Telix Pharmaceuticals Limited (ASX: TLX) is a global biopharmaceutical company based in Melbourne. The company develops diagnostic and therapeutic products. Its focus is on radiopharmaceuticals or molecularly targeted radiation. TLX globally operates in regions like Kyoto, Brussels and Indianapolis. Currently, the company is working on a portfolio related to clinical-stage oncology products.
The company had submitted a request to the FDA (United States Food and Drug Administration) to conduct a pre-NDA (New Drug Application) meeting. Ideally, the NDA is a procedure through which a company applies for marketing approval for a pharmaceutical product in the US region.
The above-mentioned request by the company is for the marketing authorization for the illumetTM, which is a prostate cancer imaging product, in the United States. Prior to this request, TLX had submitted a Drug Master File in July 2018. Various Investigational New Drug applications had followed it in the USA and Europe region. These were inclusive of Endocyte (now Novartis) VISION Phase III trial and other academic studies, building clinical experience and seeking new application areas for illumetTM.
Telix just announced that it has two new partners in its kitty for the US region. These are the UPPI (United Pharmacy Partners Inc.) and PharmaLogic. This addition rounds off the company’s product distribution network towards full commercialization. Shertech Pharmacy is a founding member of UPPI.