Grant Playter

Stevanato Group, an Italian provider of drug containment, drug delivery, and diagnostic solutions, announced a collaboration with Recipharm, a Swedish contract development and manufacturing organization, on March 16, 2023. Under the agreement, Stevanato will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.

Stevanato will provide and manufacture its proprietary glass pre-fillable syringe, Alba, assembled with the integrated spray module of Recipharm’s soft mist inhaler technology, the Pre-Filled Syringe Inhaler (PSFI). According to a company press release, the goal of this partnership is to deliver drug products more efficiently to the respiratory airways, as well as provide biopharma companies with a containment solution that features enhanced stability and safety.

“By leveraging Stevanato Group's integrated capabilities, from plastic injection molding and assembly capabilities to comprehensive scientific and analytical support services, we will be able to offer a turnkey solution, and accelerate and de-risk our pharmaceutical customers’ development programs,” said Bernhard Muellinger, general manager and chief operational officer, Resyca (a joint venture between Recipharm and Medspray), in the release. “This is particularly true for novel inhaled biological products.”

“Biopharma companies are advancing patient care with new, innovative treatments, particularly in biologics and mRNA [messenger RNA] therapies,” said Mauro Stocchi, chief business officer, Stevanto Group, in the release. “These products require specialized, high-performance drug containment systems, like our Alba syringe platform, together with patient-centric drug delivery devices [such as] the PFSI.”

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Stevanato Group will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.

Stevanato Group and Recipharm to Collaborate on Pre-fillable Syringes for Soft Mist Inhaler

Pfizer and Seagen, a global biotechnology company specializing in antibody-drug conjugates (ADC), announced a definitive merger agreement on March 13, 2023. The deal will see Pfizer acquire all outstanding shares of Seagen for a total of $43 billion. The companies expect to complete the transaction in late 2023 or early 2024, subject to approval of Seagen’s stockholders and receipt of required regulatory approvals.

According to a company press release, Seagen’s portfolio includes four approved medicines that are first- or best-in-class in their respective indications across solid tumors and hematologic malignancies: three of these, Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin), and Tivdak (tisotumab vedotin), are ADCs. The company’s technology is used in four of the twelve total FDA-approved and marketed ADCs.

In the release, Seagen stated that it expects to generate approximately $2.2 billion of revenue in 2023, representing 12% growth relative to 2022. Additionally, Pfizer indicated it believed that Seagen could contribute more than $10 billion in risk-adjusted revenues by 2030, as well as provide potential significant growth beyond that.

“Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Albert Bourla, chairman and CEO, in the release. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s ADC technology with the scale and strength of Pfizer’s capabilities and expertise. Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals.”

“Pfizer shares our steadfast commitment to patients, and this combination is a testament to the passion, dedication and talent of the Seagen team to achieve our mission to discover, develop, and commercialize transformative cancer medicines that make a meaningful difference in people’s lives,” said David Epstein, CEO, Seagen, in the release. “The proposed combination with Pfizer is the right next step for Seagen to further its strategy, and this compelling transaction will deliver significant and immediate value to our stockholders and provide new opportunities for our colleagues as part of a larger science-driven, patient-centric, global company.”

Pfizer will acquire all outstanding shares of Seagen for a total of $43 billion.

Pfizer to Acquire Seagen in $43 Billion Blockbuster Deal

The Biden-Harris administration, through the Centers for Medicare & Medicaid Services (CMS), announced on March 15, 2023 a list of prescription drugs for which Part B beneficiary coinsurances may be lower. Taking effect from April 1, 2023 to June 30, 2023, Medicare recipients may save between $2 and $390 per average dose on affected medications, although drugmakers will not be expected to pay these rebates until 2025.

According to the agency press release, these price controls, instituted on 27 different drugs, are set to hit drugs whose price increases have outpaced the rate of inflation. The 

 (1) notably includes heavy-hitters such as AbbVie’s Humira (adalimumab) and Astellas Pharma’s and Seagen’s Padcev (enfortumab vedotin). Other affected companies include Gilead Sciences, Johnson &Johnson, and Pfizer; Pfizer, had the most drugs named of any other company, with five drugs on the list,.

“The Biden-Harris Administration believes people with Medicare shouldn’t be on the hook when drug companies inexplicably jack up the prices of their drugs,” said Health and Human Services Secretary Xavier Becerra in a CMS press release. “President Biden made lowering prescription drug costs for Americans a top priority, and we’re using every lever we have to deliver results. With the inflation rebate program, we are fighting to ensure seniors can afford the treatments they need, taxpayers aren’t subsidizing drug company excess prices, and the Medicare program is strong for millions of beneficiaries now and in the future.”

1. CMS, “Reduced Coinsurance for Certain Part B Rebatable Drugs under the Medicare Prescription Drug Inflation Rebate Program,” Press Release, March 15, 2023.

27 drugs within Medicare will face penalties for having their prices raised faster than the rate of inflation. 

First Drugs Hit by Inflation Reduction Act Price Controls

Actylis, a global specialty ingredients manufacturer and supplier, announced the formal opening of its new API manufacturing facility on Feb. 27, 2023. The facility, located in Eugene, Ore., is good manufacturing practice (GMP)-compliant and designed to supply both APIs and excipients at both clinical trial and commercial scale.

“We are excited to have this state-of-the-art facility here in Eugene come on line after such an intensive design and development process,” said Christine Bellmor, site director, in a company press release. “We have [seven] manufacturing suites and our clean rooms will be ISO Class 8 compliant by Q3 [third quarter]. We have a number of different reactors to allow flexibility for a variety of chemistries. Commissioning and qualifications for clinical GMP were completed at the end of January this year and we already have our first projects completed, and more are underway.”

“We designed this facility specifically to enable us to develop and produce innovative APIs for our customers,” said Gilles Cottier, CEO, Acylis, in the release. “We worked closely with architect firm BCA (Blaise Cacciola Architect) and Coffman Engineering to build a facility that has the most up-to-date technology and equipment available.”

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Actylis Opens 30,000-square-foot API Manufacturing Facility

Merck, known as MSD outside of the United States and Canada, announced full results from a Phase III clinical trial (STELLAR) on March 6, 2023. The trial evaluated sotatercept, an investigational activin-signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH).

According to a company press release, the trial’s primary endpoint—increasing six-minute walk distance—showed a statistically significant improvement of 40.8 meters. Additionally, eight of the nine secondary measures, including World Health Organization functional class and pulmonary vascular resistance, also demonstrated clinically meaningful improvements.

“PAH is a rare, rapidly progressive, debilitating, and ultimately life-threatening condition with a five-year mortality rate of 43 percent,” said Marius Hoeper, Hannover Medical School, Germany, and lead investigator, in the release. “Sotatercept demonstrated profound improvements across the primary endpoint of six-minute walk distance and multiple secondary endpoints. These landmark results show the potential of sotatercept and the approach of targeting cellular signaling associated with vascular hyperproliferation and pathological remodeling for the treatment of PAH.”

“The results from the Phase III STELLAR trial are immensely important to physicians and patients and highlight the critical role sotatercept may play in improving exercise capacity and other meaningful clinical outcome measures for patients with PAH,” said Dean Y. Li, president, Merck Research Laboratories, in the release. “These findings are compelling given the profound reduction in the risk of clinical worsening or death in patients treated with sotatercept on top of background therapy. We look forward to discussing these pivotal data with health authorities and are working with urgency to bring this potential new treatment option to patients.”

Merck acquired the rights to sotatercept 

in an $11.5 billion acquisition of Acceleron in 2021

. The drug has been granted Breakthrough Therapy designation and Orphan Drug designation by FDA, as well as Priority Medicines designation and Orphan Drug designation by the European Medicines Agency for the treatment of PAH.

Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.

Merck Releases Data on Rare Blood Vessel Disorder Treatment

In a highly regulated industry such as pharmaceuticals each company needs to prove the quality of their products by showing data produced during their production processes. Management of records and data by these regulated companies is controlled by data governance, which embraces people, processes, and the technology required for effective data handling. All this leads directly into the production of high-quality drug product. 

Keeping up with requirements is obviously a vital step, but more generally, prioritizing how to actively demonstrate what controls you have in place to prove trust in the data in your organization, every data lifecycle step, the GxP (IT and non-IT) systems, and all related processes, makes a vital difference in how regulators see your quality management maturity (QMM) but also how both staff and clients see the company itself.

In this episode of Drug Digest, Grant Playter, associate editor, speaks with computer validation experts on how to set data controls and why efforts spent here are financially rewarding in the long run.

 is a member of the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin. Paige brings over 30 years’ experience working in a regulated environments (including Pfizer, Wyeth, Genetics Institute, Monsanto and USDA/USCS), and has been responsible for developing and implementing KM programs, quality systems for GLP, GCP, and GMP, electronic records/electronic signatures programs, and automation validation methodologies.

 is European Laboratory Compliance Specialist at Agilent Technologies. Garry has 25 years of experience working within regulated pharmaceutical environments and providing compliance guidance to regulated companies across Europe.

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.