Cotempla XR-ODT (methylphenidate XR-ODT) / Aytu BioPharma - LARVOL DELTA

Interim Safety and Efficacy of Anti-CD70 CAR-NKT (CGC729) for Patients with Refractory Metastatic Renal Cell Carcinoma (ASGCT 2024) - P1 | "2024, five patients who received at least 2 prior lines of therapy were enrolled and treated with a single infusion of CGC729 following a 3-day lymphodepletion regimen (fludarabine 25mg/m2/day; cyclophosphamide 250mg/m2/day)...Patient 0102 in DL1 was RCC CD70- and experienced progress disease (PD) on Day 28... Interim analysis of this first-in-human trial of anti-CD70 CAR-NKT demonstrates a manageable safety profile and promising antitumor activity for the treatment of refractory metastatic RCC. Figure 1: CGC729 had deep anti-tumor activity (A) accompanied with robust expansion and durable persistence (B) in DL1."

Clinical • Late-breaking abstract • Metastases • Genito-urinary Cancer • Hematological Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

Interim Safety and Efficacy of Anti-CD70 CAR-NKT (CGC729) for Patients with Advanced Renal Cell Carcinoma (ASGCT 2024) - P1 | "2024, five patients who received at least 2 prior lines of therapy were enrolled and treated with a single infusion of CGC729 following a 3-day lymphodepletion regimen (fludarabine 25mg/m2/day; cyclophosphamide 250mg/m2/day)...Among four patients evaluable for PK, robust CAR-NKT expansion in the peripheral blood was observed in all patients including Patient 0102 who had negative CD70 expression in ccRCC... Interim analysis of this first-in-human trial of anti-CD70 CAR-NKT demonstrates a manageable safety profile and promising antitumor activity for the treatment of advanced ccRCC. Figure 1: CGC729 had deep anti-tumor activity (A) accompanied with robust expansion and durable persistence (B) in DL1. Plain Language Summary: We have been developing a new therapy (CAR-NKT) for advanced kidney cancer patients by engineering one type of patient's own immune cells, called natural killer T (NKT) cells."

Clinical • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Hematological Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

Open-Label Dose Optimization of Methylphenidate Extended-Release Orally Disintegrating Tablet in a Laboratory Classroom Study of Children with Attention-Deficit/Hyperactivity Disorder. (PubMed, J Child Adolesc Psychopharmacol) - P3 | "AEs were consistent with those of other MPH products. Clinical Trial Registry: NCT01835548 (ClinicalTrials.gov)."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Psychiatry • Sleep Disorder

Neos Therapeutics has lot of upside in 2017 (SeekingAlpha) - "Cotempla also has composition of matter patent protection until 2032...So its NDA, submitted in November, looks likely unassailable by the FDA...expect it to be in the market no latter than the end of 2017..."

Launch • Patent expiry • Attention Deficit Hyperactivity Disorder • CNS Disorders

"$NEOS & $TEVA Announces Settlement on Cotempla XR-ODT Patent Litigation https://t.co/5S5GjIOYg5" (@BioStocks)

Price hikes for hundreds of medications (Physician’s Weekly) - "U.S. drug companies have started the new year by raising the prices of hundreds of medications...The largest increase was a more than 13 percent rise in the list price of Neos Therapeutics’ Cotempla XR, a stimulant used to treat attention-deficit/hyperactivity disorder and narcolepsy."

Pricing

A Phase 4, Open-Label, Single-Dose Pharmacokinetic Study of a Novel Methylphenidate Extended-Release Orally Disintegrating Tablet Formulation in Preschool-Aged Children (APSARD 2020) - "MPH XR-ODT was well tolerated in preschool-aged children. Peak plasma concentration of and exposure to d-MPH were significantly greater than those of l-MPH, and d‑MPH had a longer half-life, consistent with previous studies of oral MPH."

Clinical • P4 data • PK/PD data

Neos Therapeutics reports third quarter 2019 financial results (GlobeNewswire) - "Neos reported growth in net product sales and net revenue per pack for its two core commercial attention deficit hyperactivity disorder (ADHD) products, Adzenys XR-ODT® and Cotempla XR-ODT®, for the three months ended September 30...Adzenys XR-ODT: $122; Cotempla XR-ODT®: $128...Total product revenues were $17.5 million for the three months ended September 30, 2019...Adzenys XR-ODT: $8.8MM; Cotempla XR-ODT: $7.2MM; Adzenys ER: $0.2MM;"

Commercial

Neos Therapeutics reports second quarter 2019 financial results (GlobeNewswire) - "In the second quarter of 2019, as reported by IQVIA, aggregate prescriptions for Adzenys XR-ODT and Cotempla XR-ODT increased by 3% compared to the second quarter of 2018. Specifically, Adzenys XR-ODT and Cotempla XR-ODT prescriptions totaled 53,588 and 37,100, respectively, in the second quarter of 2019 compared to 55,390 and 32,667, respectively, in the second quarter of 2018."

Commercial

Neos Therapeutics reports first quarter 2019 financial results (GlobeNewswire) - "Neos’ two core commercial attention deficit hyperactivity disorder (ADHD) products, Adzenys XR-ODT® and Cotempla XR-ODT®, delivered strong growth in both prescriptions and net revenue per pack for the three months ended March 31, 2019...Adzenys XR-ODT: $109; Cotempla XR-ODT®: $102...Total product revenues were $14.6 million for the three months ended March 31, 2019: Adzenys XR-ODT: $6.7MM; Cotempla XR-ODT: $5.8MM...Research and development expenses for the three months ended March 31, 2019, were $3.2 million...The increase in expense was primarily attributable to clinical trial expenses associated with the Company’s Adzenys XR-ODT post marketing commitments."

Commercial

Neos Therapeutics reports fourth quarter and year-end 2018 financial results (GlobeNewswire) - "Research and development expenses for the three months ended December 31, 2018, were $2.4 million...and for the fiscal year ended December 31, 2018, research and development expenses were $8.5 million compared to $9.0 million for the same period of 2017. The increase in the fourth quarter was primarily due to clinical trial expenses associated with post-marketing commitment studies of Adzenys XR-ODT and Cotempla XR-ODT as well as a license fee paid for NT0502."

Commercial

Neos Therapeutics reports fourth quarter and year-end 2018 financial results (GlobeNewswire) - "...Neos has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT under the Teva ANDA beginning on July 1, 2026, or earlier under certain circumstances. The company previously secured brand exclusivity for Adzenys XR-ODT until September 1, 2025 following a settlement and licensing agreement with Actavis Laboratories FL, Inc..."

ANDA • Patent