uniQure « Terug naar discussie overzicht

Wat is de waarde van uniQure?

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Omlaag ↓

Prof. Dollar 31 oktober 2013 13:18

uniQure is een besloten vennootschap en dat gegeven zullen ze waar mogelijk ongetwijfeld willen benutten. Met de wetenschap dat "all eyes are on uniQure" en met het oog op de nabije toekomst, waarbij de eerste inkomsten een feit zijn, is mijn vermoedden dat ze niet al te ontvankelijk zullen zijn met het naar buiten brengen van financiële details.
Overigens, de aparte vermelding van STAK op de uniQure website is ook verdwenen. Kennelijk wil men de communicatie anders organiseren. Even geduld (en veel vertrouwen) is het devies.

Prof. Dollar 1 november 2013 06:23

Offtopic, maar wel relevant.

Fidelity Biosciences and REGENX Biosciences Launch Dimension Therapeutics to Develop and Commercialize Novel AAV Gene Therapy Products

"Fidelity Biosciences and REGENX Biosciences today announced the formation of Dimension Therapeutics, a gene therapy company focused on developing novel treatments for rare diseases. Dimension will focus on advancing its platform of gene therapy programs in rare diseases through clinical development, starting with lead programs in hemophilia, and building out a world-class product engine for AAV therapeutics. Dimension has completed an undisclosed Series A financing led by Fidelity Biosciences."

www.businesswire.com/news/home/201310...

Dimension, Backed by Fidelity, Targets Hemophilia With Gene Therapy

"And Dimension isn’t the only one doing this. Baxter International (NYSE: BAX), for instance, is also chasing gene therapy products for hemophilia with an AAV vector approach. But Dimension is betting there will be “many winners” in gene therapy, even for hemophilia alone, and that the vectors it has access to will ultimately stand up to the competition."

www.xconomy.com/boston/2013/10/31/dim...

En voor de volledigheid:

Baxter Announces Collaboration with Chatham Therapeutics for Factor IX Hemophilia B Gene Therapy Treatment

www.baxter.com/press_room/press_relea...

[verwijderd] 1 november 2013 18:41

De artikelen die Spark op hun website heeft gezet zijn gebaseerd op studies met het materiaal van AMT (nu uniQure). Mooie resultaten dus!

Alles is uiteraard gepatenteerd, neem ik aan.

Goed weekeinde guys :)

flosz 4 november 2013 15:47

Interview: Paving the way for a whole new medical paradigm

As part of a series of interviews conducted with leading industry experts in the run up to the World Orphan Drug Congress in Geneva, Total Orphan Drugs was delighted to sit down with Hans Christian Rohde, Chief Commercial Officer, uniQure. Total Orphan Drugs would like to take this opportunity to thank Hans Christian Rohde for speaking to us.
Debuting a truly game-changing therapy means thinking beyond the orphan drug box, according to uniQure Chief Commercial Officer Hans Christian Rohde

As the first company to get a gene therapy approved in the Western world, Netherlands-based uniQure is a pioneer on multiple fronts. In October 2012, the European Commission approved the marketing authorization for uniQure’s lead product, Glybera for lipoprotein lipase deficiency (LPLD), a rare, inherited disorder. Patients with LPLD cannot metabolize large fat-carrying particles called chylomicrons, which can lead to painful inflammation of the pancreas (pancreatitis), a potentially lethal condition.

Market adoption of a novel treatment paradigm requires a focus on educating patients and health care providers. As Glybera is a single intervention of intramuscular injections, according to Rohde, it should be weighed differently by the healthcare system and regulators than a drug that involves repeated, ongoing treatments. The final cost of the drug is under negotiation. “We need to think outside of the orphan drug box in determining value.” said Rohde. “As Glybera involves a one-time administration, it is not expected to use the same mechanisms of cost effectiveness. A number of patients will not be coming back to the hospital.”

The regulatory basis consisted of three open-label clinical trials in which uniQure administered Glybera to a total of 27 adult LPLD patients. “The patients experienced a significant reduction in newly formed chylomicrons, as well as reductions in acute pancreatitis resulting in a significant reduction in the number of hospitalizations.” said Rohde.
The drug was well tolerated, even after patients were followed for up to 3 years. The most common adverse event was general muscle pain at the injection site occurring in approximately one third of patients.

That is just the beginning. uniQure is expanding its gene therapy platform to other conditions. “Imagine if you have people in perhaps 10 indications, what does that mean for society, for our healthcare structure?” said Rohde. “Finally there may be a treatment for many diseases that would not otherwise have a treatment at all or a treatment which provides the patient with a potentially lifelong benefit. It will have a major impact on how our primary and secondary healthcare will look like going forward.” uniQure is also in the process of building a patient registry to collect ongoing data as part of the EMA approval of Glybera under exceptional circumstances.

Rohde notes that European and US markets are somewhat different in terms of the role patients play in orphan drug development and approval. In Europe, patient advocacy organizations are much less organized than those in the U.S. The U.S. Food and Drug Administration frequently solicits feedback from patient advocacy organizations when evaluating orphan drugs. This is less the case in Europe.

I think you should never forget the patient,.” said Rohde. “Gene therapy has so far changed the course of the lives of those patients who participated in the clinical trials.” According to Rohde, it is important that patients and patient groups understand the safety and efficacy of the drug as a one-time treatment, given that no other treatment for this condition exists today. “Apart from the administrative injectable side effects there haven’t been observed any serious side effects.” said Rohde. “However, the patient has to agree that this is a treatment that they want to have.”

1. Your drug may be rolled out globally but all reimbursement is local
The pricing and reimbursement process can vary tremendously from country to country in Europe. Obtaining P&R approval in Europe has potentially a different set of conditions than approvals in the U.S.

2. Communicate with regulators early and often
It is important to talk with pricing- and reimbursement authorities early on to ensure a constructive dialog as this paradigm is new for both parties,- it is also clear that there is as yet no structured regulatory path for gene therapy. “We had a bumpy road for the approval of Glybera.” said Rohde. “This is the first approved gene therapy treatment in the West and was recognized as a learning experience for both parties, potentially paving the way for approval of similarly medicines in future.” We are pioneering the path with the regulatory authorities, and doing the same with the price and reimbursement.”

3. Get strong support from Key Opinion Leaders
As this is breaking new ground it needs strong support from Key Opinion Leaders (KOLs) – the researchers who are driving knowledge acquisition and dissemination in the field. This is particularly critical in orphan diseases, where small populations can be scattered around the world.

Company Profile
uniQure is a world leader in the development of human gene based therapies. uniQure’s pipeline of gene therapy products in development, in-house or with collaborators, comprises hemophilia B, acute intermittent porphyria, Parkinson’s disease and Sanfilippo B. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate what it believes to be the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases.
blogs.terrapinn.com/orphan-drugs/2013...

Prof. Dollar 8 november 2013 21:28

Ter info: De financiële verantwoording (2012 en wat weetjes over 2013) is verstuurd aan de NPEX-geregistreerde certificaathouders. Veel leesplezier.

BNP 8 november 2013 22:03

Even een vraag. Ik ben wel certificaathouder, maar heb niets ontvangen. Of moet je daarvoor weer op een aparte mailinglijst van de STAK staan ofzo? Is het mogelijk alsnog die informatie te krijgen?

[verwijderd] 8 november 2013 22:13

quote:
BNP schreef op 8 november 2013 22:03:
Even een vraag. Ik ben wel certificaathouder, maar heb niets ontvangen. Of moet je daarvoor weer op een aparte mailinglijst van de STAK staan ofzo? Is het mogelijk alsnog die informatie te krijgen?

zijn de certificaten naar NPEX overgeheveld? Zo ja, dan kan je het beste even contact met hen opnemen en vragen waarom je geen mail m.b.t. STAKmeeting hebt ontvangen.

Via NPEX kan ik als het goed is alle aandeelhouders mailen t.b.v. de bijeenkomst...wel handig als iedereen ook die mail t.z.t. ontvangt.

BNP 8 november 2013 22:18

Ik zal even contact met ze opnemen, want om jouw vraag te beantwoorden mijn certificaten staan wel degelijk op de NPEX.

[verwijderd] 11 november 2013 16:04

De jaarcijfers 2012 staan nu ook op Npex onder nieuws.

Prof. Dollar 11 november 2013 18:34

If the prof says... ;-)

uniQure Announces Confidential Submission of Draft Registration Statement for Initial Public Offering

Nov 11, 2013

uniQure B.V., a leader in human gene therapy, today announced that it has confidentially submitted a registration statement on Form F-1 to the U.S. Securities and Exchange Commission (“SEC”) relating to a possible initial public offering of its ordinary shares.

Amsterdam, the Netherlands, November 11, 2013 — uniQure B.V., a leader in human gene therapy, today announced that it has confidentially submitted a registration statement on Form F-1 to the U.S. Securities and Exchange Commission (“SEC”) relating to a possible initial public offering of its ordinary shares. The number of ordinary shares to be offered and the price range for the offering have not yet been determined.

The initial public offering is expected to commence after the SEC completes the review process with respect to uniQure’s registration statement, subject to market conditions and other considerations.

This announcement is being made pursuant to and in accordance with Rule 135 under the Securities Act of 1933. This press release is not intended to, and does not, constitute an offer of any securities for sale.

www.uniqure.com/news/184/182/uniQure-...

QLVT 11 november 2013 19:10

uniQure kondigt vertrouwelijke indiening van ontwerp-registratie verklaring voor Initial Public Offering

11 Nov 2013

uniQure B.V., een leider in menselijke gentherapie, heeft vandaag aangekondigd dat het een registratie verklaring op formulier F-1 tot en met de U.S. Securities and Exchange Commission ("SEC") met betrekking tot een mogelijke beursgang van haar gewone aandelen vertrouwelijk heeft ingediend.

Amsterdam, the Nederland, 11 November 2013 — uniQure B.V., een leider in menselijke gentherapie, heeft vandaag aangekondigd dat het een registratie verklaring op formulier F-1 naar de U.S. Securities and Exchange Commission ("SEC") met betrekking tot een mogelijke beursgang van haar gewone aandelen vertrouwelijk heeft ingediend. Het aantal gewone aandelen worden aangeboden en de prijsklasse voor het aanbod zijn niet nog vastgesteld.

De beursgang naar verwachting worden begonnen nadat de SEC is voltooid het toetsingsproces met betrekking tot uniQure van registratie verklaring, onderworpen aan de marktvoorwaarden en andere overwegingen.

Deze aankondiging wordt gemaakt krachtens en overeenkomstig artikel 135 van het onder de Securities Act van 1933. Dit persbericht is niet bedoeld om, en niet het geval is, vormen een aanbieding van effecten voor verkoop.

Sluiten

QLVT 11 november 2013 19:11

Wie kan mij uitleggen wat dit allemaal inhoud .

[verwijderd] 11 november 2013 19:24

Dear holders of Depository Receipts,
Please find attached a press release that was published by uniQure BV on November 11, 2013.
The Management Board and the Supervisory Board of uniQure have requested the STAK Board to suspend trading immediately after publication of this press release announcing the filing of the registration statement on Form F-1 with the SEC and to agree to a lock-up period of 180 days from the date of the Prospectus. This includes cancellation of the trading session on NPEX scheduled for 21 November 2013.
The Management Board and Supervisory Board of uniQure have requested the STAK Board to sign a lock-up agreement which is equivalent to the terms of the lock-up agreements signed by the other uniQure shareholders. The Management Board and Supervisory Board of uniQure have confirmed that an exchange of DRs for (reclassified) ordinary shares will take place upon expiration of the lock- up period and that such ordinary shares will be tradable on NASDAQ. Moreover, the Management Board and Supervisory Board of uniQure have confirmed that the sub-classes of uniQure A, B and C ordinary shares will be consolidated into a single class of ordinary shares.
The Management Board and Supervisory Board have made these requests to the STAK Board following discussions with the underwriters to the proposed issue, to support the proposed issue and believe that these steps are in the best interest of the shareholders.
According to the Class B Shareholder Agreement, the STAK is under the obligation ‘to take all steps that are required to ensure the success of any proposed Exit [...]’. Furthermore, the STAK articles of association provide (article 3.1) that the STAK looks after the DR holders’ interests, inter alia by complying with all obligations resulting from agreements with other uniQure shareholders.
As a consequence of this, the STAK board made the following resolutions:
1. Immediately after the F-1 filing has been made public the STAK will suspend DR trading on
NPEX for the period of one year.
2. Consequently, the STAK will request NPEX to cancel the 21 November 2013 trading session
on NPEX.
3. The STAK will enter into a lock-up Agreement with Jefferies LLC and Leerink Swann LLC
providing for a lock-up for the period of 180 days from the date of the Prospectus.
4. In case the IPO is delayed or abandoned or under other circumstances which the STAK Board
deems relevant, the STAK Board will reconsider the trading frequency on NPEX.
In our upcoming DR-holders meeting we will discuss these resolutions with the DR-holders.
Kind regards, STAK Board
For further questions regarding this notice please contact:
Voor vragen met betrekking tot het persbericht kunt u contact opnemen met: Aicha Diba, Corporate Secretary
+31 20 566 8014
a.diba@uniQure.com

[verwijderd] 11 november 2013 19:32

Das super goed nieuws toch ????

Nssnl 11 november 2013 19:53

Lijkt me ook erg goed nieuws. Iemand andere gedachten?

QLVT 11 november 2013 20:04

Heb nog niets van Prof. Dollar of
Ivet gelezen over deze berichten
via onze mail om 19.12 uur.....

[verwijderd] 11 november 2013 20:12

Dus we kunnen niet meer handelen op nexp ??

My new Volvo 11 november 2013 20:13

Nee, handelen zit er niet meer in. 180 dgn.

[verwijderd] 11 november 2013 20:20

[Modbreak IEX: Gelieve op uw taalgebruik te letten, bericht is bij dezen verwijderd.]

[verwijderd] 11 november 2013 20:20

Een half jaar zeg

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