Month: June 2021

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Synchronoss Technologies, Inc. ประกาศเสนอขายหุ้นสามัญจำนวน 100 ล้านเหรียญสหรัฐฯ แก่สาธารณะ

BRIDGEWATER, N.J., June 26, 2021 (GLOBE NEWSWIRE) — Synchronoss Technologies, Inc. (SNCR) (ต่อไปนี้จะเรียกว่า “บริษัท” หรือ “Synchronoss”) ผู้นำระดับโลกและผู้ริเริ่มผลิตภัณฑ์และแพลตฟอร์มระบบคลาวด์ การส่งข้อความและดิจิทัล ได้ประกาศในวันนี้ว่าบริษัทมีความตั้งใจที่จะเสนอขายหลักทรัพย์ภายใต้เงื่อนไขของตลาดและเงื่อนไขอื่นๆ ในการเสนอขายหุ้นแก่ประชาชนทั่วไปภายใต้เงื่อนไขของตลาดและเงื่อนไขอื่นๆ มูลค่า 100 ล้านเหรียญสหรัฐฯ นอกจากนี้ Synchronoss ยังคาดหวังว่าจะให้ทางเลือกแก่ผู้จัดจำหน่ายหลักทรัพย์เป็นเวลา 30 วันในการซื้อหุ้นสามัญเพิ่มเติมสูงสุด 10 ล้านเหรียญสหรัฐฯ ในราคาเสนอขายต่อสาธารณชนทั่วไป หักด้วยส่วนลดการรับประกันภัยและค่าคอมมิชชั่น โดยไม่สามารถรับประกันได้ว่าการเสนอขายจะเสร็จสิ้นเมื่อใดหรือเมื่อไร หรือตามขนาดหรือเงื่อนไขที่แท้จริงของการเสนอขายหรือไม่

Synchronoss จะขายหุ้นทั้งหมดที่เสนอขายโดยได้รับเงินสุทธิจากการเสนอขาย และจากการเสนอขายหุ้นที่ไม่ด้อยสิทธิ์และการขายหุ้นบุริมสิทธิ Series B (ตามรายละเอียดด้านล่าง) โดยคาดว่าจะใช้เพื่อไถ่ถอนหุ้นที่จำหน่ายได้แล้วทั้งหมดของหุ้นบุริมสิทธิแบบถาวรที่เข้าร่วมโครงการ Series A ของ Synchronoss และชำระคืนตามวงเงินสินเชื่อหมุนเวียนของ Synchronoss

B. Riley Securities, Inc. (ต่อไปนี้จะเรียกว่า “BRS”) ทำหน้าที่เป็นผู้จัดการการจัดจำหน่ายหลักทรัพย์หลักและผู้จัดการฝ่ายการจัดสรรหุ้นเพียงผู้เดียวสำหรับการเสนอขาย Northland Capital Markets ทำหน้าที่เป็นผู้จัดการร่วมสำหรับการเสนอขาย

ควบคู่ไปกับการเสนอขายนี้ บริษัทได้เสนอหนังสือชี้ชวนฉบับเสริมแยกต่างหากเป็นจำนวนเงินรวม 120 ล้านเหรียญสหรัฐฯ ของหุ้นที่ไม่ด้อยสิทธิ์ที่จะครบกำหนดชำระในปี 2026 (ต่อไปนี้จะเรียกว่า “หุ้นที่ไม่ด้อยสิทธิ์”) นอกจากนี้ B. Riley Principal Investments, LLC (“BRPI”) บริษัทในเครือของ BRS ได้ทำข้อตกลงตามที่ BRPI ได้ตกลงที่จะซื้อหุ้นบุริมสิทธิ Series B ของบริษัทจำนวน 75.0 ล้านเหรียญสหรัฐฯ ในการทำธุรกรรมส่วนตัวเพื่อให้เสร็จสิ้นพร้อมกับการปิดการเสนอขาย

Synchronoss ได้เสนอขายหุ้นสามัญตามที่อธิบายไว้ข้างต้นตามแบบแสดงรายการข้อมูลการจดทะเบียนชั้นวาง (Shelf Registration) ในแบบฟอร์ม S-3 ที่ยื่นต่อสำนักงานคณะกรรมการกำกับหลักทรัพย์และตลาดหลักทรัพย์ (SEC) ก่อนหน้านี้ และประกาศให้มีผลโดยสำนักงาน SEC เมื่อวันที่ 28 สิงหาคม 2020 หนังสือชี้ชวนเบื้องต้นที่เกี่ยวข้องและอธิบายเงื่อนไขของการเสนอขายจะนำไปยื่นต่อ SEC และจะพร้อมให้ใช้งานในเว็บไซต์ของ SEC ที่ www.sec.gov เงื่อนไขสุดท้ายของการเสนอขายที่เสนอจะเปิดเผยในหนังสือชี้ชวนขั้นสุดท้ายที่จะยื่นต่อคณะกรรมการ SEC เมื่อพร้อมใช้งานแล้ว สามารถขอรับสำเนาหนังสือชี้ชวนเบื้องต้นที่เกี่ยวข้องกับหลักทรัพย์เหล่านี้ได้โดยส่งคำขอไปที่: B. Riley Securities, Inc., at 1300 North 17th Street, Suite 1300, Arlington, VA 22209 หรือโทร (703) 312‐9580 หรือส่งอีเมลไปที่ prospectuses@brileyfin.com

ข่าวประชาสัมพันธ์ฉบับนี้ไม่ถือเป็นการเสนอขายหรือการชักชวนให้ซื้อหลักทรัพย์ใดๆ เหล่านี้ และห้ามมีการขายหลักทรัพย์เหล่านี้ในรัฐหรือเขตอำนาจศาลใดๆ ที่การเสนอขาย การชักชวน หรือการขายดังกล่าวจะไม่ชอบด้วยกฎหมายก่อนการลงทะเบียนหรือคุณสมบัติตามกฎหมายหลักทรัพย์ของรัฐดังกล่าวหรือเขตอำนาจศาลอื่น

เกี่ยวกับ Synchronoss

Synchronoss Technologies (NASDAQ: SNCR) สร้างซอฟต์แวร์ที่ช่วยให้บริษัทต่างๆ ทั่วโลกเชื่อมต่อกับผู้ติดตามด้วยวิธีที่เชื่อถือได้และมีประสิทธิภาพ คอลเล็กชันผลิตภัณฑ์ของบริษัทช่วยให้เครือข่ายมีความคล่องตัว ลดความซับซ้อนของการเริ่มต้นใช้งาน และดึงดูดสมาชิกเพื่อเพิ่มกระแสรายได้ใหม่ ลดต้นทุน และเพิ่มความเร็วในการออกสู่ตลาด

แถลงการณ์ตามหลักอ่าวที่ปลอดภัย (Safe Harbor)

ข่าวเผยแพร่นี้มีข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตตามความหมายของมาตรา 21E ของกฎหมายหลักทรัพย์ปี 1934 ซึ่งแก้ไขเพิ่มเติม ซึ่งรวมถึงแต่ไม่จำกัดเพียงข้อความเกี่ยวกับการเสนอขายหุ้นต่อสาธารณชนและการใช้เงินที่คาดว่าจะได้รับจากข้อมูลดังกล่าว ข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตเหล่านี้อยู่ภายใต้ความเสี่ยงหลายประการ ซึ่งรวมถึงความพึงพอใจของเงื่อนไขการปิดตามธรรมเนียมที่เกี่ยวข้องกับการเสนอขายต่อสาธารณชนที่เสนอ และปัจจัยเสี่ยงที่กำหนดไว้เป็นครั้งคราวในเอกสารที่ยื่นต่อ SEC ของ Synchronoss รวมถึงแต่ไม่จำกัดเฉพาะความเสี่ยงที่อธิบายไว้ในหัวข้อ “ปัจจัยเสี่ยง” และ “การอภิปรายและการวิเคราะห์สภาพทางการเงินและผลการดำเนินงานของฝ่ายจัดการ” (ตามความเหมาะสม) ของรายงานประจำปีของ Synchronoss ในแบบฟอร์ม 10-K สำหรับปีที่สิ้นสุดในเดือนธันวาคม วันที่ 31 มีนาคม 2020 และรายงานรายไตรมาสในแบบฟอร์ม 10-Q สำหรับรอบระยะเวลาสิ้นสุดวันที่ 31 มีนาคม 2021 ซึ่งอยู่ในไฟล์กับ SEC และมีอยู่ในเว็บไซต์ของ SEC ที่ www.sec.gov นอกเหนือจากความเสี่ยงที่อธิบายไว้ข้างต้นและในเอกสารอื่นๆ ของ Synchronoss ที่ยื่นต่อ SEC แล้ว ปัจจัยอื่นๆ ที่ไม่ทราบหรือคาดเดาไม่ได้ก็อาจส่งผลต่อผลลัพธ์ของ Synchronoss ได้เช่นกัน ข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตไม่สามารถรับประกันได้ และผลลัพธ์ที่แท้จริงอาจแตกต่างอย่างมากจากข้อความดังกล่าว ข้อมูลในข่าวประชาสัมพันธ์นี้มีให้ ณ วันที่ของข่าวประชาสัมพันธ์นี้เท่านั้น และ Synchronoss ไม่มีภาระผูกพันในการปรับปรุงข้อความเชิงคาดการณ์เหตุการณ์ในอนาคตใดๆ ที่มีอยู่ในข่าวประชาสัมพันธ์นี้เนื่องจากข้อมูลใหม่ เหตุการณ์ในอนาคต หรือปัจจัยอื่น ยกเว้นตามที่กฎหมายกำหนด

สื่อ

Diane Rose
CCgroup
diane@ccgrouppr.com

นักลงทุน

Todd Kehrli/Joo-Hun Kim
MKR Investor Relations, Inc.
investor@synchronoss.com

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Johnson & Johnson Reaches $230 Million Opioid Settlement With New York State

NEW YORK – Johnson & Johnson agreed to pay about $230 million to resolve claims it helped fuel an opioid crisis in New York, the state’s attorney general said Saturday.

The agreement addresses claims brought by Attorney General Letitia James, and it will remove Johnson & Johnson as a defendant in a broader trial over opioids scheduled to begin next week.

J&J did not admit liability or wrongdoing in agreeing to settle. It said the agreement was consistent with its prior agreement to pay $5 billion to settle opioid claims by states, cities, counties and tribal governments nationwide.

Source: Voice of America

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UN Expert: Criminalization of Same Sex Unions Violates Human Rights Law and Must End

GENEVA – U.N. Independent Expert on Protection against Violence and Discrimination based on Sexual Orientation and Gender Identity, Victor Madrigal-Borloz, is calling for the global elimination of laws that criminalize same-sex unions by 2030. His report has been submitted to the U.N. Human Rights Council.

Currently, 69 countries criminalize homosexuality or some forms of gender identity, nearly half are in Africa. Among them are a handful of countries that apply the death sentence for same sex sexual acts. They include Brunei, Iran, Mauritania, Saudi Arabia, Yemen, and northern Nigeria.

U.N. independent Expert, Victor Madrigal-Borloz, says as of today, 2,000 million people live in criminalized environments. He says there is no justification under international human rights law for maintaining criminalized legislation in relation to sexual orientation or gender identity.

“My work has produced abundant evidence to the effect that these criminalizing provisions, even when they are not applied, they create a context, a context that is hostile to the existence of LGBT persons and that is also conducive to blackmail and to significant violence affecting the everyday lives of these persons,” Madrigal-Borloz said.

Madrigal-Borloz notes some countries have taken measures to dismantle homophobic laws. He notes the extraordinary action taken by India’s Supreme Court, which by the stroke of a pen freed more than one billion people from the threat of imprisonment based on their sexual orientation.

He says other countries that have decriminalized their legislation against homosexuality include Botswana, Trinidad and Tobago, Belize, Mozambique, and Angola.

Madrigal-Borloz is concerned at the adoption of legislation by countries that limit the rights and freedoms of LGBTQ people. He is critical of the law passed by Hungary earlier this month banning educational materials and programs for children that allegedly promote homosexuality and transgender identity.

“I see nothing in the needs of a democratic society that would justify limiting that freedom and this is the basis for my concern as I expressed it to the Hungarian State already months ago when this legislation began to take shape under that public policy,” Madrigal-Borloz said.

On the contrary, the U.N. Independent Expert says comprehensive sexual and gender education in schools will likely lead to reduced levels of violence and discrimination based on gender identity and sexual orientation.

Source: Voice of America

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Synchronoss Technologies, Inc. Announces Pricing of $100 Million Public Offering of Common Stock

BRIDGEWATER, N.J., June 25, 2021 (GLOBE NEWSWIRE) — Synchronoss Technologies, Inc. (SNCR) (the “Company” or “Synchronoss”), a global leader and innovator in cloud, messaging and digital products and platforms, today announced the pricing of an underwritten public offering of 38,461,538 shares of its common stock at a public offering price of $2.60 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Synchronoss, are expected to be $100 million. In addition, Synchronoss has granted the underwriters a 30-day option to purchase up to 3,846,154 additional shares of common stock at the public offering price, less the underwriting discounts and commissions.

All of the shares in the offering are being sold by Synchronoss. Synchronoss anticipates using the net proceeds from the offering, and from the offering of Senior Notes and sale of Series B Preferred Stock (each as described below), to fully redeem all outstanding shares of Synchronoss’ Series A Convertible Participating Perpetual Preferred Stock and repay amounts outstanding under Synchronoss’ revolving credit facility. The offering is expected to close on or about June 29, 2021, subject to satisfaction of customary closing conditions.

B. Riley Securities, Inc. (“BRS”) is acting as the lead underwriter and sole book-running manager for the offering. Northland Capital Markets is acting as co-manager for the offering.

Concurrently with the offering, the Company is offering, by means of a separate prospectus supplement, $120 million aggregate principal amount of senior notes due 2026 (the “Senior Notes”). In addition, B. Riley Principal Investments, LLC (“BRPI”), an affiliate of BRS, has entered into an agreement pursuant to which BRPI has agreed to purchase $75.0 million of the Company’s Series B Preferred Stock in a private transaction to be completed concurrently with the closing of the offering.

The shares of common stock described above are being offered by Synchronoss pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on August 28, 2020. A preliminary prospectus supplement relating to and describing the terms of the offering is filed with the SEC and is available on the SEC’s web site at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement (when available) and accompanying prospectus relating to these securities may also be obtained by sending a request to: B. Riley Securities, Inc., at 1300 North 17th Street, Suite 1300, Arlington, VA 22209 or by calling (703) 312‐9580 or by emailing prospectuses@brileyfin.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Synchronoss

Synchronoss Technologies (NASDAQ: SNCR) builds software that empowers companies around the world to connect with their subscribers in trusted and meaningful ways. The company’s collection of products helps streamline networks, simplify onboarding, and engage subscribers to unleash new revenue streams, reduce costs and increase speed to market.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the closing of the public offering and the anticipated use of the proceeds thereof. These forward-looking statements are subject to a number of risks, including the satisfaction of customary closing conditions related to the public offering and the risk factors set forth from time to time in Synchronoss’ SEC filings, including but not limited to the risks that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections (as applicable) of Synchronoss’ Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the period ended March 31, 2021, which are on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in Synchronoss’ other filings with the SEC, other unknown or unpredictable factors also could affect Synchronoss’ results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Synchronoss undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Media

Diane Rose
CCgroup
synchronoss@ccgrouppr.com

Investors

Todd Kehrli/Joo-Hun Kim
MKR Investor Relations, Inc.
investor@synchronoss.com

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Nyxoah Announces Launch of Proposed Public Offering in the United States

REGULATED INFORMATION
INSIDE INFORMATION

Nyxoah Announces Launch of Proposed Public Offering in the United States

Mont-Saint-Guibert, Belgium – June 25, 2021, 12:30 pm CET / 6:30 am ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that it is launching an underwritten registered public offering of 2,760,000 ordinary shares in the United States (the “Offering”) at an assumed public offering price of $31.461.

In connection with the Offering, Nyxoah intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of ordinary shares offered in the Offering on the same terms and conditions.

The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the size or terms of the Offering, including the price per ordinary share (in USD) and number of ordinary shares sold in the Offering.

Nyxoah’s ordinary shares are currently listed on Euronext Brussels under the symbol “NYXH”. An application has been made to list the ordinary shares on the NASDAQ Global Market under the same symbol.

Piper Sandler, Stifel and Cantor are acting as joint book-running managers for the Offering. Degroof Petercam is acting as a co-manager.

A registration statement on Form F-1 has been filed with the SEC but has not yet become effective. The ordinary shares may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or publication of an offering prospectus under the securities laws of any such state or jurisdiction.

The Offering will be made only by means of a prospectus. A copy of the preliminary prospectus, when available, can be obtained from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by e-mail at prospectus@psc.com, or by phone at (800) 747-3924; Stifel, Nicolaus & Company, Incorporated at Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022; email: prospectus@cantor.com.

Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the terms of the Offering. Forward-looking statements are based on Nyxoah’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ. Forward-looking statements contained in this announcement are made as of this date, and Nyxoah undertakes no duty to update such information except as required under applicable law.

IMPORTANT INFORMATION
No public offering will be made and no one has taken any action that would, or is intended to, permit a public offering in any country or jurisdiction, other than the United States, where any such action is required, including in Belgium. Belgian investors, other than qualified investors within the meaning of the Belgian Act of 11 July 2018 on the public offering of securities and the admission of securities to be traded on a regulated market, will not be eligible to participate in the offering (whether in Belgium or elsewhere). The transaction to which this press release relates will only be available to, and will be engaged in only with, in member states of the European Economic Area, persons falling within the meaning of Article 2(e) of Regulation (EU) 2017/1129 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market (the “Prospectus Regulation”), and in the United Kingdom, investment professionals falling within article 19 (5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), persons falling within article 49 (2), (a) to (d) of the Order and other persons to whom it may lawfully be communicated. A prospectus will be prepared by Nyxoah in accordance with Article 3 of the Prospectus Regulation for the purpose of having the new shares that will be represented by ordinary shares admitted to trading on Euronext Brussels. In the context of the Offering and in accordance with Belgian law and the articles of association of Nyxoah, the board of directors of Nyxoah has approved a conditional capital increase with issuance of up to 4,600,000 ordinary shares within the framework of the authorized capital granted to the board of directors as set out in article 7 of the articles of association of Nyxoah.

Contacts:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 24 55

Gilmartin Group
Vivian Cervantes
IR@nyxoah.com

1 Equivalent to a public offering price of €26.50 per ordinary share, assuming an exchange rate of  €1.00 = $1.1872, the noon buying rate in The City of New York on June 18, 2021 set forth in the H.10 statistical release of the Federal Reserve Board on June 21, 2021.

Attachment

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Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease

Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease  
 
JUNE 25, 2021 – ORPHAN DISEASES 

— CHELATE trial confirmed trientine tetrahydrochloride was non-inferior to d-Penicillamine and met the primary endpoint of Non-Ceruloplasmin Copper (NCC) levels as a maintenance therapy for patients with Wilson’s Disease, following six months of treatment.

— Trientine tetrahydrochloride was well tolerated and during treatment, more patients achieved the pre-specified composite endpoint of NCC and 24–hour Urinary Copper Excretion (UCE) within therapeutic target ranges, compared to patients treated with d-Penicillamine, 50% versus 24%.  

— Data from the trial to be presented today during an oral presentation at EASL’s The International Liver Congress™ 2021. 

Paris, France. June 25, 2021 (GLOBE NEWSWIRE) Orphalan SA is a company that identifies, develops and delivers innovative treatments to patients with rare diseases. Orphalan today announced positive top line results from a phase 3 head-to-head trial comparing d-Penicillamine with trientine tetrahydrochloride in Wilson’s Disease (WD). The phase 3 trial has been completed through an IND program for FDA submission. Wilson’s Disease is a rare inherited disorder of copper transport primarily affecting the liver and brain. Untreated, this is a fatal disease.

The CHELATE trial is the first prospective randomised trial comparing d-Penicillamine with trientine tetrahydrochloride. D- Penicillamine has been the only approved first line treatment for the last 70 years. Trientine tetrahydrochloride if approved has the potential to be used as maintenance therapy in patients with Wilson’s Disease.

The CHELATE trial met its primary efficacy endpoint by demonstrating that trientine tetrahydrochloride was non-inferior to d-Penicillamine as measured by copper speciation evaluation of non-ceruloplasmin copper (NCC). This novel analytical method was developed by Orphalan through consultation with the FDA. The pre-specified composite endpoint of non-ceruloplasmin copper (NCC) and 24-hour urinary copper excretion (UCE), was achieved by 50% of patients treated with trientine tetrahydrochloride versus 24% of patients treated with d-Penicillamine.

Five serious adverse events (SAEs) were observed in the 27 patients treated with d-Penicillamine, while no SAEs were observed in the 26 patients randomised to trientine tetrahydrochloride. Treatment emergent adverse events (TEAEs) temporally related to the study treatments reported in the study were comparable in both groups and were graded as either mild or moderate and transitory in nature.

The data arising from this study will be presented at EASL’s International Liver Congress today at 8.45 CEST and will be submitted for publication. Analysis of the 48-week data from the CHELATE Phase 3 investigational study is ongoing and will be presented at a future scientific forum.

“With a chronic disorder like Wilson’s Disease, interrupting or stopping treatment for any reason can provoke the return of disease activity, sometimes with severe consequences. Physicians and patients should work together to choose a medication that provides the right balance of efficacy, safety and tolerability to help manage patients’ Wilson’s Disease and meet their treatment goals,” said Dr. Michael Schilsky , Principal Investigator and Professor of Medicine and Director of the Center for Excellence for Wilson Disease at Yale University. “These top-line results suggest that trientine tetrahydrochloride offers a differentiated tolerability profile and represents a safe and effective alternative to d-Penicillamine as a maintenance therapy for patients with Wilson’s Disease.”

“Despite its poor safety profile, d-Penicillamine is the only approved first line therapy in Wilson’s Disease. The CHELATE study showed that patients on d-Penicillamine can be safely switched to trientine tetrahydrochloride, without compromising efficacy. Our commitment to this study is in line with our strategy to provide robust clinical data to physicians to enable them to make evidence-based treatment decisions.” said Dr. Naseem Amin, Chief Executive Officer at Orphalan. He added: “The clinical evidence from this trial and the use of the novel assay for NCC developed by Orphalan have the potential to make a meaningful difference to the patient’s life and the physician’s ability to monitor their disease.”

Notes to Editors

About the CHELATE Study

CHELATE is a Phase 3, multicentre, randomised, open label, active-controlled, non-inferiority study conducted in 9 countries at 15 centres designed to evaluate efficacy and safety of trientine tetrahydrochloride compared to d-Penicillamine in patients with stable Wilson’s Disease. Fifty-three adult Wilson’s Disease patients with clinically stable disease for over one year and who met specific inclusion criteria, including laboratory measures of serum non-ceruloplasmin copper (NCC), 24-hour urinary copper excretion (UCE) and liver function tests, were followed for a baseline period for 12 weeks before being randomised 1:1 to either trientine tetrahydrochloride or d-Penicillamine twice daily. The study’s primary endpoint was serum NCC as measured using Orphalan’s proprietary method using copper speciation at 24-weeks post-randomisation. A secondary composite efficacy endpoint was NCC and 24-hour UCE.

Additional secondary endpoints included were: clinical Global Impression of Change (CGIC) score; serum copper and ceruloplasmin levels; the unified Wilson’s Disease Rating Scale (UWDRS); modified Nazer score; cognitive assessments and standard safety assessments. In addition, an independent adjudication committee blinded to the allocated treatment, and study centres assessed key efficacy and safety parameters to determine clinical stability of the patient. 

About Trientine Tetrahydrochloride
Trientine tetrahydrochloride is an investigational, novel oral trientine formulation with Orphan Drug Designation under development through a 505(b)(2) pathway for the treatment of Wilson’s Disease maintenance patients. The trientine tetrahydrochloride NDA is planned to be submitted mid-year 2021. If approved by the FDA, Orphalan intends to market trientine tetrahydrochloride itself in the US.

About the Trientine Tetrahydrochloride Clinical Development Program
The key components of the clinical development program of trientine tetrahydrochloride include the CHELATE trial, a Phase 3, open-label, six-month safety and efficacy study in maintenance Wilson’s Disease patients, along with pharmacokinetic bridging studies comparing trientine tetrahydrochloride to two formulations of trientine dihydrochloride, Triumph I and Triumph 2. The CHELATE clinical development program also includes the CHELATE extension phase, assessing the safety, efficacy and tolerability of trientine tetrahydrochloride and d-Penicillamine over a period of 1 year. 

About Cuprior™
Cuprior™ is a form of trientine tetrahydrochloride which is approved in the EU for patients intolerant to d-Penicillamine. Of the estimated 5,000 diagnosed Wilson’s Disease patients in the EU, we estimate 25% are considered intolerant.

Cuprior™ is contraindicated in patients hypersensitive to trientine.

Cuprior™ is a registered and unregistered trademark of Orphalan.

For important safety information and full prescribing information, including patient information for Cuprior™ please visit  https://www.cuprior.com

Trientine tetrahydrochloride is under investigation and not approved for use in any indication in the United States.

About Orphalan
At Orphalan, our mission is clear: we are pioneers in orphan diseases. Orphalan is a company that identifies, develops and delivers innovative treatments to patients with rare diseases. Orphalan was founded in 2011 and has launched Cuprior™ across Europe with its own commercial organisation.

Contact for Orphalan:
Tel : +33 (0)1 42 49 82 64
info@orphalan.health

Contact For Media:
Consilium Strategic Communications: 
Mary-Jane Elliott, Allison Connolly
Tel: +44 (0) 203 709 5700
orphalan@consilium-comms.com

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Statement From The Association of Victims’ Families of Flight PS752: Canada’s Forensic Examination and Assessment of the Downing of Flight PS752 Reveals Iran’s Crimes, Obfuscations and Lies

TORONTO, June 24, 2021 (GLOBE NEWSWIRE) — The Association of the Families of Flight PS752 Victims (the Association) welcomes the Government of Canada’s Forensic Examination and Assessment report on the downing of Ukraine International Airlines flight PS752, released today. That report exposes the Iranian regime’s disregard for human life, failure to disclose the truth and pursue justice, and oppression of victims’ families. The Association welcomes Canada’s commitment in the report to pursuing the truth and justice, including to the International Court of Justice, and calls for the international community to hold the Islamic Republic fully accountable for what it believes to be the willful murder of their loved ones.

The Iranian regime had an obligation to transparently disclose the causes of the downing of Flight PS752 through a comprehensive report in cooperation with the affected countries. Iran had failed to meet that obligation.

Canada’s decision to conduct its own forensic examination and assessment was an important step. But it is not sufficient and cannot be the final summary of what transpired on January 8, 2020. The Report makes clear that the investigators lacked access to witnesses, fulsome evidence and sufficient information. The Government of Canada must continue its work to hold the culprits of this crime to account and bring justice to the victims, their families, and their loved ones. Even without access to much important information, the forensic examination report reveals Iran’s failure to investigate its shooting of Flight PS752 and its failure to comply with international law.

Prime Minister Justin Trudeau’s own conclusions outlined in the report speak to the intentional obfuscation and lack of accountability, cooperation and transparency on the part of the Iranian regime, and the need to hold Iran to account at the highest levels:

“Iran’s official account of events is disingenuous, misleading and superficial and intentionally ignores key factors.”

“Iran must also account for the cover-up that followed the downing of flight PS752, including bulldozing the crash site before investigators arrived.”

“… Should negotiations with Iran not result in an acceptable outcome for Canada on behalf of the families, we will pursue all available options, including recourse to the International Court of Justice.”

Canada’s forensic report makes several key observations that clearly illustrate the crimes, obfuscations and lies of Iran. First, the report rejects the Islamic Regime’s claims of “human error” as not plausible, and finds senior officials of Iran culpable. The report finds that it is not plausible that the crime was committed by a low-level operator in the field who failed to perform his duties and misjudged the situation, without regular communications with central military commanders. The report highlights the likely involvement of higher-level military and other government officials in shooting Flight PS752. The report states that although the firing of the missiles may have been delegated to a lower ranking operator, “… it is very unlikely the SAM operator would have been authorized to launch missiles without approval from his command.”

The forensic report further emphasizes that there was “… no evidence that ‘jamming’ or electronic warfare were the cause”, contrary to statements made by Iran that the missile operators had lost contact with central commanders. UN Special Rapporteur on Extrajudicial, Summary or Arbitrary Executions, Agnes Callamard, stated that: “The inconsistencies in the official explanations seem designed to create a maximum of confusion and a minimum of clarity. They seem contrived to mislead and bewilder.”

Importantly, the forensic report finds that the foundation of this crime lies with high-level strategic and national security decisions of Iran, likely made by the leader of the Islamic regime and the Supreme Council of National Security of Iran. They deliberately kept the civilian airspace open at a time of heightened military tension, and after launching an attack, possibly using PS752 passengers and other passengers on aircraft that departed earlier that morning as human shields. There are still numerous unanswered questions and facts suggesting that the downing of the civilian airliner PS752 was intentional. The onus is on Iran to transparently disclose all relevant information in order to show that the downing of PS752 was not intentional.

The revelations of Canada’s Forensic Report underscore what the Association and families have long known and further energize the families’ resolve in their fight for truth and justice. The Association’s Fact-Finding Committee intends to produce a report of its own findings and conclusions in the coming months and the Association will continue to seek an international platform that will hold the Iranian regime to account for their actions. The Association of the Families of Flight PS752 Victims requests that the Government of Canada to put forth a substantial monetary reward for any information that leads to identification and prosecution of those individuals responsible for the shooting of Flight PS752. The Association once more insists that the Government of Canada enlist the IRGC as a terrorist entity, impose targeted Magnitsky sanctions on the perpetrators of the downing, and pursue the PS752 file through a domestic criminal investigation.

For more information, contact

Colleen Ryan
Cell: 647-232-6867
Email: cryan@sussex-strategy.com

Hamed Esmaeilion
Email: speaker@ps752justice.com
Website: https://www.ps752justice.com