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Crucell announces STAR(TM) Novo Nordisk

1. aossa 21 januari 2007 16:58

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   quote:

   dedokter schreef:

   Stom optie gelul in dit draadje [/quote]
   
   Inderdaad, had je ook niet moeten reageren.
   Over naar: www.iex.nl/forum/topic.asp?forum=228&...
   

2. gogogoo 22 januari 2007 15:02

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   By: ron banged Send PM Profile Ignore Recommend Add To Favorites
   Novo signs up for Crucell's STAR tech...Article from In-Pharma out of France
   
   22/01/2007 - Dutch biotech Crucell last week announced it had signed a research licence agreement with Novo Nordisk for the company's STAR technology.
   
   Danish firm Novo will use the non-exclusive licence to evaluate the technology for the production of monoclonal antibodies (MAbs) using its proprietary mammalian Chinese hamster ovary (CHO) cell line.
   
   Details of the agreement were not forthcoming, although it was released that Novo will pay a licence insurance fee, a success-based fee and annual maintenance fees should the licence be extended beyond the evaluation period.
   
   Novo's move to obtain the STAR research licence fits with the company's announcement earlier this month that it was cutting its small molecule development to concentrate on protein –based therapies. The firm decided to refocus solely on large-molecule biopharmaceutical medicines, discontinuing small-molecule drug development projects such as oral diabetes treatments.
   
   Crucell's STAR technology is intended to increase production of recombinant antibodies and therapeutic proteins on mammalian cell lines. According to the company, the cell clones created by the STAR process produce five to 10 times more antibody or protein than clones produced by other processes.
   
   At present, CHO cell derivatives are used to produce over 90 per cent of all antibodies and therapeutic proteins. The STAR technology can be used with these cell lines (as well as others) to reduce the number of clones that need to be screened to generate a high producing cell line.
   
   The technology can be applied to produce optimal levels of protein for processes such as protein characterisation, immunisation, target discovery, or optimising downstream processes such as protein purification.
   
   Crucell was granted a patent for the STAR technology in 2005, after acquiring the company developing the product, ChromaGenics, in 2004. Several biopharmaceutical companies have agreements and licences with Crucell for the STAR technology, including Genentech, Medarex and Genzyme. Novartis, UCB, Millenium Pharmaceuticals and Xoma all signed research licence agreements with Crucell for the technology during 2006
   
   www.investorvillage.com/smbd.asp?mb=2...
3. [verwijderd] 22 januari 2007 15:08

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   www.in-pharmatechnologist.com/news/ng...
4. [verwijderd] 22 januari 2007 20:42

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   zie link v. Flosz:
   
   Novo signs up for Crucell's STAR tech
   
   by Anna Lewcock
   Get the latest Market Reports on
   Crucell
   Novo Nordisk STAR licence protein
   
   Related News
   
   Novo Nordisk stop small molecule drug development
   Novo Nordisk to sue over inhaled insulin patent knock-back
   Wyeth kicks off CMO agreement with Crucell
   Protein production in chicken eggs cracked
   
   22/01/2007 - Dutch biotech Crucell last week announced it had signed a research licence agreement with Novo Nordisk for the company's STAR technology.
   
   Danish firm Novo will use the non-exclusive licence to evaluate the technology for the production of monoclonal antibodies (MAbs) using its proprietary mammalian Chinese hamster ovary (CHO) cell line.
   Details of the agreement were not forthcoming, although it was released that Novo will pay a licence insurance fee, a success-based fee and annual maintenance fees should the licence be extended beyond the evaluation period.
   
   Novo's move to obtain the STAR research licence fits with the company's announcement earlier this month that it was cutting its small molecule development to concentrate on protein –based therapies. The firm decided to refocus solely on large-molecule biopharmaceutical medicines, discontinuing small-molecule drug development projects such as oral diabetes treatments.
   
   Crucell's STAR technology is intended to increase production of recombinant antibodies and therapeutic proteins on mammalian cell lines. According to the company, the cell clones created by the STAR process produce five to 10 times more antibody or protein than clones produced by other processes.
   
   At present, CHO cell derivatives are used to produce over 90 per cent of all antibodies and therapeutic proteins. The STAR technology can be used with these cell lines (as well as others) to reduce the number of clones that need to be screened to generate a high producing cell line.
   
   The technology can be applied to produce optimal levels of protein for processes such as protein characterisation, immunisation, target discovery, or optimising downstream processes such as protein purification.
   
   Crucell was granted a patent for the STAR technology in 2005, after acquiring the company developing the product, ChromaGenics, in 2004. Several biopharmaceutical companies have agreements and licences with Crucell for the STAR technology, ...........
   
   including Genentech.......,
   Medarex .........
   and Genzyme..........
   Novartis............,
   UCB.........,
   Millenium Pharmaceuticals and..........
   Xoma.........
   AND
   Novo Nordisk ..........
   
   all signed research licence agreements with Crucell for the technology during 2006.
   
   
5. gogogoo 23 januari 2007 13:54

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   Nov Nordisk Discontinues R&D on Small Molecules for Oral Treatment of Diabete
   Filed in archive Corporate and Industrial News , Drugs, Vaccines and Therapeutics , Genomics, Proteomics and Bioinformatics by ruth on January 23, 2007
   
   Denmark-based biopharmaceutical firm Novo Nordisk will cease all its R&D programs in small molecules for the oral treatment of diabetes and will focus instead on its protein-based pharmaceuticals.
   
   "Our core competences lie within therapeutic proteins, and it is within this area that we can make the greatest difference in terms of patient outcomes and company growth. Therefore, it is a logical move to focus all our research and development efforts on this area."
   
   All existing projects on small molecules, including NN9101, a glucokinase activator currently in phase 1 clinical testing, may be out-licensed.
   
   Source: Novo Nordisk
   
   www.biotech-weblog.com/50226711/nov_n...
   
   ......."cease all its R&D programs in small molecules for the oral treatment of diabetes and will focus instead on its protein-based pharmaceuticals."
   
   Op basis van STAR dan maar.....
6. [verwijderd] 23 januari 2007 14:33

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   Nov Nordisk Discontinues R&D on Small Molecules for Oral Treatment of Diabete
   Filed in archive Corporate and Industrial News , Drugs, Vaccines and Therapeutics , Genomics, Proteomics and Bioinformatics by ruth on January 23, 2007
   
   Denmark-based biopharmaceutical firm Novo Nordisk will cease all its R&D programs in small molecules for the oral treatment of diabetes and will focus instead on its protein-based pharmaceuticals.
   
   "Our core competences lie within therapeutic proteins, and it is within this area that we can make the greatest difference in terms of patient outcomes and company growth. Therefore, it is a logical move to focus all our research and development efforts on this area."
   
   All existing projects on small molecules, including NN9101, a glucokinase activator currently in phase 1 clinical testing, may be out-licensed.
   
   Source: Novo Nordisk
   
   www.biotech-weblog.com/50226711/nov_n...
   
   ......."cease all its R&D programs in small molecules for the oral treatment of diabetes and will focus instead on its protein-based pharmaceuticals."
   
   Op basis van STAR dan maar.....
   

   Zie ook pagina 1, PB Novo Nordisk en art. pharmaceutical-business-review, d.d. 15 jan.2007.
   www.iex.nl/forum/topic.asp?forum=228&...
7. gogogoo 23 januari 2007 14:36

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   Oh ja..inderdaad.
8. [verwijderd] 29 januari 2007 17:33

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   Former President Bill Clinton will be the keynote speaker at the Global Changing Diabetes Leadership Forum, taking place on 13 March 2007 in New York hosted by Novo Nordisk and supported by the International Diabetes Federation (IDF).
   
   The Forum will be a provocative dialogue on redefining healthcare focusing on the needs of people with diabetes, and will involve politicians, government officials, international organisations, patient organisations, healthcare professionals and media from more than 18 countries.
   “Diabetes will constitute the most significant public health challenge of the 21st century if no action is taken now. It is already causing as many deaths as HIV/AIDS. We need to explore practical ways of redefining healthcare, by focusing on the needs of people with diabetes,” says Lars Rebien Sørensen, president and CEO of Novo Nordisk.
   The discussions at the Forum will explore the concepts described last year by Harvard Professor Michael E Porter and Professor Elizabeth Teisberg in their book Redefining Health Care: Creating Value-Based Competition on Results. Professor Elizabeth Teisberg will be attending the Global Changing Diabetes Forum and share her thoughts on the importance of focusing on the needs of patients over the full cycle of care – from prevention and diagnosis through recovery to long-term disease management.
   www.novonordisk.com/include/asp/exe_n...
9. [verwijderd] 30 januari 2007 14:57

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   Stukje uit Verslag Company Visit 15 augustus 2006, by japie:
   
   Markt proteins $35 miljard, waarvan EPO $7miljard. Deze markt groeit volgens een grafiek in van 19 naar 34 miljard in 2006. Echter volgens Brus is per heden de 35 miljard al gepasseerd. In 2015 wordt de markt geschat op 150 miljard.
   Statement tussendoor: eerste commerciele deals zijn aanstaande qua proteins.
   
   De focus bij STAR ligt met name bij de ontwikkeling van nieuwe antistoffen (bestaande producten is vrij kostbaar).
   Belangrijk statement dat uit CHO (chinese hamster) 3 gram per liter wordt gehaald terwijl bij Perc.6 op dit moment al een rendement zit van 3.5 gram per liter en men het denkt te kunnen brengen tussen de 6 en 10 gram per liter. Het is volgens Brus natuurlijk ook makkelijker uit Perc.6, een menselijke cellijn, menselijke cellen te produceren. In mijn bewoordingen is de rek eruit bij CHO maar bij Perc.6 dus niet.
   
   Brus was een paar jaar geleden niet te spreken over DSM, maar de samenwerking met DSM is nu na een paar jaar zeer bevredigend. Brus gaf aan dat DSM de faciliteiten in Bosten heeft neergezet, en het ziet er geweldig uit! Zoals eerder al aangegeven denkt Crucell samen met DSM 25% van de nieuwe protein & antibody sales binnen te halen.
   
   Als je naar de R&D kosten kijkt dan wordt momenteel het meeste geld uitgegeven aan Factor V. Bloedfactoren aanmaak o.b.v. Perc.6 Met name belangrijk om de bloedstolling te kunnen beheersen (denk aan herseninfarct).
   
   Potential indications for APC-resistant factor V:
   1). Factor V and Factor V/VIII defiency (competitor: fresh frozen plasma)
   2). Hemophilia with inhibitors (competitors: NovoSeven®, High dose factor VIII
   3). Hemophilia without inhibitors (competitors: Factor VIII/IX (recombinant and plasma)
   4). Other bleeding conditions (competitor NovoSeven®).
   
   Blood factors; many products with blockbuster potential.
   Potential for own blockbuster protein. Doelstelling is om dit te bewerkstelligen. Crucell heeft alle patenten gekocht m.b.t. bloedeiwitten (Factor V). Crucell is nu bezig factor V te “produceren” (ik neem aan ofcourse in Research). Voordeel (als ik het goed heb begrepen) is dat Perc.6 een menselijke cellijn is en uitermate geschikt voor bloedfactors en niet CHO chinese hamster cellen. Daar zit de kracht in, en volgens mij dus ook de focus van Crucell mbt Perc.6 richting de proteins market.
   Met Factor V denkt Crucell een omzet te kunnen realiseren van 1 miljard.
   
   www.iex.nl/forum/topic.asp?forum=228&...
   *******************************
   Novo Nordisk A/S intends to evaluate the STAR(TM) technology using its proprietary mammalian CHO cell line along with its antibodies. Under the terms of the agreement, Novo Nordisk A/S will pay a license issuance fee, a success-based fee and annual maintenance fees provided the license is extended upon evaluation.
   
   www.novonordisk.com/science/pipeline/...
   www.novonordisk.com/science/pipeline/...
   www.novonordisk.com/therapy_areas/hae...
10. [verwijderd] 30 januari 2007 14:57

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    FDA Approves NovoLog(R) Category Change for Use in Pregnant Women with Type 1 Diabetes
    
    New Category B Rating Follows Review of the Largest Randomized Controlled Trial of Insulin Analogs in Pregnant Women
    
    PRINCETON, N.J., Jan. 30 /PRNewswire/ -- Novo Nordisk announced today that the United States Food and Drug Administration (FDA) has approved NovoLog(R) (insulin aspart [rDNA origin] injection) for pregnancy Category B rating, further validating NovoLog(R) as a safe and effective treatment for pregnant women with Type 1 diabetes and their unborn children. Diabetes and its treatment options can present significant challenges for women wishing to conceive and have a healthy pregnancy. As a safety precaution, the FDA classifies prescription drugs with specific category ratings to provide decision-making guidelines for physicians treating pregnant women. The Pregnancy Category B rating for NovoLog(R) indicates that adequate studies in pregnant women with Type 1 diabetes have demonstrated that NovoLog(R) does not increase risk to the unborn baby. Previously, NovoLog(R) was classified as a Category C rating, which indicates that adverse effects on the fetus have been demonstrated in animal reproduction studies, and that adequate and well-controlled studies in pregnant women have not been conducted to demonstrate safety(1). "While clinical research is rarely conducted in pregnant women, we at Novo Nordisk understand the needs of this special population. The confirmed safety of NovoLog(R) will allow their doctors to make informed decisions about treatment options for people with diabetes," said Martin Soeters, president of Novo Nordisk. "We are excited that the FDA has acknowledged our efforts to advance diabetes treatment and recognizes the value of our insulin analogs such as NovoLog(R)." The FDA category change was based on a review of the largest ever randomized controlled trial using an insulin analog in pregnant women with type 1 diabetes. The study, conducted at 63 sites in 18 countries, compared the safety and efficacy of NovoLog(R) versus human regular insulin (HRI) in the treatment of 322 pregnant women with type 1 diabetes. Data demonstrated that changes in HbA1c and rates of maternal hypoglycemia were comparable with NovoLog(R) compared to HRI. The study was not large enough to evaluate the risk of congenital malformations. Compared to HRI, the trial with NovoLog(R) showed improved outcomes for both mother and child in terms of: -- Fewer preterm deliveries (p<0.053) -- Reduced risk of neonatal hypoglycemia (glucose <2.6 mmol/L) requiring treatment -- Consistently low rates of major hypoglycemia -- Reduced risks to the fetus, with outcomes at least comparable to HRI(2).
    www.prnewswire.com/cgi-bin/stories.pl...
11. [verwijderd] 1 februari 2007 08:09

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    Novo Nordisk 2006 sales grew by 15% driven by modern insulins
    Robust sales performance led to operating profit growth of 13%
    Reported sales increased by 15% in 2006 (local currency growth of 16%)
    o Sales of modern insulins (insulin analogues)
    increased by 48%
    o Sales of NovoSeven® increased by 11%
    o Sales of Norditropin® increased by 19%
    o Sales in North America increased by 29%.
    Gross profit increased by 19%, primarily reflecting continued productivity improvements in Product Sypply.
    Operating profit increased by 13% to DKK 9,119 million while operating profit measured in local currencies increased by around 15%.
    Net profit increased by 10% to DKK 6,452 million, and earnings per share (diluted) increased by 12% to DKK 19.99.
    At the Annual General Meeting on 7 March 2007, the Board of Directors will propose a 17% increase in dividend to DKK 7.00 per share of DKK 2. The ongoing share repurchase programme has been increased to DKK 10 billion and is now expected to be finalised before the end of 2008.
    The expectation for 2007 operating profit growth measured in local currencies is around 15%.
    Lars Rebien Sørensen, president and CEO, said: "We are very pleased with the results we have achieved in 2006. Sales of our key products, not least our modern insulins, went well in all major markets, and we continue to see productivity improvements in Product Supply. This allows us to invest more in both R&D and sales and marketing, and we remain confident that also in 2007 we will be able to deliver a solid financial performance."
    
    www.novonordisk.com/include/asp/exe_n...
12. [verwijderd] 12 februari 2007 08:44

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    Novo Nordisk: Set to Conquer the Insulin Market
    Posted on Feb 11th, 2007
    
    Summary: Novo Nordisk (NVO) is the world sales leader of insulin-related products. Its insulin-analog products are bio-variants of the human insulin molecule that work better, are more bioavailable, sell for twice the price, and enjoy extended patent protection. Together with competitors Eli Lilly and Company (LLY) and sanofi-aventis (SNY), they have converted about 1/2 of all insulin-using patients to make the switch -- and Novo's product is the most complete and convenient. Its 2006 insulin analog sales jumped 50%, driving EPS up 12% and giving it a P/E ratio of 26. Can the company continue to merit such a lofty multiple? Tech trader Bill Alpert says yes. Diabetes 'growth' is widespread; China accounted for over 40% of its international growth last year (though the U.S. government has been slow in accommodating 'biosimilar generics'). The company has other growth opportunities: It has a Phase III drug similar to but better than Amylin Pharmaceuticals Inc.'s (AMLN) Byetta (sold by Lilly) because Novo's version is taken once daily vs. Byetta's twice. And its hemophilia drug NovoSeven promises to reduce severe bleeding in trauma patients and during heart surgery, and may prove to be the first drug to address bleeding strokes.
    biotech.seekingalpha.com/article/26675
    
    ****************************
    In this interview on CNBC Europe Novo Nordisk's CFO, Jesper Brandgaard, discusses the company’s Q4 2006 results and in particular focuses on:
    A forecast beating 44% rise in Q4 net profits
    US growth market
    Efficient production leads to higher gross margins
    Worldwide need for insulin means very solid growth
    Novo Nordisk is a focused healthcare company. With the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems, Novo Nordisk is a world leader in diabetes care. In addition, Novo Nordisk has a leading position in areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.
    www.axisto.com/webcasting/tv/uk/novon...
13. aossa 12 februari 2007 10:22

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    Re: 'It has a Phase III drug similar to but better than Amylin Pharmaceuticals Inc.'s (AMLN) Byetta (sold by Lilly) because Novo's version is taken once daily vs. Byetta's twice.'
    
    aossa - 3 nov 06, 10:09
    
    Eens alles op een rij.
    Goed voor je DYODD huiswerk.
    
    A NEW APPROACH -
    Recently approved diabetes drugs appear to be cutting out unpleasant side effects
    Albuquerque Journal (NM)
    October 30, 2006
    Author: JACKIE JADRNAK Journal Staff Writer
    
    The first question people ask about any new drug for their Type II diabetes, according to Dr. Mark Burge, is: "Am I going to gain weight?"
    
    Increasingly, the answer can be no. New drugs for diabetes — including Januvia, just approved this month — are avoiding that unwelcome side effect.
    
    Clinical trials showed Januvia had no effect on a patient's weight.
    
    That good news, together with the fact the drug is available as a pill instead of an injection, has generated excitement for Januvia, even though it will sell for $4.86 per pill.
    
    Weight gain is a side effect that is particularly pernicious {got that, Joey?} for people with diabetes — estimated at 20 million in the United States, and 130,000 in New Mexico.
    
    People who don't exercise and are overweight are more likely to have Type II diabetes, so gaining more weight will only make it harder to fight the disease.
    
    While recent developments are promising, local doctors say, there still is no magic pill. Any diabetes treatment, they add, needs to be coupled with exercise and a good diet — changes that, if adhered to strictly, could even eliminate the need for pills.
    
    When exercise for 30 minutes six times a week was compared to metformin, a commonly-used diabetes drug, "exercise actually worked better than the metformin," said Dr. Jeremy Gleeson, endocrinologist with Lovelace Medical Group.
    
    But, he added, "health plans don't typically pay for exercise programs." And, left on their own, he said, people often find they can't make the lifestyle changes that would help them get well.
    
    How drugs work
    
    That leaves us with drugs.
    
    The new ones have been creating some excitement. To understand why, though, it helps to know a little bit about diabetes and how the old drugs worked.
    
    Insulin is a hormone, secreted by the pancreas, that helps transfer glucose from our blood to our cells. Glucose is a sugar that comes from the food we eat, and it is the fuel that drives our cells.
    
    When people develop Type II diabetes, their cells become resistant to insulin, blocking delivery of the fuel and leaving the sugar in the blood. Those high sugar levels can wreak havoc throughout the system, damaging blood vessels and leading to kidney damage, blindness, heart disease and amputation of limbs.
    
    The goal of treatment is to bring those sugar levels down — but not so low that a person gets dizzy, weak, confused or lapses into a coma.
    
    The early drugs, sulfonylureas (Glucotrol or Amaryl, for example), worked by prompting the pancreas to release extra insulin, explained Burge, endocrinologist and associate professor of medicine at the University of New Mexico.
    
    Remember, though, that insulin helps bring sugar into the cells — and if it isn't used right away, it's stored for later. In other words, Burge said, they gain weight.
    
    Some of those older drugs also seem to stimulate the appetite, so people eat even more, according to Dr. Robert Ferraro with Southwest Endocrinology Associates.
    
    Metformin takes another approach to diabetes control, lowering the glucose that you absorb from food and that your liver produces. It tends not to affect weight one way or the other. Like the other drugs, though, it runs the risk of lowering the glucose level too much.
    
    One reason doctors are excited about the most recent drugs is that they don't appear to send blood sugars too low. In addition, they don't cause patients to gain weight.
    
    Byetta, approved about a year ago, actually helps patients lose weight. "I've used that with a handful of patients and had really good results," Burge said.
    
    The downside of Byetta is that is has to be injected, and many patients prefer not to deal with needles.
    
    Januvia, recently approved by the U.S. Food and Drug Administration, works in a similar way as Byetta, but is taken as a pill.
    
    Almost like nature
    
    These latest medications, plus another pending FDA approval, Galvus, have been able to take advantage of greater understanding of diabetes, Ferraro said.
    
    That came with the discovery of the workings of GLP-1, a peptide that is released from the gut in response to rising sugar levels after we eat. "This was only discovered in the last 10 years," he said.
    
    It tells the pancreas to release insulin and tells the liver to stop producing glucose.
    
    The liver produces glucose to maintain proper blood sugar levels when we haven't eaten for a while — overnight, for example. It turns out that people with Type II diabetes have a malfunction in that system, with the liver churning out glucose even when they've just eaten, Ferraro said.
    
    Byetta's main ingredient is similar to GLP-1 — it's derived from a hormone in the saliva of Gila monsters, he said. But it would be destroyed in digestion, so it has to be injected instead of taken as a pill, he said.
    
    Januvia, on the other hand, extends the life of our naturally occurring GLP-1 by inhibiting an enzyme, DPP-4, that breaks down GLP-1.
    
    GLP-1, by the way, also keeps our stomachs from emptying too fast, so it can help us feel full longer. That's how drugs in this class can help people maintain or even lose weight.
    
    Ferraro said he's seen dramatic effects in some patients who have been using Byetta. "They can eat a meal, and don't feel they have to eat again an hour or two later," he said. "They don't feel they have to clear their plate."
    
    The older diabetes drugs, according to Ferraro, affect blood surgar levels, but don't affect the progression of diabetes.
    
    In Type II diabetes, the beta cells that produce insulin in the pancreas eventually get worn out and die, he said. At that point, a person with diabetes has to start using insulin.
    
    There's some hope that the newest drugs will protect those beta cells and prolong their life, Ferraro said. "It's a hypothesis. It hasn't been proven," he stressed. "Time will tell whether this drug (Januvia or Byetta) really stabilizes the action of beta cells."
    
    And time is what it takes for doctors to decide how they will use the newest drugs. "People are very excited about (Januvia)," Burge said. "My jury is still out on it. I don't believe the hype and have to wait and see how it actually works in use."
    
    Gleeson noted that new drugs often can look really good when they are approved, but long-term use might reveal some downsides. "I always tell somebody, when there's a new drug, that there are things we don't know," he said.
    
    All the doctors said the new drugs most likely would be used as add-ons, perhaps with metformin the first drug of choice, combined with some newer ones as greater blood sugar control is needed. As people's diabetes progresses, they often need to take more than one drug to control it.
    
    "Here's another way to help them to get to where they need to be," Gleeson said.
    
    "One disconcerting thing," he added, "was the price (of Januvia). I was a little surprised at how expensive it was," at $4.86 a day.
    
    Ferraro said the price isn't out of line, though, with Januvia costing $120 per month. Byetta co
14. aossa 12 februari 2007 10:24

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    (vervolg)
    
    Ferraro said the price isn't out of line, though, with Januvia costing $120 per month. Byetta costs $150 to $200 per month, he said, with older drugs ranging from $140 to $160 a month.
    
    Spokespeople for area health plans said it may take a while to decide whether Januvia will be covered. At Presbyterian, health plan officials generally wait six months after a drug is approved before making a decision on covering it, according to spokesman Todd Sandman.
    
    While manufacturers say they want to make it available "soon," no exact date was given for when it would be on the pharmacy shelves. Before it can be sent out, the FDA has to approve the packaging and inserts.
    
    Glossary
    
    There are several different types of Type II diabetes medications:
    
    Sulfonylureas such as Glucotrol and Amaryl, and meglitinides such ASPrandin, stimulate the pancreas to release more insulin.
    
    Biguanides such as metformin (brand name Glucophage) slow down the liver's glucose production and make muscle tissue more sensitive to insulin.
    
    Thiazolidinediones such as Avandia and Rezulin also make cells more sensitive to insulin and reduce the liver's glucose production. These drugs can have a rare side effect of liver damage.
    
    Alpha-glucosidase inhibitors such as Glyset block or slow the breakdown of starches and some sugars.
    
    Incretin mimetics such as Byetta and Januvia increase levels of a hormone that stimulates the pancreas to release insulin and suppresses liver glucose production. The effect seems to stop when sugar levels are stabilized, so they don't go too low.
    
    — Source: American Diabetes Association, www.diabetes.org
    Caption:
    ROBERTO E. ROSALES/JOURNAL Judy Gurule holds an insulin pen she uses to treat her diabetes.
    
    ROBERTO E. ROSALES/JOURNAL Dr. Jeremy Gleeson of Lovelace Medical Group checks the blood pressure of Judy Gurule during a six-month check on dia
    
    JOURNAL
    Section: Health
    Page: C1
    
    Copyright (c) 2006 Albuquerque Journal
    
15. aossa 12 februari 2007 10:26

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    aossa - 3 nov 06, 10:20
    
    En hier nog een kritisch commentaar van een deskundige ter zake:
    
    Nog de bron vermelden: zie IV posts #10852 en verder.
    
    www1.investorvillage.com/smbd.asp?mb=...
    
    /quote from: www1.investorvillage.com/smbd.asp?mb=...
    
    This is plain English for LisaThompson, et al. Some science, names of drugs, method of action, price per month, insurance coverage, etc.
    
    This is plain English and some math.
    
    First, the math. At an average price of $4.86 per day, Januvia does not cost $120 per month. The math says that $4.86 times 365 equals $1773.90 per year, or $147,83 per month. This is in line, or slightly higher than, the average price for Byetta. The statement that the pricing of Januvia is in line with Byetta is essentially accurate. The implication that it costs less is not, in fact the implication is that Januvia costs a bit more than Byetta.
    
    Second, the plain English of the science. This actually has several parts to it.
    
    I will start at the end. The glossary, apparently from the American Diabetes Association, terms both Byetta and Januvia as incretin mimetics. That is not true. Byetta is an incretin mimetic as it mimics glp-1, the human protein that increases insulin production. Januvia is a DPP-IV inhibitor. It has no direct effect on insulin production, rather by inhibiting the action of DPP-IV, the natural human enzyme that degrades glp-1, insulin production increases indirectly. At first glance, it seems that the same effect is achieved, but that is not the case. Januvia, and all DPP-IV inhibitors can only act at the maximum level of naturally produced glp-1. It turns out that this is among the proteins that are under produced in type 2 diabetes, so even at the best case scenario, DPP-IV inhibitors cannot restore total function. In addition, DPP-IV is an enzyme that regulates dozens, if not hundreds, of proteins throughout the body. Among them are several very important proteins of the immune system. The long-term effect of this is not known and unpredictable. Even if the effect were only limited to glp-1, it is not true that Byetta and glp-1 act entirely the same way. These are homologous proteins, not identical proteins. Exendin-4, the active peptide of Byetta, has a stronger affinity to the glp-1 receptor than does glp-1 itself. Exendin-4 also has certain glucose-related biochemical activities, such as PI3 kinase pathway activity, that are either weak or non-existent in glp-1.
    
    The differences in activity might not turn out to be trivial in the long run. A claim that all players in this arena want to make is that these drugs improve beta cell function. That could be the result of protecting the cells from apoptosis (programmed cell death), or from metabolic dysfunction. There is evidence from cell culture and animal studies that this class of drug actually stimulates the differentiation of new beta cells. In either case, the evidence thus far is that Byetta does a better job than any other drug. There is also evidence that exendin-4 helps protect several cell types beyond beta cells.
    
    Byetta is much more effective at reducing the after meal glucose peaks that are typical of diabetes. The most recent research indicates that these fluctuations that occur after every meal are a major contributing factor to the devastating complications of diabetes. Januvia and its related compounds might do well to lower HbA1c, but over time the lack of control over post meal glucose will take its toll. Byetta, so far, is the only drug that has been shown to bring that aspect of glucose control close to normal.
    
    The contribution of weight to the pathogenesis of diabetes has become a very big consideration in the management of the disease. As a result, every manufacturer of a new drug wants to claim their drug reduces weight, or is at least weight neutral. This has been true of DPP-IV inhibitor development, with drug companies attempting to claim weight loss for their drugs even when the data said otherwise. At a minimum that indicates that Byetta is superior in this regard, as Byetta is the only drug in its class that helps diabetics lose weight. Of course, there is another drug, in a different class, that also induces weight loss but Symlin is not part of this topic. It is troubling, however, that drug developers attempted to make weight loss claims that were unsupported by the evidence. It raises the question, what else might not have been quite as what was claimed?
    
    Byetta has also had many potentially beneficial activities described. Some of these have been reported in scientific meetings. Others have come to light from individual reports from patients using Byetta. In addition to the benefits of glucose control and weight loss, many diabetics have reported improved blood pressure, cholesterol, triglycerides, and reduced edema. It is not uncommon that diabetics using Byetta reduce or eliminate other drugs from their treatment as a result of the overall benefits.
    
    The total profile of Byetta’s activity has not been duplicated by any other drug so far. The available data suggest that nothing in the near future will. From that perspective, Byetta is not only better than any potential competitor, it is also cheaper. And what price should we put on improving lives?
    
    Best regards,
    
    Marty
    
16. aossa 12 februari 2007 10:28

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    aossa - 15 nov 06, 01:20
    
    Biotechnology Model Book forecasting market share for DPP-IV's and GLP-1's
    
    Out today at www.smithbarney.com.
    Maybe you can see the whole table by registering as a guest; I'm not sure.
    
    But here's a bit of it:
    First, "DPP-IV" is defined as Galvus, Januvia, and others.
    "GLP-1" is defined as Byetta, liraglutide and ByettaLAR
    
    For patients failing control with only diet and exercise, the model predicts 10% switch to GLP-1's starting in 2009, 15% in 2010.
    For patients failing control with 1 oral anti diabetic (OAD), the model predicts 1.6% switching to GLP-1 in 2006, 3% will switch in 2007, 6% in 2008, 10% in 2009, and 15% in 2010. For same years, the model predicts the following percentages will switch to DPP-IV: 0 in 2006, 2% in 2007, 6% in 2008 13% in 2009, and 20% in 2010.
    For patients failing control with 2 OAD's, the model predicts 11.8% switching to GLP-1 in 2006, 25% in 2007, 30% in 2008, 35% in 2009, and 40% in 2010. For same years, switching to DPP-IV's will be 0 in 2006, 4% in 2007, 10% in 2008, 20% in 2009, and 26% in 2010.
    For patients failing control with 3 OAD's, the model predicts 22.6% switching to GLP-1 in 2006, 36% in 2007, 39% in 2008, 42% in 2009, and 45% in 2010. For same years, switching to DPP-IV's will be 0 in 2006, 3% in 2007, 6% in 2008, 6% (or 8%, hard to read) in 2009, and 10% in 2010.
    
    [The above seems to reflect view that late stage failures - 3 OAD users -will switch to Byetta more than DPP-IV's while early stage failures - 1 OAD users - will pick the DPP-IV's over Byetta, except that Byetta/LAR increases GLP-1 switching in 2010 somewhat for 1 -2 OAD "failures". -T]
    
    As for "market share" for DPP-IV's, the model says 50/50 for Galvus and Januvia until 2009 when it's estimated to be 40/40 with 20% to others approved by then.
    
    For "GLP-1 market share", the model says 100% Byetta in 2006 and 2007, 95% in 2008, 75% in 2009, and 32% in 2010.
    Liraglutide to get 6% of GLP-1 market in 2008, 25% in 2009, and 23% in 2010.
    ByettaLAR to get 45% of GLP-1 market in 2010.
    
    {Notice estimate for Byetta losing market share to ByettaLAR in 2010. Some on MB have wondered. Here's SB's estimate.- T}
    
    www1.investorvillage.com/smbd.asp?mb=...
17. aossa 21 februari 2007 14:30

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    Press Release Source: TransTech Pharma
    
    TransTech Pharma, Inc. Obtains Exclusive License to Glucokinase Activator Program for the Treatment of Diabetes from Novo Nordisk
    
    Wednesday February 21, 8:00 am ET
    HIGH POINT, N.C. & BAGSVAERD, Denmark--(BUSINESS WIRE)--TransTech Pharma and Novo Nordisk A/S (NYSE: NVO - News; CSE: NVO - News) announced today an agreement whereby TransTech has obtained an exclusive license from Novo Nordisk to its clinical glucokinase activator (GKA) program. Tests in a variety of mammalian species suggest that glucokinase activators can help people with diabetes control their glucose levels. Under the terms of the agreement, TransTech will obtain all rights worldwide to Novo Nordisk's GKA program including preclinical and clinical compounds, the latter with human data.
    
    On 15 January, Novo Nordisk announced a decision to focus all its research and development resources on the company's growing pipeline of protein-based pharmaceuticals. As a result of this decision the company said it would out-license existing preclinical and clinical small-molecule projects, including its GKA program which is currently in clinical testing.
    
    The drug candidates licensed by TransTech are novel, orally administered compounds discovered during a strategic research collaboration initiated in 2001 between TransTech and Novo Nordisk utilizing TransTech's proprietary small-molecule discovery engine, TTP Translational Technology®.
    
    Adnan Mjalli, PhD, founder, chairman and chief executive officer of TTP, said, "The promise of glucokinase activators to transform diabetes therapy is enormous. We are excited to obtain all the rights to these drug candidates, which we jointly discovered with Novo Nordisk, a recognized worldwide leader in diabetes therapies. The addition of the glucokinase activator program will greatly enhance our existing diabetes and obesity portfolio and allow TransTech to become a world leader in the discovery and development of novel treatments for diabetes and obesity - a key therapeutic focus of the company. Our current diabetes and obesity portfolio includes orally administered and novel therapeutic development candidates targeting PTP1b inhibitors, AgRP inhibitors, GLP1R agonists and AMPK activators."
    
    Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are very pleased that it has been possible to reach an agreement with TransTech in such short time. They have been our partners in the GKA program all along, and they have the capabilities to take on the further development. This allows us to focus our R&D on therapeutic proteins which is where we have our core competences, while keeping a financial stake in the GKA program."
    
    TransTech will make an up-front payment to Novo Nordisk for the licensed rights, and has also committed to additional payments as development milestones are reached, as well as royalties on commercial product sales. The parties have agreed not to disclose further terms of the agreement.
    
    About TransTech Pharma, Inc.
    
    TransTech Pharma is a privately held clinical-stage pharmaceutical company working on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The Company's high-throughput drug discovery platform, TTP Translational Technology®, translates the functional modulation of human proteins into safe and effective medicines. TransTech has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, type I/II diabetes, obesity, cardiovascular and cancer. For further company information, visit www.ttpharma.com.
    
    About Novo Nordisk
    
    Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 23,600 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.
    
    biz.yahoo.com/bw/070221/2007022100507...
18. [verwijderd] 27 februari 2007 08:05

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    Phase 3 stroke trial shows that NovoSeven® reduces bleeding in the brain, but does not improve long-term clinical outcomes
    
    (26 Feb 2007)
    
    
    Novo Nordisk today announced the initial results of a phase 3 clinical trial investigating NovoSeven® (recombinant activated factor VII) for the treatment of people suffering from bleeding in the brain, also known as intracerebral haemorrhage, or ICH.
    The trial showed that treatment with NovoSeven® significantly reduced intracerebral bleeding compared to placebo treatment. Improvement in clinical outcomes in terms of functional independence and neurological impairment was observed on day 15 after the bleeding, but mortality and severe disability was not improved at the end of the study period (day 90). With regard to safety, study results were in line with the established safety profile of NovoSeven®.
    As mortality and severe disability at day 90 was the primary endpoint of the study, Novo Nordisk has decided not to seek regulatory approval for NovoSeven® in ICH. Novo Nordisk's other research and development activities within the management of critical bleedings will continue as planned.
    Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk, said: "These results are disappointing, particularly given the encouraging results we saw in the phase 2 trial. We hoped that NovoSeven® could become a treatment for the people who suffer from ICH, and for whom no effective medical treatment exists."
    www.novonordisk.com/include/asp/exe_n...
19. [verwijderd] 1 maart 2007 13:14

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    Novo Nordisk divests its ownership of Dako's business activities (28 Feb 2007)
    
    
    Today the Board of Directors of Dako A/S has decided to divest its only subsidiary Dako Denmark A/S to the private equity fund EQT V. Dako Denmark A/S is the sole owner of the global business activities for the Dako Group, one of the world's leading companies within cancer diagnostics.
    Novo Nordisk has been a shareholder since 1992 and currently owns around 27% of the capital in Dako A/S. Following a successful development of Dako's business and in preparation for encouraging future prospects, the current shareholders in response to an ongoing consolidation of the cancer diagnostics industry have concluded that a new ownership structure would be in the best long-term interest of Dako.
    Jesper Brandgaard, chief financial officer, said: "As one of the main shareholders we are pleased that an attractive ownership solution has been found for Dako, which will facilitate the continued expansion of the company's business activities."
    The sales agreement is subject to a number of conditions including the approval of the transaction by applicable competition authorities and the approval of the transaction by a shareholders' meeting of Dako A/S.
    As a consequence of this transaction, Novo Nordisk now expects to record an income in 2007 of around DKK 1.5 billion in relation to Dako's sale of Dako Denmark A/S, which will be recorded under 'Share of profit in associated companies' in the 'net financials' part of the income statement.
    Updated guidance for the 'net financials' including impact from currency development will be provided in connection with the release of the financial statements for the first three months of 2007 on 2 May 2007.
    www.novonordisk.com/include/asp/exe_n...
    ***************************
    Levemir® approved in Europe for use in combination with oral antidiabetic drugs (1 Mar 2007)
    
    Novo Nordisk today announced that the European Commission has approved Levemir® (insulin detemir) for once-daily use in combination with oral antidiabetic drugs (OADs).
    Levemir® initiated once daily significantly improves blood glucose levels, with less weight gain compared to NPH insulin and insulin glargine.(1-3) Levemir® is the first long-acting insulin associated with less weight gain and the weight benefit of Levemir® has been shown to increase with increasing baseline body mass index (BMI).(4) This makes Levemir® an appealing long-acting insulin for initiating early insulin treatment for people with type 2 diabetes.
    “Our findings showed that not only did Levemir® given once daily improve glycaemic control, but unlike many other forms of insulin, it actually led to weight loss and this benefit was even greater for the more obese people with diabetes,” says Dr Anne Dornhorst, Department of Metabolic Medicine, Imperial College, London, and leading investigator of the PREDICTIVE™ study.(5)
    The weight benefit of Levemir® is both confirmed by clinical trials and in clinical practice. Thirteen out of thirteen trials have consistently confirmed significantly less weight gain with Levemir® compared to NPH insulin.(1,2,6-16) In a clinical practice study the fact is that patients treated with Levemir® did not gain weight.(4)
    Furthermore, Levemir® provides effective blood glucose control with a reduced risk of hypoglycaemia (too low blood sugar), which is one of the most serious concerns for people with diabetes. A recent trial shows that Levemir® reduces the relative overall risk of hypoglycaemia by 53% while the relative risk of nocturnal hypoglycaemic events is reduced by 65% compared to NPH insulin.(1) Therefore, the new approval of Levemir® once-daily use in combination with OADs provides a new treatment option for people with type 2 diabetes who have difficulties in maintaining acceptable blood glucose levels when treated with OADs alone.
    www.novonordisk.com/include/asp/exe_n...