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Analysts Anticipate Kamada Ltd. (NASDAQ:KMDA) Will Post Quarterly Sales of $33.17 Million
https://www.marketbeat.com/instant-alerts/nasdaq-kmda-consensus-analyst-rating-2021-01/
FRIDAY, JANUARY 15, 2021 | MARKETBEAT
Kamada logoAnalysts expect Kamada Ltd. (NASDAQ:KMDA) to announce $33.17 million in sales for the current quarter, Zacks Investment Research reports. Two analysts have issued estimates for Kamada's earnings. The lowest sales estimate is $32.40 million and the highest is $33.93 million. Kamada posted sales of $32.07 million in the same quarter last year, which would indicate a positive year over year growth rate of 3.4%. The firm is scheduled to issue its next quarterly earnings results on Wednesday, February 10th.
On average, analysts expect that Kamada will report full-year sales of $134.75 million for the current financial year, with estimates ranging from $134.10 million to $135.64 million. For the next fiscal year, analysts anticipate that the business will report sales of $103.23 million, with estimates ranging from $98.30 million to $106.70 million. Zacks' sales averages are an average based on a survey of research firms that cover Kamada.
Kamada (NASDAQ:KMDA) last released its earnings results on Wednesday, November 11th. The biotechnology company reported $0.15 EPS for the quarter, beating the Thomson Reuters' consensus estimate of $0.08 by $0.07. The firm had revenue of $35.33 million during the quarter, compared to analyst estimates of $33.49 million. Kamada had a return on equity of 12.89% and a net margin of 15.60%.
Kamada stock opened at $7.23 on Friday. The firm has a market capitalization of $321.88 million, a P/E ratio of 15.06 and a beta of 1.10. The stock has a fifty day moving average price of $6.60 and a 200 day moving average price of $8.00. Kamada has a 52 week low of $4.40 and a 52 week high of $13.33.
A number of large investors have recently made changes to their positions in the business. Ritholtz Wealth Management increased its stake in Kamada by 17.2% during the third quarter. Ritholtz Wealth Management now owns 34,276 shares of the biotechnology company's stock worth $287,000 after acquiring an additional 5,039 shares during the last quarter. Bank of America Corp DE acquired a new stake in Kamada during the second quarter worth about $56,000. O Shaughnessy Asset Management LLC increased its stake in Kamada by 10.0% during the third quarter. O Shaughnessy Asset Management LLC now owns 85,892 shares of the biotechnology company's stock worth $718,000 after acquiring an additional 7,825 shares during the last quarter. Goldman Sachs Group Inc. acquired a new stake in Kamada during the second quarter worth about $84,000. Finally, Jane Street Group LLC increased its stake in Kamada by 61.9% during the third quarter. Jane Street Group LLC now owns 32,090 shares of the biotechnology company's stock worth $268,000 after acquiring an additional 12,268 shares during the last quarter. Institutional investors own 14.25% of the company's stock.
Kamada Enters into Two New Agreements for the Distribution of Three Biosimilar Products in Israel
https://finance.yahoo.com/news/kamada-enters-two-agreements-distribution-120000004.html
Wed, January 13, 2021, 2:00 PM GMT+2
The Three Products Are Expected to Be Launched, Subject to Israeli Ministry of Health Approval, Between 2022 and 2024
Potential Collective Maximum Sales of the Three Products in the Israeli Market is Estimated at $5-$7 Million Annually
These Sales Are in Addition to the Potential $20-$30 Million from the Recently Licensed Alvotech Biosimilar Portfolio
REHOVOT, Israel, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced that the Company has entered into agreements with two undisclosed international pharmaceutical companies to commercialize three biosimilar product candidates in Israel. Subject to approval by the European Medicines Agency (EMA) and subsequently by the Israeli Ministry of Health (IMOH), the three products are expected to be launched in Israel between 2022 and 2024. The two pharmaceutical companies will maintain development, manufacturing, and supply responsibilities for these three products.
“These agreements expand our pipeline of biosimilar product candidates for distribution in Israel, which already includes six products previously licensed from Alvotech, and further position Kamada as a leader in the emerging biosimilar market in Israel,” said Amir London, CEO of Kamada. “The Israeli market for the referenced innovative products to which these three biosimilar products are targeted was between approximately $20-$25 million in 2019, and we estimate the potential collective maximum sales generated by the distribution of these three products, achievable following regulatory approval and within several years of launch, to be in the range of $5-$7 million annually. These sales will be in addition to the $20-$30 million of potential maximum sales of the six Alvotech biosimilar products, which, subject to approval by the EMA and subsequently by the IMOH, are expected to be launched between 2022 and 2025. The distribution of this biosimilar portfolio is expected to further support the anticipated future revenue and profitability growth in our Distribution Products segment.”
About Kamada
Kamada Ltd. (“the Company”) is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. Pursuant to an agreement with Takeda the Company will continue to produce Glassia for Takeda through 2021 and Takeda is planning to initiate its own production of Glassia for the U.S. market in 2021 at which point Takeda will commence payment of royalties to the Company. The Company’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® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company’s intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.
Kamada Selected as a Winner of the Genesis Prize Foundation and Start-Up Nation Central Competition
Kamada Ltd.
https://finance.yahoo.com/news/kamada-selected-winner-genesis-prize-120000160.html
Tue, January 5, 2021, 2:00 PM GMT+2
Award Recognizes Israeli Companies Working to Combat Coronavirus and the Damage of Future Pandemics
REHOVOT, Israel, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), plasma-derived biopharmaceutical company, today announced that it has been selected as one of 10 winners of the Genesis Prize Foundation (GPF) Start-Up Nation Central (SNC) competition recognizing Israeli companies working to combat coronavirus and the damage of future pandemics. Based on its development of a plasma derived immunoglobulin (IgG) product as a potential therapy for coronavirus disease (COVID-19), Kamada was selected for its significant contributions towards fighting COVID-19 and advancing a promising technology that has the potential to provide significant benefits in the near future. The winners were announced in a virtual ceremony by Reuven Rivlin, President of Israel.
The annual Genesis Prize, dubbed the “Jewish Nobel” by TIME Magazine, honors extraordinary individuals for their outstanding professional achievement, contribution to humanity, and commitment to Jewish values. Natan Sharansky, the human rights activist, was announced as the 7th Genesis Prize Laureate in December 2019 and directed his $1 million award to organizations fighting the COVID-19 pandemic. Part of Mr. Sharansky’s award was used to fund the competition.
SNC is an Israel-based non-profit organization that works to ensure the strength and vitality of the Israeli tech ecosystem and to enhance its positive global impact. SNC leverages its in-depth knowledge of the country’s innovation sector to connect multinational corporations, governments, and NGOs to those people and technologies in Israel most relevant to their needs.
“We are deeply honored to receive this prestigious award from the GPF and SNC and for being recognized for the development of our plasma-derived IgG product against COVID-19,” said Amir London, Kamada’s Chief Executive Officer. “As previously reported, we executed an agreement with the Israeli Ministry of Health (“IMOH”) to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately $3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH.”
About the Genesis Prize
The mission of the Genesis Prize is to foster Jewish identity, inspire Jewish pride and strengthen the bond between Israel and the Diaspora. The Prize celebrates Jewish talent and achievement, honoring individuals for their accomplishments and commitment to Jewish values, inspiring Jews to connect to their heritage and to Israel.
The vision of the Genesis Prize is a strong and vibrant Jewish people, aware of its roots while looking to the future; a Jewish community flourishing in diversity, yet united in appreciation of Jewish values and support for the Jewish State.
Annual Changes to the Nasdaq Biotechnology Index
Fri December 11, 2020 8:05 PM
NEW YORK, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Nasdaq (Nasdaq: NDAQ) today announced the results of the annual reconstitution of the Nasdaq Biotechnology Index (Nasdaq: NBI), which will become effective prior to market open on Monday, December 21, 2020.
The Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB).
The following 100 securities will be added to the Index:
Nasdaq KMDA Kamada Ltd. (1 of the 100)
https://seekingalpha.com/pr/18120272-
Kamada Reports Third Quarter and First Nine Months of 2020 Financial Results, Recent Achievements and Corporate Development
Kamada Ltd.
Wed, November 11, 2020, 2:00 PM GMT+2
Third Quarter and First Nine Months of 2020 Revenues were $35.3 million and $101.7 million Respectively, a 7% Increase Compared to Both 2019 Periods; Company Reiterates Full-Year 2020 Total Revenue Guidance of $132 Million to $137 Million
Net Income for Third Quarter and First Nine Months of 2020 was $6.8 million and $15.5 million, Respectively, Compared to $5.8 Million and $16.9 Million in 2019, Respectively
Continued to Advance Development of a Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) Through a $3.4 million Supply Agreement with the Israeli Ministry of Health and Positive Interim Results from an Ongoing Phase 1/2 Clinical Study
Exploring Strategic Business Development Initiatives Focused on Utilizing Kamada's Core Plasma-Derived Pharmaceuticals Development, Manufacturing and Commercialization Expertise by Leveraging Its Strong Financial Position
REHOVOT, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced financial results for the three and nine months ended September 30, 2020.
“We are pleased with our solid financial and operational results during the recently completed quarter and first nine months of 2020, achieved in the midst of the COVID-19 global pandemic,” said Amir London, Kamada’s Chief Executive Officer. “Total revenues increased seven percent for both the three and nine months ended September 30, 2020 as compared to the same periods in 2019. Based on our solid performance in the first nine months of the year, and our positive outlook for the fourth quarter, we are reiterating our full-year 2020 total revenue guidance of $132 million to $137 million.”
“We continue to achieve important progress in the development of our plasma derived immunoglobulin (IgG) product as a potential therapy for COVID-19 disease,” continued Mr. London. “We executed an agreement with the Israeli Ministry of Health (“IMOH”) to supply our product for the treatment of COVID-19 patients in Israel, under which the initial supply is expected to generate approximately $3.4 million in revenues during the first quarter of 2021. Importantly, per recent discussions with the IMOH, the treatment utilizing our product will be provided as part of a multi-center clinical study led by the IMOH. From a supply perspective, we are ramping up our COVID-19 IgG manufacturing capacity, and we intend to increase our supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets. In addition, we completed enrollment and announced positive initial interim results from our ongoing Phase 1/2 open-label COVID-19 clinical trial in Israel. Lastly, following recent response from the U.S. Food and Drug Administration (“FDA”) to our previously submitted pre-Investigational New Drug (IND) information package, we, together with our partner, Kedrion Biopharma, are currently evaluating the suitable targeted patient population for our US clinical program and will submit an IND application upon conclusion of such evaluation and successful completion of additional required activities.”
“As we move into 2021 and in anticipation of the reduction in revenues due to the planned transition of GLASSIA manufacturing to Takeda, we are exploring strategic business development opportunities that will utilize and expend our core plasma-derived therapeutics development, manufacturing, and commercialization expertise. These opportunities will be funded by our strong cash position. We believe that our COVID-19 IgG program demonstrates Kamada’s ability to quickly respond to emerging pandemic situations, and we plan to leverage these capabilities and our IgG platform technology as a strategic business line, with the ability to respond to other potentially similar future pandemic situations. These strategic opportunities are anticipated to be added to the expected organic commercial growth of our existing products portfolio, including KEDRAB, our distributed products in Israel, the anticipated future royalty payments from Takeda, and the contract manufacturing of an FDA approved and commercialized specialty IgG product.” concluded Mr. London.
Financial Highlights for the Three Months Ended September 30, 2020
Total revenues were $35.3 million in the third quarter of 2020, a 7% increase from the $33.1 million recorded in the third quarter of 2019.
Proprietary Products segment revenues in the third quarter of 2020 were $29.7 million, a 19% increase from the third quarter of 2019.
Distribution segment revenues were $5.6 million in the third quarter of 2020, a 31% decrease from the third quarter of 2019.
Gross profit was $14.8 million in the third quarter of 2020, compared to $12.9 million reported in the third quarter of 2019.
Proprietary Product segment gross margins in the third quarter were 46%, down one percentage point from the third quarter of 2019. For full-year 2020, Kamada continues to expect an annual decrease of three to five percentage points in Proprietary Product segment gross margins, primarily attributable to a change in sales product mix and reduced plant utilization.
Operating expenses, including Research and Development, Sales and Marketing, General and Administrative, and Other Expenses, totaled $7.1 million in the third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
The Company continues to expect a 13%-15% increase in Research and Development expenses for full-year 2020 as compared to 2019.
Net income was $6.8 million, or $0.15 per share, in the third quarter of 2020, as compared to net income of $5.8 million, or $0.14 per share, in the third quarter of 2019.
Adjusted EBITDA, as detailed in the tables below, was $9.3 million in the third quarter of 2020, as compared to $7.2 million in the third quarter of 2019.
Cash used in operating activities was $2.4 million in the third quarter of 2020, as compared to cash provided by operating activities of $6.1 million in the third quarter of 2019.
Financial Highlights for the Nine months Ended September 30, 2020
Total revenues were $101.7 million in the first nine months of 2020, a 7% increase from the $95.1 million recorded in the first nine months of 2019.
Revenues from the Proprietary Products segment for the first nine months of 2020 were $77.6 million, a 7% increase from the $72.5 million reported in the first nine months of 2019.
Revenues from the Distribution segment were $24.1 million in the first nine months 2020, a 7% increase from the $22.6 million recorded in the first nine months of 2019.
Gross profit was $37.4 million in the first nine months 2020, compared to $37.6 million in the first nine months of 2019.
Operating expenses, including Research and Development, Sales & Marketing, General and Administrative, and Other Expenses, totaled $20.8 million in the first nine months 2020, as compared to $20.3 million in the first nine months of 2019.
Net income was $15.5 million, or $0.35 per share, in the first nine months of 2020, as compared to net income of $16.9 million, or $0.42 per share, in the first nine months of 2019.
Adjusted EBITDA, as detailed in the tables below, was $21.1 million in the first nine months of 2020, as compared to $21.7 million in the first nine months of 2019.
Cash provided by operating activities was $6.4 million in the first nine months of 2020, as compared to cash provided by operating activities of $18.9 million in the first nine months of 2019.
Balance Sheet Highlights
As of September 30, 2020, the Company had cash, cash equivalents, and short-term investments of $99.7 million, as compared to $73.9 million at December 31, 2019. This increase is mainly related to the sale of $25 million of equity to FIMI Opportunity Fund, the leading private equity investor in Israel.
Recent Corporate Highlights
Appointed Yifat Philip, Esq. as Vice President Legal, General Counsel and Corporate Secretary.
Conference Call
Kamada management will host an investment community conference call on Wednesday, November 11, 2020, at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1-809-409-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13710863. The call will also be webcast live on the Internet on the Company’s website at www.kamada.com.
About Kamada
Kamada Ltd. (“the Company”) is a commercial stage plasma-derived biopharmaceutical company focused on orphan indications, with an existing marketed product portfolio and a late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived immune globulins. The Company’s flagship product is GLASSIA®, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. The Company markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals Company Limited and in other countries through local distributors. Pursuant to an agreement with Takeda, the Company will continue to produce Glassia for Takeda through 2021 and Takeda is planning to initiate its own production of Glassia for the U.S. market in 2021 at which point Takeda will commence payment of royalties to the Company. The Company’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® through a strategic partnership with Kedrion S.p.A. In addition to Glassia and KEDRAB, the Company has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. The Company has late-stage products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency. In addition, the Company’s intravenous AAT is in development for other indications, such as GvHD and prevention of lung transplant rejection, and during 2020, the Company initiated the development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The Company leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding 1) total revenues to be in the range of $132 million to $137 million for fiscal 2020; 2) ability to ramp up Kamada’s COVID-19 IgG manufacturing capacity and its plan to increase its supply capabilities during 2021 to support potential increased demand from the IMOH as well as from other potential international markets; 3) ability to advance the U.S. clinical development of a plasma derived hyperimmune immunoglobulin (IgG) product as a potential treatment for COVID-19; 4) ability to explore strategic business development opportunities that utilize and expend Kamada’s core plasma-derived therapeutics development, manufacturing, and commercialization expertise; and 5) Kamada’s belief that its COVID-19 IgG program demonstrates its ability to quickly respond to emerging pandemic situations, and its plan to leverage these capabilities and its IgG platform technology as a strategic line of business. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the continued evolvement of the COVID-19 pandemic, its scope, effect and duration, availability of sufficient raw materials required to maintain manufacturing plans, the effects of the COVID-19 pandemic and related government mandates on the availability of adequate levels of work-force required to maintain manufacturing plans, disruption to the supply chain due to COVID-19 pandemic, continuation of inbound and outbound international delivery routes, ability to offset significant revenue loss associated with GLASSIA manufacturing transitioning to Takeda, continued demand for Kamada’s products, including GLASSIA and KEDRAB, in the U.S. market and its Distribution segment related products in Israel, financial conditions of the Company’s customer, suppliers and services providers, ability to obtain regulatory approval for clinical trials of the plasma-derived hyperimmune IgG product for COVID-19, ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies and on-going compassionate-use treatments, Kamada’s ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
Bob@LifeSciAdvisors.com
Kamada Looks Cheap As Takeda Deal Creates Value
Nov. 2, 2020 2:11 PM ET | About: Kamada Ltd. (KMDA), Includes: TAK, TKPHF
Zach Bristow
Summary
We believe Kamada looks cheap, as there are long-tailed asset returns from the Takeda deal which the market may be overlooking.
Recent retraction in Kamada's shares on the charts signals a potential dislocation in value and to today's trading.
Our long-term thesis sees this alongside other key differentiators in COVID-19 exposure and the rabies treatment segment, setting a price target of $10.64.
Investment Thesis
We believe Kamada Ltd. (NASDAQ:KMDA) looks cheap at current valuations, and several key developments in the developmental pipeline look yet to be priced in from the market. Whilst the stock seems cheap on a valuation front, investors have shied away from share support, and the stock has given away -84% since September to today's trading of $7.05. We believe that KMDA has unique exposure to the Israeli market, alongside COVID-19 and rabies treatment differentiators, which can create value in the coming years. These points are coupled with key differentiators in these segments that insulate the company from peers on a competitive level. Such differentials include expansion to paediatrics in the rabies segment and focus on a treatment vs a vaccine in the COVID-19 segment. Further, the company has created large value through their latest production arrangement for Glassia with Takeda Pharmaceutical Company (NYSE:TAK). This sees royalty payments at a respectful yield until 2040, thus creating long-tailed asset returns and widening future reinvestment opportunities, which are included into our valuation for the company.
ChartData by YCharts
Catalysts for Price Change
KMDA has completed agreements with TAK on extension of Glassia production into 2021. Glassia is an alpha-1 proteinase inhibitor, indicated for chronic augmentation and maintenance therapy in individuals with emphysema caused by a deficiency of that molecule. Kamada, being the holder of the license applications for the drug, will continue to receive royalty payments on net sales at a yield of 12% until 2025, 6% thereafter until 2040. The agreement sets a floor on royalties to be received of $5 million per year, thus guaranteeing KMDA that minimum yearly from 2022 to 2040. In the base case, KMDA expects a royalty payment in the ranges of $10 million to $20 million per year across this time frame, based on Glassia sales trajectory and projected sales growth. This translates to a range of $180 million to $360 million across this entire period, notwithstanding the potential for future Glassia sales growth above current guidance. Also, considering the early 12% yield to 2025, the company will likely realise greater than $10 million per year over this period. Therefore, KMDA has effectively created high value on the back of this deal, generating long-tailed asset returns via the royalty payments, whilst leveraging COGS savings for future operations.
Further, the company has unique exposure to COVID-19, via their plasma-derived hyperimmune immunoglobulin product as a potential treatment. The company has levered its expertise in this segment to provide investors unique exposure to COVID-19 market potential. What's unique about this exposure is that the company isn't competing in the race for a vaccine, rather a treatment for serious symptoms associated with the illness. The phase 1/2 open trial conducted in Israel has shown promising results in COVID-19 patients with pneumonia who are unventilated. Interim results displayed improvement in 11/12 people of the sample population, within 24-48 hours of treatment. Of this 11, all were discharged from hospital within 4.5 days (median) of the initial treatment. These are statistically relevant numbers and demonstrate the effectiveness for the treatment moving through trial phases. Further, the efficacy and safety data was sound as well, which should improve the flavoring of the next trial phases. Should label acceptance occur within the coming periods, then we anticipate KMDA sales to improve drastically over the coming years, particularly if uptake is considered in major European and other EMEA markets, in light of the recent spike in COVID-19 cases.
Additionally, back in August, KMDA expanded on data for its Kedrab label, for application and safety in use for paediatric rabies cases. The study was completed in the US, and investors immediately saw around 12-15% upside on the back of the news. Kedrab, which was launched in 2018, accounted for over $30 million of sales in 2019, capturing just over 20% market share. We view this recent addition exposes the company to a larger market and will enable KMDA to continue to grab market share in their rabies segment. We view potential sales expansion over on the back of this announcement, particularly as the paediatric portion in this segment remains largely under-exploited.
With these advancements, alongside current operations, we view revenues returning to pre-COVID-19 levels by 2024. We view a large downturn in revenues after 2021 secondary to Glassia restructuring, whereby profitability will continue to expand from that point until 2024 and beyond. Over the coming single-year period, we see FCF growth to $10.52 million, on a healthy margin of around 62%, with gross margins averaging over 30% in the next 4 quarters to FY2021 end. Additionally, following the Glassia deal restructure, and with expected royalty structuring, we view an unloading of margin pressure from reduced revenue costs, offset by reduced operating income.
Valuation
Analysing multiples over the previous segments to today, we see a slight correction in most measures. We believe that the stock seems cheap on this front, where future value in years to come has yet to be priced in. Although the stock has retracted back on the charts since September (discussed later), we view that current levels of trading present a potential entry point for a stock that has retained shareholder value, and created long-tailed asset returns until 2040. Considering the company's ability to reinvest all royalty payments back into the pipeline, or generate additional returns on investment decisions from this cash flow, this must be priced into the valuation also. Therefore, on a multiples front, this supports our thesis for long-term investors at today's trading.
Data Source: Author's Calculations
We see EV/EBITDA of 8.9x as good value vs the median for the sector, alongside a FWD P/E of 19.7x as decent value relative to peers. Momentum on P/E growth also highlights investor expectations over the coming year. The company trades at 15x FCF, not unreasonable and has 6.28% FCF yield, on the high side in our view, good numbers for equity holders. The company only has $0.22 in free cash per share, but P/Sales of 2.3x offsets this point from a value perspective. Additionally, we see P/Book above 1x as value creation for shareholders, thus trading at 1.9x book value is extraordinary in our view. Reasonable double-digit ROIC and ROA of 12.49% and 10.96%, respectively, add weight to the valuation also. Although these numbers have fallen over recent periods, the company has not been immune the pandemic's effect on the markets. However, with high ROIC and ROA, alongside $0.73 per $1 committed to asset growth, we see further upside in the valuation from today's measures. We assign a 1.5x premium to our FWD P/E estimates of 19.7x, relative to our FY2020 EPS estimates of 0.36, thereby creating a price target of $10.64 over the coming 12 months. However, there are threats to this price target based on current market sentiment, as investors can see below.
Further Considerations
On the chats, we've observed a sharp retraction from August/September highs, with a large pullback to today's trading. The longer-term support line has only been realised at today's prices, whereas prior to August, shares had bounced away from the support line 5 times since the selloff in March. The stock didn't break resistance until August, where it shot north with speed, as seen below. Following the huge uptick on the back of KMDA's COVID-19 entry, we postulate that speculators took profits quickly and reallocated capital to the next whisper of a COVID-19 vaccine. We've observed this regularly on charts YTD, particularly in the 2nd quarter, where competition is high within that segment. We can view the pattern of behaviour on the charts below, where the longer-term support line has been formed, with a large dispersal of price returns away from this floor of support. Consequently, we feel that a new level or support or resistance will be formed from here, which will dictate the stocks next move from today.
Data Source: Author's Bloomberg Terminal
As seen on the chart below, there has been a descending triangle setup formed since August, with a flat lower trend line and sharp decline from the upper trend ceiling. This has occurred after a small consolidation towards the end of August, where the stock continued south up until today. We view risks for investors with this setup, as further downside may be imminent should the trend continue. Thus, the current investor sentiment is bearish in our view, which supports a contrarian's thesis for entry at these numbers.
Data Source: Author's Bloomberg Terminal
We've also witnessed these movements on the back of high volatility to the downside, where adequate compensation for this has been questionable. Most recently, the Sortino ratio reached 0.3, which is low in our view, considering record low treasury yields and the flattening of the yield curve. We see this downside volatility as a risk for investors wanting to make an adequate entry decision, and advocate for investors to perhaps wait until downside volatility has settled and the stock finds its range. We see a struggle for pricing range occurring over the next few weeks to months, but feel the market sentiment in the long-term will be bullish. This is especially true in light of the value created with the TRK agreement.
Data Source: Trading View KMDA
What ideally needs to happen is the stock bounces away from the lower support line and regains momentum in favour of the upside. Right now, the bears have it and are driving the stock south with speed. We can see this setup on the charts above, where the current level of support has reached May lows, presenting the risks outlined. On the flip side, in our view, the negatives are offset by several drivers to change. First, considering the value in the recent royalty agreement, rabies segment differentiators and unique COVID-19 exposure. Then, with our current valuations and high ROIC and ROA, this may present as an exciting entry point with a contrarian flavour to ones reasoning. We feel the stock has upside potential in the long term, thus, we believe long-term investors need to keep a close eye on KMDA's story in periods to come.
Additional Risks
There are pipeline risks that apply to KMDA's development story. Firstly, overall failure in the COVID-19 segment would be a blow to shareholders, as we have seen several overcorrections in stocks this year that have either pulled studies or failed on phase 2 clinical data. The market would likely view this in a negative light for KMDA also, especially considering the volatility with COVID-19 players, in the run for a vaccine or not. Furthermore, any disruption to Glassia sales over the next few years will see a lower than expected royalty yield from the TRK agreement. This would impact management's capital allocation, due to changes in the size and timing of the cash flows to be received. Better than expected Glassia sales will offset this point immediately, especially with a double-digit royalty on net sales over the next few years, on the high side. Investors must therefore consider competition in Glassia's operating segment to gain the most insight into extended revenues for KMDA over coming periods. Additional risks to investors lie on the charts, where further movement south in price will eat into returns, increasing downside risk and risk-adjusted return potential. Until recently, volatility to the downside has been high, thereby extending risks to investor's bottom line potential. In this view, should current trends continue, then current investors will see further downside in pricing risk, should recovery take longer than expected. Undoubtedly, we see a large uptick in price offsetting this point.
Credit Summary and Conclusion
The market has punished KMDA recently with no meaningful explanation outside of pricing activity. Fundamentally, the company's outlook remains largely unchanged, although management will provide further insights with Q3 guidance around the corner. The company left the 2nd quarter well capitalised with around $100 million in cash on the balance sheet, with LT debt of just over $30 million. Interest expenses are well covered at over 89x coverage from EBITDA level earnings, whilst total debt/EBITDA is 0.21x. Long-term debt to total capital has remained stable over recent periods, most recently at 2.22x from the Q2 exit, whilst total debt to capital and debt to equity are at 2.97 and 3.06, respectively. KMDA's debt ratio has come down by around 40% YoY, and stands at 2.52 from Q2. On a short-term solvency basis, short-term obligations are covered 5.79x from liquid assets, and the company has adequate liquidity should inventory remain stagnant. Long-term debt to total assets has also come down by around 40% since 2019, at 2.52x, whilst their Altman z-score has gained points to 7.07 from Q2. Therefore, we see the company in good health, with reasonable strength on the balance sheet, and no meaningful drags or pulls on liquidity.
A contrarian flavour to one's thinking would view a potential dislocation in KMDA's value and price. With prices continuing on the down, there may be further downside volatility over the coming weeks and months until shares find their range. Until then, we encourage investors to set up for entry, should the stock see momentum and a large uptick from the current level of long-term support. This would provide a compelling case for entry. Further, the market may be overlooking the value of the long-tailed asset returns that will surmount on the back of the deal with TRK. This must be factored into reasoning also. More news on these developments from Q3 earnings may be the upcoming catalyst to drive shares back north towards August highs. Until then, we eagerly await results from this quarter to provide additional coverage.
Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in KMDA over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Kedrion's Partner, Kamada Ltd, Signs a Supply Agreement with the Israeli Health Authorities for the Investigational Anti-COVID-19 Plasma-Derived Therapy
Published: Oct. 22, 2020 at 8:27 a.m. ET
LUCCA, Italy, Oct. 22, 2020 /PRNewswire via COMTEX/ -- LUCCA, Italy, Oct. 22, 2020 /PRNewswire/ -- The Israeli health authorities have signed a supply agreement for the investigational COVID-19 plasma-derived Immunoglobulin (IgG), to be supplied by Kamada Ltd., a biopharmaceutical company which is the partner of Kedrion Biopharma of Italy in the development of the new anti-COVID-19 therapy.
The Israeli company will manufacture the product, to be supplied to the Ministry of Health, from convalescent plasma collected by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions. The initial order to be supplied in the next few months is sufficient to treat approximately 500 hospitalized patients.
"We are pleased to work in collaboration with Kamada on the development and global distribution of this important therapy, which we hope will help patients in Israel and around the world," said Paolo Marcucci, chairman of Kedrion Biopharma.
In April 2020 Kedrion and Kamada established a global collaboration for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19.
The companies' U.S. clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance by the FDA.
Val Romberg, Kedrion's recently named CEO, said the news from Israel was "a welcome milestone" and added: "The progress made in Israel is a positive and encouraging sign for patients everywhere."
Kedrion, in collaboration with Kamada, is continuing with the development of new anti-Covid therapies together with its research partner Columbia University Irving Medical Center in New York. In July Kedrion announced it was forming a research partnership with Columbia University Medical Center that is aimed at helping to develop a new plasma-based anti-Covid therapy.
About Kedrion Biopharma
Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as antibodies for HBV, Tetanus and hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in the United States and Hungary to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States. Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,700 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at www.kedrion.com and www.kedrion.us.
Kamada to supply investigational IgG product for COVID-19
Oct. 19, 2020 9:21 AM ET|About: Kamada Ltd. (KMDA)|By: Meghavi Singh, SA News Editor
Kamada (NASDAQ:KMDA) +11% premarket, after signing an agreement with the Israeli Ministry of Health ((MoH)) to supply its anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) investigational product as a potential treatment for COVID-19 patients in Israel.
The initial order of $3.4M in revenue is expected to be supplied during the beginning of 2021 to treat ~500 hospitalized patients.
Kamada will manufacture the product to be supplied to MOH from convalescent plasma collected and supplied by the Israeli National Blood Services, a division of Magen David Adom (MADA), and additional Israeli medical institutions.
In September 2020, announced interim data from Phase 1/2 IgG trial in COVID-19.
The companies’ US clinical development of a plasma-derived IgG product as a potential COVID-19 treatment is expected to begin in early 2021 pending IND acceptance.
Kamada Provides Update on 2021 GLASSIA® Supply to Takeda
,GlobeNewswire•October 7, 2020
Kamada Expects to Receive $25 Million in Revenues from Sales of GLASSIA® to Takeda in 2021 which is Takeda’s Minimum Commitment for 2021 Pursuant to the Existing Supply Agreement
Kamada Projects Royalties from Takeda in the Range of $10 Million to $20 Million per Year from 2022 to 2040
Kamada Reiterates its Total Revenues Guidance of Between $132 million and $137 million for Full-year 2020
REHOVOT, Israel, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical company, today announced that, following recent discussions with Takeda, it expects to receive approximately $25 million in revenues from the supply of GLASSIA® to Takeda in 2021.
As previously indicated, the agreement with Takeda provided a supply range for 2021 pursuant to which Kamada’s revenues from sales of GLASSIA to Takeda were projected to be between $25 million to $50 million. The 2021 supply range was included in the agreement to provide flexibility for Takeda to address any potential changes in the expected timeline for its completion of the planned transition of GLASSIA manufacturing.
“Based on our recent discussions with Takeda, the planned transition of GLASSIA manufacturing to their plant is advancing as expected,” said Amir London, Kamada’s Chief Executive Officer. “As such, Takeda anticipates that its 2021 GLASSIA demand from Kamada will not exceed the minimum commitment under the supply agreement which is expected to generate $25 million of revenue for Kamada. The Company is prepared to make the necessary adjustments to our plant costs during 2021 to align with our manufacturing plan and future needs.”
“We continue to intensively explore business development opportunities that would over time mitigate the effects of the planned transition of GLASSIA® manufacturing to Takeda in 2021,” added Mr. London. “These opportunities, funded by our strong cash position, along with organic commercial growth of our existing products portfolio, our distributed products in Israel, the expected future royalty payments from Takeda, the contract manufacturing of an FDA approved and commercialized specialty IgG product as well as the continued advancement in the development of our COVID-19 IgG product candidate which is advancing in the clinic are expected to contribute to our future growth,” concluded Mr. London.
Based on the agreement with Takeda, 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. Although the transition of the agreement to its royalties phase will result in a reduction of Kamada’s revenue from Takeda, based on current GLASSIA sales in the U.S. and forecasted future growth, Kamada projects receiving royalties from Takeda in the range of $10 million to $20 million per year from 2022 to 2040.
https://finance.yahoo.com/news/kamada-provides-2021-glassia-supply-103000753.html
First 3 Israelis treated with new passive vaccine recover, leave hospital
Passive immunization is when you are given antibodies formed by other patients who developed them when they got the disease.
By MAAYAN JAFFE-HOFFMAN AUGUST 15, 2020 21:53
The first three patients treated with a new COVID-19 “passive vaccine,” which was developed by Hadassah Medical Center and the Israeli biopharmaceutical firm Kamada, demonstrated rapid, clinical benefit and have already been released from the hospital to their homes, Hadassah reported on Thursday.
“For three months now, despite the initial opposition of the former director-general of the Health Ministry, Hadassah has been collecting plasma donations from coronavirus patients,” Hadassah head Prof. Zeev Rotstein said.
Specifically, the plasma was collected with the help of the haredi (ultra-Orthodox) organization Yad Avraham and the haredi community. Patients who tested negative for the novel coronavirus twice and showed high levels of antibodies in their blood were asked to donate.
Those who develop any virus, including the novel coronavirus, develop special antivirus proteins or antibodies in their plasma, which can help sick patients cope with the disease. According to webmd.com, plasma is the yellow, liquid portion of blood that carries important proteins, minerals, nutrients and hormones to the right places in your body, making up more than half of the blood.
The plasma donations were collected by the blood bank at Hadassah and then transferred, together with doses collected by Magen David Adom, to the Kamada company, where appropriate antibodies were produced for the experimental treatment.
Kamada used the plasma to produce what it calls its “anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product.”
Passive immunization is when you are given antibodies formed by another patient who got the disease and developed them. An active vaccine, in contrast, is when you are injected with a dead or weakened version of an actual virus that tricks your immune system into thinking that you have the disease, and your immune system creates antibodies to protect you.
Jerusalem, where Hadassah is located, has had the country’s highest number of sick patients. As of Saturday night, according to the Health Ministry, 15,542 people have been infected in the Holy City.
Rotstein said that the vaccine, which could also be called a medicine, is being targeted toward COVID-19 patients whose situation is worsening and need a booster to fight the disease. However, it may also be used prophylactically in cases where a high-risk patient contracts coronavirus and the hospital wants to stop the disease’s progression.
“It is evident that the Hadassah team is very satisfied with the clinical research,” said Dr. Asa Kessler, a physician in the hospital's coronavirus unit. He said the plasma is being distributed to COVID-19 patients who develop pneumonia and “for now, we are very encouraged.”
Until now, Hadassah has been distributing the plasma through the country’s compassionate use program. It is not the only hospital testing Kamada's treatment. In total around a dozen patients are getting the treatment.
Last week, Kamada announced that the first patient had been recruited to its Phase 1/2 clinical trial of its new product as a potential treatment for COVID-19 in Israel. The study was approved by the Health Ministry and will assess the treatment’s safety, pharmacokinetics (the movement of drugs within the body), and pharmacodynamics (the drug’s effects and mechanism of action) in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients will be enrolled and then tracked for 84 days.
In parallel, Kamada intends to further explore the potential of its IgG product to prevent COVID-19 disease in healthy, at-risk subjects in a separate study, its website said.
Rotstein said that these preliminary results should “raise hope in Israel and around the world.”
https://www.jpost.com/health-science/first-3-israelis-treated-with-new-passive-vaccine-recover-leave-hospital-638431
KMDA / Kamada Ltd. - Institutional Ownership and Shareholders
https://fintel.io/so/us/KMDA
2 Coronavirus Treatment Stocks to Buy Right Now
Eli Lilly and Kamada are two of the most intriguing companies working on this part of the COVID-19 problem.
George Budwell
(TMFGBudwell)
Sep 9, 2020 at 10:00AM
Kamada: A convalescent plasma therapy play
Kamada is a plasma-centered biopharmaceutical company with two FDA-approved products on the market: Glassia, a treatment for the inherited lung/liver disorder known as alpha-1 antitrypsin deficiency; and Kamrab, a preventative treatment for rabies.
Although neither of its commercial-stage products is a major cash cow, relatively speaking, Kamada has been posting respectable levels of revenue growth, positive free cash flow, and a steadily improving cash position over the past few quarters.
The biotech's main draw for investors, though, arguably isn't its current product line-up, but rather its experimental convalescent plasma therapy for COVID-19. On Aug. 23, President Trump announced that the FDA had issued an emergency use authorization for this intriguing treatment to be administered to hospitalized COVID-19 treatments.
Since then, the scientific community has raised concerns about the effectiveness of convalescent plasma therapy, given the lack of placebo-controlled clinical trials for them. But this skepticism probably won't dim the commercial potential for Kamada's therapy -- at least not in the short term.
The big picture is that this biotech has one of the most advanced plasma-based COVID-19 treatments in development, a fact which might translate into a healthy boost in its sales in the not-so-distant future.
https://finance.yahoo.com/m/ed13f1d6-ee74-33f0-a242-a5492609dfc4/2-coronavirus-treatment.html?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo
Kamada Rises 5% On Initial Phase 1/2 Trial Results For Covid Treatment
SmarterAnalyst•September 9, 2020
Kamada stock surged 4.7% on September 8 even as the broader US market declined as the Israel-based plasma-derived biopharmaceutical company announced an update related to the development of its treatment for COVID-19.
Kamada (KMDA) is conducting a Phase 1/2 trial in Israel in collaboration with Kedrion Biopharma for the development, manufacturing, and distribution of a plasma-derived IgG hyperimmune immunoglobulin (or IgG) product as a potential treatment for COVID-19.
Yesterday, Kamada disclosed that the trial, which studies the effect of the IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia, enrolled 12 eligible patients and these patients received a single dose of 4 grams IgG within five to 10 days of initial symptoms. Patient follow-ups will occur for 84 days.
The company observed symptom improvement in 11 of the 12 patients within 24 to 48 hours from treatment. All of these 11 patients were subsequently discharged from the hospital within a median hospital stay of 4.5 days from treatment.
However, Kamada added that the medical condition of one patient, who completed the 14-day post-treatment follow-up, deteriorated and the patient is currently on mechanical ventilation. Also, another patient had a serious adverse event four days after treatment but this was categorized by the investigator as unrelated to the company’s IgG product administered to the patient during the trial.
With Kedrion’s support, Kamada submitted a pre-Investigational New Drug or IND information package to the US FDA, with its proposed U.S clinical development plan and the FDA’s response is expected next month.
On August 24, Kamada stock surged 17% as the US President Donald Trump announced that the FDA issued an emergency use authorization or EUA for convalescent plasma therapy as a treatment for hospitalized COVID-19 patients. (See KMDA stock analysis on TipRanks)
On August 14, Chardan analyst Keay Nakae increased his price target for Kamada stock to $11 from $7 and reiterated a Buy rating following second-quarter results and "multiple" stories in the Israeli press highlighting the initial positive response observed in the first three patients who were given the company's IgG product as a potential treatment for SARS-CoV-2 disease.
The analyst said that the higher price target was backed by the potential of this product, which takes the concept of convalescent plasma therapy "a step further" by pooling plasma from several donors.
Based on two recent Buy ratings, Kamada stock has a Moderate Buy consensus. The stock has surged over 34% so far this year and the average analyst price target of $11 indicates a 20% upside potential ahead.
https://finance.yahoo.com/news/kamada-rises-5-initial-phase-055211158.html
Why Kamada's Stock Is Trading Higher Today
Benzinga
Tanzeel Akhtar
,Benzinga•September 8, 2020
Kamada (NASDAQ: KMDA) shares are trading higher on Tuesday after the company announced the completion of enrollment and initial interim results from its Phase 1/2 clinical trial in Israel for the Plasma-derived Hyperimmune Immunoglobulin products as a potential treatment of coronavirus.
Kamada is a drug-focused, plasma-derived protein therapeutics company. It is involved in the business of developing, producing and marketing of specialty therapeutics using protein purification proprietary technology. Its product portfolio consists of Glassia, Bramitob, Foster, Ixiaro, Factor-IX etc. The company has Proprietary products and Distribution segments.
The company has two segments namely, Proprietary Products segment and Distribution segment. It derives the majority of its revenue from Proprietary products segment and generates the majority of sales from the United States. The firm categorizes its products in Lung Disease, Vaccines, Haemophilia, Immunoglobulins, Critical care, and Diagnostics.
Kamada shares are trading higher by 4% at $9.12 at time of publication on Tuesday. The stock has a 52-week high of $13.33 and a 52-week low of $4.40.
https://finance.yahoo.com/news/why-kamadas-stock-trading-higher-145030355.html
Kamada Announces Completion of Enrollment and Initial Interim Results from its Phase 1/2 Clinical Trial in Israel of its Plasma-Derived Hyperimmune Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19)
The Phase 1/2 Open-Label, Single Arm, Multi-Center Clinical Trial is Testing Kamada’s Hyperimmune IgG Product in Hospitalized, Non-Ventilated COVID-19 Patients with Pneumonia
Symptoms Improvement Observed in 11 of the 12 Patients within 24 to 48 Hours of Treatment; All 11 Patients Subsequently Discharged from Hospital within a Median of 4.5 Days from Treatment
IgG Product Demonstrated Favorable Safety Profile to Date
Top-Line Results Expected to be Available by January of 2021
U.S. FDA Response on Submitted Pre-IND Information Package Expected Next Month; U.S. Clinical Development Anticipated to Commence in Early 2021
REHOVOT, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced the completion of enrollment and initial interim results from its ongoing Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company’s anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19).
The trial is designed to assess the safety, pharmacokinetics, and pharmacodynamics of Kamada’s plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients (age 34-69) were enrolled in the trial and received the Company’s product at a single dose of 4 grams IgG within five to 10 days of initial symptoms. Patient follow-up will occur for 84 days.
To date, five of the 12 patients have completed 21-day post-treatment follow-up, two patients have completed 14-day post-treatment follow-up and the additional five patients have completed 7-day post-treatment follow-up. Symptoms improvement was observed in 11 of the 12 patients within 24 to 48 hours from treatment. All 11 patients were subsequently discharged from the hospital within a median hospital stay of 4.5 days from treatment.
The medical condition of one patient, who completed the 14-day post-treatment follow-up, deteriorated and this individual is currently on mechanical ventilation. One patient had a serious adverse event four days after treatment, which was categorized by the investigator as unrelated to the Company’s IgG product, that the patient received in the trial.
“The safety profile of our IgG product and symptoms improvement preliminarily demonstrated by these results are favorable and we plan to continue characterizing the virus neutralization activity of the product in order to calibrate the treatment dose,” said Dr. Naveh Tov, Kamada’s VP Clinical Development and Medical Director.
“We expect that these initial interim results, and the final trial results, to be available by January 2021, will support our clinical plan to advance our IgG product as a potential treatment for hospitalized COVID-19 patients,” said Amir London, Kamada’s Chief Executive Officer. “As a reminder, the FDA recently issued an Emergency Use Authorization for convalescent plasma as a potential treatment for COVID–19. Convalescent plasma plays an important role in the immediate and intermediate response to the disease. Plasma-derived IgG product, as developed by Kamada, is considered to have multiple advantages over convalescent plasma transfusion, such as standardized antibody levels, higher potency, extensive viral inactivation processing, the absence of a blood-type matching requirement, smaller infusion volumes, the ability to be produced in large quantities, an expected longer shelf life and preferred storage conditions,” concluded Mr. London.
The Phase 1/2 trial in Israel is being conducted as part of Kamada’s global collaboration with Kedrion Biopharma, established in April 2020, for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19. With Kedrion’s support, Kamada submitted a pre-Investigational New Drug (IND) information package to the U.S. FDA, with its proposed U.S clinical development plan, FDA’s response is expected next month.
https://finance.yahoo.com/news/kamada-announces-completion-enrollment-initial-110000215.html
NIH begs to differ on FDA's EUA for convalescent plasma for COVID-19
Sep. 1, 2020 3:48 PM ET|About: Kamada Ltd. (KMDA)|By: Stephen Alpher, SA News Editor
"Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19," says the NIH. "There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19."
More: "There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19 ... Prospective, well-controlled, adequately powered randomized trials are needed to determine whether convalescent plasma is effective and safe for the treatment of COVID-19."
Backed by the president, the FDA last week granted emergency use authorization for the treatment.
Related names: Kamada (KMDA -6.6%)
https://seekingalpha.com/news/3610697-nih-begs-to-differ-on-fdas-eua-for-convalescent-plasma-for-covidminus-19
Does convalescent plasma help COVID-19 patients? Studies will answer
Aug. 29, 2020 2:00 AM ET|About: Kamada Ltd. (KMDA)|By: Douglas W. House, SA News Editor
Investors in convalescent plasma players have experienced a bit of volatility of late related to the FDA emergency use nod to treat COVID-19 patients.
Shares sold off on August 19 on a delay in approval to allow the agency to review additional trial data. It finally signed off on emergency use earlier this week.
Efficacy has been challenging to prove. A study in the Netherlands was stopped after investigators saw no difference from placebo in mortality, length of hospital stay or disease severity.
Recent results from the largest study to date, run by the Mayo Clinic, showed a lower mortality rate if convalescent plasma was administered early, within three days of diagnosis, compared to later but the study has no control group so the treatment effect cannot be definitively confirmed.
At least 10 randomized trials in the U.S. are struggling to recruit participants since severe infections are waning.
Per ClinicalTrials.gov, there are 96 registered studies that are recruiting, enrolling by invitation or active not recruiting, including 19 Phase 3s.
Seven of the late-stage studies should wind up this year, followed by 10 next year and two in 2022. Only five are based in the U.S. All are still recruiting patients, only one (Stanford University) by invitation.
The largest is a 15,000-subject trial led by the University of Oxford that also includes lopinavir/ritonavir, azithromycin, tocilizumab and hydroxychloroquine. Its primary completion date is December of next year.
Selected tickers: Kamada (NASDAQ:KMDA), Grifols (NASDAQ:GRFS), XBiotech (NASDAQ:XBIT), Cerus (NASDAQ:CERS), ADMA Biologics (NASDAQ:ADMA)
https://seekingalpha.com/news/3609798-convalescent-plasma-help-covidminus-19-patients-studies-will-answer
Is convalescent plasma a breakthrough in treating COVID-19?
It's too early to know. Convalescent plasma has been used for a long time in treating other diseases with positive results. There have also been some encouraging studies thus far of convalescent plasma in treating COVID-19.
A large clinical study conducted by the Mayo Clinic found that patients who received transfusions with convalescent plasma within three days of being diagnosed with COVID-19 had a statistically significant lower average death rate than patients who received plasma four or more days after being diagnosed. The main knock against this study, though, is that it didn't include a placebo group.
Results from randomized and controlled clinical studies with placebo groups are needed before it is clear how safe and effective convalescent plasma therapies are in treating COVID-19. The FDA stated that its EUA isn't intended to replace any of the ongoing clinical trials. The agency still recommends that the designs of these studies "remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence."
Who wins?
If convalescent plasma proves to actually lower death rates, COVID-19 patients will obviously be the biggest winners from the FDA's EUA of the therapy. However, there are also some companies that benefit.
https://www.fool.com/investing/2020/08/25/what-you-need-to-know-about-the-breakthrough-coron/
Hadassah chief to Health Ministry: Approve plasma as COVID-19 treatment
So far, six patients have been treated, all of whom left the hospital virus free within 48 to 72 hours.
By MAAYAN HOFFMAN AUGUST 24, 2020 19:06Email Twitter Facebook fb-messenger
The American Food & Drug Administration approved the authorization of a coronavirus treatment that uses blood plasma from recovered patients. Now, Hadassah Medical Center chief Zeev Rotstein said he is anxiously waiting for the Israeli Health Ministry to do the same.
“From the first moment [that COVID-19 struck Israel] we realized plasma was an important tool for treating sick patients,” Rotstein told The Jerusalem Post. “The Health Ministry was reluctant even to see us collect the plasma. But at the end, the fruits are very delicious.”
Hadassah is currently running a clinical trial, testing the first-ever commercially produced plasma-derived immunoglobulin (IgG) serum for COVID-19, which Rotstein’s hospital created with Kamada Ltd., a local biopharmaceutical company. The trial is being run under the auspices of the Health Ministry.
So far, six patients have been treated, Rotstein said. All of them have left the hospital virus free within 48 to 72 hours. Another 12 patients were recently enrolled in the program.
“Instead of sending them to be hooked up to a ventilator, we sent them home,” Rotstein said.
He noted, however, that the hospital has learned from the trial the importance of administering the plasma the moment the patient shows signs of developing an acute case of the disease, such as pneumonia, strong coughing or high fever. Otherwise, he noted, that while the plasma may eradicate the virus, the patient may continue to suffer from its effects.
Earlier this summer, before the formal trial started, the serum was used to treat a critically ill 19-year-old patient who was being treated at Hadassah Hospital Ein Kerem. Although the patient stabilized for several days after receiving the serum, Rotstein said she was already too sick to be saved due to multiple previous underlying health conditions.
The antibody concentrate used at Hadassah was developed using plasma that the hospital harvested from recovered corona patients: those who had the disease and now test negative for the virus.
Those who develop any virus, including the novel coronavirus, develop special antivirus proteins or antibodies in their plasma, which could therefore help sick patients cope with the disease.
Plasma is the element of the blood that carries water, enzymes and blood cells throughout the body. It also carries the antibodies humans form to fight off disease and boost immunity.
The plasma works as a passive vaccine, which is when you are given antibodies formed by another patient who got the disease and developed them. This is in contrast to an active vaccine, when you are injected with a dead or weakened version of a virus that tricks your immune system into thinking that you have had the disease, and your immune system creates antibodies to protect you.
So far, Hadassah was able to collect 126 liters of plasma by working together with Jerusalem’s Beit Din Tzedek (Jewish court), which encouraged members of the haredi (ultra-Orthodox) community to donate their plasma after recovery. During the first and current coronavirus peaks, Jerusalem’s haredi neighborhoods have had some of the highest numbers of sick people.
Rotstein said that the vaccine, which could also be called a medicine, will likely continue to be targeted toward COVID-19 patients whose situation is worsening and need a booster to fight the disease. However, it may also be used prophylactically in cases where a high-risk patient contracts coronavirus and the hospital wants to stop the disease’s progression.
Kamada is running a parallel study of the serum and announced earlier this month that it had just recruited the first patients into its Phase I/II trial.
In America, the plasma treatment received “emergency use authorization” from the FDA.
The organization, explaining its decision, cited early evidence suggesting blood plasma can decrease mortality and improve the health of patients when administered in the first three days of their hospitalization.
The agency also said it determined this was a safe approach in an analysis of 20,000 patients who received the treatment, So far, 70,000 patients have been treated using blood plasma, the FDA said.
“It appears that the product is safe and we’re comfortable with that and we continue to see no concerning safety signals,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters in a conference call.
The World Health Organization on Monday was cautious about endorsing the use of recovered COVID-19 patients' plasma to treat people who are ill, saying evidence it works remains "low quality" even as the United States issued emergency authorization for such therapies.
"There are a number of clinical trials going on around the world looking at convalescent plasma compared to the standard of care," Soumya Swaminathan, WHO chief scientist, said.
"Only a few of them have actually reported interim results...and at the moment, it's still very low-quality evidence," she told a news conference.
Although Hadassah was the first to administer an antibody concentrate to a COVID-19 patient, several Israeli patients have been treated with frozen plasma via transfusion since the start of the first wave, also to much success.
KMDA has been collecting plasma for more than 30 years. Plasma with antibodies was used to treat patients with SARS during the outbreak in 2002. In addition, Israel offered similar treatment to patients with West Nile fever.
https://www.jpost.com/health-science/fda-approves-plasma-treatment-first-tested-in-israel-639780
Dr. Stephen M. Hahn, the commissioner of the Food and Drug Administration, said 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”
https://www.msn.com/en-us/news/us/f-d-a-grossly-misrepresented-blood-plasma-data-scientists-say/ar-BB18kEun
Leading Biotech Companies Kedrion Biopharma of Italy and Kamada Ltd. of Israel Continue Their Collaboration to Develop a New Anti-COVID Plasma-Based Treatment
CASTELVECCHIO PASCOLI, Italy, Aug. 25, 2020 /PRNewswire/ -- Two innovative bio-pharma companies specialized in plasma-derived therapeutics - Kedrion Biopharma of Italy and Kamada Ltd. of Israel - are continuing their work on the development, manufacturing and clinical distribution of a plasma-derived Anti-SARS-CoV-2 product.
The two companies, each known for their cutting-edge biopharma technology capabilities, hope to eventually obtain approval on both sides of the Atlantic for the clinical treatment of severely ill COVID-19 patients. Under the terms of the agreement, Kamada is responsible for product development, manufacturing, clinical development (with Kedrion's support) and regulatory submissions. Kedrion is responsible for collection and supply of plasma from convalescent COVID-19 patients and future distribution of the therapeutic product in the U.S., Europe, Australia and South Korea.
KEDPLASMA USA, with the approval of the Food and Drug Administration (FDA), has already begun collecting COVID-19 convalescent plasma in various collection centers in the United States.
The U.S. Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients. Pure plasma from convalescent patients that is transferred to those afflicted by the virus cannot be manufactured in millions of doses; its availability is limited by blood donations. The product being developed by Kamada Ltd. And Kedrion Biopharma instead, aims to miniaturize the dosages so it can be produced in large quantities.
Last month Kedrion announced that it had formed a research partnership with Columbia University Irving Medical Center to develop and test a new IgG therapy for COVID-19 which is being developed by Kedrion and Kamada Ltd, a leading Israeli bio-pharmaceutical company that specializes in plasma derived products.
Under the terms of the agreement, Kedrion will supply Columbia with convalescent plasma from patients who have recovered from COVID-19 to be used for the manufacturing of IgG therapy. Columbia University will test the convalescent plasma against viral proteins to check the neutralizing power of the hyperimmune Immunoglobulins.
Dr. Steven Spitalnik, Medical Director of the Clinical Laboratories at Columbia University Irving Medical Center, said in July that he hopes that if the therapy eventually receives FDA approval it can be administered to his own frontline medical workers at risk for COVID-19 at Columbia University Irving Medical Center and elsewhere.
www.kedrion.com - www.kedrion.us.
View original content:http://www.prnewswire.com/news-releases/leading-biotech-companies-kedrion-biopharma-of-italy-and-kamada-ltd-of-israel-continue-their-collaboration-to-develop-a-new-anti-covid-plasma-based-treatment-301117323.html
SOURCE Kedrion Biopharma
https://www.marketwatch.com/press-release/leading-biotech-companies-kedrion-biopharma-of-italy-and-kamada-ltd-of-israel-continue-their-collaboration-to-develop-a-new-anti-covid-plasma-based-treatment-2020-08-25?tesla=y
Kamada, Gap, TravelCenters: 5 Stock Gainers for Monday
TheStreet.com TheStreet.com•August 24, 2020
Kamada | Percentage Increase Over 17%
Kamada (KMDA) - Get Report shares climbed after President Donald Trump said the Food and Drug Administration issued an emergency use authorization for convalescent plasma therapy to treat hospitalized covid-19 patients. Kamada is the Rehovot, Israel, developer of plasma-derived biopharmaceuticals.
https://finance.yahoo.com/m/99c18edc-3d74-3cc4-b585-7a31906a2aba/kamada%2C-gap%2C-travelcenters%3A-5.html?puc=yahoo&cm_ven=YAHOO&yptr=yahoo
Kedrion is currently collecting COVID-19 convalescent plasma from U.S. recovered patients that will be used by Kamada to manufacture additional batches of the product.
This global collaboration expands the existing relationship between Kamada and Kedrion beyond KEDRAB®, a plasma-derived FDA-approved human rabies immunoglobulin that was launched successfully in the U.S. during 2018.
Partnership with Kedrion Biopharma
Kamada and Kedrion Biopharma, a global leader in plasma collection and plasma-derived therapeutics, announced a global collaboration for the development, manufacturing and distribution of a human plasma-derived immune-globulin for Coronavirus. as a potential treatment for COVID-19 patients.
https://www.kamada.com/therapeutic_areas/covid-19/?fbclid=IwAR0Quimguoc5_oFGKEw_EPVEzha5c79Eh7YMs9iK6f5sN8R-SnjEdS6zz_0
These guys could emerge as A big winner here
Why ADMA Biologics, iBio, and Kamada Are Jumping Today
The FDA's emergency use authorization of convalescent plasma therapy is sending these three stocks higher today.
George Budwell
Aug 24, 2020 at 8:42AM
What happened
At a news conference Sunday, President Donald Trump announced that the Food and Drug Administration issued an emergency use authorization (EUA) for convalescent plasma therapy as a treatment for hospitalized COVID-19 patients. Convalescent plasma is the liquid component of blood containing antibodies from patients previously infected with the virus.
In response to this news, shares of the convalescent plasma therapy players ADMA Biologics (NASDAQ:ADMA), iBio (NYSEMKT:IBIO), and Kamada (NASDAQ:KMDA) each got a nice boost in pre-market trading Monday morning. ADMA Biologics' stock jumped by a healthy 68%, iBio's shares rose by a handsome 28%, and Kamada's equity perked up as much as 24% in early morning action today.
So what
ADMA Biologics is a member of the CoVIg-19 plasma alliance. However, it doesn't have a late-stage COVID-19 plasma therapy in development quite yet. Nonetheless, the biotech may still benefit from this regulatory development in the short term by becoming an integral part of the supply chain.
iBio's connection to the current pandemic mainly stems from its plant-based vaccine efforts. In the past, though, the company has shown the ability to produce human plasma proteins with its platform. Investors are apparently hoping iBio will decide to push further in the therapeutic arena in the wake of this EUA.
Kamada, a small biotech based in Israel, is arguably the leader in the COVID-19 plasma-based therapy space. The company's plasma treatment is already available to COVID-19 patients in Israel via a compassionate use program. Kamada also has designs for initiating a U.S.-based trial for this therapy later this year.
https://www.fool.com/investing/2020/08/24/why-adma-biologics-ibio-and-kamada-are-jumping-tod/
KMDA the Trump pump is on: https://www.fool.com/investing/2020/08/24/why-adma-biologics-ibio-and-kamada-are-jumping-tod/
Seems to be the frontrunner for plasma plays. $kmda
FDA Issues Emergency Use Of Convalescent Plasma For COVID–19 Treatment
Aniket Chatterjee
August 23, 2020 5:50pm 2 min read Comments
FDA Issues Emergency Use Of Convalescent Plasma For COVID–19 Treatment
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.
The FDA was successful in determining it's reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients.
Patients who are below the age of 80 and are not on mechanical ventilation responded positively to the plasma therapy, provided they are treated within three days of the diagnosis.
https://www.benzinga.com/general/biotech/20/08/17202394/fda-issues-emergency-use-of-convalescent-plasma-for-covid-19-treatment?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+benzinga+%28Benzinga+News+Feed%29
Taking part in the fight against COVID-19
Over the past few months, our lives have changed dramatically as a result of the Coronavirus (COVID-19) pandemic. COVID-19 is caused by the novel virus SARS-CoV-2. As new facts about the virus and the pandemic are revealed, the international scientific community, along with the pharmaceutical industry, are making tremendous efforts in order to combat the disease.
Since the outbreak of COVID-19, Kamada has been leveraging its unique human-plasma purification technology to develop an immune-globulin for Coronavirus Disease (COVID-19).
Kamada has extensive experience in the development, manufacturing and marketing of plasma-derived immunoglobulin therapies including Anti-Rabies, Anti-Rho(D) and Anti-snake venom. Kamada’s Anti-Rabies IgG product is FDA approved and is distributed in the US market through a collaboration agreement with Kedrion Biopharma. Kamada’s other IgG products are currently marketed in over 25 countries.
https://www.kamada.com/therapeutic_areas/covid-19/
US FDA announces emergency authorization for convalescent plasma to treat Covid-19
By Dr. Sanjay Gupta, Jamie Gumbrecht and Maggie Fox, CNN
Updated 0240 GMT (1040 HKT) August 24, 2020
(CNN)The US Food and Drug Administration on Sunday issued an emergency use authorization for convalescent plasma to treat Covid-19, saying the "known and potential benefits of the product outweigh the known and potential risks of the product."
The FDA said more than 70,000 patients had been treated with convalescent plasma,which is made using the blood of people who have recovered from coronavirus infections.
Researchers hope this old-fashioned treatment will work for coronavirus
Researchers hope this old-fashioned treatment will work for coronavirus
"Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," President Trump said at a White House briefing, referring to the coronavirus that causes Covid-19. "Today's action will dramatically increase access to this treatment."
Last week, Trump accused some health officials of playing politics regarding an EUA for convalescent plasma. When asked about the FDA not having granted an EUA, Trump said the reason was political.
On Sunday, a source who is close to the White House Coronavirus Task Force told CNN the FDA had reviewed additional data to inform its EUA decision. This official has not personally reviewed the data. They added the FDA is under no obligation to consult anyone outside the agency about its decision.
Convalescent plasma is taken from the blood of people who have recovered from Covid-19. At the end of March, the FDA set up a pathway for scientists to try convalescent plasma with patients and study its impact. It has already been used to treat more than 60,000 Covid-19 patients.
However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.
https://edition.cnn.com/2020/08/23/health/covid-19-convalescent-plasma-eua-white-house/index.html
Convalescent plasma players under pressure on FDA hold on emergency use nod
Aug. 19, 2020 9:39 AM ET|About: Kamada Ltd. (KMDA)|By: Douglas W. House, SA News Editor
Processors of antibody-rich convalescent plasma, derived from COVID-19 patients who have recovered from the infection, are under the gun on a delay of the expected emergency use authorization from the FDA for the treatment of COVID-19.
NIAID clinical director Dr. H. Clifford Lane says the authorization is on hold to allow for the review of more data since clinical trials have not proven that the plasma helps patients fight SARS-CoV-2.
Recent data from the largest study to date, conducted by the Mayo Clinic, were not strong enough to support emergency use approval according to top health officials, including NIAID's Dr. Anthony Fauci. Results involving more than 35K patients showed a lower mortality rate if the convalescent plasma was administered within three days of diagnosis compared to later administration but the study has no control group so it is not possible to confirm the treatment effect. Enrollment in the study has ballooned up to an "unmanageable" level says Dr. Lane.
A study in the Netherlands was stopped after investigators saw no difference in mortality, length of hospital stay or disease severity compared to placebo.
At least 10 randomized trials in the U.S. are struggling to recruit participants since they need to be sick and the pandemic is waning in many cities.
Selected tickers: Kamada (KMDA -8.8%), Grifols (GRFS +0.1%), XBiotech (XBIT -1.8%), Cerus (CERS -1.1%), ADMA Biologics (ADMA -8.3%)
https://seekingalpha.com/news/3607063-convalescent-plasma-players-under-pressure-on-fda-hold-on-emergency-use-nod
Hold off approving plasma for emergency use, Fauci and others warn the F.D.A.: The data isn’t strong enough yet.
Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.
The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.
Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.
But clinical trials have not proved whether plasma can help people fighting the coronavirus.
Several top health officials — led by Dr. Francis S. Collins, the director of the National Institutes of Health, and including Dr. Fauci, the government’s top infectious disease expert, and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.
The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and in animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has infused more than 66,000 people with Covid-19 thanks to financing from the federal government.
An F.D.A. spokeswoman declined to comment.
Plasma, the pale yellow liquid left over after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for vaccines.
F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold
Government health leaders including Dr. Francis S. Collins and Dr. Anthony S. Fauci urged caution last week, citing weak data from the country’s largest plasma study.
By Noah Weiland, Sharon LaFraniere and Sheri Fink
Aug. 19, 2020
Updated 9:30 a.m. ET
WASHINGTON — Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.
The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.
Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.
But clinical trials have not proved whether plasma can help people fighting the coronavirus.
Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.
The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has given infusions to more than 66,000 Covid-19 patients thanks to financing from the federal government.
Plasma, the pale yellow liquid leftover after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for coronavirus vaccines.
Emergency authorizations, which do not require the same level of evidence as a full F.D.A. approval would, have been a fraught subject for the government during the pandemic. The agency gave one to the malaria drugs hydroxychloroquine and chloroquine only to rescind it months later after the drugs were found to be ineffective against the coronavirus, and potentially harmful. An emergency authorization for blood plasma would most likely ease the clerical burdens on hospitals in conducting infusions.
Senior health officials have privately expressed concern about the rapid growth of the Mayo program and the perceived rush to declare plasma effective without the affirmation of results from randomized trials, which scientists have long relied on as the gold standard of evidence. Skyrocketing enrollment in the program has prompted a debate among researchers about what kind of empirical certainty is needed in treating patients in a public health emergency.
An emergency approval now would “change the way people view trials,” said Dr. Mila B. Ortigoza, an infectious disease specialist at N.Y.U. Langone Health who started a trial with colleagues at Montefiore Medical Center.
“We want to make sure that when we say it works, we are confident, with indisputable evidence,” she said. “We’re dealing with patients’ lives here.”
Unlike the malaria drugs, plasma, which has been used since the 1890s to treat infectious diseases, has earned the attention of a highly credentialed community of microbiologists and immunologists eager to prove its usefulness. The Mayo Clinic has already published analysis on tens of thousands of patients in its expanded access program showing that plasma is safe.
The most recent batch of data from the program included more than 35,000 Covid-19 patients, many of them in intensive care and on ventilators, and suggested that plasma administered within three days of a diagnosis reduced mortality rates. When calculated a month after the infusions, the death rate of patients who received plasma within three days of diagnosis was lower (21.6 percent) than it was for those who received plasma later (26.7 percent).
But the study did not have a control group of patients given a placebo to compare with those given plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it is not clear how realistic treating patients within three days of diagnosis would be.
The program’s enrollment has surged to more than 30 times as high as initially expected, complicating the ability of scientists to recruit sick patients to randomized trials.
It “ballooned to a degree that, you know, is becoming unmanageable,” Dr. Lane said.
Statisticians at the F.D.A. are now examining the Mayo data to better understand what factors other than the treatment might have influenced patient responses, such as higher-quality care in the hospital, Dr. Lane said.
A research team from Houston Methodist hospitals also published preliminary results from a plasma trial last week. Their study of hospitalized Covid-19 patients in the American Journal of Pathology reported that a group of 136 patients who received the treatment were more likely to be alive four weeks later compared with 251 patients who did not receive it. That study found a statistically significant benefit only when patients were treated within three days of admission and when the plasma contained a high concentration of antibodies.
The Houston study was not randomized, meaning that all of the patients enrolled received the treatment and none received a placebo. (The researchers later compared their outcomes to records from other Covid-19 patients who were not in the study but were matched to be similar to them.)
A surge in cases in Texas this summer quickly brought the hospital system to its enrollment cap, and doctors there have not been able to provide the experimental treatment since mid-July. If the F.D.A. gave an emergency authorization, doctors at the hospital could possibly begin administering it again, said Dr. Eric Salazar, the study’s principal investigator.
But an emergency authorization could have the unintended effect of making it harder for rigorous clinical trials to definitively show whether plasma works. Scientists have struggled to recruit patients for randomized trials, as many patients and their doctors — knowing they could get the treatment under the Mayo program — have been unwilling to risk receiving a placebo.
Last month, one such trial in the Netherlands was stopped when researchers realized that patients given plasma showed no difference in mortality, length of hospital stay or disease severity compared with those given a placebo. Most of the patients had already developed their own antibodies by the time they entered the study, the researchers noted.
At least 10 randomized trials in the United States have collectively enrolled only a few hundred people. They have also been stymied by the waning of the virus outbreak in many cities, complicating the ability of researchers to recruit sick people. Dr. Collins has encouraged a strategy of pooling the results from randomized trials, an idea that has met resistance from some researchers.
Dr. R. Scott Wright, who is helping oversee the Mayo Clinic’s plasma program, was an early proponent of conducting randomized trials. But he said in a recent interview that the mechanics of setting up large studies were complicated by early shortages of plasma, coordination via videoconference calls and the difficulty of predicting where the virus would spread next.
If the F.D.A. does grant the emergency authorization, it could make it even harder to get answers, said Dr. Ortigoza of N.Y.U.
“We will keep going, because we’re in desperate need of a randomized placebo-controlled trial for convalescent plasma,” she said. “This is something our country and the world really needs right now.”
https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html
Israel starts clinical trial of plasma-derived Covid drug
12 patients are receiving Kamada’s immunoglobulin for coronavirus disease; so far, three patients were well enough to go home from the hospital.
By Abigail Klein Leichman AUGUST 13, 2020, 7:57 AM
Physicians at Hadassah University Medical Center in Jerusalem report promising early results of a clinical study in which they are treating Covid-19 patients with immunoglobulin (IgG) derived from the plasma of recovered patients found to have high levels of antibodies.
Three patients have already received the serum and are doing well, according to Dr. Yaron Ilan, chief of internal medicine at Hadassah University Medical Center. “The first patient demonstrated a rapid clinical benefit and went home after previously being in moderate condition.”
The other two also have been released from the hospital.
Ilan stressed that this experimental treatment, though very encouraging, is in an early phase.
Dr. Zeev Rotstein, director general of Hadassah Medical Center, called their recovery “almost a miracle.”
Rotstein was among the initiators of the collection of plasma from recovered corona patients. He also revealed to the Jerusalem Post on August 12 that Hadassah will help test a Russian-developed vaccine for coronavirus.
For the past three months, Hadassah has been collecting plasma donations from recovered patients with the cooperation of ultra-Orthodox communal organizations.
Kamada said additional Israeli hospitals are taking part in this Phase 1/2 clinical trial of the anti-SARS-CoV-2 plasma-derived IgG.
“This open-label, single-arm multicenter study was approved by the Ministry of Health in Israel. The trial will assess the safety, pharmacokinetics and pharmacodynamics of the company’s plasma-derived IgG product in hospitalized, non-ventilated Covid-19 patients with pneumonia,” Kamada reported.
“A total of 12 eligible patients will be enrolled and receive Kamada’s product at a single dose of 4g within 10 days of initial symptoms. Patients will be followed for 84 days. In parallel, Kamada intends to further explore the potential of its IgG product to prevent Covid-19 disease in healthy subjects at risk in a separate study.”
This milestone is part of the global collaboration agreement established in April 2020 between Kamada and its partner Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived immunoglobulin product as a potential treatment for coronavirus disease.
Kamada and Kedrion intend to conduct a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration soon in anticipation of obtaining FDA approval of the proposed clinical development program. Meanwhile, Kedrion will collect Covid-19 convalescent plasma from recovered American patients.
“We are encouraged by the results of the product neutralization activity and we believe our product has the potential to be an effective treatment for hospitalized, non-ventilated COVID-19 patients with pneumonia, and look forward to the results from this trial,” said Amir London, Kamada’s CEO.
https://www.israel21c.org/israel-starts-clinical-trial-of-plasma-derived-covid-drug/
Kamada and Kedrion Biopharma Announce Results of First and Only U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG); The Study Met Its Primary Objective
The Study of KEDRAB® (Rabies Immune Globulin [Human]) Conducted in Children was the First and Only Pediatric Study for any HRIG Available in U.S.
The Study Met its Primary Objective, Which Was to Confirm the Safety of KEDRAB in the Pediatric Population.
Study Results Have Been Submitted to the U.S. FDA for Review and Potential Update to the KEDRAB Prescribing Information.
KEDRAB was Launched in the U.S. in 2018 and it Generated In-Market Sales of $31 Million in 2019, Representing Approximately 20 Percent Share of the U.S. HRIG Market.
REHOVOT, Israel and FORT LEE, N.J., Aug. 19, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immune Globulin [Human]). The study represents the first and only trial of a currently available human rabies immune globulin (HRIG) conducted in children in the U.S. to date. The results have been submitted to the U.S. Food and Drug Administration for review and inclusion as pediatric data in the KEDRAB full prescribing information. KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) treatment of rabies infection, when given promptly after contact with a rabid or possibly rabid animal.
The KEDRAB U.S. Pediatric Trial was conducted at two sites, one in Arkansas and another in Rhode Island. The study included 30 pediatric patients (ages 0-17 years old), each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population. Secondary objectives included the evaluation of antibody levels and the efficacy of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine according to the PEP recommended guidelines.
No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the 84-day study period.
“These key study results represent the first clinical trial data in the U.S. pediatric population for any HRIG currently available in the US,” said Michal Stein, M.D., Vice President, Medical Director (Immunology) at Kamada. “According to the World Health Organization, 40 percent of people bitten by suspected rabid animals are children under 15 years of age. Despite the large proportion of pediatric cases, limited safety and efficacy data from clinical trials currently exist for this population. Meeting the primary study objective of KEDRAB in children further strengthens our ongoing confidence in the product. We continue to believe that sales of KEDRAB has the potential to continue growing in the U.S., capturing a significant share of the estimated annual $150 million U.S. HRIG market.”
“We know the incidence of kids being exposed to animals that may transmit rabies is high in the U.S. and abroad,” said Novinyo Amega, M.D., Head of U.S. Medical Affairs at Kedrion Biopharma. “However, little data exist that can help clinicians better understand the safety profiles of the various HRIG products currently available. Therefore, we are pleased to see that top-line results of this pediatric study support KEDRAB’s safety profile. Importantly, we believe that meeting the primary objective of this study could further differentiate KEDRAB from other currently available HRIGs in the U.S.”
KEDRAB was launched in the U.S. in April 2018 and generated in-market sales of $31 million in 2019, representing approximately 20 percent of the U.S. HRIG market.
About KEDRAB®
KEDRAB [Rabies Immune Globulin (Human)] is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given promptly after contact with a rabid or possibly rabid animal. KEDRAB should be administered concurrently with a full course of rabies vaccine.
Important Safety Information
Patients who can document previous complete rabies pre-exposure prophylaxis or complete post-exposure prophylaxis should only receive a booster rabies vaccine without KEDRAB, because KEDRAB may interfere with the anamnestic response to the vaccine.
KEDRAB should not be injected into a blood vessel because of the risk of severe allergic or hypersensitivity reactions, including anaphylactic shock.
Patients with a history of prior systemic allergic reactions following administration of human immune globulin preparations should be monitored for hypersensitivity.
KEDRAB contains a small quantity of IgA. Patients who are deficient in IgA have the potential to develop IgA antibodies and may have anaphylactic reactions following administration of blood components containing IgA.
KEDRAB administration may interfere with the development of an immune response to live attenuated virus vaccines.
KEDRAB is derived from human plasma; therefore, the potential exists that KEDRAB administration may transmit infectious agents.
In clinical trials, the most common adverse reactions in subjects treated with KEDRAB were injection site pain, headache, muscle pain, and upper respiratory tract infection.
Please see KEDRAB Full Prescribing Information for complete prescribing details.
About Rabies
Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. It is a serious, and nearly always fatal, infection. In the U.S., rabies in wild animals, especially raccoons, skunks, foxes and bats, accounts for most cases of rabies passed on to humans, pets, and other domestic animals. An acute, progressive viral encephalomyelitis, rabies carries the highest case fatality rate of any conventional etiological agent. Rabies is one of the oldest described infectious diseases, known for over 5,000 years.
https://finance.yahoo.com/news/kamada-kedrion-biopharma-announce-results-110000844.html
Awesome set up here, once news hits, this stock will move to 16-20 dollars real fast.
Fantastic close, stair step up is the best way. Keep an eye TASE stock exchange tonight.
Something very important, take a good look at the bottom of this article. This article has been shared 9700 times since August 13th, which implies people are finding out about the possibilities and waiting on the next data to come out and once it does and if the results are great, you will not be able to catch this one.
https://www.timesofisrael.com/worlds-1st-trial-for-covid-antibody-drug-off-to-flying-start-in-jerusalem/
This is the largest shareholder 23%
http://www.fimi.co.il/fimi-funds
Treatment: Anti-Corona Immunoglobulin (IgG)
Type: Polyclonal immunoglobulin based on company’s proprietary plasma-derived IgG platform technology as a potential treatment for severely ill coronavirus patients. The treatment is expected to be produced from plasma derived from donors recovered from the virus, which is anticipated to include antibodies to COVID-19.
Status: Kamada on March 11 announced plans to initiate development of an Anti-Corona IgG, emphasizing that its development and manufacturing plans were “highly” dependent on the availability of hyper-immune plasma and on the treatment’s to-be-determined regulatory path. “We are working with the Israeli regulatory authorities and local medical institutions to advance our program,” Kamada CEO Amir London stated.
BFR*A is in the same space as KMDA, only difference that KMDA is in a much better position financially and they already booking revenues of 40 million each quarter and 130 million in the books. They just recently had a board change, the largest shareholder just became the Chairman of the board, which tells me something is brewing behind the scenes.
Another find that Plasma Technology could be the answer we are looking for COVID
https://www.texmed.org/TexasMedicineDetail.aspx?id=54348
Plasma Technology could be the answer to treatment of covid, because in the past it has helped with other diseases, such as the Flu, measles, meningitis, ebola, SARS and MERS. That is why BFR*A was running from the single digits to mid double digit dollars, 55 dollars to be exact, KMDA is still heavily under the radar, once they prove the other batches of patients quickly left the hospital with this treatment, this is going to run very, very hard. The plasma technology is just the new thing that the house and the administration is trying to put out there as possible treatment and prevention. Buckle up.
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2 Holzman Street
Science Park PO Box 4081
Rehovot 7670402
Israel
972 8 940 6472
http://www.kamada.com
2 Holzman Street
Science Park PO Box 4081
Rehovot 7670402
Israel
972 8 940 6472
http://www.kamada.com
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