Lorraine Palmer, Pharma Analyst at GlobalData, comments: “While the first 52 weeks of the PASADENA trial were randomized, double-blind, and placebo controlled, subsequent years had all participants receiving prasinezumab in an open-label extension where long-term follow-up outcomes were presented. With no control arm present, Roche selected to use an open access dataset from the Parkinson’s Progression Marker Initiative [PPMI] observational study.”

To support the validity of the comparison to the external control, Roche applied the same inclusion and exclusion criteria to the PPMI cohort as was applied to the PASADENA cohort. Subsequently, propensity score weighting was applied to mimic the characteristics of a randomized controlled trial that compared the baseline characteristics and progression over one year of the PPMI cohort with the PASADENA placebo group from the first year.

When comparing the PPMI cohort back to the first year of the trial, there is no significant difference in PD progression between all cohorts, as measured by Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts I and II. This is in line with the PASADENA trial failing to meet its first-year primary endpoint as measured by sum of Parts I, II, III of the MDS-UPDRS. It is important to note that in this first year, there was no PD progression even in the PASADENA placebo, as measured by the MDS-UPDRS Parts I and II.

Palmer continues: “A potential treatment effect on disease progression can only be measured when participants in the placebo group progress sufficiently toward the endpoint of interest. Since this didn’t happen in the first year of PASADENA trial with the MDS-UPDRS Parts I and II secondary endpoints, these endpoints cannot be used to evaluate the effect of PRX-002 on PD progression for the first year. The reliability of the first-year readout for the primary endpoint is contentious. Additionally, positive outcomes from the first-year readout for the MDS-UPDRS Part III secondary endpoint suggested PRX-002 led to a slowing of PD progression. The inconsistencies in the year one results suggest that the open-label extension of the study to obtain longer-term outcomes was warranted.”

With the longer-term follow-up results from the open-label extension announced at AAN 2024, a significant shift can be seen in the treatment effect from three years of treatment onwards. At the three- and four- year intervals, the PRX-002 -treated cohort showed a significant reduction in PD motor progression as measured by MDS-UPDRS Part II and Part III scores, suggesting that PRX-002 slows PD motor progression in the longer-term.

Palmer adds: “Besides indicating positive outcomes with PRX-002, the results following the extension of the PASADENA trial highlight that in order to effectively measure the potential DMTs on the progression of patient-reported motor symptoms, functional activity of daily living, and the progression of non-motor symptoms, studies running for longer than one-year may be required.”

In addition, KOLs interviewed by GlobalData have stated high hopes for monoclonal antibodies targeting alpha-synuclein, such as PRX-02, for modifying-disease progression and offering neuro-protective effects.

Palmer concludes: “As an open-label exploratory extension, the results presented by Roche should still be treated as preliminary. However, considering that even prior to these latest results, PRX-002 was unanimously highly regarded by KOLs who were hopeful about its potential as a DMT offering neuroprotection, the recent results from the PASADENA extension greatly raises the anticipation for the conclusion of PADOVA, the ongoing Phase IIb trial evaluating PRX-002.”

The post Roche’s PRX-002 shows promise in slowing Parkinson’s disease motor progression, says GlobalData appeared first on GlobalData.

An analysis of GlobalData’s Deals Database reveals that Skadden, Arps, Slate, Meagher & Flom achieved its leading position in terms of value by advising on $115.9 billion worth of deals. Meanwhile, Kirkland & Ellis led in terms of volume by advising on a total of 101 deals.

Aurojyoti Bose, Lead Analyst at GlobalData, comments: “Kirkland & Ellis was the clear winner in terms of volume as it was the only adviser to hit the triple-digit deal volume during Q1 2024. Interestingly, it was the top adviser by volume in Q1 2023 as well. Apart from leading by volume, Kirkland & Ellis occupied the fifth position by value in Q1 2024.

“Meanwhile, Skadden, Arps, Slate, Meagher & Flom, which occupied the second position by value in Q1 2023, went ahead to top the chart by this metric in Q1 2024 due to its involvement in big-ticket deals. It is noteworthy that the average size of deals advised by it jumped from $2.4 billion in Q1 2023 to $5.3 billion in Q1 2024.”

Wachtell, Lipton, Rosen & Katz occupied the second position in terms of value, by advising on $109.5 billion worth of deals, followed by Paul, Weiss, Rifkind, Wharton & Garrison with $104.2 billion, Cravath Swaine & Moore with $73.8 billion and Kirkland & Ellis with $60.9 billion.

Meanwhile, Latham & Watkins occupied the second position in terms of volume with 33 deals, followed by Gibson, Dunn & Crutcher with 32 deals, Paul, Weiss, Rifkind, Wharton & Garrison with 26 deals and Jones Day with 26 deals.

The post Skadden, Arps, Slate, Meagher & Flom and Kirkland & Ellis top M&A legal advisers in North America during Q1 2024, reveals GlobalData appeared first on GlobalData.

An analysis of GlobalData’s Deals Database reveals that JP Morgan achieved its leading position in terms of value by advising on $135.9 billion worth of deals. Meanwhile, Houlihan Lokey led in terms of volume by advising on a total of 33 deals.                             

Aurojyoti Bose, Lead Analyst at GlobalData, comments: “Houlihan Lokey was the top adviser by volume during Q1 2023 and managed to retain its leadership position by this metric in Q1 2024 as well.

“Meanwhile, JP Morgan experienced a significant jump in the total value of deals advised by it during Q1 2024 compared to Q1 2023. Resultantly, there was a jump in its ranking by value and it went ahead from occupying the fifth position in Q1 2023 to top the chart by this metric in Q1 2024. During the quarter, JP Morgan advised on 22 billion-dollar deals*, which also included five mega deals valued more than $10 billion. These big-ticket deals helped JP Morgan to register growth in terms of value and occupy the top position by this metric.”

Evercore occupied the second position in terms of value, by advising on $100.7 billion worth of deals, followed by Goldman Sachs with $88.9 billion, Citi with $88.6 billion and Morgan Stanley with $74.5 billion.

Meanwhile, JP Morgan occupied the second position in terms of volume with 30 deals, followed by Jefferies with 28 deals, Stifel/KBW with 27 deals and Goldman Sachs with 23 deals.

*Deals valued ≥ $1 billion.

The post JP Morgan and Houlihan Lokey top M&A financial advisers in North America during Q1 2024, reveals GlobalData appeared first on GlobalData.

According to GlobalData, the worldwide market for robotic surgical systems and accompanying accessories is forecasted to reach $10 billion by the end of this year, with a projected rise to $15.8 billion by 2030. This highlights the predicted expansion of the market in the coming years.

Several factors drive the growth of robotic surgery, including increased demand from the growing elderly population seeking minimally invasive and precise surgical options, the emphasis on value-based healthcare to enhance surgical outcomes, and ongoing technological advancements facilitating the development of more efficient and less invasive robotic surgical platforms.

Graysen Vigneux, Medical Analyst at GlobalData, comments: “TAVI procedures have emerged as a less invasive alternative to traditional open-heart surgery for treating aortic valve stenosis, a condition characterized by the narrowing of the heart’s aortic valve. With the introduction of robotic technology, CaranX Medical aims to further enhance procedural outcomes while minimizing patient discomfort and recovery time.”

CaranX Medical’s robotic platform offers precise control and maneuverability, enabling physicians to navigate complex anatomical structures with unparalleled accuracy. By combining robotics with transcatheter techniques, the company aims to expand access to minimally invasive treatments for patients worldwide.

Vigneux concludes: “The successful outcome of the world’s first robotic TAVI procedure heralds a new era in cardiovascular medicine, where innovative technologies empower clinicians to deliver personalized, minimally invasive interventions that redefine the standard of care for patients with valvular heart disease.”

The post CaranX Medical’s TAVI success highlights transformative potential of robotic-assisted techniques in cardiovascular medicine, says GlobalData appeared first on GlobalData.

Data presented from EMPACT-MI investigated the safety and efficacy of empagliflozin in 6,000 patients with acute myocardial infarction (AMI). Empagliflozin has previously been identified to improve cardiovascular (CV) outcomes in patients with HF, patients with type 2 diabetes (T2D) who have high CV risk, and patients with chronic kidney disease (CKD). It is likely the market share for empagliflozin across T2D, HF, and CKD will increase in direct competition with the other market-leading SGLT-2I, AstraZeneca’s dapagliflozin (Farxiga).

Akash Patel, Pharma Analyst at GlobalData, comments: “For patients with an increased risk of HF after AMI, treatment with empagliflozin did not impact the primary endpoint. However, improvement was seen in HF hospitalization rates when examined individually, with patients 23% less likely to be hospitalized for HF for the first time and 33% less likely to experience any HF hospitalization and all-cause mortality.”

The potential for SGLT-2I therapies to treat HF with or without T2D remains significantly promising, and the data from this study demonstrating improvement in HF hospitalization rates is consistent with studies in populations using SGLT-2Is in T2D and CKD.

Patel concludes: “An unmet need remains in the HF space to reduce the risk of new-onset HF and other common complications after an AMI and it has previously been found that in chronic HF, Jardiance reduces the risk of CV death and HF hospitalization. SGLT-2I therapies have strong clinical data to support improved outcomes for patients with cardio-metabolic disorders.”

The post ACC 24: Empagliflozin remains competitive therapy in HF market despite EMPACT-MI trial outcome, says GlobalData appeared first on GlobalData.

Erela Dana, Director of Neurology at GlobalData, comments: “Amyloid beta (Aβ)-targeting therapies hold promise, with this mechanism of action (MOA) recently seeing some success with the FDA’s approval of Biogen’s anti-Aβ monoclonal antibody (mAb) Aduhelm (aducanumab) in 2021, followed by Eisai/Biogen’s anti-Aβ mAb Leqembi (lecanemab) in January 2023.”

GlobalData forecasts that the anti-Aβ therapies will reach approximately $7.1 billion in the mild cognitive impairment (MCI) and mild AD patient populations by 2030 globally (US, France, Germany, Italy, Spain, UK, Japan, and China), with ALZ-801 accounting for approximately 10% of this market as the only oral asset to become available outside of China in an MOA dominated by mAbs.

ALZ-801 is currently in Phase III, being evaluated for the treatment of apolipoprotein E 4 (APOE4) carrier patients with early AD.

The key opinion leaders (KOLs) previously interviewed by GlobalData highlight that the ALZ-801 target population of early AD patients, who are homozygous for the APOE4 allele, represent a subgroup that has a strong unmet need for novel disease-modifying approaches.

Thus far, the results over two years of treatment with ALZ-801 have been presented of the four-year open-label biomarker study. Overall, ALZ-801 treatment demonstrated sustained improvement over two years in plasma biomarkers, hippocampal volume, and cognitive effects in the target population.

Dana comments: “There is a strong correlation between the biomarker outcomes and ALZ-801’s cognitive benefits. The presented biomarker results support the disease-modifying effects of ALZ-801 in APOE4 carriers with early AD with promising clinical efficacy and favorable safety, with no observed cases of amyloid-related imaging abnormalities related to underlying vasogenic edema (ARIA-E), a known side effect of the anti-Aβ mAbs, to date.”

Further to its Phase II biomarker study, Alzheon plans to announce the topline results of its pivotal APOLLOE4 (NCT04770220) Phase III trial in Q3 2024, with a potential NDA submission to the US FDA later this year.

Dana concludes: “Should Phase III outcomes follow the positive outcomes from the two-year Phase II biomarker data and support the hypotheses that by acting upstream of anti-Aβ mAbs, ALZ-801 could provide significantly improved amyloid clearance, it would pave the way for Alzheon to launch its AD asset in 2025 as the first oral anti-Aβ DMT in the US.”

The post Alzheon’s oral anti-amyloid drug has potential to be first oral Aβ-targeting therapy approved in US and EU, says GlobalData appeared first on GlobalData.

Erela Dana, Director of Neurology at GlobalData, comments: “The new delivery systems by AbbVie and NeuroDerm offer a 24-hour continuous subcutaneous (SC) infusion of levodopa and are proposed to improve the rate of compliance while reducing risk of motor fluctuations and levodopa-induced complications such as levodopa-induced dyskinesia and “off” episodes.”

According to GlobalData’s Drug Database, there are three subcutaneous infusion devices in late stage (Phase III – Pre-registration) pipeline in the US. While Produodopa/Vyalev and ND0612 offer continuous levodopa infusion, Supernus’s SPN-830 is a SC apomorphine infusion device. When comparing the SC continuous infusion of levodopa and apomorphine, key opinion leaders (KOLs) previously interviewed by GlobalData stated a preference for levodopa formulations as it is the naturally occurring precursor to dopamine, which is converted in the brain.

Efficacy data and subgroup analysis presented by NeuroDerm from a randomized controlled Phase III study (BouNDless; NCT04006210) at AAN 2024 showed that treatment with an optimized ND0612 regimen provided an additional 1.72 hours of “on” time without troublesome dyskinesia compared with immediate-release LD/CD. The subgroup analysis demonstrated a homogeneous treatment effect in relation to “on” time improvements and minimal differences in safety and tolerability.

Dana comments: “The lack of differences seen in therapeutic effect and safety and tolerability of ND0612 across the different analyzed subgroups, including age, sex, body mass index (BMI), and geographical region, suggests wide adoption potential for the drug in all advanced PD patients with severe motor fluctuations.”

AbbVie presented the long-term safety and tolerability of Produodopa/Vyalev (NCT04379050) from an open-label extension (OLE) study of advanced PD patients. Overall, 83.7% of patients experienced ≥1 adverse events (AEs), with infusion site erythema and cellulitis being two of the most common AEs experienced by 16.3% and 15.5% of patients, respectively.

Dana adds: “The success of levodopa infusion systems requires avoidance of infusion-site reactions and reduced discontinuation rates due to safety and tolerability issues. The OLE outcomes presented by AbbVie address some of these concerns through the demonstration of a long-term favorable safety profile.”

Produodopa/Vyalev was launched in Germany, Spain, the UK, and Japan in 2023, and in France, Italy, and Canada in early 2024; However, its US launch hit a snag when it received a complete response letter (CRL) in March 2023.

Dana concludes: “NeuroDerm’s ND0612 is anticipated to launch in the US market later this year with an FDA Prescription Drug User Fee Act (PDUFA) date of Q2 2024, meaning that it could beat AbbVie in the race to US commercialization. However, if both products receive US approval, real-world evidence (RWE) and longer-term follow-up data could provide a competitive edge in the absence of a head-to-head trial comparing Produodopa/Vyalev and ND0612.”

The post AbbVie and NeuroDerm race to US launch of levodopa infusions intensifies with additional benefits highlighted at AAN 2024, says GlobalData appeared first on GlobalData.

Philippa Salter, Senior Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Although the migraine market is saturated with acute treatments, the key opinion leaders (KOLs) interviewed by GlobalData welcomed the combination product as an alternative acute treatment option, pointing out that the combination was more effective that rizatriptan monotherapy in clinical trials.

“However, other KOLs had reservations about the combination product preferring monotherapy in their migraine treatment strategy. Some KOLs also raised concerns around the potential high cost of AXS-07 in a market where there are multiple triptan therapies with wide cheap, generic availability, including rizatriptan.

“Further, some KOLs likened AXS-07 to Currax Pharmaceuticals’s Treximet, a combination tablet containing sumatriptan and naproxen which, despite being the first and only approved combination prescription medicine for migraine treatment, has seen its uptake hindered by its cost (five times the cost of taking a tablet of generic sumatriptan and a tablet of naproxen in the US) since its launch in 2008.

“Axsome Therapeutics is expecting to resubmit a new drug application (NDA) for ASX-07 in H2 2024 following a complete response letter received from the FDA in May 2022. However, due to the significant competition in the acute migraine market, not only from generic triptans but also from the new class of gepants, with AbbVie’s Ubrelvy (ubrogepant), and Pzifer’s Nurtec (Rimegepant) and Zavzpret (zavegepant) all approved in the US for acute migraine treatment, it is unlikely that AXS-07 will have a large impact in the migraine market.”

The post Despite positive efficacy data highlighted at AAN 2024, Axsome Therapeutic’s ASX-07 will struggle to make significant impact in acute migraine market, says GlobalData appeared first on GlobalData.

Charles Garrett, Principal Global Telecom Consumer Services Analyst at GlobalData, a leading data and analytics company, offers his view:

“With the fixed wireless access (FWA) challengers sucking up much of the oxygen in the US home internet space these days and the impending demise of the Affordable Connectivity Program (ACP) broadband subsidy credit looming large, Comcast’s decision to roll out a holistic prepaid connectivity proposition may be the definition of ‘opportunely timed.’ This is not only a riposte to the continued FWA incursion, but also a well-considered response to the increasing inevitability of the ACP broadband subsidy lapsing in the coming weeks.

“That said, framing Comcast’s NOW launch as simply a response to those market forces – significant though they may be – is to miss a substantial part of the thrust here. This is also an attempt by one of the sector heavyweights to broaden its addressable market without cannibalizing its existing base of bread-and-butter residential broadband customers. Moreover, Comcast is already a practiced hand at prepaid home internet and the NOW Mobile service should benefit from the same handsome offload margins as Xfinity Mobile. So, while entering a new space or launching a new brand always feels audacious, this also feels decidedly low-risk considering some of the strengths Comcast has to lean into here.

“Of course, the US is also a hypercompetitive space, spinning up brand awareness among the public does not necessarily happen in short order, and there are still loads of details left to sort out yet in these early days. The internet and mobile aspects of this portfolio are still in the trial phases, and it is yet to be seen exactly what shape the channel approach is going to take. And with the prepaid space often a testbed for app-driven service approaches, there is also the question of whether and how much Comcast may eventually bake on-the-fly customization into NOW subscribers’ digital service management.

“To be clear, though, beyond being the first operator in the US prepaid space to put together a prepaid portfolio spanning home internet, mobile, and pay-TV – not to mention those millions of WiFi access points Comcast has at its disposal – it is really Comcast’s entry into the wireless prepaid space which is entirely new here. And long term, that may be the real rub for NOW’s prospects: The US prepaid wireless space is not only incredibly volatile these days, with Verizon, AT&T, and Dish registering a combined 547,000 prepaid subscriber losses in Q4 2023, but the space itself is shrinking.  Those Q4 2023 results dovetail with GlobalData’s long-term projections for the space – i.e., a decline of over 4.5 million prepaid wireless subscribers in the US from end-2022 through 2028, according to its March 2024 US mobile broadband forecast. Consequently, while Comcast is wise to broaden its target market into the value-oriented offerings – and wiser still to do that at a moment when so many consumers are scrutinizing their monthly spend closer than ever – it is also jumping into a space that is contracting.”

The post Comcast takes a big, timely swing at holistic prepaid connectivity with NOW brand launch, says GlobalData appeared first on GlobalData.

Based on its Financial Deals Database, the leading data and analytics company has revealed that Skadden, Arps, Slate, Meagher & Flom achieved its leading position in the deal value rankings by advising on $120.9 billion worth of deals. Meanwhile, Kirkland & Ellis led in terms of volume by advising on a total of 113 deals.

Aurojyoti Bose, Lead Analyst at GlobalData, comments: “Kirkland & Ellis was the top adviser by volume in Q1 2023 and managed to retain its leadership position by this metric in Q1 2024 as well. It was the only firm with triple-digit deal volume during Q1 2024. Moreover, Kirkland & Ellis also managed to advise on some big-ticket deals, and resultantly, apart from leading by volume, it occupied the fifth position by value in Q1 2024 as well.  During the quarter, it advised on 15 billion-dollar deals*, which also included three mega deals valued more than $10 billion.

“Meanwhile, Skadden, Arps, Slate, Meagher & Flom, which led by value in Q1 2024, advised on 16 billion-dollar deals that also included five mega deals valued more than $10 billion. Apart from leading by value, Skadden, Arps, Slate, Meagher & Flom also occupied the ninth position by volume during Q1 2024.”

An analysis of GlobalData’s Deals Database reveals that Wachtell, Lipton, Rosen & Katz occupied the second position in terms of value, by advising on $112 billion worth of deals followed by Paul, Weiss, Rifkind, Wharton & Garrison with $104.2 billion, Cravath Swaine & Moore with $73.8 billion, and Kirkland & Ellis with $67.9 billion.

Meanwhile, CMS occupied the second position in terms of volume by advising on 55 deals followed by White & Case with 50 deals, Latham & Watkins with 43 deals, and Gibson, Dunn & Crutcher with 38 deals.

*Deals valued more than or equal to $1 billion

The post Skadden, Arps, Slate, Meagher & Flom and Kirkland & Ellis top M&A legal advisers in Q1 2024, finds GlobalData appeared first on GlobalData.