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Kamada Announces Expansion of Plasma Collection Operations in Texas With the Opening of New Site in Houston

Kamada Announces Expansion of Plasma Collection Operations in Texas With the Opening of New Site in Houston

Kamada宣佈在得克薩斯州擴大血漿收集業務,在休斯頓開設新站點。
Kamada ·  2024/09/23 12:00
  • New Plasma Collection Center in Houston Now Open, with Planned Annual Collection Capacity of Approximately 50,000 Liters and an Estimated Annual Revenue Contribution of $8 Million to $10 Million at its Full Capacity
  • Center Will Collect Normal Source Plasma and Specialty Plasma, such as Anti-Rabies and Anti-D, and is Anticipated to be One of the Largest Sites for Specialty Plasma Collection in the U.S.
  • The New Center Supports Kamada's Strategy and Development as a Leading Global Vertically-Integrated Specialty Plasma-Derived Company
  • Kamada Expects to Open its Third Plasma Collection Center in San Antonio, TX, During the First Half of 2025
  • 休斯敦的新血漿收集中心現已開放,計劃年收集能力約爲5萬升,滿負荷預計年收入爲800萬至1000萬美元
  • 該中心將收集普通來源血漿和特種血漿,例如抗狂犬病和抗D,預計將成爲美國最大的特種血漿收集場所之一
  • 新中心支持鐮田作爲全球領先的垂直整合特種等離子體衍生公司的戰略和發展
  • Kamada預計將於2025年上半年在德克薩斯州聖安東尼奧開設第三個血漿收集中心

REHOVOT, Israel, and HOBOKEN, NJ – September 23, 2024 – Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced the expansion of its plasma collection operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada's wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually.

以色列雷霍沃特和新澤西州霍博肯——2024年9月23日——Kamada有限公司(納斯達克股票代碼:KMDA;TASE:KMDA.TA)是一家全球生物製藥公司,其上市產品組合適用於罕見和嚴重情況,也是特種等離子體衍生領域的領導者。該公司今天宣佈擴大其血漿收集業務,在德克薩斯州休斯敦開設新的血漿收集中心。這座佔地12,000平方英尺的新中心由Kamada的全資子公司Kamada Plasma運營,計劃爲50多張捐贈牀位提供支持,估計每年的總收集容量約爲50,000升。

"We are extremely pleased to announce the opening of our new state-of-the-art plasma collection center in Houston," said Amir London, Chief Executive Officer of Kamada. "The opening of this center is an important milestone in Kamada's development and vertical integration, expanding the collection capacity of specialty plasma for our internal use beyond our existing site in Beaumont, TX. The new center in Houston is expected to be one of the largest sites for specialty plasma collection in the U.S. and will also collect normal source plasma to be sold to third parties. We are especially grateful for the skilled and experienced team of plasma collection experts we have hired to lead the development and operations of our new center."

Kamada首席執行官阿米爾·倫敦說:「我們非常高興地宣佈,我們在休斯敦開設了最先進的新血漿採集中心。」「該中心的開業是鐮田發展和垂直整合的重要里程碑,它將特種等離子體的收集能力擴展到了德克薩斯州博蒙特現有場地之外,供我們內部使用。休斯敦的新中心預計將成爲美國最大的特種血漿收集場所之一,還將收集普通來源的血漿出售給第三方。我們特別感謝我們聘請了技術精湛且經驗豐富的血漿採集專家團隊來領導我們新中心的開發和運營。」

Kamada intends to submit to the FDA a prior approval supplement to Kamada Plasma's existing Biologics License Application (BLA) for the approval of the Houston site, as well as a plasma master file (PMF) to the European Medicines Agency (EMA), during the first half of 2025. The FDA and EMA's regulatory process for obtaining approval for plasma collection centers includes onsite inspection. During the review process, the company is authorized to collect plasma donations at the center. Kamada currently anticipates approval decisions within 9-12 months of submissions.
In addition to the new Houston center, the company has begun construction of its third plasma collection site in San Antonio, TX, which is expected to open during the first half of 2025. Each collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity.

鐮田打算在2025年上半年向美國食品藥品管理局提交Kamada Plasma現有的生物製劑許可申請(BLA)的事先批准補充文件,以批准休斯敦基地,以及向歐洲藥品管理局(EMA)提交血漿主文件(PMF)。FDA和EMA獲得血漿採集中心批准的監管程序包括現場檢查。在審查過程中,該公司有權在該中心收集捐贈的血漿。Kamada目前預計將在提交後的9-12個月內做出批准決定。
除了新的休斯敦中心外,該公司還開始在德克薩斯州聖安東尼奧市建造其第三個血漿收集基地,預計將於2025年上半年開放。預計每個收集中心將爲正常源血漿的滿負荷銷售貢獻800萬至1000萬美元的年收入。

About Kamada
Kamada Ltd. (the "Company") is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company's strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company's commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM, KEDRAB, WINRHO SDF, VARIZIG, HEPAGAM B and GLASSIA, as well as KAMRAB, KAMRHO (D) and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, the Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers. During recent years the Company added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D), KARAB and KEDRAB and recently opened a new plasma collection center in Houston, Texas in which it plans to collect normal source plasma and specialty plasma, such as Anti-Rabies and Anti-D. In addition to the Company's commercial operation, it invests in research and development of new product candidates. The Company's leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company's controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares.

關於鐮田
Kamada Ltd.(以下簡稱 「公司」)是一家全球生物製藥公司,其上市產品組合適用於罕見和嚴重的疾病,是特種血漿衍生領域的領導者,專注於治療替代方案有限的疾病。該公司還在推進一項針對重大未滿足醫療需求領域的創新開發管道。該公司的戰略側重於利用其重要的商用催化劑及其在等離子體衍生和生物製藥領域的製造和開發專業知識來推動盈利增長。該公司的商業產品組合包括六種經美國食品藥品管理局批准的血漿衍生生物製藥產品:CytoGam、Kedrab、WINRHO SDF、VARIZIG、HepaGam b和GLASSIA,以及Kamrab、KAMRHO(D)和兩種馬類抗蛇毒(ASV)產品。該公司直接分銷其商業產品組合,並通過戰略合作伙伴或第三方分銷商分銷其商業產品組合,包括美國、加拿大、以色列、俄羅斯、阿根廷、巴西、印度、澳大利亞以及拉丁美洲、歐洲、中東和亞洲的其他國家。該公司利用其在以色列市場的專業知識和影響力,分銷國際製造商提供的超過25種藥品,供以色列使用。近年來,該公司在其以色列分銷產品組合中增加了11種生物仿製藥,這些產品有待歐洲藥品管理局(EMA)和以色列衛生部的批准,預計將在2028年之前在以色列推出。該公司在得克薩斯州博蒙特擁有一家獲得美國食品藥品管理局許可的血漿採集中心,該中心目前專門收集用於製造KAMRHO(D)、Karab和KedRAB的超免疫血漿,最近在德克薩斯州休斯敦開設了一個新的血漿收集中心,計劃在那裏收集正常來源的血漿和特種血漿,例如抗狂犬病和抗D。除了公司的商業運營外,它還投資於新候選產品的研發。該公司領先的研究產品是用於治療Aat缺乏症的吸入式Aat,該公司正在繼續推進InnovaAte臨床試驗,這是一項隨機、雙盲、安慰劑對照的關鍵性3期試驗。以色列領先的私募股權公司FIMI Opportunity Funds是該公司的控股股東,受益擁有約38%的已發行普通股。

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) an estimated total annual collection capacity of approximately 50,000 liters and an estimated annual revenue contribution of $8 to $10 million of the new plasma collection center in Houston from sales of normal source plasma at its full capacity; 2) the center will collect normal source plasma to be sold to third parties and specialty plasma such as Anti-Rabies and Anti-D, and is expected to be one of the largest sites for specialty plasma collection in the U.S; 3) Kamada expects to open its third plasma collection center in San Antonio during the first half of 2025; 4) the new center is planned to support over 50 donor beds; 5) the company plans to submit with the FDA a prior approval supplement to Kamada Plasma's Biologics License Application (BLA) for the approval of the Houston site and submit with the European Medicines Agency (EMA) a plasma master file (PMF) for its approval, during the first half of 2025 and currently anticipates such approvals decision within 9-12 months of submission; and 6) each collection center is expected to contribute annual revenues of $8 to $10 million from sales of normal source plasma at its full capacity. 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 evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry and political conditions in Israel, the U.S. and globally, continuation of inbound and outbound international delivery routes, continued demand for Kamada's products, financial conditions of the Company's customer, suppliers and services providers, Kamada's ability to integrate the new product portfolio into its current product portfolio, Kamada's ability to grow the revenues of its new product portfolio, and leverage and expand its international distribution network, ability to reap the benefits of the acquisition of the plasma collection center, including the ability to open additional U.S. plasma centers, and acquisition of the FDA-approved plasma-derived hyperimmune commercial products, the ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, including the BLA and PMF approvals related to the plasma collection centers, prevailing market conditions and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise, and other risks detailed in Kamada's filings with the U.S. Securities and Exchange Commission (the "SEC") including those discussed in its most recent Annual Report on Form 20-F and in any subsequent reports on Form 6-K, each of which is on file or furnished with the SEC and available at the SEC's website at www.sec.gov. 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.

關於前瞻性陳述的警示說明
本新聞稿包括經修訂的1934年《美國證券交易法》第21E條和1995年《美國私人證券訴訟改革法》的安全港條款所指的前瞻性陳述。前瞻性陳述是非歷史事實的陳述,包括以下方面的陳述:1) 休斯敦新血漿採集中心的年總收集能力估計約爲5萬升,預計年收入爲800萬至1000萬美元;2) 該中心將收集正常來源的血漿和抗狂犬病和Anti-D等特種血漿,預計將成爲最大的基地之一特種血漿採集美國;3) Kamada預計將於2025年上半年在聖安東尼奧開設第三個血漿採集中心;4) 新中心計劃爲50多張捐贈牀位提供支持;5) 該公司計劃向美國食品藥品管理局提交Kamada Plasma生物製劑許可證申請(BLA)的事先批准補充文件,以供休斯敦工廠批准,並向歐洲藥品管理局(EMA)提交血漿主文件(PMF)以供其批准,在2025年上半年,目前預計將在提交後的9-12個月內做出此類批准決定;6)每次收集該中心預計將從正常來源等離子體的滿負荷銷售中貢獻800萬至1000萬美元的年收入。前瞻性陳述基於Kamada當前的知識及其目前對未來可能事件的信念和預期,並受風險、不確定性和假設的影響。由於多種因素,實際結果和事件發生時間可能與這些前瞻性陳述中的預期存在重大差異,包括但不限於中東衝突不斷變化的性質以及此類衝突對以色列、中東和世界其他地區的影響,這些衝突對市場狀況以及以色列、美國和全球總體經濟、工業和政治狀況的影響,入境和出境國際交付路線的延續,持續的需求爲了鐮田的產品、公司客戶、供應商和服務提供商的財務狀況、Kamada將新產品組合整合到其當前產品組合中的能力、Kamada增加其新產品組合收入以及利用和擴大其國際分銷網絡的能力、從收購血漿收集中心中受益的能力,包括開設更多美國血漿中心以及收購美國食品藥品管理局批准的血漿衍生超免疫商用產品的能力繼續關鍵的3期InnovaATE臨床試驗的註冊、臨床研究的意外結果、Kamada管理運營支出的能力、Kamada競爭市場的額外競爭、監管延誤,包括與血漿採集中心相關的BLA和PMF批准、當前市場狀況以及美國、以色列或其他地區總體經濟、行業或政治狀況的影響,以及Kamada向美國證券公司提交的文件中詳述的其他風險和交易委員會(「SEC」),包括中討論的內容其最新的20-F表年度報告以及任何後續的6-k表報告中,每份報告均已存檔或已向美國證券交易委員會提供,可在美國證券交易委員會網站www.sec.gov上查閱。除非法律另有要求,否則本文中的前瞻性陳述僅代表截至本公告發布之日,Kamada沒有義務公開更新此類前瞻性陳述以反映隨後的事件或情況。

CONTACTS:
Chaime Orlev
Chief Financial Officer
R@kamada.com

聯繫人:
Chaime Orlev
首席財務官
R@kamada.com

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com

布萊恩·裏奇
LifeSci 顧問有限公司
212-915-2578
britchie@LifeSciAdvisors.com

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