I te Wenerei, i tukuna e te kaiwhakapae a Bristol Myers Squibb Company (BMS) he kereme ki te kaiwhakapae Xspray Pharma AB i te Rohe o New Jersey. Ko te kereme takahi mana pateni e whai ana kia kaua e hangaia, e hokona rānei e ngā Kaiwhakapae ngā putanga whānui o te rongoā Sprycel a te kaiwhakapae.
Ko te Sprycel he mea hanga mō te rongoā i ngā pakeke me ngā tamariki kua pāngia e ngā momo mate toto toto. E rua ngā mana pateni kei ngā kaiwhakapae, he mana pateni '725 me te mana pateni '103 (mana pateni kei roto i te kereme), ko "Ngā Tikanga mō te Whakarite i ngā Carboxamides 2-aminothiazole-5-aromatic hei aukati kinase" te taitara. I tukuna ngā mana pateni i te tau 2009 me te tau 2014. Haunga te mana pateni e pā ana, he tono rongoā hou (NDA) anō hoki tā ngā kaiwhakapae mō te rongoā ā-waha.
E ai ki te amuamu, kua tukuna e Xspray tētahi whakaaetanga kore-whakaaturanga ki te FDA e tono ana rātou kia whakaaetia kia hangaia me te hokohoko i tētahi putanga whānui o Sprycel. I roto i ētahi atu mea, i whakapā atu a Xspray ki ngā kaiwhakapae me te whakamōhio atu ki a rātou kāore ngā kereme patent tautohetia i whai mana, kāore rānei i takahia e ngā hua a meake nei a ngā kaiwhakapae.
Nā te reta a Xspray ki ngā kaiwhakapae i hoatu he urunga muna ki ētahi wāhanga o te Xspray NDA, engari kāore i hoatu he urunga ki ngā kaiwhakapae ki te kōnae matua o te rongoā. Kāore he urunga a ngā kaiwhakapae ki ngā kōnae matua o te rongoā, e whakararu ana i tō rātou "kaha ki te arotake i ngā mōhiohio e pā ana ki tā rātou tātaritanga o ngā takahi ture," e ai ki te amuamu.
E kī ana te amuamu kei te takahi a Xspray i te iti rawa i te kotahi kereme o ia o ngā patene e pā ana. Hei tāpiri, e whakamārama ana ngā Kaiwhakapae i whakapuakina e ngā Kaiwhakapae tō rātou hiahia ki te hanga me te hokohoko i ā rātou hua NDA i muri tonu i te whakaaetanga a te FDA, ā, e kī ana ngā Kaiwhakapae he takahi anō tēnei i ngā patene kua whakahuatia ake nei.
I tautohe a BMS mēnā kāore ngā kaiwhakapae i āraia i te takahi anō i ngā mana pateni e pā ana ki tēnei take, ka pāngia rātou e "ngā kino nui, kāore e taea te whakatika". E rua ngā take o te takahi mana pateni e whakarārangihia ana i roto i te amuamu. Kei te rapu ngā kaiwhakapae i tētahi whakataunga pai mō ia take, he aukati hei ārai i ngā takahi mana pateni, he whakahau kia kore ai e hangaia ngā hua NDA a ngā kaiwhakapae i mua i te paunga o te mana pateni e pā ana ki tēnei take, he āwhina moni mēnā ka whakatairanga ngā kaiwhakapae i ā rātou hua NDA, me ētahi atu.
Wā tuku: Paenga-whāwhā-12-2023