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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO (vericiguat). In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world. Bayer also issued a news release earlier today announcing the EC approval.

In January of this year, the U.S. Food and Drug Administration (FDA) approved VERQUVO in the U.S. to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. In the U.S., the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see Selected Safety Information below. In June, the medicine was approved by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. Bayer has also submitted applications for marketing authorization of the medicine in China as well as multiple other countries worldwide.

This announcement reflects another important regulatory milestone in the development of this medicine, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.

About VERQUVO (vericiguat) tablets for once daily oral use (2.5 mg, 5 mg and 10 mg)

VERQUVO is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

Selected Safety Information for VERQUVO in the United States

WARNING: EMBRYO-FETAL TOXICITY

Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.

VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.

In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).

Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension.

There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

About the Worldwide Collaboration Between Bayer and Merck

Since October 2014, Bayer and Merck have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2020 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.

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VERQUVO (vericiguat) Approved in the European Union - Business Wire

The European Union, as one of the largest greenhouse gas emitters behind China and the United States, is set to become the leader of global climate change initiatives as they release their new Fit for 55 plan last Wednesday.If successful, the EU will cut their total emissions 55% by 2030, based on levels from 1990. Already, they are on track to reach their target, as emissions have been reduced by 24%, leaving another 21% to be cut in 9 years. The policies included within the plan cover many sectors of the economy that have been slower to reduce emissions, including industry, transportation, energy, and housing. With a goal this ambitious, the 27 member states and the European Parliament will go through months of negotiations before the package is passed. However, it looks promising that the EU will become the first and largest economy to be driven by greener, more sustainable practices.

European lawmakers have so far responded positively to the new policies, with EU Commission President Ursula von der Leyen at the forefront, calling the target to cut emissions our generational task and the package a part of political aspiration [turning] to legal obligation. Even though other states made initiatives to reduce their overall negative impacts on the environment, the Fit for 55 plan is the first of its kind to have an effect on global trade flows. But, as U.S. Treasury Secretary Janet Yellen claims, theres a powerful incentive once one significant country has adopted this that might inspire other states to follow suit. In all, the transition to a greener economy might be difficult, but beneficial in that our economy will look a lot better, and we can get the climate crisis under control as EU Commissioner Frans Timmermans says.

The EU has made a bold step in combating climate change with their new plan, one that will force a change in how these states and the EU as a whole will operate. But this is the type of legislation needed to make a significant difference in slowing the effects of climate change, because what has been done up to now is not enough. Even if not all of the policies are passed into law, initiatives like carbon border tariffs will pressure companies to reduce their emissions and create a wider impact that reaches outside the EU. The Fit for 55 package is a symbolic move in the right direction and a call for all leaders and policymakers, such as in the U.S., to consider passing stricter legislation that will streamline companies and consumers into moving towards a green economy.

Until this point, many large-scale climate initiatives have been more on an agreement basis, where states will sign a protocol or plan without much enforcement and repercussions for not following policy, such as the Kyoto Protocol. States could even just leave, like the U.S. did with the Paris Accords. But the policies that are adopted with this new package will bind all states in the EU to these standards, and hopefully other outside states move in that direction as their industries will be left at a competitive disadvantage. The EU has already taken initiative in their larger goal towards carbon neutrality by 2050 under the name the European Green Deal. The Fit for 55 is just the most recent proposal moving to fulfill that ambition.

With the introduction of the EUs new set of climate initiatives, there comes praise that this is the beginning of widespread stricter legislation that will hold states, industries and consumers accountable in helping to fight climate change. But there are also its critics, for questions are being raised concerning rising consumer costs such as with energy bills and renovated housing, as well as industry opposition against higher taxes. There is also to consider the gap between richer and poorer states within the EU and being able to front the extra costs ofmoving to renewable practices. Either way, whether those view the Fit for 55 deal as too much or too little, it is still an important step in the wider movement to combat climate change, for the good of everyone.

Excerpt from:
The European Union's New Climate Plan: A Move In The Greener Direction - The Organization for World Peace

In late June, the Council of the European Union gave the green light to the first European Climate Law, following the adoption of the legislation by the European Parliament a few days earlier. The law is designed to reduce greenhouse emissions by 55 per cent (compared to 1990 levels) by 2030 and reach climate neutrality in the next 30 years. The EU is gradually turning into a climate champion, and this step converts its moral commitment into a legal obligation. The law provides European citizens and businesses with certainty and clarity about the path for the green transformation.

While MEPs from opposing sides of the political spectrum rejected some of the provisions of the law, 26 member states voted in favour of it at the Council of the EU. The only exception was Bulgaria. The countrys caretaker government, which has been in place since mid-May, explained the abstention with a brief, vague comment: the final compromise does not reflect sufficiently our national position. Subsequently, the Bulgarian Ministry of Environment and Water specified that the adopted text does not take into consideration several requests from the Bulgarian government, such as the inclusion of natural gas as transition fuel until 2030; recognition of the technology neutrality approach in the transition; or a proposal for a smoother reduction of coal subsidies, which currently sustain Bulgarian coal mining and processing.

The Bulgarian government has acted too late to oppose or affect the EUs legal framework for tackling climate change. The abstention runs counter to both the expectations of Bulgarian citizens and the unions long-running efforts to transform Europe into the first climate-neutral continent.

Successive Bulgarian governments and leaders have been reluctant to commit to a clear path for the green transition within a set timeframe

Since early 2021, the Sofia office of the European Council on Foreign Relations has conducted extensive research into the ways in which Bulgarian businesses and citizens view the EUs green recovery and climate policy efforts. According to a public opinion poll commissioned by ECFR, 80 per cent of Bulgarians support the 55 per cent emissions-reduction target and only 3 per cent oppose it. The survey shows that Bulgarians are strongly supportive of climate-oriented policies, but their concerns are not reflected in the programmes of the political parties. In Bulgaria, 85 per cent of respondents believe that global warming and its consequences are a problem of paramount importance, while just 3 per cent are climate change sceptics 4 percentage points lower than the EU average. Despite their concerns, three-quarters of Bulgarians do not feel informed about or satisfied with the governments position on climate issues. These polling numbers are confirmed by recent Eurobarometer findings. The Eurobarometer study reveals that only 10 per cent of Bulgarian respondents regard their national governments climate actions as sufficient, compared to the EU average of 20 per cent.

Generally, Bulgaria is among the least advanced EU countries in terms of the public debate and executive decisions within the framework of the European Green Deal. Climate change and the commitment to net zero still receive too little attention from Bulgarian politicians and scientists. Lately, the Bulgarian public debate on the European Green Deal has concentrated on the amount, timing, and allocation of EU funds Bulgaria will receive from the blocs planned financing mechanisms. The main rationale for the new EU policy achieving carbon neutrality and resource-saving or recycling has been absent from the national discussion. Successive Bulgarian governments and leaders have been reluctant to commit to a clear path for the green transition within a set timeframe.

The political debate in the country does not reflect the urgency of the issue and, instead of producing forward-looking solutions, is mainly focused on populist slogans on issues such as the danger of high unemployment in the energy sector. This is particularly apparent in the region of Stara Zagora, where a coal mine and two thermal power plants are located. One cannot expect much support for the climate agenda from residents of this area, as political actors have prevented a reasoned debate on the potential closure of the plants.

Moreover, Bulgarias abstention on the European Climate Law not only isolates the country within the EU once again but also reveals two familiar shortfalls in Bulgarian diplomacy. Firstly, the abstention on such an important and unprecedented law shows the Bulgarian civil services lack of expertise and negotiation skill. It had years to negotiate a solution to Bulgarias grievances, while equipping the economy for a low-carbon future. Secondly, the reaction to the abstention in the union resembles the response to the Bulgarian veto of the start of EU accession talks with North Macedonia in late 2020, which damaged Sofias reputation and diminished its bargaining power within EU institutions. And, by resisting the EUs vital efforts to create a joint carbon-neutral future, Bulgaria has undermined European taxpayers confidence that the country will efficiently allocate its share of the Just Transition and Recovery and Resilience facilities to climate mitigation and green investment. While the previous Bulgarian government was struggling to adjust to Europes ambitions of climate leadership, the Commission launched the new legislative package Fit for 55. Adopted on 14 July 2021, the package includes 13 new or revised pieces of legislation that will have a broad impact on all EU economies if the Commission succeeds in addressing all the technical, social, and diplomatic challenges it presents, as ECFRs Alex Clark recently explained. The proposed extension of carbon pricing to the construction and transport sectors is likely to have a major impact on Bulgarian society, as is the carbon border-adjustment mechanisms effect on the price of products imported from neighbouring Turkey and Serbia. This was not the case with the EU Emissions Trading System, whse effect on energy prices largely spared Bulgarian consumers (due to their countrys coal subsidies and partially regulated energy markets). The Bulgarian government will now have to face up to the climate challenge, by the raising expectations of Bulgarian voters and catching up to climate policy developments in Brussels and further afield.

The European Council on Foreign Relations does not take collective positions. ECFR publications only represent the views of its individual authors.

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Bulgarias abstention from the fight against climate change - European Council on Foreign Relations

The latest confrontation between Warsaw and Brussels is more than a judicial disagreement: it marks a key moment in the fight between the rule of law and autocracy that threatens to very essence of the European project.

Last week, Polands constitutional tribunal ruled that decisions of the Court of Justice of the European Union (CJEU) regarding Polish courts violate the Polish constitution. Two days later, the CJEU declared that a chamber of the Polish Supreme Court does not fulfill EU criteria of an independent court and has to cease operations. The Polish authorities, in turn, said that they are not bound to follow the ruling and simply ignored it.

Questioning the supremacy of the EU law and verdicts of the blocs highest judicial body is not a minor offence. The EU is in its very essence a system of rules which requires respect and needs an ultimate arbiter when their application is disputed.

However, the EU institutions are not omnipotent. The boundary between what they are allowed to do and what is reserved for the authorities of the member states is often a matter of controversy. National tribunals and governments tend to complain about the power grab by the European institutions and even question decisions taken by the CJEU.

The current conflict between Warsaw and Brussels/Luxembourg is of a different magnitude, and framing it as a defense of Polish sovereignty against a EU overreach is nonsense.

The subjugation of the judiciary is a key part of the anti-democratic project of Jaroslaw Kaczynski, the leader of the ruling party Law and Justice (PiS). And the intention of the Polish authorities is nothing less than to deny the EU the power to ensure that the courts in its member states remain independent and are not subject to political pressure.

Article 19 of the EU treaty guarantees "effective legal protection" for all EU citizens and companies. The Polish government says that this fundamental provision violates the Polish constitution because it grants the CJEU competence to assess if the national courts including those in Poland meet standards of judicial independence, standards which are internationally recognised and consolidated.

Should the EU the Commission, CJEU and the member states tolerate this defiance, it would pave the way for the destruction of the union. It would give member states a free hand to decide not just the structure of their judicial systems which is the sovereign right of all countries but also the principles they are based on. The EU is a union based upon a common market and common citizenship, but an independent judiciary is also a common good. Allowing member states to subvert it would be suicidal.

In Poland, judges have been harassed for standing up for the separation of power, for submitting questions to the CJEU and for implementing its rulings. The disciplinary system for judges is fully controlled by the minister of justice who nominates both prosecutors and judges and can personally go after each and every judge in the country.

This system, unsurprisingly condemned last week by the CJEU as violating EU principles, is used to intimidate judges, persecute those who criticise the demolition of the rule of law and ultimately to silence any form of resistance to these practices. And it is in the defense of this system as a pillar of the ongoing autocratic transformation that the Polish government and its subservient constitutional tribunal risk the future of the country and that of the EU.

All this is reflected in a report published this week by the European Commission in the framework of its yearly monitoring of the rule of law. In spite of an unemotional language, the report reads like a desperate cry or even an indictment.

"There are risks as regards the effectiveness of the fight against high-level corruption, including a risk of undue influence on corruption prosecutions for political purposes," the paper notes about Poland, proving it wasn't the lack of knowledge but political resolve that failed to prevent the current showdown. Now the stakes for both the EU and Poland could not be higher.

The Commission has already given Warsaw until 16 August to comply with the CJEU verdict. Otherwise, Brussels will request the court to impose daily financial penalties.

But the Commission must go further than issuing an ultimatum: it needs to clearly say that, as long the constitutional barriers for the application of the EU law are in place in Poland, payments from the Recovery Fund will be withheld. Moreover, the executive should trigger the newly established conditionality mechanism which is supposed to protect the EU financial interests against the risks related to deficiencies of the rule of law. Obviously, all of this will not work without the public backing from the member states.

In short, the EU needs to let the money its most powerful argument speak, since all more diplomatic ways have failed.

The recent escalation in Warsaws conflict with the EU could be the swan song of Kaczynskis waning power. His parliamentary majority is crumbling and the return of Donald Tusk his old political enemy to Poland revives unpleasant memories. For Kaczynski, this is a race against time. By tightening autocratic screws, he wants to secure the power before it slips away. But yet another, after Hungary, autocracy beefed up by huge EU funds would open the way for self-destruction of the European project.

This is the moment of truth when both the EU and Poland need a very powerful political signal that crossing indisputable red lines the binding nature of the rule of law can and will not be tolerated.

--

Piotr Buras is the head of the Warsaw office of the European Council on Foreign Relations and co-author of the report "Defending the EU against grand corruption. The rule of law mechanism and Poland".

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Poland's legal defiance is the EUs moment of truth | View - Euronews

Ursula von der Leyen, head of the European Commission, first unveiled the Canada-EU partnership at a summit in June. Courtesy of the European Commission.

Canadas Minister of Natural Resources, Seamus ORegan, and the European Commissioner for Internal Market, Thierry Breton, released a joint statement on July 19 on the Canada-EU Strategic Partnership on Raw Materials. The statement is a follow-up on the framework for the partnership, which was released on June 15.

At that time, Ursula von der Leyen, head of the European Commission, said that the agreement was intended to encourage market diversification from Chinas raw materials supply chain. We as Europeans want to diversify our imports away from producers like China because we want more sustainability, less environmental damage and we want transparency on raw materials. Justin Trudeau, at the time, underscored the potential climate and employment benefits of the partnership, saying that, in order to continue creating good, green jobs for the middle class, we must secure supply chains for critical minerals and metals that are essential for things like electric car batteries, indicating the centrality of materials crucial to the development of green tech to the partnership.

Related: Funding will go to phasing out the use of coal at the Sault Ste. Marie steelmaker

The partnership is designed with the intention of solidifying supply chains for raw materials between Canada and the EU, with the stated goals of creating jobs and combatting climate change.

In Mondays joint statement, the two parties announced some of the key initial deliverables for the project: securing European and Canadian financial support for critical mineral projects in both Canada and the EU; setting up prize-based innovation challenges; and advancing best practices on mapping and classifying critical minerals. A joint event is also planned on Tracing Net-Zero Battery Minerals in order to support research and innovation.

The joint statement also re-emphasized some of the goals of the partnership: Through this strategic partnership, we are joining forces to tackle strategic dependencies, build critical minerals and metals value chains, boost our competitiveness in global markets and develop the clean technologies needed [to accomplish those goals].

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Canada and European Union outline critical minerals partnershipSome of the key initial deliverables of the partnership are intended to diversify and...