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Uitbreiding activiteiten naar VS

8 Posts
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  1. harrysnel 22 januari 2013 15:28


    uniQure Appoints Philip Astley-Sparke President US

    Jan 22, 2013

    Amsterdam, The Netherlands – January 22, 2013 – uniQure B.V., the leader in the field of human gene therapy, today announced the appointment of Philip Astley-Sparke, former President and CEO of BioVex, as President US to provide strategic leadership and help build uniQure’s clinical, regulatory, and commercial infrastructure in the US.

    Since May 2012, Philip is a venture partner at Forbion Capital Partners, uniQure’s largest investor. As a venture partner he works with selected portfolio companies to help management execute on their business plans. Philip served as Vice President and General Manager at Amgen, Inc. until December 2011, following the acquisition of BioVex, Inc. in March 2011. Philip had been President and CEO of BioVex since 2005, during which he achieved several milestones for the company: its relocation from the UK to the US, the formation of a commercial grade manufacturing facility and nascent commercial capabilities, and the successful negotiation with Amgen to acquire BioVex for up to $1bn. BioVex focused on the development of pioneering first-in-class oncolytic vaccines. Prior to BioVex, Philip was an investment banker with JP Morgan H&Q (Robert Fleming) where he advised on a number of high profile mergers and public financings. He qualified as a Chartered Accountant with Arthur Andersen in London and holds a Bachelor’s Degree in Cellular Pathology and Molecular Pathology from Bristol University (UK).

    “Philip’s experience and expertise will be invaluable in building a successful US infrastructure for uniQure,” says Jörn Aldag, CEO of uniQure. “He is to devote an important part of his time to uniQure, and will become a key member of our management team. We look forward to establishing a foothold in the US, and developing uniQure to full commercial maturity.”

    About uniQure
    uniQure is a world leader in the development of human gene based therapies. uniQure’s Glybera, a gene therapy for the treatment of lipoprotein lipase deficiency has been approved in the European Union, and is the first approved gene therapy in the Western world. uniQure’s product pipeline of gene therapy products in development comprise hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. 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 probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene. uniQure's largest shareholders are Forbion Capital Partners and Gilde Healthcare, two of the leading life sciences venture capital firms in the Netherlands. Further information can be found at www.uniqure.com.
  2. harrysnel 22 januari 2013 15:36
    Reactie op bovenstaand pb met interessante opmerking over de taken van de nieuwe President US (nb: vet zelf aangebracht):

    "Biotech vet Astley-Sparke takes U.S. lead for pioneering gene therapy player

    January 22, 2013 | By John Carroll


    Longtime biotech exec Philip Astley-Sparke will take the U.S. lead for uniQure, the Amsterdam-based developer which recently won the first European approval for a new gene therapy. Named as its new U.S. president, Astley-Sparke--who ran BioVex up until Amgen bought it out in a $1 billion deal and recently was named a Forbion venture partner--tells FierceBiotech that his first task will be to secure a new manufacturing site for the pioneering uniQure, which is planning to file for its first U.S. approval later this year.

    "The whole platform has been de-risked," says Astley-Sparke, citing the EU approval of uniQure's Glybera, a gene therapy that treats rare cases of lipoprotein lipase deficiency, an enzyme deficiency which prevents patients from metabolizing fatty blood particles, triggering inflammation that can lead to a long list of serious ailments. Only one or two people in a million suffer from the condition, and Glybera is expected to test payers' appetite for rare disease drugs once it hits the market with a price expected to approach a million dollars, according to a recent report from Reuters.

    Amsterdam Molecular Therapeutics had failed on several occasions to win an approval for Glybera. Early in 2012, Forbion financed a transfer of the AMT assets into uniQure, which is now one of several upstart biotechs which believe that the decades-long roller coaster ride for gene therapies is ending as a new generation of treatments starts to win regulatory approval. Cambridge, MA-based bluebird bio is also committed to pushing new gene therapies to regulators. And Astley-Sparke says his task will be to build the infrastructure of uniQure as it plots more product launches over the next 5 years.

    "Hemophilia B is the next priority," says Astley-Sparke, with treatments for other conditions like porphyria to follow. His responsibilities as U.S. president also include scouting for fresh capital, which may involve a possible IPO at some point as uniQure builds up its commercial arm."

    www.fiercebiotech.com/story/biotech-v...
  4. harrysnel 15 juli 2013 08:38
    Boston lijkt logische keuze voor VS tak Uniqure, Hier artikel over de hernieuwde aandacht (met name daar) voor gene therapy:

    Gene therapy’s time seems to have come
    Once considered too risky, now offering hope to patients long without it

    ...

    Years after it was hyped, then vilified after the death of a teenager, then mostly forgotten by the general public, gene therapy has rebounded, and hospitals, companies, and investors in the Boston area have jumpedon the bandwagon. Patients are enrolling in a growing number of clinical trials here, and in some cases showing dramatic improvement. The technique, in which doctors “infect” patients’ cells with viruses engineered to carry useful genes, has matured and evolved.

    ...

    Bluebird Bio went public earlier this month, raising $101 million. The first gene therapy, Glybera, made by the Dutch company uniQure, was approved in Europe last year, for a rare disease that causes fat to build up in the bloodstream. A spokesman for the company said it had requested a meeting with the US Food and Drug Administration to get clarity on the approval process.
    nb:vet zelf aangebracht

    ...

    www.bostonglobe.com/lifestyle/health-...
  5. harrysnel 30 juli 2013 11:13
    uniQure bouwt 5100 m2 state-of-the-art gentherapiefabriek in de VS om AAV-productiekracht ten volle te benutten

    • Benoeming Lance Weed tot VP US Operations
    • USD 10 miljoen opgehaald in venture debt

    Amsterdam, 30 juli, 2013 — uniQure B.V., een leider in humane gentherapie, kondigde vandaag aan dat een aanvang is gemaakt met de inrichting van een 5100 m2 state-of-the-art productiefaciliteit in Lexington, Massachusetts voor de productie van gentherapieproducten van commerciële kwaliteit gebaseerd op adeno-geassocieerde virussen (AAV). uniQure heeft in Amsterdam reeds een productiefaciliteit die is goedgekeurd door het Europees Geneesmiddelenbureau (EMA). De onderneming verwacht dat de Amerikaanse fabriek begin 2015 operationeel zal zijn.

    De Amerikaanse site zal de huidige productiecapaciteit van het bedrijf sterk uitbreiden. Zodra de faciliteit operationeel is verwacht uniQure ten volle haar modulaire productieplatform te kunnen benutten en te kunnen profiteren van haar procesleiderschap in de productie van AAV-producten van commerciële kwaliteit. Met twee gevalideerde productielocaties zal de onderneming in staat zijn om materiaal van commerciële kwaliteit te produceren voor haar pijplijnproducten die zich
    richting registratiestudies begeven en de partner bij uitstek zijn voor de productie, ontwikkeling en commercialisering van gentherapieën gebaseerd op AAV.

    In verband met uniQures expansie in de VS heeft de onderneming Lance Weed aangesteld als Vice President US Operations. Mr Weed was voorheen Executive Director, Site Operations bij Amgen en daarvoor VP Operations van BioVex, Inc. Mr Weed heeft uitgebreide ervaring met de productie van geneesmiddelen gebaseerd op virale vectoren en leidde vanaf de allereerste fase de bouw van Amgens (BioVex’) productiefaciliteit voor virale producten van commerciële kwaliteit in Woburn, Massachusetts. Hij treedt aan op 1 september.

    Daarnaast haalde uniQure USD 10 miljoen op in venture debt van Hercules Technology Growth Capital, Inc (NYSE: HTGC) ("Hercules") om de bouw van de Amerikaanse fabriek te financieren en voor algemene werkkapitaaldoeleinden.

    "Met de bouw van deze faciliteit geven wij onze ambitie gestalte om een wereldwijd opererend en volledig geïntegreerd gentherapiebedrijf neer te zetten, terwijl wij onze leidende positie op het gebied van AAV-gentherapieproducten verder bestendigen," zei Jörn Aldag, CEO van uniQure."

    www.uniqure.com/uploads/uniQureHercul...
  6. harrysnel 30 juli 2013 11:23
    Lance Weed is net als Astley-Sparke afkomstig van Biovex; bedrijf dat uiteindelijk door Amgen is gekocht voor zo'n $1mrd. Astley-Sparke was tijdens zijn dienstverband bij Biovex verantwoordelijk voor de relocatie van het bedrijf van UK naar VS, de realisatie van een goedgekeurde produktiefaciliteit en uiteindelijk de verkoop aan Amgen. Weet niet of dit scenario ook opgang zal doen bij Uniqure maar het is wat mij betreft een gunstig teken dat management team bewezen heeft succesvol te zijn bij dergelijke stappen.
  7. flosz 30 september 2013 10:03
    When Will Gene Therapy Come to the U.S.?
    Several gene therapies are or will soon be in late-stage human trials. One of them could be the first to get FDA approval for sale in the U.S.
    By Susan Young on September 30, 2013

    Though many gene therapies have been tested in patients around the world in hopes of curing hereditary diseases, few governments have approved their sale, and none has been approved in the United States. That could change in coming years as several therapies enter advanced trials.

    A big step forward already came in November 2012, when the European Medicines Agency gave the Dutch biotech startup UniQure permission to sell its treatment. That approval came as a relief to many in the field, who had been waiting for a break in the clouds hanging over the technology since failed and fatal trials in the 1990s. “You see a resurgence in terms of investors, and in truth, a number of problems have been solved,” says Katherine High, a medical researcher at Children’s Hospital of Philadelphia, who is overseeing a late-stage clinical trial for a different gene therapy.
    Still, experts say it is likely to be a few years before a treatment is approved in the U.S. With its European approval in hand, UniQure may have good chance of also getting the first U.S. approval, but the company says it has not yet submitted an application to the FDA.

    Like most gene therapies, UniQure’s treatment uses a modified virus to deliver a working copy of a gene to patients who lack a healthy version. In this case, the gene is needed for the body to break down fats; without it, patients can develop painful and even fatal inflammation of the pancreas. UniQure uses a modified version of a virus that most of us already carry. The choice of virus used to deliver a gene therapy depends in part on where the treatment needs to go in the body and whether the viruses are intended to replicate themselves. Some viruses, for instance, are designed to spread throughout the body to kill cancer cells.

    There are several groups that could be the first to develop a U.S.-approved gene therapy (see table). High’s team is one; they are enrolling patients in a late-stage trial of a treatment for a disorder that causes blindness at an early age. The patients in this trial have previously been given the gene therapy in one eye, and now the other will be tested.
    In the experimental treatment, doctors inject a virus-based particle just behind a patient’s retina. The treatment improved some patients’ vision to the point that they were no longer legally blind. Some patients have been stable for nearly six years. The trial is scheduled to end in April 2015.

    Another possibility comes from Massachusetts-based Bluebird Bio, which has published results from patients who have seemingly been cured of a genetic blood disease (see “Gene Therapy Combats Hereditary Blood Disease”). The company is about to start testing its approach in a hereditary neurological disorder that is often fatal in young boys.
    In a different form, gene therapy could also become an option for cancer treatment. At a meeting this summer, Amgen announced that it had met its goals for an advanced test of a gene therapy for melanoma that has spread from the skin to other parts of the body. The Amgen treatment, which was engineered from a virus that normally causes cold sores, takes a two-pronged approach to fighting cancer. The virus selectively infects cancer cells, where it replicates until the cell bursts. While growing inside the cell, the virus also produces a protein that rouses the immune system. When the cell explodes, immune cells are attracted to the tumor site to fight the disease.
    In a test in patients with late-stage melanoma, 26 percent of patients whose cancer had spread saw a partial or complete tumor response for at least six months. In 11 percent of patients, the cancer completely disappeared, which suggests that the therapy spreads throughout the body, targeting tumors that weren’t initially injected. Overall survival rates for cancer patients in the trials are expected to be reported in the first half of 2014.
    The completion of these clinical trials is no guarantee that the technology will become widely used. However, companies and hospitals are also starting to build manufacturing plants capable of producing large amounts of virus-based cures. UniQure, for example, announced in July that it is building a 55,000-square-foot plant in Massachusetts to manufacture commercial-grade gene therapy products. It expects the facility to be operational by early 2015.
    www.technologyreview.com/news/519071/...
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