Oral Paclitaxel definition

Oral Paclitaxel means the Product oral paclitaxel and encequidar, together with any improvements or modifications thereto.
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Oral Paclitaxel means the P-gp inhibitor encequidar and oral paclitaxel.
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Examples of Oral Paclitaxel in a sentence

  • No Obligor will, nor will it permit any of its Subsidiaries to, enter into or become or remain bound by any outbound exclusive license of Intellectual Property relating to U.S. commercialization rights to the Product Oral Paclitaxel, except for Permitted Licenses.

  • In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm in the Phase III study.

  • We are working to consider the appropriate next steps in the development of Oral Paclitaxel.

  • Athenex issued a press release announcing that the FDA had accepted for filing the Company’s U.S. NDA for Oral Paclitaxel and Encequidar in metastatic breast cancer with priority review.

  • Athenex is a biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies for the treatment of cancer including, without limitation, its Klisyri/ONAKTA (active ingredient: Tirbanibulin API), Oral Paclitaxel (active ingredients: Paclitaxel (Semi-Synthetic) API, Oral Docetaxel (active ingredients: Docetaxel Trihydrate API or Docetaxel Anhydrous API), and Encequidar Methanesulfonate Monohydrate API) (the “Athenex Product”).

  • The FDA recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The FDA determined that adequate risk mitigation strategies to improve toxicity, which may involve dose optimization as well as, or in addition to, exclusion ofpatients deemed to be at higher risk of toxicity, would be required in any new clinical trial of Oral Paclitaxel.

  • Athenex issue a press release presenting “Updated Phase 3 Data on Survival and Tolerability Associated with Oral Paclitaxel and Encequidar in Patients with Metastatic Breast Cancer.” The Company announced that data presented at the 2020 San Antonio Breast Cancer Symposium “indicate[s] benefits of oral paclitaxel and encequidar .

  • Athenex will bear the expenses of [*] in the Territory for each Licensed Product in an amount not to exceed (i) $[*] in the aggregate or (ii) with respect to each Licensed Product, the following amounts: Oral Paclitaxel: $ [*] Oral Irinotecan: $ [*] XX0-000 Xxxxxxxx: $ [*] XPH shall be responsible for [*].

  • In exchange for the Product Payment, the Company agreed to make payments to Sagard equal to 5.0% of its world-wide net sales of Oral Paclitaxel, subject to a hard cap equal to the lesser of 170% of the Product Payment and the Put/Call Price as discussed below and further set forth in the Revenue Interest Financing Agreement.

  • Athenex announced “Superior Response and Survival with Lower Neuropathy of a Novel Oral Paclitaxel versus IV Paclitaxel in Treatment of Metastatic Breast Cancer.” This release provided, in relevant part, that Athenex was going to present these results an oral presentation at the 2019 San Antonio Breast Cancer Symposium.

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