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Government
MOBILE & TELECOMMUNICATIONS
europa.eu

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Investments

141

Portfolio Exits

11

Funds

3

Partners & Customers

10

About European Commission

The Commission represents and upholds the interests of the EU as a whole, and is independent of national governments. It is headed by 28 Commissioners, one per EU country. The European Commission prepares legislation for adoption by the Council (representing the member countries) and the Parliament (representing the citizens). It administers the budget and the policy programmes (Agriculture, Fisheries, Research etc.) in cooperation with authorities in the member countries.

European Commission Headquarter Location

Belgium

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Latest European Commission News

European Commission Approves Filsuvez® for the treatment of Dystrophic and Junctional EB

Jun 23, 2022

Filsuvez® will be the first and only approved treatment for EB Patients DUBLIN, Ireland, and Boston MA, June 23, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market. The centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East. The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. Dr Joe Wiley, CEO of Amryt Pharma, commented: “The EC approval of Filsuvez® in Europe is a major positive development for European patients who suffer from this debilitating condition. Filsuvez® will be our fourth commercial product for rare diseases. We have in place the team, financial flexibility and global infrastructure to bring it to market swiftly and to execute our significant growth plans. We are very excited to begin delivering Filsuvez® to treat European patients as soon as possible.” About Epidermolysis Bullosa Epidermolysis Bullosa (EB) is a rare and devastating group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development. Patients with severe forms of EB suffer from severe, chronic blistering, ulceration and scarring of the skin, mutilating scarring of the hands and feet, joint contractures, strictures of the esophagus and mucous membranes, a high risk of developing aggressive squamous cell carcinomas, infections and risk of premature death. The global market opportunity for EB is estimated by the Company to be in excess of $1.0 billion. About EASE The EASE trial ( NCT03068780 ) is the largest ever global Phase 3 trial conducted in patients with EB, performed across 58 sites in 28 countries. It comprises a 3-month double-blind randomised controlled phase followed by a 24-month open-label, single-arm phase. Patients with dystrophic and junctional EB target wounds of between 10 and 50cm2 in size that were present for > 21 days and < 9 months were randomized in the double-blind phase to study treatment in a 1:1 ratio and wound dressings applied according to standard of care. 223 patients were enrolled into the trial including 156 pediatric patients. Of those that completed the double-blind phase, 100% entered the open label safety follow up phase. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link . Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link . Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com . Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com

European Commission Investments

141 Investments

European Commission has made 141 investments. Their latest investment was in Hy2Care as part of their Project Finance on June 6, 2022.

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European Commission Investments Activity

investments chart

Date

Round

Company

Amount

New?

Co-Investors

Sources

6/14/2022

Project Finance

Hy2Care

$7.14M

Yes

1

4/15/2022

Grant

GeneusBiotech

Yes

1

4/4/2022

Grant - II

HYBRIT

$157.18M

Yes

3

3/11/2022

Unattributed - II

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$99M

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10

12/27/2021

Loan

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$99M

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10

Date

6/14/2022

4/15/2022

4/4/2022

3/11/2022

12/27/2021

Round

Project Finance

Grant

Grant - II

Unattributed - II

Loan

Company

Hy2Care

GeneusBiotech

HYBRIT

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Amount

$7.14M

$157.18M

$99M

$99M

New?

Yes

Yes

Yes

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Co-Investors

Sources

1

1

3

10

10

European Commission Portfolio Exits

11 Portfolio Exits

European Commission has 11 portfolio exits. Their latest portfolio exit was Aelis Farma on February 18, 2022.

Date

Exit

Companies

Valuation
Valuations are submitted by companies, mined from state filings or news, provided by VentureSource, or based on a comparables valuation model.

Acquirer

Sources

2/18/2022

IPO

1

7/6/2021

Acquired

$99M

8

7/6/2021

Acquired

$99M

10

5/3/2021

Acquired

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10

3/2/2021

Acquired

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10

Date

2/18/2022

7/6/2021

7/6/2021

5/3/2021

3/2/2021

Exit

IPO

Acquired

Acquired

Acquired

Acquired

Companies

Subscribe to see more

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Valuation

$99M

$99M

Acquirer

Subscribe to see more

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Sources

1

8

10

10

10

European Commission Fund History

3 Fund Histories

European Commission has 3 funds, including Venture Capital Fund of Funds.

Closing Date

Fund

Fund Type

Status

Amount

Sources

11/8/2016

Venture Capital Fund of Funds

$437.9M

2

European Startup Fund I

10

Connecting Europe Broadband Fund

$99M

10

Closing Date

11/8/2016

Fund

Venture Capital Fund of Funds

European Startup Fund I

Connecting Europe Broadband Fund

Fund Type

Status

Amount

$437.9M

$99M

Sources

2

10

10

European Commission Partners & Customers

10 Partners and customers

European Commission has 10 strategic partners and customers. European Commission recently partnered with Moderna Therapeutics on June 6, 2022.

Date

Type

Business Partner

Country

News Snippet

Sources

6/2/2022

Vendor

United States

1

5/2/2022

Vendor

United States

Poland has no 'rationale to invoke force majeure in Pfizer vaccine deal -EU official

In April Poland 's health minister Adam Niedzielski saidWarsaw had informed the European Commission and Pfizer that itwould no longer take or pay for COVID-19 vaccines under a supplycontract co-negotiated by the EU , acknowledging this wouldtrigger a legal conflict .

1

4/15/2022

Partner

Italy

Food diplomacy: EU and UN to fight Russia with agricultural aid

`` The EU is committed to strengthening our partnership with the UN to ensure that we leave no one behind and continue to provide humanitarian aid to the most vulnerable while keeping our longer-term engagement to address the root causes of food crises . ''

1

4/7/2022

Vendor

United States

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10

3/16/2022

Vendor

France

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10

Date

6/2/2022

5/2/2022

4/15/2022

4/7/2022

3/16/2022

Type

Vendor

Vendor

Partner

Vendor

Vendor

Business Partner

Country

United States

United States

Italy

United States

France

News Snippet

Poland has no 'rationale to invoke force majeure in Pfizer vaccine deal -EU official

In April Poland 's health minister Adam Niedzielski saidWarsaw had informed the European Commission and Pfizer that itwould no longer take or pay for COVID-19 vaccines under a supplycontract co-negotiated by the EU , acknowledging this wouldtrigger a legal conflict .

Food diplomacy: EU and UN to fight Russia with agricultural aid

`` The EU is committed to strengthening our partnership with the UN to ensure that we leave no one behind and continue to provide humanitarian aid to the most vulnerable while keeping our longer-term engagement to address the root causes of food crises . ''

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Sources

1

1

1

10

10

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