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"such analyses are very complex"
You can demonstrate that your drug is structurally highly homologous to another using high-resolution 3D structure, determined by X-ray crystallography.
Glycosylation can be analysed to determine the glycan structure and glycan quantitative ratio using sequential digestion with various exoglycosidases and HPLC, GC-MS, FAB-MS and DE-MALDITOF-MS and use HPAEC-PAD following digestion with trypsin and PNGase procedure to permits chromatographic comparison of oligosaccharide patterns in a qualitative and quantitative manner.
After doing all this, you can say that your drug is highly similar to the other. You still can never know if your drug will provoke an immune reaction.
From the same paper I cited in the previous post, here is the answer to the glycosylation issue:
"As complex glycans in mammalian cells do not terminate in mannose residues, which are essential for the biological uptake of GCD via macrophage mannose receptors in human patients with Gaucher's disease, an in vitro glycan modification is required in order to expose the mannose residues on the glycans of Cerezyme. In this report, the production of a recombinant human GCD in a carrot cell suspension culture is described. The recombinant plant-derived GCD (prGCD) is [b[targeted to the storage vacuoles, using a plant-specific C-terminal sorting signal. Notably, the recombinant human GCD expressed in the carrot cells naturally contains terminal mannose residues on its complex glycans, apparently as a result of the activity of a special vacuolar enzyme that modifies complex glycans. Hence, the plant-produced recombinant human GCD does not require exposure of mannose residues in vitro, which is a requirement for the production of Cerezyme."
>and there's always the risk of immunogenicity (I think the risk is low).<
Since the immunogenicity issue came up with MNTA (even though this is not the same case because PLX is doing a biosimilar and not generics) , here is what PLX said about this:
From Plant Biotechnology Journal 2007 Sep;5(5):579-90.
"There are conflicting reports regarding the immunogenicity of plant-derived biopharmaceutical glycoproteins (Cabanes-Macheteau et al., 1999; Chargelegue et al., 2000; van Ree et al., 2000). Bardor et al. (2003) have shown that 50% of non-allergic blood donors have specific antibodies for core xylose in their sera, and that 25% have specific antibodies to core α-(1,3)-fucose. It remains to be determined whether such antibodies may limit the use of plant-derived biopharmaceutical glycoproteins. However, the current regulatory viewpoint, based on data accumulated in a number of clinical trials involving plant-expressed proteins, is quite promising in this regard (Hellwig et al., 2004). Preclinical data from a single-dose toxicity study with prGCD in mice, in multiples of one, five and 10 times the clinical dose (60 units/kg), demonstrated that there were no obvious treatment-related adverse reactions or clinical findings, indicating the potential safety of plant cell-expressed GCD. Currently, prGCD is undergoing human clinical trials and additional preclinical studies."
The credit goes to CapraVacca who posted the very same article before I did.
PARD has $97.1M in cash, which should be sufficient to complete ph.III trial of picoplatin in 2nd-line SCLC (data expected in 08) and other ongoing trials (Ph.I and early Ph.II data of picoplatin in CRC and prostate cancer expected to report throughout 08).
First pt dosed with oral picoplatin in ph.I trial.
I agree that every development must start with very careful planning and taking into account ALL variables and potential pitfalls. There is always the risk of immunogenicity and MNTA now have to come up with convincing data or they will have to generate it.
First Patient Undergoes Expanded Cord Blood Transplant in the ExCell Registration Study of StemEx(R) for Leukemia and Lymphoma
Patients are now being enrolled in the U.S. for the Gamida Cell-Teva Joint Venture ExCell trial studying StemEx(R) as an alternative treatment for bone marrow transplants.
JERUSALEM--(BUSINESS WIRE)--The Gamida Cell-Teva Joint Venture announced today that the first patient in the international, pivotal registration ExCell study has undergone a StemEx® transplant at the Ireland Cancer Center of University Hospitals Case Medical Center. StemEx® is a graft of expanded stem/progenitor cells, derived from a single unit of umbilical cord blood and transplanted in combination with non expanded cells from the same unit.
The single arm, multi-center ExCell study will assess the efficacy and safety of the StemEx® transplantation as a treatment for hematological malignancies, including leukemia and lymphoma. The U.S. Food and Drug Administration (FDA) granted ExCell a Special Protocol Assessment (SPA) in October 2006 and StemEx® orphan drug status in March 2005.
“We are pleased to report that we have conducted the first StemEx® transplant in the ExCell study,” said Mary J. Laughlin, MD, Associate Professor of Medicine and a Dr. Donald and Ruth Weber Goodman Professor of Innovative Cancer Therapeutics at Case Western Reserve University, a hematologist/oncologist at the Ireland Cancer Center of University Hospitals Case Medical Center, and one of the study’s principal investigators. "There is a need for improved options for patients, who cannot find a matched bone marrow donor, that will expedite the matching process and decrease rates of transplant related mortality and Graft versus Host Disease (GvHD).”
According to the National Marrow Donor Program, each year in the United States alone, more than seventy percent of the 35,000 patients with life-threatening diseases who could benefit from a marrow transplant cannot be matched with a donor. Cord blood has less matching requirements than bone marrow or peripheral blood transplants, providing the potential to increase the number of suitable transplant matches and to shorten the time it can take to find a match. However, there are a limited number of stem/progenitor cells in cord blood, enabling a quantity sufficient generally only for pediatric treatment. StemEx® employs a technology that expands this small number of cord blood stem/progenitor cells, increasing their therapeutic capacity for transplantation in adolescents and adults.
“Cell therapy products are no longer a vision of the future, but a solid deliverable for the present,” said Gamida Cell CEO Dr. Yael Margolin. “We are excited to advance the clinical development of StemEx® and will continue with our efforts to bring this first of a kind product to market.”
StemEx® is being developed by a Joint Venture equally owned and managed by Gamida Cell and Teva Pharmaceutical Industries (NASDAQ: TEVA - News).
“StemEx® is an important innovation and an exciting part of Teva’s research and development pipeline,” said Dr. Aharon Schwartz, Vice President, Innovative Ventures from Teva. “We are committed to working with Gamida Cell and look forward to the potential of providing an improved treatment option for patients with hematological cancers.”
About the Study
The full title of the ExCell study is A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx®, Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies Following Myeloablative Therapy.
The Phase I/II study, conducted at The University of Texas M. D. Anderson Cancer Center in Houston, showed preliminarily positive results, which prompted the registration ExCell study and its further investigation of the safety and efficacy of StemEx®.
The ExCell study is currently enrolling 100 patients, ages 12 to 55, with high-risk hematological malignancies, who do not have a matched, family-related bone marrow donor, and who meet all of the eligibility criteria of the study. The study will take place in 11 of the leading cord blood transplantation centers in the United States, Europe and Israel. Additional information regarding study parameters and participating sites may be accessed at (http://clinicaltrials.gov/ct/show/NCT00469729).
About Teva
snip
http://biz.yahoo.com/bw/071106/20071106005916.html?.v=1&printer=1
So this new requirement for information addressing the issue of immunogenicity extends to all potential generic formulations of Lovenox.
Do they know what requirement the FDA wants? Sounds that this will include clinical trials and 2 years setback.
UPDATE 1-Merck says paired cholesterol drugs very effective
Mon Nov 5, 2007 4:42pm EST By Ransdell Pierson
http://www.reuters.com/article/health-SP/idUSN0531367020071105
NEW YORK, Nov 5 (Reuters) - Patients were able to safely and comfortably use Merck & Co's (MRK.N: Quote, Profile, Research) experimental Cordaptive drug to raise "good" HDL cholesterol alongside Merck's older Zocor cholesterol medicine, with impressive cholesterol control, researchers said on Monday.
Results of the Phase III trial, which involved about 1,400 patients and lasted 12 weeks, were presented at the annual scientific sessions of the American Heart Association in Orlando, Florida.
Cordaptive is itself a combination of an extended release form of niacin -- a nutrient that raises heart-protective HDL -- and an experimental drug called laropiprant that reduces the uncomfortable facial flushing which is a side effect of niacin.
Industry analysts have said Cordaptive, now awaiting U.S. marketing approval, could be a big seller because sales of existing niacin-based drugs -- including Abbott Laboratories Inc's (ABT.N: Quote, Profile, Research) Niaspan -- have been limited due to their strong tendency to cause flushing.
Merck aims to seek approval next year for a separate product called MK-524B. It would combine Cordaptive in the same tablet with simvastatin, the active ingredient of Zocor which works by cutting the body's production of LDL.
In the trial described on Monday, levels of LDL fell 48 percent among patients receiving simvastatin as well as Cordaptive containing the full recommended 2 gram dose of niacin. That effectiveness against LDL, the primary goal of the trial, was deemed highly statistically significant.
The Cordaptive/simvastatin combination raised HDL cholesterol by 28 percent, while cutting levels of triglycerides -- a potentially harmful type of fat in the bloodstream --by 33 percent. Those results were also highly statistically significant.
Patients taking Cordaptive by itself in the trial experienced favorable, but less-impressive results: a 17 percent decrease in LDL, a 23 percent boost in HDL and a 22 percent drop in triglycerides.
About 4.8 percent of patients taking the Cordaptive/simvastatin combination dropped out of the trial due to flushing, compared with 8.7 percent of those taking Cordaptive alone and 0.3 percent taking simvastatin alone.
The discontinuation rate due to flushing was higher by a "slightly statistically significant" degree among those taking Cordaptive by itself than those taking it with simvastatin, Merck said. But the company did not speculate on reasons for the somewhat counter-intuitive trend.
Merck said levels of blood sugar rose somewhat among patients taking Cordaptive, noting that niacin has a tendency to increase blood glucose.
But overall side effects were similar among those taking simvastatin alone, and those taking Cordaptive either by itself or in combination with simvastatin, said John Paolini, a senior Merck research official.
"Addition of simvastatin does not change the safety profile," Paolini said.
"The results seen in this study suggest that Cordaptive with simvastatin together may offer a new strategy to treat patients" with high levels of LDL and triglycerides and/or low levels of HDL, said Dr. Christie Ballantyne, a Baylor College cardiologist who helped conduct the study.
Current cholesterol drugs like Zocor and Pfizer Inc's (PFE.N: Quote, Profile, Research) Lipitor, both members of the statin family of treatments, focus on reducing LDL.
Interest in HDL-raising drugs is intensifying because of data showing that a high percentage of people experiencing heart attacks have relatively normal levels of LDL, but low levels of protective HDL.
HDL works like a garbage truck, removing excess levels of artery-clogging LDL from the bloodstream. (Additional reporting by Kim Dixon in Orlando; Editing by Tim Dobbyn)
Yes I heard him this time and the first time in Tel-Aviv.
They can affect glycosylation up to a certain point but in this case I tend to think that there is a large amount of luck involved.
UPDATE 2-Bayer says temporarily suspends Trasylol marketing
http://www.reuters.com/article/companyNewsAndPR/idUSL055423720071105
Mon Nov 5, 2007 3:03pm EST By Mantik Kusjanto
FRANKFURT, Nov 5 (Reuters) - Germany's Bayer AG (BAYG.DE: Quote, Profile, Research) has suspended temporarily the global marketing of its anti-bleeding drug Trasylol, which has been linked to a higher risk of death, pending final results of a Canadian study on the medicine.
Trasylol is aimed at preventing blood loss in patients with an increased risk for blood loss during heart bypass surgery.
The drug, approved in 1993 and known generically as aprotinin, has been under a cloud for more than a year amid data suggesting it might boost the risk of death, serious kidney damage and stroke, so the step was not unexpected.
Bayer said in a statement on Monday that the decision followed requests from German, U.S. and other regulators for the company to suspend the drug until final BART study data were available.
The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.
Trasylol global sales in the first nine months of 2007 were around 93 million euros, including about 63 million euros from the United States and 5 million euros in Germany
What a title:
Pretender to Avastin throne poised to enter clinical trails
http://www.drugresearcher.com/news/printNewsBis.asp?id=81110
By Mike Nagle 05/11/2007- BioInvent and ThromboGenics' new anticancer antibody is poised to enter clinical trials and could prove a serious rival to VEGF-blocking drugs, due to fewer side-effects and less drug resistance.
The overall affect of TB-403 is to starve cancer tumours by cutting off their blood supply. In this way, it is similar to Genentech and Roche's Avastin (bevacizumab), a blockbuster antibody that targets vascular endothelial growth factor (VEGF). However, the pretender to the Avastin throne exerts its effect through a totally different target - placental growth factor (PlGF).
The drug's developers believe this new target gives TB-403 a couple of advantages over VEGF drugs. The first is that VEGF inhibitors act on normal, as well as diseased, tissue causing side-effects such as blood clots, high blood pressure, blood vessel pruning in healthy organs, interruption of pregnancy, and other side effects, according to scientists at the University of Leuven, Belgium, and the Flanders Institute for Biotechnology (VIB).
Writing in the latest edition of the journal Cell, the researchers explain that, by comparison, PlGF levels are virtually undetectable and dispensable in normal, healthy tissue.
"PlGF knockout mice survive and are healthy," said Peter Carmeliet from the University of Leuven.
"With no VEGF, they die before birth."
PlGF is overexpressed in cancer and chronic inflammatory conditions and induces new vessel formation in tissues under stress. This means that, unlike VEGF, PlGF does not seem to affect normal blood vessel growth, according to BioInvent.
"This mode of action, which is different from and complementary to current anti-VEGF inhibitors, makes it attractive as both a stand-alone and combination therapy," said Prof. Desire Collen, CEO of Belgium-based ThromboGenics.
The hope is that PlGF inhibitors could cause limited side-effects yet still provide the desired efficacy.
The second potential advantage to attacking this new target in preference to VEGF paradoxically stems from the fact that PlGF inhibitors don't seem to be as effective as their more established rivals. Avastin and others do their job to such an extent that the body begins to produce other molecules that promote new blood vessel growth (angiogenesis), including PlGF.
This effectively 'rescues' the tumour from the effects of Avastin and can lead to some patients becoming resistant to the therapy. By working less well, TB-403 doesn't induce this rescue attempt and the developers hope patients won't become resistant to it.
The antibody has now been tested in more than 12 mouse models of cancer, including ones resistant to VEGF-inhibiting therapy. TB-403 blocked angiogenesis and the ability of tumour cells to move. It also prevented infiltration of blood vessel-promoting immune cells, called macrophages.
It will be several years before TB-403 makes it anywhere near approval but Svein Mathisen, CEO of BioInvent, is confident enough to have proclaimed that "TB-403 will secure a prominent place in the oncology armoury."
The first step of the process is ready to start, with a humanised form of the antibody having already been created. The two companies say they expect to begin a Phase I clinical trial before the end of this year.
"It needs to stand the test of time and rigorous clinical testing, but the findings in mice look promising," said Carmeliet.
Clinical trials to assess the drug's ability to block blood vessel growth in conditions such as age-related macular degeneration (AMD) and diabetic retinopathy - two of the developed world's leading causes of blindness - are also planned.
GILD reported additional data from the positive phase III 102 and 103 studies of Viread in Chronic Hepatitis B.
http://www.reuters.com/article/marketsNews/idUKWNAS017120071102?rpc=44
NEW YORK, Nov 2 (Reuters) - Gilead Sciences Inc (GILD.O: Quote, Profile, Research) on Friday said a second late-stage trial has shown that its HIV treatment Viread was more effective in treating hepatitis B than Gilead's drug Hepsera, which is already approved for treating the liver infection in adults.
Favorable results for Viread in a similar late-stage trial were reported in June. In that 48-week study, about 71 percent of the 250 patients in the Viread arm had a complete response, compared with 49 percent in the Hepsera arm of 125 patients. Side effects were comparable in both treatment groups of the trial, which included some patients previously treated for hepatitis B.
The separate 266-patient study described on Friday compared the two Gilead drugs among patients who had never previously been treated for hepatitis B, an infection that over years can seriously harm or destroy the liver and increase the risk of liver cancer.
After 48 weeks of treatment, 67 percent of patients taking Viread had a complete response, compared with 12 percent of those taking Hepsera, Gilead said in a statement.
Both drugs were generally well tolerated, as in the separate previously reported Phase III trial, Gilead said. (Reporting by Ransdell Pierson, editing by Gerald E. McCormick)
ghmm,
This is a good place to get you started: #msg-21278838
In about 25 min you'll be able to reply to my PM.
Since you took all the trouble here are a few point to consider:
Cerezyme is taken IV every 2 weeks and dosed based on symptoms.
It doesn't penetrate the BBB, so it has no impact on neurological symptoms, and is not used for Type 2 or 3 Gaucher disease. Type 1 are about 90% of 10,000 patients.
Only about 5,200 are currently receiving commercial enzyme replacement therapy, partly due to the price (about $200,000 a year).
Shire is developing a human enzyme produced in human cell line. They initiated two phase III trials in 1Q07 and expects to launch the drug in 2010, but they recently reported that enrollment in the studies has been slower than expected.
Amicus is currently conducting two phase II studies for their oral chaperone-mediated (Plicera). I am skeptic regarding this as it is not clear if restoration of residual mutant enzyme function could yield the same activity as replacement enzyme. Moreover, tolerability over longer dosing may be a challenge.
If it works, it may have the advantage of crossing the BBB and treat Types 2 and 3 patients.
There is one approved treatment from Actelion but its lower long term efficacy and side effects limit its use to those who can't tolerat Cerezyme.
Protalix is developing its enzyme in a plant-derived expression
system, they started phase III under an SPA.
Their drug showed a longer plasma half-life and higher activity than Cerezyme in a phase I study. this may mean smaller and less frequent dosing. Their expression systems is cheaper but efficacy in patients is yet to be shown, and there's always the risk of immunogenicity (I think the risk is low).
UTHR-
ghmm, why do you suppose no differences were found for Viveta on the secondary endpoints (Borg Dyspnea Scale, NYHA functional class improvement, or time to clinical worsening)? T.I.A
Transgenic butyryl choline esterase story
http://www.the-scientist.com/article/home/53619/
Poisoning the Poison
A new biologic could save the thousands of people killed by pesticides every year.
Despite using only 25% of the world's pesticides, developing countries are home to 99% of pesticide-related deaths.
In the year 2000, hospitals in six Turkish cities were flooded by 2,000 students with poisoning symptoms after eating hazelnuts. Fortunately, nobody died. The nuts had been stored for a long time in a grain depot disinfected with an organophosphate (OP) pesticide.
The problem of pesticide poisoning is most acute in developing countries, where workers mix OP pesticides and spray fields without using gloves, goggles, or protective clothing, and then enter sprayed areas without waiting a safe interval. Despite using only 25% of the world's pesticides, these countries are home to 99% of pesticide-related deaths.
It's not just a problem in the developing world: In 1998 in California, all 34 workers fell ill after returning to weed a crop sprayed with an OP pesticide without waiting the recommended 48 hours. One was hospitalized. (Eating food treated with OPs is, of course, not nearly as harmful as swallowing heavily contaminated nuts or walking in newly-sprayed areas.)
A 2005 report on the International Workshop on Secure Access to Pesticides in conjunction with the Annual Congress of the International Association for Suicide Prevention, Durban, South Africa, estimated that there were 3 million cases of pesticide poisoning resulting in as many as 300,000 deaths per year, more than 100,000 of them in China. There's another risk: In rural areas, a significant percentage of people attempting suicide (up to 90%, in Malaysia) use pesticides, and close to 80% of all pesticide-related attempted suicides use OPs. This is a situation that needs some kind of a solution. Enter the military.
OPs are also used as nerve gases such as Sarin, of the infamous Tokyo metro attack. In this context, OPs act as powerful pesticides for people. OPs are cholinesterase inhibitors, interfering with the transmission of signals between nerve cells. Molecularly, all OPs are generally quite similar. Before the first Gulf War, Saddam Hussein converted the Muthanna, Iraq, pesticide factory into a production unit for the OP nerve gases Sarin, Tabun, and VX. The US military currently deploys an atropine-2PAM (2-pyridine aldoxime methylchloride) combination for preexposure prophylaxis and postexposure therapy for OP nerve agents. (Some of you may recall Nicolas Cage stabbing himself in the heart with a syringe-full of antidote after being exposed to Sarin in the 1996 movie, "The Rock"). But this combination has various undesirable side-effects, such as breathing and vision problems.
So researchers are turning to butyrylcholinesterase (BChE), a naturally occurring protein found in human blood that counters the anticholinesterase activity of organophosphates, including those used for agriculture, biowar, and bioterror. Before, BChE could be recovered only in microgram amounts from human blood, but in September 2006 the Annapolis, MD-based biotech PharmAthene was awarded a contract of up to $213 million from the Department of Defense for production of kilogram quantities of recombinant human butyrylcholinesterase (rHuBChE) from the milk of transgenic goats. (I have no ties to PharmAthene, financial or otherwise.)
Preliminary in vivo research suggests that the product's biochemical properties are similar to HuBuChE (Chem Biol Interact, 363:157-8, 2005). Material from PharmAthene does not mention its potential for prophylactic treatment of pesticide workers and for treating poisoned people. The basic mechanism is generic, however, so if the product works against OP nerve gases, could it not also protect people against poisoning from OP pesticides?
Could the benefits be even bigger? New research presented in April at the 8th International Conference on Alzheimer's and Parkinson's Diseases in Salzburg, Austria, from the Hebrew University of Jerusalem, in collaboration with PharmAthene, showed that rBChE dramatically suppresses the formation of intermediary fibrils, believed to play a crucial role in the development of the neurotoxic amyloid plaques that occur in patients with Alzheimer disease. Anticholinesterases are already being used in treating Alzheimer disease; rBChE could be more effective.
In my view, the potential of rHuBChE for prevention and treatment of accidental or intentional exposure to OP pesticides, and of Alzheimer disease, is likely to produce tangible benefits far outweighing its putative military use. It'll take time and money to test the product's effectiveness against pesticides and plaques, and there are obvious challenges associated with making it available to the millions who would need it in developing countries. But wouldn't all that be worth it if it worked?
Jack Woodall is former director of the Nucleus for the Investigation of Emerging Infectious Diseases in the Institute of Medical Biochemistry at Brazil's Federal University of Rio de Janeiro.
Just one last point: The Novo drug is given once daily so it does not directly compete against LAR, do they have one for a weekly dosing?
You sound a bit bearish about LAR or AMLN.
I thought that the HbA1C control were very good combined with the strong weight loss trend, the lower nausea rate and the convenient once weekly dosing, were all very bullish. The Novo drug is given once daily. They could be in the market by the end of 09. You think it is too late? You think patients will not tolerate the needle?
They did say in the call that they plan to initiate a phase I study of the new protease inhibitor, VX-500, in 4Q07.
Nothing much was added in the CC.
3Q07 total Copaxone sales $441M (up 24% from 3Q06), so Tysabri's market share is growing on the expanse of other MS drugs.
Thanks much Novo, I feel as good as new today so I think I'll spare his life...
They've probably just missed a short one at the end of the line.
I bet you do too but mine will be gone by tomorrow morning.
No can do. Only one of my arms is functioning and it's the one with two fingers.
Well, you can't win them all...
I was going to buy myself a get-well present but the Mac online shop in Israel is down. Apple's Leopard is one big cat I do want.
The cat fits but unlike the old lady, I'm kind of happy about it right now.
My anti virus strategy includes lots of sleep, green tea and lemon juice. However, the one who gave me the virus will be reformatted big time as soon as I get well.
I like this cat better (I know I'm slow but I'm also under a virus attack):
An old lady sits on her front porch, rocking away the last days of her
long life, when all of a sudden, a fairy godmother appears and informs
her that she will be granted three wishes.
''Well, now,'' says the old lady, ''I guess I would like to be really rich.''
*** POOF *** Her rocking chair turns to solid gold.
''And, gee, I guess I wouldn't mind being a young, beautiful princess.''
*** POOF *** She turns into a beautiful young woman.
''Your third wish?'' asks the fairy godmother. Just then the old
woman's cat wanders across the porch in front of them. ''Ooh - can you
change him into a handsome prince?'' she asks.
*** POOF ***
There before her stands a young man more handsome than anyone could
possibly imagine. She stares at him, smitten. With a smile that makes
her knees weak, he saunters across the porch and whispers in her ear,
''Bet you're sorry you had me neutered.''
Since several early-stage protease inhibitors competitors that appear to be progressing through clinical trials, will also present at AASLD, perhaps VRTX showed its own next generation - VX-500.
CC later on today. Will pay attention to issues such as the retirement of the CFO, guideline, buyback plan, Protonix update and generic version for Lovenox update.
Not sad at all, I'll be right behind you!
I find it hard to decide about anosmia, lacking the sense of smell could be a great advantage sometimes :)
Can you already climb more than 20 stairs without me pushing your behind?
"Rebif took U.S. market share from Betaferon in April 2006 and now leads with 19 percent against 13 percent for Betaferon."
{BTW, This study was performed by Bayer not Teva!}
UPDATE 2-Bayer takes charges, higher Betaferon dose fails
Mon Oct 29, 2007 8:10am EDT By Mantik Kusjanto
http://www.reuters.com/article/marketsNews/idUKL2923113720071029?rpc=44
FRANKFURT, Oct 29 (Reuters) - Bayer (BAYG.DE: Quote, Profile, Research) will take a 152 million-euro ($218 million) impairment charge after its higher dose multiple-sclerosis drug Betaferon failed to show it could work better than the standard dose Betaferon and rival Teva's (TEVA.O: Quote, Profile, Research) Copaxone, the German company said on Monday.
"The overall outcome of the trial did not show a statistically significant superiority of the 500 microgram Betaferon dose compared to the 250 mcg Betaferon dose and Copaxone," Bayer said in a statement.
Bayer said the risk for relapses, which was the primary end point of the trial, was similar in all three study arms. In this study there was a very low relapse rate in the entire study population, unlike in previous trials, it added.
The BEYOND (Betaferon Efficacy Yielding Outcomes of a New Dose) study with 2,244 patients was to investigate the efficacy, tolerability and safety of a 500 mcg dose of Betaferon, compared with the standard 250 mcg Betaferon dose and Copaxone.
Bayer was hoping to increase sales of Betaferon, also known as Betaseron, if the study was successful.
Betaseron was Bayer's top selling drug last year with sales of 991 million euros, up 14 percent.
Bayer Schering Pharma, a Bayer unit, said it expected sales of Betaferon to grow in the range of 7-9 percent in 2007 and at the same magnitude in 2008.
Bayer shares were down 1.2 percent at 57.59 euros at 1010 GMT, compared with a 0.6 percent rise in the German blue-chip DAX index (.GDAXI: Quote, Profile, Research).
Bayer shares have risen more than 40 percent since the start of the year partly because of its strong drug pipeline. It is the fifth-best performing stock in the DAX index so far this year.
Analysts said it would be difficult for Bayer to defend its market share for multiple sclerosis in competition with rival drugs like Merck KGaA's (MRCG.DE: Quote, Profile, Research) Rebif.
"High-dose Betaferon could have slowed share erosion by Rebif," Citibank analyst Amit Roy said in a note. Rebif took U.S. market share from Betaferon in April 2006 and now leads with 19 percent against 13 percent for Betaferon.
JPMorgan analysts, who had expected the trial to fail, said they remained upbeat on Bayer and kept their 'overweight' investment rating.
"With this potential negative catalyst out of the way we anticipate solid third-quarter results," they said in a note.
Bayer said it would book the one-off charge in the third quarter. The company is due to release its results on Nov. 6.
Separately, Bayer and its U.S. partner Genzyme (GENZ.O: Quote, Profile, Research) had started a late clinical trial with alemtuzumab for multiple sclerosis, with filing for marketing approval expected in 2011.
A mid-stage study confirmed that the experimental multiple sclerosis drug worked better than Merck's Rebif.
Alemtuzumab is also known as Campath and is already marketed as a cancer treatment.
Good to have you in the breather's club :)
Correct.
Quiz: There is a difference between yahoo http://finance.yahoo.com/q?s=plx
and marketwatch http://www.marketwatch.com/quotes/plx
in the calculated MC. Which one is the right one and why?
They've advanced as expected but it was not factored into my evaluation in April. I was thinking of the $400M Merck/GlycoFI deal. I believe that Glycofi was not even in clinical trials, am I right?