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AASLD abstracts were posted online today.
This phase II of Nexavar+paclitaxel in 1st line locally recurrent or metastatic HER-2 negative BC is even less impressive.
Bayer, Onyx Pill Doesn’t Slow Breast Cancer in Study
http://www.bloomberg.com/apps/news?pid=20601202&sid=aAb8rYOVYkgo
By Naomi Kresge
Sept. 30 (Bloomberg) -- Bayer AG and Onyx Pharmaceuticals Inc.’s Nexavar cancer drug failed to slow the progression of breast cancer in the second of four studies that combine the medicine with different types of chemotherapy.
The pill in combination with chemotherapy drug paclitaxel showed a “positive trend” toward helping women live longer without their disease getting worse though the results weren’t statistically significant, the two drugmakers said in an e- mailed statement today. Bayer and Onyx didn’t say how long it took the women’s tumors to progress.
“These encouraging data warrant further investigation,” lead scientist William Gradishar, a professor of medicine at Northwestern University, said in the statement, adding that women with advanced breast cancer often lack treatment options.
Results of a different trial presented last week at the European Cancer Organization and European Society for Medical Oncology conference in Berlin showed that Nexavar delayed progression of breast cancer by 6.4 months when combined with Roche Holding AG’s chemotherapy pill Xeloda, compared with 4.1 months for chemotherapy alone. Bayer is now considering whether to begin the last stage of clinical trials needed before Nexavar, already approved for use in kidney and liver tumors, could be marketed for breast cancer as well.
Bayer will decide by early next year whether to move Nexavar into the final stage of clinical testing, Robert Rosen, head of global oncology at Bayer, said in an interview at last week’s conference. The German drugmaker doesn’t expect the medicine to reach the breast cancer market before late 2012.
Additional Trials
Bayer, based in Leverkusen, Germany, and Emeryville, California-based Onyx are conducting two more mid-stage trials of Nexavar in breast cancer, the companies said. Full results of the study reported today will be presented at a future medical conference.
Onyx shares fell $2.13, or 6.6 percent, to $29.93 at 12:29 p.m. New York time in Nasdaq Stock Market composite trading. Bayer declined 3.1 percent to close at 47.35 euros in Frankfurt trading.
Bayer forecasts that Nexavar may generate as much as 750 million euros ($1.1 billion) in annual sales for breast cancer if approved by regulators, Rosen said.
I am just curious if it's normal to see adverse events of any kind in a Phase 1a trial for an HCV PI in healthy patients
Astra may face takeover after Solvay bid
http://www.thisismoney.co.uk/markets/article.html?in_article_id=491249
Ian Lyall, 28 September 2009, 8:30pm
The £4bn takeover of Belgian chemical giant Solvay's pharmaceutical business could light the fuse under another wave of consolidation in the sector, with AstraZeneca touted as the next bid target.
Ambitious Novartis, which recently recruited former AZ finance director Jonathan Symonds to the same role, is seen as a would-be buyer of the UK pharma group.
But the Swiss maker of Lamisil and Exlax would require incredibly deep pockets to bag Zeneca, up 77p at 2829p, and currently valued at £40bn. 'This is not some bitesized deal,' one analyst said.
Sparking the speculation was yesterday's confirmation that America's Abbott Labs has agreed to buy the Solvay drugs business. This was swiftly followed by the news that acquisitive healthcare specialist Johnson & Johnson has taken an 18pc stake in the biotechnology firm Crucell for £277m.
All of this of course pales in comparison with the deal cut by Pfizer, the world's largest drugmaker and inventor of Viagra, which in January agreed to pay £40bn for US rival Wyeth.
This was swiftly followed by the 'shotgun marriage' of Merck and Schering Plough, which turned two sub-scale pill poppers into a company worth an estimated £25bn.
The need to cut costs has been behind the seismic changes in the sector as governments and insurers have shown unwillingness to pay exorbitant prices for the latest pills and potions.
Barack Obama's root-andbranch reforms of the Medicare system in the States promises to place more pressure on the global players.
The only big firm to publicly eschew the merger mania sweeping the sector is Glaxo-SmithKline (up 24p at 1252p).
Yesterday it lined up an innovative deal in China, but coupled the announcement with news it is canning one its new generation of drugs. The product in question, known as Rezonic or Zunrisa, was created to combat nausea caused by chemotherapy.
The US authorities were happy to approve the compound for sale, but only after more safety tests were carried out. GSK decided not to bother.
With estimated annual sales of just £30m, Rezonic's contribution to Glaxo's financial wellbeing was never going to be great. But it took the edge off what should have been a very positive day for the group.
Glaxo signed a deal to take the energy drink Lucozade to China - a huge market, second only to the US in size.
Its partner is Uni-President China Holdings, one of the largest drinks firms in the People's Republic.
Meanwhile, the FDA delays Glaxo cervical cancer vaccine ruling:
http://www.msnbc.msn.com/id/33073409/ns/health-cancer/
Glaxo spokeswoman Sarah Alspach said the death did not influence the FDA's decision to extend its review.
Testosterone replacement treatment - New candidate by Acrux:
A transdermal spray formulation of testosterone spray applied to the armpits once daily. Acrux is also the maker of Evamist (transdermal estradiol spray) and Testosterone MDTS (for HSDD in women), both were licensed to Vivus (the former was later sold to KV pharma).
Sex Drive Boosted by Testosterone Spray, Study Finds
http://www.bloomberg.com/apps/news?pid=20601081&sid=ane3CoaT8NSg
By Simeon Bennett
Sept. 29 (Bloomberg) -- Men with low sex drive because of decreased amounts of testosterone may someday find help as easy as applying an underarm spray.
The spray, called Axiron, restored levels of the hormone to normal in 84 percent of testosterone-deficient men after four months, its developer Acrux Ltd., said in a statement today. The Melbourne-based company said it will seek approval this year from the Food and Drug Administration to sell Axiron in the U.S., the world’s largest pharmaceuticals market.
More than a third of American men over 45 years suffer testosterone deficiency, U.S. researchers found in a 2006 study. It can sap sex drive and cause impotence, osteoporosis and memory loss, according to the Mayo Clinic in Rochester, Minnesota. Shares of Acrux, which has never made a profit, have more than tripled this year on anticipation of the trial results.
The trial “exceeded all of our expectations,” Chief Executive Officer Richard Treagus said on a conference call today. “We believe this will generate significant revenue for our company from 2010 onwards.”
The global market for testosterone treatments was worth $1 billion in the year ended March and grew more than 20 percent in the U.S., Acrux said, citing data from IMS Health Inc. The company plans to start discussions with potential partners next month, Treagus said.
Take Profits
Acrux rose 1 cent to A$1.61 on the Australian stock exchange, valuing the company at A$257 million ($225 million).
“We suggest that investors who entered Acrux for the release of these results may care to take profits today,” Tanya Solomon, a health-care analyst with RBS Morgans Ltd. in Brisbane, said in a note to clients today. She owns the stock and rates it a “buy.”
Axiron overcomes problems associated with testosterone gels, which are considered messy, sticky and slow-drying, Acrux said. About 94 percent of patients and 92 percent of doctors rated the product better than testosterone gels when considering the risk of the product rubbing off on other people, the company said.
Acrux Chief Financial Officer Jon Pilcher declined to estimate Axiron’s sales potential. Androgel, a product made by Brussels-based Solvay SA, had sales of 337 million euros ($493 million) in 2008, according to data compiled by Bloomberg. A Testosterone gel made by Malvern, Pennsylvania-based Auxilium Pharmaceuticals Inc. had 2008 sales of $125 million.
In the company-funded study involving 135 men in six countries, test subjects reported having twice as much sex and 80 percent more libido on average after using Axiron. They also had a 35 percent increase in sexual performance and a 13 percent increase in positive mood, the study showed. No serious side- effects were reported, Acrux said in the statement.
Biotech co Can-Fite looks to Phase III trial
http://www.globes.co.il/serveen/globes/docview.asp?did=1000501282&fid=942
CEO Pnina Fishman: CF101 is unique for treating psoriasis, because it is given orally, and its safety and effectiveness profile are impressive.
Adi Ben-Israel29 Sep 09 11:51
Can-Fite BioPharma Ltd. (TASE:CFBI) today announced that it has begun preparations for the Phase III clinical trial of its flagship drug, CF101, for the treatment of psoriasis. Three weeks ago, the company announced that the Phase II trial of CF101 for this treatment was a success. If the Phase III trial is successful, the company can apply for marketing approval of the drug for this treatment.
In the Phase II trial, CF101 in 2 mg dosages was found effective in treating psoriasis. This dosage was found to be statistically significant most effective of the three dosages administered during the study.
Article continues after advertisements
Can-Fite will have to obtain approval of the US Food and Drug Administration (FDA) and other regulatory agencies to begin the Phase III trial. The company believes that these procedures will take several months, after which it will begin recruiting patients for the trial.
Can-Fite CEO Pnina Fishman said, "CF101 is unique for treating psoriasis, because it is given orally, and its safety and effectiveness profile are impressive."
Can-Fite's share rose 2.2% in morning trading to NIS 0.80, giving a market cap of NIS 167 million.
ACHN has completed Phase 1a of ACH-1625, a protease inhibitor for the treatment of HCV infection, and has begun dosing HCV-infected patients in the Phase 1b segment of the trial. ACH-1625 was safe and well-tolerated in both the single and the multiple ascending dose segments.
http://finance.yahoo.com/news/Achillion-Completes-Phase-1a-pz-1106588304.html?x=0&.v=1
Amgen/Vectibix data from the phase III PRIME study in first-line mCRC look quite similar to those of Erbitux from the CRYSTAL trial. No median OS results yet.
http://finance.yahoo.com/news/VectibixR-in-Combination-With-prnews-4022563444.html?x=0&.v=1
I do not find the explanation for the inverse dose response cited in the PR to be especially compelling.
Cerezyme shipments are on track but Fabrazyme delayed
Genzyme provides mixed update on drug supplies
http://www.reuters.com/article/marketsNews/idCNN2339075320090923?rpc=44
By Toni Clarke
BOSTON, Sept 23 (Reuters) - Genzyme Corp (GENZ.O: Quote, Profile, Research, Stock Buzz), which has been struggling to resolve quality control issues that shut down a key manufacturing plant and led to shortages of some of its drugs, offered an update on Wednesday that did nothing to inspire investors.
The Cambridge, Massachusetts-based biotech company, which has sanitized and restarted the plant, said production of Cerezyme, a treatment for Gaucher disease and its biggest product, is proceeding on track and will be available for shipment in November and December.
However, it said shipments of Fabrazyme, a treatment for Fabry disease, will been delayed until mid-December, in part because the Fabrazyme bioreactors were the last to be sanitized and because the reactors are producing less volume than normal.
Gaucher and Fabry diseases are rare genetic disorders in which the build-up of certain fats in the body can lead to life-threatening organ damage. Genzyme is the world's leading supplier of drugs to treat the conditions.
"We believe this announcement highlights the unpredictability inherent in restarting complex manufacturing processes, and believe manufacturing issues will continue to be a near-term overhang" on the stock, said Brian Abrahams, an analyst at Oppenheimer & Co.
Genzyme said it now expects 2009 sales of Cerezyme of $800 million. Previously the company said it expected sales to be at the lower end of a $750 million to $1 billion forecast.
It expects sales of Fabrazyme to be $450 million, down from a previous forecast of between $510 million and $520 million.
"We think the Cerezyme update is an incremental positive since everything appears to be on track, but 2009 guidance of $800 million is still below the Street consensus of $839 million," said Geoffrey Meacham, an analyst at JP Morgan. "The Fabrazyme news is disappointing since the company's plan was once again off the mark."
Of the two drugs, investors are most focused on Cerezyme, which faces near-term competition from British drugmaker Shire Plc (SHP.L: Quote, Profile, Research, Stock Buzz) and Protalix Biotherapeutics Inc (PLX.A: Quote, Profile, Research, Stock Buzz) of Israel. Both companies are being allowed by the U.S. Food and Drug Administration to supply patients with their drugs even though they have not yet been formally approved.
Interruptions of treatment can occur temporarily without harm in some patients, but the supply shortage has hurt Genzyme's reputation with physicians, patients and investors alike.
Genzyme said if production proceeds as planned, it expects to begin meeting anticipated patient demand for both products during the first quarter of 2010.
"We have reached a point in this process where we can anticipate with greater confidence the timing and amount of the first finished product to be shipped from the ... plant," Chief Executive Officer Henri Termeer said in a statement.
The company did not provide an update on an expected reinspection of the plant by the FDA. Inspectors working on behalf of European regulators recently found what they described as a "major" deficiency at the plant. So far there has been no update on that investigation.
Genotyping was accomplished in 101 Caucasian participants...
I was referring to a US filing for 1st line CRC. I think the COIN data were needed to support such a filing together with the CRYSTAL data, but now it looks a long-shot.
Indeed the retrospective analysis of CRYSTAL using K-ras testing, showed Erbitux+FOLFIRI had good results for Erbitux but the COIN data are needed to support a filing for first line CRC.
Nexavar's results from phase II in BC look no more than solid to me, but the drug should proceed to phase III and might still become an important treatment for HER2- patients.
Bayer, Onyx pill beats hopes in breast cancer test
http://www.reuters.com/article/marketsNews/idCNLN48052220090923?rpc=44
* Time without disease worsening increased by 74 percent
* Bayer, Onyx say committed to Nexavar for breast cancer
* Results boost drug's long-term sales potential
By Kate Kelland
BERLIN, Sept 23 (Reuters) - Women with breast cancer lived significantly longer without their disease getting worse when treated with Bayer BAYG.DE and Onyx Pharmaceuticals' (ONXX.O: Quote, Profile, Research, Stock Buzz) cancer pill Nexavar, researchers said on Wednesday.
Nexavar, a targeted anti-cancer drug sold as a liver and kidney cancer therapy in more than 70 countries, beat analysts' expectations in the breast cancer trial, increasing the time patients lived without their disease progressing by 74 percent.
"The magnitude of the benefit... suggests... this agent will be an important addition to our therapeutic armoury in breast cancer," said Jose Baselga, head of oncology at Barcelona's Vall d'Hebron University Hospital and lead investigator of the study.
The Phase II trial showed that Nexavar, when combined with standard chemotherapy agent Xeloda, halted tumour growth for 2.3 months more than Xeloda alone, giving patients 6.4 progression-free months -- a result analysts described as impressive.
"Results from the... trial testing Nexavar in metastatic breast cancer exceed expectations," said JP Morgan analyst Cory Kasimov in a research note.
Kasimov and other analysts got a first glimpse of the data in an abstract published earlier at Europe's largest cancer congress in Berlin. But detailed clinical data were unveiled on Wednesday at the ECCO-ESMO cancer congress.
Baselga told the congress his study showed the Nexavar combination with Xeloda, which is sold by Switzerland's Roche (ROG.VX: Quote, Profile, Research, Stock Buzz), had thrown up "no new or unexpected side-effects", and the expected side effects were "mostly manageable".
He said the fact Nexavar is a pill made it a "unique and convenient treatment option".
Breast cancer is the leading cause of cancer deaths among women worldwide. According to American Cancer Society, there are around 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year, and in 2007 some 1.3 million new cases were diagnosed across the world.
Nexavar is one of Bayer's most promising drugs, and the German drugmaker is aiming to generate worldwide sales of more than 2 billion euros ($2.9 billion) a year from it.
Bayer and U.S. biotech company Onyx are also testing Nexavar in further ongoing breast cancer studies and Bayer's oncology vice-president Dimitris Voliotis told the Berlin congress the two firms were "committed to the development of Nexavar in breast cancer in a variety of settings."
Analysts said Nexavar's promise in early trials may open up opportunities for doctors to prescribe it off-label before it undergoes the final-stage trials that usually precede a licence.
Doesn't look like Erbitux will make it in first line CRC now
Merck KGaA’s Erbitux Failed to Extend Lives in Study
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWHXmXDJEJn4
By Naomi Kresge
Sept. 23 (Bloomberg) -- Merck KGaA and Eli Lilly & Co.’s Erbitux drug failed to lengthen colon cancer patients’ lives or keep their disease from worsening, U.K. researchers said in an independent study that looked at 1,600 people.
Erbitux surprised researchers by not keeping cancer at bay in its target group of patients, people with a normal version of the so-called KRAS gene, lead author Timothy Maughan, a professor of cancer studies at the School of Medicine at Cardiff University, said in an interview. Based on previous studies, researchers expected those people to benefit, while a mutant version of the gene would foil the drug.
The results of the so-called COIN trial, released today at the European Cancer Organization and European Society for Medical Oncology conference in Berlin, contradict data that Merck presented separately today. The German drugmaker’s own study found that Erbitux helped normal KRAS patients live an average 3.5 months longer than those given chemotherapy alone.
“We really, really expected progression-free survival to be better,” Maughan said, referring to the length of time before patients’ tumors get worse. “It’s absolutely shocking.”
The benefit of Erbitux in both trials was disappointing, said Scott Kopetz, assistant professor of gastrointestinal medical oncology at M.D. Anderson Cancer Center in Houston. The results probably will influence care, limiting Erbitux use mainly to patients who undergo therapy in the hope that their tumors will shrink and subsequent surgery can be done, he said.
‘Standard of Care’
Roche Holding AG’s Avastin “remains the default standard of care, in combination with chemotherapy,” he said in a telephone interview. “We need to see better results than these in order to change that.”
The discrepancy between the studies may be the result of differences in the types of chemotherapy patients received alongside Erbitux, known chemically as cetuximab, Maughan said. About two-thirds of the patients in the U.K. trial chose Roche’s Xeloda, known generically as capecitabine, a chemotherapy pill. The Merck study, known as Crystal, combined Erbitux with standard infused chemotherapy.
Merck shares fell 89 cents, or 1.3 percent, to 67.88 euros at 1:40 p.m. in Frankfurt trading. The stock rose as much as 2.9 percent earlier today, when the results of the Crystal study were released.
Patients in the U.K. study who received Erbitux also got less chemotherapy and other medicine, based on an analysis of 800 of the people in the trial, Maughan said. This is because their side effects were so much worse -- 70 percent of the Erbitux group had serious side effects, compared with half of the others -- that their doctors cut their chemotherapy dosages.
Patient Enrollment
The U.K. trial didn’t put any restrictions on colon cancer patients allowed to join, meaning that the people who enrolled were sicker than is common in pharmaceutical company trials. Forty percent hadn’t had their main tumors surgically removed, and five percent of the patients had cancer that had spread again immediately after previous surgery and treatment.
The only patients to be helped were a small group with a normal KRAS gene whose inoperable cancer had spread only to the liver. Erbitux reduced the risk of dying by about 23 percent for that group, though the group was too small for the result to be statistically significant, Maughan said. These are the only colon cancer patients approved to get Erbitux under the National Institute for Health and Clinical Excellence, the U.K. adviser on medical spending.
Skepticism
The results could leave doctors skeptical about using Erbitux as a first-line treatment in combination with Xeloda, Maughan said. Researchers are still analyzing the data.
“It clearly doesn’t mean that cetuximab doesn’t work,” he said. “I don’t think we’ve gotten to the whole bottom line of the story.”
The contradictory Merck trial released today is the first time anyone has shown Erbitux helps patients live longer, lead author Eric Van Cutsem, a professor at University Hospital Gasthuisberg in Belgium, said before the results were released. The trial tested tumors from patients in a previous Erbitux trial to find enough people with normal KRAS genes for researchers to draw conclusions.
“These are the first survival data ever,” Wolfgang Wein, executive vice president of oncology at Merck, said in an interview this week. “They are robust. They are highly significant.”
The independent study, on the other hand, drew from a “very frail and maybe not so typical population,” Wein said.
U.K. Study
Had the U.K. study shown that Erbitux keeps colon cancer patients alive, the therapy could have challenged sales of Swiss drugmaker Roche’s Avastin in Europe, said Amit Roy, head of health-care equity research at Nomura International in London, in a note to clients before the results were released. No other drug has been shown to keep patients alive in combination with modern chemotherapy, he said.
Lilly and partner Bristol-Myers Squibb Co. market Erbitux in the U.S., while Merck sells it elsewhere. Sales of the drug outside the U.S. are not likely to reach 1 billion euros ($1.48 billion) a year before 2011, Wein said.
Merck, which is based in Darmstadt and not affiliated with U.S. drugmaker Merck & Co., provided Erbitux for the U.K. trial, sponsored by the London-based Medical Research Council.
Now doctors will have the task of weighing the differences between Merck’s results and the independent trial, said Richard Adams, an investigator on the U.K. trial and a senior lecturer in oncology at Cardiff University.
“I suspect clinicians may increase their use of cetuximab in a first-line setting, but then they’ve got to weigh that against Avastin as well,” Adams said. “It’s a very complex area all of a sudden.”
BioLineRx’s BL-1020 significantly improves cognitive function in patients with schizophrenia
Jerusalem, Israel 23 September 2009: Following our previous press release (published September 14th, 2009) announcing that BL-1020 has successfully met its primary and secondary efficacy endpoints from the phase 2b EAGLE (Effective Anti-psychosis via GABA Level Enhancement) trial, we are pleased to report positive final results regarding the effects of BL-1020 on cognition.
Patients with schizophrenia suffer from significant cognitive dysfunction. This is reflected in difficulty of daily functioning, decreased ability to maintain a normal social relationships and impaired job performance. Currently available antipsychotics have not been shown to improve cognition.
Cognitive function in the EAGLE trial was measured by the “Brief Assessment of Cognition in Schizophrenia” (BACS). The BACS test comprises the following six components: verbal memory, digit sequencing, token motor task, verbal fluency, symbol coding and the “Tower of London” puzzle. All of these functions are significantly impaired in patients with schizophrenia.
The EAGLE trial results indicate that patients treated for six weeks at the 20-30mg dose of BL-1020 exhibited a clinically relevant and statistically significant improvement of 9.27 points in the BACS score as opposed to the placebo control group (6.01 points) and the Risperidone group (6.2 points). BL-1020 exhibited statistical significance to both the placebo and Risperidone control groups (p=0.027 for both).
These results constitute a breakthrough in the treatment of patients with schizophrenia. BL-1020 offers for the first time, high efficacy, an improved safety profile and improved cognitive function.
The global anti-psychotic drug market is expected to reach approximately $17 billion by 2016. According to a comprehensive market research report prepared for BioLineRx, based on its’ profile, BL-1020 could capture 20-30% of this market. In addition, we believe that BL-1020 could be beneficial for other neurological/psychiatric disorders that affect cognitive function. The global market for compounds that may improve cognition is estimated at $20-30 billion.
Professor Michael Davidson MD, Chairman of Psychiatry, Tel Aviv University and consultant to BioLineRx, states: “Persistent and treatment refractory cognitive impairment is present in the majority of schizophrenia patients and contributes to social and vocational impairment even more than psychosis. Improving cognition remains a significant unmet medical need. The results of the double blind EAGLE clinical trial showed that while the cognitive function of patients treated with BL-1020 improved, patients treated with Risperidone and placebo did not.”
Richard Keefe, PhD, Professor of Psychiatry and Behavioral Sciences at Duke University, CEO of NeuroCog Trials, Inc., and consultant to BioLineRx, states: “In this double-blind trial, patients treated with the 20-30mg dose of BL-1020 demonstrated greater improvement in cognition as measured by the Brief Assessment of Cognition in Schizophrenia score than either Risperidone or placebo. The amount of improvement with BL-1020 compared to the other treatments was large enough to be not only statistically significant, but clinically significant as well.”
About BL-1020...snip
AMGN’s D-mab in BC trial - more data:
The median time to first on-study SRE was not reached for denosumab (meaning it is >34 months) and was 26.5 months for Zometa.
http://wwwext.amgen.com/media/media_pr_detail.jsp?year=2009&releaseID=1334123
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added entry for HCV2009
SEPTEMBER 2009
Cardiovascular and Interventional Radiological Society of Europe - CIRSE
September 19-23, 2009
Lisbon, Portugal
http://www.cirse.org/index.php?pid=391
European Cancer Organisation - ECCO and
European Society for Medical Oncology -ESMO
September 20-24, 2009
Berlin, Germany
http://www.esmo.org/events/berlin-2009-congress.html
World Stem Cell Summit
September 21-23, 2009
Baltimore, USA
http://www.worldstemcellsummit.com/program_overview.html
OCTOBER 2009
International Symposium on HCV and Related Viruses
October 3-7, 2009
Nice, French
http://www.hcv2009.org/
International Congress on Coronary Artery Disease - ICCAD
October 11 to 14, 2009
Prague, Czech Republic
http://www2.kenes.com/cad/pages/home.aspx
American College of Rheumatology - ACR
October 17-21, 2009
Philadelphia, USA
http://www.rheumatology.org/annual/index.asp
Society for Neuroscience - SFN
October 17-21, 2009
Chicago, USA
http://www.sfn.org/am2009/
World Diabetes Congress - IDF
October 18-22, 2009
Montreal, Canada
http://www.worlddiabetescongress.org/
American Society of Human Genetics - ASHG,
October 20-24, 2009
Honolulu, Hawaii
http://www.ashg.org/2009meeting/
Renal Week 2009
October 27 November 1, 2009
San Diego, CA
http://asn-online.org/education%5Fand%5Fmeetings/renal%5Fweek/
American Association for the Study of Liver Diseases (AASLD)
Oct 31-Nov3, 2009
Boston
http://www.aasld.org/thelivermeeting/Pages/default.aspx
American College of Chest Physicians - CHEST
October 31 - November 5, 2009
San Diego, California
http://www.chestnet.org/CHEST/program/about09.php
NOVEMBER 2009
American College of Allergy, Asthma & Immunology - ACAAI
November 5-11, 2009
Miami Beach, FL
http://www.acaai.org/Member/Annual_Meeting/Annual+Meeting.htm
American Heart Association - AHA
November 14-18, 2009
Orlando, Fl
http://scientificsessions.americanheart.org/portal/scientificsessions/ss/seeyounextyear2009
DECEMBER 2009
American Epilepsy Society - AES
December 4-8, 2009
Boston, MA
www.aesnet.org
American Society of Hematology - ASH
December 5-8, 2009
New Orleans, LA
http://www.hematology.org/meetings/2009/index.cfm
International Respiratory Congresses - AARC Convention
Dec. 5–8, 2009
San Antonio, Texas
http://www.aarc.org/education/meetings/#future_congress
American College of Neuropsychopharmacology - ACNP
Dec 6-10, 2009
Hollywood, Florida
www.acnp.org
--
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Lilly Drug Launch Seen Sluggish But CFO Sees Progress
By Peter Loftus Of DOW JONES NEWSWIRES
Sales of LLY and Daiichi new anti- clotting drug Effient appear sluggish, a Wall Street analyst said Monday, but Lilly's finance chief said the drug maker is making progress convincing health plans to pay for it.
The latest data for U.S. prescription volumes "reinforce our view that Effient's U.S. launch will be muted," Leerink Swann analyst Seamus Fernandez wrote in a research note Monday.
Fernandez, citing data from health-information provider IMS Health, said there have been 1,823 new prescriptions written for Effient since shortly after its August launch, which puts it significantly behind the most successful new drug launches of the past seven years.
The analyst said possible demand was hampered by the vacation season, and that the next four to six weeks may provide a clearer picture of demand for the drug.
Another factor is that Effient is supposed to be given to patients initially in the hospital, and IMS data don't reflect such usage. The IMS data should show whether patients continue to use the drug after they're discharged.
"There will be a delay in prescription data showing up in IMS, given that initial use occurs in the hospital setting," Lilly Chief Financial Officer Derica Rice told investors at a UBS conference in New York, which was available by Webcast.
Rice said the first six months of Effient's launch will be critical to getting the drug placed on hospitals' preferred-drug lists, or formularies. He said Lilly has made "positive" progress in efforts to persuade health insurers to pay for the drug, including Tricare, the government-funded health plan for the military.
Outside the U.S., Rice said several countries have agreed to reimburse for the drug, such as the U.K. and Argentina. France has recommended reimbursement, but assigned its "lowest rating" to the drug, Rice said, though he noted that three- fourths of new products get such a rating. Lilly spokeswoman Tammy Hull said the drug is fully reimbursed by France's national health system, but a French commission concluded the drug didn't provide added medical benefit. Lilly and Daiichi disagree with the commission's rating, Hull said.
Effient is competing with the blockbuster drug Plavix, which is co-marketed by BMY and SNY. Some analysts still see Effient exceeding $1 billion in annual sales eventually, but Wall Street enthusiasm for the drug has generally waned due to delayed regulatory approval and the bleeding risk associated with the drug.
Topicals are used for mild-to-moderate psoriasis and there are quite a few OTC and prescription meds that dominant the market.
NKTR/AZN deal for NKTR-118 and 119:
Nektar signs licensing deal with AstraZeneca, shares up
http://www.reuters.com/article/marketsNews/idCNBNG4775720090921?rpc=44
* AstraZeneca to develop Nektar's NKTR-118 and NKTR-119
* Nektar to get upfront payment of $125 mln for both drugs
* Brean Murray ups price target on Nektar stock to $12
* Shares of Nektar soar 17 pct to new 2-yr high (Adds CEO comments; updates share movement)
By Anuradha Ramanathan
BANGALORE, Sept 21 (Reuters) - Nektar Therapeutics (NKTR.O: Quote, Profile, Research, Stock Buzz) said it signed a deal with AstraZeneca Plc (AZN.L: Quote, Profile, Research, Stock Buzz) to develop two of its experimental drug candidates, sending shares of the biopharmaceutical company soaring to a new two-year high.
AstraZeneca will develop Nektar's late-stage drug to treat opioid-induced constipation, NKTR-118, and NKTR-119, which is in early-stage studies to treat pain without the side effects of constipation, and bear all costs related to development, manufacturing and commercialization.
Under the worldwide license agreement, Nektar will receive an upfront payment of $125 million for both drugs regardless of any regulatory milestone hurdles.
The company intends to use this cash to fund development programs for its existing drug candidates and also plans to preserve some cash, Chief Executive Officer Howard Robin told Reuters.
Nektar's current pipeline includes drug candidates for cancer, HIV and psoriasis.
Robin said the company is "very cautious" on how money is spent, and added that this upfront payment gives it "sufficient cushion" against the need to raise additional capital in the market.
He expects to end the year with about $390 million to $400 million in cash.
Under the AstraZeneca deal, Nektar is eligible to receive up to $235 million in aggregate payments for NKTR-118 upon the achievement of certain regulatory milestones, and additional tiered sales milestone payments of up to $375 million.
Nektar will also receive "significant" double-digit royalty payments on NKTR-118 and NKTR-119 net sales worldwide.
"While I am not able to disclose specifics of the royalty rates... we retain at least one-third ownership in our programs," CEO Robin said in a conference call.
He sees sales potential of "well in excess of a billion dollars" for NKTR-118.
Brean Murray Carret and Co analyst Jonathan Aschoff sees the deal with AstraZeneca as a "hugely positive development for Nektar."
The deal could make Nektar cash flow positive once the drugs get marketing approval, added Aschoff, who has a "buy" rating on the stock.
The analyst also raised his price target on the company's shares to $12 from $10.
AstraZeneca expects to file NKTR-118 for U.S. marketing approval in 2013, Nektar said in a statement.
However, Nektar's CEO Robin said that the timeline "is exceptionally conservative" and hopes to file the New Drug Application with the U.S. Food and Drug Administration prior to the anticipated date.
INCY - topical formulation of JAK2 inhibitor in psoriasis:
Incyte says psoriasis drug meets main goal
http://www.reuters.com/article/rbssHealthcareNews/idUSBNG49021520090921
* Drug meets primary and secondary goals
* Drug was well-tolerated at all doses
* Shares rise as much as 9 percent
(Updates share movement, adds analyst comments)
Sept 21 (Reuters) - Incyte Corp (INCY.O: Quote, Profile, Research, Stock Buzz) said its psoriasis drug met the main and secondary goals in a mid-stage trial, sending its shares up as much as 9 percent.
In the 200-patient trial, the drug INCB18424 showed a statistically significant improvement over dummy drug in the reduction in total lesion score -- the primary goal.
Psoriasis is a skin disorder, which can cause thick red skin lesions that are often itchy, sometimes painful and covered by silvery scales.
The drug was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters, the company added.
"Today's announcement provides validation for topical INCB18424 in psoriasis and additional proof-of-concept for JAK2 inhibition in autoimmune disorders," Cowen & Co analyst Eric Schmidt wrote in a note to clients.
Janus kinases (JAK) are enzymes that mediate signaling of several important drivers of inflammatory diseases and certain bone marrow disorders. Incyte's drug INCB18424 is a JAK inhibitor.
"The news is unlikely to have material impact on Incyte's prospects or financial condition", Schmidt said, adding that the market for topical psoriasis drugs is relatively modest.
Amgen bone drug proves itself in cancer studies
http://www.reuters.com/article/rbssHealthcareNews/idUSLL70670220090921
* Denosumab promising in breast, mixed tumours vs Zometa
* Adverse events and survival rates similar for both drugs
* Amgen R&D head says denosumab has clear advantages
* Amgen shares up 1.5 percent
(Recasts with abstract on breast cancer study, executive comments, latest shares)
By Ben Hirschler
BERLIN, Sept 21 (Reuters) - Amgen's (AMGN.O: Quote, Profile, Research, Stock Buzz) closely watched experimental bone-strengthening drug denosumab helped patients with advanced cancer, researchers said on Monday, reinforcing its potential as an alternative to standard therapy.
Breast cancer patients on the drug survived without their disease progressing for longer than those using Novartis' (NOVN.VX: Quote, Profile, Research, Stock Buzz) Zometa, according to a late-stage Phase III study to be presented this week at the ECCO-ESMO cancer congress in Berlin.
Shares of Amgen rose 1.5 percent in early trade as another study data also showed denosumab helped patients with a mix of advanced cancer types.
Amgen research and development chief Roger Perlmutter told Reuters in an interview in New York that denosumab had clear advantages over Zometa in effectiveness, in convenience and in not causing the kidney toxicity seen with the Novartis drug.
Amgen shares had soared in July when it announced denosumab reduced and delayed serious bone complications among patients with advanced breast cancer. But analysts said investors were subsequently concerned the detailed data would show worrisome trends about time-to-tumour progression.
In fact, an abstract released at the cancer meeting in Berlin showed a hazard ratio of 0.99, where anything over 1 would have indicated a negative trend for denosumab.
"With an ever-so-slight trend favoring (denosumab)..., we think concerns as to the potential for increased risk of tumour progression are now effectively alleviated," Chris Raymond, an analyst with Robert W. Baird, said in a research note.
The second study in mixed tumour types showed denosumab was similarly effective as Novartis's Zometa in delaying time to fracture or other skeletal-related events (SREs).
The delay to first SRE was actually numerically greater with Amgen's drug at 20.6 months, against 16.3 months for Zometa, but this difference was not statistically significant.
The study's goal had been to show non-inferiority and Amgen had announced last month that it met this endpoint.
The trial looked at 1,776 advanced cancer patients with solid tumours, not including breast and prostate cancer, or multiple myeloma. Bone destruction is a major cause of pain in approximately 70 percent of patients with metastatic disease.
Adverse events, including jaw damage, were similar between the two groups, as was survival and the time to cancer progression. The study investigators added the drug's profile on kidney function was reassuring.
"It is encouraging to see denosumab's efficacy in this broad cancer population. There is no need for renal monitoring or dose adjustments due to renal impairment," said David Henry of Pennsylvania Hospital, Philadelphia.
Full results of the study in breast cancer patients will be detailed at the meeting on Tuesday.
Amgen believes denosumab will be a popular choice with doctors and patients, since it is given as a monthly injection under the skin rather than intravenously. It also avoids the flu-like symptoms associated with Zometa.
Henry said this made it "an exciting potential treatment option for advanced cancer patients".
"I'm a practising oncologist and what is so important to our patients is convenience and safety," he said.
"In our clinics we see patients every day (and what is important is) helping patients get in and out quickly with the least impact on quality of life."
Denosumab is the first in a new class of drugs that inhibit proteins that activate bone-destroying cells. It is expected to be used first for osteoporosis, or brittle bone disease.
Next on the list is FTY720, and there's Tasigna in front-line CML, which is important for NVS, who will face competition from Sprycel and wants to protect from Gleevec's patent expiration.
Eric E. Schadt is one of my idols in the systems biology field, an exceptionally talented guy, who thinks only about the big picture. Regarding third generation sequencing technologies developers, PacBio looks like a possible winner, but there are other runners to watch such as Oxford Nanopore, which has some former Solexa (the developer of ILMN's Genome Analyzer) people in its team.
Point is this time, PillCam Colon II, might be good enough to gain FDA approval!
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Add CIRSE, ECCO/ESMO, World Stem Cell Summit; delete obsolete entry.
SEPTEMBER 2009
Cardiovascular and Interventional Radiological Society of Europe - CIRSE
September 19-23, 2009
Lisbon, Portugal
http://www.cirse.org/index.php?pid=391
European Cancer Organisation - ECCO and
European Society for Medical Oncology -ESMO
September 20-24, 2009
Berlin, Germany
http://www.esmo.org/events/berlin-2009-congress.html
World Stem Cell Summit
September 21-23, 2009
Baltimore, USA
http://www.worldstemcellsummit.com/program_overview.html
OCTOBER 2009
International Congress on Coronary Artery Disease - ICCAD
October 11 to 14, 2009
Prague, Czech Republic
http://www2.kenes.com/cad/pages/home.aspx
American College of Rheumatology - ACR
October 17-21, 2009
Philadelphia, USA
http://www.rheumatology.org/annual/index.asp
Society for Neuroscience - SFN
October 17-21, 2009
Chicago, USA
http://www.sfn.org/am2009/
World Diabetes Congress - IDF
October 18-22, 2009
Montreal, Canada
http://www.worlddiabetescongress.org/
American Society of Human Genetics - ASHG,
October 20-24, 2009
Honolulu, Hawaii
http://www.ashg.org/2009meeting/
Renal Week 2009
October 27 November 1, 2009
San Diego, CA
http://asn-online.org/education%5Fand%5Fmeetings/renal%5Fweek/
American Association for the Study of Liver Diseases (AASLD)
Oct 31-Nov3, 2009
Boston
http://www.aasld.org/thelivermeeting/Pages/default.aspx
American College of Chest Physicians - CHEST
October 31 - November 5, 2009
San Diego, California
http://www.chestnet.org/CHEST/program/about09.php
NOVEMBER 2009
American College of Allergy, Asthma & Immunology - ACAAI
November 5-11, 2009
Miami Beach, FL
http://www.acaai.org/Member/Annual_Meeting/Annual+Meeting.htm
American Heart Association - AHA
November 14-18, 2009
Orlando, Fl
http://scientificsessions.americanheart.org/portal/scientificsessions/ss/seeyounextyear2009
DECEMBER 2009
American Epilepsy Society - AES
December 4-8, 2009
Boston, MA
www.aesnet.org
American Society of Hematology - ASH
December 5-8, 2009
New Orleans, LA
http://www.hematology.org/meetings/2009/index.cfm
International Respiratory Congresses - AARC Convention
Dec. 5–8, 2009
San Antonio, Texas
http://www.aarc.org/education/meetings/#future_congress
American College of Neuropsychopharmacology - ACNP
Dec 6-10, 2009
Hollywood, Florida
www.acnp.org
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting any new items in chronological order.
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Early data indicate that the second generation PillCam Colon 2 capsule, which uses better technology, has higher sensitivity and specificity than first generation.
Given Imaging Announces Progress With Second-Generation PillCam(R) COLON
http://finance.yahoo.com/news/Given-Imaging-Announces-iw-3918105136.html?x=0&.v=1
Encouraging Results From the First Trial in Israel; CE Mark Obtained
YOQNEAM, ISRAEL--(Marketwire - 09/14/09) - Given Imaging Ltd. (NASDAQ:GIVN - News) today announced encouraging results from a trial that validated new features of the company's second-generation PillCam Colon video capsule and system. The Company also announced that it has obtained the CE mark for the sale of PillCam COLON 2 in Europe.
Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risk or warning symptoms of colon pathology. Like other PillCam capsules in Given Imaging's suite of products, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure. The Company intends to reveal PillCam COLON 2 in Europe at the Gastro 2009 conference this fall at which time it will disclose additional details, including product specifications and software enhancements.
"The main purpose of the trial was to evaluate the performance of new technologies embedded in the new capsule and PillCam platform. The results of this feasibility trial confirm the functionality of the system and give us increased confidence about the potential of PillCam COLON 2 as a useful tool for visualizing pathology in the colon. Despite statistical limitations resulting from the size of the trial and the relatively low prevalence of polyps, we are very pleased with the high degree of consistency in the sensitivity and specificity of the data, both of which were high and balanced," said Homi Shamir, CEO and President of Given Imaging Ltd. "We are now initiating additional multicenter clinical trials in Europe and Israel and intend to complete these trials over the next few months. Subsequently, we will begin a phased roll out of PillCam COLON 2 in Europe and a few other countries outside of the U.S. in 2010. On a parallel track, we have initiated pre-registration studies in the United States with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."
PillCam COLON currently is not available for sale in the United States.
About Colorectal Polyps...snip
Thanks for letting me know about the new board, Gary. Right on time to wish SHANA-TOVA to those who celebrate the Hebrew new year tomorrow.
On efficacy - BL-1020 was statistical significance better than placebo and non-inferior to Risperidone (remember that the study was powered to show statistical significance vs placebo and not Risperidone).
Not sure what it means 'safer than placebo', could be for example on a suicidal thoughts or such. BL-1020 was surely better than placebo on the cognition parameters. We'll know the drug's profile when full data are out.
The most interesting part in the phase 2b results of BL-1020 is the dimension of cognition, which is kind of surprising as you don't expect to see this after only 6 weeks. The most disappointing part is that BL-1020 didn't differ from Risperdone on EPS side effects.
COPD - NVS' QD LABA
Novartis lung drug beneficial in late stage study
http://www.reuters.com/article/rbssPharmaceuticals%20-%20Generic%20&%20Specialty/idUSLE16644120090915
* Improved lung function, reduced breathlessness
* "Smoker's lung" affects 210 million people worldwide
* Company confident on drug unit's performance
* Shares flat, outperform peers
(Adds Vectura data, shares)
By Sam Cage
ZURICH, Sept 15 (Reuters) - Swiss drugmaker Novartis (NOVN.VX: Quote, Profile, Research, Stock Buzz) said a respiratory medicine improved lung function and significantly reduced breathlessness in a late stage trial.
The once-daily QAB149 drug, which treats chronic obstructive pulmonary disease (COPD), improved a key measure of lung function at both 12 and 26 weeks of treatment compared with bronchiodilator tiotropium, also known as Spiriva.
The outcome added to data suggesting QAB149 will challenge blockbusters like Pfizer's (PFE.N: Quote, Profile, Research, Stock Buzz) Spiriva and GlaxoSmithKline's (GSK.L: Quote, Profile, Research, Stock Buzz) Advair, giving Novartis an edge in one of the industry's most lucrative therapeutic areas. [ID:nLM109152]
"We believe there is significant upside to our $1 billion sales forecast in COPD," said Helvea analyst Karl-Heinz Koch, who expects the drug to hit the market at the end of 2009.
Spiriva, marketed by Pfizer and Boehringer Ingelheim, is currently considered the gold standard treatment for COPD, or "smoker's lung", commonly caused by cigarette smoke and other harmful fumes and characterised by a persistent obstruction of airflow in the lungs which results in breathlessness.
Novartis plans to use QAB149 both on its own and as the base of combination treatments with other lung medicines, including QVA149, a mix with Vectura's (VEC.L: Quote, Profile, Research, Stock Buzz) NVA237. It is being reviewed for approval in Europe and the United States.
Vectura said on Tuesday the QVA149 combination had shown promising results in mid stage trials and was safe and well tolerated. [ID:nWLA3399]
The franchise is a key plank in Novartis's strategy to overcome the loss of exclusivity on top-selling blood pressure drug Diovan, which loses patent protection in 2012.
Novartis shares were flat at 49.42 Swiss francs by 1402 GMT, against a 0.8 percent drop in the European healthcare sector and helped by a sell-side event hosted late on Monday in which the group explained its focus on improving efficiency. Vectura shares were up 1.5 percent.
EFFICIENCY
At that event, Novartis drugs chief Joe Jimenez suggested impressive first-half growth was continuing in the third quarter and was confident the buy of a majority stake in Alcon (ACL.N: Quote, Profile, Research, Stock Buzz) would go through soon, said Vontobel analyst Andrew Weiss.
Novartis, which already holds 25 percent of the eye care company, has a deal to buy Swiss food group Nestle's (NESN.VX: Quote, Profile, Research, Stock Buzz) 52 percent stake between January 2010 and July 2011.
"We reckon, however, that Novartis will need to gain full control, if it wants to start extracting synergies by combining business units," Weiss said.
Data on QAB149, which would be the first such medicine to be given once rather than twice a day, were presented this week at a European Respiratory Society meeting in Vienna and add to results presented to the American Thoracic Society this year.
Smoker's lung is a debilitating and progressive respiratory disease that affects 210 million people worldwide, according to Novartis.
BiolineRX Ltd. (TASE:BLRX) reported top line results* for its schizophrenia drug, BL-1020, from phase IIb. Final results are expected in 2-3 weeks.
*Only the Hebrew link is available for now
The 2nd lot had been released and all 6 bioreactors at Allston are up and running.
http://supplyupdate.genzyme.com/weblog/2009/09/update-on-remaining-lots-of-cerezyme-091109.html
Got it, thanks. I'm trying hard to remember why was VVUS confident about that JNJ '537 patent. Think there was a paper published a few years before the patent filing which talked about the use of topiramate in obesity.
Topamax composition-of-matter patent expired but the method-of-use patent in obesity (U.S. patent #6,071,537) expires June 2017. However, a deal to avoid litigation makes more sense, like rkrw noted and you probably meant.
Agreed. AM/PM dosing for phentermine and topiramate when dosed separately, should yield similar efficacy and tolerability as the combo pill. That's why I think the separate components that are available generically will be widely substituted.
It is a tough job and still requires a very long research. People are gaining understanding about some of the genes involved but it is still too early to guess what would be the best approach. I believe that in the meantime standard breeding, with genetic markers, will continue to be the best approach.