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Merck & Co., Inc. and Crucell Sign Cross-lice

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  1. forum rang 4 Opstapelen 28 december 2006 10:06
    Maxen,
    Dat lijkt me niet, Merck krijgt namelijk de rechten "on an exclusive basis in additional undisclosed vaccine fields". Als Crucell zelf in deze vaccin velden actief was, is de licensie voor Merck niet meer exclusief....

    Dat ligt eraan Maxen. Je kunt met exclusiviteit ook gewoon bedoelen dat je geen nieuwe klanten op dezelfde basis aanneemt. Dat wil niets zeggen over de mensen die al lid zijn van de club.
    Zo zie ik het,
    Erik
  2. sharkie 28 december 2006 10:41
    De exclusiviteit van Merck kan ook de reden zijn dat er de laatste maanden weinig licenties aan andere bedrijfen zijn verleend. Misschien is Crucell wel heel lang in onderhandeling geweest over deze deal en kon deze met goedkeuring van klinische testen van het malaria vaccin pas echt worden getekend.
    Dit zou dan indirect moeten inhouden dat het een superdeal is, want crucell weet ook wel dat het vele licenties kan sluiten wanneer het geen exclusiviteit met Merck afsluit.

    Gr J
  3. [verwijderd] 28 december 2006 10:46
    quote:

    Smartlapje schreef:

    Dat ligt eraan Maxen. Je kunt met exclusiviteit ook gewoon bedoelen dat je geen nieuwe klanten op dezelfde basis aanneemt. Dat wil niets zeggen over de mensen die al lid zijn van de club.
    Zo zie ik het,
    Erik
    Exclusief=exclusief. Is volgens mij redelijk standaard. Dus als Crucell een licentie voor een bepaald vaccin uitgeeft, is dat (denk ik, is wellicht te checken bij PBs) vaak exclusief.
    Dus noch toekomstige, noch huidige klanten die aan een vaccin voor dezelfde infectieziekte werken.
  4. [verwijderd] 28 december 2006 11:17
    Blijft nog de vraag, wat zijn de “vaccin velden” waarvoor Merck een exclusieve licensie krijgt? En voor welke technieken?

    Om met het laatste te beginnen: Staat niks over in het PB, dus zou Advac, Per.C6 of een Berna (of SBL) techniek kunnen zijn. Gezien Mercks voorgeschiedenis, en waarschijnlijk goede ervaringen met Ad5, is het het meest waarschijnlijk dat het hier weer om Ad vectoren gaat, gemaakt op Per.C6.

    Wat betreft de vaccin velden, de vaccins die Merck nu verkoopt zijn tegen:

    Papillomavirus (baarmoederhalskanker)
    Rotavirus
    Measles, Mumps, Rubella and Varicella (mazelen, bof, rode hond waterpokken)
    Zoster/Shingles (reactivatie waterpokken)
    Hib bacterie (hersenvliesontsteking)
    Pneumococcus bacterie (hersenvliesontsteking
    Hepatitis A
    Hepatitis B
    combinaties van bovenstaande

    En dit is de pipeline van Merck:
    www.merck.com/finance/pipeline.swf
    Er zijn twee types coderingen voor de geneesmiddelen in de pipeline,
    MK-xxx en Vxxx. Ik neem aan dat de MK-xxx ‘standaard’ geneesmiddelen betreft, en dat de Vxxx vaccins in ontwikkeling zijn. In dat geval zijn dit Mercks vaccins in de pipeline:

    Phase I:
    CancerV930
    Infectious disease (flu) V512
    Infectious disease (S. aureus) V710

    Phase II:
    HIV V526 (PerC6/Crucell)
    HPV (papilloma) V502
    Infectious disease (pediatric) V419

    Phase III:
    -

    Mercks vaccins in de verkoop en in de pipeline, geven een indruk van Mercks vaccin bezigheden. Nu is niets zeker. Het lijkt me echter onwaarschijnlijk dat Crucell licenties verleent voor HepA of HepB, waar het zelf in betrokken is via Berna. Voor HepC heeft Crucell al een licentie aan Merck verleend. De kinderziektes mazelen, bof, rode hond en waterpokken? Zou kunnen, want daar is Crucell zelf niet in actief. Maar Merck heeft al een vaccin daarvoor...Influenza? Dacht het niet: Sanofi.

    Het meest waarschijnlijk acht ik dat de AdVac techniek wordt ingezet voor vaccins die nog niet in phase I zitten. En in een “vaccine field”, dus niet één afzonderlijk vaccin, maar een hele familie. En Merck denkt groot. Ze hebben vaccin-kandidaat CancerV930 in phase I. Ik denk dus aan kanker vaccins, een sterk opkomend veld, waar Crucell nog geen Advac/Per.C.6 licensees voor heeft.
    (Wel is het zo dat Crucell’s 50%-deelname Pevion een virosoom-gebaseerd borstkanker vaccin in ontwikkeling heeft, en overigens óók een HepC vaccin).
    De tijd zal het leren. Gezien de geheimzinnigheid kan dat echter nog erg lang duren.....
  5. [verwijderd] 28 december 2006 11:34
    quote:

    maxen schreef:

    En Merck denkt groot. Ze hebben vaccin-kandidaat CancerV930 in phase I. Ik denk dus aan kanker vaccins, een sterk opkomend veld, waar Crucell nog geen Advac/Per.C.6 licensees voor heeft.
    (Wel is het zo dat Crucell’s 50%-deelname Pevion een virosoom-gebaseerd borstkanker vaccin in ontwikkeling heeft)
    V950 is overigens een vaccin gericht tegen kankers die een overmaat aan HER-2 eiwit produceren:
    www.clinicaltrials.gov/ct/show/NCT002...
    Net als Pevion's vaccin:
    www.iex.nl/forum/topic.asp?forum=228&...
    en dat dus ook het doelwit is van Genentech's Herceptin antibody's.
  6. [verwijderd] 28 december 2006 14:09
    By: grapesharvester Send PM Profile Ignore Recommend Add To Favorites
    Posted as a reply to msg 967 by dukesig_56
    Re: Who said what to whom

    Both malaria and TB vaccines in development are based upon advac + perc6.
    So I think you read it correctly.

    Apparently some pressure is put on Crucell (most likely by health organisations)to speed up the process of the development of upscaling the production capacity of both very promising vaccines so that mass prodution can take place once they are approved.
    TB is a killer, especially in Africa in combination with HIV.
    TB is also expanding its geographical reach just like malaria.

    As Merck is working with both CRXL technologies, Merck is a natural partner for achieving mass production quickly. Merck is also a close partner of the USA anti bio-tech terror research facilities. Mr Merck supervised the US anti biotech research activities in the early days. So here is a link to the Ebola vaccine development.

    Would be interesting to know when we can expect results from the current tests.
    Actual income for Crucell from both products may arrive quicker than so far assumed after such tests prove that they can be applied commercially.
    www.investorvillage.com/smbd.asp?mb=2...
  7. [verwijderd] 28 december 2006 14:11
  8. aossa 28 december 2006 14:26
    Multivalent vaccines ?

    Door samenvoegen van technologieën en groter vaccineveld bestaat ook de mogelijkheid imo om multivalent vaccines te ontwikkelen. J.Goudsmit gaf al aan dat het aantal dragers beperkt is en wanneer iedereen ongebreideld zijn vaccine op dezelfde dragers gaat enten dat men dan snel op immuniteitsproblemen zal stoten. Nog volgens j.Goudsmit heeft Crucell een techniek ontwikkeld om één en ander te omzeilen. Wat denken de specialisten terzake daarover ?
  9. [verwijderd] 30 december 2006 21:07
    BIOT 240

    Characterization of cholesterol and lipid content in PER.C6 ®Cell Membrane

    Marie-Pierre Gentile1, Nedim Emil Altaras1, and Aboli Rane2. (1) Fermentation and
    Cell Culture, Bioprocess R&D, Merck Research Laboratories, Merck & Co, WP17-201
    PO Box 4, West Point, PA 19486, Fax: 215 993 4884,
    mariepierre_gentile@merck.com, (2) Cornell University

    PER.C6® cells, a human embryonic retinoblast cell line, are grown successfully in
    small and large-scale suspension cultures in serum-free, lipid free culture medium.
    However, addition of a cholesterol-containing concentrate to certain process steps,
    such as cell banking for cryopreservation and vial thaw, has been shown to increase
    process robustness and cell recovery. The cholesterol and lipid content in cell
    membranes were compared for different PER.C6® cell banks and for cultures grown
    under different conditions. Several lipid extraction methods, including solvent-based
    and detergent based methods, were developed and optimized for PER.C6® cells.

    www.acs.org/portal/resources/ACS/Subp...

    Pagina 119.
  10. [verwijderd] 6 januari 2007 18:05
    JANUARY 8, 2007
    Making Her Mark At Merck
    Margaret McGlynn, critical to a post-Vioxx turnaround, is on a fast track

    For Merck's Margaret G. McGlynn, developing drugs is a deeply personal pursuit. As a child growing up in Buffalo, she learned early about the ravages of disease after three of her seven brothers and sisters died in childhood—one of measles before McGlynn was born and two of a rare genetic disorder. She was four years old when the measles vaccine was introduced, and as her mother drove her to a mass-immunization clinic, she reminded her of the child they'd lost. "I was a real believer that vaccines have a critically important role," says McGlynn.

    Today vaccines have a critical role in Merck & Co.'s (MRK ) turnaround effort, and McGlynn is right in the thick of it. The drug giant has launched four new vaccines since McGlynn took over as president of Merck Vaccines in September, 2005. Among them is Gardasil, hailed as a breakthrough because it prevents some forms of human papilloma virus (HPV), a leading cause of cervical cancer. Merck rolled out Gardasil in June for females aged 9 to 26, with marketing focused on educating patients about the link between HPV and cancer. The product brought in $80 million in three months—a debut that CEO Richard T. Clark says beat expectations. When asked if McGlynn, 47, could be a CEO candidate one day, Clark says: "Absolutely. She's definitely CEO material."

    McGlynn, a pharmacist who started at Merck as an intern in 1981, is helping restore some luster to the company's tarnished record. After its $2.5 billion-a-year arthritis medication Vioxx was yanked from the market in late 2004 because of cardiovascular side effects, Merck set out to slash costs and improve the way it develops and markets drugs. Merck expects to report 2006 earnings of at least $5.4 billion before special charges—slightly exceeding the estimate Clark gave at the beginning of the year—on sales of $22 billion. Investors pushed Merck's stock up 36% in 2006, to 43. Analysts are counting on McGlynn to drive much of Merck's growth: Some predict revenues from her division will triple by 2010, to $6 billion.

    Early on, McGlynn proved that she could churn out hits. As a product manager in the late 1980s, she turned Merck's treatment for high blood pressure, Vasotec, into the company's first $1 billion product. Her strategy stressed that the drug was also approved to treat congestive heart failure—an advantage competitors couldn't yet match. When McGlynn spotted rivals working on next-generation blood pressure remedies, she spearheaded an effort to license one from DuPont (DD ), because she knew this would be a faster way into the market than starting from scratch. That drug, Cozaar, and a follow-up are still among Merck's biggest successes, bringing in $3 billion a year.

    An ability to argue her case in a "relentlessly logical and wonderfully intense way," as ex-boss David Anstice puts it, helped McGlynn rise rapidly. She worked in consumer marketing, managed care, and business development. She held top posts in U.S. marketing during the time Merck came under fire and then withdrew Vioxx. But most of the juries that have heard cases against the company have ruled in favor of Merck, and Mc-Glynn has emerged unscathed.

    McGlynn's powers of persuasion have also helped her achieve results on Capitol Hill. Last summer, after Merck won approval to market a vaccine for shingles—a painful disease that strikes the elderly—she started knocking on doors all over Capitol Hill. Turned out that the new Medicare Part D drug plan prevented doctors from getting fully paid to administer vaccines. "I explained to [policymakers] that shingles is a debilitating illness that causes a major impact on quality of life," she says. They seem to have listened: On Dec. 9, Congress passed a bill that fixes the Medicare payment shortfall, which the President signed on Dec. 20.

    Leading Merck's charge into the world of vaccines with the likes of Gardasil presents McGlynn with a new set of challenges. She has spent most of her career working on traditional pharmaceuticals, where success hinged almost entirely on the strength of Merck's marketing muscle. Vaccines, on the other hand, are heavily influenced by a range of powerful organizations, including the Centers for Disease Control and the American Academy of Pediatrics, which issue guidelines for physicians.

    In Gardasil's case, Merck has been lobbying state legislators to mandate the vaccine for all young girls. The idea at first generated resistance from some conservative groups, who feared it would sanction promiscuous behavior, since HPV is sexually transmitted. McGlynn sent members of her team out to talk to the groups: "We meet with anyone, whether they share our viewpoint or not."

    A PEOPLE PERSON
    In the end, McGlynn's skill at navigating political mazes could make the difference between a success and a multi-billion-dollar blockbuster. Kris Jenner, a health-care portfolio manager at T. Rowe Price Group Inc. (TROW ), estimates Gardasil sales will peak at $2 billion a year, but could go as high as $4 billion if the states require it. Four states are weighing laws to mandate Gardasil.

    A talent for marketing and connecting with customers was apparent back in McGlynn's teenage years, when she clerked at her father's community pharmacy. "She got to know all the personalities," says her brother Ed Hempling. "It was like Mayberry." Her admiration for her father's role as neighborhood medical expert led her to follow in his footsteps. Hempling describes her as "one of those kids with a 10-year plan."

    A likely item in McGlynn's plan: fending off GlaxoSmithKline (GSK ), which could launch an HPV vaccine in 2007. Glaxo's record of fierce price competition has some analysts worried that Merck might have to slash Gardasil's $360 price tag. To expand the potential market, Merck is testing it in older women and in men, who can be carriers. Taking a page from her Vasotec playbook, McGlynn plans to promote Gardasil's prime advantage: It protects against four HPV strains, whereas Glaxo's drug guards against only two. "That's a fair price for offering the broadest possible public health benefit," she says. Spoken like a real believer.

    www.businessweek.com/magazine/content...
  11. [verwijderd] 8 januari 2007 20:02
    Generics sale on the cards as Merck Serono starts dealing

    by Anna Lewcock

    Related News

    Merck acquires Serono for €10.4bn
    Actavis gains foothold in Russian generics market
    Hospira bids for global domination in generic injectables
    Actavis sets Barr higher in bidding war for Pliva
    Generic pie to grow bigger but also carved up into smaller pieces
    Actavis Group acquires Alpharma generics business
    Teva to regain generics lead with Ivax purchase

    08/01/2007 - Merck KGaA last week confirmed that it is considering selling off its generics division, prompting mass speculation over potential buyers within the industry.

    While the company itself has released few details and no sale process has yet been initiated, commentators are estimating the sale could be worth up to €4bn.
    Despite Merck stating that it had not yet begun discussions with any potential buyers, industry analysts have proposed several companies that they expect will be paying close attention following the announcement.

    It has been suggested that Sandoz, the generics division of Swiss pharmaceutical Novartis, could be interested in the unit in an effort to keep up with Israel-based Teva Pharmaceuticals, which recently snapped up IVAX putting them at the top of the generic drug manufacturing tree.

    Other organisations being touted are Barr Pharmaceuticals (who recently bought up Croatian generics company Pliva), French firm Sanofi-Aventis, and Iceland-based Actavis which is fast rising up the ranks following recent acquisitions in the generics sector. It is also thought that private equity firms Blackstone and KKR could bid for the business.

    Merck Generics is one of the top generics businesses worldwide, though is in competition with major players Teva, Novartis and Barr. Fighting off the rivals would involve continued investment and further acquisitions, moves which the company is unlikely to make following its acquisition of Swiss biotech Serono for €10.6bn last year.

    Merck Serono

    The new division, Merck Serono, was officially launched by the company today, and is due to be combined with the Merck Ethicals division during 2007 before beginning operation within the pharmaceuticals business division of Merck KGaA. Particular emphasis is being placed on the therapeutic areas of oncology, neurology and autoimmune and inflammatory diseases.

    Under pressure to reduce its debt following the Serono purchase, industry analysts are of the opinion that further investments by Merck to promote its growth in the generics business would not seem a viable option, whereas selling off the unit would appear to make strategic sense for the company. Shares in the firm rose 6.5 per cent following the announcement of the possible sale.

    Consolidation within the generics sector has also pushed Merck lower down the global rankings, and although generic drugs are less profitable than branded versions, the market for copies is growing at a significant rate. The global market for generics was valued at around €29bn in 2005, up 14.3 per cent on 2004. The generics market as a whole has doubled in size since 2001.

    Although selling off the generics unit will cut off over a quarter of Merck's operating profit, divesting in the current climate could enable the company to demand a higher price. In 2005 the generics unit reported sales of €1.8bn and an operating result of €238m. Irrespective of the decision to consider selling the unit, Merck still plans to make a capital increase of €2bn - €2.5bn in Q1 of 2007.

    Consolidation has been the theme within the generics sector of late, with major pharmas snapping up generics manufacturers in a bid to expand product portfolios and geographical range to crowd out smaller competitors.

    The trend is not exclusively within the European sector - Indian firms Ranbaxy and Dr Reddy's have been quick to get in on the game, acquiring generics manufacturers Terapia in Romania and Betatherm in Germany respectively during 2006. Ranbaxy also added GSK's Spanish generics unit Mundogen in July 2006.

    Other major players in generics manufacture include Mylan, Watson Pharmaceuticals and Ratiopharm.

    As more branded blockbuster drugs come up for patent expiry the generics market seems poised for even further growth, suggesting that the trend for consolidation is unlikely to slow down soon.
  12. [verwijderd] 9 januari 2007 06:38
    quote:

    janh1 schreef:

    Generics sale on the cards as Merck Serono starts dealing
    ...
    08/01/2007 - Merck KGaA last week confirmed that it is considering selling off its generics division, prompting mass speculation over potential buyers within the industry.
    Dit stukje gaat overigens over het duitse Merck KGaA, niet over het Amerikaanse Merck & Co, de partner van Crucell, en onderwerp van dit draadje...
  13. [verwijderd] 10 januari 2007 22:00
    quote:

    Japies schreef:

    Allemaal positief, ikke ook, maar vergeten we niet om wat kritisch te kijken naar de deal....?
    Is alles kraakhelder bij jullie omtrent deze deal?

    Ik vind de deal "vreemd" qua de combinatie tussen exclusiviteit en 'niet nader genoemde' vaccins.
    Immers exclusiviteit geef je niet zomaar weg. Sanofi is uit mijn hoofd de enige die exclusiviteit heeft verkregen voor een griepvaccin obv PerC6 en ze betalen er aanzienlijk voor (aanzienlijke milestone payments, royalty 10% en 10 medewerkers van crucell qua salaris uit mijn hoofd).

    =>>Hoe zet je deze deal als crucell nu op papier? <=
    Zijn daar wel de vaccins vermeld waar Merck nu exclusiviteit op heeft?

    Enerzijds is de deal mooi met Merck gezien het vertrouwen (HIV vaccin moet denk ik wel succesvol door clinical trial phase II lopen) en de toegang voor crucell tot de productiefaciliteiten van Merck.
    Anderzijds beperkt Crucell middels de exclusiviteit de aanwas van nieuwe PerC6 licenties voor de 'nader niet genoemde' vaccins...
    Tevens roept het vragen op als de productiefaciliteiten van Merck qua capaciteit 'vol' zitten over een paar jaar. Welk recht of aanspraak heeft Crucell nu hierop (voorrecht boven eigen vaccins Merck?)

    Zoals gesteld de exclusiviteit voor niet nader genoemde vaccins roept bij mij vragen op. Wat als een andere partij dan Merck een PerC6 licentie wil op een 'niet nader genoemd vaccin'. Wat dan?
    Een aantal vragen en onduidelijkheden.

    Hopelijk kunnen we samen hier 'helderheid' in geven.

    Japie
    Is dit misschien het antwoord?

    cws.huginonline.com/C/132631/PR/20001...
    22-12-2000
    .
    Crucell Announces Third Quarter Financial Results
    Op ongeveer midden van de pagina
    In the fourth quarter we have already made good progress on all fronts. We signed an exclusive agreement with Merck & Co., Inc., granting them a license for the PER.C6 platform technology to develop vaccines for the prevention and treatment of one disease. Merck has the option to extend this exclusivity to cover three additional diseases in the future.

    Louis
  14. [verwijderd] 11 januari 2007 00:41
    quote:

    maxen schreef:

    [quote=janh1]
    Generics sale on the cards as Merck Serono starts dealing
    ...
    08/01/2007 - Merck KGaA last week confirmed that it is considering selling off its generics division, prompting mass speculation over potential buyers within the industry.
    [/quote]
    Dit stukje gaat overigens over het duitse Merck KGaA, niet over het Amerikaanse Merck & Co, de partner van Crucell, en onderwerp van dit draadje...
    zo Moeder..zo dochter..
  15. [verwijderd] 11 januari 2007 07:21
    quote:

    janh1 schreef:

    [quote=maxen]
    Dit stukje gaat overigens over het duitse Merck KGaA, niet over het Amerikaanse Merck & Co, de partner van Crucell, en onderwerp van dit draadje...
    [/quote]
    zo Moeder..zo dochter..
    Moeder en dochter spreken elkaar sinds 1917 al niet meer...
    en.wikipedia.org/wiki/Merck_%26_Co.
  16. [verwijderd] 28 februari 2007 14:31
    Merck Announces First Quarter Earnings Per Share Guidance and Raises Full-Year 2007 Earnings Per Share Guidance
    WHITEHOUSE STATION, N.J., Feb. 28, 2007 - Merck & Co., Inc. announced today that it anticipates its first-quarter earnings per share (EPS) will be $0.63 to $0.67, excluding restructuring charges related to site closures and position eliminations, and anticipates reported first-quarter EPS of $0.58 to $0.64. Merck attributed these anticipated results to early revenue trends across the Company's range of products. The Company also raised its anticipated full-year 2007 EPS range to $2.55 to $2.65, excluding restructuring charges related to site closures and position eliminations, and its full-year 2007 reported EPS range to $2.40 to $2.55.
    This guidance does not reflect the establishment of any reserves for any potential liability relating to the Vioxx litigation.
    Merck will hold a first-quarter 2007 sales and earnings conference call with institutional investors and analysts beginning at 9 a.m. ET on Thursday, April 19. During this call, Richard T. Clark, chief executive officer and president, and Judy C. Lewent, executive vice president and chief financial officer, will provide an overview of Merck's financial performance for the quarter. The first-quarter sales and earnings press release and supplemental financial disclosures will be issued that day, prior to the start of the conference call.
    Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782. Journalists are invited to listen only by calling (706) 758-9928 or (800) 399-7917. A replay of the call will be available starting at 11 a.m. ET on April 19 through 5 p.m. ET on April 26. To listen to the replay, dial (706) 645-9291 or (800) 642-1687 and enter ID # 1307506.
    Investors, journalists and the general public may access a live audio webcast of the call on Merck's website at www.merck.com/newsroom/webcast. Software needed to listen to the webcast is available on the corporate website and should be downloaded prior to the beginning of the webcast. A replay of the webcast will be available from 11 a.m. ET on April 19 through 5 p.m. ET on April 26.
    www.merck.com/newsroom/press_releases...

    NL-Betten berichtje in draadje Draadje OT, bijzaken & geleuter in de marge! - Deel 2
    www.iex.nl/forum/topic.asp?forum=228&...

    Nog "méér" via
    www.iex.nl/forum/topic.asp?forum=228&...
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