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Xeris Pharmaceuticals Announces Gvoke HypoPen™– the First Autoinjector for Severe Hypoglycemia – Now Available

Xeris Pharmaceuticals Announces Gvoke HypoPen™– the First Autoinjector for Severe Hypoglycemia – Now Available

Xeris製藥公司宣佈推出Gvoke HypoPen™--第一個治療嚴重低血糖的自動注射器--現已上市
Business Wire ·  2020/07/01 11:00

$0 copay card available for eligible commercial patientsApproximately 78% of commercially insured and Medicare lives have unrestricted access to Gvoke HypoPen at launch

為符合條件的商業患者提供0美元的聯名卡大約78%的商業保險和聯邦醫療保險在推出時可以不受限制地使用Gvoke HypoPen

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that Gvoke HypoPen™ (glucagon injection) is now available by prescription in the U.S. for the treatment of severe hypoglycemia in adults and children with diabetes ages 2 years and above. Gvoke HypoPen is the first ready-to-use glucagon in a premixed autoinjector, with no visible needle.

Xeris製藥公司。納斯達克股票代碼:XERS)今天宣佈,Gvoke HypoPen™(胰高血糖素注射液)現已在美國按處方藥上市,用於治療2歲及以上糖尿病患者的嚴重低血糖。Gvoke HypoPen是第一個在預混自動注射器中使用的現成的胰高血糖素,沒有可見的針頭。

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200701005285/en/

本新聞稿以多媒體為特色。點擊此處查看完整版本:https://www.businesswire.com/news/home/20200701005285/en/

Xeris_HypoPen_1920x1080.jpg

(Photo: Business Wire)

(圖片來源:Business Wire)

Gvoke HypoPen offers simple administration with the certainty of delivery. Studies have shown it is:Easy to use: premixed and ready-to-goA reliable method of delivery: 99% of people were able to use it correctlyProven to work: 99% of adults and 100% of kids had their blood sugars raised to safe levels.

Gvoke HypoPen提供簡單的管理和交付的確定性。研究表明,這是一種易於使用:預混即用的可靠的分娩方法:99%的人能夠正確使用它。事實證明:99%的成年人和100%的兒童的血糖都升到了安全水平。(編者注:這是一種可靠的分娩方式,99%的人能夠正確地使用它,99%的成年人和100%的兒童的血糖水平都上升到了安全水平。

Gvoke HypoPen is available in two doses: 0.5 mg/0.1 mL for children (who weigh less than 100 pounds) and 1 mg/0.2 mL for adolescents and adults (who weigh 100 pounds or greater).

Gvoke HypoPen有兩種劑量可供選擇:0.5毫克/0.1毫升兒童(體重小於100磅)和1毫克/0.2毫升青少年(體重100磅或以上)。

“We are excited to announce that Gvoke HypoPen is now available. The simplicity and reliability of Gvoke HypoPen has the potential to change people’s ability to confidently respond to a severe hypoglycemic event in a timely manner,” said Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals. “In addition, as we prepared for launch, we had a heightened focus on ensuring Gvoke HypoPen is covered by insurance. Currently, approximately 78% of commercially insured and Medicare lives have unrestricted access to Gvoke HypoPen.”

我們很高興地宣佈,Gvoke HypoPen現已上市。Gvoke HypoPen的簡單性和可靠性有可能改變人們的能力Xeris製藥公司董事長兼首席執行官保羅·R·埃迪克(Paul R.Edick)表示:“我們有能力自信地及時應對嚴重的降糖事件。此外,在我們為推出做準備時,我們更加註重確保Gvoke HypoPen受到保險的覆蓋。目前,大約78%的有商業保險和醫療保險的人可以不受限制地使用Gvoke HypoPen。“

"Gvoke HypoPen allows the diabetes community to change how we approach treating severe low blood sugar events," said Bruce Bode, MD, FACE, Atlanta Diabetes Associates. "Anyone can use Gvoke HypoPen in two simple steps. That opens the door for some patients to even give it to themselves, in certain situations. My hope is that what was once considered a crisis moment, can now become a manageable situation with Gvoke HypoPen."

亞特蘭大糖尿病協會醫學博士布魯斯·博德説:“Gvoke HypoPen使糖尿病社區能夠改變我們治療嚴重低血糖事件的方式。“任何人只需兩個簡單的步驟就可以使用Gvoke HypoPen。這為一些患者在某些情況下甚至給自己使用Gvoke HypoPen打開了大門。我希望,曾經被認為是危機時刻的事情,現在可以通過Gvoke HypoPen變成一種可控的情況。”

Xeris is committed to ensuring that patients have access to this important new advancement. For a limited time, eligible commercially insured patients may pay as little as $0 for a two-pack of Gvoke HypoPen by using the Gvoke®copay savings card*. Xeris also offers a Patient Assistance Program to help those who qualify to get Gvoke.

Xeris致力於確保患者能夠獲得這一重要的新進展。在有限的時間內,符合條件的商業保險患者只需支付0美元即可使用Gvoke®Copay儲蓄卡*購買兩盒裝的Gvoke HypoPen。Xeris還提供患者援助計劃,幫助那些有資格獲得Gvoke的人。

Please visit www.GvokeGlucagon.com to learn more.

請訪問www.GvokeGlucager.com瞭解更多信息。

*Offer not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, TRICARE, or other federal or state health programs (such as medical assistance programs).

*根據Medicaid、Medicare藥品福利計劃、TRICARE或其他聯邦或州健康計劃(如醫療援助計劃)報銷的處方無效。

INDICATION AND IMPORTANT SAFETY INFORMATION

指示和重要安全信息

GVOKE®is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.

GVOKE®適用於治療2歲及以上糖尿病成人和兒童患者的嚴重低血糖。

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications

禁忌症

GVOKE is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

GVOKE禁忌用於嗜鉻細胞瘤、胰島素瘤以及已知對胰高血糖素或GVOKE中任何輔料過敏的患者。據報道,胰高血糖素的過敏反應包括過敏性休克、呼吸困難和低血壓。

Warnings and Precautions

警告及預防措施

GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

GVOKE是嗜鉻細胞瘤患者的禁忌,因為胰高血糖素可以刺激腫瘤中兒茶酚胺的釋放。如果患者出現血壓急劇升高,並且懷疑是以前未被診斷的嗜鉻細胞瘤,5-10毫克的甲磺酸酚妥拉明靜脈注射已被證明能有效降低血壓。

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GVOKE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.

對於胰島素瘤患者,服用胰高血糖素可能會導致最初的血糖升高;然而,GVOKE的服用可能會直接或間接(通過最初的血糖升高)刺激胰島素瘤過度釋放胰島素,並導致低血糖。GVOKE是胰島素瘤患者的禁忌品。如果患者在服用GVOKE後出現低血糖症狀,可以口服或靜脈注射葡萄糖。

Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. GVOKE is contraindicated in patients with a prior hypersensitivity reaction.

已有關於胰高血糖素過敏反應的報道。這些症狀包括全身皮疹,在某些情況下,過敏性休克伴有呼吸困難和低血壓。有過敏性反應的患者禁忌使用GVOKE。

GVOKE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for GVOKE administration to be effective. Patients with these conditions should be treated with glucose.

只有在肝糖原充足的情況下,GVOKE才能有效治療低血糖。處於飢餓狀態、腎上腺功能不全或慢性低血糖的患者,可能沒有足夠的肝糖原水平使GVOKE治療有效。有這些情況的患者應該用葡萄糖治療。

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas, has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia.

壞死鬆解性遷移性紅斑(NME)是一種通常與胰高血糖素相關的皮疹,據報道,在持續注射胰高血糖素後上市,並通過停用胰高血糖素而得到解決。如果發生NME,考慮持續輸注胰高血糖素是否利大於弊。胰高血糖素瘤患者服用胰高血糖素可能導致繼發性低血糖。

Adverse Reactions

不良反應

Most common (≥5%) adverse reactions associated with GVOKE are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.

與GVOKE相關的最常見的不良反應(≥5%)是噁心、嘔吐、注射部位水腫(升高1 mm或以上)和低血糖。

Drug Interactions

藥物相互作用

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE. In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin.

服用β-受體阻滯劑的患者在服用GVOKE時可能會有一過性的脈搏和血壓增加。在服用消炎痛的患者中,GVOKE可能會失去升高血糖的能力,甚至可能產生低血糖。GVOKE可增強華法林的抗凝作用。

Please see full Prescribing Information for GVOKE on www.xerispharma.com . Manufactured for Xeris Pharmaceuticals, Inc. by Pyramid Laboratories Inc., Costa Mesa, CA 92626.

請訪問www.xerispharma.com查看GVOKE的完整描述信息。由加利福尼亞州科斯塔梅薩的金字塔實驗室公司為Xeris製藥公司製造,郵編92626。

About Severe Hypoglycemia

關於嚴重低血糖

Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month. Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers. Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and, if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.

任何嚴重程度的低血糖事件都是糖尿病患者日常關注的問題。輕度或中度低血糖一個月可發生多次。嚴重低血糖的特點是嚴重的認知障礙,需要外部幫助才能康復,對患者和照顧者來説可能是極其可怕的。嚴重的低血糖會導致心血管疾病、癲癇、昏迷,如果不治療,還會導致死亡。這些嚴重的低血糖事件一年可能會發生多次。這類事件需要另一個人或照顧者(如家人、朋友或同事)的緊急援助。

About Glucagon

關於胰高血糖素

Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted, and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.

胰高血糖素是一種由胰腺分泌的代謝激素,通過使肝臟迅速將糖原(葡萄糖的儲存形式)轉化為葡萄糖,然後葡萄糖釋放到血液中,從而提高血糖水平。胰高血糖素和胰島素是血糖控制系統中的兩種關鍵荷爾蒙,它們使健康人的血糖保持在正確的水平。對於依賴胰島素的糖尿病患者,這種控制系統被破壞,必須注射胰島素以避免高血糖(高血糖)。相反,由於胰高血糖素分泌失調,低血糖(低血糖)在這一人羣中也很普遍。嚴重低血糖是一種嚴重的疾病,可能導致癲癇發作、昏迷、潛在的腦損傷,如果不治療,甚至死亡。

Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L). Leveraging XeriSol™, one of Xeris’ two proprietary formulation technology platforms, Xeris has the potential to provide the first ready-to-use, room-temperature stable liquid glucagon for use by people with diabetes and other conditions to prevent or manage various forms of hypoglycemia and improve glucose control.

胰高血糖素是治療嚴重低血糖的標準治療藥物。根據美國糖尿病協會的説法,胰高血糖素應該開給所有臨牀上有明顯低血糖風險的人,定義為血糖。

About Xeris Pharmaceuticals, Inc.

Xeris製藥公司簡介

Xeris (Nasdaq: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

Xeris(納斯達克市場代碼:XERS)是一家專業製藥公司,提供創新的解決方案,簡化世界各地人們每天依賴的重要療法的管理經驗。

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke®. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

憑藉一種新的技術平台,該公司能夠實現即用型、室温穩定的可注射療法和不溶性療法的配方,該公司正在推進各種治療類別的解決方案組合,包括其首個商用產品Gvoke®。其專有的XeriSol™和XeriJect™配方技術有可能提供與傳統產品配方相比的獨特優勢,包括消除重構的需要、實現長期的室温穩定性、顯著減少注射量以及不需要靜脈(IV)輸液。有了Xeris的技術,新產品配方被設計成更容易被患者、護理人員和健康從業者使用,並幫助降低支付者和醫療系統的成本。

Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow us on Twitter, LinkedIn or Instagram.

Xeris的總部設在伊利諾伊州的芝加哥。欲瞭解更多信息,請訪問www.xerispharma.com,或關注我們推特, LinkedIn或者是Instagram。

Forward-looking Statements

前瞻性陳述

Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the availability and acceptance of Gvoke®in the marketplace, the market and therapeutic potential of its product candidates, the timing or likelihood of commercialization of its product candidates, the potential utility of its formulation platforms and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the "Risk Factors" section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

本新聞稿中有關Xeris製藥公司未來預期、計劃和前景的任何陳述,包括有關Gvoke®在市場上的供應和接受程度、其候選產品的市場和治療潛力、其候選產品商業化的時機或可能性、其配方平台的潛在用途以及包含“將”、“將”、“繼續”和類似表述的其他陳述,均屬“1995年私人證券訴訟改革法案”中定義的前瞻性陳述。由於各種重要因素,包括但不限於監管部門對其候選產品的批准、其產品的營銷和銷售能力(如果獲得批准)、以及在提交給美國證券交易委員會的最近一份Form 10-Q季度報告中的“風險因素”部分討論的其他因素,以及Xeris在隨後提交給證券交易委員會的文件中對潛在風險、不確定性和其他重要因素的討論,實際結果可能與前瞻性聲明中顯示的結果大不相同。本新聞稿中包含的任何前瞻性陳述僅表示截至本新聞稿之日,Xeris明確表示不承擔任何因新信息、未來事件或其他原因而更新任何前瞻性陳述的義務。

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

本公司擬使用其網站的投資者關係部分作為披露重大非公開信息的手段,並遵守FD規則下的披露義務。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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