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AMRI to Focus on Large Scale Manufacturing

By Dan Stanton , 18-Feb-2013
Last updated on 18-Feb-2013 at 13:32 GMT

AMRI has predicted continuing revenue growth in its contract manufacturing with its API pipeline and once-troubled Burlington site leading the way.

End of year results for the contract development and manufacturing organization (CDMO) saw total revenue increase by 9% year-on-year, reaching $226.7m (€170m), of which $190m came from its contract services.

Michael Nolan, Vice President, Chief Financial Officer and Treasurer of Albany Molecule Research (AMRI), told this publication that on the back of such figures, guidance would see a revenue increase of up to 14% for large scale manufacturing.

Nolan said this was due to: “Our view of a robust API (Active Pharmaceutical Ingredient) pipeline of business as well as our Burlington Aseptic Fill and Finish business continuing to improve.”

Burlington Boost

The Burlington, Massachusetts facility has benefitted from a number of contracts including a deal with Cardium Therapeutics for pre-filled syringes and was up 25% overall for the year.

The plant - acquired in AMRI’s takeover of Hyaluron in 2010 – was once described as “a money pit” due to costs incurred from fixing issues brought up in a US Food and Drug Administration (FDA) warning letter .

In a conference call, Thomas E. D’Ambra - Chairman, Chief Executive Officer and President of AMRI – reminded investors that though the facility is awaiting a final FDA audit in the near future the facility is presently fully operational and serving a number of customers.

D’Ambra added: “The Burlington site was audited by perspective customers 13 times during 2012, including by two different large pharmaceutical companies and was approved as a supplier every time.”

API Contracts to Lead the Way?

Whilst contract revenues from discovery services and development were essentially flat, large scale manufacturing increased 22% on 2011’s results making up $38m for the fourth quarter and $116m for the year.

Nolan said that 2012 saw a “record revenue” from the API business with much of the improvement in large scale contracting coming from a number of high-profile deals and contact renewals.

GE Healthcare renewed a contract late last year for the production of raw materials and active ingredients for its diagnostic imaging business at AMRI’s Rensselaer facility in New York.

This came two months after a five year extension of a supply agreement with Shire who, through its subsidiary New River Pharmaceuticals, also has a contract penned with AMRI for the manufacture of the API in ADHD drug Vyvanse.

Large Scale at Cost to Small Scale and Discovery?

Results saw an overall loss of $3.8m for fiscal 2012, though this does fare better than the year prior which saw the company lose $32m.

The closure of two discovery services facility last year – Hungary and Bothell, Washington – indicate a move away from contract small scale manufacturing and contract research as AMRI chase the market to get back in the black.

The move is backed with plans, according to Nolan, to invest further in the Rensselaer site as well as AMRIs UK and Indian manufacturing facilities in order to maintain “quality, reliability and capability with demand.”

When we asked if AMRI were planning to move further in the direction of large scale manufacturing at a cost to contract discovery and early development, Nolan said that “AMRI will continue to focus on profitably growing our contract manufacturing, as well as our development, discovery and small scale businesses.”