KedRAB (human rabies immune globulin) / Kamada, Kedrion - LARVOL DELTA

Kamada Reports Record Top and Bottom Line 2024 Financial Results and Affirms 2025 Guidance Representing Double-Digit Profitable Growth (GlobeNewswire) - "Total revenues for 2024 were $161.0 million, a 13% increase from the $142.5 million generated in 2023. The increase in revenues was primarily attributable to KEDRAB and CYTOGAM growth year-over-year...Obtained positive feedback from the U.S. FDA, confirming the Agency's agreement with the Company's previously proposed relaxed two-sided Type 1 error rate control of 10% (p-value of 0.1) for the inhaled AAT pivotal Phase 3 study, reducing the study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial. Announced its plan to conduct an interim futility analysis for the inhaled AAT pivotal Phase 3 study by the end of 2025."

Commercial • FDA event • P3 data • Alpha-1 Antitrypsin Deficiency • Cytomegalovirus Infection • Infectious Disease

Epidemiology of rabies immune globulin use in paediatric and adult patients in the USA: a cross-sectional prevalence study. (PubMed, BMJ Open) - "Paediatric patients represent a significant proportion of the patient population receiving RIG, and are associated with higher prevalence of codes reporting repair of larger, more complex wounds in highly innervated anatomical regions. Dosing and administration of RIG must be informed by animal bite wound characteristics; clinicians should understand the differences between presentations in adults and children and treat accordingly."

Journal • Infectious Disease • Pediatrics

Commentary on the implications of safety and efficacy studies in pediatric patients with administration of human rabies immune globulin (HRIG)? (PubMed, Hum Vaccin Immunother) - "Currently there are 3 HRIG products on the US market, KEDRAB®, HyperRab® and Imogam® Rabies HT, but only KEDRAB® has published safety and efficacy data in a pediatric population. While it is common practice to prescribe medications for pediatric patients "off-label" there now exists one product with safety data in children. It is worth considering if this creates a higher medical liability for the prescriber and institution."

Journal • Pain • Pediatrics

KAMRAB-003: Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects (clinicaltrials.gov) - P2/3; N=118; Completed; Sponsor: Kamada, Ltd.; Active, not recruiting ➔ Completed

Clinical • Head-to-Head • Trial completion

Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies (clinicaltrials.gov) - P3; N=30; Completed; Sponsor: Kamada, Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

"$KMDA Kedrion and Kamada Announce FDA Approval of KEDRAB® Label Update, Confirming Safety and Effectiveness in Children https://t.co/4O09r7D6FX #fdaapproval" (@stock_titan)

Clinical • FDA event

Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure. (PubMed, Hum Vaccin Immunother) - "We report the safety, efficacy, and immunogenicity of a phase 4, prospective, 2-center, open-label, single-arm clinical trial evaluating human rabies immunoglobulin (HRIG150; KEDRAB 150 IU/mL) as part of PEP in patients (aged <17) with suspected or confirmed rabies exposure, where PEP was indicated...These results demonstrate that HRIG150 is well tolerated and effective in pediatric patients as a component of PEP. To the authors' knowledge, this study is the first to establish pediatric safety and efficacy of HRIG in the US."

Clinical • Journal • Infectious Disease • Pediatrics

Kamada Ltd (KMDA) Q3 2020 Earnings Call Transcript (The Motley Fool) - "...current status of our InnovAATe Phase III clinical program....We recently resumed recruitment to the study, the COVID-19 pandemic has slowed down the rate of recruitment and the current pandemic situation, mainly across Europe, affects of ability to currently open new study....In the third quarter, total revenues were $35.3 million....These results were driven by 19% year-over-year increase in sales of our proprietary products, which is attributable to increase in sales of GLASSIA and KEDRAB to our partners, Takeda and Kedrion....We sell GLASSIA outside of the US in multiple markets and that business is growing by us either identifying additional patients, applying for reimbursement and submission and registration in addition countries."

Enrollment status • Sales • Alpha-1 Antitrypsin Deficiency

"The @US_FDA has approved KedRab for treatment of rabies infection. Learn more, https://t.co/l7NPgZUIWU" (@CWPatient)

Biosimilar • Immunology

Safety and efficacy results of simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine in healthy subjects: a comparative phase 2/3 trial. (PubMed, Hum Vaccin Immunother) - "We conducted a clinical trial to assess the safety and putative efficacy of an additional human rabies immune globulin (HRIG; KEDRAB) versus an older product (Comparator, HyperRAB S/D® [Grifols]) and determine whether HRIG interferes with development of endogenous antibodies versus Comparator, when each is given with an active rabies vaccine. One subject in the HRIG group did not meet the seroconversion criteria for anti-rabies antibody, and one subject in the Comparator group showed an anamnestic response, with much higher than expected anti-rabies antibody levels at both baseline and on day 14. Thus, HRIG allows for prophylactic anti-rabies antibody titers and is non-inferior to Comparator, when administered with rabies vaccine."

Clinical • Journal • P2/3 data

Kamada Reports Discussions with Takeda Regarding a Potential Extension of the Period for the Transition of GLASSIA Manufacturing to Takeda (GlobeNewswire, Kamada Ltd.) - REHOVOT, Israel, Aug 08, 2019 (GLOBE NEWSWIRE) -- Kamada Ltd (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, reports that it is currently in discussions with Takeda to extend the period prior to transitioning the manufacture of GLASSIA, Kamada’s proprietary product for the treatment of Alpha-1 Antitrypsin Deficiency, to Takeda. As background, Kamada has supplied GLASSIA to Takeda, or its predecessors, since 2010. Kamada’s second leading product is KamRAB, a rabies immune globulin (Human) for Post-Exposure Prophylaxis against rabies infection. KamRAB is FDA approved and is being marketed in the U.S. under the brand name KEDRAB...

Commercial • Regulatory

"New KEDRAB® Dose Calculator Launches to Help Hospitals in Treating Rabies Exposures https://t.co/rIwvNCV8bG" (@NewsFromBW)

Clinical

Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies (clinicaltrials.gov) - P3; N=30; Recruiting; Sponsor: Kamada, Ltd.; Trial completion date: Jun 2019 ➔ Jun 2020; Trial primary completion date: Apr 2019 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date