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
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.
Oct. 16, 2015, 8:17 AM
- Baxalta (NYSE:BXLT) extends its Glassia [Alpha1-Proteinase Inhibitor (Human)] supply contract with manufacturer Kamada Ltd. (NASDAQ:KMDA) for the third time. The agreement, originally inked in August 2010, will now be effective through 2018. Kamada will receive a minimum of $50M in new revenue as a result of the extension. The total revenue it expects from the entire contract will be at least $240M.
- Baxalta intends to begin manufacturing Glassia in 2019 whereby the agreement with shift to royalty payments to Kamada.
- Glassia is a proprietary, ready-to-infuse liquid alpha-1 antitrypsin (AAT) treatment for adults with clinically evident emphysema due to severe congenital AAT deficiency. AAT is a protein made in the liver that protects the organs from the harmful effect of other proteins, especially the lungs. People with a deficiency in AAT are at higher risk for lung disease, especially if they smoke.
Jul. 30, 2015, 7:12 AM
- Kamada (NASDAQ:KMDA): Q2 Adj. Net Loss of $1.8M.
- Revenue of $19.2M (+21.5% Y/Y) misses by $2.62M.
Jul. 8, 2015, 7:35 AM
- Kamada (NASDAQ:KMDA) reports that its H1 revenue of $28M is in line with its plan and allows it to affirm its full-year revenue guidance of $70M - 73M. Proprietary Product revenue was ~$16M.
- Q1 Proprietary Product revenue was negatively impacted by a delay in the release of product batches due the to final validation of a filling process. The validation was completed in April and the delayed revenue was recognized in Q2. Glassia revenue is also on target after significant orders from Baxalta.
- Complete financial results will be released on June 30.
Jun. 22, 2015, 7:48 AM
- Kamada (NASDAQ:KMDA) collaborates with Baxter (NYSE:BAX) subsidiary Baxalta on a Phase 1/2 clinical trial evaluating Kamada's proprietary alpha-1 antitrypsin (AAT) for the prevention of lung transplant rejection.
- Under the terms of the agreement, Baxalta will assist in the development of the study as well as the funding. The trial is expected to commence in H1 2016.
- Kamada's AAT demonstrated positive results in a proof-of-concept Phase 2 study in Graft-versus-Host-Disease conducted with Baxalta.
- Baxalta has distribution rights to AAT, branded as Glassia, for all indications in the U.S., Canada, Australia and New Zealand. Kamada retains full rights in all other territories.
- Baxalta will begin trading as a separate company on July 1 under the symbol "BXLT."
May 12, 2015, 7:03 AM
- Kamada (NASDAQ:KMDA): Q1 Adj. Net Loss of $4.8M.
- Revenue of $8.93M (-32.3% Y/Y) misses by $7.19M.
Mar. 23, 2015, 8:13 AM
- The European Commission grants Orphan Drug status to Kamada's (NASDAQ:KMDA) intravenous Alpha-1 Antitrypsin (AAT) for the treatment of Graft-versus-host disease (GvHD). The action follows the FDA's designation in October.
- If approved in Europe, AAT will have a 10-year period of market exclusivity. If approved in the U.S., its market exclusivity will be seven years.
- GvHD is a common complication following an allogeneic tissue transplant, usually stem cells, but it can apply to other forms of tissue graft. In GvHD, the leukocytes (white blood cells) in the tissue graft recognize the recipient (host) as foreign and then attack the host's body cells. It occurs in 30 - 70% of patients who undergo hematopoietic stem cell transplantation as a treatment for blood cancers.
- AAT (brand name Glassia) is currently FDA-approved for the treatment of adults with emphysema with AAT deficiency. It is distributed by Baxter International (NYSE:BAX) in the U.S., Canada, Australia and New Zealand.
- Shares are up 6% premarket on higher-than-average volume.
Feb. 11, 2015, 10:12 AM
- Kamada Ltd. (KMDA +0.5%) Q4 results: Revenues: $25.8M (+5.7%); COGS: $17.7M (+13.5%); R&D Expense: $3.4M (-5.6%); SG&A: $2.4M (-17.2%); Operating Income: $2.2M (-8.3%); Net Income: $1.7M (+6.2%); EPS: $0.05 (+25.0%); CF Ops: $0.7M (-82.5%).
- FY2014 results: Revenues: $71.9M (+1.8%); COGS: $56.3M (+27.4%); R&D Expense: $16M (+26.0%); SG&A: $10.5M (+5.0%); Operating Loss: ($10.9M) (-394.6%); Net Loss: ($12.6M) (-999%); Loss Per Shasre: ($0.35) (-999%); Quick Assets: $51.9M (-30.1%); CF Ops: ($9.9M) (-153.8%).
- No guidance given.
Kamada Ltd. engages in the development and production of pharmaceutical products. It operates through the Proprietary Products and Distribution segments. The Proprietary Products segment develops, manufactures and sells plasma-derived therapeutics products. The Distribution segment supplies... More
Industry: Drug Manufacturers - Other
Country: United States
Other News & PR