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Pharmasset Reports Positive Preliminary Antiviral Data with PSI-938 for the Treatment of Hepatitis C
http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=524015
PRINCETON, N.J., Oct 28, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 ("PSI-938") for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.
PSI-938 Phase 1 Multiple Ascending Dose Study Overview
In August 2010, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-938 administered once daily (QD) or twice daily (BID) for 7 days. The trial was conducted at two US centers as a blinded, randomized, and placebo-controlled study in 40 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-938 administered over 7 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized within each cohort to receive either PSI-938 (8 patients per cohort) or placebo (2 patients per cohort). Four dose cohorts of PSI-938 (100 mg QD, 200 mg QD, 300 mg QD and 100 mg BID) have been completed.
PSI-938 Antiviral Activity Summary
Preliminary Antiviral Response Observed Following PSI-938
Administered as Monotherapy for 7 Days
--- ---Dose n Median Change in Range Number of Subjects with
HCV RNA at Day 8 HCV RNA
(log10 IU/mL) (log10 IU/mL) <LOD <LOQ
100 mg QD 8 -4.31 -2.66 to -5.12 1 3
200 mg QD 8 -4.64 -3.49 to -5.35 5 7
300 mg QD 8 -3.94 -3.43 to -5.29 4 4
100 mg BID 8 -4.59 -3.94 to -5.08 2 3
Placebo 8 -0.05 +0.17 to -0.29 0 0
------- --- ----- --------------
It's just not the way they work, imo. I also don't think they would have made all the statements after M-enox was approved if they knew their generic is so different. I think the only question in is - can Teva's generic pass the high bar Momenta placed.
Sorry for not being clear, by "low-quality" I referred to characterization quality in terms of the sameness to the branded drug. The topic of my posts indeed is not a new branded drug—it’s an application to the FDA for a generic version of Lovenox and my points there were that I'm pretty sure Teva had characterized the generic drug using all the available techniques and I don't believe they would have submitted an ANDA without doing so or in case the drug had been found to be so different from the branded.
What I'm saying is - it is very unlikely that Teva took a low quality drug like Lupenox and just did the paper-work to submit the ANDA.
I find this very hard to believe. I know first hand that even with small projects when Teva is involved they insist on taking every molecule or procedure and test them in-house before moving to the next step. And it's not that Teva doesn't have the ability or knowledge to do MALDI-MS, ESI-MS, HPLC, NMR and such to characterize enoxaparin (although not to the higher quality Momenta can).
Tysabri/JCV test
The Leerink Swann analyst asked about the false negative rate (test's sensitivity), which was 2.5% in the STRATA study and Scangos replied that so far they get similar rate from STRATIFY 1 study. It will take few more years to know the predictive value and PML risk of the assay.
On Tysabri sales - they said units grew by 6% year-over-year in the U.S. but number of new patients was somewhat lower than last quarter. On the JCV immunoassay, they need the data from the ongoing STRATIFY studies to get the test approved. They are planning to submit labeling changes by the first quarter of next year.
I assume BMY got a green light from the FDA to submit a “freestanding” NDA based on AVERROES data alone.
I think belatacept will be a niche drug anyway.
JCV immunoassay might help Tysabri when established in the future and of course so will do more/new negative safety data from Gilenya if these emerge.
Tysabri's sales look even weaker considering the 18.7% price hike from early July.
I think that the on treatment response-guided therapy in this study is based on negative HCV RNA at week 4 only.
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted old entries; Added entries for ACR, ACAAI, SFN, AHA
OCTOBER 2010
Infectious Disease Society - IDSA
Vancouver, Canada
October 21-24, 2010
http://www.idsociety.org/Content.aspx?id=238
American Association for the Study of Liver Diseases - AASLD
Boston, MA
October 29-November 2, 2010
http://www.aasld.org/
American Society for Therapeutic Radiology and Oncology - ASTRO
San Diego, CA
October 31-November 4, 2010
http://www.astro.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
Society for Melanoma Research (International Melanoma Congress) - SMR
4-7 November
Sydney, Australia
http://www.melanoma2010.com/
American College of Rheumatology - ACR
Atlanta, GA
November 6-11, 2010
http://www.rheumatology.org/
American College of Allergy, Asthma & Immunology - ACAAI
Phoenix, AZ
November 11-16, 2010
http://www.acaai.org/Pages/default.aspx
Society of Neuroscience - SFN
San Diego, CA
November 13-10, 2010
http://www.sfn.org/
American Heart Association - AHA
Chicago, IL
November 13-17, 2010
http://aha-pda.com/presenter.jhtml?identifier=3064925
World Orphan Drug Congress
Nov 29-Dec 1
Geneva, Switzerland
http://www.terrapinn.com/2010/orphandrugs/programme.stm
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Next time you edit the 2010 FDA-approval table:
Shire/Vpriv for Gaucher #msg-47221025
GENZ/Lumizyme for Pompe
ACOR/Ampyra for MS
SVNT/Krystexxa for Gout
HRA Pharma/Ella for emergency contraceptive
Kamada/Glassia (IV) for AAT deficiency
DNA/Actemra for RA
CRXX/Exalgo for pain
AGN/Zymaxid for bacterial conjunctivitis
Not following but data presented at ASCO 2010 looked good
http://www.sunesis.com/data-pdf/595/sunesis-voreloxin-20100607-ASCO-03.pdf
TMC278 data look approvable to me but its profile puts it behind Sustiva and GILD are hoping for 1st line.
GENZ' Clolar failed in phase III in AML
http://finance.yahoo.com/news/Genzyme-Announces-Results-of-bw-1356862241.html?x=0&.v=1&.pf=banking-budgeting&mod=pf-banking-budgeting
Abbott sales fall short of estimates; shares lower
http://www.reuters.com/article/idCNN1929480820101020?rpc=44
Wed Oct 20, 2010 12:05pm EDT
* Q3 EPS ex-items $1.05; Street view $1.04
* Sales rise 11.8 pct to $8.68 bln; Street view $8.92 bln
* Shares fall 1 percent (Adds analyst and company comments; updates share move)
By Ransdell Pierson
NEW YORK, Oct 20 (Reuters) - Abbott Laboratories (ABT.N) reported quarterly sales below Wall Street expectations, hurt by a recall of Similac infant formula, sending its shares down 1 percent.
Third-quarter profit fell almost 40 percent, depressed by the September recall and costs of the recent acquisition of Solvay SA's (SOLB.BR) pharmaceuticals business.
Excluding special items, the suburban Chicago drugmaker earned $1.05 per share. Analysts on average had expected $1.04, according to Thomson Reuters I/B/E/S.
Revenue rose 11.8 percent to $8.68 billion, below Wall Street expectations of $8.92 billion. Sales growth in the second quarter was 18 percent.
Abbott, like diversified healthcare rival Johnson & Johnson on Tuesday, was punished by Wall Street for not delivering expected sales growth.
Abbott shares were down amid moderate gains for the drug sector and broad stock market.
"The sales number was weak," said JPMorgan analyst Michael Weinstein. He cited disappointing revenue from Abbott's nutritionals and its line of medical diagnostics. He said many analysts had not adjusted their sales estimates to account for the $100 million cost of the Similac recall.
Leerink Swann analyst Rick Wise said Abbott's sales shortfall was mostly due to the recall.
Even so, he noted the company's profit margin improved by more than 1 percentage point, which Abbott attributed to strong performance of its prescription drugs, diabetes care and diagnostic products.
"Better-than-expected gross margin drove much of the in-line earnings performance, highlighting the ongoing leverage and earnings power in Abbott's business," Wise said.
NARROW BEAT
Third-quarter profit fell to $891 million, or 57 cents per share, from $1.48 billion, or 95 cents per share, a year earlier.
Global sales of nutritional products -- normally a strong contributor to company results -- fell 1.5 percent to $1.37 billion, largely due to the Similac recall. The recall came after beetles were found in the powdered infant product and in a Michigan plant where it is made.
Abbott said Similac is now being produced again in the plant and that retailers should have near-normal supplies of the formula in coming months. But the company forecast a high-single-digit percentage decline in U.S. nutritionals sales in the fourth quarter.
Worldwide sales of Abbott's diagnostic products edged up 0.8 percent to $916 million, a marked slowdown from 8 percent growth seen in the second quarter.
Pharmaceuticals revenue rose 22 percent to $4.94 billion in the third quarter, bolstered by brands acquired in the Solvay deal. Sales of arthritis treatment Humira, Abbott's best-selling product in recent years, rose almost 13 percent to $1.68 billion.
Sales of Trilipix and TriCor, which lower blood fats called triglycerides, rose 22 percent to $404 million. But sales of HIV treatment Kaletra fell 7 percent to $328 million amid competition from rival medicines.
Revenue from Abbott's vascular products, most notably its market-leading Xience heart stent, rose almost 19 percent to $790 million.
Abbott raised the low end of its full-year earnings forecast, excluding special items, to $4.16 a share from $4.13 in July, while keeping the high end at $4.18.
The new forecast translates into gains of 11.8 percent to 12.4 percent over last year -- the kind of double-digit profit growth that now eludes most rival drugmakers.
I don't see why non-compliance would be so different in both arms. So, hard to believe resistance to TMC278 could be largely explained by that. There should be another mechanism by which patients who took TMC278 had more mutations that emerged during treatment.
I'm not Dew's source but the 3rd party could be Novopharm, a private comp Teva bought in 2000. Aventis sued Novopharm in 2005 on Novo-enoxaparin in Canada.
Cheaper, more effective treatment of type 1 Gaucher disease possible
http://www.biocetera.com/inthenews.php?id=135105
Researchers at Yale School of Medicine have found that new disease pathways involving more than one cell type leads to Type 1 Gaucher disease, a rare genetic disorder in which fatty substances called glycosphingolipids accumulate in cells, resulting in liver/spleen enlargement, osteoporosis, bone pain, and increased risk of cancer and Parkinson's disease.
The new findings could lead to less expensive and more effective ways to treat the disorder, which affects about 1 in 50,000 people in the general population. Those of Eastern and Central European (Ashkenazi) Jewish heritage are at highest risk for the disease, with 1 in 750 affected. The results are published in the October 18 issue of Proceedings of the National Academy of Sciences.
Treatment for Type 1 Gaucher disease—the type that does not cause a rare and fatal neurodegenerative childhood disease—involves expensive recombinant enzyme infusions every two weeks for life, which on average cost $200,000 per year. Gaucher disease symptoms are unpredictable, even among affected siblings. "In order to tailor treatment to individuals, we need an improved understanding of the disease mechanisms," said senior author of the study, Pramod Mistry, M.D., professor of pediatrics and internal medicine at Yale School of Medicine.
For almost 20 years, investigators around the world have tried and failed to develop mouse models of Type 1 Gaucher disease that replicate the human disease faithfully. Mistry and his team were able to develop a mouse model that replicates all of the features of the human disease.
It was previously thought that the disease affects only one cell type in the body called macrophages. "In our study we show that all cell types are involved and lipids that accumulate trigger abnormal signaling resulting in the malfunction of many cell types," said Mistry. "This helps explain aspects of the disease, such as osteoporosis, cancer risk, and risk of Parkinson's disease, all of which did not respond to macrophage-directed enzyme therapy. With this knowledge, we can look forward to developing treatments that are directed not only to macrophages, but to all cell types involved in the disease process."
Mistry and his team have just started enrolling patients in an international trial of a small molecule substrate inhibitor—in the form of a pill, which was developed by Genzyme Corporation. "Because it is a pill and will affect all cell types, we expect it to reverse all, not just part, of the disease. Also, it should be less expensive than enzyme treatment," he said.
Yes, heard/seen these rumors and yes, as far as I know rumors are correct. For further information regarding how well the inspection went, one has to capture an FDA guy for interrogation. Haven't done that...yet
Scientific Meeting Calendar
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Deleted old entries; Added World Orphan Drug Congress
OCTOBER 2010
American Society for Bone and Mineral Research - ASBMR
Toronto, Canada
15-19 October, 2010
http://www.asbmr.org/
American College of Gastroenterology - ACG
San Antonio, Texas
October 15-20, 2010
http://www.acg.gi.org/acgmeetings/
American Academy of Ophthalmology - AAO
Chicago, IL
October 16-19, 2010
http://www.aao.org/meetings/annual_meeting/
Infectious Disease Society - IDSA
Vancouver, Canada
October 21-24, 2010
http://www.idsociety.org/Content.aspx?id=238
American Association for the Study of Liver Diseases - AASLD
Boston, MA
October 29 - November 2, 2010
http://www.aasld.org/
American Society for Therapeutic Radiology and Oncoogy - ASTRO
San Diego, CA
October 31-November 4, 2010
http://www.astro.org/
NOVEMBER 2010
American Society of Human Genetics - ASHG
Washington, DC
November 2-6, 2010
http://www.ashg.org/
Society for Melanoma Research (International Melanoma Congress) - SMR
4-7 November
Sydney, Australia
http://www.melanoma2010.com/
World Orphan Drug Congress
Nov 29-Dec 1
Geneva, Switzerland
http://www.terrapinn.com/2010/orphandrugs/programme.stm
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Any later filed patents will not trigger a new thirty-month stay, unless the ANDA is amended to assert that it does not infringe a new patent that has been listed in the Orange Book.
The Maximum Tolerated Dose was not achieved and SGEN said that dosing schedule and dose escalation continues in this trial:
http://www.marketwatch.com/story/seattle-genetics-reports-preliminary-data-from-phase-i-clinical-trial-of-sgn-75-2010-10-11?reflink=MW_news_stmp
I believe Abiraterone's bigger opportunity is as an option for chemo/biologic naive patients who fail anti-androgens in other words as a second-line hormone therapy (#msg-55413563).
I think that by the time patents expires, Integrilin sales will likely be more in the $200M range as data from trials were kinda mixed and that trial failed #msg-36668503.
There's another abiraterone phase III trial but in chemo/biologic naive CRPC patients, who failed anti-androgen therapy, also under an SPA. Primary endpoints are OS and PFS but JNJ can file based on PFS.
http://clinicaltrials.gov/ct2/show/NCT00887198?term=Abiraterone+phase+iii+prostate&rank=1
I think the guy in the cartoon may be George Scangos :)
Yes, that trial was halted and all patients were offered abiraterone. JNJ suppose to offer it to some more patients via an early-access program.
Results from abiraterone phase III in CRPC presented at ESMO abstract :
http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=516967&year=2010
A former AF piece on this:
J&J Prostate Cancer Drug Boosts Survival
http://www.thestreet.com/story/10857472/jj-prostate-cancer-drug-boosts-survival.html
Adam Feuerstein 9/10/10 - 09:38 AM EDT
NEW BRUNSWICK, N.J. (TheStreet) -- A Johnson & Johnson(JNJ) drug was found to prolong survival in men with advanced prostate cancer, but fear not Dendreon(DNDN) fans for Provenge is safe -- for now.
The J&J drug abiraterone prolonged survival in patients with advanced, metastatic prostate cancer whose tumors were no longer responding to treatment with chemotherapy, most notably the commonly used drug Taxotere, according to results from an interim look at a phase III study.
The early positive finding of a survival benefit prodded J&J to unblind the phase III study and allow all patients access to abiraterone, the company said Thursday night.
The phase III study had enrolled 1,195 prostate cancer patients, randomizing them to treatment with abiraterone plus the steroid prednisone or a placebo plus prednisone.
For now, abiraterone does not pose a competitive threat to Dendreon's Provenge because the patients treated with the newly launched prostate cancer immunotherapy have less advanced disease than those treated in the abiraterone study.
Doctors administer Provenge to patients who also have advanced prostate cancer but before chemotherapy drugs like Taxotere are used. In the J&J trial, abiraterone was used after chemotherapy.
Abiraterone could potentially compete immediately with Sanofi-Aventis'(SNY) new drug cabazitaxel, which also prolonged survival in prostate cancer patients previously treated with chemotherapy.
Earlier this year, Sanofi reported results from a phase III study showing a median overall survival of 15.1 months for patients treated with cabazitaxel compared to 12.7 months for patients treated with another chemotherapy drug mitoxantrone. The U.S. Food and Drug Administration approved cabazitaxel in June.
J&J has not yet disclosed the extent of the survival benefit derived from abiraterone. That data will come at the European Society for Medical Oncology (ESMO) meeting, being held Oct. 8-12.
J&J said it is evaluating its approval filing strategy for abiraterone in light of the new prostate cancer data.
Abiraterone works by interfering with the way prostate cancer cells feed from testosterone produced in the body. That's different from cabazitaxel, which interferes with cancer cell division.
J&J is conducting a second phase III study of abiraterone in "Provenge-eligible" prostate cancer patients i.e. in the pre-chemotherapy setting, but results are not expected until late in 2011 or early 2012.
Medivation(MDVN) and partner Astellas are developing MDV3100, a prostate cancer drug that works in a very similar way to abiraterone. Phase III studies are underway.
SGEN/vedotin (SGN-35) in ALCL :
http://www.marketwatch.com/story/seattle-genetics-and-millennium-announce-positive-top-line-brentuximab-vedotin-sgn-35-data-from-phase-ii-trial-in-relapsed-or-refractory-alcl-2010-10-11?reflink=MW_news_stmp
"...Eighty-six percent of patients in the trial achieved an objective response as assessed by an independent central review. Overall response rate, including both complete and partial remissions, is the primary endpoint of the study. The median duration of response has not yet been reached at a median follow up on study of approximately six months."
Kamada's inhaled AAT phase 2/3 clinical trial in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency. The primary end point is exacerbation events and lung density:
http://clinicaltrials.gov/ct2/show/NCT01217671?term=kamada&rank=2
EXEL - BMY
Exelixis licenses two drug programs to Bristol
http://www.reuters.com/article/idCNN1110706720101011?rpc=44
* Bristol to pay $60 mln upfront for two deals
* Exelixis exits development of XL-139
* Bristol waives rights to 3rd cancer candidate
By Deena Beasley
LOS ANGELES, Oct 11 (Reuters) - Exelixis Inc (EXEL.O) has licensed two more experimental drug programs to Bristol-Myers Squibb Co (BMY.N) for $60 million upfront, and potential milestone payments of up to $505 million.
The deals -- for programs in diabetes and inflammation -- bring to five the total number of collaborations between the two companies, Exelixis Chief Executive Michael Morrissey told Reuters in a telephone interview.
Bristol-Myers in June dropped out of a partnership to develop the smaller company's experimental cancer drug XL184.
As part of the latest deal, the companies said they made "minor amendments" to their XL281 and liver X receptor agreements.
In addition, Exelixis has opted to drop out of further co-development of experimental cancer drug XL139 and will receive an accelerated milestone payment.
Under the latest deal, Bristol Myers will be responsible for research, development, manufacturing, and commercialization of a small-molecule drug called TGR5, which targets a bile acid receptor and has potential as a treatment for diabetes.
Under the other part of the deal, the two companies will collaborate on ROR antagonist programs -- with potential in inflammatory disorders -- up to a preclinical transition point after which Bristol-Myers have sole responsibility for further work and potential commercialization.
Exelixis said it is granting rights to the ROR program in exchange for Bristol-Myers waiving rights to receive a third investigational new drug candidate under the companies' 2006 oncology development agreement.
Morrissey, who became CEO at Exelixis in July, said the $60 million upfront payment was included in the company's previous estimate for cash holdings of $250 million at the end of 2010.
"This shows that the company and team is still functioning well in terms of new deals and compounds," he said.
[OT] Let's go out for lunch instead
Not following either (as Jim said, even if approved it would be a niche drug), just posted for those who thought it might be a threat to Savella.