Three years after the release of disappointing Phase II results, Novartis is discontinuing the NIC002 project, which focused on a therapeutic vaccine candidate for the treatment of nicotine addiction. As a result of the discontinuation, Novartis will terminate the license granted in 2007 and will return to Cytos Biotechnology the licensed rights.
In a Phase II study from November of 2005, NIC002 (formerly CYT002-NicQb) was found in a study by Cytos to promote and sustain continuous abstinence from smoking from week 8 to 52 after start of treatment in participants who achieved high antibody levels upon vaccination versus those participants who received only counseling and a placebo. However, in October 2009, Novartis released results from a Phase II study with NIC002 that showed formation of nicotine-specific antibodies in patients but did not meet its primary endpoint of increased smoking cessation, which was defined as a difference in continuous abstinence from smoking from weeks 8 to 12 after start of treatment compared to placebo.
Under the original agreement's terms, Novartis was granted worldwide exclusive rights for NIC002 and was responsible for late-stage clinical development, manufacturing, and commercialization of the vaccine. Cytos would have been eligible to receive up to CHF 600 million (near $646 million) in up-front and potential development, regulatory approval, and sales milestone payments based on the successful development and commercialization of NIC002. The up-front payment by Novartis was CHF 35 million (around $37.7 million). Cytos Biotechnology would have also received royalty payments on net sales of products.
However, all is not lost for the vaccine yet: in November of 2010, Duke University, in collaboration with Wake Forest University, commenced a Phase II clinical pharmacokinetic/pharmacodynamic study with NIC002 performed with 65 smokers that aims to assess how nicotine antibodies, induced by vaccination, affect the pharmacokinetics of nicotine during cigarette smoking. The study is being conducted in the United States with funding from the NIH.