Organix, Inc.

Dutch CDMO Symeres has acquired a company to further strengthen its position in the US. The company is buying Exemplify BioPharma, a CRO that provides drug development services, formulation development and CMC services to customers. Exemplify also has an 18,000-square-foot facility in Cranbury, NJ where the CMC services are done. Under the deal, which began in talks last year, Exemplify will maintain its leadership structure for its roughly 20 employees as it moves into Symeres’ fold, according to Symeres. In an email to Endpoints News, Symeres CEO Eelco Ebbers said the acquisition was a perfect fit for the company’s strategy. “Our strategy is based on strong organic growth with existing services and sites, complemented with an active acquisition strategy for complementary services in dedicated areas that are closely connected with existing services, or in certain regions. Exemplify’s services and expertise are a good complementary fit to Symeres’ existing development services in process R&D and GMP production.” Ebbers also said that over 40% of the company’s business originates from US-based companies, and with the acquisition, it can increase the support of its US-based customers. To boost its US presence, Symeres already acquired Organix, based in Woburn, MA, earlier this year. The deal is expected to close in a few weeks, according to Ebbers. After capping an expansion in North Carolina, Cambrex is moving its focus to the Midwest part of the US. The company announced that it is investing $16.5 million in two projects in Iowa and Minnesota. First, the company is planning to create a 21,000-square-foot R&D facility in Minneapolis. This will expand the capacity for small molecule development and manufacturing. The site will be near the Minneapolis-St. Paul airport and will conduct analytical and chemical development for drug candidates. The site will also act as an extension of Cambrex’s facility in Charles City, Iowa. The project is expected to add around 40 jobs in Minneapolis over the next two to three years. At the same time in Charles City, Cambrex is launching a 9,000-square-foot expansion and a 21,000-square-foot renovation project at the API manufacturing site. The Charles City expansion will add a new QC laboratory and office space, as well as add 40 jobs. The project will also “modernize” the AC and R&D facilities as well. The Iowa Economic Development Authority (IEDA) has also awarded the company tax benefits and $300,000 in direct financial assistance in support of the project. “Our new facility in Minneapolis will double our analytical and chemical development footprint in the Midwest, providing clients with easy access to state-of-the-art capabilities and top scientific experts. We continue to invest in our U.S.-based footprint to support the demand for high-quality API development and manufacturing,” said Thomas Loewald, CEO of Cambrex, in a statement . ABL, a French CDMO, has entered a strategic partnership with another French CDMO, RD-Biotech. The partnership will provide GMP manufacturing for cell and gene therapies. The deal will see RD’s manufacturing services combined with ABL’s production of viral vectors to provide end-to-end services for cell and gene therapy companies. The agreement will allow customers to have the option to use each company as a single supplier and work with each CDMO independently. “ABL’s partnership with RD-Biotech is a major step forward in enabling our company to roll out our ‘Gene to Cell’ strategy, aimed at offering all-in-one services to our customers whatever their needs are in Adeno Associated Virus-based (AAV) and lentivirus GMP manufacturing,” said Thierry Van Nieuwenhove, CEO of ABL, in a statement. The move comes as RD is planning to open a new facility next year to manufacture plasmid DNA and ABL is producing an “in-house AAV platform” along with opening a new facility to produce gene therapies. Landmark Bio has opened a new biomanufacturing facility in Watertown, MA. The 44,000-square-foot facility will test and manufacture cell and gene therapies made by the company and has eight cleanrooms to produce cell therapies, viral vectors, mRNA and lipid nanoparticles. It also has an area for fill-and-finish operations and QC testing. The facility will also provide services such as drug development, regulatory counseling and other support services. It also has around 60 staff members at present and will look to grow to 100 over the coming years. “Landmark Bio is a unique venture bringing together the best of academia, industry, and research hospitals to translate groundbreaking research into life-changing therapies,” said Ran Zheng, Landmark Bio’s CEO, in a statement . Mylan Institutional is pulling its octreotide acetate injection, in 500ml dosage, off the shelves. The recall is being issued, according to the FDA, due to a “product complaint” of glass particles in a syringe. The drug was made by Italfarmaco SpA, Italy, and was distributed by Mylan Institutional LLC in the US between Jan. 11 and June 21 of this year. The drug is used to reduce blood levels of growth hormone and insulin growth in acromegaly patients as well as treat patients with metastatic carcinoid tumors in certain cases. While the presence of glass in an intravenous drug can lead to several issues, including irritation, swelling, allergic reactions and microvascular obstructions, the FDA has so far not received any reports of “adverse reactions” for the recalled drugs. The FDA is encouraging wholesalers and retailers to examine inventory to see if the drug lot is in stock or has been distributed.

Exemplify, which is based in Cranberry, New Jersey, and has 20 employees, provides end-to-end small-molecule chemistry manufacturing and controls services to pharmaceutical and biotech partners. Symeres has acquired Exemplify BioPharma for an undisclosed price, marking the CRO and CDMO’s second purchase in the U.S. in 2022. In April, Netherlands-based Symeres snapped up U.S. lipid maker and organic chemistry contractor Organix as part of the company’s efforts to expand its drug discovery business into the lipids market to meet demand from developers of mRNA therapeutics and vaccines. Financial terms of the deal weren't disclosed. Next in its sights is Exemplify, which is based in Cranberry, New Jersey, and has 20 employees who provide end-to-end small-molecule chemistry manufacturing and controls services to pharmaceutical and biotech partners. Exemplify also offers services in process chemistry, analytical chemistry and formulation development. “This acquisition, following the addition of Organix earlier this year and our investment plans for all of our R&D facilities, is a further tangible demonstration of Symeres' strategy of building a leading mid-sized transatlantic pharmaceutical R&D service provider for our clients around the world,” Symeres CEO Eelco Ebbers, Ph.D., said in the release.

Symeres, a global drug discovery Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO), has acquired Exemplify BioPharma, a U.S.-based CRO that provides integrated drug development services in Process & Analytical Chemistry and Formulation Development to pharmaceutical and biotech partners. Keensight Capital, a private equity manager dedicated to pan-European Growth Buyout investments and the majority shareholder in Symeres, has worked together with the management teams of both companies to facilitate this business combination. About Exemplify Exemplify BioPharma, based in Cranbury, New Jersey, is a provider of high-quality integrated end-to-end small molecule Chemistry Manufacturing and Controls (CMC) services to pharmaceutical and biotech partners. The company offers functional expertise and consultancy services in Process Chemistry, Analytical Chemistry, and Formulation Development for a successful transition of programs from late-stage lead optimization through candidate selection to first-in-human. Exemplify employs 20 people, of which the majority are Ph.D-level scientists. The company will remain under the current management of co-founders: Yadan Chen, chief executive officer, and Dr. Paul O’Shea, chief scientific officer. This acquisition further strengthens Symeres’ strategic foothold in the U.S., where the company already generates about 50% of its revenues. Exemplify operates from its new state-of-the-art 18,600 sq. ft. facility in New Jersey. Its functional expertise in Process & Analytical Chemistry and Formulation Development represents a highly synergistic combination with Symeres capabilities and service offering. Exemplify BioPharma is Symeres’ second acquisition in the US this year, following the acquisition of Organix Inc., an organic chemistry services provider based in the Boston area specialized in lipids addressing the mRNA therapeutics and vaccines market. Yadan Chen, CEO of Exemplify BioPharma, stated: “Symeres is a trusted partner that shares our values and business philosophy of strong customer focus. Exemplify BioPharma’s recent move to our new and larger state-of-the-art facility, and the combination with a global business like Symeres, will allow us to better serve our clients under one roof. We look forward to accelerating our growth together.” Dr. Eelco Ebbers, co-founder and CEO of Symeres, commented: “We are pleased to welcome Exemplify BioPharma into the group. Exemplify has an excellent track record of supporting the development needs of North American biotech companies through their experience and outstanding laboratory-based science.” Amit Karna, Partner at Keensight Capital, added: “The addition of Exemplify BioPharma in New Jersey marks another milestone in Symeres’ strategy to build a truly transatlantic business, serving the biopharma industry globally. The scientific and cultural fit of Exemplify BioPharma within the group is excellent. Keensight Capital is delighted to support Symeres in this exciting acquisition.” Saola Healthcare Partners acted as strategic and financial advisor, Goodwin Procter LLP as legal advisor, and Alvarez & Marsal as financial due diligence advisor to Symeres.