FDA accepts Endo’s application for CCH for cellulite; shares up 4% after hours
The FDA accepts for review Endo International’s (NASDAQ:ENDP) marketing application seeking approval to use collagenase clostridium histolyticum (CCH) to treat cellulite of the buttocks.
The agency’s action date is July 6, 2020.
Roche to buy back up to $2B of debt
Roche Holdings (OTCQX:RHHBY +0.7%) launches a tender offer for up to $2B of its outstanding notes (yielding 5.25 – 7.00%, depending on the tranche) due 2023 – 2039. The offer will expire at 11:59 pm ET on Tuesday, December 17.
Teva prices upsized $2.1B debt offering
Teva Pharmaceutical Industries (TEVA +0.5%) has priced its $2.1B (from $1.5B) offering of senior notes at par. Net proceeds plus cash on hand will fund its tender offer for two tranches of debt due in 2021 and to partially redeem €650M of its currently outstanding ~€1.7B of euro-denominated debt (0.375% Senior Notes) due in 2020.
The offering consists of $1.0B of 7.125% Senior Notes due 2025 and €1.0B of 6.000% Senior Notes due 2025.
Closing date is November 25.
Alkermes submits NDA for ALKS 3831 for schizophrenia and bipolar I disorder
Alkermes (NASDAQ:ALKS) has submitted a New Drug Application (NDA) to the FDA seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.
ALKS 3831 is an investigational, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.
Antares Pharma inks deal with Idorsia Pharma
Antares Pharma (NASDAQ:ATRS) has entered into a global agreement with Idorsia Pharmaceuticals to develop a novel, drug-device product combining selatogrel, Idorsia’s potent, fast-acting and highly selective P2Y12 receptor antagonist, with the Antares subcutaneous QuickShot auto-injector.
Selatogrel is being developed for the treatment of a suspected acute myocardial infarction (AMI) in adult patients with a history of AMI.
Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product.
The parties intend to enter into a separate commercial license and supply agreement pursuant to which Antares will provide fully assembled and labelled product to Idorsia at cost plus margin. Antares will be entitled to receive royalties on net sales of the commercial product.
