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Are Big Pharma giants getting the right ROI on their R&D investments? A visual exploration

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While annual reports show broadly similar R&D strategies among Merck & Co., Pfizer, Johnson & Johnson and AbbVie, their 2020–2023 financial metrics reveal a concerning trend. Merck & Co. may be the new top dog of Big Pharma, but the firm’s 1.4% revenue growth in 2023 represents a significant slowdown. Pfizer’s 41.7% revenue decline from its COVID-inflated $100.3 billion peak in 2022 is even more stark. Similarly, J&J’s modest 4.2% growth and AbbVie’s 6.4% revenue dip also signal a departure from previous patterns.

In raw numbers, R&D spending in the pharmaceutical industry has surged over the past few decades, jumping from about $30 billion across the industry to more than $200 billion annually by the 2020s. Despite record-breaking R&D spending hitting $161 billion in 2023, marking a nearly 50% increase since 2018, as IQVIA has noted, …

AbbVie president and COO to move into corner office

Robert Michael is slated to become AbbVie’s CEO in July 2024. [Image courtesy of AbbVie]

AbbVie (NYSE: ABBV) recently announced that its board of directors has decided to promote the company’s president and COO Robert A. Michael into the corner office.

Michael will succeed Richard A. Gonzalez, who is retiring as CEO on July 1. Gonzalez will stay as executive chair of AbbVie’s board.

“On behalf of AbbVie’s board, I am extremely excited that Rob has agreed to serve as AbbVie’s next CEO,” Gonzalez said in a Feb. 20 news release.

“As a key member of the executive leadership team, he has had a tremendous impact on AbbVie. From establishing our financial planning organization, to the development of our diversified business strategy, to successfully navigating the end of exclusivity for Humira in the U.S., Rob has been integral to AbbVie’s impact since…

AbbVie is expanding its Singapore biologics plant

AbbVie (NYSE: ABBV) recently announced that it will spend $223 million to expand its Singapore biologics manufacturing facility.

Construction will commence immediately, with the facilities coming online in 2026. The added facilities will create 100 new jobs at the plant, boosting total employment to more than 500 positions in manufacturing, quality assurance, supply chain, engineering and administration roles, according to AbbVie.

AbbVie said the investment strengthens its global manufacturing network and supports its growing pipeline in treatment areas such as immunology and oncology. The Singapore expansion will add 24,000 liters of biologics drug-substance capacity to AbbVie’s global network, supporting current projects and emerging immunology and oncology compounds within AbbVie’s pipeline.

The company has invested $740 million in acquiring, modernizing and expanding its Singapore facility over the past 10 years.

“This expans…

AbbVie launches Produodopa in the EU to treat Parkinson’s

AbbVie (NYSE: ABBV) recently announced the launch of its Parkinson’s disease drug Produodopa (foslevodopa/foscarbidopa) in the European Union.

Produodopa is for the treatment of advanced Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement). It’s indicated for use when combinations of Parkinson’s medicinal products have not given satisfactory results.

North Chicago, Illinois–based Abbvie described Produodopa as the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations. The continuous delivery of Produodopa provides levodopa 24 hours a day. According to AbbVie, this could help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.

“People living with Parkinson’s disease experience daily challenges and uncertainty, especially as th…

Pharma M&A activity primed for another high-flying year in 2024

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Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While the pandemic boosted research into areas such as mRNA, it had something of a chilling effect on M&A. As pharma companies begin to put the pandemic in the rearview mirror, M&A activity has gained momentum.

Analysts upbeat on biopharma M&A activity in 2024

According to PwC, the M&A activity in the pharmaceutical and life sciences sector could continue humming in 2024. Despite a challenging interest rate environment, PwC projects the sector to see deal values ranging from $225 billion to $275 billion. Deal volume in 2023 was in line with pre-pandemic levels. …

AbbVie bets on quality of life approach to gain share in migraine treatment market

In a crowded migraine treatment landscape, AbbVie is aiming to differentiate itself by redefining migraine treatment beyond just counting headache days and other traditional clinical endpoints. At the European Headache Congress (EHC), the company touted its patient-centered approach in evaluating quality of life, daily functioning, rapid relief, and balanced benefit-risk profiles, while aiming to continue addressing unmet needs in the disease area.

“Everyone always talks about patient centricity, but really showing that with our treatments is what matters and what we highlighted with atogepant,” said Michael J. Seminerio, global therapeutic lead at AbbVie. “We actually improved function, quality of life and disability across all trials.”

The ELEVATE, PROGRESS, and ADVANCE atogepant trials

This approach was a guiding principle in the ELEVATE, PROGRESS, and ADVANCE studies, all featured at EHC. The trio of studies concentrated on atogepan…

AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies

Epcoritamab Image courtesy of Genmab

The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab.

Epcoritamab for relapsed/refractory diffuse large B-cell lymphoma

Epcoritamab is an investigational bispecific antibody for adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. CHMP made the decision after reviewing data from the pivotal EPCORE NHL-1 phase 1/2 trial showing an overall response rate of 63.1% with epcoritamab monotherapy in DLBCL patients. If approved, epcoritamab would be the first subcutaneous bispecif…

The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

AbbVie and Janssen voluntarily withdraw Imbruvica from accelerated approvals for MCL and MZL

AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S.

Ibrutinib is a selective Bruton’s tyrosine kinase (BTK).

The main reasons for the move relate to FDA’s request for additional studies to confirm clinical benefits that relate to the accelerated approval status granted by the FDA for MCL and MZL. Initially, FDA authorized the accelerated approval program for the two indications following the publication of positive overall response rate data in phase 2 trials.

While the phase 3 shine study in previously untreated MCL met its primary endpoint of progression-free survival, there was an increased rate of adverse reactions when combining Imbruvica and chemotherapy compared to the placebo-controlled arm.

Conversely, the phase 3 SELENE study in re…

Sandoz’s Hyrimoz to challenge AbbVie’s Humira dominance

A robotic arm transfers Humira pens from the conveyor to two-pack cartons. [Image from AbbVie]

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This fact could dramatically impact the marketplace for AbbVie’s version of the drug, as it is priced lower and could lead to a decrease in market share for Humira.

The FDA approved Sandoz’s Hyrimoz, a biosimilar of AbbVie’s Humira, to treat seven conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,…

AbbVie and Capsida join forces to target serious eye diseases

AbbVie (NYSE:ABBV) will work with the gene therapy platform company Capsida Biotherapeutics (Thousand Oaks, California) to develop serious eye diseases with few treatment options. The partnership will unite AbbVie’s development and commercialization capabilities with Capsida’s adeno-associated virus (AAV) engineering platform. AbbVie will also help explore therapeutic cargo approaches. The companies plan on identifying and advancing three programs.

The collaboration will center around Capsida’s AAV engineering platform and manufacturing capabilities to develop novel ophthalmological therapies.

Under the terms of the agreement, AbbVie will pay Capsida an upfront payment of $70 million. In addition, AbbVie could also make potential equity investments in the expanded agreement.

Capsida is also eligible for up to $595 million in option fees and R&D milestones if the company reaches commercial milestones. It could also receive mid-to-hig…

AbbVie files sNDA with FDA to expand atogepant label

AbbVie (NYSE:ABBV) has submitted a supplemental New Drug Application (sNDA) to the FDA to support the use of atogepant (Qulipta) as a preventive treatment of both episodic and chronic migraine.

FDA approved the drug in September 2021 as a preventive treatment of episodic migraine in adults.

In March 2022, AbbVie announced that the Phase 3 PROGRESS study testing atogepant met its primary endpoint of reducing mean monthly migraine days over placebo in patients with chronic migraine.

In its recent sNDA filing, AbbVie included data from the pivotal Phase 3 PROGRESS trial in patients with chronic migraine. The placebo-controlled study met its primary endpoint, which related to a statistically significant reduction from baseline in mean migraine days per month.

Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) developed as a preventive migraine therapy.

Q…