in October 2024 with $400 million to develop Jiangsu Hengrui Pharmaceuticals’ metabolic disease portfolio outside of greater China.
“What is interesting in China is they have borrowed the best of U.S. healthcare policy in many ways,” Axelsen told BioSpace.
Me Too But Better
China has a lot going for it when it comes to attracting interest from the biopharma industry. Data coming from the region is becoming more transparent and trustworthy, Axelsen said, and it’s just plain cheaper to conduct early research there. A quarter of clinical trials and early drug development is happening in China, Axelsen added, a feat she calls “remarkable.”
Historically, oncology has been the focus for pharmas seeking deals in China. IQVIA reported that 46% of the 318 deals involving Chinese companies in 2023 were oncology-focused, although not all of these involved foreign companies. The firm said that the most notable deals were in oncology, particularly involving ADCs.
But pharmas have broadened their prospecting, signing deals in obesity, immunology and cardiometabolic diseases, Jefferies noted. The firm thinks this simply reflects pharma’s insatiable appetite for “whatever’s perceived as ‘hot’ at the moment.” The trend initially began with PD-1s, then moved on to CD19 and BCMA, then antibody-drug conjugates, and now GLP-1s and PD1xVEGF.
“China becomes a place for deal hunters to look for a ‘me too better’ version of the target,” Jefferies’ analysts said.
Jefferies does not see this rush stopping anytime soon, but said future deals may focus more on next-generation versions or assets that can bring costs down in the U.S. market. This is particularly likely in obesity, where numerous deals and companies are emerging from China, such as Kailera. The company’s most advanced asset so far is the Phase II GLP-1/GIP recepter dual agonist KAI-9531, an injectable already being tested in the country.
ADCs have been red-hot for pharmas seeking out deals in China. According to Evaluate, more than half of the ADC, bispecific antibody and CAR-T clinical pipeline is China-originated or China-partnered. Roche signed an ADC deal with China’s Innovent worth $80 million upfront and $1 billion in milestones on the first day of the year. Prior to that, GSK inked two ADC partnerships at the end of 2024 with Hansoh Pharma worth $1.7 billion, then with DualityBio for $1 billion.
BioNTech also signed a major deal with Duality in 2023, worth up to $1.5 billion, to work on solid tumor candidates. The partners announced early Phase I/II data in December 2024 showing responses in just over 56% of 73 patients with small cell lung cancer. The German biotech also bought China’s Biotheus in November for up to $1 billion to nab a pipeline of anti-PD-1/VEGF bispecifics, Evaluate pointed out.
An FDA Intervention
Trial starts by China-headquartered companies rose 28% in 2023 compared to just 3% a decade ago, according to a February 2024 report from IQVIA. This came as trial starts overall declined by 15%.
Drugmakers do have to be careful, however, to ensure they meet trial diversity standards to avoid scrutiny from the FDA. IQVIA reported that Chinese companies typically stick to the region for clinical trials, with just 27% including non-China sites.
Eli Lilly ran into this challenge in 2022 when the pharma partnered with Innovent Biologics to bring an immunotherapy to the U.S. market. The drug, marketed as Tyvyt in China, was rejected by the FDA, which requested another global clinical trial. The partners are still working together through a global licensing deal on Tyvyt and other oncology drugs, howeverthey have not to-datereturned an application to the U.S.
The Lilly-Innovent debacle, as well as a similar situation with Hutchmed’s surufatinib, dented deal values in its aftermath, according to Jefferies. Summit Therapeutics also trumpeted data in September that could beat Merck’s megablockbuster Keytruda in non-small cell lung cancer, only for analysts to caution that the results were only from a single Chinese-only trial.
But pharma seems to have moved on. Average deal size including upfront payments for China-focused deals increased over the past two years as total deal count also ticked up.
It seems that companies are seeking early-stage assets that have already been tested in China-based trials or will be soon, with the intention of bringing successful candidates elsewhere for the later stages of clinical development, Jefferies said, adding: “This seems wise and logical.”
“These trends [indicate] that China’s influence on the global pharma industry is likely to deepen in 2025,” Evaluate predicted. “There is a big ‘but’ here, however, in the shape of the Trump administration.” Trump has indicated a desire to “protect U.S. interests,” according to Evaluate, which many experts fear could trigger a trade war. He could also renew support for the BIOSECURE Act.
On the regulatory front, Axelsen believes the FDA needs to provide more robust guidance on what it wants from drugs tested in China. The agency has not explicitly said what portion of trial data or population can come from China. Absent that directive, more and more applications are going to roll in from the region with industry keenly watching for patterns. China’s regulatory agencies can also help by increasing harmonization efforts.
“It’s in China’s best interest to have standards that are what the FDA is looking for,” Axelsen said, “because that makes their developed drugs more valuable.”
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