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VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.

Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option, said Peter Greenleaf, President and Chief Executive Officer, Aurinia. People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, were excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes.

Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.

A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.

The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.

About Lupus Nephritis

LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About LUPKYNIS

LUPKYNIS is the first U.S. FDA-approved and EC-approved oral medicine for the treatment of adult patients with active lupus nephritis (LN). LUPKYNIS is a novel, structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinias proprietary personalized eGFR-based dosing protocol. Boxed Warning, warnings, and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis. The Companys head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS

LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

ADVERSE REACTIONS

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

SPECIFIC POPULATIONS

Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

Renal Impairment: Not recommended in patients with baseline eGFR 45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinias estimate as to the timing of marketing authorization for Great Britain; and Aurinias estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who have developed LN at time of SLE diagnosis; Aurinia being confident that it is poised for growth and success. It is possible that such results or conclusions may change. Words such as anticipate, will, believe, estimate, expect, intend, target, plan, goals, objectives, may and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; that Aurinias intellectual property rights are valid and do not infringe the intellectual property rights of third parties; assumptions related to timing of interactions with regulatory bodies; and that Aurinias third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the market for the LN business may not be as estimated; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinias business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinias clinical studies and from third party studies and reports may not be accurate; Aurinias third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; regulatory bodies may not grant approvals on conditions acceptable to Aurinia and its business partners, or at all; and Aurinias assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinias control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinias most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators System for Electronic Document Analysis and Retrieval (SEDAR) website at http://www.sedar.com or the U.S. Securities and Exchange Commissions Electronic Document Gathering and Retrieval System (EDGAR) website at http://www.sec.gov/edgar, and on Aurinias website at http://www.auriniapharma.com.

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Aurinia Announces European Commission Approval of LUPKYNIS (voclosporin) for the Treatment of Lupus Nephritis - Business Wire

Issued on: 16/09/2022 - 14:51

The European Commission unveiled a raft of new rules on Friday to ensure media independence after growing fears of state meddling in eastern EU countries such as Hungary and Poland.

Brussels has grown increasingly worried about the weight of the state on news and media in a growing number of EU countries, with public television in Hungary widely seen as a mouthpiece for Prime Minister Viktor Orban.

Media pluralism is also a concern in the Czech Republic where former prime minister Andrej Babis owns a major media group and has been accused of subverting press freedom after he used his newspapers to attack the integrity of other news outlets.

The European Media Freedom Act will provide "common safeguards... to guarantee that our media are able to operate without any interference, be it private or public," said EU commissioner Thierry Breton.

"We're proposing a regulation which will apply across the board in Europe in the same way and according to the same rules," he said.

One of the main components of the law will be a new authority that will allow the EU's 27 countries to have an eye on media mergers that would affect the plurality of media ownership.

It will also demand that funding of state media be "adequate and stable" in order to prevent governments using budget allocations to pressure publicly owned media companies and newsrooms.

The regulation, which needs to be approved by EU member countries and the European Parliament, would also require that national governments pass laws that adequately guarantee the protection of journalistic sources.

The European-wide watchdog will be composed of national regulators that would ensure the proper enforcement of the law across the EU.

They would also coordinate the EU's response to non-EU media, a key source of concern after the difficulty of aligning a united response to the presence of Russia Today, a Kremlin-funded television channel, in the days following the Russian invasion of Ukraine.

"We want it to apply as quickly as possible... because we consider it to be a matter of great urgency," said EU commission Vice President Vera Jourova.

(AFP)

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European Union toughens stance on state meddling in media - FRANCE 24 English

In its Resolution of 15 September 2022 on the situation of fundamental rights in the European Union in 2020 and 2021, the European Parliament calls on EU Member States to accept, without delay, that they should be bound by Article 31 of the Revised European Social Charter on the right to housing.

It stresses in that respect that housing is a fundamental necessity and that access to housing, particularly housing assistance, is a fundamental right, as citizens who lack housing cannot participate fully in society or avail themselves of all of their fundamental rights. It also expresses particular concern that young people are deprived of housing due to the huge increase in house prices, especially in certain urban areas.

In addition, the European Parliament calls on the European Commission to look into steps needed for the EU to accede to the European Social Charter.

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European Parliament calls on EU Member States to accept Article 31 of the Revised Charter on the right to housing - Council of Europe

FAIRFIELD, Conn. (Sept. 14, 2022)In response to todays State of the European Union Speech, Director of Save the Children Europe Ylva Sperling issued the following statement:

In todays State of the European Union address, President Ursula von Der Leyen spoke of the massive challenges that children face as a result of the conflict in Ukraine.

Since February, over three million children have been internally displaced and approximately two million children have fled Ukraine to the EU. Save the Children welcomes the President's recognition of the harm children face, her commitment to fund the aid response, including the specific investment of 100 million EUR to reconstruct destroyed schools, and her steadfast solidarity with refugees from Ukraine.

We also strongly agree with President von Der Leyen that the welcome shown to Ukrainian refugees in the EU must not be an exception, and should be the blueprint for moving towards a Europe that treats all children on the move with dignity and respect. Today, too many children at Europes borders face violence and denial of asylum or adequate servicesthe response to the arrival of refugees from Ukraine shows that another way is possible.

The impacts of the conflict extend far beyond children from Ukraine, however, and children in Europe and around the world are at a critical juncture. The economic shocks from the Ukraine conflict are creating an unprecedented energy and cost-of-living crisis in the EU, and President von Der Leyens recognition that much more needs to be done is important. Key instruments like the Child Guarantee should be fully and urgently implemented and EU funds such as the ESF+ should be strategically allocated to support struggling children and families.

The shocks are also exacerbating an already critical global food crisis, with some 60 million children around the world acutely malnourished. These children must not be forgotten or deprioritized.

We welcome President von Der Leyens commitments to future generations, particularly in the face of the escalating climate crisis. Following through on climate commitments and redoubling efforts to phase out fossil fuels are of critical, existential importance.

We strongly support the need to ensure the ideas and values of the younger generation are at the center of the EUs democratic process, and welcome the announcement that 2023 will be Europes Year of Education and Training. Save the Children looks forward to engaging in the upcoming Child Participation platform to ensure that the views of children, especially marginalized and vulnerable children, are included in the upcoming European Convention.

Save the Children will continue working with and for children in Europe and around the world, and is ready to support the European Union institutions and Member States in delivering their commitments to build a fairer society.

Save the Childrenbelieves every child deserves a future.Since our foundingmore than100 years ago, weve changed the lives of more than 1 billion children. In the United States and around the world, we give children a healthy start in life, the opportunity to learn and protection from harm. We do whatever it takes for children every day and in times of crisis transforming their lives and the future we share. Follow us onFacebook,Instagram,TwitterandYouTube.

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Save the Children Europe Responds to State of the European Union Speech - Save the Children

European Commission President Urusla von der Leyen delivers state of the European Union address to the European Parliament, in Strasbourg, France, September 14, 2022. REUTERS/Yves Herman

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BRUSSELS, Sept 14 (Reuters) - The European Union executive will recommend suspending billions of euros earmarked for Hungary over corruption woes, two officials told Reuters on Wednesday, in what would be the first such move against Prime Minister Viktor Orban.

The head of the executive, European Commission President Ursula von der Leyen said in her annual policy speech to the European Parliament on Wednesday she would freeze funding for members damaging democracy, and singled out corruption.

"We must fight for our democracies... I would like to focus on corruption," she said, without naming Hungary specifically.

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But her executive was expected to recommend on Sunday the suspension of up to 70% of 22.5 billion euros ($22.44 billion)worth of cohesion funds earmarked for Hungary from the EU's 2021-27 budget, according to the EU officials. Neither specified the exact sum in question.

The Hungarian forint and bonds weakened on the news on Wednesday as European lawmakers denounced Orban for years of dismantling the rights of migrants, gays and women, as well as the freedom of media, academics and courts.

"Hungary isn't really a true democracy at all," said Gwendoline Delbos-Corfield, a Green French lawmaker.

Hungary's veteran premier Orban denies such criticism but is under pressure to secure funds for his ailing economy. Budapest promised to set up an anti-corruption agency and said repeatedly it was hoping for a deal with Brussels.

But the Commission has been cautious, with distrust running high after years of acrimonious feuds with Orban.

Any cuts would come on top of some 6 billion euros from the bloc's separate COVID-19 economic stimulus earmarked for Hungary but blocked by the Commission over the same corruption concerns.

EU countries would have up to three months to decide on the Commission recommendation through a majority vote.

One of the officials said any final decision could still change if Hungary follows up with "more detail and implementation" of the anti-graft measures it proposed during that time.

Hungary had by far the highest share of irregularities in the whole bloc in spending EU funds in 2015-19, according to the EU anti-fraud agency. Brussels has long called for transparency, competition and accountability in Hungarian public procurement.

($1 = 1.0025 euros)

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Additional reporting by Gergely Szakacs and Anita Komuves, Writing by Gabriela Baczynska, Editing by Andrew Cawthorne

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EU executive to recommend cutting billions for Hungary - sources - Reuters