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IDM's ace in the hole- is the ten year monopoly granted by the EMEA for Mepact. Whatever business entity (IDM or a buyer/partner of the company) which markets Mepact has an artificial restriction upon the extension of its use. Any monopoly power is clearly capital (revenues) to its individual owner. The degree (exclusive) and duration (ten years) is an intangible any business owner would covet because of its predictability.
Scientific research and its technical application are carried on at a cost and with the expectation of a return in some form. The uncertainty here, as tzm has posted, is what the pricing structure will be for Mepact, as well as the costs to produce the product.
At least cancer patients will have access to Mepact to help fight their battles. With Palo Alto on watch, I believe the value of IDM's ten year monopoly on Mepact will be recognized and rewarded by the market. Let us not forget what certainties we DO have with IDM, which is the artificial restriction by the EMEA upon Mepacts use. As of 5/8/09 IDM is at about $1.70, and I believe the market is not properly valuing this monopoly. Time will tell. JMHO
Brightpoint will be bigger than you think. (from lbcamera on Yahoo mb)
The deal they have with T-Mobile is all inclusive
from what I understand. This will finally I
believe make Sncr less dependent on AT&T.
Brightpoint has a very good customer base and by them implementing Sncr within their mix, Sncr
will surely benefit.
OEM's Dell etc.. will be imbedding the Sncr
platform within their devices if I understand this correctly the end user will have to use
the imbedded platform for any services they want to use. Why would anyone want to take 2 or 3 addtional steps to add a service?
Very smart business in my mind anyway.
Sprint more automation than manual this is also a very good scenerio. Adds more to the bottom line going forward.
Sprint's most recent Quarter just reported and although they have lost paid contract subscriber growth their pre paid business more or less made up for that loss.
Reading into the transcripts on Gross Margins
will be slim very short term. R&D expense for
this coming Quarter will increase taking away from the EPS because of situations that are happening faster then they had anticipated and need to spend the money I would imagine on the software side.
This is a very young company and yes it started out with a bang Iphone related and did very well. The success story started there.
If AT&T & Aaple hadn't gotton greedy and decided to eliminate Sncr from the 3G roll out
I believe we would have a different stock price right now.
After getting screwed by AT&T I guess management woke up and lloked at all the different directions they could go in.
The have diversified into different areas and going forward I believe this story gets much better with time.
LB
Synchronoss Technologies, Inc. Announces 1st Q 2009 Financial Results @$13.31
First quarter revenue was $29.6 million and non-GAAP diluted EPS was $0.11
ConvergenceNow® Plus+ continues to gain traction as two major Smartphone manufacturers enter agreements with Synchronoss
Relationships outside of AT&T increased to 37% of total revenue
On Wednesday May 6, 2009, 4:01 pm EDT
Related: Synchronoss Technologies, Inc.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Synchronoss Technologies, Inc. (NASDAQ: SNCR - News), the leading global provider of on-demand transaction management software platforms today announced its financial results for the first quarter 2009.
Stephen G. Waldis, President and Chief Executive Officer of Synchronoss, said, “We were pleased with the company’s performance in the first quarter. The significant amount of activity on-boarding new programs and customers onto our platform enabled Synchronoss to deliver solid first quarter results that were consistent with our expectations.”
Waldis added, “We are excited with the growing traction of our ConvergenceNow® Plus+ solution, which is designed specifically to support embedded communication devices such as smartphones, mobile internet devices, laptops and wirelessly enabled consumer electronics such as digital cameras and global positioning systems. Two of the world’s leading smartphone handset providers have agreed to use ConvergenceNow® Plus+, and we believe Synchronoss is uniquely positioned to capture the large and growing emerging device market opportunity.”
For the first quarter of 2009, Synchronoss reported net revenue of $29.6 million, an increase compared to $29.1 million in the first quarter of 2008. Gross profit, including the impact of fair value stock-based compensation expense, was $14.4 million in the first quarter of 2009. Income from operations, in accordance with generally accepted accounting principles ("GAAP"), was $3.3 million, including $1.9 million of fair value stock-based compensation expense. Based on an effective tax rate of 39.4% in the first quarter of 2009, GAAP net income was $2.1 million and GAAP diluted earnings per share was $0.07, compared to $0.13 in the first quarter of 2008.
Non-GAAP gross profit for the first quarter of 2009 was $14.8 million, representing a non-GAAP gross margin of 50%. Non-GAAP income from operations, which excludes fair value stock-based compensation expense, was $5.2 million in the first quarter of 2009, representing a non-GAAP operating margin of 18%. Non-GAAP net income in the first quarter was $3.3 million, leading to non-GAAP diluted earnings per share of $0.11, compared to $0.16 in the first quarter of 2008.
A reconciliation of GAAP to non-GAAP results has been provided in the financial statement tables included in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."
Synchronoss had cash, cash equivalents, and marketable securities of $74.4 million at March 31, 2009, a decrease of $4.4 million compared to the end of the previous quarter. The company’s positive operating profitability in the first quarter was outweighed by $5.6 million in capital expenditures, including the opening of a new global research & development center and data facility in Bethlehem, PA, in addition to quarter-to-quarter fluctuations in working capital accounts.
“We continue to monitor our overall expenses carefully in order to drive profitability in an environment when many of our customers are facing increasing economic pressures in their business," said Lawrence R. Irving, Chief Financial Officer and Treasurer. "We continue to be pleased with the progress of the growth initiatives in which we are continuing to invest. We have begun the on-boarding process for new transactions and channels at AT&T, in addition to early stage efforts related to a growing number of opportunities with our CSP, VoIP and emerging device customers. We believe our efforts will position Synchronoss to enhance its long-term revenue growth and profitability.”
Other First Quarter Business Highlights
Business related to AT&T represented 63% of total revenue in the first quarter, compared to 64% in the previous quarter and 72% in the year ago quarter. Business outside of the AT&T relationship represented approximately 37% of total revenue in the first quarter, compared to 36% in the previous quarter and 28% in the year ago quarter.
Brightpoint entered into an agreement whereby it will act as an Online Master Dealer for T-Mobile USA. Under the terms of the agreement, Brightpoint will enable its approved customers the ability to offer and sell wireless services from T-Mobile via its end-to-end integrated online activation solution. Brightpoint is utilizing Synchronoss’ ConvergenceNow® Plus+ platform as part of this solution to provide online activation of T-Mobile wireless services.
Announced that Synchronoss’ ConvergenceNow® Plus+ platform enables the end-to-end customer management for AT&T’s CruiseCastSM Mobile TV Service. From purchase and activation to account changes, ConvergenceNow® Plus+ consolidates the orchestration and customer-care operations while providing customers with a superior and seamless experience. AT&T CruiseCast service will offer a robust lineup of 42 entertainment channels, 22 satellite TV and 20 radio channels at launch. The AT&T CruiseCast service enables families, commuters and mobile professionals to watch the same type of television experience in the rear seat entertainment systems of their vehicles that they now have in their homes.
DNDN $1.98B; IDMI $45.5M market caps. Hard to figure/believe when you look at key stats of both companies and the fact that IDM has EMEA approval and DNDN has, at this point at least, only smoke and mirrors.
I feel like I am missing something here. Any comments?
You might be right. I have the details of how I got to 28.35M buried somewhere, I will try to find it.
I have 28.35M shares outstanding for IDM.
April, 2007, to be specific. It was just a general observation that the last time DNDN popped, so did IDM. But DNDN really does have any tradable new information on the table yet (Friday's 30%+ pop was on pure speculation, not solid advantageous new information), whereas IDM does! We shall see.
IDMI & DNDN gallery charts. Notice the price correlation in the weekly charts.
http://stockcharts.com/charts/gallery.html?IDMI
http://stockcharts.com/charts/gallery.html?DNDN
good post tzm: <<Therefore, pricing and reimbursement for mifamurtide will have to be negotiated on a Member State by Member State basis according to national rules, as there does not exist a centralized European process.>>
I remember Bassett was saying this was one of the hurdles IDM faces in the EU (IF Mepact was approved!), that this very issue was going to cost IDM time and money to negotiate.
Well, time to buy the Breaking Away soundtrack cd and crank it .
IDM @ $1.81 on 3/31/09, down from $2.51 on Thursday 3/26. Well, at least we know what the catalyst was, putting the FDA reconsideration on hold, Imho. (I knew I should not have posted those resistance levels, actually when we broke $2.21 last Friday I knew we were in trouble).
We are witnessing the greatest financial delveraging since the end of WWII, and in this financial environment I do not think the sale of the company is appropriate, unless the sale price is >$8.50 per share. 28.35M shares outstanding x $8.50= $241M market cap.
Yet the current management is seeking advice to do just that, sell the company. So, my fear that current executive management and the BofD put IDM behind the eight ball, and in an inferior bargaining position seems to have come to pass, unfortunately. Lord knows I hope I am wrong.
I agree with cybear on the Yahoo mb, right now the best thing for IDM S/H's would be that the company partner and/or finance to produce and sell MEPACT itself, in which some posters projected based on x3 revs, IDM's value at about $6.00 a share.
I know this means much more time to realize S/H value, but anything <$8.50 a share in a buyout would be to low, and what about IDM 2101??. Jmho. Glta.
IDMI @ $2.08, last chance to load up. Has approval of MEPACT in EU and under review with FDA. Company worth $6.00+ a share just on projected sales of MEPACT in EU (x3 revs). 28.35M outstanding shares. Palo Alto Investors owns about 40%+ of float. Do your own DD. JMHO. GLTA.
JMHO ignore the Yahoo mb. In fact I will start to worry when all those bashers leave! If the vol today was 2.2M, then I would be worried, but what was it, about 270K? No, there is no way to know who was selling in the last 1/2 hour today. But if I did not know any better, I would venture to guess it was on obvious "take-down," someone could have unloaded their shares in much less dramatic fashion. Like I said, the fact that we could not hold $2.21 is much more important, then again if next week we close above $2.21 and hold it, all of this drama will be forgotten. GLTU
IDMI @ $2.08. Looks like about 88K vol in last 1/2 hour of trading. 3 month avg is 44.1K, so relatively speaking we had twice the 3 month vol in the last 1/2 hour and obviously all sells and no buying.
Late Friday take-down is of no concern. Yet it is interesting that we could not hold last weeks gains and find support @ $2.21, last Fridays closing price.
OT: DNDN. Interesting response to Forbes article on DNDN. http://www1.investorvillage.com/smbd.asp?mb=971&mn=253563&pt=msg&mid=6944434
IDMI @ $2.51, thus we are about equal to a four month high.
Resistance:
$2.54 11/18/08;
$3.29 9/22/08;
$ 3.63 9/2/08;
$ 4.84 6/5/07;
$ 8.94 5/4/07.
glta
IDMI, @ $2.45, among other immunotherapy stocks(CEGE, NWBO, FVRL) soared after FDA gave reccomendation of approval for provenge in March of 2007. 5 days later on april 4 2007 IDMI reached $10.00 and an all-time high of 10.75 at the end of that month.
If DNDN passes the benchmark for statistical significance that basically means ultimate approval within 6 months. This will be a HUGE event and will be covered by news outlets all across the world, some will even report it as possible "cure" for cancer which would add to the frenzy. This will force the FDA to have a paradigm shift in regards to immunotherapy and its going to lead to more investment in biotech stocks. Their will be hundreds of thousands of google searches looking up "Immunotherapy" "what is immunotherapy?".
DNDN reaching SS will open the door for IDMI FDA approval and will bring many new investors driving up the stock price of IDMI, this company is the next in line for FDA approval.
I have read speculation that buy-out could depend on stock price at the time of sale. Is it possible that this thing jumps up to $7-8 dollars after DNDN event and thereby raising the final sale price to maybe $15 or $20? I hope so, I am anxiously awaiting results from DNDN's impact study.
btw I bought this stock because i heard the CEO of this company went to provenge rallies and told some provenge ralliers that he wants to see provenge approved because his company uses the same technology and this would validate Junovan and the field of immunotherapy. I have been long ever since. By knickerbocker on IDMI Yahoo mb.
75K share block buy started the pop up, see bigcharts.com daily chart by the minute. Someone either took a position or added to an existing one.
IDMI @ $2.20 on 3/20/09. Do your own DD. GLTA
Meixatech, Been wondering why <$2.00? Seeing all this M & A activity in medical/biotech and market in general; then watching some of the big banks rebound about 100% in days (BAC, WFC), which are currently backing off a bit; I was wondering when some of that money was going to come our way at IDM? Maybe today: March 20, 2009, the first day of Spring.
http://www.eurekalert.org/pub_releases/2009-03/uotm-ida031009.php
from Victor on Yahoo IDM mb.
SNCR reported Q4 revenue of $31.2 million and non-GAAP profits of 12 cents a share, ahead of the Street at $30.5 million and 10 cents.
I have outstanding shares of IDM @28.35M:
<<5. Bio interest in Cancer and immune therapy -- with pipeline and one approved drug, IDMI is a gem to BIG pharma, and 250Mil (assuming 10PPS), is less costly and risky than starting similar research..>> thus @ $10pps= $283.5M.
The U.S. Govenment "Bailout." Barrons 3/16/09 page 14:
"A number of big banks, including GS and DB, were paid roughly $50B from the U.S. bailout of AIG last fall, the WSJ reported. The news came as lawmakers sought names of firms that received money from AIG."
San Francisco Chronicle 3/4/09 pageC2:
Est. cost of "the government's [U.S. taxpayers] package of bank bailouts, loans and economic stimulus plans" "$3 TRILLION."
(S&L crisis 1986-95: $256B)
Did they get billions without giving anything in exchange?
By definition: a Bailout does not require "anything in exchange."
"Bailout- of pertaining to, or consisting of means for relieving an emergency situation." Random House Dictionary. The "thing in exchange" is the so called relief of "the emergency situation." (In fact "the bailout" is the greatest grab of U.S. Taxpayer money in the history of the U.S.)
The "bailout" was an "Emergency rescue plan," proposed by Fed Chairman Ben Bernanke and then-Treasury Secretary Henry Paulson [originally for $700B, which has become about $3T+ in 2009) in 2008. The governments [U.S. taxpayer] initiative was to pump liquidity into the markets and to encourage consumer and business lending [to John Q. Public]. But this is not what has happened.
Read: "Getting off Track: How Government Actions and Interventions Caused, Prolonged, and Worsened the Financial Crisis" by John B. Taylor, a senior fellow at the Hoover Institution (Conservation Think Tank at Stanford University), who was a Treasury undersecretary in Bush's first administration.
Read: "The Creature from Jekyll Island- A Second Look at the Federal Reserve" by G. Edward Griffin, to learn about the Federal Reserve and its history, a must read to understand this.
Final question: Why does not the U.S. Treasury issue it's own money, (instead of the Federal Reserve, which is actually owned by the banks themselves) and what would the effect of that be on the banks and the public of the U.S.?
OT: The U.S. Govenment "Bailout." Barrons 3/16/09 page 14:
"A number of big banks, including GS and DB, were paid roughly $50B from the U.S. bailout of AIG last fall, the WSJ reported. The news came as lawmakers sought names of firms that received money from AIG."
San Francisco Chronicle 3/4/09 pageC2:
Est. cost of "the government's [U.S. taxpayers] package of bank bailouts, loans and economic stimulus plans" "$3 TRILLION."
(S&L crisis 1986-95: $256B)
Did they get billions without giving anything in exchange?
By definition: a Bailout does not require "anything in exchange."
"Bailout- of pertaining to, or consisting of means for relieving an emergency situation." Random House Dictionary. The "thing in exchange" is the so called relief of "the emergency situation." (In fact "the bailout" is the greatest grab of U.S. Taxpayer money in the history of the U.S.)
The "bailout" was an "Emergency rescue plan," proposed by Fed Chairman Ben Bernanke and then-Treasury Secretary Henry Paulson [originally for $700B, which has become about $3T+ in 2009) in 2008. The governments [U.S. taxpayer] initiative was to pump liquidity into the markets and to encourage consumer and business lending [to John Q. Public]. But this is not what has happened.
Read: "Getting off Track: How Government Actions and Interventions Caused, Prolonged, and Worsened the Financial Crisis" by John B. Taylor, a senior fellow at the Hoover Institution (Conservation Think Tank at Stanford University), who was a Treasury undersecretary in Bush's first administration.
Read: "The Creature from Jekyll Island- A Second Look at the Federal Reserve" by G. Edward Griffin, to learn about the Federal Reserve and its history, a must read to understand this.
Final question: Why does not the U.S. Treasury issue it's own money, (instead of the Federal Reserve, which is actually owned by the banks themselves) and what would the effect of that be on the banks and the public of the U.S.?
P.S. Bernanke is on 60 Minutes tonight, 3/15/09.
New FDA Head? Good for IDM
Obama to tap ex-N.Y. health official for FDA
Lauran Neergaard,Erica Werner, Associated Press
Thursday, March 12, 2009
(03-12) 04:00 PDT Washington - --
President Obama intends to name former New York City Health Commissioner Margaret Hamburg to lead the troubled Food and Drug Administration.
A person close to Hamburg said Wednesday that an announcement was imminent. The person spoke on condition of anonymity because there was no White House confirmation. Spokesmen for the White House and the Health and Human Services Department declined to comment on the nomination.
The two physician-outsiders will be asked to restore credibility to an agency that has suffered a string of failures such as repeated food recalls - including the huge salmonella outbreak in peanut products.
Hamburg is a well-known bioterrorism expert who served as an assistant health secretary during the Clinton administration and helped lay the groundwork for much of the government's bioterrorism preparations and pandemic flu planning.
But she may be best known as the chief health officer of the nation's largest city during the early 1990s, when she designed a program that cut high rates of drug-resistant tuberculosis, supported needle-exchange to cut the spread of the AIDS virus and helped introduce smoking restrictions.
Sharfstein is a pediatrician who has been outspoken in efforts to improve oversight of children's cold and flu medications. Before becoming Baltimore's health chief in 2005, he served as health policy adviser to Rep. Henry Waxman, D-Los Angeles.
Neither is steeped in the drug-approval process that is FDA's best-known function. But public health specialists had been pushing for outsiders who could bring a conflict-free perspective to an agency that struggles to balance the need for new treatments with ensuring that they're as safe as possible.
"What this to me represents is leadership at the Food and Drug Administration that will keep the public health first and foremost in mind," said Dr. Harvey Fineburg, president of the prestigious Institute of Medicine. He called Hamburg "a person committed to the public well-being, and that's the value you really want represented at the FDA."
"You've got an organization that's demoralized and one that wants to enhance its scientific integrity," said Dr. Georges Benjamin of the American Public Health Association. "She's all about integrity and science. ... She can be tough when she needs to be, and she's going to need to be real tough in that job."
Sharfstein declined to comment Wednesday; Hamburg didn't return e-mails seeking comment.
Hamburg will require Senate confirmation; Sharfstein won't.
This article appeared on page A - 8 of the San Francisco Chronicle
From a market cap perspective: IDM 28.35M shares; simple math @$10= $283.35M market cap, plus figure in whatever cash is left at the time of the sale, which at the end of 2008 was listed as $18.38M (source: Yahoo);
@$5= $141.75M. I still believe the sale price of IDM will be between $5 to $10 a share.
Mepact, after approval, is now for real, at least in the EU, and in the pipe is IDM-2101. If these drugs can do one half of what some people have said they believe they will do for cancer patients, IDM should be sold for $1.4175B! or $50 a share. (Alright, so I said it).
I do not think P.A. will take anything less than $5 a share or $141.75M market cap. We are in the mist of the greatest financial deleveraging since the end of WWII, but I do not think P.A. will let some shark "steal" IDM for a song. My guesstimate, $8.50 a share, or $240.98 market cap, plus the $10M or so of cash that is left. JMHO
Nobody's got cash, and if they have cash they don't want to spend it.
IDMI @$1.63: Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma
- First New Agent Approved to Treat Osteosarcoma in More Than 20 Years
Monday March 9, 2009, 11:44 am EDT
IRVINE, California, March 9 /PRNewswire/ -- IDM Pharma, Inc. (Nasdaq: IDMI - News) today announced that the European Commission has formally granted a Centralized marketing authorization for MEPACT® (mifamurtide, L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. The Centralized marketing authorization allows MEPACT to be marketed in the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. MEPACT was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
"Today's approval of MEPACT is a significant milestone for physicians and patients in Europe, giving them access to the first new osteosarcoma treatment option in 20 years," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "As our lead product candidate and first to receive approval, this is also a major milestone for IDM Pharma. We look forward to amending the New Drug Application (NDA) for mifamurtide in the United States and continuing to work toward bringing this important treatment to market in the U.S."
The approval was based on the Phase 3 MEPACT trial (INT-0133), a National Cancer Institute (NCI) funded cooperative group study conducted by the Children's Oncology Group (COG) and the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study evaluated patient outcomes with the addition of MEPACT to three- or four-drug adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide). Results demonstrated that the addition of MEPACT to chemotherapy resulted in approximately a 30 percent decrease in the risk of death with 78 percent of patients surviving after six years of follow-up after treatment with MEPACT.
"MEPACT is the first therapy in more than 20 years to demonstrate any significant long-term survival advantage in osteosarcoma," said Ian Lewis, MD, Professor of Cancer Research at St. James University Hospital in Leeds, England. "The approval of MEPACT is the culmination of two decades of research and dedication to children and young adults with osteosarcoma and brings real hope for a patient population in need of an innovative treatment option for this devastating disease."
"As an investigator who has been involved in the development of MEPACT, I am thrilled that years of hard work and commitment by researchers around the world has resulted in this positive outcome," said Eugenie Kleinerman, MD, professor and head of the Division of Pediatrics and professor of Cancer Biology at The University of Texas M.D. Anderson Cancer Center. "This is a remarkable advance for treatment of young patients with osteosarcoma and should give physicians and their patients hope in treating this rare disease."
The Company continues to evaluate strategic alternatives, which may include seeking strategic partners, a merger and/or the sale of all or part of its operations and assets, or raising additional capital to secure operational sales and marketing infrastructure for MEPACT.
Mifamurtide U.S. Regulatory Status
As previously announced, in the U.S., the Company continues to work with the COG as well as external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of mifamurtide and to respond to other questions in the non-approvable letter the Company received from the U.S. Food and Drug Administration (FDA). The Company plans to submit an amended New Drug Application (NDA) for mifamurtide in mid-2009 and expects to be in a position to provide an update on the progress of the filing, including timing, following a meeting scheduled with the FDA in March.
Mifamurtide was granted orphan drug status in the United States in 2001. The NDA was submitted to FDA in October 2006 and was accepted for review in December 2006.
About Osteosarcoma
Between two and three percent of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly affects children and young adults experiencing their adolescent growth spurt. Boys and girls have a similar incidence rate until later in their adolescence, when boys are more commonly affected. While most tumors occur in larger bones, such as the femur, tibia, and humerus, and in the area of the bone that has the fastest growth rate, they can occur in any bone. The most common symptom is pain, but swelling and limited movement can occur as the tumor grows.
Osteosarcoma is an orphan disease with approximately 1,200 new cases diagnosed in the United States each year. A similar incidence of the disease exists in Europe. According to the Children's Oncology Group (COG), the survival of children with osteosarcoma has remained at 60-65 percent since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemotherapy before and after surgery.
IDMI @$1.63: IDM Receives Approval in Europe for Treatment of Patients with Non-Metastatic, Resectable Osteosarcoma
- First New Agent Approved to Treat Osteosarcoma in More Than 20 Years
Monday March 9, 2009, 11:44 am EDT
IRVINE, California, March 9 /PRNewswire/ -- IDM Pharma, Inc. (Nasdaq: IDMI - News) today announced that the European Commission has formally granted a Centralized marketing authorization for MEPACT® (mifamurtide, L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. The Centralized marketing authorization allows MEPACT to be marketed in the 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. MEPACT was granted orphan medicinal product status in Europe in 2004 and under European pharmaceutical legislation is entitled to a period of 10 years market exclusivity in respect of the approved indication.
"Today's approval of MEPACT is a significant milestone for physicians and patients in Europe, giving them access to the first new osteosarcoma treatment option in 20 years," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "As our lead product candidate and first to receive approval, this is also a major milestone for IDM Pharma. We look forward to amending the New Drug Application (NDA) for mifamurtide in the United States and continuing to work toward bringing this important treatment to market in the U.S."
The approval was based on the Phase 3 MEPACT trial (INT-0133), a National Cancer Institute (NCI) funded cooperative group study conducted by the Children's Oncology Group (COG) and the largest study ever completed in osteosarcoma, enrolling approximately 800 patients. The study evaluated patient outcomes with the addition of MEPACT to three- or four-drug adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate with or without ifosfamide). Results demonstrated that the addition of MEPACT to chemotherapy resulted in approximately a 30 percent decrease in the risk of death with 78 percent of patients surviving after six years of follow-up after treatment with MEPACT.
"MEPACT is the first therapy in more than 20 years to demonstrate any significant long-term survival advantage in osteosarcoma," said Ian Lewis, MD, Professor of Cancer Research at St. James University Hospital in Leeds, England. "The approval of MEPACT is the culmination of two decades of research and dedication to children and young adults with osteosarcoma and brings real hope for a patient population in need of an innovative treatment option for this devastating disease."
"As an investigator who has been involved in the development of MEPACT, I am thrilled that years of hard work and commitment by researchers around the world has resulted in this positive outcome," said Eugenie Kleinerman, MD, professor and head of the Division of Pediatrics and professor of Cancer Biology at The University of Texas M.D. Anderson Cancer Center. "This is a remarkable advance for treatment of young patients with osteosarcoma and should give physicians and their patients hope in treating this rare disease."
The Company continues to evaluate strategic alternatives, which may include seeking strategic partners, a merger and/or the sale of all or part of its operations and assets, or raising additional capital to secure operational sales and marketing infrastructure for MEPACT.
Mifamurtide U.S. Regulatory Status
As previously announced, in the U.S., the Company continues to work with the COG as well as external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of mifamurtide and to respond to other questions in the non-approvable letter the Company received from the U.S. Food and Drug Administration (FDA). The Company plans to submit an amended New Drug Application (NDA) for mifamurtide in mid-2009 and expects to be in a position to provide an update on the progress of the filing, including timing, following a meeting scheduled with the FDA in March.
Mifamurtide was granted orphan drug status in the United States in 2001. The NDA was submitted to FDA in October 2006 and was accepted for review in December 2006.
About Osteosarcoma
Between two and three percent of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly affects children and young adults experiencing their adolescent growth spurt. Boys and girls have a similar incidence rate until later in their adolescence, when boys are more commonly affected. While most tumors occur in larger bones, such as the femur, tibia, and humerus, and in the area of the bone that has the fastest growth rate, they can occur in any bone. The most common symptom is pain, but swelling and limited movement can occur as the tumor grows.
Osteosarcoma is an orphan disease with approximately 1,200 new cases diagnosed in the United States each year. A similar incidence of the disease exists in Europe. According to the Children's Oncology Group (COG), the survival of children with osteosarcoma has remained at 60-65 percent since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemotherapy before and after surgery.
OT. So FDA approves this drug, and we wait. Amazing.
Ruling says patients can sue drugmakers
Bob Egelko, Chronicle Staff Writer
Thursday, March 5, 2009
(03-04) 17:08 PST WASHINGTON -- In a resounding victory for consumers over the pharmaceutical industry, the Supreme Court ruled Wednesday that patients harmed by medication can sue the drugmaker for neglecting to list known dangers on the label even if federal regulators haven't required them to do so.
The 6-3 decision upheld $6.7 million in damages to a musician from Vermont who lost an arm to gangrene after being injected in 2000 with an anti-nausea drug manufactured by Wyeth Pharmaceuticals.
The majority rejected arguments by Wyeth and the Bush administration that the U.S. Food and Drug Administration's approval of the drug's label in 1955 barred all claims of negligence under state laws.
The label warned doctors to use extreme caution in injecting the drug but did not tell them it should never be injected. The court said the company was on notice of the danger - citing at least 20 similar reports of amputations since the 1960s - and could be sued for not adding such a warning on its own.
"Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness," Justice John Paul Stevens said in the majority opinion.
Noting that the federal agency "has limited resources to monitor the 11,000 drugs on the market," Stevens said Congress in more than 70 years of regulating pharmaceuticals has never barred damage suits against drugmakers. Despite FDA oversight, he said, "the manufacturer bears responsibility for the content of its label."
The ruling means patients who believe a more complete warning label could have prevented their illness or injury can take a pharmaceutical company to court, rather than relying on the FDA to protect them.
Dissenting view
Dissenters, led by Justice Samuel Alito, said the ruling interferes with uniform national regulation of pharmaceuticals and allows local juries to second-guess FDA decisions on what warnings are required for consumer protection.
"Juries are ill-equipped to perform the FDA's cost-benefit-balancing functions," said Alito, joined by Justice Antonin Scalia and Chief Justice John Roberts.
Bert Rein, a lawyer for Wyeth, said the company's FDA-approved label provided "clear warnings about the very risks at issue in this case" and should have precluded damages. But the court said a drugmaker can justify omitting a known danger from a label only when the FDA has considered and rejected such a warning.
Pfizer Inc. of New York, which announced in January it had agreed to purchase Wyeth, said it was disappointed with the ruling. "Pfizer believes that, due to its medical and scientific expertise, the U.S. Food and Drug Administration is the best authority to weigh the benefits and risks of prescription medicines and to ensure that those benefits and risks are being appropriately communicated in product labels," the company said in a written statement.
The ruling follows a court decision in December that allowed smokers to sue tobacco companies under state deceptive-advertising laws for the companies' promotion of "light" cigarettes, rejecting similar arguments based on federal regulation of cigarette labeling.
Drug manufacturers, however, were hoping the court would follow a precedent it set a year ago when it threw out a lawsuit in a state court by a patient injured by an FDA-approved catheter. That ruling cited a law shielding federally approved medical devices from state requirements, which the court interpreted to include suits for damages.
Precluding regulation
No such law exists for drugs. But drug companies, joined by President George W. Bush's administration and the FDA officials he appointed, argued that the existence of federal regulation should preclude suits for damages in individual states, based on the same safety concerns that federal regulators are supposed to consider.
The court's rejection of that argument has implications for other federally regulated industries and businesses covered by similar laws. San Francisco attorney Mark Savage, who filed arguments in the case on behalf of the Consumers Union of the United States, said the ruling should also help California and other states that are trying to enforce consumer-protection laws against national banks.
One such case, to be argued before the Supreme Court in April, involves New York's attempt to enforce a state predatory-lending law.
Attorney Allen Untereiner, who filed arguments on behalf of the U.S. Chamber of Commerce, said Wednesday's ruling was perplexing for businesses in light of last year's decision on medical devices. He said the court should have accepted the FDA's conclusion that allowing state suits for damages would result in excessive product warnings and would undermine the agency's regulatory authority.
But the court, which usually defers to a regulatory agency's view of the law, said it would not do so in this case because of the FDA's "dramatic change in position" after approving such lawsuits during earlier administrations.
The court ruled in favor of Diana Levine, a professional guitarist and piano player who went to a Vermont health clinic in August 2000 with a migraine headache and nausea and was given Phenergan, Wyeth's anti-nausea drug. The drug was injected into a vein but migrated into an artery, causing gangrene that required amputation of her right arm.
A Vermont jury awarded $6.7 million in damages to Levine, finding that the manufacturer knew intravenous injection of Phenergan was risky and should have warned doctors against it. The Vermont Supreme Court upheld the verdict, prompting the company's appeal to the nation's high court, which drew an outpouring of briefs from business and consumer advocates.
Levine, 63, said she learned of the ruling from a reporter Wednesday morning and collapsed in tears.
"It feels like a tremendous weight has been lifted off of me," she said in a conference call with reporters. "I feel like I did something worthwhile, which is one good thing that came out of a tragedy."
The case is Wyeth vs. Levine, 06-1249. The ruling is available at links.sfgate.com/ZGHW.
Staff writer Bernadette Tansey contributed to this report. E-mail Bob Egelko at begelko@sfchronicle.com.
This article appeared on page A - 1 of the San Francisco Chronicle
re: "naked" short selling, SEC et. al. www.businessjive.com
re: "naked" short selling, SEC et. al. www.businessjive.com
GST uses the full cost accounting based on the "ceiling test."
Article on different accounting methods:
http://seekingalpha.com/article/118662-what-devon-s-huge-write-down-means-for-natural-gas?source=yahoo
Taking out the stops on 141K vol.
ot. Synta suspends late-stage study on safety concerns. snta @$1.36; -$5.03
Synta Pharmaceuticals suspends late-stage study for potential cancer drug on safety concerns
Thursday February 26, 2009, 6:12 pm EST
LEXINGTON, Mass. (AP) -- Synta Pharmaceuticals Inc. said Thursday it is suspending a late-stage study of its cancer drug candidate elesclomol over safety concerns, including a higher number of deaths in patients taking the drug.
The decision was made based on an analysis by an independent data monitoring committee, the company said, and has also prompted the suspension of other studies using the drug.
The shares plummeted $4.64, or 73 percent, to $1.75 in after-hours trading following the statement. The stock lost 8 cents to close at $6.39 during the regular trading session.
The SymmetrySM study compares the benefit of elesclomol in combination with the cancer treatment paclitaxel versus only using paclitaxel for late-stage metastatic melanoma patients. Melanoma are tumors mainly found in the skin.
The company is also suspending a prostate cancer study that uses the drug candidate.
"Our first concern is for the safety of patients, and therefore we acted promptly to halt the Symmetry trial once it was evident that there were serious safety concerns," said Chief Medical Officer Dr. Eric Jacobson.
The company said it will be in discussions with partner GlaxoSmithKline about the next move for development of elesclomol.
Comment: snta was @$9 a share in January, >$350M market cap.
To compare: idmi @$10 a share would be <$300M market cap.
Synchronoss Technologies Inc. said Thursday its fourth-quarter profit declined sharply as sales dropped due mainly to a loss of revenue from its deal with AT&T Inc. to help support Apple's iPhone.
Related Quotes
Symbol Price Change
SNCR 10.20 -0.92
The company provides transaction management software for communications companies.
Synchronoss earned $2.7 million, or 9 cents per share, down 60 percent from a profit of $6.6 million, or 20 cents per share, in the same period a year earlier. Adjusted earnings were 12 cents per share in the latest quarter.
Revenue fell 14 percent to $31.2 million from $36.4 million.
Analysts, on average, were expecting a profit of 10 cents per share on sales of $30.5 million, according to a poll by Thomson Reuters.
"We were pleased with the company's strong profitability in the fourth quarter, and we will continue to manage the business with tight cost controls," said Lawrence R. Irving, chief financial officer and treasurer, in a statement.
Synchronoss, whose largest customer is AT&T, said it recently signed a new three-year deal with the company. AT&T represented 64 percent of the quarter's revenue.
For the full year, the company earned $11.9 million, or 37 cents per share, down from a profit of $23.8 million, or 71 cents per share, a year earlier.
Revenue dropped to $111 million from $123.5 million.
SNCR @$10.20. 2/19/09 by lbcamera. Several elements are quite different then they were in the past. Some of the text below I am copying from the transcript,and I will post my comments after each entry.
PROS
1. In respect to AT&T the new contract they
have is with AT&T Corporate which encompasses a lot more " products" then
the contract with AT&T mobility.
2. the agreement provides them with greater visibility into their long-term cost structure with volume discounts as they scale through higher levels beyond today’s current volumes and higher and more robust guaranteed service levels as compared to our prior agreement. So the
volumes will be higher.
COMMENT:
How much higher? That they do not tell us.
More volume more transactions. But they state higher than todays volumes. I wonder what the volume numbers were 2 years ago.
3."We have higher guaranteed material minimums that we have not had in our prior agreement. And finally, our related aspect is that we believe our new agreement has natural incentives in place which will allow AT&T to expand Synchronoss platform across new channels throughout the new AT&T."
COMMENT:Higher Miniminums again we don't know how much higher.
4. "Synchronoss is now managing a segment of transactions specific to local number porting for the 3G iPhone on behalf of AT&T independent of that which channel the iPhone is purchased through."
COMMENT: Yes they are now doing the activation for 3G Iphone but only in specific local areas so they are not activating all the 3G Phones. So we don't know how many areas or local porting numbers they are handeling at this point.
It could be 3 or 40.
ConvergenceNow Plus platform is focused on supporting and enabling different types of wireless enabled consumer devices to be activated and supported on multiple networks.
In extends our platform into account and lifecycle management expanding the types of transactions our platform can match such as credit card transactions, inventory management of emerging devices, trouble ticketing on devices and product catalog capabilities for emerging devices to mention a few. All of these are obviously in addition to the core activation related services that we automate for all of our customers.
COMMENT:
ConvergenceNow Plus platform is definitely
a plus (no pun intended) My interpertation of this is that Sncr will take on the responsibility of handeling the entire
product line that AT&T has to offer.
All phones,navagation devices,paid radio
and video services as AT&T has announced
that they are teaming up with RaySat to CruiseCast in vehicle entertainment and the partnership extends through Avis Budget Group. They will be in direct
competition with Sirus who is on the verge of bankrupcy. Certainly opens the door for the Convergence platform to handle many more products other than phone & cable activations. This is where I believe
is the biggest news of all. They have expanded their services way beyond what they were doing 2 years ago!
After the debacle with the failed attempt
when the 3G Iphones came out if anyone remembers it was a nightmare for the activation process. So AT&T in there
not so good wisdom decided at that time to
eliminate Sncr and do it themselves.
I guess they learned a hard lesson by doing
that so now SNCR is back in.
Question from an analysts:
Tom Roderick - Thomas Weisel
Okay, last question from me, maybe you could just provide a little bit of an update from non-traditional transaction types and update on the retailer big box opportunities that you had talked a bit about last year? And then you also mentioned Dell Computer, which seems to be a little bit out of the norm of traditionally what you have done, so can you provide an update in terms of the strategy, getting away from some of the carriers-centric deliveries there?
Steve Waldis
So, it’s a big part of our ConvergenceNow Plus initiative and essentially the, let me start by answering the Dell question, the Dell is to our relationship with Brightpoint and through Brightpoint they use our technology and platform as they go into pick back and shift opportunities for Nokia’s and Dell and which there maybe hot air cards being shifted out with the actual computers.
I think the opportunities that Synchronoss sees going forward and why we’re excited about our first appointment with CruiseCast is there is big push in the industry today to get devices onto the networks that the large carriers that are offering today and I think it is a big growth opportunity as wireless saturation happens here in the U.S. the way for wireless carriers to grow is to offer ways to allow other devices are called the non-traditional devices to be activated in the networks.
Panasonic devices for example, cell phones, cameras, navigation devices and so Synchronoss sees a great opportunity to play in that field and that we can be a great enabler of those devices and titles into the various different networks and that existed both not for just wireless but even for high speed data or IP type services and so that’s the growth area that we believe to our partnerships to Brightpoint as well as directly with consumer OEM manufacturers or devices manufacturers like CruiseCast that will want to contract us to have us managed that subscriber process from start to finish.
COMMENT:
This is all wonderful news and it opens
up many new doors for SNCR. They are not limited to one or two services they can manage. Since they did a great job with the roll out of the first Iphone
Which was the biggest roll out of a phone ever in modern history they have proven
what they can do. This was even more apparent when the 3G was rolled out
eliminating Sncr and was a total failure.
Ok now for the CONS:
1. I believe that the new contract with
AT&T corporate will only tie Sncr into
a more dependent situation that they are in now. Currently AT&T represents 66% of
Sncr's revenue I think this number will
be greater in the quarters going forward.
Not good to have all your eggs in one basket as we all know.
2. With the current state of the economy
and the unemployment level reaching historical levels and the slow down of consumer spending I don't think 2009 will
be a year that the average consumer will
be looking to spend money on what I call
ammenities like the latest and greatest
cell phone,navagation system,laptop etc..
Sncr is not the only company faced with this dilema. If the economy was not in the condition it is currently based on all that I read and heard on the conference call I believe Sncr's stock price would be considerably higher. 2009 will be tough for everyone.Once the economy stablizes
whenever that may be, look for Sncr to make new highs if they stay on track with the plan!
Best to all LB
2/19/09 by lbcamera. Several elements are quite different then they were in the past. Some of the text below I am copying from the transcript,and I will post my comments after each entry.
PROS
1. In respect to AT&T the new contract they
have is with AT&T Corporate which encompasses a lot more " products" then
the contract with AT&T mobility.
2. the agreement provides them with greater visibility into their long-term cost structure with volume discounts as they scale through higher levels beyond today’s current volumes and higher and more robust guaranteed service levels as compared to our prior agreement. So the
volumes will be higher.
COMMENT:
How much higher? That they do not tell us.
More volume more transactions. But they state higher than todays volumes. I wonder what the volume numbers were 2 years ago.
3."We have higher guaranteed material minimums that we have not had in our prior agreement. And finally, our related aspect is that we believe our new agreement has natural incentives in place which will allow AT&T to expand Synchronoss platform across new channels throughout the new AT&T."
COMMENT:Higher Miniminums again we don't know how much higher.
4. "Synchronoss is now managing a segment of transactions specific to local number porting for the 3G iPhone on behalf of AT&T independent of that which channel the iPhone is purchased through."
COMMENT: Yes they are now doing the activation for 3G Iphone but only in specific local areas so they are not activating all the 3G Phones. So we don't know how many areas or local porting numbers they are handeling at this point.
It could be 3 or 40.
ConvergenceNow Plus platform is focused on supporting and enabling different types of wireless enabled consumer devices to be activated and supported on multiple networks.
In extends our platform into account and lifecycle management expanding the types of transactions our platform can match such as credit card transactions, inventory management of emerging devices, trouble ticketing on devices and product catalog capabilities for emerging devices to mention a few. All of these are obviously in addition to the core activation related services that we automate for all of our customers.
COMMENT:
ConvergenceNow Plus platform is definitely
a plus (no pun intended) My interpertation of this is that Sncr will take on the responsibility of handeling the entire
product line that AT&T has to offer.
All phones,navagation devices,paid radio
and video services as AT&T has announced
that they are teaming up with RaySat to CruiseCast in vehicle entertainment and the partnership extends through Avis Budget Group. They will be in direct
competition with Sirus who is on the verge of bankrupcy. Certainly opens the door for the Convergence platform to handle many more products other than phone & cable activations. This is where I believe
is the biggest news of all. They have expanded their services way beyond what they were doing 2 years ago!
After the debacle with the failed attempt
when the 3G Iphones came out if anyone remembers it was a nightmare for the activation process. So AT&T in there
not so good wisdom decided at that time to
eliminate Sncr and do it themselves.
I guess they learned a hard lesson by doing
that so now SNCR is back in.
Question from an analysts:
Tom Roderick - Thomas Weisel
Okay, last question from me, maybe you could just provide a little bit of an update from non-traditional transaction types and update on the retailer big box opportunities that you had talked a bit about last year? And then you also mentioned Dell Computer, which seems to be a little bit out of the norm of traditionally what you have done, so can you provide an update in terms of the strategy, getting away from some of the carriers-centric deliveries there?
Steve Waldis
So, it’s a big part of our ConvergenceNow Plus initiative and essentially the, let me start by answering the Dell question, the Dell is to our relationship with Brightpoint and through Brightpoint they use our technology and platform as they go into pick back and shift opportunities for Nokia’s and Dell and which there maybe hot air cards being shifted out with the actual computers.
I think the opportunities that Synchronoss sees going forward and why we’re excited about our first appointment with CruiseCast is there is big push in the industry today to get devices onto the networks that the large carriers that are offering today and I think it is a big growth opportunity as wireless saturation happens here in the U.S. the way for wireless carriers to grow is to offer ways to allow other devices are called the non-traditional devices to be activated in the networks.
Panasonic devices for example, cell phones, cameras, navigation devices and so Synchronoss sees a great opportunity to play in that field and that we can be a great enabler of those devices and titles into the various different networks and that existed both not for just wireless but even for high speed data or IP type services and so that’s the growth area that we believe to our partnerships to Brightpoint as well as directly with consumer OEM manufacturers or devices manufacturers like CruiseCast that will want to contract us to have us managed that subscriber process from start to finish.
COMMENT:
This is all wonderful news and it opens
up many new doors for SNCR. They are not limited to one or two services they can manage. Since they did a great job with the roll out of the first Iphone
Which was the biggest roll out of a phone ever in modern history they have proven
what they can do. This was even more apparent when the 3G was rolled out
eliminating Sncr and was a total failure.
Ok now for the CONS:
1. I believe that the new contract with
AT&T corporate will only tie Sncr into
a more dependent situation that they are in now. Currently AT&T represents 66% of
Sncr's revenue I think this number will
be greater in the quarters going forward.
Not good to have all your eggs in one basket as we all know.
2. With the current state of the economy
and the unemployment level reaching historical levels and the slow down of consumer spending I don't think 2009 will
be a year that the average consumer will
be looking to spend money on what I call
ammenities like the latest and greatest
cell phone,navagation system,laptop etc..
Sncr is not the only company faced with this dilema. If the economy was not in the condition it is currently based on all that I read and heard on the conference call I believe Sncr's stock price would be considerably higher. 2009 will be tough for everyone.Once the economy stablizes
whenever that may be, look for Sncr to make new highs if they stay on track with the plan!
Best to all LB
2/19/09: Today the D-J Industrial Average closed below it November 20 bear market low, the Dow confirmed the prior breakdown of the Transportation Average. The two Averages jointly closed at new lows today, thereby signaling that the great bear market is alive.
OT. Palo Alto is shaking the tree at SNG, requesting special meeting of S/H's to replace SNG's BofD. Just mentioned this to show P.A. is probably happy with the status of IDMI and management handling of current situation. JMHO