Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda - LARVOL DELTA

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) - P2 | N=2 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed | N=20 ➔ 2

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Transplantation • Type 1 Diabetes Mellitus

Purified Versus Plasma Alpha-1 Antitrypsin Effects on Cellular Activities. (PubMed, Methods Mol Biol) - "By adding purified exogenous alpha-1 antitrypsin (AAT) to peripheral blood mononuclear cells in 20% autologous serum and measuring AAT-induced cellular adherence, it was determined that purified AAT differs from plasma AAT. The known association of AAT with lipoproteins and the negative feedback between AAT and low-density lipoprotein (LDL) suggest that purification may separate AAT from a plasma component such as LDL that participates in their normal plasma functions."

Journal • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease

Kamada Announces Receipt of Marketing Authorization for Glassia for Treatment of Alpha-1 Antitrypsin Deficiency in Switzerland (Kamada Press Release) - "Kamada Ltd...today announced that Swissmedic has granted marketing authorization for Glassia® [Alpha-1 Proteinase Inhibitor (Human)] in Switzerland for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary Alpha-1 antitrypsin deficiency (AATD)....'The commercial launch of the product in Switzerland is expected to occur during the second half of this year, upon obtaining the required reimbursement coverage....In the U.S., Kamada currently receives royalties, anticipated to be in the range of $10 million to $20 million per year through 2040, for Glassia from Takeda. Ex-U.S. sales of Glassia were approximately $6 million in 2022....The Company intends to meet with the FDA and the European Medicines Agency to discuss study progress and potential opportunities to shorten regulatory pathways in the first half of 2023."

Commercial • European regulatory • FDA event • Launch Europe • Alpha-1 Antitrypsin Deficiency

Intravenous Alpha-1 Antitrypsin Therapy for Critically Ill COVID-19 Patients. (PubMed, Isr Med Assoc J) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Comparative biochemical efficacy analysis of an alpha-proteinase inhibitor (Glassia®) in patients with alpha-1 antitrypsin deficiency. (PubMed, Pulm Pharmacol Ther) - P2/3 | "For functional A1PI, the GMR (90% CI) was 98.7 (92.5-105.4) for baseline corrected and 107.8% (102.3-113.5) for uncorrected concentrations. In conclusion, the biochemical efficacy of Glassia using the endpoints of plasma antigenic and functional A1PI trough concentrations at steady state was comparable with Prolastin in patients with AATD."

Clinical • Journal • Alpha-1 Antitrypsin Deficiency • Genetic Disorders • Hepatology • Pulmonary Disease • Respiratory Diseases

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) - P2; N=20; Active, not recruiting; Sponsor: Massachusetts General Hospital; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Transplantation • Type 1 Diabetes Mellitus

Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation (clinicaltrials.gov) - P2; N=30; Completed; Sponsor: Kamada, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Transplantation

Long-term effect of α-antitrypsin augmentation therapy on the decline of FEV in deficient patients: an analysis of the AIR database. (PubMed, ERJ Open Res) - "In our study population, we could not detect a significant difference in the annual decline of FEV by AAT augmentation treatment over a mean period of 8.6 years. Other approaches are needed to validate any benefit of augmentation therapy."

Clinical • Journal • Alpha-1 Antitrypsin Deficiency • Hepatology • Pulmonary Disease • Respiratory Diseases

Glassia: Regulatory data protection in US until July 2022 (Takeda) - Annual Report 2020

Commercial • Graft versus Host Disease

Kamada Reports Fourth Quarter and Fiscal Year 2020 Financial Results, Recent Achievements and Corporate Development Activities (GlobeNewswire) - "Expanding the sales of Glassia and the Company’s IgG portfolio in ex-U.S. markets, including registration and launch of the products in new territories. Generating royalties from Glassia, projected to be in the range of $10 million to $20 million per year commencing in 2022."

Commercial • Alpha-1 Antitrypsin Deficiency

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

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) - P3; N=34; Completed; Sponsor: Baxalta now part of Shire; Active, not recruiting ➔ Completed

Clinical • Trial completion • Alpha-1 Antitrypsin Deficiency • Hepatology • ELANE

Kamada Provides Update on 2021 GLASSIA Supply to Takeda (GlobeNewswire) - "Kamada Reiterates its Total Revenues Guidance of Between $132 million and $137 million for Full-year 2020; Kamada Ltd....today announced that...it expects to receive approximately $25 million in revenues from the supply of GLASSIA® to Takeda in 2021....Upon the initiation of sales of GLASSIA manufactured by Takeda, Kamada will receive royalty payments at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually for each of the years from 2022 to 2040....Kamada projects receiving royalties from Takeda in the range of $10 million to $20 million per year from 2022 to 2040."

Commercial • Alpha-1 Antitrypsin Deficiency

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Massachusetts General Hospital; Trial completion date: Jan 2020 ➔ Jan 2022; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Renal Disease • Severe Hypoglycemia • Transplantation • Type 1 Diabetes Mellitus

Glassia: Top-line data from P2 trial (NCT02614872) for prevention of lung transplant rejection in H2 2019 (Kamada) - Corporate Presentation

P2 data • Graft versus Host Disease • Immunology

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) - P3; N=34; Active, not recruiting; Sponsor: Baxalta now part of Shire; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Alpha-1 Antitrypsin Deficiency • Genetic Disorders • ELANE

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Alpha-1 Antitrypsin (AAT) (Glassia) in the Treatment of Recent-Onset Type 1 Diabetes. (PubMed, Int J Mol Sci) - "The AAT intervention showed promise in the subgroup of adolescents with recent-onset type 1 diabetes. Further studies are warranted to determine the impact and proposed mechanism of action of AAT in β-cell preservation."

Clinical • Journal • P2 data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Kamada reports financial results for fourth quarter and fiscal year 2019 (GlobeNewswire) - "Total revenues were $32.1 million in the fourth quarter of 2019, a 33% decrease from the $48.2 million recorded in the fourth quarter of 2018. As a reminder, Kamada’s fourth quarter 2018 financial results significantly increased due to the release and shipments of GLASSIA lots to the U.S. that were delayed from the third quarter of 2018 due to the then labor strike in the Company’s manufacturing facility....During 2020, we expect to announce results from a proof-of-concept clinical trial of our IV-AAT as preemptive therapy for patients at high-risk for the development of steroid-refractory acute GvHD, as well as top-line data from our phase 2 trial of IV-AAT for the prevention of lung transplant rejection..."

Commercial • P2 data

Kamada reports financial results for fourth quarter and fiscal year 2019 (GlobeNewswire) - "Randomized the first patient in Europe into the pivotal Phase 3 InnovAATe clinical trial evaluating the safety and efficacy of the Company’s proprietary inhaled Alpha-1 Antitrypsin therapy for the treatment of Alpha-1 Antitrypsin Deficiency."

Trial status

New patient-centric approaches to the management of alpha-1 antitrypsin deficiency (Dovepress) - "Going further, other patient-centric initiatives involve improving the convenience of intravenous AAT therapy infusions through extended-interval dosing and self-administration. The present review will discuss the implementation of these initiatives and their potential contribution to the optimization of patient care in AATD."

Review

Kamada raises $25M to pick up products to fill manufacturing facility (Biopharma Reporter) - "Kamada sells shares to private equity group to support push to fill capacity at plasma production site."

Commercial • Financing

Kamada announces preliminary revenue for fourth quarter and full-year 2019 and provides full-year 2020 revenue guidance (Kamada Press Release) - "Looking further ahead, while the planned transition of GLASSIA manufacturing to Takeda is expected to decrease our revenue and profitability during the years 2021 and 2022, our continued business development efforts are expected to result in resumed revenue and profitability growth beginning in 2023. This growth will be driven by...the royalties to be paid to Kamada by Takeda on GLASSIA sales. We remain focused on creating long-term shareholder value."

Commercial

Kamada announces preliminary revenue for fourth quarter and full-year 2019 and provides full-year 2020 revenue guidance (GlobeNewswire) - "In addition, due to the planned acceleration in 2020 of the recently initiated pivotal Phase 3 InnovAATe clinical trial evaluating the safety and efficacy of the Company’s proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of AAT Deficiency, Kamada expects an approximately 15% to 18% increase in R&D expenses in 2020, as compared to 2019."

Commercial

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study (clinicaltrials.gov) - P3; N=36; Recruiting; Sponsor: Baxalta now part of Shire; Trial completion date: May 2020 ➔ Aug 2020; Trial primary completion date: May 2020 ➔ Aug 2020

Clinical • Trial completion date • Trial primary completion date • ELANE

Kamada reports financial results for third quarter and first nine months of 2019 (GlobeNewswire) - "Extended strategic supply agreement with Takeda for GLASSIA supply through 2021..."

Commercial