Thu, Nov. 10, 7:03 AM
Mon, Nov. 7, 7:24 AM
- The FDA accepts for review the Biologics License Application (BLA) from Kamada Ltd. (NASDAQ:KMDA) seeking approval of its anti-rabies immunoglobulin (IgG) therapy for post-exposure prophylaxis. The company has been marketing the product since 2003 ex-U.S. under the brand name KamRAB. The agency's action date (PDUFA) is August 29, 2017.
- Kedrion Pharma has exclusive U.S. commercialization rights.
- Rabies affects ~40K Americans each year.
Thu, Oct. 6, 7:14 AM
- Kamada Ltd. (NASDAQ:KMDA) announces that it has extended its GLASSIA [Alpha-1 Proteinase Inhibitor (Human)] agreement with Shire plc (NASDAQ:SHPG) for the fourth time since 2010. It will now produce the product for Shire through 2020, after which Shire may produce it and pay Kamada a royalty.
- During the new contract term, Kamada will recognize ~$237M in revenue with a potential upside of $288M. Shire's revenue target for 2017 is $100M.
- Shire is the exclusive distributor of GLASSIA in the U.S., Canada, Australia and New Zealand and is licensed to produce the product in those countries.
- GLASSIA is a ready-to-use IV plasma-derived Alpha-1 Antitrypsin (AAT) product approved in the U.S. for the treatment of clinically evident emphysema due to severe AAT deficiency.
Thu, Sep. 1, 7:16 AM
- Kamada Ltd. (NASDAQ:KMDA) and collaboration partner Kedrion S.p.A. announce the filing of a Biologics License Application (BLA) in the U.S. seeking approval of Kamada's post-exposure rabies treatment human anti-rabies immune globulin (IgG). A decision is expected in mid-2017. If all goes well, the commercial launch by Kedrion will commence soon thereafter. The U.S. market is valued at over $100M. About 40K post-exposure prophylaxis treatments are administered here each year.
- Kamada has been marketing the product ex-U.S. since 2003 under the brand name KamRAB. It has sold over 1M vials to date.
Tue, Aug. 30, 9:15 AM
Tue, Aug. 30, 8:18 AM
- Thinly traded micro cap Kamada Ltd. (NASDAQ:KMDA) is up 7% premarket on increased volume, albeit on turnover of only 44K shares, in response to its announcement of positive results in a Phase 2 clinical trial assessing its proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), an orphan disease currently treated by intravenous AAT augmentation therapy.
- The double-blind, placebo-controlled study enrolled 36 AATD subjects. They were treated with Kamada's inhaled AAT therapy (80 mg/day or 160 mg/day) or placebo for 12 weeks during the double-blind period, after which eligible patients (n=26) entered into a 12-week open-label extension stage with the 160 mg/day dose to further assess safety and tolerability.
- The primary efficacy endpoints included antigenic AAT levels and Anti-Neutrophil Elastase Inhibitory (ANEC) levels in the lung as well as additional anti-proteolitic and anti-inflammatory biomarkers.
- Patients in the inhaled AAT therapy cohort showed a statistically significant increase in endothelial lining fluid (ELF) AAT antigenic level compared to placebo (p<0.0005). The levels were more than twice the increase observed in an earlier study of intravenous (IV) AAT therapy. ELF ANEC levels also showed statistically valid increases for both doses and, again, were more than twice those observed with IV AAT.
- The company intends to initiated a pivotal study in the U.S. to confirm the results.
- AATD is a rare inherited disorder that severely damages the lungs and liver.
- Related tickers: (NASDAQ:ARWR)(NASDAQ:NTLA)
Tue, Aug. 2, 6:34 AM
Wed, Jun. 15, 8:09 AM
- Kamada Ltd. (NASDAQ:KMDA) and U.S. distributor Shire plc (NASDAQ:SHPG) announce that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)] allowing for self-infusion at home after appropriate training in order to accommodate patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency who have great difficulty with traveling to a healthcare facility.
- Kamada began supplying GLASSIA to Baxalta in 2010. Shire, who finalized its takeover of Baxalta several weeks ago, has exclusive distribution rights in Canada, Australia and New Zealand as well.
Mon, May 9, 6:31 AM
- Kamada (NASDAQ:KMDA): Q1 Adjusted net loss of $1.9M
- Revenue of $14.8M (+65.7% Y/Y) misses by $0.3M.
Mon, May 2, 8:45 AM
- The achievement of certain regulatory and sales milestones triggers the payment of two undisclosed milestone payments to Kamada (NASDAQ:KMDA) from strategic partners Chiesi Farmaceutici S.p.A. and Baxalta (NYSE:BXLT).
- The milestone from Chiesi was based on the filing of a Marketing Authorization Application (MAA) in Europe for inhaled alpha-1 antitrypsin (AAT) for the treatment of AAT deficiency.
- The Baxalta payment was based on achieving a sales milestone related to Glassia, Kamada's intravenous AAT treatment. Baxalta is the exclusive distributor for all indications in the U.S., Canada, Australia and New Zealand.
- Kamada will record the payments as deferred revenue and will recognize them during the terms of the agreements. The company expects Glassia revenue to hit $100M next year.
- Shares are up 9% premarket on light volume.
Wed, Apr. 6, 11:12 AM
- Kamada (KMDA -0.2%) commences a Phase 2 clinical trial, in collaboration with Baxalta (BXLT +1%), assessing its proprietary Alpha-1 Antitrypsin (AAT) for the prevention of lung transplant rejection. The open-label, single-site study will evaluate the safety and efficacy of intravenous (IV) AAT on top of standard-of-care (SOC) treatment versus SOC alone in 30 lung transplant recipients. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is January 2020. The estimated study completion date is December 2020.
- Baxalta has distribution rights to IV AAT for all indications in the U.S., Canada, Australia and New Zealand.
- AAT, a protein derived from human plasma, has immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The company's flagship product is Glassia [Alpha1-Proteinase Inhibitor (Human)], a ready-to-use IV plasma-derived AAT product approved in the U.S. for the treatment of AAT deficiency. It is marketed by Baxalta.
- Read now Kamada: Huge Potential But Lack Of Investor Interest
Tue, Feb. 2, 9:28 AM
- Kamada (KMDA) Q4 results: Revenues: $25.9M (+4.0%); R&D Expense: $4.4M (+29.4%); SG&A: $3M (+25.0%); Operating Income: $0.8M (-50.0%); Net Income: $1M (-16.7%); EPS: $0.03 (unch).
- FY2015 results: Revenues: $70.1M (-1.4%); R&D Expense: $16.5M (+3.1%); SG&A: $10.9M (+3.8%); Operating Loss: ($11.4M) (+0.9%); Net Loss: ($11.3M) (+14.4%); Loss Per Share: ($0.31) (+16.2%); Quick Assets: $28.3M (-45.5%).
- No guidance given.
Tue, Feb. 2, 7:23 AM
- Kamada (NASDAQ:KMDA): Q4 Adjusted Net Income of $1.4M.
- Revenue of $25.87M (+3.8% Y/Y) misses by $1.23M.
Dec. 23, 2015, 8:59 AM
- A Phase 2/3 clinical trial assessing Kamada's (NASDAQ:KMDA) human rabies immune globulin (IgG or KamRAB or KedRAB) therapy for the post-exposure treatment of rabies met its primary endpoint of non-inferiority (no worse than) compared to an IgG reference product. The study was a prospective, randomized, double-blind study in 118 healthy subjects. No drug-related serious adverse events were observed.
- The company intends to file a Biologics License Application (BLA) with the FDA in mid-2016. It will be branded as KedRAB in the U.S., once approved.
- It has been promoted as KamRAB in 10 countries outside of the U.S. since 2003.
- KamRAB/KedRAB is a protein therapeutic derived from hyper-immune plasma that contains high levels of antibodies from donors previously exposed to rabies. It is administered via a one-time injection.
Dec. 2, 2015, 8:32 AM
- Kamada (NASDAQ:KMDA) reports that it will unblind the current clinical trial assessing its human Alpha-1 Antitrypsin (AAT) in pediatric and young adults with type 1 diabetes (T1D) at the planned interim analysis. Assuming positive data, the change will accelerate the timeline for the future commercialization of the product. Patients were treated with the company's Glassia product, which contains the AAT protein.
- The original plan was to establish safety and provide futility analysis for ~90 patients after one year in the study, while maintaining the blinding. The company decided that doing this would not provide the information it needs to negotiate with potential strategic partners and/or to decide to continue with the trial. It now plans to generate its final report based on data from 60 participants (all should be enrolled by the end of this month) who have completed one year of therapy by the end of 2016. The report should be completed by H1 2017.
- Glassia (Alpha1-Proteinase Inhibitor-Human), administered once per week, is a ready-to-use liquid alpha1-proteinase inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with AAT deficiency. AAT, a protein derived from human plasma, exhibits immunomodulatory, anti-inflammatory, tissue protective and antimicrobial properties. It is approved for the treatment of AAT deficiency in the U.S. and is marketed by Baxalta (NYSE:BXLT).
- In an earlier Phase 1/2 study, 60% of newly diagnosed pediatric T1D patients treated with AAT showed peak C-peptide levels greater than 0.2 pmol/ml 10 months following the last AAT infusion, indicating functioning beta cell capacity (beta cells in the pancreas secrete insulin).
Nov. 10, 2015, 7:03 AM
- Kamada (NASDAQ:KMDA): Q3 Adj. Net Loss of $4.1M
- Revenue of $16.07M (-6.3% Y/Y) misses by $2.6M.