Novartis Inaugurates Flu Cell-Culture Vaccine Facility in North Carolina

Novartis (Basel, Switzerland) reported last week that it officially inaugurated its large-scale flu cell-culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina. The $1-billion investment through Novartis and the US Department of Health and Human Services supported the design, construction, validation, and licensing of the facility. The partnership with HHS also requires Novartis to provide two commercial-scale annual lots of prepandemic vaccine for a minimum of three years. HHS has the right to exercise options to purchase additional vaccine for up to 17 years.

Although cell-culture technology for influenza vaccines is not yet approved in the US, the company’s contract with HHS includes funding for developing a flu cell-culture vaccine. If licensed in an emergency, the facility will be able to respond to a pandemic as early as 2011, according to Novartis. The plant is planned to be running a full-scale commercial production in 2013. The facility can also start producing MF59, the company’s proprietary adjuvant, as early as December 2009. Although not approved in the US, studies with such adjuvants are underway in the US. Novartis also operates a cell-culture-based manufacturing plant in Marburg, Germany.

In other news, the US Food and Drug Administration approved last week, Novartis’s seasonal flu vaccine Agriflu. The vaccine is manufactured by Novartis Vaccines and Diagnostics in Sienna, Italy.

Novartis also signed a collaboration and licensing agreement with Incyte (Wilmington, DE) for two of Incyte’s investigational hematology-oncology therapies: INCB18424, an oral JAK1/JAK2 inhibitor in Phase III development for myelofibrosis, and INCB28060, an oral cMET inhibitor that is about to enter Phase I development as a potential treatment for multiple cancers.

Under the agreement, Incyte retains exclusive rights for the development and potential commercialization of INCB18424 in the US. Novartis will be responsible for the future development and commercialization of INCB18424 in all hematology–oncology indications outside of the US and will also be responsible for the future worldwide development of INCB28060. Novartis will make an upfront payment of $150 million to Incyte plus an immediate $60-million milestone payment for the initiation of the European Phase III trial of INCB18424, which began in July of this year. Incyte may also be eligible over time for additional payments of up to approximately $1.1 billion if future contingent development and commercialization milestones are achieved.