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Kamada Reports Positive Proof-of-Concept Data for Inhaled Alpha-1 Antitrypsin in Bronchiectasis:
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090609005612
Is 10% good enough? :)
Didn't listen to the CC but ALNY is down 7%, so data cannot be too good.
Alnylam, Cubist: Drug meets midstage safety goals
http://finance.yahoo.com/news/Alnylam-Cubist-Drug-meets-apf-15463028.html?.v=1
Alnylam Pharmaceuticals, Cubist Pharmaceuticals say ALN-RSV01 meets midstage study goals
NEW YORK (AP) -- Alnylam Pharmaceuticals Inc. and Cubist Pharmaceuticals Inc. said Monday their developing treatment for respiratory infections in lung transplant patients met key safety and tolerability goals in a midstage study.
The drug, ALN-RSV01, is based on RNAi, or gene-silencing technology. It showed no significant side effect differences when compared with placebo. The drug is specifically aimed at treating the respiratory syncytial virus which can be particularly dangerous for lung transplant patients.
The study involves 24 lung transplant patients.
The company, meanwhile, said there were imbalances in the results for the placebo group and released results showing that the drug was no more effective in several cases than placebo. Still, the study itself is not meant to assess effectiveness, the company said, as the patient sample size is too small.
The companies have been partners since January. Cubist is paying Alnylam up to $102.5 million, plus royalties and in return the companies will equally share profit in North America. Cubist will have sole worldwide rights, excluding Asia. In Asia, the program's partner is Kyowa Hakko Kirin Co.
CSL, Talecris terminate merger agreement
http://www.reuters.com/article/rbssHealthcareNews/idUSN0827865520090608
* Costs, distraction cited as reason to terminate merger
* CSL to pay $75 million breakup fee
DX-88 could be approved by year end for acute HAE:
Dyax says FDA accepts genetic-disease drug response
http://www.reuters.com/article/marketsNews/idINBNG25559220090608?rpc=44
* FDA sets Dec 1 as new target action date
* Shares up 16 pct in pre-market trade
June 8 (Reuters) - Biotechnology company Dyax Corp (DYAX.O: Quote, Profile, Research, Stock Buzz) said U.S. health regulators accepted the complete response submission for its experimental treatment for a rare genetic disease, sending its shares up 16 percent.
The company said the U.S. Food and Drug Administration (FDA) has set Dec. 1 as a target action date to complete the review of the drug.
The drug, ecallantide, is for the treatment of acute attacks of hereditary angioedema (HAE), a potentially life-threatening genetic disease characterized by painful swelling of the skin, intestine, mouth and throat.
In March, the FDA declined to approve the drug in the present form and sought additional data on the safe use of the drug. [ID:nBNG366348]
"We are confident that our proposed risk evaluation and mitigation strategy for assuring the safe use of DX-88 and our response to other FDA requests thoroughly address the matters raised in the agency's letter," said Chief Executive Gustav Christensen
Shares of the company were up 20 cents at $2.07 in pre-market trade. They closed at $1.87 Friday on Nasdaq.
Novartis moves cancer drug into new lymphoma study
http://www.reuters.com/article/rbssHealthcareNews/idUSL838109420090608
* Cut tumour size by 50 pct or more in mid-stage trial
* Started late-stage trial in lymphoma
* Seen as one of Novartis' most important new drugs
* Shares rise 1.1 pct
By Sam Cage
ZURICH, June 8 (Reuters) - Novartis AG's (NOVN.VX: Quote, Profile, Research, Stock Buzz) Afinitor medicine cut tumour size by 50 percent or more in a third of patients with lymphoma in a mid-stage clinical trial, the Swiss drugmaker said on Monday.
Novartis said it had started a late-stage trial to evaluate Afinitor's potential to extend disease-free survival in patients with diffuse large B-cell lymphoma (DLBCL).
The daily oral treatment Afinitor is one of the Swiss group's most important new drugs and is being tested for use against several different types of cancer, which could help it achieve sales of more than $1 billion annually.
Novartis shares rose 1.1 percent to 43.24 Swiss francs by 0809 GMT, compared with a 0.2 percent drop in the European health care sector .
The current gold standard treatment against DLBCL is Rituxan, made by Novartis' Swiss rival Roche Holding AG (ROG.VX: Quote, Profile, Research, Stock Buzz), whose stock was up 0.3 percent.
Afinitor works by blocking a protein known as mTOR and disrupting the growth, division and metabolism of cancer cells and is a key plank of Novartis' strategy to expand in cancer drugs.
The U.S. Food and Drug Administration approved Afinitor earlier this year for use in advanced kidney cancer and European regulators have also recommended it. Novartis expects a filing for use in neuroendocrine tumours within the next year.
Vontobel analyst Andrew Weiss sees peak sales at $500 million in advanced kidney cancer but has not yet included possible revenue from other indications, which could be further positives if the drug reaches the market.
The mid stage trial assessed the drug in patients with relapsed non-Hodgkin's lymphoma and Hodgkin's disease, a variety of cancers which affect the immune system. Afinitor significantly shrunk tumours in 33 percent of patients, data which prompted Novartis to start the late stage study, the company said.
LEAD-3: Two-year data reveal sustained glycemic improvements with liraglutide [and no difference in calcitonin levels]
http://www.endocrinetoday.com/view.aspx?rid=40663
American Diabetes Association's 69th Scientific Sessions
Liraglutide monotherapy for two years was associated with significant, sustained improvements in glycemic control and body weight compared with glimepiride monotherapy, according to new results of the LEAD-3 trial.
At two years, patients assigned to once-daily liraglutide 1.8 mg (Victoza, Novo Nordisk) experienced a 1.1% decrease in HbA1c levels from baseline compared with 0.9% with the 1.2-mg dose and 0.6% with glimepiride. Additionally, more patients assigned to the human glucagon-like peptide 1 analog achieved a target HbA1c <7% (1.8 mg, 58%; 1.2 mg, 44%) at two years compared with glimepiride (37%).
The data are similar to the one-year data published in The Lancet in February, which concluded that liraglutide 1.8 mg reduced HbA1c by 1.14% and the majority of patients achieved a target HbA1c of <7%.
LEAD-3 compared the safety and efficacy of once-daily liraglutide at two doses – 1.8 mg and 1.2 mg – and glimepiride 8 mg. The trial had a one-year randomized, double-blind period followed by an open-label extension. About 90% of one-year completers entered the extension and 73% completed two years of treatment.
Liraglutide was associated with sustained weight loss; glimepiride was associated with sustained weight gain. After two years of treatment, mean body weight decreased significantly (-2.7 kg) among patients assigned to liraglutide 1.8 mg compared with an increase of 1.1 kg with glimepiride.
Hypoglycemia (<56 mg/dL) was more than six times less frequent among patients assigned to liraglutide at either dose compared with glimepiride.
In addition, intention-to-treat and two-year completer analyses revealed comparable between-group HbA1c differences. The researchers reported significant reductions in HbA1c, fasting plasma glucose and hypoglycemia with liraglutide vs. glimepiride in an intention-to-treat analysis.
The researchers reported a new finding that calcitonin levels remained stable and did not increase during the two-year period in a subset of 146 randomized patients. Further, there was no differentiation in calcitonin level by treatment.
“There does not seem to be any cause for concern with regard to calcitonin as a marker of excess c-cell stimulation. While there may be some issue with regard to GLP-1 stimulation of c-cells in rodents it does not appear in humans,” Alan J. Garber, MD, Endocrine Today Chief Medical Editor and professor of medicine at Baylor College of Medicine in Houston, said in an interview. – by Katie Kalvaitis
Exactly what I was telling go seek. And to add rkrw's point - once the FDA will approve Momenta's unique technology platform, no doubt the company will be a leading player/asset in the biogeneric/biosimilar field.
I believe that when it comes to the FDA it's safety before reducing healthcare costs.
HGSI/GSK GLP-I analogue - Syncria (albiglutide) data presented at ADA:
Glaxo's GLP-1 diabetes drug beats Byetta in test
http://www.reuters.com/article/marketsNews/idINL515978120090607?rpc=44&sp=true
* Syncria shows promise in Phase II clinical trial
* No sign of thyroid cancer problems in monkey tests
* Glaxo embarked on 2-3 years Phase III programme
By Ben Hirschler
LONDON, June 7 (Reuters) - An experimental diabetes drug from GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz) was more effective than Eli Lilly (LLY.N: Quote, Profile, Research, Stock Buzz) and Amylin Pharmaceuticals' (AMLN.O: Quote, Profile, Research, Stock Buzz) Byetta in controlling blood sugar, a mid-stage test unveiled on Sunday.
Glaxo's injectable Syncria belongs to the same class of medicines, called GLP-1s, as Byetta and Novo Nordisk's (NOVOb.CO: Quote, Profile, Research, Stock Buzz) Victoza, which the Danish drugmaker expects to launch in Europe this summer.
Safety issues have recently clouded prospects for the GLP-1 drug class.
In a 356-patient Phase II clinical study, presented at the annual meeting of the American Diabetes Association, Glaxo's Syncria, given once weekly, reduced HbA1C -- a common measure of blood sugar -- by 0.9 percent compared to 0.5 percent for Byetta, which is injected twice daily.
Syncria also caused patients to lose 0.9-1.8 kilos in weight, depending on dose. Common side effects included nausea, vomiting and headache.
British-based Glaxo began a final-stage Phase III clinical programme for the new medicine at the beginning of 2009, which is expected to take two to three years to complete.
GLP-1s have been touted as potential multibillion-dollar sellers, given demand for new ways to fight a global epidemic of type two diabetes driven by rising obesity levels.
But recently doubts have grown about the drug class, after Novo's Victoza caused thyroid cancer in rats and there were cases of pancreas inflammation last year with Byetta.
In case of Syncria, Glaxo's vice president of clinical development Murray Stewart said the drug could not be tested on rats for technical reasons but ongoing studies using monkeys had shown no signs of thyroid problems.
He remains optimistic that GLP-1s will emerge as an important new treatment option for difficult-to-treat diabetics, since they are highly effective at controlling blood sugar levels and also help people lose weight.
Some analysts have predicted they will lose out to DPP-4 inhibitors, another novel type of treatment for diabetes.
"I think in four years time people will realize there is probably no risk with pancreatitis and the thyroid issue is more related to animals than it is to humans," Stewart said.
"There is scientific reason to believe these issues will not be real and the benefits of the GLPs compared to the DPP-4s will be demonstrated."
The fact that the FDA has not requested human trials to date, does not eliminate the possibility it will do so in the future. As said before, M-enoxaparin is not strictly an FoB, but it is complex enough to make the FDA require all filers to perform clinical trials to prove clinical non-inferiority to the current drug or to wait for legislation from Congress on biosimilars. I think chances are modest that the FDA will approve without/before that. If I want to bet on that, I'll simply buy MNTA's stocks.
VPHM re Cinryze label expansion for self-administration:
First, (for those who didn't read the SI thread), we differ in our views regarding the commercial benefit: I do think that self-administration results in better compliance and will have positive effect on sales. My point is: before the revised label patients had to visit the clinic every three to four days, in an effort to prevent attacks (prophylaxis). Now the label allows self-administration so they can do it at home - independently, and save a lot of time and hassle.
On how to administer the drug:
Having an installed IV port does increased the risk of infection but implanting it under the skin helps reducing infection, and if the patient is taking routine disinfect measures, and being given antibiotics before and after dental work, the risk for infection is very low.
An implanted port is not absolutely essential for HAE patient who is on prophylaxis treatment, but it requires very little daily care, makes administration easier and less discomfort and is a good idea when maintaining home-based therapy. The decision is of course individual, but I personally would prefer a port over a needle, if I had to choose.
Agree with you on this. Lovenox is not a biosimilar but rather a complexed generic, far too complicated to be handled like small molecule generics. Moreover, I also doubt the FDA will approve a generic version without proper clinical trials.
There is also an oral formulation of rolofylline in development and I assume it is safe to say - it's dead as well.
Another worry is - rash incidence and severity with longer dosing might worsen. While anti-viral activity at 400mg BID will probably have strong efficacy, not sure if rash could be manageable. ANDS thinks, based on PK/PD analysis that loading dose followed by reduced doses can do the trick but ANA598 chances to be successfully developed don't look too good for now.
Takeda pulled its marketing application in the EU for alogliptin:
http://www.genengnews.com/news/bnitem.aspx?name=55661199
Sure they see a market - the entire Homo erectus
JNJ tidbit - company is pursuing U.S. approval for Priligy (it got a not approvable letter back in 2005)
http://www.bloomberg.com/apps/news?pid=20601202&sid=aHVl8HLbbhX4
Here we go again:
Elan up on Pfizer talk
http://uk.reuters.com/article/hotStocksNews/idUKL338578920090604
Trial should take over a year and CLS's C1 inhibitor could be approved very soon and block Cinryze for acute due to orphan exclusivity.
ANDS said it will cut 40 percent of its workforce and suspend the development of ANA773
http://www.reuters.com/article/marketsNews/idINBNG41756220090604?rpc=44
and they also did a private placement
http://www.biocetera.com/inthenews.php?id=119638
ADLR laid off 45 employees, or 28% of its workforce:
http://finance.yahoo.com/news/Adolor-Corporation-Announces-bw-15429636.html
Stem-cell clarity
http://www.nature.com/nature/journal/v459/n7247/full/459615b.html
The draft NIH guidelines on stem-cell research are a good first step, but some revision is needed.
The proposed guidelines on federal funding for stem-cell research issued in April by the US National Institutes of Health (NIH) are a welcome effort to assert ethical and regulatory leadership over this field — especially given the vacuum in oversight left by the previous US administration. Yet concerns aired by the scientific community during the public comment period that closed last week have underscored the need for the NIH to revise the guidelines to allow the responsible progress of research.
For example, the NIH has acted admirably in setting forth nine strict informed-consent provisions regarding the source material for stem-cell lines that are eligible for federal funding. As currently written, however, the provisions would probably exclude funding for most embryonic stem cells now in use, because the cells were derived from leftover embryos at fertility clinics under rules less stringent than the ones now called for. In particular, one provision requires that embryo donors affirm that they are donating "without any restriction or direction" regarding the patients who may benefit from the research. Few of the consent forms currently in use by fertility clinics ask for that affirmation. Also absent from many forms is the stipulation that the donors "would not receive financial or any other benefits" from commercial development of the research.
It is doubtful that the guidelines are intended to bar future NIH funding from stem-cell lines that are currently eligible — or, indeed, from the hundreds of lines that are now in use but are not among the score of US-approved lines. That would contradict US President Barack Obama's intention, stated on 9 March, to "expand NIH support for the exploration of human stem cell research". The NIH should explicitly state that the informed-consent provisions apply only to newly created lines. All previously eligible lines should continue to be eligible, and existing non-eligible lines should become so — provided that the latter were created in accordance with guidelines issued by the US National Academies or the International Society for Stem Cell Research.
A much less clear-cut issue is whether federal funding should support work on lines created from sources other than leftover embryos. The NIH's draft guidelines currently exclude support for research on lines created through somatic-cell nuclear transfer (SCNT), also known as therapeutic cloning. And they prohibit funding for lines created through the generation of an embryo from an unfertilized egg cell.
Some investigators have protested this provision of the guidelines, arguing that the NIH should not cut off any avenues of research. Their contention is somewhat hypothetical, however, because no one has yet shown conclusive evidence that SCNT can successfully create a human embryo. Regardless of this, the ethical issues involved are extremely sensitive. Polls consistently show that a majority of the American public is willing to pay for research on stem cells derived from embryos that would be discarded otherwise. But it is not clear that a majority would support the use of taxpayers' money to study stem cells from embryos created and destroyed for research purposes alone. So unless the scientists arguing for federal funding of research on SCNT-derived stem cells can make a much stronger case, by spelling out the specific situations in which the research might be warranted and explaining how they will ensure proper oversight of the work, the NIH's proposed exclusion should stand.
At the same time, however, the NIH should affirm that it will revisit its draft guidelines as the science progresses. The past decade shows us that basing research policy on arbitrary cut-off dates does not serve science or the public interest well.
The recent downdraft in share price of GILD was partly due to worries regarding cv events in darusentan's phase III DAR 311 trial in resistant hypertension. In the HIV arena, which they dominate, GILD is after a quad combo - to include elvitegravir in a single pill with Truvada and GS-9350, this will be a big commercial advantage over potential competition.
Novartis Chief May Waive Chance to Buy Alcon After Share Slump
http://www.bloomberg.com/apps/news?pid=20601202&sid=aF3SYV_NKC8w&refer=healthcare
By Eva von Schaper
June 3 (Bloomberg) -- Novartis AG may pass on a chance to buy a majority stake in eye-care company Alcon Inc. for $28.2 billion after Alcon shares slumped, Chief Executive Officer Daniel Vasella said.
Novartis last year acquired 25 percent of Alcon from Nestle SA for $143.18 a share, or $11 billion. Under the agreement, Novartis can purchase another 52 percent between January 2010 and July 2011 for $181 a share. Alcon has fallen 25 percent since Nestle and Novartis announced the deal on April 7, 2008, closing yesterday on the New York Stock Exchange at $111.45.
Buying Alcon would help Basel, Switzerland-based Novartis reduce its reliance on pharmaceuticals at a time when its biggest-selling drugs, the hypertension treatment Diovan and the cancer drug Gleevec, are set to lose patent protection. Still, completing the purchase would require the drugmaker to pay a 62 percent premium over Alcon’s current price.
“You can calculate the likelihood of that happening,” Vasella, said in a May 28 interview in his Basel office. “From the point of the fundamentals, of the fit of the business, of the strategy, all that has not changed, but you cannot look at that in isolation. It is in a context of financial terms. I hope that it can be done, but obviously there are also significant uncertainties.”
Novartis may still end up buying the Alcon stake. Nestle can require Novartis to buy the shares at a 20.5 percent premium to Alcon’s stock price when the option is exercised, up to a maximum of $181. A Nestle spokeswoman declined to comment on whether it plans to exercise that option. The remaining 23 percent of Alcon, the world’s largest eye-care products company, is publicly traded.
Vasella, 55, also said that two personnel moves in the past seven months -- elevating Joerg Reinhardt to chief operating officer and hiring Jonathan Symonds as chief financial officer - - will give the board options in planning for Vasella’s successor.
Alcon’s Stock
Alcon, based in Hunenberg, Switzerland, makes Opti-Free contact-lens disinfectants, treatments for eye infections and glaucoma, and machines used in cataract surgery.
In past years, Novartis reduced its dependence on prescription medicines by developing generic drugs and expanding its vaccine unit by acquiring Chiron Corp. Vasella repeated that he’s looking for acquisitions to aid growth.
“If we can acquire now at a decent price then we should,” he said. Acquisitions “could be biotechs, could be generics could be vaccines. If we can make the case that it adds value more than cash, we would do it.”
Last month, Novartis agreed to buy Ebewe Pharma’s injectable-drug unit for $1.2 billion in cash to gain generic copies of cancer treatments, including chemotherapy. In February, it said it will pay Portola Pharmaceuticals Inc. as much as $575 million for the global rights to a blood thinner that could challenge Bristol-Myers Squibb Co.’s and Sanofi- Aventis SA’s Plavix.
Smaller Deals
Novartis, along with GlaxoSmithKline Plc and AstraZeneca Plc in the U.K. and France’s Sanofi, has said it prefers smaller deals to megamergers. This year, Pfizer Inc. agreed to acquire Wyeth for $63.6 billion, Merck & Co. said it will pay about $46 billion for Schering-Plough Corp. and Roche Holding AG purchased the rest of Genentech Inc. for $46.8 billion.
“The question is: why do you consider big transactions, and I think the worst reason is because it is fashion,” the Novartis chief executive said.
In October, Vasella shook up top management, replacing the heads of three of four business units. He moved Reinhardt from head of the vaccines unit into the new position of chief operating officer, sharing leadership duties with Vasella. Last month, the company hired Symonds, a former AstraZeneca executive-turned investment banker.
While Vasella declined to say how long he planned to stay in his job, he said succession played a role in both moves.
“Succession planning is not an option, it’s a must,” Vasella said. “You don’t want to be in front of a situation where you have one choice. One choice is no choice.”
If they would have come up with an alternative solution to hunger it might have made a good impression. Otherwise, this is sounds like nonsense that obstruct improvements to me.
Semi OT - on a lawsuit and anonymous postings on an online forum:
Judge Allows Online Posts In Schering Vytorin Lawsuit
http://money.cnn.com/news/newsfeeds/articles/djf500/200906021647DOWJONESDJONLINE000597_FORTUNE5.htm
June 02, 2009: 04:47 PM ET
A federal judge will allow anonymous postings on a raucous online forum to be remain in a lawsuit accusing Schering-Plough Corp. (SGP) of misleading investors about the results of a cholesterol-drug study.
Judge Dennis Cavanaugh of the U.S. District Court in New Jersey on May 18 denied Schering-Plough's request to strike from the lawsuit comments posted on the Web site CafePharma.com, which suggest Schering insiders knew the study had failed well before the results were made public. He also denied Schering's request to exclude statements provided to plaintiffs from six anonymous former company employees.
The "Enhance" trial of the cholesterol drug Vytorin -- which is marketed by a joint venture of Merck and Schering-Plough -- ended in 2006 but its results weren't released publicly until January 2008. The study found Vytorin was no better than a generic drug at slowing artery thickening, causing sales to plummet and damaging the stock prices of both companies.
Schering shareholders subsequently filed suit, alleging executives violated securities laws by making false and misleading statements and omissions that artificially inflated Schering's share price between 2006 and 2008.
Schering-Plough has said its top officials remained blinded to the final results of the study until shortly before they were released publicly, and that it took so long to release them due to data quality problems that required follow-up analyses.
Schering-Plough, Kenilworth, N.J., has since agreed to be acquired by Merck of Whitehouse Station, N.J., in a cash-and-stock deal originally valued at $41 billion. The transaction is expected to close by the end of the year.
CafePharma is a Web site aimed at pharmaceutical sales representatives, who trade anonymous gossip and information about their employers. The message boards are grouped by company.
In March 2007, the author of one post on the Schering section of CafePharma claimed to have a "buddy" in Schering's research arm. "He says that the study is a bust," the post stated. Another post in 2007 stated, "Heard it crashed and burned!" A third, detailed post about the study stated, "Adding Zetia to high dose generic statin provides no real benefit." Vytorin is a single-pill combination of the drugs Zetia and simvastatin.
The lawsuit, filed by several U.S. state public-employee pension funds, claims the substance of these posts was confirmed in 2008 when the results were finally made public.
Schering-Plough asked the judge to exclude these posts from the lawsuit because their authors' identities couldn't be confirmed. It's possible they were written by rival company reps, short sellers or other "mischief makers," the company argued. CafePharma has a policy of not recording any identifying information of its posters.
Schering also tried to discredit CafePharma by calling it "the cyberspace equivalent of scrawls left on a men's room wall." It's true -- many posts are filled with profanity and slurs, and have little to do with the task of marketing prescription drugs.
But Judge Cavanaugh ruled that both the CafePharma postings and the confidential witness statements "are relevant to the ultimate issue" because they "purport to show the timing within which defendants became aware of the Enhance study's results."
Members of Congress, who are investigating Merck's and Schering's actions, also have sought information about the CafePharma posts.
Schering and other defendants, who include investment banks that did business with Schering, have filed motions to dismiss the lawsuit's claims. No trial has been scheduled.
Clinical Data Says Antidepressant Preserves Sex Drive
http://www.bloomberg.com/apps/news?pid=20601103&sid=aY_7uIjB4X_Q
By Julie Ziegler
June 2 (Bloomberg) -- Clinical Data Inc.’s flagship antidepressant is effective without reducing sexual drive, according to a study that paves the way for the company to seek U.S. approval for the medication by year’s end.
The drug, vilazodone, reduced depression on two rating scales among those who took it compared with a placebo, upholding earlier results, the Newton, Massachusetts-based pharmaceutical developer said today. The study failed to identify a so-called biomarker that would make it easier to determine which individuals would be most receptive to the medication, the company said.
Sexual dysfunction is a commonly reported side effect of treatment with antidepressants. Several popular drugs for depression decrease desire or sexual enjoyment, causing patients to stop taking the medication, according to researchers. If approved by regulators, vilazodone may compete with treatments including Eli Lilly & Co.’s Prozac, Pfizer Inc.’s Zoloft and GlaxoSmithKline Plc’s Paxil.
The study “validates, as a company, our drug development capabilities,” Chief Executive Officer Drew Fromkin said in an interview. Almost 21 million Americans a year suffer from depressive disorders, including major depression, according to the National Institute of Mental Health.
The failure to identify the biomarker “is an issue and will be an issue in terms of commercialization going forward,” said Andrew Vaino, an analyst at Roth Capital Partners LLC based in Newport Beach, California. Vilazodone’s success will depend on the magnitude of the effectiveness shown in the trial, Vaino said, adding that detailed results have yet to be released.
The clinical trial of 481 patients was the second of two studies in the final stage of testing normally needed for U.S. regulators to consider approving a drug.
Kamada has submitted a BLA to the FDA for its lead clinical candidate, intravenous alpha-1 antitrypsin, for the treatment of AAT.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000454873&fid=942
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added - NCDEU, ICAD, AACC
MAY 2009
Digestive Disease Week - DDW
May 30-June 4, 2009
Chicago, IL
http://www.ddw.org/wmspage.cfm?parm1=605
JUNE 2009
American Diabetes Association - ADA
June 5-9, 2009
New Orleans, LA
http://professional.diabetes.org/Meetings_GeneralList.aspx
Endocrine Society - ENDO
June 10-13, 2009
Washington, DC
http://www.endo-society.org/endo/media.cfm
European Neurological Society - ENS
Milan, Italy
June 20–24, 2009
www.ensinfo.com
New Clinical Drug Evaluation Unit (of mental health)- NCDEU
June 29-July 2, 2009
Hollywood, FL
http://www.ncdeumeeting.org/
JULY 2009
International Conference On Alzheimer’s Disease - ICAD
July 11-16, 2009
Vienna, Austria
http://www.alz.org/icad/
International Society on Thrombosis and Haemostasis - ISTH
July 11-16, 2009
Boston
http://isth2009.com/
American Association of Clinical Chemistry - AACC
July 19-23, 2009
Chicago
http://www.aacc.org/events/2009am/Pages/default.aspx
AUGUST 2009
International Congress of Respiratory Science - ICRS
August 9-13, 2009
Bonn, Germany
http://www.respiratory-science.org/
European Society of Cardiology - ESC
August 29-September 2, 2009
Barcelona, Spain
http://www.escardio.org/congresses/esc-2009/Pages/welcome.aspx
SEPTEMBER 2009
Interscience Conference on Antimicrobial Agents and Chemotherapy - ICAAC
September 12-15, 2009
San Francisco
http://www.icaac.org/
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
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 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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Procedure for Updating Calendar
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Novel anticancer strategy targets DNA repair
Could poly(ADP–ribose) polymerase inhibitors provide a major advance in the therapy of difficult-to-treat tumours, such as triple-negative breast cancer?
News & ANAlysis NATURe RevIewS | Drug Discovery vOlUMe 8 | JUNe 2009 | 437
By Alisa Opar
In April, Sanofi–Aventis announced that it will acquire BiPar Sciences, a California-based company that is developing novel cancer therapies, for up to US$500 million in milestone payments, including an undisclosed upfront payment. Among the agents that Sanofi–Aventis will gain is BiPar’s promising anticancer compound, BSI-201 — a potential first-in-class poly(ADP–ribose) polymerase (PARP) inhibitor that is currently in Phase II clinical trials.
PARP1, the major PARP isoform, is an enzyme involved in the repair of DNA damage, particularly under stressful conditions, such as exposure to radiation, carcinogens or anti-tumour drugs. Preclinical studies indicate that PARP inhibitors could enhance the efficacy of radiation therapy and chemotherapies such as alkylating agents and platinum-based drugs by preventing cancer cells from repairing DNA damage, thereby promoting apoptosis.
It is hoped that this therapeutic strategy could soon show clinical success for cancers that are currently difficult to treat. “It’s exciting because not only is this a new class of agents, but they may target some cancers that have been pretty resistant to treatment, like high-grade ovarian cancers and triple-negative breast cancers (TNBCs),” says Karen Gelmon, Professor of Medicine at the British Columbia Cancer Agency, Canada, who is the lead investigator of a Phase II trial of another PARP inhibitor, olaparib (AstraZeneca).
The eagerly awaited results of Phase II trials of both olaparib and BSI-201 will be presented at the American Society for Clinical Oncology (ASCO) meeting in Orlando, Florida, USA, from 29 May to 2 June 2009. BSI-201 has been studied in combination with chemotherapy (gemcitabine and the platinum-based drug carboplatin) in patients with metastatic TNBC — so called because the cancer cells lack receptors for oestrogen and progesterone and do not overexpress the human epidermal growth factor receptor 2 (HeR2). This cancer subtype, which accounts for about 15% of all breast cancers, does not respond to current hormone-based and HeR2-targeted therapies and does not have an approved standard of care.
BiPar reported interim safety data from this trial at the annual San Antonio Breast Cancer Symposium in December 2008, showing that the drug was well tolerated with no added toxicities compared with chemotherapy alone. The company also presented an interim analysis of gene expression data showing that, in tumours of the first 50 patients enrolled (there were 89 patients altogether), there was significant upregulation of PARP expression. “I think there is a possibility that this kind of agent will allow for a reduction in some of the doses of standard chemotherapy,” says Barry Sherman, BiPar’s executive vice President of Development. “As we go forward, we’ll use these drugs to get greater efficacy with fewer side effects.”
Next, as a wholly owned subsidiary of Sanofi–Aventis, BiPar plans to move its PARP inhibitor into Phase III trials for TNBC. BiPar will keep its name and maintain operations in California, says Hoyoung Huh, BiPar’s President and Chief executive Officer. “Obviously, Sanofi will provide a lot of the commercial input and late-stage development support, as well as the resources needed to accelerate the development and launch of this promising compound,” he says, adding that the deal ensures “...the momentum and the culture...” of BiPar will continue. looking ahead, Huh expects to continue ongoing trials of BSI-201 and chemotherapy in gliobastoma multiforme, uterine cancers and ovarian cancers.
Ovarian cancers and TNBC are both often characterized by mutations in the genes encoding breast cancer type 1 susceptibility protein (BRCA1) and BRCA2, which are normally involved in the repair of double-stranded DNA breaks through homologous recombination. Indeed, among the current clinical trials of PARP inhibitors (Table 1), the most advanced trials involve patients with mutations in BRCA genes, as early investigations showed BRCA-deficient cells to be particularly sensitive to PARP inhibition.
In addition to enhancing the effects of DNA-damaging chemotherapies, it is hoped that PARP inhibitors will also show activity as monotherapies in patients with BRCA mutations. This might provide a pioneering demonstration of the clinical exploitation of a general concept known as ‘synthetic lethality’ — that a loss of the function of either of two proteins alone is compatible with cell viability, but loss of both functions causes cell death (Nature Rev. Cancer 5, 689–698; 2005). In this case, the BRCA mutation gives rise to a defective homologous recombination pathway, and so the loss of further DNA repair pathways owing to PARP inhibition could result in synthetic lethality in the BRCA-mutant cancer cells, whereas normal cells with functional BRCA alleles survive.
“If you put together inhibition of PARP and lack of function of BRCA1 or BRCA2, you suddenly get a perfect storm of DNA repair deficiency and genome instability in the tumour, and tumour-selective killing,” says Andrew Tutt, Director of the Breakthrough Breast Cancer Research Unit at King’s Health Partners’ Academic Health Sciences Centre in london, UK. At ASCO, Tutt will present Phase II trial data of olaparib as a monotherapy for the treatment of patients with advanced breast cancer that have inherited mutations of BRCA1 or BRCA2. “The use here is based not on synergy with chemotherapy, but synergy with a tumour-restricted genetic defect in DNA repair.”
Breakthrough Breast Cancer and Cancer Research UK contributed to the development of the synthetic lethality hypothesis and preclinical proof of concept. In Phase I trials, olaparib showed significant efficacy and modest toxicity in patients with mutated BRCA1 or BRCA2. And the synthetic lethality approach may not be limited to carriers of BRCA1 or BRCA2 mutations, says Tutt. “It may occur in a wider range of cancers as yet to be defined.”
Currently, there are ~20 trials for olaparib in clinical development for the treatment of BRCA1- and BRCA2-defective breast cancers and ovarian cancers, as well as TNBC; serous ovarian, pancreatic and colorectal tumours; and melanoma. The compound is being investigated both as a monotherapy and in combination with platinum-based DNA-damaging agents, cytotoxic drugs and radiotherapy. Olaparib was originally developed by the UK biotechnology company KuDOS, which has been a wholly owned subsidiary of AstraZeneca since 2006. “we have been maintained as a specialized discovery unit in Cambridge, where we focus on finding new inhibitors of DNA damage-response that will then be developed by AstraZeneca,” says KuDOS’s Chief Scientist, Mark O’Connor.
Gabriel Hortobagyi, Chairman of the Department of Breast Medical Oncology at MD Anderson Cancer Center in Houston, Texas, USA, emphasizes that there is still much to be discovered about PARP inhibitors and the various cancers linked to BRCA mutations. “we haven’t even started to scratch the surface of whether PARP inhibitors would be similarly effective in BRCA-related prostate and pancreatic cancers.”
KuDOS is investigating which other types of tumours might have lost the homologous recombination repair pathway, says O’Connor. “It seems the more we look into this, the greater the potential is for targeting HRD [homologous recombination deficiency] tumours. So, I think the loss of this pathway might be a relatively common event in both solid tumours and haematological tumours.”
“I think it remains to be seen how common synthetic lethal interactions with cancer-relevant mutations will be in cancer cells,” says william Kaelin, of the Dana–Farber Cancer Institute in Boston, Massachusetts, USA. “But I think there’s still hope that the general concept is correct, and that we should be looking for vulnerabilities that are created upon the mutation of specific cancer genes, either alone or in combination, in cancer cells.”
Ultimately, Hortobagyi and Gelmon expect the drugs to be used in combination with other therapies and, at the very least, to provide the first somewhat specific agents for patients with BRCA1- and BRCA2-related cancers.
“I think that PARP inhibitors are not going to be without their toxicities,” says Gelmon. “But there’s so much potential in understanding more about how genes might cause cancers to occur. Once you start targeting a gene, then you can start saying, ‘can we prevent this gene from misbehaving and causing cancer?’
Bristol-Myers Isn’t in Talks for Elan Stake, UBS Says
http://www.bloomberg.com/apps/news?pid=20601202&sid=ahP1AeNbcA.M#
By Tom Randall and Ambereen Choudhury
June 1 (Bloomberg) -- Bristol-Myers Squibb Co. isn’t in talks to buy a stake in Elan Corp., the Irish drugmaker that’s seeking financing, according to UBS AG analysts.
“BMY has confirmed to us that it is not currently in talks to buy a minority stake in Elan,” Roopesh Patel and Keyur Parekh, New York-based analysts for UBS, wrote in a report today. Brian Henry, a spokesman for New York-based Bristol- Myers, said in an e-mail the company had “no comment on rumors and speculation.”
Elan in January said it hired Citigroup Global Markets Inc. to consider a merger, sale or strategic alliance as possible options to finance tests on its experimental drugs, led by bapineuzumab for Alzheimer’s, and repay $1.1 billion in debt due in 2011. A person familiar with the deal said yesterday that Bristol-Myers was in talks with the Dublin-based company.
Elan Chief Executive Officer Kelly Martin said April 22 the “preferred outcome” was a partnership with another drugmaker, including the sale of a minority stake.
Pfizer Inc., the world’s largest drugmaker, is acquiring Madison, New Jersey-based Wyeth for $65 billion. Merck & Co. of Whitehouse Station, New Jersey, is spending about $44 billion to buy rival Schering-Plough Corp. of Kenilworth, New Jersey. Bristol-Myers in March formed a group of top managers to pursue deals and drug development.
James Cornelius, Bristol-Myers chief executive officer, has said he is looking for acquisitions after the company finished 2008 with $8 billion in cash. Bristol-Myers had $7.8 billion in cash at the end of March, according to data compiled by Bloomberg.
Specialty Drugs
Elan, like Bristol-Myers, is focused on specialty drugs for multiple sclerosis, Alzheimer’s and Parkinson’s disease, the UBS analysts wrote. The value of a deal would have hinged on successful trials of bapineuzumab, which in our view has meaningful development risks,” according to the analysts, who have a “buy” rating on Bristol-Myers.
Niamh Lyons, a spokeswoman for Elan, declined to comment in an interview today. Representatives of the two companies previously had declined to comment on the report that they were in talks. Bristol-Myers was one of two contenders for a stake in Elan, the Wall Street Journal reported May 30.
Elan shares rose 34 cents, or 6.6 percent, to 5.40 euros at 12:33 p.m. in London. The stock surged as much as 10 percent. Markets in Dublin are closed for a national holiday.
Elan reported a first-quarter loss of $102.6 million, a 20 percent increase from a year earlier. Sales of its multiple sclerosis drug Tysabri, which is marketed with Biogen Idec Inc. of Cambridge, Massachusetts, rose 44 percent over the same period a year earlier, Biogen reported April 16. It is developing bapineuzumab for Alzheimer’s with Wyeth.
Elan’s shares rose 8.5 percent on May 5 on speculation that Danish drugmaker H. Lundbeck A/S would make a bid for the company.
BioLineRx's BL-1040 interim data look good. Trial should be completed by Oct. 2009.
Celldex to buy CuraGen in $94.5 mln stock deal
http://www.reuters.com/article/marketsNews/idINBNG42442920090529?rpc=44
* Celldex to buy CuraGen for $94.5 mln in stock
* Deal expected to close in Q3
* Deal to add to Celldex's immunotherapy platform
May 29 (Reuters) - Celldex Therapeutics Inc (CLDX.O) said it agreed to acquire CuraGen Corp (CRGN.O) for $94.5 million in stock.
With the acquisition, Celldex will add 11 oncology-focused antibodies to its precision targeted immunotherapy platform. [ID:nWNAB4554]
CuraGen is expected to have a cash balance of at least $54.5 million at the close of deal, which is expected to occur in the third quarter.
Celldex will assume $14.1 million of CuraGen's 4 percent convertible debt due in February 2011 at the close of the deal.
CuraGen shares were up 7 percent at $1.34 in pre-market trade, after closing at $1.25 Thursday on Nasdaq.
One more pessimistic issue - even if aggressive treatments did the trick, the price is quality of life
On next-generation DES - biodegradable polymer approaches:
I believe most players have such programs (ABT's ABSORB, JNJ's NEVO, BSX's Labcoat Element, and MDT has one but I don't know its name). I can see the possible advantages of these stents, can you tell me where the disadvantages may be?
VTE prevention is nice but Xarelto's sales potential is going to be real huge if results in AF and ACS trials are positive.
Novartis, Roche unveil promising cancer drugs data
http://www.reuters.com/article/rbssHealthcareNews/idUSLS56369220090528
* Novartis' Sandostatin LAR helps fight mid-gut tumours
* Other Novartis drugs help advanced melanoma
* Roche says new drug helps shrink breast tumours
By Sam Cage
ZURICH, May 28 (Reuters) - Swiss drugmaker Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) said late stage data showed its Sandostatin LAR drug helped fight tumuors of the mid-gut, while other drugs showed benefits for treating advanced melanoma.
Novartis' rival Roche Holding AG (ROG.VX: Quote, Profile, Research, Stock Buzz) also said on Thursday a new drug helped shrink the tumours of 25 percent of women with HER2-positive breast cancer, according to data from a mid-stage clinical trial.
Cancer drugs are seen as a key growth area for pharmaceutical makers like the two Swiss companies, which along with many others are presenting data on cancer drugs at an American Society of Clinical Oncology (ASCO) meeting.
Novartis said a Phase III study showed Sandostatin LAR more than doubled time without tumour growth and reduced the risk of disease progression by 67 percent.
It also said mid stage data on two of its drugs showed potential as treatments for advanced melanoma. Favourable results from a study into the drug Glivec mean the study will continue to a second expanded stage of enrolment.
The Swiss company also presented preliminary results which showed that 72 percent of melanoma patients treated with Afinitor combined with Roche's Avastin experienced a clinical benefit.
Afinitor, one of Novartis' most important new drugs, also helped patients with advanced liver cancer in an early stage trial.
Data from a mid stage trial of the new treatment from Roche, a combination of its Herceptin and chemotherapy known as trastuzumab-DM1, showed about 35 percent of a total 112 patients had their tumours shrink, or their disease stabilise for at least six months.