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The company announces in the initiation of a Phase 2 clinical trial with its proprietary Alpha-1 Antitrypsin (AAT) for the prevention of lung transplant rejection. The study is being conducted in collaboration with Baxalta Incorporated (NYSE: BXLT), which has distribution rights to the Company's intravenous (IV) AAT for all indications in the U.S., Canada, Australia and New Zealand.
The company announces the submission of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for the Company's proprietary, inhaled alpha-1 antitrypsin (AAT) therapy as a treatment for AAT deficiency (AATD). The filing was validated by the EMA.
The company announces that it will release financial results for the three and twelve months ended December 31, 2015 prior to the open of the U.S. stock market open on Tuesday, February 2, 2016.
The company reports financial results for the three and 12 months ended December 31, 2015. Full year total revenues of $70.1 million, including $43.1 million from the Proprietary Product segment and $27.0 million from the Distributed Product segment; fourth quarter total revenues of $25.9 million compared with $24.9 million in the 2014 fourth quarter;
The company reports further positive interim results from a Phase 1/2 clinical trial of its proprietary alpha-1 antitrypsin (AAT) to treat steroid-refractory Graft Versus Host Disease (GvHD) which is being conducted in collaboration with Baxalta US, Inc. (NYSE: BXLT) and the Fred Hutchinson Cancer Research Center in Seattle.
The pivotal Phase 2/3 clinical trial with Kamada's human rabies immune globulin (IgG or KamRAB™ or KedRAB™) therapy as a post-exposure treatment for rabies successfully met the trial's primary endpoint of non-inferiority when measured against an IgG reference product. The Company expects to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in mid- 2016. Kamada has a strategic agreement with Kedrion for clinical development and marketing.
All subjects were eligible to enter an additional 12-week open-label extension study with the active drug to further assess safety and tolerability.
NESS ZIONA, Israel (December 2, 2015) – Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces it will un-blind the current clinical trial of the Company's proprietary human Alpha-1 Antitrypsin (AAT) to treat newly diagnosed pediatric and young adult patients with type 1 diabetes (T1D) at the planned […]
Financial highlights of the 2015 third quarter included: Total revenues of $16.1 million compared with $17.2 million for the third quarter of 2014; Proprietary product revenue of $9.6 million compared with $9.1 million in the 2014 third quarter; Distributed product revenue of $6.5 million compared with $8.0 million in the same period of 2014; Gross profit of $3.7 million compared with $4.4 million in the year-ago third quarter; and Net loss of $4.6 million compared with a net loss of $2.9 million in the year-ago third quarter.
Kamada management will host an investment community conference call on Tuesday, November 10, 2015 at 8:30 a.m. Eastern time to discuss these results and answer questions.