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I'm on the phone calling Scynexis telling them to get ready for partnering SCY-635 :)
Record global in-market sales of Copaxone of $2.8 billion in the year ended 2009, up 25% in the fourth quarter and for the full year compared to 2008. Copaxone® continues to be the leading MS therapy in the U.S. and globally.
Teva Reports Record Full Year 2009 And Fourth Quarter Results
http://www.tevapharm.com/pr/2010/pr_905.asp
There's a third Cyclophilin Inhib in the clinic that I'm aware of from scynexis. Here are the results from phase Ib study reported at the EASL meeting Apr 2009:
SCYNEXIS’ SCY-635 Demonstrates Clinically Relevant Single-Agent Results in a Phase 1b Study in Adults with HCV
http://au.sys-con.com
By: Business Wire
Drug discovery company SCYNEXIS, Inc. today presented positive results from a Phase 1b single-agent, randomized, double-blind, placebo-controlled study of its lead, oral, antiviral drug candidate, SCY-635, in adult patients with genotype 1 chronic hepatitis C infection. SCY-635, a novel cyclophilin inhibitor, represents a new pharmacological class of inhibitors of hepatitis C virus (HCV) replication. Results were presented during an oral presentation at the European Association for the Study of the Liver (EASL) Annual Meeting in Copenhagen on April 24, 2009.
In this 15-day study, SCY-635 was well-tolerated with no serious adverse events, no discontinuations and no dose-limiting toxicities. At the highest dose tested in the study (900 milligrams/day) SCY-635 exhibited clinically relevant antiviral activity and substantial suppression of plasma viremia throughout the treatment period. In the 900 mg cohort all treated patients showed a viral load reduction with a group mean maximum decrease of 2.2 log10 on the last day of the study (p < 0.05 for the day 15 comparison).
“In this single-agent study SCY-635 demonstrated highly potent antiviral activity that was sustained throughout treatment with the nadir occurring on the last day of the study, suggesting that with a longer treatment period we may see even greater reductions in viral load,” said Dr. Sam Hopkins, SCYNEXIS’ Chief Scientific Officer. “These clinical results combined with earlier preclinical work demonstrating additive or synergistic activity with both approved and investigational agents suggest that in a combination regimen, SCY-635 may improve rates of sustained virological response.”
“These results establish proof-of-concept for SCY-635 in HCV patients and more broadly support our proprietary discovery platform, which is focused on the development of cyclophilin inhibitors for multiple diseases,” said Dr. Yves Ribeill, President and Chief Executive Officer of SCYNEXIS. “Given that we have seen no dose related adverse events at our highest tested dose, we are in the process of optimizing the dose and regimen of SCY-635 in ongoing Phase 1 studies and plan to initiate a Phase 2 study in patients infected with HCV in the second half of the year.”
About the Clinical Trial
The clinical study was conducted as a Phase 1b, randomized, double-blind, placebo-controlled, multi-dose study in adult volunteers with genotype 1 chronic hepatitis C infection. SCY-635 was given as an oral capsule for 15 consecutive days. Patients were eligible for entry if they had plasma viremia in excess of 100,000 IU/ml, no evidence of decompensated liver function, no co-infections and if liver function tests were = 2.5x Upper Limit of Normal. The study was conducted in two parts. Thirty-six subjects received SCY-635 once daily and twenty subjects received SCY-635 three times daily. All studies were conducted in the U.S.
About SCY-635 and SCYNEXIS’ Cyclophilin Inhibitor Platform
SCY-635 represents a new class of therapeutic agents for the treatment of HCV infection. SCY-635 is the first candidate in a novel class of non-immunosuppressive cyclophilin inhibitors owned by SCYNEXIS. Cyclophilins are a family of enzymatic proteins that assist in the folding and transport of other proteins synthesized within a cell. Cyclophilin inhibitors, such as Cyclosporine A, have been used for decades for the prophylaxis of organ rejection in transplant patients. Scientists at SCYNEXIS have synthesized derivatives of Cyclosporine A in which cyclophilin binding activity (which mediates anti-HCV activity) is separated from calcineurin binding activity (which mediates immunosuppression). A growing body of scientific evidence indicates that non-immunosuppressive analogs of Cyclosporine A may have applications in multiple therapeutic areas. Cyclophilins play a central role in the pathophysiology of chronic viral infection, neurodegenerative diseases and malignant transformation. Cyclophilin inhibition therefore represents an attractive target for drug discovery and development.
About SCYNEXIS
SCYNEXIS is a premier drug discovery and development company delivering effective and innovative drug pipeline solutions to pharmaceutical and global health partners. The Company, which is located in Research Triangle Park, North Carolina, is also developing a proprietary internal pipeline based on cyclophilin inhibitors, a class of drugs that hold significant potential for the treatment of a broad range of diseases. Please visit our website at www.scynexis.com
NVS Licenses Debio 025 Cyclophilin Inhibitor for HCV
Duplicate
Another one from NICE, this time a quite restricting recommendation for Victoza:
NICE recommends liraglutide for diabetes triple therapy
http://www.nice.org.uk/newsroom/news/newsdiabetes.jsp
15 February 2010
GP consultation NICE has recommended the use of liraglutide (Victoza), a once-daily injection, for the treatment of type-2 diabetes as part of triple therapy regimens, under latest draft guidance.
UK cases of diabetes have soared in recent years, fuelled by an increase in obesity rates. Currently, it is estimated that there are over 2.5 million people with diabetes in the UK and a further half a million people who are unaware that they have the condition.
This latest announcement offers a new alternative for patients who are unable to control their diabetes with current treatments. Patients who are already taking metformin and a sulfonylurea, or metformin and a thiazolidinedione, but still have poor blood glucose control should be offered liraglutide in combination with their current treatments. Patients must also be overweight, with a body mass index (BMI) of 35kg/m2 and over, to be eligible for the drug.
However, diabetics who have a BMI below 35kg/m2 could also benefit from the drug if it is considered that its use could help to achieve levels of weight loss that could be beneficial in treating other conditions caused by being obese.
Dr George Kassianos, a member of the British Cardiovascular Society and a GP in Berkshire, described the approval by NICE of the use of liraglutide in triple therapy as “a very welcome development for primary care physicians.”
“Controlling hyperglycaemia and its indicators is not easy. The addition of liraglutide to our formulary will be welcome by patients and will go a long way to helping them achieve their glycaemic goals,” he said.
Under the draft guidance, liraglutide is not recommended for use in dual therapy or in the 1.8mg daily dosage.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “We are pleased to recommend liraglutide, 1.2 mg daily, as a clinically and cost effective treatment option as part of triple therapy regimens for some patients under restrictions.
“However we felt that there was not sufficient evidence to recommend it in dual therapy regimens for type-2 diabetes mellitus. The Committee concluded that there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual therapy regimens for this type of diabetes. The next step for the manufacturer is to consider the committee’s comments and respond to its concerns.”
Forgot to mention that Treanda was approved in the US in March 2008, so an ANDA cannot be filed before March 2013.
IP is a problem with Treands as Bendamustine was discovered and marketed in EU ages ago and has no CoM patent protection. It has 5 years of exclusivity due to Hatch-Waxman NCE regulations, plus as you know Cephalon is also trying to enhance Treanda IP and and several patent applications are pending at the USPTO.
CEPH gets diversification to its brands portfolio and a footprint in ex-US regions such as Switzerland, Portugal, and the Middle-east where they had no presence. There are tax benefits and it also opens the way to biosimilars. My primary interest is in Treanda (not in CEPH). I think it might in time be used even outside of NHL/CLL in solid tumors where alkylating agents are commonly used.
Cephalon's cancer drug Treanda (Bendamustine) 4Q09 sales rose 70% to $61.6M year-over-year.
Data Monitoring Committee nod implies Gamida Cell clinical trial progress
http://www.globes.co.il/serveen/globes/docview.asp?did=1000538601
Gali Weinreb11 Feb 10 17:35
Umbilical cord blood stem cell developer Gamida Cell Ltd. has received a favorable sign for its Phase III clinical trial of its blood cancer treatment, StemEx. After the Data Monitoring Committee reviewed the trial results on the first 15 patients of the planned 100-patient study, it recommended continuing the study as planned.
The decision is a positive indication, especially with regard to StemEx's safety, but also with regard to its effectiveness. An independent committee is required to halt the trial, if the trial is found to be hazardous to patients. If the committee decides to proceed with the trial, this means that the committee saw no severe side effects from the treatment.
Article continues after advertisements
StemEx is being evaluated as a therapeutic treatment for adolescents and adults with blood cancers such as leukemia and lymphoma, who cannot find a family related matched bone marrow donor. The trial is a joint study with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA, which invested $3 million in Gamida Cell.
In the case of patients with blood cancer, even the absence of complete effectiveness jeopardizes their health, and it is better to switch to a different treatment. Therefore, the Data Monitoring Committee's decision to pursue the trial probably means that the treatment has some degree of effectiveness, even if it is not yet clear if the trial will be a success.
Gamida Cell expects to complete recruitment of the 100 patients for the trial by the end of 2011. Only then will it be allowed to analyze the results and submit them to the US Food and Drug Administration (FDA).
Gamida Cell is run by president and CEO Dr. Yael Margolin. The company has raised $40 million to date from Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Israel Healthcare Ventures Ltd., Biomedical Investments Ltd., Pamot VC, Auriga Partners, Denali Ventures, Comverse Technology Inc's (Pink Sheets: CMVT) Comverse Investments Ltd., and Israel Phoenix Assurance Ltd's (TASE: PHOE1;PHOE5) Atara Technology Ventures.
Last week, Elbit Imaging announced that it plans to set up and then float on the Tel Aviv Stock Exchange (TASE) a wholly-owned subsidiary that will hold the company's 60% stake in InSightec Ltd. Ltd. and 28% stake in Gamida Cell. This will give public investors their first chance to gain exposure to Gamida Cell.
OT -
I thought Harrison Ford was too old to play John Crowley
Sure we did: #msg-45812585
FOLD/amigal phase 2 extension study in Fabry
Amicus released results on safety, tolerability, and kidney GL-3 in uringe, at the ACMG, end of March, 2009. The added data here are on renal function, another secondary endpoint in the phase III trial.
There were no serious adverse events in phase II trials and I think the problem will be efficacy. Key word used in FOLD's PRs is 'responders'. The definition of a 'good responder' was post-hoc, and there was a lot of variation in effect between 'good responders' and the others, due to many different mutations, I assume.
Btw, unlike the FDA, the EMEA wants a head-to-head phase III trial vs. ERT, and it will be difficult for the chaperone to be as effective as ERT, imo.
Roche/taspoglutide - again a PR without material details such as the exact reductions in HbA1C, but those will be presented at ADA.
http://www.easybourse.com/bourse/actualite/update-roche-s-experimental-diabetes-drug-meets-study-goals-FR0010259150-797371
They are talking about MNTA's valuation which is different in case of other generics and/or authorized generic.
GENZ started two phase III trials for eliglustat in Aug. and Estimated Study Completion Date is December 2011 for both. I'm sure they'll be looking at bone improvement.
PLX technology allows them to take a gene, (theoretically any gene), insert and express it in plant cells and get a recombinant product. As for how long it takes, between a couple of months to a year for a known gene. But then comes the hard part - see if the protein works properly...
Note that Shire's Velaglucerase also looks clinically indistinguishable from Cerezyme, and should be approved by the FDA on Feb. 28 (PDUFA date), ahead of PLX.
GENZ/eliglustat tartrate (GENZ-112638)- its efficacy is even more robust than I would have thought. If no surprises occur in phase III and switchover trial, it will be a game changer, imo. Btw, I believe PLX is also looking at bone MRI, but it's too early to tell if data are better than Cerezyme's historical studies.
I would not expect Mendelian arithmetic to work here since homozygous form of FH develop severe premature atherosclerosis and often die at a young age from coronary artery disease. HeFH population should be a lot bigger.
ISIS/mipomersen
At the very least they are going to need a very large safety database
Proteologics (http://www.proteologics.com/index.htm) is going for an IPO on the TASE. Still very early days, not even in preclinical phase, but with a Nobel prize and strong collaboration with Teva, it may move ahead quicker than Compugen did.
ISIS/mipomersen
As in other mipomersen trials, elevations in liver transaminases were observed that were similar in magnitude and duration to those seen in other studies.
Reminder - Crestor's patent trial vs. six generic manufacturers will begin in two weeks.
MYGN weakness - perhaps also cause management did not reiterate its prior guidance and said demand for BRACAnalysis tend to slow in Q3 due to insurance re-sets.
AGN one more tidbit - Juvederm XC (dermal filler with Lidocaine) was approved last week. Not sure how important this formulation is but MRX (thx for the typo correction, R.F) is also going for such formulation i.e. Restylane with Lidocaine.
P.s. Cheating with Ronny Gal is legal :)
Teva believes that laquinimod has a big potential and Active Biotech knows Teva can do a better marketing job, imo.
AMGN/D-mab - I have posted a while ago #msg-39267362 and #msg-29499235
David Pyott answers Ronny Gal's question on that:
Yes, I think answering your question on LATISSE in a nutshell, it’s clear that it’s much more convenient for patients to just fill their LATISSE prescription at the doctor’s office. It’s obvious you don’t have to forget to go to the drug store. Now clearly big three states that – dispensing isn’t permitted is Texas, New York, and Massachusetts. And we are continuing to work hard in those states because clearly there is a real benefit to doctor’s offices of bringing in a complete new generation and a new type of consumer into the medical aesthetic space with LATISSE. So, we are rather pleased with the growth in the dispensing states and as I had remarked in my script, the prescriptions only tell a rather small part of the story.
Carfilzomib Development Strategy:
Onyx Pharmaceuticals Announces Agreement with the FDA on a Special Protocol Assessment for Planned Phase 3 Carfilzomib Combination Trial in Relapsed Multiple Myeloma
http://www.onyx-pharm.com/view.cfm/658/Onyx-Pharmaceuticals-Announces-Agreement-with-the-FDA-on-a-Special-Protocol-Assessment-for-Planned-Phase-3-Carfilzomib-Combination-Trial-in-Relapsed-Multiple-Myeloma-
It sure lifts question marks for the long-acting GLP-1 class on thyroid c-cell hyperplasia and pancreatitis and so indeed lowering the risk for Byetta LAR.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed January's entries; Added WORLD, SSO, SIR, AAD, ACC, SGO
FEBRUARY 2010
American Academy of Pain Medicine - AAPM
San Antonio, TX
February 3-6, 2010
http://www.painmed.org/annual_mtg/index.html
Lysosomal Disease Network - WORLD
Miami, Fl
February 10-12, 2010
http://www.lysosomaldiseasenetwork.org/
American Academy of Emergency Medicine -AAEM
Las Vegas, NV
February 15-17, 2010
http://www.aaem.org
Generic Pharmaceutical Association - GPhA
Naples, FL
February 16-18, 2010
http://www.gphaonline.org
Conference on Retroviruses and Opportunistic Infections - CROI
San Francisco, CA
February 17-20, 2010
http://retroconference.org/2010/
American College of Preventive Med -ACPM
Crystal City, VA
February 17–20, 2010
http://www.acpm.org
International Stroke Conference - ISC
San Antonio, TX
February 24-26, 2010
http://strokeconference.americanheart.org/portal/strokeconference/sc/
American Society for Bone Marrow Transplant - ASBMT
Orlando, FL
February 24-28, 2010
http://www.asbmt.org/
American Academy of Allergy Asthma and Immunology -AAAAI
New Orleans, LA
February 26 - March 2, 2010
http://www.aaaai.org
MARCH 2010
Society of Surgical Oncology - SSO
St. Louis, MO
March 4-7, 2010
http://www.surgonc.org/
American Academy of Dermatology - AAD
Miami, FL
March 5-9, 2010
http://www.aad.org/
Society of Interventional Radiology - SIR
Tampa, Fl
March 13-18, 2010
http://www.sirweb.org/
American College of Cardiology - ACC
Atlanta, GA
March 14-16, 2010
http://acc.org/
Society of Gynecological Oncologists - SGO
San Francisco, CA
March 14-17, 2010
http://www.sgo.org/
American College of Medical Genetics - ACMG
Albuquerque, New Mexico
March 24-28, 2010
http://www.acmgmeeting.net/
APRIL 2010
European Association for the Study of the Liver - EASL
Vienna, Austria
April 14-18, 2010
http://www.easl.eu/
MAY 2010
Digestive Disease Week - DDW
New Orleans, LA
May 1-5, 2010
http://www.ddw.org/
American Thoracic Society - ATS
New Orleans, LA
May 14-19, 2010
http://conference.thoracic.org/
JUNE 2010
European Society of Human Genetics - ESHG
Gothenburg, Sweden
June 12-15, 2010
https://www.eshg.org/
OCTOBER 2010
American Association for the Study of Liver Diseases - AASLD
Boston, Massachusetts
October 29 - November 2, 2010
http://www.aasld.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
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Preclinical data from CGEN:
Compugen announced today the discovery and experimental validation of CGEN-15001 for the treatment of autoimmune disorders. CGEN-15001 is the extracellular region of a previously unknown membrane protein in the B7/CD28 family. The existence and potential utility of the newly discovered parent protein from which CGEN-15001 is derived was predicted in silico utilizing Compugen's LEADS Platform and other proprietary algorithms.
Update for taliglucerase alfa: FDA has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the NDA. PLX is working diligently to provide the requested data to the FDA and anticipates submitting the requested data during the second quarter of 2010.
http://www.reuters.com/article/idCNSGE6110F620100202?rpc=44
The stock (Biocell) is down 8% at TASE.
UTHR/Tadalafil (Adcirca ) patents:
[Adcirca] orphan drug exclusivity in PAH, which can’t be overturned by a P-IV challenge, runs until Apr 2016.
Knocking out the Adcirca CoM patent, which expires in Nov 2017, won’t provide much economic benefit to the P-IV challenger.
UTHR/Tadalafil (Adcirca )
I see it's on the FDA's 'Paragraph IV Patent Certifications' list:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm
PLX is the "NEXT TEVA"?
It sure lifts question marks for the long-acting GLP-1 class on thyroid c-cell hyperplasia and pancreatitis and so indeed lowering the risk for Byetta LAR.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added entries for February 2010
JANUARY 2010
Society of Thoracic Surgeons - STS
Fort Lauderdale, FL
January 25-27, 2010
http://www.sts.org/
American Academy of Cosmetic Surgery - AACS
Orlando, FL
Jannuary 28-31, 2010
http://www.cosmeticsurgery.org/
Annual Clinical Cancer Update
North Lake Tahoe, CA
January 29-31, 2010
http://www.cme.ucsf.edu/
FEBRUARY 2010
American Academy of Pain Medicine - AAPM
San Antonio, TX
February 3-6, 2010
http://www.painmed.org/annual_mtg/index.html
American Academy of Emergency Medicine -AAEM
Las Vegas, NV
February 15-17, 2010
http://www.aaem.org
Generic Pharmaceutical Association - GPhA
Naples, FL
February 16-18, 2010
http://www.gphaonline.org
Conference on Retroviruses and Opportunistic Infections - CROI
San Francisco, CA
February 17-20, 2010
http://retroconference.org/2010/
American College of Preventive Med -ACPM
Crystal City, VA
February 17–20, 2010
http://www.acpm.org
International Stroke Conference - ISC
San Antonio, TX
February 24-26, 2010
http://strokeconference.americanheart.org/portal/strokeconference/sc/
American Society for Bone Marrow Transplant - ASBMT
Orlando, FL
February 24-28, 2010
http://www.asbmt.org/
American Academy of Allergy Asthma and Immunology -AAAAI
New Orleans, LA
February 26 - March 2, 2010
http://www.aaaai.org
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Prolor - it's the same Dr. Phillip Frost.