Ablynx says first nanobody drug may hit market by 2013

* Ablynx-Pfizer rheumatoid arthritis drug in Phase II

Belgium's Ablynx (ABLX.BR), which specialises in ultra-small drugs derived from llamas, could see its first product on the market in 2013, its chief executive said in an interview.

Ablynx specialises in nanobodies -- touted as the next generation in antibody treatment -- which are developed from the antibodies in llamas. They have the potential to enable drugs to get to diseases that are too small for traditional antibodies to reach.

One of its lead drugs, being developed in partnership with U.S. drugs giant Pfizer (PFE.N), which inherited it when it took over Wyeth last year, is currently in Phase II trials and could become its first commercialised product.

"The earliest we think it could be on the market is 2013, that's a tangible distance away," Chief Executive Edwin Moses told Reuters in an interview late on Thursday at the company's headquarters in Ghent.

Pfizer is hoping it will be able to use the new nanobody drug to replace its arthritis medicine Enbrel -- which made almost $1 billion in the third quarter of 2008 [ID:nN21437632] -- Moses said.

The company also has partnerships with Merck (MRCG.DE), Boehringer Ingelheim and Novartis (NOVN.VX).

In a twist of nature, llamas have evolved to produce extra small antibodies, which are in turn used to make nanobodies. They are stable enough to be inhaled or inserted under the skin, setting Ablynx' technology apart from rivals like GlaxoSmithKline's (GSK.L) Domantis, Moses said.

Nanobodies are being tested on animals for Alzheimer's disease and they are currently in mid-size human trials for arthritis and thrombosis.

They also cost about a third of the price of developing traditional antibodies, Moses said.

"We take two or three llamas, give them an injection and go away on holiday (and create) what might have taken 20 medical chemists a year to come up with," said Moses. ($1=.7040 Euro) (Editing by Karen Foster).

Reference-

http://www.reuters.com/article/idUSLDE60O0DM20100125

Disclaimer- This posting is for information purposes only and sould not be considered as medical advise.

Clinical research updates on new drugs-

Stevioside associated with inhibited artherosclerosis in obese, insulin-resistant mice.
According to a study published online in the International Journal of Obesity, "stevioside treatment was associated with increased adiponectin and insulin sensitivity and improved antioxidant defense in both the adipose tissue and the vascular wall, leading to inhibition of atherosclerotic plaque development and inducing plaque stabilization." After treating "14 mice...with 10 mg/kg stevioside and 20 with placebo for 12 weeks," researchers found that "stevioside treatment...lowered levels of glucose and insulin, improved adipose tissue maturation, and increased glucose transport, insulin signaling and antioxidant defense in white visceral adipose tissue, compared with placebo," and "reduced plaque volume in the aortic arch.

"Shire Plc's Replagal [agalsidase alfa] provided 'substantial and sustained' benefits to patients with a rare condition called" Fabry disease "after five years taking the enzyme replacement therapy, according to" data collected on 181 multinational patients. In fact, the "drug improved all areas studied, including heart mass and function, kidney function, pain, and quality of life," investigators noted in their paper in The Lancet. However, "advanced complications of Fabry disease do not appear to be fully reversible with treatment and that future studies [should] examine whether early initiation of treatment can improve long-term outcomes more than was evident in the current study."


Specific drug combination may be more effective in patient with high HIV viral load.
"In patients with a high HIV viral load at the start of initial therapy, regimens based on tenofovir/emtricitabine (Truvada) were more effective than those based on abacavir/lamivudine (Epzicom)," Brigham and Women's Hospital researchers found after evaluating 1,858 patients. "Current guidelines for initial HIV therapy suggest a regimen based on two nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor."

While such combinations are "potent," it has "not been clear if they differ in antiviral activity, tolerability, and safety." The new "surprise finding," however, "suggests that physicians should be aware of the difference when prescribing initial treatment for patients with a high level of HIV-1 RNA in their blood," according to the paper in the New England Journal of Medicine.


Roche says experimental diabetes drug works better than Januvia.
In a clinical trial, Roche Holding AG's experimental diabetes treatment, taspoglutide, worked better than Merck & Co. Inc.'s Januvia [sitagliptin]. In a phase III trial for treatment of type 2 diabetes, the drug met its primary endpoints. Researchers found that the drug lowered blood-glucose levels more than Januvia, and showed superior HbA1c reduction compared to placebo.


Pharmaxis says Bronchitol improved lung function in patients with cystic fibrosis.
Drugmaker Pharmaxis Ltd. said "its Bronchitol [mannitol] drug improved patients' lung function" in "a study of 170 patients with cystic fibrosis." Researchers found that patients "who switched to the drug after taking a placebo for six months improved by 10.3 percent."


FDA rejects approval of Merck's cladribine to treat Multiple Sclerosis.
Merck KGaA announced that the FDA rejected approval of its cladribine drug to treat multiple sclerosis. The company sought approval of cladribine as a potential short-course treatment for the condition, but the agency said Merck's application is not adequately complete. Merck intends "to request a meeting with the FDA" to discuss the agency's "concerns with its application for approval," according to a spokesperson.

Disclaimer – This information is presented for knowledge purpose only and should not be interpreted as medical advise.

Drug- Clinical research updates-

Sanofi fails to win preliminary NICE backing for its Multaq heart drug.
Sanofi-Aventis SA failed to win the preliminary backing of the UK's health-cost panel for its Multaq [dronedarone] heart medicine after a committee said the medicine isn't more beneficial than standard therapies." The UK's "National Institute for Health and Clinical Excellence's [NICE] independent appraisal committee found that the drug doesn't work as well and costs more than medicines already on the market, NICE said today in an emailed statement and added that "NICE will make a final recommendation on whether the UK's National Health Service should pay for the medicine after a consultation period that ends on Jan. 28 2010.

MedImmune responds to FDA inquiry regarding motavizumab.
AstraZeneca PLC, the London pharmaceutical that owns MedImmune, said the local subsidiary has filed its formal responses to the Food and Drug Administration's questions about motavizumab, an enhanced version of MedImmune's blockbuster drug Synagis." According to the Business Journal, the drug, which treats respiratory syncytial virus disease in infants, "has hit its share of delays to market."

Combination therapy with mirtazapine may be more effective than fluoxetine alone.
According to a study published online Dec. 15 in the American Journal of Psychiatry, "mirtazapine used in combination with fluoxetine, venlafaxine, or bupropion is more effective and as well tolerated in treating major depressive disorder (MDD) as fluoxetine alone." After treating "a total of 105 patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria for MDD," researchers found that "patients treated with these combinations had mean differences of 4.5 to 4.8 points on the Hamilton Depression Rating Scale (HAM-D) by day 42, compared with those treated with monotherapy."

FDA says Aridol cannot be approved in present form.
Pharmaxis, Ltd. reported that it has received a so-called complete response letter from the US Food and Drug Administration saying the application for its lung-function test Aridol [mannitol dry powder for inhalation] couldn't be approved in the present form." The agency "cited deficiencies at three manufacturing and testing subcontractors, a labeling issue, and post-marketing requirements, Pharmaxis said in a statement." The company plans to "address the issues and seek approval as soon as possible," Pharmaxis CEO Alan Robertson said. Aridol, which is already "approved for sale in Australia, major European countries, and Korea," is "a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness."

Monoclonal antibody may be promising in Ewing's sarcoma.
A monoclonal antibody that targets an insulin-like growth-factor receptor (IGF-1R) was well tolerated and demonstrated antitumor activity in refractory Ewing's sarcoma," according to research appearing online in Lancet Oncology. In a study of "29 patients with advanced sarcomas treated with figitumumab," researchers assessed "tumor response...every six to eight weeks by CT, MRI, or both." The study showed that "two patients...had confirmed responses," and eight "had disease stabilization." Researchers found "no cardiac toxicity," and "no substantial change in cardiac valve function or left ventricular ejection fraction," which they said "was noteworthy...because IGF-1R is expressed on cardiac myocytes, and three-quarters of the patients had previously received potentially cardiotoxic anthracyclines."

Patients with MDD taking paroxetine may undergo greater personality change.
According to a study published in the Dec. issue of the Archives of General Psychiatry, "patients with major depressive disorder (MDD) taking paroxetine underwent greater personality change than those taking placebo, including a significant reduction in neuroticism and a marked increase in extraversion, even after controlling for depression improvement." Researchers arrived at that conclusion after randomizing "240 MDD patients aged 18 to 70 years to receive paroxetine (n = 120), placebo (n = 60), or cognitive therapy (n = 60)," then following them for a year. Notably, paroxetine "appears to have a positive effect on personality that is separate and distinct from its antidepressant effects."

Disclaimer : The information presented here is for knowledge purpose only and should not be interpreted as medical advise.

Cancer drugs : Clinical research updates

Researchers increasingly targeting cellular environments in cancer research.
NewYork Times reports that "more and more researchers are studying tumors in their cellular environments," a "major shift in thinking about why cancer occurs and how to stop it." The approach is rooted in the idea "that cancer cells cannot turn into a lethal tumor without the cooperation of other cells nearby," which implies that "cancer might be kept under control by preventing healthy cells around it from crumbling." Drugmakers are also "investigating the way some skin, ovarian, colon, and brain cancers signal surrounding cells to promote cancer growth." Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health, noted, however, that such ideas are not new, pointing to a 1962 study in The Lancet that suggested "cancer may be a disorder of cellular organization."


Compugen confirms development of cancer treatment target.
Israeli drug developer Compugen Ltd. said that it has discovered a potential cancer treatment target using its RNA sequence technology." The company claims to have validated CGEN-671, which "can be used to better tailor treatments to target a wide range of cancers." According to Compugen's research, CGEN-671 "is expressed in more than 75 percent of colorectal and breast cancers, and 50 percent in lung cancers."

Teva seeks approval for copy of Amgen's Neupogen.
Teva Pharmaceutical "has tired of waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs," and has instead decided to seek approval "for its copy of Amgen's Neupogen under the normal branded-drug process." Teva has recently submitted a Biologic License Application "for XM02, its copycat of Neupogen - a drug that stimulates the production of a type of white blood cells in cancer patients." However, "it doesn't mention having tested XM02 in acute myeloid leukemia or severe chronic neutropenia," and is "likely settling for fewer patients in exchange for a more restrictive label."

Synta Pharmaceuticals begins mid-stage trial of treatment for gastrointestinal stromal tumors.
Synta Pharmaceuticals Corp. Reported that it has started a mid-stage trial of a cancer drug candidate as a treatment for cancers of the digestive tract." The drugmaker will examine STA-9090 in patients with gastrointestinal stromal tumors "who have not responded to treatment with two other cancer drugs, Novartis AG's Gleevec [imatinib] and Pfizer Inc.'s Sutent [sunitinib]." The drug works by inhibiting a protein, Hsp90, which "activates other proteins that cancer cells need to grow.

Gefitinib may improve survival among lung cancer patients with EGFR mutations.
According to research appearing online Dec. 21 in Lancet Oncology, "Asian patients with lung cancer and epidermal growth-factor receptor (EGFR) mutations respond well to initial treatment with gefitinib." In a study of 177 patients, researchers found that "gefitinib conferred superior progression-free survival time vs. standard treatment with platinum-based combination chemotherapy." The study also showed that "the objective response rate in patients with measurable disease was significantly higher among patients receiving gefitinib," and "the disease control rate was also higher."

Findings may help researchers understand how cordycepin inhibits cancer cell growth.
According to findings published in the Journal of Biological Chemistry, "scientists have discovered how a promising cancer drug, first discovered in a wild mushroom, works." Researchers found that the drug cordycepin "inhibits the uncontrolled growth and division of the cells" at low doses by interfering "with the production of mRNA, the molecule that gives instructions on how to assemble a protein." Meanwhile, "at high doses it stops cells from sticking together, which also inhibits growth." The results may help investigators determine which cancers may be treated with cordycepin.

Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.

Pharma and biotech news -

Pharma News

Five years, twice the revenue.

That's what Teva Pharmaceutical Industries chief Shlomo Yanai is predicting: By 2015 his feisty generics company can more than double its annual sales to $31 billion. That would make it big enough to become one of the Top 10 drugmakers worldwide--on the 2008-revenue ranking at least.

Further details at http://www.fiercepharma.com/story/will-teva-join-big-pharma-2015/2010-01-08?utm_medium=nl&utm_source=internal

Judge tosses two more Seroquel suits

Once again, a judge has nipped Seroquel litigation in the bud. A Delaware state court judge dismissed two more lawsuits, saying that the plaintiffs couldn't prove via medical testimony that the drug contributed to their developing diabetes, Pharmalot reports. That makes eight lawsuits dismissed. No Seroquel lawsuit has made it to trial.Of course there are still plenty of Seroquel suits floating around in U.S. courts. But a lawyer representing AstraZeneca says that plaintiffs have been trying--and failing--for years. "This litigation has been around since 2003 and they still can't get a case to trial," Michael Kelly of McCarter & English tells The Am Law Litigation Daily. "These are presumably their best cases. It's telling that they can't even get these to trial."Plaintiffs' lawyers undoubtedly see the issue differently. Almost 40 federal Seroquel cases are in pre-trial proceedings right now, awaiting their moment in federal district courts. And another New Jersey state court case is set for trial next month. We'll have to wait and see how those proceed.

Further details at http://www.fiercepharma.com/story/judge-tosses-two-more-seroquel-suits/2010-01-08?utm_medium=nl&utm_source=internal

Biotech News

Cambridge, MA-based Molecular Insight Pharmaceuticals announced today that it is cutting nine positions as it seeks to reduce operating costs. The company will take a one-time charge of $200,000 in the first quarter, but expects to save about $1 million annually as a result of the cuts.

Research Triangle Park, NC-based PhaseBio Pharmaceuticals has raised $25 million in a Series B financing round. New investors New Enterprise Associates and OSI Investment Management, a subsidiary of OSI Pharmaceuticals, led the round.

Clavis Pharma announced today that the FDA has granted its intravenous pancreatic cancer treatment CP-4126 orphan drug designation. Clavis signed a $380 million development and commercialization deal with cancer-drug powerhouse Clovis Oncology in November. As part of the deal, Clavis handed off all development of the Phase II CP-4126 to Clovis. The FDA designation follows a similar move by European regulators in October of last year.

A fresh set of promising Phase IIa data for its lead therapy helped Irving, TX-based Reata Pharmaceuticals score a $272 million licensing pact with Kyowa Hakko Kirin covering Japan and a slate of key Pacific Rim countries. The collaboration on bardoxolone calls for $35 million of that to arrive as an upfront payment with $97 million in development milestones, $140 million in sales milestones and escalating double-digit royalties.

Disclaimer- This information is for knowledge purpose only. Specialist opinion should be sought for your specific circumstance.

Who are the 50 Best Employers in Canada?

Who are the 50 Best Employers in Canada and where are they headquartered? The list goes-

PCL Constructors Inc., Edmonton, AB
EllisDon Corporation, London, ON
Cisco Canada, Toronto, ON
Bennett Jones LLP, Calgary, AB
CIMA+ Partner in Excellence, Laval, QC
WestJet , Calgary, AB
JTI-Macdonald Corp., Mississauga, ON
BC Biomedical Laboratories Ltd., Surrey, BC
Farm Credit Canada, Regina, SK
Edward Jones, Mississauga, ON
Wellington West Holdings Inc., Winnipeg, MB
Stikeman Elliott LLP, Montreal, QC/Toronto, ON
Aecon Group Inc., Toronto, ON
Marriott Hotels of Canada Ltd., Mississauga, ON
GlaxoSmithKline Inc., Mississauga, ON
Chubb Insurance Company of Canada, Toronto, ON
McDonald's Restaurants of Canada Limited, Toronto, ON
The Co-operators, Guelph, ON
Flight Centre Canada, Vancouver, BC
Delta Hotels and Resorts, Toronto, ON
LoyaltyOne Inc., Toronto, ON
G&K Services Canada Inc., Mississauga, ON
OMERS Administration Corporation, Toronto, ON
Scotiabank Group, Toronto, ON
AstraZeneca Canada Inc., Mississauga, ON
TD Bank Financial Group, Toronto, ON
Conexus, Regina, SK
Earl's Restaurants Ltd., North Vancouver, BC
Novartis Pharmaceuticals Canada Inc., Dorval, QC
Starwood Hotels & Resorts Worldwide Inc. (Canada), Toronto, ON
Ivanhoe Cambridge Inc., Montreal, QC
Co-operators Life Insurance Company, Regina, SK
Graham Group Ltd., Calgary, AB
Bentall LP, Toronto, ON
Canadian Western Bank, Edmonton, AB
ATB Financial, Edmonton, AB
Ericsson Canada Inc., Town of Mount Royal, QC
Keg Restaurants Ltd., Toronto, ON
Federal Express Canada Ltd., Mississauga, ON
Coast Capital Savings Credit Union, Surrey, BC
Nova Scotia Community College, Dartmouth, NS
Envision Financial, Langley, BC
Meyers Norris Penny, Calgary, AB
Ceridian Canada Ltd., Markham, ON
Cintas Canada Limited, Mississauga, ON
British Columbia Automobile Association, Burnaby, BC
Clark Builders, Edmonton, AB
Procter & Gamble, Inc., Toronto, ON
Nexen Inc., Calgary, AB
Novotel Canada, Mississauga, ON

The 2010 list of Best Employers in Canada includes 25 organizations from Ontario, nine from Alberta, six from British Columbia, four from Quebec, three from Saskatchewan, one from Manitoba, one from Nova Scotia and one headquartered jointly in Ontario and Quebec. Eight organizations have never appeared on the Best Employers in Canada list before.

For more information about the Best Employers in Canada study visit,http://www.workopolis.com/work.aspx?action=Transfer&View=Content/Common/ArticlesDetailView&lang=EN&articleSource=SpecialEN2&articleId=sp20100105File1Article2&cid=551%3A19L%3A13728

WHO says Tamiflu-resistant cases call for "vigilant monitoring."
The recent reports of Tamiflu resistance has prompted the World Health Organization to recommend "boosted antiviral treatment for hospital patients with severely weakened immune systems who contract swine flu." WHO maintained that there had been "no evidence" that the reported cases represented a wider public health threat, but "reiterated calls for vigilance and modified treatment advice for the frontline flu drug."

Cervarix may protect against HPV for more than six years.
Cervarix, one of two FDA-approved vaccines against human papillomavirus (HPV), protects against infection for more than six years, researchers found." In a Lancet paper, researchers reported that through "follow-up as long as 6.4 years, the vaccine had an efficacy of 95.3% for preventing infection with the two types of HPV most commonly implicated in cervical cancer -- HPV-16 and -18." In addition, Cervarix was found to be "100% effective at preventing cases of cervical intraepithelial neoplasia grade 1 and above, the investigators reported."

“Wellness" blog also notes that previous "research has shown that the equivalent vaccine, Gardasil, from fellow pharmaceutical giant Merck, protects for up to five years."

Scientists find association between "recreational drug use," sleep apnea.
Researchers at Johns Hopkins have found an association between "recreational drug use" and sleep apnea. "It is a problem some physicians are calling 'the agony of ecstasy.'" In fact, an editorial accompanying the study in Neurology points out that "two major epidemics are sweeping across the United States -- one is methylenedioxymethamphetamine abuse and the other is obstructive sleep apnea."

With that in mind, investigators "enrolled [71] medically healthy 'club drug users' for a sleep lab study. Sixty-two "participants who said they did not use ecstasy -- but might use others drugs -- formed the control group." All subjects "were required to abstain from drug use for two weeks before the sleep lab test, in which the polysomnographers were blinded to the status of the volunteers.

The team soon found that "ecstasy users had a more than eight-fold increased risk of sleep apnea compared to non-users. Mild sleep apnea rates were similar in both groups (21 percent of ecstasy users and 27 percent of non-users), but only ecstasy users had moderate (13 percent) or severe (one percent) sleep apnea. And, "the longer a person used ecstasy, the more sleep apnea episodes they experienced. Surprisingly, "ecstasy use was a greater risk factor for sleep apnea than obesity.

Novavax H1N1 vaccine study seen as meeting goals.
Novavax Inc. announced that its H1N1 flu vaccine proved safe and effective in a study conducted in Mexico." Novavax "said that the vaccine, which uses lab-created virus-like particles rather than the entire live virus strain, produced favorable initial results from the first stage of a two-stage pivotal Phase II study." Based on the findings, the company also "said it has been cleared to proceed to a second stage of testing in which vaccine safety will be evaluated in 3,000 subjects with a single dose regimen." An independent panel said the vaccine was well tolerated at three dose levels and showed no systemic side effects.

Lenalidomide plus bortezomib may be promising for relapsed, refractory multiple myeloma.
Lenalidomide (Revlimid) combined with bortezomib (Velcade) appears to be a promising treatment for patients with relapsed and refractory multiple myeloma," according to a study published in the Journal of Clinical Oncology. Researchers found that "overall, the combination treatment was well tolerated." But, in an accompanying editorial, Jesús F. San Miguel, MD, of the University of Salamanca in Spain, noted that "similar results have been observed with combination therapy that includes bortezomib, cyclophosphamide, and dexamethasone, or lenalidomide, doxorubicin, and dexamethasone," which "could be considered as an...argument in favor of the sequential rather than simultaneous use of bortezomib and lenalidomide."

Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.