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, N.J., Sept. 26, 2016 (GLOBE NEWSWIRE) — Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), today announced that it has agreed to acquire PharmaCore Inc., a privately-owned company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million. PharmaCore was founded in 1999 and occupies a 35,000 sq. ft. GMP site in High Point, North Carolina, USA.
PharmaCore develops and produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg to support clinical trials from Phase I to Phase III. The company is licensed with the US Drug Enforcement Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. PharmaCore has more than 60 full time employees, focused on projects at laboratory and pilot plant scale, with nearly 40 lab-based Process and Analytical Chemists, the majority of whom hold PhDs.
The acquisition will enhance Cambrex’s portfolio of small molecule API services and complements its existing large scale, multi-purpose manufacturing facilities in the US and Europe. PharmaCore is currently generating $15 to $17 million per year in revenues and just over two million dollars per year in EBITDA. Cambrexexpects the transaction, net of deal fees, to have a neutral impact on earnings per share in 2016 and to be accretive in 2017.
“We are excited to announce our acquisition of PharmaCore, which we believe underlines our commitment to continually enhancing our service offering to our global pharmaceutical and biotech customers. The acquisition will provide the capability and expertise to efficiently develop early clinical phase products and new technologies. We expect PharmaCore’s substantial customer base and robust project pipeline to broaden our potential late stage clinical development and commercial manufacturing opportunities,” commented Steven Klosk, CEO of Cambrex.
He added, “Through the end of 2016, Cambrex will have invested over $200 million in capital projects within our existing facilities, including a recently completed $50 million production and warehousing expansion of our large scale US API facility in Charles City, Iowa, and a $9 million investment to expand large scale manufacturing capacity at our Karlskoga facility in Sweden, which we expect will be completed shortly.”
Rob Maddox, President of PharmaCore added, “PharmaCore is proud of the reputation we have developed, both as a trusted CMO and a company with a strong track record of innovative chemistry. We are thrilled to be joining Cambrex’s global network and to have the opportunity to participate in Cambrex’s growth strategy.”
PharmaCore’s NC facility has a 15,000 sq. ft. chemistry laboratory and a 13,000 sq. ft. pilot plant, with reactor capacity ranging from 20L to 2000L, with supporting GMP analytical services.
The completion of the transaction is subject to customary closing conditions, and is expected to occur within 30 days. PharmaCore was advised on this transaction by Wombat Capital Markets, LLC.
Forward Looking Statements
This document contains “forward-looking statements,” including statements regarding expected impact of the PharmaCore acquisition on earnings per share and other potential benefits of the transaction. These and other forward looking statements may be identified by the fact that they use words such as “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, 2015, 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. Important factors include, but are not limited to, the risk that the conditions required to consummate the transactions described herein may not occur or may be materially delayed, the risk that the expected benefits of the transactions may not be realized to the extent we anticipate or at all, unexpected delays in the completion of ongoing capital projects, pharmaceutical outsourcing trends, competitive pricing or product developments, market acceptance and adoption rate of our 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 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, 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, 2015, including the Forward-Looking Statement sections therein, and other filings with the SEC. The Company cautions investors and potential investors not to place significant 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 our 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), 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 and controlled substances. For more information, please visit www.cambrex.com.