Ferrer Announces Distribution Agreement With United Therapeutics for Treprostinil Inhalation Solution for Pulmonary Hypertension Associated With Interstitial Lung Disease

PH-ILD is a rare, serious, and progressive illness without an approved treatment in Europe and many other parts of the world Ferrer BARCELONA, Spain, Feb. 28, 2022 (GLOBE NEWSWIRE) — In the run up to Rare Disease Day, which is held on 28 February, International pharmaceutical company Ferrer has strengthened its focus on pulmonary vascular and interstitial lung […]

PH-ILD is a rare, serious, and progressive illness without an approved treatment in Europe and many other parts of the world

Ferrer

Ferrer

BARCELONA, Spain, Feb. 28, 2022 (GLOBE NEWSWIRE) — In the run up to Rare Disease Day, which is held on 28 February, International pharmaceutical company Ferrer has strengthened its focus on pulmonary vascular and interstitial lung diseases, as well as neurological disorders, by announcing today the signing of a distribution agreement with United Therapeutics Corporation (Nasdaq: UTHR) for Tyvaso® (treprostinil) inhalation solution – a pharmaceutical drug-device combination product for the treatment of WHO Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) 4.

According to Mario Rovirosa, Ferrer’s Chief Executive Officer, “This is an important milestone for Ferrer, a B Corp company. As a company, we aim to deliver the best possible solutions to underserved patients around the globe by promoting a new way of doing business and approaching the world.

Under the agreement, Ferrer has been appointed as the exclusive, worldwide distributor (except for the U.S., Canada, Japan, China and Israel), to commercialise this therapeutic option for the treatment of PH-ILD – a rare, serious and progressive disease without an approved treatment in Europe and many other parts of the world1-3.

We’re proud of our strong and lasting relationship with Ferrer, and this distribution agreement has the potential to bring Tyvaso to PH-ILD patients in need worldwide, who currently have no other treatment options,” stated Michael Benkowitz, President and Chief Operating Officer, United Therapeutics. “Having recently converted into a public benefit corporation ourselves, we applaud and share Ferrer’s patient-driven mission – underscored by its recent B Corp certification.”

The agreement leverages Ferrer’s strong capabilities and expertise in pulmonary vascular and interstitial lung diseases and underscores both companies’ commitment to expanding global access to treprostinil inhalation solution for the treatment of PH-ILD.

Tyvaso is the perfect fit for Ferrer’s mission to create lasting change by bringing transformative products in this challenging field to market and strengthens our pipeline for the coming years,” added Oscar Pérez, Chief Business Development and Global Alliances Officer, Ferrer.

Ferrer is a long-term partner of United Therapeutics, responsible for providing global access to Remodulin® (treprostinil) Injection, a prostacyclin vasodilator for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to reduce symptoms associated with exercise.

We’ve found Ferrer to be an excellent partner for the distribution of our treprostinil-based products around the world and are thrilled to expand our collaboration. Without Ferrer, patients outside of our core markets would not have access to these life-sustaining therapies,” commented Beth Rhodes, Vice President, Global Supply Chain and Alliance Management, United Therapeutics.

Upon signing, Ferrer made a down payment to United Therapeutics, who will also receive a transfer price and revenue sharing on future sales of this product by Ferrer.

Ferrer is now working with health authorities to determine the appropriate regulatory pathway to obtain approval for this product (currently only authorised in the US) for the treatment of PH-ILD in other territories.
For more information, please contact:
Emma Simms
BDB Account Director
emma@bdb.co.uk
+44 (0) 161 925 4700

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Samsung Bioepis Celebrates 10 Years of Realizing Passion for Health, Innovating Patients Access Worldwide

Samsung Bioepis 10 Years Anniversary Milestones Holds a virtual ceremonial event for the first time to mark the anniversary with its global employees Pledges to keep innovating access to biologic medicines worldwide INCHEON, Korea, Feb. 28, 2022 (GLOBE NEWSWIRE) —  Samsung Bioepis Co. Ltd. today celebrated its 10th anniversary of its establishment by reflecting the past, present […]

Samsung Bioepis 10 Years Anniversary Milestones

Samsung Bioepis 10 Years Anniversary Milestones

  • Holds a virtual ceremonial event for the first time to mark the anniversary with its global employees
  • Pledges to keep innovating access to biologic medicines worldwide

INCHEON, Korea, Feb. 28, 2022 (GLOBE NEWSWIRE) —  Samsung Bioepis Co. Ltd. today celebrated its 10tanniversary of its establishment by reflecting the past, present and the future of its passion for health in increasing patient access to quality biologic medicines. The company held a virtual ceremonial event to mark the company’s anniversary with its global employees.

“I am very proud of our colleagues here at Samsung Bioepis as their hard work have made it possible for us to have six products approved and five marketed around the world, increasing patient access to medicines. We have made remarkable achievements with a proven track record in just a decade which is unprecedented in biopharmaceutical industry,” said Christopher Hansung Ko, President and Chief Executive Officer at Samsung Bioepis. “We are continuing to make history by pioneering in ophthalmology biosimilars, innovating the global healthcare landscape for caregivers, physicians and patients alike. Seeing what we have built together over the last decade makes me optimistic about the future of our company and of the biosimilar industry.”

Samsung Bioepis was established in 2012 with a mission to increase patient access to quality medicines through the development of biosimilars. In 2016, the company had its first product, SB4, a biosimilar to Enbrel® (etanercept), gained the European Commission (EC)’s approval and in the span of five years, added five additional products to its portfolio, ranging from immunology, oncology to ophthalmology. Its latest product, SB11, a biosimilar to Lucentis® (ranibizumab), was the first ophthalmology biosimilar approved by both the EC and the U.S. Food and Drug Administration (FDA) in August and September 2021, respectively.

Besides the six approved products, Samsung Bioepis has four other biosimilar candidates in the stage of Phase 3 clinical development – SB12, SB15, SB16 and SB17 covering a spectrum of therapeutic areas including ophthalmology, hematology and endocrinology.

With the goal of becoming a socially responsible and sustainable company, Samsung Bioepis published its very first sustainability report in 2021, highlighting the company’s Environment, Social and Governance (ESG) performance. The report details Samsung Bioepis’ efforts across the three pillars of sustainability and commitment (supply chain and environmental management, healthy and safe workplace culture, and corporate governance) to developing long-term ESG initiatives which will be navigated by a dedicated ESG team.

The decade of commitment and dedication of Samsung Bioepis to becoming the world’s leading biopharmaceuticals can be found at www.samsungbioepis.com and the company’s full ESG report can be viewed at https://bit.ly/33AybZx.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – TwitterLinkedIn.

MEDIA CONTACT

[EU news release] Yoon Kim, yoon1.kim@samsung.com

[US news release] Anna Nayun Kim, nayun86.kim@samsung.com

[ROW news release] Jane Chung, ejane.chung@samsung.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/909b0207-cba0-4024-b865-46fb68afd694


 

Europe and Canada move to close skies to Russian planes

Published by
Reuters

By Allison Lampert and David Shepardson (Reuters) -European nations and Canada moved on Sunday to shut their airspace to Russian aircraft, an unprecedented step aimed at pressuring President Vladimir Putin to end his invasion of Ukraine, the biggest attack on a European state since World War Two. Aeroflot said it would cancel all flights to European destinations after E.U. foreign policy chief Josep Borrell said the European Union had decided to close its airspace to Russian traffic. The United States is considering similar action, but has yet to make a final decision, according to U.S. offici… Continue reading “Europe and Canada move to close skies to Russian planes”

13 dead after tourist boat sinks in Vietnam

At least 13 people were killed and four others missing after a tourist boat capsized Saturday in bad weather off the coast of Hoi An, a world heritage-listed Vietnamese city, an official said.The accident occurred as the vessel carrying 39 local touris…

At least 13 people were killed and four others missing after a tourist boat capsized Saturday in bad weather off the coast of Hoi An, a world heritage-listed Vietnamese city, an official said.

The accident occurred as the vessel carrying 39 local tourists and crew members was returning to Hoi An from Cu Lao Cham island — a popular spot for diving, snorkeling and water sports.

Local Communist Party chief Nguyen Sinh confirmed 13 people drowned and four were missing.

Rescue efforts were suspended in the evening because of fading light, he said.

“We cannot do anything further as it is too dark,” he told AFP, adding a full investigation would be carried out and some survivors were receiving medical treatment.

“We will resume the search at first light tomorrow morning for the other four people.”

A local border guard said among the missing were two children.

“Chances of them being found alive are small,” he said.

There had been rough weather — strong winds and big waves in recent days, he said.

Vietnam’s domestic tourism industry rebooted in early February, at the beginning of the Tet traditional lunar new year, after shutting down during strict coronavirus lockdowns and restrictions last year.

Hoi An’s sandy beaches and beautiful architecture are a drawcard for both local and international travelers.

Source: Thai Public Broadcasting Service

Former Thai PM Yingluck to be charged over transfer of NSC chief

The Office of the Attorney-General (OAG) in Thailand has resolved to file malfeasance charges, under Section 157 of the Penal Code, with the Supreme Court’s Criminal Division for Political Office Holders against exiled former prime minister Yingluck Sh…

The Office of the Attorney-General (OAG) in Thailand has resolved to file malfeasance charges, under Section 157 of the Penal Code, with the Supreme Court’s Criminal Division for Political Office Holders against exiled former prime minister Yingluck Shinawatra over the illegal transfer of Thawil Pliensri, secretary-general of the National Security Council back in 2011.

Secretary-General of the National Anti-Corruption Commission (NACC) Niwatchai Kasemmongkol told the media today (Monday) that a joint committee of the NACC and the OAG have agreed that there is sufficient grounds for the OAG to indict Yingluck, as proposed by the NACC.

In 2020, the NACC faulted the former prime minister for abusing her power when she transferred Thawil to the Prime Minister’s Office in 2011. He was succeeded by the then national police chief, Pol Gen Wichean Potephosree.

Wichean was then succeeded by Pol Gen Priewpan Damapong, a close relative of Yingluck, who was due to retire in the following year.

The NACC ruled that the transfer of Thawil was done with undue haste, taking just four days to complete the entire process to pave the way for Pol Gen Priewpan to assume the national police chief’s post.

According to the NACC’s findings, Yingluck placed a phone call to the Office of the Secretary-General of the PM’s Office on September 4th, 2011, to arrange for a vacancy in the Office to accommodate Thawil’s transfer.

On the same day, a memo from the PM’s Office was sent ordering the acceptance of Thawil as an advisor. Another memo was then sent from the to then-deputy prime Minister Kowit Wattana, seeking his approval for Thawil’s transfer. The dates of the two memos were later changed from Sept 4th, which was Sunday, to Sept 5th.

Thawil later took the case to the Administrative Court and he won in both the Administrative and the Supreme Administrative courts.

Source: Thai Public Broadcasting Service