Pharma Contract Market Update

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Contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) continue to grow and expand to keep up with the latest advances and breakthroughs in services and technology for their clients. The following are some notable acquisitions, expansions, and industry partnerships that have occurred in recent months.

Acquisitions

Recipharm announced in November 2019 that it acquired Consort Medical, a drug delivery and device company headquartered in the United Kingdom, for £505 million (US$649 million) (1). Through the agreement, Recipharm will gain technological intellectual property along with access to new customers and Consort’s product portfolio from both of the company’s divisions, Bespak and Aesica. The acquisition is also expected to build up Recipharm’s scale and profitability with an annual pro forma revenue of SEK 10,847 million (US$1.1 billion) and pro forma earnings before interest, tax, depreciation, and amortization of SEK 1793 million (US$186 million).

On Dec. 4, 2019, Cambrex Corporation announced its sale to an affiliate of the Permira funds had been completed. The acquisition agreement was valued at approximately $2.4 billion (2).

In a press release, Cambrex said the investment “will support the ongoing growth of Cambrex’s integrated services offering by enhancing the company’s ability to service its global customer base, and broadening its capabilities to provide additional world-class services to support the analysis, development and manufacturing-from preclinical through commercial phases-of drug substances and products.”

“The completion of this transaction kicks off the next exciting phase of growth for our company,” said Steve Klosk, president and CEO of Cambrex in the press release. “We look forward to working with the Permira team to further enhance our best-in-class capabilities, strengthen our market-leading position, and broaden and deepen our customer relationships.”

New facilities, expansions, updates

Catalent announced it completed the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility in Anagni, Italy in January 2020 (3). The 28,000-square-meter (305,000-square-foot) facility offers aseptic liquid and powder filling for biologics and sterile products for multiple vial sizes, and primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. Catalent has also revealed that it plans to make further investments in the site’s growth, the company said in a press release.

“The Anagni facility supplements our European commercial supply capabilities and will integrate well with our existing global early development and clinical supply sites to smooth the transition from development to commercial supply,” said Alessandro Maselli, Catalent’s president and chief operating officer in the press statement. “Anagni provides our European customers with great biologics and oral dose capabilities that can help us reduce time-to-market, simplify tech transfers, and minimize program risk.”

Additionally, Catalent announced it was investing $9 million into a new clinical supply facility in San Diego, CA that will begin operations in the summer of 2020 (4). According to a Sept. 5, 2019 press release, the new facility will provide clinical supply services to pharmaceutical and biopharmaceutical customers and will specialize in services for early phase clinical trials while enhancing the company’s OptiForm Total Supply service, which offers customers integrated development, clinical supply manufacturing, and distribution. The facility will also handle clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction and will include stability chambers.

In early 2020, WuXi STA, a subsidiary of WuXi AppTec, announced the opening of its new large-scale oligonucleotide API manufacturing facility in Changzhou, China (5). At 30,000 square feet, the new site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, which will further expand the company’s ability to deliver new oligonucleotide therapies to market, according to a company press release. The facility can also provide services for small molecules, peptide process R&D, and manufacturing from laboratory to commercial scales.

“By leveraging our small-molecule CMC (chemical, manufacturing, and control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large-scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide,” said Dr. Minzhang Chen, CEO of WuXi STA, in the press release.

PCI Pharma Services announced a facility expansion at its Tredegar facility in Wales, UK and a facility expansion completion at its Rockford, IL, facility in December 2019. The Tredegar facility is set to be completed by late 2021, and the expansion will double the facility’s large-scale granulation and fluid bed drying capacity, create additional space for new potent handling capabilities, and will add an analytical and a small-scale processing area for early stage non-good manufacturing practice (GMP) processing and formulation, according to a company press release (6).

After the expansion, the Rockland site is now the largest of the company’s eight locations and features four high-potent-compound-capable suites built to International Organization for Standardization (ISO) 8 standards, high-efficiency particle air filtration technology, three new secondary packaging areas, and three new coolers and a new freezer for 20 °C to -8 °C cold-chain requirements (7).

“Across the globe, we are making strategic decisions that enable us to continue to support our clients’ business and meet increased demands for our integrated services,” said Salim Haffar, CEO, PCI Pharma Services, in a press release.

On Jan. 22, 2020, The Discovery Labs, an MLP Venture company and provider of cGMP manufacturing, turnkey laboratory solutions, critical materials, and office space, and Deerfield Management, a healthcare investment management firm, announced that they have formed The Center for Breakthrough Medicines, a new contract development and manufacturing organization (CDMO) and specialty investment company (8). Under the new CDMO, the companies will invest $1.1 billion to build a manufacturing facility for cell and gene therapies.

“The Center for Breakthrough Medicines will be serving companies from the earliest stages through commercialization. Its exceptional scale and offering will quickly relieve the production bottleneck for advanced therapies by reducing the time, complexity, and cost of commercializing vitally needed gene and cell therapies,” noted Audrey Greenberg, board member and executive managing director for The Discovery Labs, in a company press release.

Partnerships

Lonza revealed in October 2019 that it was extending its partnership with Genmab, a Denmark-based biotechnology company specializing in antibody therapeutics for cancer, to cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline (9). The companies have been in collaboration since 2002.

The agreement aims to provide Genmab with security of supply and to enable Genmab to move rapidly into clinical manufacturing with the flexibility needed to manage an extensive pipeline through the demands of clinical trials. It will also include developing complex molecular formats using Genmab’s DuoBody technology.

Lonza also entered into a partnership with Cryoport in November 2019 to strengthen its ‘vein-to-vein’ delivery network by removing supply chain hurdles faced by developers of personalized therapeutics (10). The new collaboration will aim to provide fully integrated solutions, including co-location of manufacturing bioservices and distribution facilities, automated data management, and process optimization.

“The Lonza-Cryoport collaboration is an enabling part of a wider goal for Lonza to create a network of strategic partnerships and capabilities that enable seamless vein-to-vein delivery of cell and gene therapies for its customers and their patients,” said Alberto Santagostino, SVP head of Cell & Gene Technologies, Lonza Pharma & Biotech, in a press release. “There is no doubt that this partnership enables us to provide a best-in-class solution to cell and gene therapy companies for manufacturing and supply chain services, allowing us to provide a fully integrated solution that reduces risk and increases transparency.”

In September 2019, Catalent entered into a long-term commercial supply agreement with Minerva Neurosciences, a Waltham, MA-based biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders (11). The collaborations will center on roluperidone (MIN-101), an investigational compound under development by Minerva, for the treatment of negative symptoms of schizophrenia. If its successful in Phase III clinical trials, the drug will be the first treatment approved to treat symptoms of schizophrenia in the United States, according to the companies.

Catalent announced two additional partnerships in December 2019, one with Ethicann Pharmaceuticals for the development of a new combination pharmaceutical-grade cannabidiol and tetrahydricannabinol product to treat multiple sclerosis (12), and one with Bridge Therapeutics for the formulation, development, and production of BT-219, a new opioid addiction treatment (13). Both drugs will be used with Catalent’s Zydis orally disintegrating tablet technology.

“The Zydis technology platform has been shown to be very versatile and effective in developing easy-to-administer dose forms for innovators and to date, more than 36 products have been launched using Zydis technology in over 60 countries,” said Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business unit, in a press release.

Samsung Biologics announced a long-term agreement with Ichnos Sciences, a Paramus, NJ-based biotech company, in November 2019 for the manufacturing of drug substance for ISB 830, an anti-OX40 monoclonal antibody in development as a potential treatment for moderate-to-severe atopic dermatitis (14). Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale, according to Samsung.

References

1. Recipharm, “Recipharm Offers to Acquire Consort Medical to Become a Leading Inhalation Company and Top Five Global CDMO Player,” Press Release, Nov. 18, 2019.
2. Cambrex, “Cambrex Announces Completion of Acquisition by the Permira Funds” Press Release, Dec. 4, 2019.
3. Catalent, “Catalent Completes Purchase of Biologics Fill-Finish and Oral Solid Dose Facility in Anagni, Italy,” Press Release, Jan. 7, 2020.
4. Catalent, “Catalent To Open New Clinical Supply Facility in San Diego,” Press Release, Sept. 5, 2019.
5. WuXi STA, “WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility,” Press Release, Jan. 3, 2020.
6. PCI, “PCI Pharma Services Announces UK Facility Expansion,” Press Release, Dec.17, 2019.
7. PCI, “PCI Expands Illinois Pharmaceutical Manufacturing Facility,” Press Release, Dec. 6, 2019.
8. The Discovery Labs, “The Center for Breakthrough Medicines is Building the World’s Largest Cell and Gene Therapy Contract Development and Manufacturing Organization (CDMO) to Launch in King of Prussia, PA,” Press Release, Jan. 23, 2020.
9. Lonza, “Lonza’s Ibex Solutions to Support Genmab’s Growing Clinical Portfolio,” Press Release, Oct. 14, 2019.
10. Lonza, “Lonza Partners with Cryoport and Strengthens its ‘Vein-to-vein’ Delivery Network in Cell & Gene Therapy,”  Press Release, Nov. 5, 2019.
11. Catalent, “Catalent and Minerva Neurosciences Enter Commercial Supply Agreement for Schizophrenia Drug Roluperidone,” Press Release, Sept. 24, 2019.
12. Catalent, “Catalent to Partner with Ethicann on New Fast-Dissolve Cannabinoid-Based Treatment for Multiple Sclerosis Spasticity,” Press Release, Dec. 3, 2019.
13. Catalent, “Catalent Partners with Bridge Therapeutics on Formulation, Development and Production of New Opioid Addiction Treatment,” Press Release, Dec. 10, 2019.
14. Samsung Biologics, “Samsung Biologics and Ichnos Sciences Announce Agreement for Manufacture of ISB 830,” Press Release, Nov. 5, 2019.

Article Details

Pharmaceutical Technology
Supplement: Partnering for Bio/Pharma Success
February 2020
Pages: s32–s34

Citation

When referring to this article, please cite it as, “Pharma Contract Market Update," Pharmaceutical Technology Partnering for Bio/Pharma Success Supplement (February 2020).