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Plexxikon Publishes PLX4032 Phase 1 Data Demonstrating 81 Percent Response Rate in Metastatic Melanoma Patients in the New England Journal of Medicine
This is the most exciting cancer data I have seen in a long time.
ShareretweetEmailPrintPress Release Source: Plexxikon On Wednesday August 25, 2010, 5:00 pm
BERKELEY, Calif.--(BUSINESS WIRE)--Plexxikon today announced publication of data from the Phase 1 clinical trial of PLX4032 (RG7204), confirming that treatment of metastatic melanoma patients with the BRAF V600E mutation resulted in significant tumor shrinkage in the majority of patients. Specifically, in the melanoma extension cohort of the study, nearly all patients showed some response; 81 percent of patients had tumor shrinkage of at least 30 percent. The data were published in the August 26, 2010 issue of the New England Journal of Medicine, based on an analysis as of January 31, 2010. These results further support the current PLX4032 development strategy, which includes parallel and ongoing Phase 2 (BRIM2) and Phase 3 (BRIM3) studies to support registration. PLX4032 is a novel, orally administered, targeted agent that is selective for a key oncogenic driver in melanoma and other cancers.
The data published in the New England Journal of Medicine focused on the Phase 1 dose-escalation trial of PLX4032 (RG7204), and a subsequent melanoma extension cohort at the established maximum tolerated dose (MTD). Primary objectives of the melanoma extension cohort were to establish further safety and pharmacokinetics (PK) data beyond the dose-escalation phase, as well as demonstrate proof-of-concept in the target patient population at the MTD of 960 mg twice daily.
Results Demonstrate Significant Anti-tumor Activity with PLX4032
In the melanoma extension cohort, in which 32 patients with metastatic melanoma harboring the BRAF mutation were enrolled, data showed an 81 percent response rate by RECIST criteria, including:
2 complete responses (no evidence of disease)
24 partial responses (tumor shrinkage of at least 30 percent)
All patients except two showed some tumor regression. The estimated median progression-free survival (PFS) among these patients was at least seven months as of January 31, 2010, compared to historical PFS of less than two months. Sixteen patients were still on study as of January 31, 2010.
Drug-related adverse events were predominantly mild in severity and included rash, joint pain, photosensitivity and fatigue. Among the 48 patients treated in the dose-escalation and extension cohorts, 18 patients developed cutaneous squamous cell carcinoma in sun exposed areas of the skin (primarily keratoacanthoma subtype) that were treated by excision, while treatment with PLX4032 was continued.
“This PLX4032 trial represents the first evidence that a treatment that targets activating BRAF mutations can induce significant tumor regressions in patients,” said K. Peter Hirth, Ph.D, chief executive officer of Plexxikon. “These data are particularly encouraging, with responses observed at all sites of disease, including challenging visceral lesions in the bone, liver and small bowel. These findings prompted the initiation of two pivotal trials in both second- and first-line melanoma patients. We are hopeful that PLX4032 will provide similar benefit to these patients so urgently in need of effective therapies.”
Accelerated Path to Potential Registration for PLX4032
PLX4032 is currently being tested in a randomized, controlled Phase 3 (BRIM3) trial in previously untreated metastatic melanoma patients who test positive for the BRAF mutation. Enrollment for the trial is currently under way. The primary endpoint for the BRIM3 trial is overall survival. Enrollment was completed earlier this year for the single-arm Phase 2 (BRIM2) trial in previously treated melanoma patients, and data are expected to be presented at a scientific conference later this year. The primary endpoint for the BRIM2 trial is best overall response. Patients interested in enrolling in the Phase 3 trial may find additional information at the Roche Clinical Trials Registry (http://www.roche-trials.com/), at genentechclinicaltrials@druginfo.com, by visiting www.clinicaltrials.gov, or by contacting the Roche/Genentech Call Center at 888-662-6728.
About PLX4032 (RG7204)—A Personalized Medicine for Cancer Treatment
PLX4032 is a novel, investigational, oral small molecule for melanoma and other cancers harboring the BRAF mutation. Plexxikon utilized its structure-guided chemistry platform to discover PLX4032, and initiated clinical development in 2006. PLX4032 is now being co-developed under a 2006 license and collaboration agreement between Plexxikon and Roche. A DNA-based companion diagnostic to identify patients whose tumors carry the BRAF mutation is being co-developed by Plexxikon and Roche Molecular Systems, Inc. in parallel with the therapeutic development of PLX4032.
About Melanoma
Melanoma is the most serious type of skin cancer and is growing at a rate of about five to six percent annually. More than 50,000 people in the U.S. and 160,000 people worldwide are diagnosed with melanoma each year, which contribute to approximately 48,000 deaths. It is one of the deadliest cancers, with a five-year survival rate of 15 percent. The median progression-free survival for a patient with metastatic melanoma is less than 60 days, and the median overall survival for these patients is approximately eight months.
Risk factors for melanoma include a positive family history of melanoma, prior melanoma, multiple clinically atypical moles or dysplastic nevi, inherited genetic mutations, fair skin and sun exposure. However, melanoma can occur in any ethnic group and also in areas of the body without substantial exposure to the sun.
About Plexxikon
Plexxikon is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s lead compound, PLX4032, is in late-stage clinical trials for the treatment of melanoma. Other clinical-stage programs include PLX5568 for the treatment of polycystic kidney disease, PLX204 for the treatment of diabetes, and PLX3397 for the treatment of metastatic cancer. Among the company’s preclinical development programs, candidates are being developed for the treatment of rheumatoid arthritis, neuro-inflammatory disorders, multiple sclerosis and other autoimmune diseases as well as for the treatment of other cancers.
Plexxikon’s proprietary Scaffold-Based Drug Discovery™ platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches. The company has discovered a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in cardio-renal disease, CNS disorders, inflammatory and neuro-inflammatory diseases, and oncology. For more information, please visit www.plexxikon.com.
Contact:
Plexxikon Inc.Kathleen Sereda Glaub, +1-510-647-4009Presidentkglaub@plexxikon.comorFor PlexxikonSusan Kinkead, +1-415-751-3611susan@kinkeadcomm.comorJennifer Cook Williams, +1-360-668-3701jennifer@cwcomm.org
This would be a biosimilars company but it is private
Pfenex Inc. Establishes Reagent Protein Distribution Agreement With Cedarlane Corporation
Companies will cooperate in the sales and distribution to the Canadian and US research market of high value reagent proteins produced by Pfenex. Products will include vaccine carrier proteins and cell culture related growth factors.
ShareretweetEmailPrintPress Release Source: Pfenex Inc. On Tuesday August 24, 2010, 9:41 am EDT
SAN DIEGO, Aug. 24 /PRNewswire/ -- Pfenex Inc. and Cedarlane today announced that they have entered into a non-exclusive distribution agreement. Cedarlane will market and distribute high value reagent proteins produced by Pfenex to researchers in Canada and the United States. Among the products initially distributed will be vaccine carrier proteins such as CRM197 and Cholera Toxin B and cell culture related growth factors including G-CSF and Interferon beta 1-b. New products which are developed by Pfenex will be added to the Cedarlane catalogue upon launch.
"We are pleased to establish this distribution relationship with Cedarlane," stated Patrick K. Lucy, Vice President, Business Development at Pfenex Inc. "Leveraging the Pfenex Expression Technology™ platform, we are now producing and making available complex reagent proteins to meet the needs of the biotech R&D and clinical development community. As Pfenex grows its reagent proteins business, we welcome the opportunity to work with world class distributors such as Cedarlane to enable placing Pfenex products in the hands of life science researchers around the world."
"CEDARLANE is proud to add Pfenex Inc. products to its extensive portfolio," said John Course, CEDARLANE Vice President. "Canadian scientists have an even greater opportunity to consolidate their ordering from a long list of high-quality suppliers of scientific reagents." Key components of the CEDARLANE mission are to provide quality products, assure the highest in customer satisfaction and respond to the dynamic needs of every research community.
About Pfenex Inc.
Pfenex Inc. is a protein production company leveraging the unique and powerful Pfenex Expression Technology™ platform based on the microorganism, Pseudomonas fluorescens, for the production of research proteins, reagent proteins, biosimilars and innovator biopharmaceuticals. For more information please visit www.pfenex.com
About CEDARLANE
In business since 1957 and incorporated in 1975, CEDARLANE is a 100% Canadian Corporation and a leading supplier of research reagents in North America and worldwide. The company is ISO 9001 accredited and ISO 13485 certified.
Drug combination helped kill deadly cancer in mice
By Julie Steenhuysen
CHICAGO, Aug 24 (Reuters) - Adding an experimental drug to chemotherapy helped wipe out brain cancer cells in mice, offering a promising new treatment approach for the deadly cancer, U.S. researchers said on Tuesday.
They said a drug called a gamma secretase or Notch inhibitor, combined with Merck & Co's (MRK.N) chemotherapy Temodar or temozolomide, dramatically improved survival in mice with glioblastoma multiforme.
Glioblastoma is the most common and most aggressive form of brain cancer in people.
"Glioblastomas are horrendous tumors, and new therapies are desperately needed," said Alonzo Ross of the University of Massachusetts Medical School, whose study appears in the journal Cancer Research.
"We found that this double therapy of combining temozolomide with a Notch inhibitor was highly effective at treating tumor cells in culture and in mice," he added.
The finding is exciting because several drug companies including Eli Lilly and Co (LLY.N) and Merck (MRK.N) are developing gamma secretase inhibitor drugs that block or inhibit Notch, a cell signaling pathway. [ID:nN11265908]
Ross said adding the Notch inhibitor into the mix appeared to make the chemotherapy more potent, apparently permanently stopping the tumor cells from growing..
In half of the mice given the combination treatment, tumors disappeared. In the other half, they shrank.
Lilly last week halted a trial of its drug semagacestat, a notch inhibitor, in Alzheimer's patients because their symptoms got worse. [ID:nN17120793]
But Ross said that may not be an issue in brain cancer patients. "They were trying to keep people on the drug for a long period of time whereas we are talking about a transient period," Ross said.
"I don't think one has to be concerned about the side effects."
More testing is needed before the treatment combination can be tried in people.
The team still needs to test the combination in tumors that have been treated by radiation, which is the standard regimen for patients with glioblastoma tumors.
Ross said it is not clear what effect radiation may have.
"It may enhance it. We just don't know yet," he said.
In addition to Eli Lilly, AVEO Pharmaceuticals (AVEO.O) is developing a Notch inhibitor drug. (Editing by Maggie Fox)
anyone have a list of companies working on biogenerics, biosimilars, etc? just trying to pull together a good list these type of companies.
PBTH , MNTA , PLX
ibpm mdg.to
I didn't feel that way. I was responding to a post of Dew's that seemed to imply that outcome
why is everyone of your responses to my posts so nasty.
I don't understand you.
wouldn't this mean that if Teva's product does not show immunogenicity it will be approved because if there is no immunogenicity it defacto proves purity?
The reason GHB helps in Narcolepsy and Catiplexy is that it straigtens out the REMS sleep state.
it also increases IGF while you are sleeping. People with Fibromyalgia tend to have reduced levels of igf-1.
If you take ghb when you go to sleep it will increase igf-1 and growth hormone levels while you are sleeping which should in turn increase the benefits of weight lifting.
Soligenix, Inc. (SNGX, Buy; $1.50 Target Price): Reports 2Q10 Results – Focus Remains on the Confirmatory Phase 3 Trial in Acute GI-GVHD
COMPANY UPDATE
Soligenix, Inc.
(SNGX.OB/OTC)
August 19, 2010
Jonathan Aschoff, Ph.D., 212-702-6652
aschoffj@bmur.com
Reports 2Q10 Results – Focus Remains on the Confirmatory Phase 3 Trial in Acute GI-GVHD
Buy
Target Price:$1.50
Investment Summary
2Q10 Results.Soligenix reported grant revenue of $445,000, which beat our estimate of $350,000, and 2Q10 EPS was $(0.01), which met our estimate. The increased revenues were primarily due to an increase in grants from the NIH for the thermostable vaccine development program. R&D costs were about $1.1 million and G&A costs were $545,000. We expect an uptick in operational expenses in 2H10 as Soligenix initiates the Phase 2 trial of orBec in Chronic GI-GVHD and completes the Phase 2 trial of orBec in GVHD prophylaxis. Soligenix ended the quarter with about $11 million in cash and investments, which combined with the cash provided from grants, should provide a runway through 2011.
Upcoming Catalysts. Quarterly results are not meaningful for Soligenix, at this point. Investor focus is on the confirmatory pivotal trial of orBec in acute GI-GVHD, and we look forward to top-line data from this trial in mid-2011. We are confident about the trial demonstrating results that were at least as robust as the first Phase 3 trial. As such, we anticipate a Class 2 complete response submission to the FDA by YE11, followed by FDA approval by 1Q12 in acute GI-GVHD. Nearer term, we look forward to top-line data from the Phase 2 trial of orBec for GVHD prophylaxis in 3Q10. We anticipate that Soligenix will initiate a Phase 2 trial of orBec in chronic GI-GVHD by YE10.
Valuation. We arrive at a value of $1.50 per share for Soligenix using a discounted cash flow valuation on revenue generated from orBec sales for GVHD (treatment and prophylaxis), and taking into account the company’s projected mid-2011 cash balance.
Risks.Risks to the achievement of our target price include market adoption risks, business development risks, competition, and high share price volatility.
.
Price
$0.23
52-Week High/Low
$0.38 - 0.18
Shares Outstanding (mm)
215.81
Market Cap. (mm)
$49.64
Average Daily Volume (mm)
0.46
you are fairly sure they will do the split I am pretty sure they will not do it at least until the phase 3 data is out.
The company does not plan to do a reverse split. They put it on the proxy for flexiblilty, and it would be available to them for three years.. the proxy was out in July
If the orBec data is positive and the drug is approved they may do a reverse split, but the stock will be a lot higher after those positive events.
you confirmed what I said, but you said it in English.
I was speaking in Ebonics, sorry.
if sandoz picks up 70 to 80 percent of the market then sny will get an make an authorized generic deal which will hurt mnta
you should be happy if they stay in the 40 to 50 percent range
how often does this delay happen?
Human Genome Sciences: Expect Positive FDA Update Soon
We are maintaining our 1-Overweight rating on shares of HGSI ahead of expected BLA acceptance for Benlysta. While concerns have emerged regarding apparent delay in communication of review status we understand that HGSI has yet to be contacted by FDA and we continue to expect 6-month priority review.
HGSI was expected to hear from FDA by August 10th regarding acceptance of its BLA for Benlysta in SLE and designation of 6-month priority review vs. 10-month standard review. While FDA guidance would suggest 60-day response from June 10 BLA submission, feedback from HGSI yesterday suggests that they have yet to receive communication from FDA and that the company remains optimistic regarding priority review.
We continue to believe that Benlysta review is straightforward and deserving of priority. Irrespective of review status we believe that likelihood of approval is high following 2 positive studies, favorable AE profile and significant unmet need in Lupus.
talk about biting the hand that feeds you
Glaxo Slaps Former Sirtris Execs
Adam Feuerstein
08/12/10 - 08:19 PM EDT
CAMBRIDGE, Mass. (TheStreet) -- GlaxoSmithKline(GSK) has cracked down on two of its U.S. executives for selling the anti-aging supplement resveratrol without the company's knowledge or permission, and by doing so, conceivably undermining Glaxo's nearly $1 billion investment in resveratrol drug research.
The U.K.-based pharmaceutical giant ordered Cristoph Westphal and Michelle Dipp Thursday to cease selling a resveratrol dietary supplement through a nonprofit venture known as the Healthy Lifespan Institute that the two executives helped establish last year, TheStreet has learned.
Westphal and Dipp were both principal executives at Sirtris Pharmaceuticals when Glaxo acquired the company in 2008 for $720 million. Glaxo bought Sirtris for its expertise in developing drugs based on resveratrol, a chemical found in red wine which some research suggests may ramp up the metabolic activity in cells and could one day be used to treat diabetes, cancer and many other diseases.
Westphal and Dipp joined Glaxo after the Sirtris acquisition and continued to direct Glaxo's continuing efforts into resveratrol drug development. Unbeknownst to Glaxo, the two executives were also moonlighting as purveyors of their own custom-made dietary formulation of resveratrol. The resveratrol sold by Westphal and Dipp is formulated differently and is less potent than Glaxo's resveratrol drugs, according to the company.
Consumers could purchase resveratrol online from the Healthy LifeSpan Institute run by Westphal and Dipp at a cost of $540 for a one-year supply. The web site Xconomy first reported on Westphal and Dipp's extra-curricular activities Thursday.
Westphal and Dipp informed Glaxo about the formation of the Healthy Lifespan Institute, but "GSK [Glaxo] was not aware that the Healthy Lifespan Institute was selling a resveratrol formulation on the Internet. The company has instructed the GSK employees to cease their association with this activity and Michelle Dipp and Christoph Westphal will be resigning their positions on the board of Healthy Lifespan," said Glaxo spokeswoman Sarah Alspach in a statement emailed to TheStreet.
Westphal, who is also a partner in a venture capital firm based in Boston, would not answer questions, according to his spokeswoman. Dipp could not be reached.
Resveratrol is a natural compound and can therefore be sold via retail channels as a dietary supplement without regulatory approval. Glaxo, however, spent $720 million to acquire Sirtris with the hope that a prescription drug made from resveratrol would one day be approved by U.S. or European regulators with a specific medical claim to treat or cure a disease like diabetes or cancer.
A resveratrol drug like that could potentially generate billions of dollars in sales for Glaxo. To succeed, the pharmaceutical giant would have to argue successfully that only its prescription formulation of resveratrol -- and not the similar substances sold on the Internet, in health food stores or TV infomercials -- provide real therapeutic benefit.
Yet, Glaxo's huge investment in resveratrol drug research is potentially undermined, even jeopardized, by the Sirtris-turned-Glaxo executives who sold them on the idea but then turned around and started selling their own cheap resveratrol over the Internet.
Glaxo's Alspach had no further comment.
Glaxo's decision to acquire Sirtris for $720 million was a gamble because at that time, Sirtris had very little clinical data to support its theory that resveratrol drugs could extend life or treat and cure disease. In fact, no clinical trial in humans to date has substantiated the anti-aging or disease-modifying claims made about resveratrol
In April, Glaxo terminated a clinical trial of its resveratrol drug SRT501 in multiple myeloma after some patients developed kidney damage. Other studies of Glaxo's resveratrol drugs have either been completed or are still enrolling patients.
Dipp told Xconomy that her Healthy Lifespan Institute was selling the custom-made resveratrol formulation web site at cost and was not profiting from sales.
Dipp was one the first employees at Sirtris and is now senior vice president of Glaxo's Center of Excellence for External Drug Discovery, responsible for helping Glaxo form drug development partnerships with smaller biotech firms.
Westphal was the CEO of Sirtris both before and after Glaxo's acquisition. He now runs SR One, Glaxo's internal venture investing unit.
Dipp and Westphal are also founding partners of Longwood Founders Fund, a Boston-based venture capital firm in which Glaxo is an investor.
-- Reported by Adam Feuerstein in Boston.
Follow Adam Feuerstein on Twitter.
teva has been saying their approval is coming soon. If two or three months go by and Teva hasn't received their approval I think investors will assume it isn't coming in the near term. They wouldn't need to see any letter from the fda to confirm that.
Hospira to Host Biosimilars Investor Education Event
Press Release Source: Hospira, Inc. On Thursday August 12, 2010, 2:00 pm
LAKE FOREST, Ill., Aug. 12 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE:HSP - News), a leading global specialty pharmaceutical and medication delivery company, today announced that it will host a biosimilars investor education forum on Thursday, Aug. 19, 2010. The event, which will feature presentations by various members of the company's R&D and Specialty Pharmaceuticals organizations, will highlight biosimilars in general, as opposed to focusing on the company's biosimilar program.
A streaming audio webcast of the event, which will include the slides presented during the event, will be available on the Investor Relations section of Hospira's Web site at www.hospirainvestor.com. The presentations are expected to begin at approximately 8 a.m. Central time and conclude at approximately 12 p.m. They will be available to all interested parties through a live audio webcast accessible via the investor relations section of Hospira's Web site at www.hospirainvestor.com. Listeners should log on approximately 10 minutes in advance to ensure proper setup for accessing the audio webcast. A replay of the webcast will be available on the Hospira Web site approximately 24 hours after the conclusion of the event.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 13,500 employees. Learn more at www.hospira.com.
Pediatric Exclusivity for Viagra?! It's No Joke
http://invivoblog.blogspot.com/2010/08/pediatric-exclusivity-for-viagra-its-no.html
You can be forgiven for skipping yesterday's Cardiovascular and Renal Drugs Advisory Committee. After an incredible series of important committee topics (Avandia! Qnexa! Opioid REMS! Avastin! Brilinta!), a day long session focused on pediatric study endpoints for pulmonary arterial hypertension drugs doesn't exactly cry out for attention.
But it was a doozy. Not so much for what the committee decided...or maybe failed to decide. Heck, this was a mess of a meeting, and our colleagues did an amazing job to make sense of the outcome in "The Pink Sheet" DAILY.
No, this was a doozy of a meeting because it is laying the groundwork for what could be a very interesting regulatory decision by FDA: granting a six-month pediatric exclusivity extension for sildenafil, the active ingredient in Pfizer's PAH drug Revatio and another product you might have heard of called Viagra.
Yes, it is true: Pfizer is (we think) going to get a six month pediatric exclusivity extension for an erectile dysfunction product. In fact, we would go so far as to say after the meeting, by any fair interpretation of how the program works, Pfizer should get an extension.
Viagra? Viagra has no role in the pediatric population--except to increase the numbers of children in the US. (Badda Bing!)
Okay, okay: the pediatric extension won't be for Viagra; it will be for Revatio--a truly important therapy for the rare but debilitating condition of PAH. And all indications are that the Pfizer product does have an important role in treating the 500-600 children in the US who suffer from the disease. Pfizer has done extensive research on that population, despite significant challenges finding a viable endpoint given that no one wants to run long-term placebo controlled trials in this setting.
The pediatric exclusivity program was created in 2002 to encourage sponsors to conduct studies in children, by granting them an extra half-year of patent life/exclusivity for completing studies pursuant to a written request by FDA. Pediatric research, everyone agrees, is a very challenging and neglected field, and the law has clearly worked to encourage many more studies than would have occured without it. The Revatio program looks exactly what the law was supposed to deliver.
But the law (as implemented by FDA) is clear: the extension applies to the active ingredient, and so--if Pfizer gets a reward--the basic sildenafil patent will be extended from March 27, 2012 until September, 2012.
That is obviously a big deal for Pfizer. Revatio sales in the US were $300 million last year, so an extra six months is nothing to sneeze at. But Viagra is almost $1 billion, so that's where all the action is. (Badda Bing!, again.)
Now, Pfizer claims Viagra will be protected from generic competition until 2019, thanks to a use patent covering the ED claim. However, use patents tend not to hold up against generic challenges, and Pfizer is already facing a challenge from Teva. On the other hand, given the unusual circumstances of Viagra's development, the use patent on ED may be more robust than most.
Nevertheless, the patent extension will still matter. Obviously it delays the earliest possible date for a generic Viagra in the event Pfizer loses the case. In the more likely event that litigation is still pending, it will delay by six months the earliest possible date that Teva could consider an "at risk" generic launch. That in turn would affect the terms of any possible settlement of the litigation (assuming pending "pay for delay" legislation in Congress doesn't put the kibosh on settlements altogether.)
The extension will also put off the date on which Pfizer will have to wrestle with the possiblity that generic versions of Revatio will start eating into the Viagra market. Revatio is marketed as a 20 mg pill, while Viagra is available as 25, 50 and 100 mg pills. As brands, Revatio retails for slightly less per pill than Viagra ($15.60 vs. $17 on drugstore.com), but it certainly doesn't make economic sense to take two Revatios instead of one Viagra. If Revatio generics are widely available, those economics could change.
So, no matter how you look at it, Viagra will benefit from the pediatric exclusivity award.
Here's the thing: the pediatric exclusivity program has strong support, but it isn't without its critics. When the program came up for reauthorization in 2007, some members of Congress wondered why a sponsor might be given an extra six months of sales for a multi-billion brand in exchange for conducting a relatively small, inexpensive study in children.
It is fair to say those arguments will come up again in 2012--especially if FDA grants an extension to Viagra, every politician's favorite target for criticizing Big Pharma.
Look for more coverage of how the advisory committee wrestled with this issue in an upcoming issue of The RPM Report.
pcrutch
My guess is that you are on the biomed paid subscriber list that gets 24 hours advance notice about an article that they are going to generate.
http://biomedreports.com/articles/most-popular/49968-aryx-on-the-verge.html
otherwise it was incredible timing
I am not worried about the US right now.
They did a deal with Servier, the company doing 300 million a year in revenues right now. Servier's twice a day sachet comes off patent in 2015. As you say the royalty they are paying OLGX is low. The cost to produce the pill will be less than the twice a day sachet.
It will be in Servier's best interest to get OLGX's drug on the market as soon as possible before their drug comes off patent. The drug should be ready to be launched in 2012. It will be in Servier's power to stop selling the sachet and convert everyone to the once a day pill. Because it will be a lot more consumer friendly to take a once a day pill vs a twice a day bad tasting sachet, sales will probably grow faster than the sachet has.
It is easy to see a mid single digit royalty on an immediate 300 million in sales. The European patent goes through 2024.
Just based on the European revenue stream the stock is extremely cheap.
YOU KNOW EVERYTHING.
I am valuing the US as zero even though it should have some value to someone.
catastrophic risk from hyper allergic reactions in europe.
This catastrophic risk, as you call it, slowed down the sales ramp when it was first discovered but sales have been growing very nicely since that event. I guess the risk isn't that catastrophic. the rash may have come from the ranelate in the protelos product. That salt is not used in any other product.
What do you think of the chances of this scenario?
Wasn't there a thread about a month ago that since mnta could fully categorize their product they could get a fully substitutable anda, whereas Teva may get a approval but it wouldn't be able to be substituted for the brand. Hence they would need a sales force which would be tantamount to having an approval that wouldn't be worth very much.
GlobeImmune
presentation for Globeimmune... they seem to be concentrating on a particular IL28b genotype
Discussion
The discovery of the IL-28 B genotypes (Ge et al., 2009) and their predictive value for spontaneous
clearance of HCV (Thomas et al., 2009) and response to pegIFN/ribavirin therapy (Ge et al. 2009) are
significant breakthroughs in the understanding of the molecular biology of HCV. The role of IL-28 B
variants in acute clearance of HCV strongly suggests that it is a marker of the immune capacity of the
patient, and influences response to interferon therapy based on the immune differences in the IL-28 B
subgroups. IL-28 B testing in GI-5005-02 showed excellent balance between the GI-5005 triple therapy
and SOC groups. Furthermore, important differences were noted for the different IL-28 B genotypes
related to the timing and magnitude of viral clearance and SVR. GI-5005 triple therapy improved end
of treatment viral clearance in all IL-28 B genotypes (C/C; 84% vs 76%, C/T; 69% vs 54%, T/T; 60%
vs 20%) and improved SVR in the C/C (74% vs 65%) and T/T groups (60% vs 0%).
The pattern of response in the C/T group suggests an important role for response guided therapy due
to the fact that an advantage of 15% in response was observed at end of treatment but not at 6 months
post-treatment. The majority of GI-5005 treated C/T patients who relapsed in the post-treatment period
cleared HCV virus after 12 weeks of therapy, suggesting that they would have benefited by a lengthened
duration of treatment. The greatest favorable treatment effect for GI-5005 was observed in the T/T group
with an advantage in end of treatment viral clearance of 40% and an advantage in SVR of 60%. This
may reflect an immune deficiency inherent in the T/T group, and suggests that GI-5005 can stimulate
HCV specific immunity in a manner that compensates for this deficit.
Differentiated therapeutic vaccine platform
Advanced portfolio of clinical products
GI-5005: completed phase 2 in HCV
GI-4000: multiple phase 2 trials in Ras mutated cancers
$150 million invested capital
$500+ million Celgene oncology alliance
Tarmogen® platform
Targeted molecular immunogen
Recombinant S. cerevisiae expressing target proteins
Selectively activates T cells
WW IP through mid-2020s
Tarmogen pipeline
Immune response matters in HCV
Natural history
20% acutely exposed clear without treatment
80% of acutely exposed progress to chronic infection
6 to 9 months of consolidation required after viral negativity
Hepatic clearance requires immune response
Anti-virals including IFNs suppress replication but do not enhance hepatic clearance
IL-28 B SNP > clearance and IFN response
GI-5005
GI-5005-02 phase 2 design
Demographics
End of treatment response (ETR)
Sustained virologic response / naïve
IL28B predicts response to IFN therapy
T/T genotype disproportionately represented in AAs
Viral clearance by IL-28 B genotype
ALT normalization at end of treatment
Safety summary
Commercial launch time line
Tarmogen products
Celgene alliance
Exclusive option to all oncology Tarmogens
Economics
$40 million up-front
$10 million in equity
$30 million in R&D funding
In excess of $500 million in milestones
Double digit royalties
GlobeImmune runs development
Alliance governed by joint development committee
Targeting mutated Ras
Unmet medical need
Ras-mutation related cancers ~170,000/year in the US
Ras mutation+ CRC (~40%) resistant to EGFR MAbs
Ras mutation+ NSCLC (~25%) resistant to chemo/TKIs
Primary biology of pancreas cancer (>90% Ras+)
Un-druggable target
GI-4000?immunologic elimination of mutated cells
GI-4000 series targets mutated Ras
GI-4000 program
Randomized Phase 2b in pancreas cancer
Adjuvant study in resected pancreas cancer
Up to 200 patients
Survival data ~YE 2010
Phase 2a in NSCLC (MSK)
Consolidation therapy following successful first-line treatment for Stage I-III Ras-mediated NSCLC
24 patients
Complete enrollment ~YE 2010
First colorectal trial starts Q2 - 2010
2010 milestones
GI-5005-02 final data AASLD
Non-responders
Immunology
GI-5005 pivotal program
Commercial manufacturing process
Expansion of T/T subgroup
End of phase 2 meeting
GI-4000
GI-4000-02 pancreas early data ~ YE
GI-4000-03 NSCLC – immunology and safety data
Subject : BMC: Soligenix, Inc. (SNGX.OB: Buy, $1.50 Target Price) - A Complete S olution for the Management of Graft-Versus-Host Disease; Initiating Co verage with a Buy Rating
Someone should post to the Biotech Values Board I can't do it
Date : Tue, Aug 03, 2010 07:30 AM
Click here to view full report.
INITIATION REPORT Soligenix, Inc. (SNGX.OB/OTC)
August 3, 2010
Jonathan Aschoff, Ph.D., 212-702-6652
aschoffj@bmur.com
A Complete Solution for the Management of Graft-Versus-Host Disease; Initiating Coverage with a Buy Rating
Initiating Coverage at Buy
Target Price:$1.50
Investment Summary
§We are initiating coverage of Soligenix Inc. with a Buy rating and a one-year target price of $1.50. We arrive at a value of $1.50 per share using a discounted cash flow valuation based on revenue generated from orBec sales for Graft-Versus-Host disease (treatment and prophylaxis), and the company’s projected mid-2011 cash balance. There are currently no FDA-approved treatments or prophylactic agents for Graft-Versus-Host disease (GVHD), and orBec has the potential to satisfy a critical unmet medical need.
§GVHD represents a critical unmet medical need.There are about 12,000 allogeneic hematopoetic cell transplants (HCT) in the U.S. and the EU each year. Of these 24,000 patients worldwide, about two-thirds develop GVHD. About 75% of GVHD patients suffer from grade 2 GI-GVHD. The current first-line treatment for GI-GVHD is prednisone, a glucocorticoid. Other drugs are used off-label to treat the disease, but are associated with several toxicities. As such, a safe and effective treatment is required for this critical unmet medical need.
§Soligenix has already completed a Phase 3 trial. The trial failed to meet its primary endpoint: time to treatment failure through day 50. However, the trial met most of its secondary endpoints. Specifically, treatment failure rate at day 80 was highly statistically significant (p=0.005). There was also a significant reduction of mortality associated with orBec treatment at 200 days post-HCT. Soligenix is now conducting a confirmatory Phase 3 trial under a Special Protocol Assessment (SPA) from the FDA. It is a replica of the first pivotal trial with a key difference – the secondary endpoint in the first pivotal trial, which achieved statistical significance (p=0.005), will serve as the primary endpoint in the confirmatory Phase 3 trial. We believe that the confirmatory trial will likely meet its endpoint with the same level of statistical significance that was observed in the first pivotal trial. We look forward to top-line results from this trial in 1H11.
§We estimate the global market opportunity for orBec to be around $450 million. Soligenix has partnered with Sigma-Tau and will earn a 35% royalty on sales in the U.S., and we assume a similar partnership for ex-U.S. commercialization. In addition to the Phase 3 acute GVHD trial, Soligenix is exploring the use of orBec in GVHD prophylaxis and chronic GVHD. Given the positive results observed heretofore in acute GVHD, we believe that orBec will likely also demonstrate similar results in the prophylactic setting and in the chronic form of the disease. The potential revenue from orBec sales in the U.S. and EU is about $450 million. With a potential peak GVHD market penetration of 65%, orBec has the potential to generate about $300 million in sales.
Price $0.24
52-Week High/Low
$0.38 - 0.18
Shares Outstanding (mm)
215.81
Market Cap. (mm)
$50.74
Average Daily Volume
422,439.00
Dangerous liaisons at IBM: Inside the biggest hedge fund insider-trading ring
http://money.cnn.com/2010/07/06/news/companies/ibm_insider_trading.fortune/index.htm
Robert Moffat, who was a top manager at Big Blue, was considered a candidate for CEO. Then he met Wall Street analyst Danielle Chiesi. Both were consumed by the flames of the Galleon hedge fund scandal.
By James Bandler with Doris BurkeJuly 6, 2010: 5:51 PM ET
FORTUNE -- At 7:30 in the morning on Oct. 16, 2009, Robert Moffat had already been at his desk at IBM's headquarters in Armonk, N.Y., for an hour and a half. As he had almost every day in his 31-year career at the company, he had left home at 5:30 a.m. to get a jump on work. He had just finished his first call of the day when his phone rang. It was his wife, Amor.
He needed to come home immediately, she said. Five FBI agents were at the house to arrest him for conspiracy related to insider trading. "What's going on?" Amor implored.
"I don't know," Moffat said. He hung up and called a senior IBM (IBM, Fortune 500) lawyer, who gave him the name of a white-collar criminal defense attorney. His heart pounding, Moffat bolted across the marble lobby and nearly bowled over a startled colleague. By the time he reached the parking lot he was sprinting hard for his Lexus. It was the last time anyone saw him at IBM.
Moffat, the senior vice president of IBM's systems and technology group, was the most prominent tech executive arrested in the federal dragnet that snagged Raj Rajaratnam, founder of the Galleon Group hedge fund. The bust sent tremors through Wall Street, exposing a world of illicit, back-channel dealings between prominent hedge fund managers and senior executives in the high-tech industry. Among those caught in the federal bust were a McKinsey & Co. director, a high-level Intel (INTC, Fortune 500) executive, and the head of New Castle Partners, a hedge fund that was once part of Bear Stearns. So far, 11 of 21 people charged have pleaded guilty.
While the scandal seemed to many people a confirmation of all they've suspected is wrong with Wall Street and the hedge fund industry, Moffat's arrest was utterly shocking to the people who knew him. He wasn't a speculator. He was a confidant of IBM CEO Samuel Palmisano and widely considered a candidate to succeed him. He had plenty of money and a family who adored him. On so many levels it didn't compute. IBM itself, with a squared-away corporate culture and a stock favored by long-term investors, was one of the last Fortune 500 companies you'd expect to be dragged into an insider-trading case. Moffat didn't make a penny from the information he provided, nor did he trade a share of stock. And of all the buttoned-down executives at Big Blue, Moffat was the last one that old friends could imagine being caught up in a scandal, let alone a crime. The former Eagle Scout had a reputation for loyalty as solid as his 6-foot-2, 265-pound frame.
Kenneth Hammer, a former IBM attorney who had worked with Moffat, recalled his reaction on hearing of the arrest: "There was no planet on which I could have understood what was being said about Bob. I just shut down."
Moffat was a number cruncher of the first order: He had been, among other things, the head of IBM's supply chain. Spreadsheets sang to him; he carried three-ring binders stuffed with data about the business. Some people might think his work was dull. But in 2002 he met a hedge fund analyst who found what he did insanely alluring. Danielle Chiesi, a former teenage beauty queen, was a woman for whom business information was the ticket to gratification. She liked older men, and she enjoyed pushing their buttons. "I love the three S's," she would tell them. "Sex, stocks, and sports."
Chiesi, arrested on the same day as Moffat, maintained a stable of highly placed sources at the tech companies she covered for New Castle. She has pleaded not guilty to charges of securities fraud and conspiracy. The government alleges that she was one of Rajaratnam's many gatherers of insider information and that both their hedge funds illegally profited from trading on it. "Moffat's terrific," Chiesi told Rajaratnam, according to an excerpt of a government wiretap. "He's a huge coup for me."
The ballad of Moffat and Chiesi is a classic tale of desire and betrayal. Chiesi had an affair with Moffat, but the person she truly loved was her boss, Mark Kurland, the co-founder of New Castle. But Kurland wouldn't leave his wife and ultimately renounced Chiesi.
Sex was part of the picture, to be sure, but the dangerous elixir that really bound these people to one another was information. It enriched some of them, it thrilled all of them, and it eventually ruined their careers. Trading business information, Chiesi would say, was "like an orgasm."
Moffat's path to prominence at IBM
The late Jerry York, IBM's legendary former CFO and one of the great turnaround artists in American business, had an indelible memory of working with Moffat when Moffat was just a second-tier finance guy at the company's personal computer division. "He was highly regarded and considered to be a real comer," York told Fortune last spring, days before he died suddenly of a brain hemorrhage.
In the mid-1990s, York, a famously tough boss, had a difficult inventory task for Moffat. Assigning him the job, York produced a sheet of paper and said, "Please sign this." The document said that if Moffat didn't have the problem fixed by the year's end, he would agree to resign immediately. Moffat signed it without hesitation.
Moffat rose from the very bottom rung of IBM to steps from the pinnacle. His main attributes were loyalty, inhuman work habits, and the mental bandwidth of an orchestra conductor. He moved his family around the world as the company asked him to. Approached several times with offers to run rival tech companies, he turned them down. He worked so hard that on one rare date night with his wife, he fell asleep at the restaurant table. She told a friend she worried that by the time he retired there would be nothing left for her but a skeleton.
Moffat grew up in a small, two-story wood frame house in a working-class neighborhood in Stamford, Conn. His father, Robert Moffat Sr., was a typesetter and his mother, Edith, a stay-at-home mom. They instilled in their children a love of hard work, competition, and abiding loyalty to the Moffat clan.
The eldest boy in the family of five children, Moffat was idolized by his siblings. He seemed to excel at everything he did. His older sister, Susan, expected he'd go into medicine or science. He could analyze almost any issue or problem. "He was such a geek," she recalled.
Moffat was a precocious track athlete, and his father told him that running would be his ticket to college. Every day he would run the seven miles to school, and his father would follow in the car with lunch and gear. To boost his confidence, he took to wearing a Superman shirt, even wearing it outside his singlet in one race. (For a long time his kid brother, Stephen, actually believed Bob was the caped crusader.) He got into Union College in upstate New York.
His freshman year in college, Moffat met the woman who would be his wife. She was a year older and a manager of the track team. Like his mother, Amor Boullosa was slight, raven-haired, and beautiful.
It was by no means love at first sight. Walking from the field house to the cafeteria, she overheard an upperclassman ask Moffat how he thought he would do in the next day's race. "You'll be eating my dust," the lanky freshman boasted. Amor raised her eyebrows. Sure enough, Moffat won the race. Amor still thought he was a cocky jerk. (By the time he graduated, Moffat was a three-time All American middle-distance runner.)
A few months later Amor and Bob had their first date, and her opinion changed. "Moff," as she later called him, seemed so grounded. He proposed to Amor on Christmas Day of his senior year in front of his entire family. She opened a refrigerator box to find a smaller box inside. Many boxes later she found the ring. Another woman might have been put off by the presumption and the pressure. But Amor was moved by his old-fashioned devotion.
The couple was married in June 1978, right after Bob's graduation. The day after they got back from the honeymoon, Moffat started at IBM with a $15,120-a-year job as a junior programmer. Their first child, Bobby, was born in 1983. But the joy was tempered by terrible news. Three months after Bobby's birth, Amor lost sight in her left eye. Two days later she couldn't walk. The doctors finally gave her the terrifying diagnosis: multiple sclerosis. The disease could be managed but never cured. Flare-ups seemed particularly acute in times of stress.
As Moffat advanced at IBM, the family moved to Minnesota, to France, back to New York, and to North Carolina. They had three more children. In Raleigh, Moffat took a finance job in the personal computer division. He quickly bonded with his boss, Sam Palmisano, the head of the PC business. Like Moffat, Palmisano came from a simple background, spoke bluntly, and had little tolerance for people who made excuses. When Palmisano moved on to take over the enterprise systems group in October 1999, he asked Moffat to come with him. "I need someone I trust," Palmisano told Moffat. Another executive took the helm of the PC unit, and the business foundered.
In the fall of 2000, Moffat was asked to come back to the PC division, which by then was losing around $1 billion a year. Except for Palmisano, almost every head of the business had failed at the job. "Look at the tombstones before you accept the job," then-CEO Louis Gerstner warned Moffat.
Soon Moffat was getting a reputation outside IBM. Forbes and the Wall Street Journal wrote profiles about the miracle worker who was turning the troubled PC division around. The image of Moffat that emerged was that of a stoic soldier. He told the Journal, "I've never missed a commitment to Sam Palmisano."
The close ties between the two men became something of a joke among Moffat's staff. Once they superimposed the boss's face over the office photographs of Moffat's wife and kids. Moffat took the prank well, but behind the kidding lay a hard truth: In Moffat's world, Sam Palmisano and IBM were starting to crowd out the family.
In 2002, after Palmisano was named CEO, he asked Moffat to take IBM's disparate supply chains and integrate them into one smoothly running operation. It was a task to rival the cleanup of the Augean stables, but Moffat was up to it. In his first year he slashed $5.6 billion in costs. His team built a system to track every silicon chip, diode, and widget in IBM's supply chain from purchase to sale. Later Moffat devised an ingenious, albeit spooky, system for including humans in the supply chain too -- categorizing each employee's skills and strengths. But Moffat's human taxonomy system had its limits. It couldn't tell which employee's character was strong or which was weak. It couldn't tell loyalist from traitor, or predict how a middle-aged man would behave after colliding with a force of nature like Danielle Chiesi.
Danielle Chiesi: from pageant queen to corporate "yenta"
Blond, blue-eyed, and petite, Chiesi grew up in Binghamton, N.Y., where she won the regional Southern Tier beauty contest at age 15 wearing a tiara and a black size-0 dress made by her mother, Gloria. Her father, Alex, an insurance executive, was an accomplished gourmet chef, the son of Alex Chiesi, a Swiss immigrant who had studied under Auguste Escoffier and owned the Hapsburg House restaurant in New York City.
Danielle earned a bachelor's degree in economics from the University of Colorado in 1988, then moved back east to seek her fortune on Wall Street. She got a job as an analyst at a brokerage called Mabon Nugent & Co. There she met the man who would be her boss and eventually her lover on and off for the next two decades, an analyst named Mark Kurland. He became Chiesi's tutor, in a way, driving her to dig hard for information on stocks. Her friends say he pushed her relentlessly. She took to the game with zeal, developing a fascination with the powerful men who ran the companies she covered. Eventually, the feds allege, their partnership became part of a criminal enterprise.
It is not clear when exactly Chiesi's romance with Kurland began, but a person close to her says it started when she was 27. She left Mabon in 1991 and moved from job to job, married, divorced, and became engaged at least two more times. One of her betrothals even made the news. As vice president of sales at Arnhold & S. Bleichroeder, she fell in love with Stephen Morris, the head of Digicall, an Australian mobile-phone reselling company that Arnhold was backing.
"Chiesi, whose gregarious nature and stunning diamond engagement ring left a dazzling impression as she swept through Sydney on Stephen's arm last October, helped sell the Digicall story in the U.S.," the Sydney Morning Herald reported on Sept. 7, 1996. But Digicall's stock crashed, and so did the engagement. Co-workers remember Chiesi at the time as talented, resourceful, and hardworking. "In all of her dealings that I observed, nothing was unethical," says Steve Gluckstein, a former Arnhold analyst.
She left Arnhold in 1997 and was soon working again for Kurland, who had become CEO of Bear Stearns's asset management business. He persuaded management to let him form an equity hedge fund within Bear called New Castle.
Chiesi covered technology companies at New Castle. Her pay was not outsize for Wall Street. She earned less than $1 million most years and $2 million in her best year. A lengthy profile on her in Bloomberg Markets after her arrest said that she favored low-cut tops and short skirts. She knew her powers. Some men would fall in love with her voice, others with her body and the close cut of her suit. She knew it was manipulative, but as a person close to her explained to Fortune, this was Wall Street: "You do what you do to get information."
Behind her tradecraft lay a genuine affection for the companies she covered and the men who ran them. She loved underdogs. Like a devoted sports fan, she rooted for chipmaker AMD (AMD, Fortune 500) in its war with Intel (INTC, Fortune 500) and was continually trying to connect the company with other companies and analysts that could be helpful. "She struck me as sort of a yenta -- get this person with that person," says Deborah Stapleton, who runs an investor-relations firm in Palo Alto.
One of her contacts was John Joyce, then IBM's CFO. Chiesi had approached Joyce in the late 1990s at an investors' conference. You need to do a stock split, she told him, watching him carefully to gauge his reaction. If he liked the idea, she surmised, it would mean he had confidence in IBM. Joyce wasn't keen on the idea, but he seemed to like Chiesi, and a long-term friendship commenced.
In 2002, Chiesi asked Joyce to introduce her to an up-and-comer at IBM, a person, as she put it, with "game." Joyce suggested Moffat.
An introduction was arranged at a conference in New York. The encounter was brief, but it made a big impression. Afterward Moffat told his friend and colleague Ken Hammer about the meeting with this aggressive, in-your-face woman. "She told him it was urgent that she see him again," Hammer recalls. "It was the kind of story guys share -- 'Hey, this woman is stalking me' -- a way of elevating himself in the eyes of other guys. I think he was kind of flattered."
He was a perfect contact. As head of the global supply chain, he spoke regularly with the biggest technology companies in the world, both vendors and customers. He had the ear of the CEO.
Moffat was under pressure, at home and at work. He was uprooting the family from Raleigh to the countryside of Connecticut. The transition was rocky. And Moffat's mother, Edith, was dying. Repeatedly when Moffat was traveling, Amor would have to take her to the hospital and spend nights there with her. When she died in September 2002, Moffat was devastated. Months later Chiesi was also grieving over the loss of her father, who had accompanied her to analyst conferences.
Chiesi and Moffat struck up a business friendship. With an impressive array of sources who confided in her, Chiesi had her finger on the industry pulse, Moffat soon discovered. She talked with everyone. She was brimming with ideas about which alliances IBM needed to build and which companies IBM needed to stand up to. In time the conversations took on the intensity of pillow talk, as Chiesi's voice would modulate from sultry whisper to squeak with excitement and delight. I think you should do this! Baby, you gotta pay attention! Some time in 2003, Chiesi and Moffat began sleeping together.
Chiesi's Sutton Place apartment overlooking the 59th Street Bridge was becoming an East Coast salon for Silicon Valley executives. A guest on one occasion was Hector Ruiz, the CEO of AMD. Some guests found the gatherings odd. "She sort of flitted around," recalls Deborah Stapleton, who was invited to one. "It seemed odd that someone of Hector Ruiz's stature would be in this tiny apartment drinking wine and eating cheese balls," Stapleton says. A person close to Ruiz said there was nothing odd about the gathering, which he described as a typical industry function attended by analysts and tech industry executives.
Trading secrets and buying stock
In the summer of 2008, AMD was in talks to spin off its manufacturing business, Fabco, creating a joint venture that would be 50% owned by a Middle Eastern sovereign wealth fund. IBM was involved in the discussions because it had been asked by AMD to provide a license for the use of its technology as part of the reorganization. Moffat was IBM's point man for the talks. With access to the two men in charge of the deal, Chiesi was soon getting detailed information that no other analyst had. Amazingly, she persuaded Ruiz to let her sit in on one of the confidential meetings between him and Moffat. As the deal progressed, Moffat kept her updated, telling her in August that it would be completed by September 9. She in turn regularly briefed Kurland about the developments, according to the criminal complaint against her. "I'm working hard on this AMD thing," Chiesi told Kurland, adding that she would be meeting with Moffat "on fucking Sunday at my mom's house." When Kurland asked whether AMD's stock price would rise after the spin-off, Chiesi said she'd try to get the "lay of the land" from Moffat, talk to Ruiz, and then "triangulate" with Moffat. Kurland directed her to buy several hundred thousand shares of stock. "Don't put anything in e-mail," Kurland told her. "Be careful." New Castle bought 199,400 shares.
Kurland pushed her to get better and more specific information about the deal and its timing. On Aug. 22, Moffat told Chiesi, "The Arabs are gonna pay $2.1 billion...for a 50% stake in Fabco." As Moffat talked, Chiesi allowed Kurland to eavesdrop on the conversation.
Kurland wasn't the only person to whom Chiesi was giving information. She was also feeding the information she gleaned from Moffat and Ruiz to her friend Raj Rajaratnam.
Rajaratnam then was one of the 300 richest men in the world, with a net worth of around $1.8 billion. The Sri Lankan native's hedge fund, Galleon, was worth around $7 billion at its peak. His sources of business information included highly placed individuals at McKinsey & Co. and Intel Corp. According to the government, Rajaratnam paid at least one of his sources for his help and traded information with others. Chiesi, who had met him at an analysts' conference, appeared to fall into the second category. Rajaratnam's Sutton Place apartment was only blocks from hers. At one point he talked about helping her break loose from New Castle and putting up some money to set up her own hedge fund. The fund was to be called Hapsburg Capital, after her grandfather's New York restaurant, but the deal was never done.
All summer long, the government alleges, Chiesi fed Rajaratnam information she'd gleaned from Moffat. Rajaratnam and Chiesi talked about the importance of keeping the information confidential. "If this leaks, I think I'm out of business," Chiesi told him. "Because...who knows IBM? And who's in bed with AMD?"
By the end of September, New Castle had upped its stake in AMD to 2.3 million shares. Galleon owned more than 8 million shares.
What they didn't realize was that the government was listening to their telephone conversations. The feds had been investigating Rajaratnam since 2007. The probe had started with information supplied by a confidential informant and then led to a tap on the Galleon head's phone. By the summer of 2008 wiretaps expanded to include other associates of Rajaratnam's, including Chiesi. In addition to recording her conversation with Moffat about the AMD deal, the government soon was gathering evidence suggesting that Moffat was telling Chiesi about confidential results at IBM and about takeover talks between IBM and Sun.
The government wiretaps show Chiesi to be a formidable digger. At times Moffat seemed almost to give up confidential information by accident after she caught him off-guard. Chiesi befriended his secretary and even gave her a gift. One day in September 2008, the assistant told Chiesi that her boss was at a meeting with Lenovo. When Moffat emerged from the meeting, the secretary connected him with Chiesi. He was cranky and tired, and when she asked him how the meeting went, he blurted out that Lenovo's results would be poor. They're going to crap the bed, he said, according to a person familiar the probe.
Talking with Steve Fortuna, a hedge fund adviser in Westwood, Mass., Chiesi noted Moffat had recently purchased a new Audi R8, a $100,000 sports car. IBM must be doing well if he went out and spent all that money on a car, she told Fortuna, the person familiar with the wiretaps says. It isn't clear whether anyone traded on this particular bit of information, although Fortuna did plead guilty to charges of conspiracy and securities fraud in connection with the Galleon investigation.
All told, according to the government, Galleon and New Castle made $20.8 million from insider information provided by Chiesi and other sources. But even with the help of Moffat's insider information, New Castle and Galleon didn't always make money. They lost money on AMD, for example -- partly because of the financial crisis of 2008, and partly because they misjudged Wall Street's reaction to the deal.
The fallout: An industry's golden boy loses his good name
In late 2009 the government had amassed a rich trove of evidence. In the predawn hours of October 16, FBI agents on two coasts made the move to arrest the first confederates of the Galleon ring.
Amor Moffat was still in her pajamas when she heard the doorbell's insistent ring. Trailed by her two black dogs, she walked downstairs, where she was surprised to see metal badges pressed up against a stairwell window. Five federal agents stood on the porch. "Open the door," one of the agents said. "We're here to arrest Robert Moffat."
She recoiled but opened the door as instructed and then retreated to the kitchen with the agents in tow. "He's long gone," Amor said. The agents looked at each other quizzically and started peppering her with questions. Did her husband normally go to work this early?
Two agents emerged from the Moffats' bedroom. One asked if anyone else was there. Amor looked at them incredulously. "Look, I am standing here in my pajamas, my dogs have already managed to get their hair all over your uniforms," she told them. "What you see is what you get." She picked up the phone and dialed her husband.
After turning himself in to the FBI, Moffat was transported by agents to Manhattan, where he was fingerprinted, photographed, and given a urinalysis. U.S. marshals ushered him to a holding cell with Kurland and Rajaratnam -- both of whom Moffat had met through Chiesi. They'd been arrested that morning too. Also in the cell was a twentysomething African American. Moffat asked him how he'd landed in jail. "Gun possession," said the young man. "Maybe we should swap," Moffat joked. "No, you don't want to do that," the man said. "This is my third offense."
At 7 p.m., Moffat was released on $2 million bail. He hugged his kid brother Stephen, who had once believed he was Superman. "Did you do this?" Stephen asked. "No," Moffat replied, looking his brother in the eye.
No one said much during the ride out of Manhattan. Moffat was too ashamed. In the Bloomingdale's parking lot next to the FBI office in White Plains, Moffat picked up his Lexus and drove home with Amor. "I'm so sorry," Moffat said. She listened quietly and then told him that she would give him time to mourn the loss of his career and reputation.
"I won't stand by and let you be destroyed by this," she said firmly. He decided that weekend to resign from IBM.
For months Moffat lived in a sort of legal limbo. He'd been criminally charged but not indicted. He told friends that he was innocent and intended to fight the charges. To gain a conviction, the government didn't need to prove that Moffat had profited financially, only that he had obtained a benefit of some kind. The bad news for Moffat: The affections of a comely woman qualified.
After agonizing for months, Moffat agreed to plead guilty to one count of conspiracy and one count of securities fraud involving insider information he had passed to Chiesi. A court fight, he and his wife decided, would be too risky.
On a rainy March morning in New York, Moffat, accompanied by his lawyer, Kerry Lawrence, raised his right hand and swore to tell the truth. Then, voice trembling, he admitted guilt. "I disclosed this information to Ms. Chiesi intentionally, and I knew that what I was doing was wrong," he said in his allocution, describing Chiesi as a "friend." Moffat was allowed to remain free on bail that day. Prosecutors are expected to recommend that he spend six months in prison, the minimum in the sentencing guidelines.
Mark Kurland was the first of the Galleon defendants to be sentenced. He admitted his crimes but attempted to minimize their significance, saying he was only a "minor" player in the ring. Kurland argued he was significantly less culpable than Moffat, the tipper, and should receive a similarly light sentence. He also threw his former star employee and lover under the bus. Chiesi, he declared, actively solicited inside information. His lawyer wrote in a brief, "Chiesi is responsible for involving him in the unlawful inside-trading conspiracy."
In handing down a sentence, the judge sternly rebuked Kurland for trying to evade responsibility: "In this court's view of matters now of common knowledge, to some extent this country's financial meltdown was fueled precisely by the attitudes manifest by Mr. Kurland in this proceeding." Kurland, he added, abused his power and surrendered "to the spree of the financial market's virtual mob mentality that nearly brought down this nation's economy in the quest for bigger and faster gains." He sentenced the former hedge fund chief to 27 months in prison and ordered him to pay the government $900,000.
Some of Chiesi's other friends have also paid a price, including friends who have not been implicated in wrongdoing. Among them was John Joyce, IBM's former CFO, who introduced Chiesi and Moffat. He resigned this spring from private equity firm Silver Lake Partners amid questions from Fortune about his friendship with Chiesi. Joyce, who remains a director of Hewlett-Packard (HPQ, Fortune 500), declined to comment.
Hector Ruiz, the former CEO of AMD, is under investigation by federal authorities in connection with his dealings with Chiesi, according to a person familiar with his legal situation. He also declined to comment.
Chiesi has tough choices ahead. She can stand and fight and risk the possibility of decades in jail, or she can try to work out a deal with the government. So far she has indicated that she plans to fight. One possible defense would be that she had been a pawn of Kurland. "She is a victim of a man who was supposed to be her mentor," says William Bischoff, a former fiancé. "I think Mark was a psychologically abusive person who took advantage of her and pushed her to the limit. She's a fundamentally good person." In the meantime she is trying to look ahead. Following in her grandfather's footsteps, she has enrolled in the French Culinary Institute. Alan Kaufman, a lawyer for Chiesi, declined to comment on her legal situation, saying he would make her defense in court.
As for Moffat, he has struggled to adapt to his new life outside IBM as a convicted felon. The toll on the family has been hardest on his wife, Amor. She believes the stress since his arrest has caused her MS to flare after decades of dormancy. On some days her eyesight is so blurry that she can't drive to the grocery store, and her legs are so weak that she can't make multiple trips up and down the stairs.
In an interview with Fortune, Moffat came across as emotional, repentant, and chastened. He wept describing the embarrassment he'd brought upon IBM, his colleagues, and family. While he showed little self-pity, he rebuffed the notion that he hadn't paid a price for his crimes, noting that by leaving IBM he was giving up an estimated $65 million in lost stock options and pension that he would have collected when he retired at 60. "The biggest thing I've lost," he said, "is my reputation." Moffat was not allowed by his lawyer to discuss his case or his relationship with Chiesi, but when told that Fortune intended to write about the affair, he said this: "Everyone wants to make this about sex. Danielle had an extensive network of business people. And she added clarity about what was going on in the business world...I know in my heart what this relationship was about: clarity in the business environment." He may even believe that.
Moffat often thinks back to some jail-cell advice he got from the young felon. "Remember," the young man said, "what is important in your life is your family."
The words were meant to comfort. But they also chilled. When his son asked him whether all the long hours at IBM had been worth it, Moffat couldn't answer.
Please do not name you child Dundee and travel to england
the brits do not appear to like anything named dundee
Meat from cloned cow offspring in UK food chain
By SYLVIA HUI, Associated Press Writer Sylvia Hui, Associated Press Writer – Tue Aug 3, 5:56 pm ET
LONDON – Meat from the offspring of a cloned cow in the United States entered the British food chain without official authorization, the UK's Food Standards Agency said Tuesday.
The agency carried out its investigation after media reports said milk from a cow produced from a cloned parent was sold in Britain. Products from cloned animals and their offspring are considered "novel foods" in Britain and cannot be marketed unless authorized by the FSA, a government department.
The agency said it identified two bulls born in the U.K. from embryos harvested from a cloned cow in the U.S.
One of the bulls, known as Dundee Paratrooper, was slaughtered in July 2009, and its meat entered the food chain and "will have been eaten," the agency said.
The other bull, called Dundee Perfect, was slaughtered on July 27, but officials stopped its meat from entering the food chain, the FSA said. The meat is still held in refrigerators at a British farm and did not reach consumers.
A third cow — also an offspring of the same cloned U.S. cow — is believed to be part of a dairy herd. The agency said it was still investigating whether milk from the cow, known as Dundee Paradise, was sold.
A New York Times report last week quoted an unidentified British dairy farmer as saying he was using milk from a cow bred from a clone as part of his daily production, triggering a media frenzy and the FSA probe.
British consumers are wary of tainted beef and dairy products because of a mad cow disease epidemic in the 1990s. The FSA was careful to stress this week that products from cloned animals and their offspring pose no known food safety concerns. But the agency said it is investigating the cloned milk and meat because the products did not get proper authorization.
Farmers in Britain can legally buy embryos from cloned animals overseas, but they need to apply for authorization at a European level before they can sell food products from clones.
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Very informative information about China impending problem
I think we should open up our plan to allow the poor rural chinese to be protected under our system. Maybe we can open up our medicaid system to serice them. We are looking to focus our resources on the global economy.
It was a weak deal. Even with the low royalty rate the stock is priced so cheaply that the annual royalty is more than the market cap
You know everything. What are their funding needs? Servier is paying for the approval in Europe and the drug's develpment in Japan.
usually you don't file for the summary judgement until the judge issues the claims construction. do you know why they did it this way?
Osteologix and Servier Announce ex-US Licensing Agreement
It certainly isn't sexy, but this is an excellent deal. Servier is doing over 300 million revenues selling Proteos in Europe. The patent runs out in 2015. Oesteologix's drug can be approved in early 2012, in Europe. Because the roylaty is low Servier would have no reason not to start selling strontium malonate as early as possible. Then all of a sudden Oesteologix can get about a 15 million dollar euro royalty a year. So you have a company with a 15 million dollar market cap that will be able to achieve royalties similar to their market cap starting within a couple of years. This values the Japanese license at zero.
Press Release Source: Osteologix, Inc. On Monday August 2, 2010, 8:45 am EDT
GLEN ALLEN, Va. & NEUILLY, France--(BUSINESS WIRE)--Osteologix, Inc. (OTCBB: OLGX - News) through its wholly owned Irish subsidiary Osteologix Limited and the Servier Research Group, the leading French independent pharmaceutical company, today announced that Osteologix has granted Servier an exclusive royalty bearing license to develop and commercialize NB S101 (strontium malonate) to treat post menopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the U.S. NB S101 is an innovative molecule acting on both bone formation and bone resorption.
Under the terms of the agreement, Osteologix will receive up to €12 million in upfront and milestone payments.
Additionally, Osteologix is eligible to receive up to €30 million in minimum royalty payments creditable against mid to low single digit royalties on sales. Osteologix will also be eligible to receive milestone payments and royalties on product development and sales in Japan. The agreement is subject to customary termination provisions.
Servier will be responsible for all costs outside of the U.S. associated with development, regulatory approval and commercialization of NB S101. Osteologix will continue to own intellectual property rights for development in the U.S.
Philip J. Young, Osteologix' President and Chief Executive Officer commented, “I am very happy that we have been able to reach agreement on this important collaboration. This endorsement from one of the top Pharmaceutical Companies worldwide is appropriate recognition for NB S101 and its value in treating osteoporosis. Servier is consistently recognized as a benchmark for excellence in the pharmaceutical industry, having received multiple industry accolades for its attention to patients’ and doctors’ needs, and successful clinical development of 'first in class' innovations. We fully expect this history of excellence to continue, as they prepare for the commercial launch of NB S101.”
Emmanuel Canet, M.D., Ph.D., Head of Servier Research and Development, stated, “We are very pleased with this collaboration which will allow us to further develop our franchise in osteoporosis and other bone & joint diseases that affect millions of patients worldwide with much suffering and disability. Osteoporosis in particular is a serious public health problem that requires effective and well tolerated treatments in order to significantly decrease the risk of vertebral and hip fractures.”
About osteoporosis
The World Health Organization defines osteoporosis as a progressive skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.
About NB S101
NB S101 is a novel dual acting bone agent, or DABA, the active component of which significantly improves bone mineral density and reduces fracture risk. NB S101 has demonstrated significant beneficial effects in a Phase 2 clinical trial by reducing bone resorption and increasing strong bone formation. This dual action on bone – a significant medical need not served by current therapies in the U.S. – suggests that NB S101 could fundamentally change the treatment paradigm of patients with osteoporosis. Importantly, NB S101 appears to help build bone in a manner similar to the body’s own metabolic processes by rebalancing bone metabolism in a way that favors strong bone formation. Key patents for NB S101 have been issued in the United States, Europe and Japan, providing protection to at least 2024.
About Servier
Servier is the leading independent pharmaceutical company in France and the second in the world. The Servier Research Group is established in 140 countries with its main therapeutic products used to treat diabetes, cardiovascular disease, CNS disorders, oncology and rheumatology. More than 25% of Servier's turnover is invested in Research & Development (R&D). Servier has 20,000 employees worldwide, including nearly 3,000 in R&D. For further information please see the website at www.servier.com.
About Osteologix
Osteologix is a specialty pharmaceutical company committed to developing innovative therapies for the treatment and prevention of diseases of bone and joint tissues. Its lead product candidate, NB S101, is a novel pharmaceutical agent for the treatment and prevention of osteoporosis. In November 2007, Osteologix completed a Phase 2 clinical trial of NB S101 that demonstrated the ability of NB S101 to reduce markers of bone resorption and increase bone mineral density. For more information please visit www.osteologix.com.
Safe Harbor Statement:
Statements in this press release are not strictly historical, including statements about potential payments and royalties from Servier and their impact on Osteologix’s finances, the potential uses and benefits or NB S101, Servier’s potential commercial launch of NB S101, and patent protection of NB S101 are forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or assumed in such forward-looking statements, including, without limitation, Osteologix’s obligations to Aditech Pharma AB, risks related to Servier’s ability to conduct additional clinical trials of NB S101, Servier’s ability to obtain approval from government authorities for the sale and distribution of NB S101, Servier’s compliance with terms of our agreement, market acceptance of NB S101 and potential success and introduction of competing products. Additional factors that could cause actual results to differ materially are included under the heading “Risk Factors” in Part II, Item 1A of our Quarterly Report on Form 10-Q filed May 17, 2010. All forward-looking statements and risk factors included in this document are made as of the date hereof, based on information available to us as of the date hereof, and we assume no obligation to update any forward-looking statement or risk factor. You should consult the risk factors listed in our Annual Report on Form 10-K and from time to time in our Quarterly Reports on Form 10-Q.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6379928&lang=en
MULTIMEDIA AVAILABLE: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6379928
Contact:
For Osteologix:Media and InvestorsBaxter Phillips, III+1.804.754.6970baxter.phillips@osteologix.comorFor Servier:Servier Communication Department+33 1 55 72 40 82karine.bousseau@fr.netgrs.com
Out of the Markman hearings what positives may we look for besides a summary judgement in favor of MNTA? If it goes to trial, will they detail it where we can determine an underdog/overdog?
I believe there is a misconception that the judge would issue a summary judgement. The judge rules on the claims. Based on those rulings the company can request filing a request for summary judgement that the judge can rule on once it is received by the court.
The CC had about as much excitement as a late September ballgame between the Baltimore Orioles and the Kansas City Royals.
The excitement of the call doesn't matter. All that matters is if pirfenidone gets approved in the EU.
if it gets approved it is a forty dollar stock if disapproved it is 4 dollars or less.
this is something like the mnta profile pre approval.
if they would have been told by the fda that they needed to run clinical trials it would have been a 4 dollar stock
Alnara Pharmaceuticals flourishes from Altus demise
By Julie M. Donnelly
Video Gallery
http://www.masshightech.com/stories/2010/03/01/daily48-Alnara-Pharmaceuticals-flourishes-from-Altus-demise-.html
Alnara Pharmaceuticals Inc. stands ready to send its drug target to treat cystic fibrosis to the U.S. Food and Drug Administration, a mere 16 months after the company raised its first venture capital round of $20 million.
The pharma couldn’t have done it without the demise of another local biotechnology company, Waltham-based Altus Pharmaceuticals Inc. Alnara executives, scientists and intellectual property all have roots at the failed company.
At least five Massachusetts biotechs — Dynogen Pharmaceuticals Inc., Epix Pharmaceuticals, Oscient Pharmaceuticals, Biopure Corp. and Altus — have more or less ceased operations since the stock market meltdown in September 2008.
But the fall of 2008 turned out to be a great time to launch Alnara.
“The investors didn’t flinch. Putting money into a preclinical company on Oct. 3 took guts,” CEO Alexey Margolin said.
Margolin left his job as chief scientific officer at Altus in 2007 and said there was no indication at the time that Altus would go under. Margolin said he had been with the company since 1993 and was looking for a change.
But Altus then suffered a number of blows. Investors were puzzled when in December 2007 California-based biotech giant Genentech Inc. ended a partnership with Altus — worth a potential $280 million — to develop a human growth hormone.
In October 2008, investors reacted unfavorably to the results of the first Phase 3 trial for the company’s CF drug target, then called Trizytek. This followed closely on the heels of the stock market meltdown that crushed the company’s market value and made it difficult to raise capital.
Altus went into a tailspin, laying off 107 workers in January 2009. Soon after, the company decided to abandon its CF drug candidate, then in a second Phase 3 trial, to focus efforts on the human growth hormone target.
Trizytek landed in the lap of the Cystic Fibrosis Foundation, with which Altus shared a partnership since 2001. It quickly found its way to Alnara, at very beneficial terms, Alnara officials said. Already, $200 million had been invested in the compound’s development.
“We never thought we would work on this drug program again, but the CF Foundation felt that our 10-person company was best positioned to move it forward quickly,” Chief Business Officer Bob Gallotto said.
Alnara quickly changed gears, convincing investors it could become a commercial-stage company. It promptly raised a $35 million venture capital round led by Boston and San Francisco-based MPM Capital. Cambridge-based Third Rock Ventures, Frazier Healthcare, with offices in Seattle and Menlo Park, Calif., and Bessemer Venture Partners, with global offices, also participated.
Alnara picked up 35 to 40 of Altus’ former scientists and got to work on completing the second Phase 3 trial.
Gallotto, who was recruited by Margolin from Altus in October 2008, said Altus’ financial troubles were not the reason for his departure. But, he said, Alnara has learned some lessons from Altus. One is that you have to run lean.
“You have to make sure that the organization is structured around the life cycle of the product. After we file with the FDA, all those scientists don’t need to stay, we have to be flexible,” Gallotto said. So the former Altus workers were hired on a contract basis, and now the company will turn to building the commercial structure of the company.
The company hopes the CF drug target, now known as liprotamase, will be approved six to 10 months after the application is submitted to the FDA in the coming days.
“Absolutely, luck plays a role. But we deserve this luck. I started this program 10 years ago with a government grant of $100,000. I was happy because I thought that’s all I would need,” Margolin said.
But there was no shortage of losers when Altus finally declared bankruptcy in November, including Margolin himself. Margolin owned 135,204 shares of Altus stock when the company went under, regulatory filings show.
Among the company’s other major investors included U.S. Venture Partners, SV Life Sciences, Warburg Pincus LLC, and Nomura Europe.
worst management for the shareholders but the new owners are made up of prior management
What was bad for the stockholders was good for the management.
Maybe the management wasn't as dumb as they look. They made out like bandits
this is a better analysis then any response I could make to your questions
From Alex To -- ROG.VX: Avastin Setbacks (Notice the Plural on Setbacks)
• The FDA oncology advisory panel voted just now to remove the breast cancer
indication from the Avastin label. Avastin was initially approved for the first-line
treatment of metastatic breast cancer in 2008 through an accelerated review based on an
initial trial demonstrating a large benefit in progression free survival. The panel
decided that the 2 confirmatory trials completed since the accelerated approval did not
confirm the magnitude of the PFS benefit seen in the initial trial. Further, none of the
trials demonstrated a survival benefit.
• Current sales of Avastin are about $6 billion. The US sales of Avastin attributable
to breast cancer are about $800 million to $1 billion. About $500 million of the breast
cancer sales are "on-label" for first-line usage, while the rest is off-label
for second-line and beyond. Now, it is likely the $500 million is going away. We think
the off-label use will dwindle as well, as payers will be unlikely to want to pay and
doctors will be afraid of liability.
• The other casualty is the potential for Avastin label expansion in ovarian cancer.
As in breast cancer, a pair of recently completed Avastin ovarian cancer trials showed
only PFS benefit. The overall survival endpoint was not reached. Previously, Roche had
indicated it was planning on filing for the ovarian indication based on PFS data. Now,
considering the panel discussion of the Avastin breast cancer experience, the chance of
Roche getting through in ovarian based on PFS alone is slim to none. Ovarian cancer could
have fetched $1 billion in US Avastin sales for Roche.
• We know it is unkind for us to mention this, but we couldn't resist. Avastin is
perhaps the #1 reason for Roche buying Genentech last year. Yet, the colorectal adjuvant
trial that was to dramatically expand Avastin sales failed within weeks of the deal
closing. Then, Avastin label expansion trials failed, one after another. The approval for
GBM in May was a positive. Now, Avastin sales face a decline with the removal of the
breast cancer indication. The future for an expansion in ovarian cancer is in doubt. So,
supposing Genentech were still freely trading today, where would the stock have been? $50
instead of the $95 Roche paid last spring? Much of the recent decline in Roche's stock
could be explained by this discrepancy.
• However, as we previously mentioned, the next main catalyst for Roche is the data
flow of dalcetrapib. The possibility of a mega-blockbuster looming on the horizon should
allow Roche's stock to make a bottom. Until, of course, there isn't a mega-blockbuster.
We haven't seen enough data on dalcetrapib to make a bet one way or the other yet.
Alex To, MD
Roche's Avastin Should Lose Breast Cancer Approval 12-1
when the panel members called me for my advice on the subject I just pointed them to my earlier post.
Mature survival data showed a HR of 1.103 (95% CI 0.84, 1.45) favoring the placebo arm over the 7.5mg/kg bevacizumab arm. The HR for overall survival was 1.003 (95% CI 0.76, 1.32) for the 15 mg/kg bevacizumab arm compared to the placebo arm
I say approval in this indication should be withdrawn. Society shouldn't have to pay more money for a drug, in this indication, where the person doesn't live longer and has to be sent to the hospital to be treated for severe side effect of the drug.
Mature survival data showed a HR of 1.103 (95% CI 0.84, 1.45) favoring the placebo arm over the 7.5mg/kg bevacizumab arm. The HR for overall survival was 1.003 (95% CI 0.76, 1.32) for the 15 mg/kg bevacizumab arm compared to the placebo arm
I say approval in this indication should be withdrawn. Society shouldn't have to pay more money for a drug, in this indication, where the person doesn't live longer and has to be sent to the hospital to be treated for severe side effect of the drug.
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for
OMAPROTM
• Company will submit new NDA in CML patients who have failed multiple TKIs
• Investor Teleconference to be held today - Wednesday 14th July 10.30am AEST /
Tuesday 13th July 5.30pm PDT
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (14 July 2010) –
ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today it has agreed with the
U.S. Food and Drug Administration (FDA) a potential regulatory path to progress OMAPRO™
(omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia
(CML).
The recent Type A Meeting, which included discussion of a regulatory path forward,
addressed outstanding issues regarding the previously received Complete Response letter
dated 8 April 2010.
Based on the discussion with the FDA, ChemGenex intends to combine data from its two
pivotal studies, Study 202 and Study 203, and submit a New Drug Application (NDA) for
OMAPRO for those patients with CML who have failed prior treatment with two or more
currently approved tyrosine kinase inhibitors (TKIs). The proposed indication of this new NDA
will be for the treatment of CML patients who have failed two or more TKIs, regardless of
their mutation status.
“The FDA’s agreement that a combined data set could serve as the basis of an NDA in a
third-line setting provides us with a pathway to an expanded indication for OMAPRO to treat
CML patients who are resistant to at least two TKIs,” said Adam Craig, MD, Chief Medical
Officer of ChemGenex.
“We also appreciate FDA’s invitation to discuss this approach further in a pre-NDA meeting,"
he added. “We welcome the opportunity granted by the agency to submit combined data
from our two completed pivotal studies and to potentially provide a new therapeutic choice for
this significant group of patients who currently have very limited treatment options.”
Greg Collier Ph.D., Managing Director and Chief Executive Officer of ChemGenex added:
“We are pleased with the outcome of this Type A meeting as it provides another option for
advancing the development timeline for OMAPRO. By pursuing this new indication for multi
TKI-resistant patients, OMAPRO can potentially treat a significantly larger patient population
in the United States, and we plan to submit our new NDA to the FDA by the end of the year.”
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
Page 2 of 4
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100
Email: chemgenex@chemgenex.com ABN 79 000 248 304
ChemGenex is continuing its discussions with the FDA’s Center for Devices and Radiological
Health towards approval of a diagnostic test for the T315I mutation, and the existing NDA for
T315I positive CML patients who have failed imatinib remains open.
The Company also has a Marketing Authorisation Application under review with the
European Medicines Agency for CML patients who have failed imatinib and have the T315I
mutation. This review is on track, with a potential approval in Europe in the first quarter of
2011.
The updated corporate overview for ChemGenex is available on the company’s website.
Investor teleconference
ChemGenex will host an investor teleconference today: Wednesday 14th July 10.30am
Australian Eastern Standard Time / Tuesday 13th July 5.30pm Pacific Daylight Time
To join the call please dial the access number below for your location. A participant pin
number is not required.
Dial-In numbers: 1800 131 617 Australia Free Call
866 746 2596 USA/Canada Free Call
+61 7 3107 0222 International / Metered Number
0800 446 958 New Zealand Free Call
800 120 4406 Singapore Free Call
800 962 283 Hong Kong Free Call
001 803 011 4106 Indonesia Free Call
0044 22 132 558 Japan Free Call
0800 376 8339 UK Free Call
0800 330 2094 Germany Free Call
0805 111 476 France Free Call
0800 001 230 Switzerland Free Call
A recording of the call will be made available on the ChemGenex website.
About OMAPRO™ (omacetaxine mepesuccinate)
Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent
in a range of hematological malignancies. Omacetaxine has a novel mechanism of action,
specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived
oncoproteins that are up-regulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-
Myc).
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs.
It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine has
been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA)
and European Medicines Agency (EMA) as well as Fast Track status by the FDA.
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
Page 3 of 4
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100
Email: chemgenex@chemgenex.com ABN 79 000 248 304
About Chronic Myeloid Leukemia (CML)
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence
of greater than 100,000 patients. The bone marrow is responsible for the production of
specialized cells that constitute blood; these cells include red blood cells (to carry oxygen
around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the
body’s defense system against infection). In patients with CML the cell production system is
diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate)
into functional blood cells.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small
molecules with new mechanisms of action to treat malignancies with significant unmet
medical needs. A New Drug Application is under review by the U.S. Food and Drug
Administration and a Marketing Authorisation Application is under review by the European
Medicines Agency for CML patients who have failed imatinib therapy and have the Bcr-Abl
T315I mutation. ChemGenex has established a corporate alliance with Hospira to develop
and commercialize omacetaxine in Europe, the Middle East and parts of Africa, and is
seeking to establish commercial partnerships in the rest of the world. ChemGenex plans to
commercialize omacetaxine itself in North America. ChemGenex trades on the Australian
Stock Exchange under the symbol "CXS" For additional information on ChemGenex
Pharmaceuticals, please visit the company’s website at http://www.chemgenex.com.
OMAPRO™ is a trademark of ChemGenex Pharmaceuticals Limited.
ChemGenex Contacts:
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Aust): +61 419 897501
Cell (USA): +1 650 200 8145
Email:
gcollier@chemgenex.com
Kyahn Williamson
Buchan Consulting
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Email:
kwilliamson@bcg.com.au
Remy Bernarda
Blueprint Life Science Group
Tel: +1.415.375.3340 x 2022
Cell: +1.415.203.6386
Email:
rbernarda@bplifescience.com
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
Page 4 of 4
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100
Email: chemgenex@chemgenex.com ABN 79 000 248 304
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a hyperlink has
been provided) that use the words “estimate”, “project”, “intend”, “expect”, “believe” and
similar expressions are intended to identify forward-looking statements within the meaning of
the US Private Securities Litigation Reform Act of 1995. These forward-looking statements
involve known and unknown risks and uncertainties which could cause the actual results,
performance or achievements of the company to be materially different from those which
may be expressed or implied by such statements, including, among others, risks or
uncertainties associated with the development of the company’s technology, the ability to
successfully market products in the clinical pipeline, the ability to advance promising
therapeutics through clinical trials, the ability to establish our fully integrated technologies, the
ability to enter into additional collaborations and strategic alliances and expand current
collaborations and obtain milestone payments, the suitability of internally discovered genes
for drug development, the ability of the company to meet its financial requirements, the ability
of the company to protect its proprietary technology, potential limitations on the company’s
technology, the market for the company’s products, government regulation in Australia and
the United States, changes in tax and other laws, changes in competition and the loss of key
personnel. These statements are based on our management’s current expectations and are
subject to a number of uncertainties that could change the results described in the forwardlooking
statements. Investors should be aware that there are no assurances that results will
not differ from those projected.
dew,
if the quote below was said by Berger than he is intimating that it was a pretty good chance that they were going to be able ti file based on the second interim. these are pretty strong words.
Based on the current status of enrollment and disease progression events in the Phase 3 SUCCEED trial of ridaforolimus, as well as the statistical power and design of the trial, the Company believes that there is a reasonable possibility that the available clinical data at the time of the second interim analysis of efficacy by the independent Data Safety Monitoring Board would be sufficient to demonstrate a statistically significant difference in the primary endpoint of the trial, progression-free survival, when comparing the ridaforolimus and placebo treated patients
If the patent was lisenced in 1992 there can't be much time left on it.
What have they been doing with the patent for the last 18 years, pickling it.
The future of healthcare in america..
according to Obama's new czar
UK's NICE rejects Roche's Avastin in breast cancer