Catalent Archives - Medical Design Sourcing

Catalent cuts 300 jobs ahead of acquisition by Novo Holdings

Catalent said this week that it reduced its headcount by approximately 300 employees as part of a restructuring effort.

The company confirmed the workforce reduction in its 10-Q quarterly report, filed on Feb. 14. This also coincides with preparations for an acquisition as Novo Holdings agreed to buy the leading pharmaceutical CDMO for $16.5 billion earlier this month.

In connection with the headcount slash, Catalent incurred cumulative employee-related charges totaling approximately $12 million. Those are primarily associated with cash severance programs through Dec. 31, 2023.

The company says that it adopted plans to reduce costs, consolidate facilities and optimize infrastructure during the fiscal year ended June 30, 2023. During the three months ended Dec. 31, 2023, it extended those plans to reduce costs and headcount in its Biologics and Pharma and Consumer Health segments.

In October 2023, the company committed to closing operations at a Sa…

Prominent cell and gene therapy vendors in 2023

[Image courtesy of catalin/Adobe Stock]

In recent years, the cell and gene therapy market has grown at a rapid clip. The momentum is likely to continue. According to Vision Research Reports, the global cell and gene therapy market size could hit around $42.56 billion by 2030, growing at a CAGR of 39% from 2022 to 2030.

The burgeoning demand in the industry, along with an increasing number of FDA-approved therapies, is also fueling the growth of cell and gene therapy vendors offering tools and services for product development and manufacturing.

The following table includes notable vendors and suppliers active in the call and gene therapy marketplace. This curated selection of companies includes a brief overview of their focus areas.

We have a separate feature focused on companies with prominent cell and gene therapy development efforts.

Company Name Description Notable partnerships Founded He…

Catalent shares up almost 60% in 2023 as acquisition rumors swirl

Contract manufacturing giant Catalent (NYSE:CTLT) is rumored to be the target of a Danaher (NYSE:DHR) acquisition, according to a Bloomberg report.

CTLT shares were trading at $72.15 in afternoon trading on Tuesday, an increase of 58.75% over its valuation at the beginning of 2023.

The company’s market cap is close to $13 billion.

If the deal moves forward, it could help Danaher compete against Thermo Fisher Scientific (NYSE:TMO), whose market cap is $226.36 billion.

Two diversified life sciences companies

Catalent offers a range of advanced delivery technologies, development, and manufacturing services for drugs, biologics, gene therapies and consumer health products. Its offerings are diverse, spanning oral, topical, inhalation and injectable drug delivery as well as biologics.

Thermo Fisher Scientific’s traditional focus is on analytical instruments, reagents and services for research, analysis and diagnostics. The company ha…

Catalent to invest $40M in biologics facility in Durham, North Carolina

Contract manufacturing giant Catalent has announced that it will set up a new biologics analytical center of excellence in North Carolina’s Research Triangle.

The new plant will offer analytical development and testing services for biologics, including cell and gene therapies.

Catalent obtained a Job Development Investment Grant (JDIG) from the North Carolina Economic Investment Committee (EIC) to provide 201 new jobs over the next five years in Durham County.

It anticipates that construction of the facility will be completed by mid-2023.

Catalent also operates a biologics and analytical center of excellence in Kansas City, Missouri. The company has committed $12 million to expand that facility.

Earlier this month, the company announced that it had opened a sizeable commercial-scale cell therapy manufacturing facility in Gosselies, Belgium.

Additionally, it expanded a clinical supply facility in Shanghai while laying off about 600 wo…

Catalent lays off workers, expands clinical supply facility in Shanghai

Contract manufacturing giant Catalent has wrapped up the expansion of a clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.

The company is also cutting 400 temporary and full-time workers in Bloomington, Indiana and more than 210 workers in Texas and Maryland.

In a statement from Bloomington, Indiana Mayor John Hamilton blames the layoffs on cooling demand for COVID-19 therapies. “My understanding is that in responding to the pandemic, Catalent significantly ramped up operations to accommodate the manufacturing of life-saving vaccines, but at present, the same volume of production is not necessary and thus is not economically sustainable as before,” Hamilton said.

After an inspection this summer, the FDA recommended that Catalent conduct voluntary quality improvements at the Bloomington site.

In addition, Catalent has halted construction on the Vaccine Manufacturing and Innovation Centre near Oxford in …

Novo Nordisk settles Danish securities lawsuit

Novo Nordisk (NYSE:NVO) has settled a securities lawsuit in Denmark filed in August 2019 in the district court of Glostrup.

In 2019, Novo Nordisk vowed to fight the allegations contained in the lawsuit, which alleged that the company’s insulin-related profits fell at the same time prices and sales increased from February 2015 and February 2017. The dip in profits resulted from an uptick in rebates to pharmacy benefit managers.

Investors behind the suit claimed that Novo Nordisk had exaggerated its U.S. insulin revenue in this time period.

In the settlement, the Bagsværd, Denmark–based company did not admit any liability or wrongdoing.

The lawsuit was related to several shareholders alleging that Novo Nordisk did not appropriately disclose facts related to its U.S. sales of insulin products. The shareholders initially sought DKK 11,785,192,218 (approximately $1.8 billion) in damages.

NVO shares have fallen steadily in January 2022 in …

Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

Catalent beats The Street in Q1, raises revenue guidance

Catalent (NYSE:CTLT) shares dipped today despite first-quarter financial results that beat the consensus forecast.

The Somerset, New Jersey-based company posted profits of $93 million, or 49¢ per share, on sales of $1.025 billion for the three months ended Sept. 30, 2021, for a 13.4% bottom-line gain on sales growth of 21.2%.

Adjusted to exclude one-time items, earnings per share were 71¢, 6¢ ahead of Wall Street, where analysts were looking for sales of $1 billion.

“Catalent’s strong start to fiscal 2022 was driven by robust growth in our Biologics segment and improving dynamics in both our softgel and oral technologies and oral and specialty delivery segments,” Catalent Chair & CEO John Chiminski said in a news release. “We continued to support global efforts to address the pandemic and execute on our long-term growth strategy through disciplined acquisitions, including our recent purchase of Bettera, and continued investments in biologics drug sub…

Catalent to make Phathom Pharmaceuticals stomach acid blocker if it wins FDA approval

Catalent announced today that it entered into a commercial supply agreement with Phathom Pharmaceuticals for its acid blocker.

The commercial supply agreement covers Phathom’s lead compound, vonoprazan, which is a novel, orally active-potassium competitive acid blocker (P-CAB) for treating gastrointestinal diseases, according to a news release.

Phathom currently has vonoprazan in late clinical-stage development for treating gastric acid-related diseases and disorders, including gastroesophageal reflux disease (GERD) and Helicobacter pylori (H. pylori) bacterial infection. The company owns rights for developing and commercializing vonoprazan in the U.S., Europe and Canada.

Under the agreement, Catalent will undertake the commercial manufacturing and packaging of the product at its large-scale oral solid dose manufacturing site in Winchester, Kentucky, should the drug receive FDA approval.

“As Phathom readies for the …

Catalent acquires gummies firm Bettera Holdings for $1B

Catalent has been on something of a spending spree during the pandemic.

Looking to bolster its nutraceutical business, the company announced it would acquire Plano, Texas–based Bettera Holdings LLC for $1 billion.

Bettera specializes in gummy, soft chew and lozenge products within nutritional supplements.

Also this year, Catalent has acquired RheinCell Therapeutics, which develops induced pluripotent stem cells (iPSC) technologies and the gene therapy CDMO Delphi Genetics. It has also acquired an additional facility at its Gosselies, Belgium Campus for plasmid DNA manufacturing. In addition, Catalent entered into an agreement with Acorda Therapeutics (NSDQ:ACOR) to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility.

The latest deal will bolster Catalent’s capacity for producing gummy-based vitamins, minerals and supplements. Bettera has four production facilities in the U.S. in California, Indiana, New Jersey and Virg…

AstraZeneca could enlist Catalent to produce COVID-19 vaccines

After stopping the production of its COVID-19 vaccine at an Emergent Biosolutions facility in Baltimore, AstraZeneca (LON:AZN) is in negotiations with Catalent (NYSE:CTLT) to shift production to one of its plants in nearby Harmans, Md.

FDA has yet to authorize the AstraZeneca COVID-19 vaccine, although it has won full approval in Australia and Brazil and has received emergency use authorization (EUA) in 168 other countries.

As a majority of U.S. citizens have already received at least one COVID-19 vaccine dose, officials at AstraZeneca are reportedly mulling the option of pursuing full approval of its vaccine instead of EUA, according to The Wall Street Journal.

The U.S. government required Emergent Biosolutions to halt production of the AstraZeneca vaccine after a production error forced Emergent to discard 15 million COVID-19 vaccine doses. Emergent intended to produce AstraZeneca’s and Johnson & Johnson’s adenovirus-vectored vaccines in the same f…

Catalent expands biologics manufacturing facility in Wisconsin

[Image from Catalent]

Catalent announced today that it completed the expansion of two new suites at its biologics manufacturing facility in Madison, Wis.

Somserset, N.J.-based Catalent also commenced work on customer programs in addition to completing the expansion of the biologics drug substance development and manufacturing facility, according to a news release. The company now has five manufacturing suites at the site, more than doubling its overall CGMP-scale capacity.

Catalent announced its plan to add two new mammalian cell culture sites in Madison in January 2019, with each new suite including a 2×2, 000-liter, single-use bioreactor system capable of processing batches of 2,000 liters or 4,000 liters for CGMP clinical and commercial manufacturing.

The first engineering batch in the new suite began last month, with the first CGMP batch expected to be manufactured next month. The secon…