on baxter international for the manufacture of tecemotide, and on glaxosmithkline plc (gsk) for the manufacture of the adjuvant in tecemotide, monophosphoryl lipid a (mpl). as of 2013, there was a risk that if tecemotide were not approved by 2015, gsk could terminate its obligation to supply mpl. in this case, oncothyreon would have had to retain the necessary licenses from gsk required to have the adjuvant mpl manufactured, but the transfer of the process to a third party would delay the development and commercialization of tecemotide. competition there are currently two products approved as maintenance therapy following treatment of inoperable locoregional stage iii nsclc with induction chemotherapy: tarceva (erlotinib), a targeted small molecule from genentech, a member of the roche group, and alimta (pemetrexed), a chemotherapeutic from eli lilly and company. tecemotide has not been tested in combination with or in comparison to these products. it is possible that other existing or new agents will be approved for this indication. in addition, there are at least two vaccines in development for the treatment of nsclc, including gsk's mage a3 vaccine in phase 3 and transgene's tg-4010 in phase 2/3. tg-4010 also targets muc1, although using technology different from tecemotide. drug development cost the costs spent on tecemotide development – beginning in the late 1990s – have not been published in detail by the companies biomira/oncothyreon, merck kgaa, and ono pharmaceutical. additionally, the estimation of the full cost of bringing a new drug to market – from discovery through clinical trials to approval – is complex and controversial. however, a cautious estimate of the tecmotide development cost spent until 2014 ranges from 300 to 500 million euros (390 to 650 million us$; for more information see drug development). timeline dateevent may 1998biomira files a blp25 (tecemotide) patent may 2001biomira licenses blp25 (tecemotide) to merck kgaa aug 2001biomira publishes results of a phase i study of the blp25 (tecemotide)palmer m, parker j, modi s, butts c, smylie m, meikle a, et al. (august 2001). "phase i study of the blp25 (muc1 peptide) liposomal vaccine for active specific immunotherapy in stage iiib/iv non-small-cell lung cancer". clinical lung cancer. 3 (1): 49–57, discussion 58. doi:10.3816/clc.2001.n.018. pmid 14656392. mar 2006results of the phase iib study (emr 63325-005): subgroup analysis favorable aug 2007merck kgaa acquires worldwide marketing rights for tecemotide from oncothyreon and will be entirely responsible for the further clinical development of tecemotide sep 2007biomira changes company name to oncothyreon dec 2008merck kgaa acquires manufacturing rights for tecemotide from oncothyreon dec 2009inspire study (emr63325-012) started. estimated primary completion date is may 2020 oct 2011ono pharmaceutical acquires a co-development and co-marketing license for tecemotide in japan dec 2012results of the start study (emr 63325-001): primary endpoint not met. subgroup analysis favorable mar 2014start2 study (emr 63325-021) started. estimated primary completion date is july 2018 aug 2014results of the japan study (emr 63325-009): primary endpoint and secondary endpoints not met. subgroup analysis not favorable sep 2014merck kgaa terminates the nsclc development