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Crucell announces STAR(TM) Research License
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De omschakeling van cho naar PerC6 is ingewikkelder dan het lijkt. Natuurlijk voornamelijk in het goedkeuringstraject, maar ik verwacht toch ook dat er flinke aanpassingen in de productie noodzakelijk zijn. Wellicht weet een van onze bioboys hier meer van?
Abbott Sues ImClone, Claims Erbitux Infringes Patent By Jeff St.Onge Feb. 6 (Bloomberg) -- Abbott Laboratories, maker of the arthritis drug Humira, sued ImClone Systems Inc., claiming the colon-cancer treatment Erbitux infringes a patent. ImClone makes Erbitux by ``willfully and knowingly'' using Abbott's patented method for creating antibodies, Abbott said in a complaint filed yesterday in federal court in Boston. Erbitux, New York-based ImClone's only marketed product, generated U.S. sales of $652.2 million last year. Abbott, based in Abbott Park, Illinois, said the infringed patent covers ``enhancer sequences'' that stimulate the expression of a gene for the C225 antibody. David Pitts, a spokesman for ImClone, didn't immediately return a voicemail seeking comment. The biotechnology company is controlled by billionaire investor Carl Icahn. Bristol-Myers Squibb Co. helps market Erbitux. ImClone shares fell 13 cents to $29.35 in Nasdaq Stock Market trading at 11:50 a.m. New York time. Abbott fell 19 cents to $52.31 in New York Stock Exchange composite trading. Abbott reported sales of $22.5 billion last year, led by Humira. A separate lawsuit is pending in Boston over a related patent. Repligen Corp. and the Massachusetts Institute of Technology sued ImClone for infringement in 2004. Repligen has an exclusive license to MIT's patent for a cell line it claims was used to develop Erbitux. In September, ImClone lost a court ruling over a patent on a way to inhibit the growth of tumor cells. A U.S. judge ruled that researchers with the Weizmann Institute of Science in Israel developed the technology, a decision that may result in ImClone paying royalties to the institute and its licensing arm, Yeda Research & Development Co. The case filed yesterday is Abbott Laboratories v. ImClone Systems Inc., 07-cv-10216, U.S. District Court, District of Massachusetts (Boston). www.bloomberg.com/apps/news?pid=20601...
Abbott (ABT) Statement Regarding CMS' Proposed Expansion of Coverage for Carotid Artery Stenting 02-06-2007 11:24:57 AM Abbott (NYSE: ABT) expressed support for the proposed National Coverage Determination (NCD) put forth by the Centers for Medicare & Medicaid Services (CMS) to expand its coverage policy for carotid artery stenting (CAS). Under the proposed policy, certain Medicare patients who have a severe carotid blockage and have not yet experienced stroke or a transient ischemic attack (TIA) and are at risk for surgery would, for the first time, have access to carotid artery stenting, a new, innovative technology for patients at risk of stroke. Previously, a subset of high surgical risk patients was covered by Medicare for carotid stenting, specifically those who had already experienced symptoms of TIA or stroke and whose blockages were severe. Carotid stenting is approved by the U.S. Food and Drug Administration (FDA) for high surgical risk patients, both for those who have experienced symptoms and for those who have not.www.abbott.com/global/url/pressReleas... ************************** Abbott to Initiate First Study to Evaluate Xience V Everolimus Eluting Coronary Stent System in Treatment of Women with Cardiovascular Disease First-of-its-Kind Study Designed to Learn More About Cardiovascular Disease in Women ABBOTT PARK, Illinois, February 6, 2007 — Abbott today announced plans to initiate the world’s first drug-eluting stent clinical trial solely in women. The SPIRIT WOMEN trial will aim to increase understanding of how heart disease affects women, and will assess the performance of the XIENCE™ V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions. Each year, more women than men die of cardiovascular disease (CVD), yet women receive only 33 percent of angioplasties, stents and bypass surgeries; 28 percent of implantable defibrillators; and 36 percent of open-heart surgeries. This may be attributed to the fact that diagnosis of CVD in women is more challenging than in men, as women typically exhibit different symptoms than men because their symptoms are more gradual and subtle. Rather than the more commonly-recognized symptoms, such as sudden violent chest pain, or uncomfortable pressure, or fullness, that are predominate in men, women may experience other warning signs, particularly shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue and back, shoulder blade or jaw pain. "Even though more women than men die from cardiovascular disease each year, women today comprise only 25 percent of participants in all heart-related research studies,” said Marie-Claude Morice, M.D., Institute Jacques Cartier, Massy, France, principal investigator for SPIRIT WOMEN. "Cardiovascular disease in women is underdiagnosed and undertreated because the differences between men and women are not well understood. The SPIRIT WOMEN trial is meant to help improve our understanding of cardiovascular disease in women, and the best ways to care for women with CVD.” The SPIRIT WOMEN clinical trial is the first large interventional study to solely study CVD in women and how it differs from men. The SPIRIT WOMEN trial will include approximately 2,000 women from 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The study will evaluate patient and disease characteristics specific to women as well as treatment outcomes such as rate of death, heart attack and target vessel revascularization (TVR) and potential risk of stent thrombosis. The trial will yield specific data on CVD and how it is diagnosed in women. "The SPIRIT WOMEN trial will contribute to therapy access by increasing awareness and understanding of CVD in women while further evaluating the performance of our XIENCE V drug-eluting stent in this patient population,” said John M. Capek, Ph.D., president, Abbott Vascular. “As a leader in vascular care, Abbott believes that it is our role not only to provide the best technologies, but also to ensure that they are being used effectively in as broad a patient population as possible.”www.abbott.com/global/url/pressReleas...
Abbott's Humira Threatens Amgen in $3 Billion Psoriasis Market By Luke Timmerman Feb. 7 (Bloomberg) -- Abbott Laboratories, armed with a drug that delivers better results and is easier to take, stands to take sales from Amgen Inc. in the $3 billion-a-year market for treating the skin disorder psoriasis. Abbott's test results show its Humira is almost twice as effective as Enbrel. Sales representatives plan to argue it's also more convenient, as patients can self-administer Humira twice a month instead of once or twice a week for Amgen's Enbrel. Enbrel was approved in April 2004 for psoriasis; Humira hasn't yet been cleared by U.S. regulators. ``The drug at the head of the class is Enbrel, but Humira may now give them a run for the money,'' said Robert Kalb, a dermatologist at the University at Buffalo School of Medicine in New York, in a telephone interview. Abbott expects psoriasis sales of Humira, its fastest- growing drug, to reach $500 million a year after the Food and Drug Administration gives approval. Sales of the drug to treat rheumatoid arthritis will reach $2.7 billion this year without the additional approval, Abbott says. Enbrel, which also treats arthritis, accounted for 80 percent of 2006 psoriasis drug sales. About 30 percent of Enbrel sales come from psoriasis and psoriatic arthritis -- a combination of psoriasis and rheumatoid arthritis -- according to Thousand Oaks, California-based Amgen. ``We expect that Humira will emerge as a key competitor to Enbrel in 2008 and beyond,'' Geoffrey Meacham, an analyst at J.P. Morgan Securities Inc., wrote in a note to investors. Humira Results About 71 percent of patients on Humira had at least three- fourths of lesions clear up, compared to 6.5 percent of patients on a placebo, the Abbott Park, Illinois-based company reported at a meeting of dermatologists last week. About 47 percent of patients on Amgen's Embrel did as well in an earlier study. Kalb, the dermatologist, said he was impressed by the number of patients who responded to Humira. Kalb has been a clinical investigator and a consultant for all the psoriasis drugmakers. ``That 71 percent is a very lofty number,'' he said. None of the biological psoriasis drugs have been compared head-to-head, only against placebos or standard chemotherapy. Amgen is likely to claim that Enbrel is safer than rival drugs, J.P. Morgan's Meacham wrote. Unlike Enbrel, Humira's label carries a so-called ``black box'' warning -- the most serious caution required by the FDA -- alerting users to a small risk of serious infections, including tuberculosis. Risk of Infections Enbrel also carries a risk of infections including pneumonia and sepsis, and about 4 percent of patients in clinical trials quit taking it because of severe side effects, Amgen has said. The most common side effect is mild redness and swelling at the injection site. ``Enbrel is the No. 1 biologic for moderate to severe psoriasis, and that's a testament to physicians' confidence in it,'' said Sonia Fiorenza, an Amgen spokeswoman. ``It has a strong safety and effectiveness profile and is well-established.'' The psoriasis market includes other types of treatments such as ultraviolet light therapy, for a total of about $3 billion in sales a year, according to the National Psoriasis Foundation. The biotech drugs are all costly, roughly $10,000 to $35,000 a year. That leads many insurers to insist patients first try lower-cost light therapy or methotrexate, a chemotherapy drug, before switching to so-called biologicals, said John Winfield, a dermatologist in private practice in Bellevue, Washington. Millions Afflicted As many as 7.5 million Americans, mostly adults, suffer from psoriasis, according to the National Institutes of Health. Amgen estimates about 1.1 million Americans have moderate to severe forms that make them candidates for Enbrel; only about 6 percent are treated with a biotech drug. The disease occurs when white blood cells produced by the immune system become overactive. Instead of attacking foreign viruses or bacteria, they lash out against otherwise healthy skin cells with inflammation. Both Enbrel and Humira work by soaking up excess inflammatory cells. Humira's results were among the most impressive data presented at the American Academy of Dermatology meeting in Washington, said Mark Lebwohl, chairman of the dermatology department at Mt. Sinai Medical Center in New York. Results for trials of Johnson & Johnson's Remicade and Genentech Inc.'s Raptiva were also reported at the 5-day meeting ended yesterday. Lebwohl, who has consulted for all the psoriasis drugmakers, said Enbrel will remain competitive after Humira arrives because it has developed a strong hold after almost 3 years on the market. ``Having a head start is a big deal,'' Lebwohl said in a telephone interview. ``Enbrel has things going for it. A lot of people already use it and are happy with it. They won't switch just to try something new.'' `Derm Wars' Abbott expects to apply for approval of Humira for psoriasis in the first half of this year and hopes to bring it to market in 2008. Abbott is telling reporters to brace for the ``Derm Wars.'' ``Our data are strong,'' company spokeswoman Liz Shea said in a telephone interview. ``Humira is much more effective at clearing skin than Enbrel, and much more convenient than Remicade. We feel we have a best-in-class therapy.'' To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net Last Updated: February 7, 2007 00:06 ESTwww.bloomberg.com/apps/news?pid=20601...
February 27, 2007 Media Inquiries: Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Treatment For Crohn's Disease The Food and Drug Administration (FDA) today approved Humira (adalimumab) to treat adult patients with moderately to severely active Crohn's disease, a chronic inflammatory disease of the intestines, which affects an estimated one million Americans. Humira is a human-derived, genetically-engineered monoclonal antibody (a protein that can be produced in large quantities in a manufacturing plant). The product acts to reduce excessive levels of human tumor necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses. The labeling includes a boxed warning about potential serious adverse events. Crohn's disease is a chronic, incurable, inflammatory bowel disease that causes diarrhea, cramping and abdominal pain, and in some cases, abnormal connections (fistulas) leading from the intestine to the skin. "Humira has been shown to reduce signs and symptoms, and to induce and maintain clinical remission of Crohn's disease in patients who have had an inadequate response to conventional therapy, and in those patients who did not benefit from treatment, or who were intolerant to previous treatment with Remicade (infliximab) therapy," said Dr. Douglas Throckmorton, Deputy Director of FDA's Center for Drug Evaluation and Research. "Today's approval provides patients and their health care providers with a new treatment option. The product has been studied in 1,478 patients with Crohn's disease in four clinical trials comparing the drug to a placebo (contains no active ingredient) and two longer term extension studies. The labeling of Humira includes a boxed warning, the strongest type of label warning, that use of this product has been associated with serious, sometimes fatal, infections, including cases of tuberculosis, opportunistic infections, and sepsis. Before initiating Humira treatment, patients should be evaluated for tuberculosis risk factors and tested for latent tuberculosis infection. Other serious adverse events reported by Humira users include lymphoma, a type of cancer. The most frequent adverse events included upper respiratory infections, sinusitis, and nausea. Humira requires subcutaneous injections (under the skin) to initiate treatment for Crohn's disease, and maintenance treatment is administered as one injection every other week. Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, a chronic inflammation of the joints; psoriatic arthritis, which causes joint swelling and scaly skin; and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints. Humira is manufactured by Abbott Laboratories, Abbott Park, Ill. www.fda.gov/bbs/topics/NEWS/2007/NEW0... www.abbott.com/global/url/pressReleas...
Abbott Labs cuts research, sales jobs February 28, 2007, 02:28 AM ABBOTT PARK, Ill. (UPI) — U.S. pharmaceuticals company Abbott Laboratories Inc. is cutting 200 research jobs and several hundred sales jobs following an acquisition, the company said. The drug-research jobs include scientists and researchers in northern Illinois, The Chicago Tribune reported. The scientists were conducting research into early clinical compounds that we are stopping research on, an Abbott spokesman said. Abbott spends more than $2 billion a year on research and development and employs about 7,000 scientists. The sales force reduction is intended to end jobs duplication following last year's $3.7 billion purchase of cholesterol-drug developer Kos Pharmaceuticals Inc. of Cranbury, N.J., Abbott said. Abbott inherited about 1,400 employees in the purchase. Abbott would not say how many of the several hundred sales reps being eliminated are from Kos.www.imedinews.ge/en/news_read/23791
Meer nieuws over STAR op 9 en 10 Juli 2007 ? First International Epigenomics & Sequencing 2007 Meeting on ‘Chromatin Methylation to Disease Biology & Theranostics’ July 9-10, 2007 The Conference Center at Harvard Medical School 77 Avenue Louis Pasteur, Boston, MA 02115, USA “A Unique Theme to Combine Chromatin biology and Diseases with Sequencing Chemistry” Menzo Havenga, Ph.D. Vice President Research Crucell Holland BV, Leiden, The Netherlands Title: STAR and STAR-select technology to increase yield and expression stability of proteins in mammalian cellswww.expressgenes.com/epi07/main.html
Van dirk & aossa: Dirk R. Wijnen - 16 jul 08, 14:40 Abbott verhoogt winstverwachting 2008 16-07-2008 14:17:00 AMSTERDAM (Dow Jones)--Abbott Laboratories Inc. heeft de winstverwachting voor 2008 verhoogd. Dat heeft het Amerikaanse farmaceutische concern woensdag bekendgemaakt bij de publicatie van de tweedekwartaalcijfers. Voor het gehele boekjaar gaat Abbott nu uit van een winst per aandeel exclusief eenmalige items van $3,24 tot $3,28. Eerder rekende het bedrijf op een jaarwinst van $3,20 tot $3,25 per aandeel. De opwaartse bijstelling is het gevolg van sterke internationale verkopen. Daarnaast stelt Abbott de omzetverwachting voor 2008 te verhogen naar een groei van circa 15%. De verwachting van een tweecijferige groei van de winst per aandeel in 2009 blijft gehandhaafd. Over het tweede kwartaal rapporteerde Abbott een stijging van de nettowinst van 34% tot $1,32 miljard. Per aandeel klom de winst naar $0,85 van $0,63. Exclusief items kwam de winst uit op $0,84 per aandeel, tegen $0,69 een jaar eerder. De omzet steeg met 15% tot $7,3 miljard. Analisten gepolst door FactSet Research gingen gemiddeld uit van een winst per aandeel van $0,78 en een omzet van $7,22 miljard. Voor het derde kwartaal voorziet het bedrijf een winst per aandeel exclusief items van $0,76 tot $0,78. D. _____________________________________________ aossa - 16 jul 08, 15:38 Dirk R. Wijnen schreef: Abbott verhoogt winstverwachting 2008 Iets bekend ivm STAR licentie die Abott genomen heeft einde januari 2007 ?crucell.yourbb.nl/viewtopic.php?f=8&t... www.iex.nl/forum/topic.asp?forum=228&... ___________________________ ********************************************* Abbott, WAAR.......www.crucell.com/Partners%20-%20Genera... Van de STAR pagina: Available for licensing Was: Several biopharmaceutical companies have already selected Crucell's STAR™ technology to develop their own products across a wide range of therapeutic areas. Current partners and licensees include GENENTECH, Medarex, Genzyme, Xoma and Millennium. maart 02, 2007 Later: Several biopharmaceutical companies have already selected Crucell's STAR® technology to develop their own products across a wide range of therapeutic areas. Current partners and licensees include Genzyme, Xoma, UCB Celltech, Novartis, Novo Nordisk and ABBOTT. okt 30, 2007 Nu: Several biopharmaceutical companies have already selected Crucell's STAR® technology to develop their own products across a wide range of therapeutic areas. Current partners and licensees include Genzyme, Xoma, UCB Celltech, Novartis and Novo Nordisk. (Uit post mrt., 2008 crucell.yourbb.nl/viewtopic.php?f=8&t...
Abbott niet meer? l.u.l hannessen in Leiden Maar misschien zie ik dat verkeerd.
Volgens mij staat Abbott er niet meer bij. De website is voor het laatst bijgewerkt op 22 april 2008 voor wat betreft de lijst met licensees. Grootoorvleermuis.
wilb52 schreef:
Abbott niet meer?
In eerste instantie zou je dat denken, maar imo is er nevernooit een update incl. Abbott voorbij gekomen. Ook geen vermelding onder kopje terminated. Overigens vermelding op één vd slides laatste AVA met een paar namen (Schering , Selective Genetics )jaren geleden (2003) terminated. (GenVec staat ook op de slide). De pagina part.&lic.-houders is een FLINKE puinhoop en absoluut niet up to date. Mitsubishi Pharma staat er bv nog steeds bij… terminated in 2007, Millennium 2006........
STAR licentie met Abott dd. 31 jan 2007 is een evaluatie licentie. Kan een éénmalige betaling (of toestemming) zijn zonder termijnverplichting (?). Vergelijk met de STAR evaluatielicentie met Genentech.
aossa schreef:
STAR licentie met Abott dd. 31 jan 2007 is een evaluatie licentie.
Kan een éénmalige betaling (of toestemming) zijn zonder termijnverplichting (?).
Vergelijk met de STAR evaluatielicentie met Genentech.
Welke STAR licentie met Genentech. Was puur een farce, das onderhand wel duidelijk. Dus geen enkele STAR overeenkomst is te vergelijken met die van DNA Dirk
Evaluatielicentie is imo geen onderzoekslicentie ! Is derhalve een farce ... "Even een proefritje maken sir ? " "OK maar mag niets kosten hé, en GEEN verplichtingen aub ! "
Ik ben de Brussiaanse zomer nog niet vergeten (2005) Het was ZEKER dat Genentech wel even een licentie zou nemen, niets van terecht gekomen. Dirk (wantrouw)
De omschakeling van cho naar PerC6 is ingewikkelder dan het lijkt. Natuurlijk voornamelijk in het goedkeuringstraject, maar ik verwacht toch ook dat er flinke aanpassingen in de productie noodzakelijk zijn. Wellicht weet een van onze bioboys hier meer van? Productietechnisch hoeft er niet veel te veranderen hoor. Bovendien is Per C6, een stuk 'stabieler', levert hogere celdichtheden en titers. In principe alles groen licht dus. Een probleem is echter dat waarschijnlijk alle equipment waar product mee in aanraking is gekomen "vervuild" is met de voorgaande productie methode (lees product), en zal dus vervangen moeten worden. Je praat over een extreme wijziging in je goedgekeurde drug substance, dus het zal enorm veel voordelen moeten bieden wil een farmaceut overstappen op een ander productie organisme (en dus feitelijk alle klinische studies over zal moeten doen). Vandaar dat er b.v. nog steeds eieren worden gebruikt. De meeste kansen liggen m.i. dus bij producten met een hoge turn over (influenza) of nieuwe producten waar nog wel wat gesleuteld kan worden in efficientie.
Imo is STAR op CHO cellen toepasbaar.
Dat dacht ik ook. Juist geschikt voor CHO. Grootoorvleermuis.
Dirk R. Wijnen schreef:
Ik ben de Brussiaanse zomer nog niet vergeten (2005)
Het was ZEKER dat Genentech wel even een licentie zou nemen, niets van terecht gekomen.
Dirk (wantrouw)
En ik zou wel eens willen weten van Crucell, wat de reden is geweest dat Genentech niet verder is gegaan met STAR. STAR moet wel werken wat anders zou ik niet weten waarom anderen wel verder gaan met STAR. Grootoorvleermuis.
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