Alessandro Maselli, Catalent’s President and COO

Catalent is continuing to expand its fast-growing biologics operations, agreeing to acquire Bristol-Myers Squibb (BMS)’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy, for an undisclosed price.

At the Anagni site, Catalent will decide to continue to manufacture treatments for BMS, but will also offer access to customers seeking a European facility offering sterile biologics fill/finish, as well as oral solids manufacturing and packaging platforms, the companies said Wednesday.

Catalent says the Anagni plant complements its existing sterile fill/finish capabilities in Brussels, Belgium, as well as its drug substance, analytical, and fill/finish capabilities in North America.

“The addition of the Anagni facility provides our European customers with great biologics and oral dose capabilities to accelerate their development programs and improve commercial supply,” Alessandro Maselli, Catalent’s president and COO, said in a statement. “Bristol-Myers Squibb has invested in the facility to create a center of excellence for new product launches with a robust quality and delivery record, and an employee base who shares Catalent’s operational excellence and patient focus.”

Opened in 1966, the Anagni facility manufactures and packages cardiovascular, neuroleptics, anticancer, metabolic, and anti-inflammatory medicines, as well as non-penicillin-based antibiotics, antivirals, analgesics as injectables, and biologics, according to BMS’ website.

The facility consists of approximately 19,300 square meters (207,743 square feet) of floor space on a site of 34 hectacres (84 acres) that is located in an industrial area 100 kilometers (62 miles) southeast of Rome.

Catalent and BMS said they anticipate completing their deal by the end of 2019, subject to regulatory approvals, consultation with union representative of the plant’s employees, and satisfaction of other customary closing conditions.

Headquartered in Somerset, NJ, Catalent is a provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products.

Growing EBIDTA, revenue

Biologics continues to be a growth area for Catalent. The company’s Biologics and Specialty Drug Delivery segment saw its earnings before interest, taxes, depreciation, and amortization (EBITDA) rise 38% year-over-year for the first three quarters of its current fiscal year 2019, the nine months ending March 31, to $119.1 million from $86.4 million in the year-ago period.

Revenue for the segment rose nearly 26% year-over-year, to $511.1 million from $406.4 million in the nine months ending March 31, 2018.

Biologics accounted for 28.5% of the $1.792 billion in total revenue Catalent reported for its 2019 fiscal year, which ends June 30. That’s up from 26% of the $2.463 billion in total revenue Catalent reported for its 2018 fiscal year—which was nearly double the 14% of FY 2017.

“We’re still seeing strong growth in demand for development and production of proteins and monoclonal antibodies,” Michael A. Riley, Catalent vp, general manager, drug substance & bioanalytical, told GEN on January 7, in an interview during the J.P. Morgan 37th Healthcare conference, held in San Francisco. “We’re really trying to invest to get out in front of that demand. That’s demand from current customers as well as the market in general.”

To meet that demand, Catalent has expanded in recent months: In January, Catalent committed $200 million over three years to its drug substance manufacturing capacity and drug product fill/finish capacity in Bloomington, IN, and Madison, WI. Also this year, Catalent expanded into the gene therapy field by acquiring Paragon Bioservices, a leading developer and manufacturer of viral vectors, for $1.2 billion in a deal announced April 15 and completed May 20.

Lou Schmukler, president, global product development and supply, BMS, said that the sale of the Anagni site marked an important step in the ongoing evolution of the pharma’s manufacturing network to support its innovative product portfolio.

“We believe that the sale to Catalent will continue the vital role the Anagni facility plays for its workforce, the community, and patients,” Schmukler stated. “Bristol-Myers Squibb has a long history in Italy, and we intend to maintain a continued strategic presence in Italy, which is critical for our ability to deliver transformational medicines to patients.”

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