IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
If you’re looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project.
From pre-formulation to commercial manufacturing and packaging, you can trust Cambrex to deliver your complex dosage forms with the perfect combination of technology, expertise, and collaboration.
At Cambrex, we offer a tried and trusted approach to technology transfer, for scale-up or when transitioning to a different facility.
We are equipped to take on projects at any size or scale, offering established pediatric formulation and development expertise and to-scale manufacturing capabilities.
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them.
We can support you, at any size or stage, with a range of primary and secondary packaging solutions.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex offers a comprehensive suite of testing services for complex biopharmaceuticals including standalone analytical R&D, method validation, release testing, ICH stability, and routine QC testing.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
East Rutherford, NJ – January 2, 2019 – Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), and finished dosage forms, today announced that it has completed the acquisition of Avista Pharma Solutions (“Avista”), a contract development, manufacturing, and testing organization, from Ampersand Capital Partners. The transaction, announced on November 20, 2018, strengthens Cambrex’s position as the leading, fully integrated small molecule contract development and manufacturing organization (CDMO) across the entire drug lifecycle.
Avista’s four sites in Durham, NC, Longmont, CO, Agawam, MA and Edinburgh, Scotland, UK will be integrated into Cambrex’s global network, as well as the company’s service offerings ranging from API and drug product development and cGMP manufacturing to stand-alone analytical, microbiology testing and solid state sciences.
“Acquiring Avista adds a full complement of early stage development capabilities to Cambrex’s larger scale capabilities for both APIs and finished dosage forms. We are excited to start off 2019 integrating Avista into Cambrex’s global network of facilities. Adding Avista today and Halo Pharma in September significantly increases our customer base and funnel of projects, provides significant cross selling opportunities and allows us to offer an integrated service offering for most small molecules from the pre-clinical stage through the commercial stage,” commented Steve Klosk, President and CEO of Cambrex.
Shawn Cavanagh, COO of Cambrex added, “I would like to welcome all of Avista’s employees into the Cambrex family, and I look forward to working with them as we continue to be the experts our customers enjoy working with.”
In September 2018, Cambrex acquired Halo Pharma, adding formulation development and finished dosage manufacturing capabilities to Cambrex’s existing global API manufacturing network. With the acquisition of Avista, Cambrex now operates 12 facilities around the globe and employs approximately 2,000 people.
The acquisition of Avista was funded with a combination of cash on hand and borrowings under Cambrex’s new senior secured credit facility, following a refinancing that was also completed today. The new facility, which replaces Cambrex’s prior facility, includes a 5-year $200 million term loan and a $600 million revolving credit facility. Loans under the new facility will initially bear interest at LIBOR plus 1.75%, subject to adjustment each fiscal quarter depending upon Cambrex’s total net leverage ratio. Additional details regarding the credit agreement governing the new facility will be included in a Current Report on Form 8-K that Cambrex will file with the Securities and Exchange Commission.
This press release contains “forward-looking statements” within the meaning of the federal securities laws, including statements about anticipated benefits of the acquisition of Avista by Cambrex Corporation (the “Company”). These and other forward-looking statements may be identified by the fact that they use words such as “guidance,” “expects,” “anticipates,” “intends,” “estimates,” “believes” or similar expressions. Any forward-looking statements contained herein are based on current plans and expectations and involve risks and uncertainties that could cause actual outcomes and results to differ materially from current expectations. The factors described in Item 1A of Part I of the Company’s Annual Report on Form 10-K for the period ended December 31, 2017 captioned “Risk Factors,” or otherwise described in the Company’s filings with the SEC provide examples of such risks and uncertainties that may cause the Company’s actual results to differ materially from the expectations the Company describes in its forward-looking statements, including, but not limited to, customer and product concentration, the Company’s ability to win new customer contracts and renew existing contracts on favorable terms, significant declines in sales of products to our customers, pharmaceutical outsourcing trends, competitive pricing or product developments, market acceptance and adoption rate of its customers’ products, government legislation and regulations (including those pertaining to environmental issues), tax rate, interest rate, technology, manufacturing and legal issues, including the outcome of outstanding litigation, environmental matters, changes in foreign exchange rates, uncollectible receivables, the timing and/or volume of orders or shipments and the Company’s ability to meet its production plan and customer delivery schedules, expected timing of completion of capacity expansions, our ability to successfully integrate acquired businesses (including Avista and Halo Pharma) and to realize anticipated benefits from acquisitions, loss on disposition of assets, cancellations or delays in renewal of contracts, lack of suitable raw materials, the Company’s ability to receive regulatory approvals for its products, continued demand in the U.S. for late stage clinical products and the successful outcome of the Company’s investment in new products.
For further details and a discussion of these and other risks and uncertainties, investors are encouraged to review the Cambrex Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including the Forward-Looking Statement and Risk Factors sections therein, and other filings with the SEC. The Company cautions investors and potential investors not to place undue reliance on the forward-looking statements contained in this press release and to give careful consideration to the risks and uncertainties listed above and contained in the Company’s SEC filings. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements.
Cambrex Corporation is an innovative life sciences company that provides products, services and technologies to accelerate the development and commercialization of small molecule therapeutics. The Company offers Active Pharmaceutical Ingredients (APIs), finished dosage forms, advanced intermediates and enhanced drug delivery products for branded and generic pharmaceuticals. Development and manufacturing capabilities include enzymatic biotransformations, high potency APIs, high energy chemical synthesis, controlled substances and continuous processing. For more information, please visit www.cambrex.com
About Avista Pharma
Avista Pharma Solutions is a contract development, manufacturing, and testing organization that understands what it takes to rapidly advance products through every stage of development. With over 200,000 square feet of laboratory and manufacturing space in the US and UK, Avista offers a broad suite of scientifically differentiated services ranging from early stage discovery, API and Drug Product development and cGMP manufacturing to stand-alone analytical and microbiology testing support. Led by its broad experience and collaborative approach, Avista is committed to finding the shortest, most efficient path to success for its clients – success that goes beyond science. For more information, please visit www.avistapharma.com
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