Shire purchase to affect Albany Molecular contract
eventually affect a contract manufacturing arrangement with Albany
Molecular Research (AMR).
UK-based Shire will use the New River purchase to gain full control over the attention deficit and hyperactivity disorder (ADHD) drug Vyvanse (lisdexamfetamine dimesylate) that the two firms have been co-developing. AMR has been making clinical quantities of the drug from its plant in Rensselaer, New York, and signed an agreement in July last year with New River for the long-term commercial production of the drug. AMR Investor Relations spokesperson Curtis Schenck described the contract to Outsourcing-Pharma.com as "reasonable in size", bringing in between $3m-$10m (€2.3m-€7.6m) in revenue each year. However, as part of a $25m cost-cutting drive announced alongside the New River purchase, Angus Russell, Shire chief financial officer, said that the firm plans to eventually bring a significant portion of Vyvanse's final production in-house. "As commercial demand for Vyvanse grows we will begin producing the drug from our plant in Owings Mills, Maryland, although we will still continue to use AMR for some of the drug's production," Shire spokesperson Jessica Mann, told Outsourcing-Pharma.com. "Our Maryland plant currently has extra capacity so it is cost-effective for us to do this and it also fits in with a 'dual sourcing' risk management strategy that we want to have in place," she said. Shire will pay $2.6bn for New River in a deal expected to close in the second quarter of this year. Vyvanse was approved in the US by the Food and Drug Administration (FDA) on Friday and Shire expects it to be a "big selling" successor to its current ADHD drug Adderall XR (dextroamphetamine plus levoamphetamine) as it begins facing generic competition. Some analysts have forecast annual sales of over $1bn for the new drug - currently the US ADHD market worth $3.3bn with an estimated yearly market prescription volume growth of 4 per cent, which Shire said it expects to rise to 6 per cent with the introduction of new products. Vyvanse is New River's most advanced compound, designed along with Shire for oral delivery and made as a pharmacologically inactive prodrug using New River's Carrierwave technology, which Shire will also own after the acquisition deal closes. This technology creates a new derivative molecule made of the active pharmaceutical ingredient (API) of a drug such as an amphetamine or opioid, covalently attached to an adjuvant. The pharmacologically inactive drug is only activated, or "bioreversed", when taken as directed. In Vyvanse, d-amphetamine is covalently bonded to l-lysine, a naturally occurring amino acid, and it is not until undergoing hydrolysis that the pharmacologically active d-amphetamine molecule is gradually released, making drug tampering difficult and impractical. Thus, this method confers overdose protection by restricting the release of the API from the formulation at greater than therapeutically prescribed amounts. The drug is also designed to be less prone to abuse and addiction by limiting the "rush" or "high" available from the API released and limiting the ability of abusers to obtain greater doses of the active ingredient through alternative routes of administration or extraction techniques. Vyvanse was designed with the expectation to have comparable efficacy and tolerability to currently marketed once-daily extended-release stimulants with reduced potential for abuse, diversion and overdose toxicity.
