Somerset, NJ-based contract research organization (CRO) Catalent announced it is acquiring Baltimore-based Paragon BioServices for $1.2 billion. Paragon develops and manufactures viral vectors for gene therapies.
Paragon has specialized expertise in adeno-associated virus (AAV) vectors, which are the most common vectors for gene therapies. It also has significant capabilities in GMP plasmids and lentivirus vectors.
“Paragon’s unparalleled expertise in the rapidly growing market of gene therapy manufacturing will be a transformative addition to our business that we believe will accelerate our long-term growth,” stated John Chiminski, Catalent’s chair and chief executive officer. “Paragon brings to Catalent a complementary capability that will fundamentally enhance our biologics business and our end-to-end integrated biopharmaceutical solutions for customers.”
On March 25, Thermo Fisher Scientific acquired gene and cell therapy manufacturer Brammer Bio for $1.7 billion in cash. Brammer Bio is a contract development and manufacturing organization (CDMO) focused on manufacturing viral vectors for gene and cell therapies.
Both of these deals underline how important gene and cell therapies are becoming in the biopharma industry. For example, on Friday, March 22, bluebird bio, headquartered in Cambridge, Mass., announced it was opening its new gene therapy manufacturing facility in Durham, NC. That factory will produce lentiviral vectors for its gene and cell therapies, including bb2121 and bb21217 for multiple myeloma and possibly LentiGlobin for transfusion-dependent beta-thalassemia (TDT) and sickle cell disease.
According to a recent industry report, there are almost 300 gene therapies being developed to treat more than 100 diseases.
Unlike bluebird bio, which is working to handle its vector manufacturing itself, many companies will contract with CROs and CDMOs for their vector manufacturing. In gene therapies, vectors are typically a genetically altered virus that contains human DNA. The virus, often adeno-associated virus (AAV), has the viral DNA or RNA stripped out with the replacement gene intended for the patient inserted. The virus then is injected into the patient, where it infiltrates the cells and inserts the therapeutic DNA into the cells, which integrate them into their genome.
Catalent projects that the gene therapy market is expected to have sustained growth of 25% in the medium term. In the near term, it expects Paragon will represent a small percentage of its business but will over time “meaningfully accelerate its revenue and EBITDA growth over time.” Paragon is expected to bring in more than $200 million this year.
Paragon will remain under the leadership of Pete Buzy and its management team. Paragon has about 380 employees, who will join the Catalent team.
“Our existing investors, NewSpring Health Capital and Camden Partners were extremely supportive in getting us to where we are today,” Buzy stated. “We are excited to join forces with the leading drug development and manufacturing partner in our industry. This transaction will enable us to achieve our next stage of development and expand our capabilities and platform for the benefit of our customers and their patients.”
According to The Wall Street Journal, Catalent had about $2.5 billion in sales in 2018. The company’s chief executive officer John Chiminsky has been working to grow the company’s capabilities in high-growth markets, such as gene and cell therapies, where it currently doesn’t have a strong presence.
In 2018, Catalent acquired Cook Pharmica, based in Bloomington, Indiana, for $950 million. Cook’s expertise is in manufacturing complicated drugs. And in 2018, Catalent acquired UK-based Juniper Pharmaceuticals in order to expand its contract manufacturing.
总部位于新泽西萨默塞特的合同研究组织（ CRO ） Catalent 宣布，将以12亿美元收购总部位于巴尔的摩的 ParagonBioServices 。Paragon 开发和制造用于基因治疗的病毒载体。
Paragon 在腺相关病毒载体（ AAV ）方面拥有专业知识，这是基因治疗最常见的载体。它在 GMP 质粒和 lentivirus 载体上也有显著的能力。
“ Paragon 在快速增长的基因治疗制造市场拥有无可比拟的专业知识，这将是对我们业务的一种革命性补充，我们相信这将加速我们的长期增长，” Catalent 董事长兼首席执行官约翰•奇明斯基( John Chiminski )表示。“ Paragon 为 Catalent 带来了一种补充能力，将从根本上增强我们的生物制剂业务以及我们面向客户的端到端集成生物制药解决方案。”
3月25日， Thermo Fisher Scientific 以17亿美元现金收购了基因和细胞治疗制造商 Brammer Bio 。Brammer Bio 是一家专注于基因和细胞治疗病毒载体制造的合同研发和制造组织（ CDMO ）。
这两项协议都凸显了基因和细胞疗法在生物制药行业的重要性。例如，在3月22日星期五，总部位于马萨诸塞州剑桥市的蓝鸟生物公司。宣布将在北卡罗来纳州达勒姆开设新的基因治疗制造工厂。该工厂将生产用于基因和细胞治疗的 lentiviral 载体，包括用于多发性骨髓瘤的 bb2121和 bb21217，以及可能用于输血依赖性β-地中海贫血（ TDT ）和镰状细胞疾病的 LentiGlobin 。
与蓝鸟生物不同，许多公司将与 CRO 和 CDO 签订载体制造合同。在基因疗法中，载体通常是一种含有人类 DNA 的转基因病毒。病毒，通常是腺相关病毒（ AAV ），病毒的 DNA 或 RNA 被剥离出与替代基因打算插入病人。然后病毒被注射到病人体内，在病人体内渗透细胞，并将治疗性 DNA 插入细胞中，将其整合到他们的基因组中。
基因治疗市场有望在中期持续增长25%的催化项目。该公司预计，在近期内， Paragon 将只占其业务的一小部分，但随着时间的推移，“将显著加快收入和 EBITDA 的增长。”预计巴拉圭今年将带来2亿多美元。
Paragon 将继续在 PeteBuzy 及其管理团队的领导下。Paragon 有大约380名员工，他们将加入 Catalent 团队。
Buzy 表示：“我们现有的投资者 NewSpringHealthCapital 和 Camden Partners 在帮助我们走上今天的道路方面非常支持。”“我们很高兴与业内领先的药物研发和制造合作伙伴携手合作。这项交易将使我们能够实现下一阶段的发展，并扩大我们的能力和平台，以造福于我们的客户和他们的患者。”
据《华尔街日报》报道， Catalent 2018年的销售额约为25亿美元。该公司首席执行官约翰•奇明斯基( John Chiminsky )一直致力于在基因和细胞疗法等高增长市场提升公司的能力，目前该公司在这些市场的影响力还不大。
2018年， Catalent 以9.5亿美元收购了总部位于印第安纳州布卢明顿的库克制药公司。库克的专长是制造复杂药物。2018年， Catalent 收购了总部位于英国的 Juniper Pharmaceuticals ，以扩大合同制造。