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Issue29

February 2024 - April 2024



Celltrion Launches Zymfentra, a Subcutaneous Form of Infliximab

Celltrion USA introduces Zymfentra, the first subcutaneous infliximab formulation approved for moderateto-severe active ulcerative colitis and Crohn’s disease maintenance therapy. Priced at $6,181.08 for two shots over four weeks, commercially insured patients receive copay assistance of $5 per month. Uninsured or underinsured patients may qualify for free treatment. Unlike Inflectra, approved through the biosimilar process, Zymfentra underwent a stand-alone biologics license application. It boasts patent protection until 2037 for dosage form and 2040 for administration route. Supported by pivotal phase 3 data, Zymfentra showcases efficacy and safety comparable to placebo, with studies indicating low relapse risk post-switch from IV to subcutaneous administration. Presented at the European Crohn’s and Colitis Organization, extended studies affirm its long-term benefits. As the pioneer of Remicade biosimilar, Celltrion extends its impact with Zymfentra’s innovative delivery method, promising a new horizon in IBD treatment.


Johnson & Johnson boosts heart device business with $12.5 billion Shockwave Medical deal

Johnson & Johnson (J&J) announces a $12.5 billion acquisition of Shockwave Medical, expanding its cardiac health portfolio. The deal grants access to Shockwave’s intravascular lithotripsy (IVL) device, which breaks down calcified plaque in heart vessels. J&J prioritizes cardiovascular products, evident in previous acquisitions like Abiomed and Laminar. With potential competition for Stelara, its flagship Crohn’s disease drug, J&J seeks diversification. The acquisition, expected to close by mid-2024, values Shockwave at $13.1 billion, reflecting its $730.2 million product sales in 2023. Financed by cash and debt, the deal offers a 17% premium to Shockwave’s stock price, signaling confidence in future growth.


FTC Issues Warning Letters to Pfizer, Thermo Fisher, and Others

The US Federal Trade Commission (FTC) issued “close-at-risk” letters to numerous companies, including Pfizer, Baxter International, and Thermo Fisher Scientific, warning of potential antitrust challenges post-deadline. Initiated between June 2021 and July 2022, these letters aim to regulate the surge in merger filings. Led by Chair Lina Khan, the FTC faced criticism from GOP commissioners and business groups for potentially hindering legitimate mergers. Despite issuing 204 warnings, the FTC hasn’t dismantled any deals, with acquisitions like Pfizer’s $6.7 billion purchase of Arena Pharmaceuticals proceeding despite caution.

Most Cancer Drugs Granted Accelerated FDA Approval May Not Work

A recent study scrutinizing the U.S. Food and Drug Administration’s accelerated approval program for cancer drugs reveals that within five years, most of these medications fail to demonstrate improvements or extensions in patients’ lives. Initiated in 1992 to expedite access to promising HIV drugs, today 85% of accelerated approvals target cancer treatments. However, despite early access, many drugs don’t deliver anticipated benefits, with only 43% showing clinical advantages in follow-up trials. The study, discussed at the American Association for Cancer Research meeting, underscores the importance of transparent communication to patients regarding the uncertainty surrounding these accelerated approvals, especially considering their vital role in treating rare or advanced cancers.


NASA, Health and Human Services Highlight Cancer Moonshot Progress

AstraZeneca and Daiichi Sankyo’s Enhertu received accelerated approval from the FDA to treat advanced solid tumors in patients with HER2-positive (IHC 3+) expression who have undergone prior systemic treatment without satisfactory alternatives. HER2, a growth-promoting protein, is often associated with aggressive cancers. The FDA’s decision was based on positive results from trials like DESTINYPanTumor02, DESTINY-Lung01, and DESTINY-CRC02, showing significant objective response rates and duration of response. Dave Fredrickson of AZ highlighted Enhertu’s role as the first ADC with a tumor-agnostic indication, emphasizing the importance of biomarker testing. Daiichi Sankyo’s Ken Keller called it a milestone for eligible patients.


AstraZeneca, Daiichi Drug Gets Broad Tumor Approval in US

The White House is incorporating artificial intelligence (AI) into its Cancer Moonshot initiative, aiming to reduce the cancer death rate by half over 25 years and enhance the lives of patients and caregivers. Catherine Young, Assistant Director for Cancer Moonshot Engagement and Policy, emphasized the ambitious yet achievable goals and highlighted the role of AI in advancing the initiative. Key areas for AI implementation include aiding radiologists in faster cancer diagnosis, processing large data quantities, streamlining drug discovery and testing, and evaluating new drugs’ effectiveness. Young stressed the need for proper controls to avoid exacerbating healthcare inequalities and biases in AI applications.


FDA approves Merck’s drug for rare, deadly lung condition

The FDA approved Merck’s Winrevair for adults with pulmonary arterial hypertension (PAH), a rare and lifethreatening lung condition. This marks a breakthrough as it targets the root cause, unlike existing drugs that manage symptoms. With a $14,000 per vial price tag, Merck offers patient assistance programs. Winrevair enhances exercise capacity, mitigates PAH severity, and reduces disease progression risk. Projected as a $5 billion annual sales by 2030, it’s seen as a major revenue driver for Merck, especially as its key drug Keytruda nears market exclusivity. The drug, acquired through Acceleron Pharma, demonstrated significant efficacy in trials, offering hope to PAH patients.


BMS Sees Early ROI for $14B Karuna Buy with Phase III Schizophrenia Win

Bristol Myers Squibb presented interim Phase III EMERGENT-4 study data at the SIRS 2024 Congress, revealing KarXT’s promising results in treating schizophrenia. Over 75% of patients experienced at least a 30% improvement in symptoms at 52 weeks, with a notable drop in PANSS scores. KarXT, acquired from Karuna Therapeutics for $14 billion, activates muscarinic receptors, differing from conventional treatments. Long-term safety data from EMERGENT-4 and EMERGENT-5 showed favorable tolerability and weight loss in patients. BMS plans to further discuss KarXT with the FDA, anticipating its PDUFA date in September 2024, aiming to offer a novel option for schizophrenia management.


Novartis finally ready for Pluvicto filing in earlier prostate cancer as patient survival data clear up

Novartis is preparing to submit its radiotherapy Pluvicto for FDA approval in earlier-stage prostate cancer treatment, after favorable patient survival data from the PSMAfore trial. The trial showed Pluvicto’s benefit against a comparator in metastatic castration-resistant prostate cancer. Novartis aims for a pre-chemo approval, crucial for its $3 billion sales projection. Despite past delays due to immature data, Novartis plans to file in the second half of 2024. Concerns linger about the sustainability of survival trends. Novartis attributes past survival concerns to patient crossover. Similar issues occurred with Bristol Myers Squibb’s Abecma, yet it gained FDA backing based on strong progression-free survival benefits.


FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

The FDA has cleared Rejoyn, a prescription digital therapeutic developed by Otsuka Pharmaceutical and Click Therapeutics, for treating major depressive disorder. Rejoyn delivers cognitive behavioral therapy lessons and exercises digitally, serving as an adjunct to antidepressant medication. Although the clinical trial showed a non-statistically significant difference compared to a sham app, Otsuka believes there is a trend favoring continued improvement. Rejoyn will be available for download this summer, with prescriptions sent electronically to pharmacies. Unlike previous digital therapeutics, Rejoyn benefits from Otsuka’s support and existing market presence, potentially facilitating reimbursement. Pricing details are yet to be disclosed.


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