Last year, Albany, NY, contract developer AMRI watched its founding CEO retire and its business model evolve, shifting its priorities to deliver a jump in revenue, and now the company believes it's on track for bigger growth in 2014.
With the FDA's all-clear under its belt, AMRI's once-troubled Burlington, MA, "money pit" is poised to push the Albany, NY, company into new markets, the company's new CEO reportedly told investors at the J.P. Morgan Healthcare Conference last week. The former Teva executive said he's eyeing generics and high-tech drug delivery among potential expansion areas.
With three year's of back-and-forth with the FDA under its belt, contract drug developer AMRI has finally closed the book on an agency warning letter tied to its Burlington, MA, plant, ending a protracted saga that has cost the company millions.
When AMRI bought Hyaluron in June 2010, it enjoyed a brief, two-month honeymoon before the FDA slapped the acquired sterile syringe and vial filling plant with a warning letter. The hangover has lasted three years, but now the agency has finally issued a letter to close out the failings it found at the Burlington site.
AMRI has signed a long-term contract with the U.K.'s defense department, agreeing to take an investigational drug to Phase I with a chance to re-up once there.
Twenty-two years after founding the Albany contract developer, AMRI CEO Thomas D'Ambra will retire from his post on New Year's Eve, leaving the helm as the company works to get out from regulatory scrutiny and grow revenue.
Bristol-Myers Squibb is calling it quits on a depression drug it was working on with Albany Molecular Research, and investors sent the contractor's shares into a plunge as its CEO preached patience.
BMS-820836--an investigational triple reuptake inhibitor in a pair of midstage studies for treatment-resistant depression--failed the primary endpoints when compared to Eli Lilly's Cymbalta (duloxetine).
AMRI watched a spike in costs erode its solid second-quarter sales, but the the contract drugmaker still believes it can churn out an annual profit and boost its revenue.
After years of back-and-forth with the FDA, AMRI believes it's close to getting clear of a 2010 warning letter for its Burlington, MA, plant, completing a reinspection and preparing a final report.