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GTCB...
Dew,
Any reason why Pharming and GTCB wouldn't merge? I understand that GTCB may want an amount that Pharming wouldn't or doesn't want to pay, however, one would think a bigger company (Pharming + GTCB) would be able to have cheaper capital funding costs, as well as, some good synergies in the corporate offices (eliminate some of the duplicate costs). I guess I'm on the side of being as efficient as possible and why not put two companies together that would make each other stronger. Not hoping or thinking such a thing will happen. Thank you for all of your posts.
10nis
The warrants really equally buying shares at $1.41 + .12 = $1.53 since the warrants were purchased for $.12 a piece. I don't see why purchasing GTCB tomorrow at $1.24 is such a bad thing especially as smart money just purchased $17.5 million at $1.38.
10nis
Dew,
Have you spoken to management regarding the latest cash infusion? Just wondering what they told you. Is Pharming a bigger company than GTC? I cannot find the market cap of Pharming. Thanks again for all of your hard work and posting.
10nis
GTCB....
Could they need cash related to an upcoming Merrimack announcement?
10nis
GTCB...
Dew,
How bad will this hurt the long-term valuation? Any reason for getting cash now vs. later? I'm sure you'll be talking to management about their decision to raise cash so hopefully, you'll be able to report there was some good reasons. I assume the market won't see the offering at market prices as too negative however, dilution always hurts.
TIA,
10nis
GTCB....
It would be interesting to know how many total shares of the company (GTC) are owned/controlled by members who post on this board.
IDIX
Dew,
What kind of probability are you putting on Sebivo (Telbivudine) for HBV being approved by the FDA? EU? I bought some IDIX at $9 but sold most of it when it hit $11 last week. I plan on getting buying back-in but I'm wondering what kind of probability you're placing on approval.
Thanks,
10nis
Some tricks to get around the new Yahoo viewing that I've obtained from the message boards...
Go to MESSAGE BOARD SETTINGS. Go to VIEW SETTINGS, then set TOPIC for simple, and set AS for Message List. The message will be chronological order.
Or use this link: http://finance.yahoo.com/q/mb?s=ebay
You'll get to see the old message board although the messages pop up in the new format. You can change the symbol as you like, I just used ebay for an example.
If anyone else knows of any tricks to viewing the old message board let me know.
TIA,
10nis
GTCB....
Did anything new come out of this presentation? I haven't had time to listen to the presentation.
TIA,
10nis
GTC Biotherapeutics to Webcast Corporate Presentation at the C.E. Unterberg, Towbin Emerging Growth Conference
Thursday July 6, 11:53 am ET
FRAMINGHAM, Mass.--(BUSINESS WIRE)--July 6, 2006--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that Geoffrey Cox, Ph.D., GTC's Chairman and CEO, is scheduled to present on Wednesday, July 12, 2006 at 9:28 a.m. Eastern Time during the C.E. Unterberg, Towbin Emerging Growth Conference. The conference is being held at the Mandarin Oriental Hotel, New York, New York from July 11-12, 2006.
Big Pharma valuations / Market leadership....
Dew/Board,
Anyone think PFE and the rest of the dirt cheap big pharma will take leadership of the markets in the near future (over the next 3-6 months)? Nice dividend yields and relatively steady cash flows (with some patent expiration problems and a few lawsuits) should weather any major inflation storm. I'm trying to figure out if it makes sense to skew the portfolio to more healthcare related issues. Any opinions would be greatly appreciated.
10nis
GTCB....
Looks like the market is giving everyone yet another chance to buy some cheap shares -- currently down 6% to 1.40.
10nis
GTCB...
Dew,
What day does your wife think GTCB will get EU approval?
TIA,
10nis
GENR... HUGE NEWS!! Up 17% on patent news. Congrats to all the GENR holders (only down 70% from 52 week high)
Press Release Source: Genaera Corporation
Genaera Receives Patent for Gene Variants of Interleukin-9 Receptor
Friday June 23, 8:30 am ET
http://biz.yahoo.com/prnews/060623/phf008.html?.v=56
PLYMOUTH MEETING, Pa., June 23 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced issuance by the United States Patent and Trademark Office of patent number 7,056,698 entitled "Nucleic Acids Encoding Interleukin-9 Receptor Variants." The patent relates to the diagnosis, treatment and methods for discovery of new therapeutics for atopic asthma and related disorders based on variants of Interleukin-9 (IL-9) receptor. Patent expiry occurs in November 2018.
ADVERTISEMENT
"The protection provided by this patent further strengthens our intellectual property position around the naturally occurring variants of the IL-9 receptor," said Jack Armstrong, President and Chief Executive Officer. "This receptor is central to the development of diagnostic methods, research tools, and most importantly, new therapies for atopic asthma, allergy and other IL-9 related diseases. We are delighted to have secured additional value for our research efforts in allergy and respiratory diseases."
About IL-9
IL-9 has been associated with symptoms of asthma including mucous production, lung infiltration of inflammatory cells, and IgE (an immune globulin associated with allergic disease) production. It is one of at least 29 naturally occurring interleukins in the human body. Under the April 2001 collaboration and license agreement between Genaera and MedImmune, Inc., U.S. Patent Number 7,056,698 is exclusively licensed to MedImmune for the development of an IL-9 product for the treatment or prevention of asthma and other diseases and/or disorders. Genaera retains the rights to diagnostics and vaccines.
MLMN...
Was the lack of disclosure of the bid allowed because it was an "unsolicited offer/bid"?
TIA,
10nis
MLNM...
Isn't the company required to disclose the offer to its shareholders under RegFD or whatever as it seems to be a material event? Anyone know the rules on this? I should know however, I've slacked off on my GAAP/SEC readings.
TIA,
10nis
GTCB...
Now its at $1.33.. Now $1.31 (down 11% on higher than normal volume). Pretty amazing. I think if Pharming was really smart they would offer $2.50-$3.00 for it today.
Dew are you hearing anything on your end? I'm tempted to buy more.
GTCB...
I'm amazed how quickly I can buy shares at the bid. I just picked up another 5k shares. FWIW...
10nis
Apology accepted. My recommendation for you is to put the computer away and get some rest.
Take care,
10nis
BSR_David,
I'm probably putting myself where I don't belong, but oh well. Mr. BSR_David - why do you sound so defensive? Dew was only making a statement that was completely factual and correct. Why can't you accept the fact that you aren't perfect?
InvestorsHub is here to discuss and debate investment ideas, analysis, etc. Some of us are experts, some of us are not. Nobody should be acting like they have the expertise to answer every question correctly.
So, BSR_David... accept the fact that Dew was right and that he knows more about statistics than you ever could. So, keep using the biostatistcians to run the numbers and let Dew answer the stats questions here. That way everyone can end up making good factual decisions.
Thanks,
10nis
ELOS....
Does anyone have any opinions of Syneron Medical, Ltd (ELOS)? Its been hit pretty hard but seems to be trading at a decent value net of its cash.
TIA,
10nis
GTCB..
I second that (no problems w/electronic trading). I wonder who's selling out of their positions? Just daytraders taking their losses from Friday? GTCB looks like a screaming buy at current levels. May we all have prosperous returns....
10nis
NVS - Strikes again... I wonder if biotech is undervalued when a 109% premium is offered?
UPDATE 2-Novartis buys "superbug" firm NeuTec for $569 mln
Wed Jun 7, 2006 2:00am ET
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060607:MTFH04410_2....
By Thomas Atkins and Ben Hirschler
ZURICH/LONDON, June 7 (Reuters) - Novartis AG (NOVN.VX: Quote, Profile, Research) boosted its infectious diseases portfolio on Wednesday by agreeing to buy British "superbug" specialist NeuTec Pharma Plc (NTP.L: Quote, Profile, Research) for $569 million.
Novartis said it was offering 10.50 pounds per NeuTec share and sought to acquire a 100 percent of the company, valuing the business at 305 million pounds.
The NeuTec board of directors has already recommended the takeover and shareholders with 39 percent in the firm support the deal, Novartis added.
"We believe this is a good and full offer after having completed due diligence," said Novartis spokesman John Gilardi.
NeuTec shares surged more than 80 percent on Tuesday after the company said it was in takeover discussions and a person familiar with the situation told Reuters that the approach had come from a large pharmaceutical company.
The Novartis offer represents a premium of 109 percent to the share price before Tuesday's news.
NeuTec specialises in developing medicines against hard-to-treat hospital-acquired infections, or "superbugs".
It is a relative rarity among biotechnology companies in having a number of late-stage experimental drugs that have not yet been partnered with a large drugmaker.
The bid is part of a two-year-old drive by Novartis to strengthen its portfolio of treatments for infectious diseases, focusing on hepatitis and life-threatening infections.
NeuTec's most advanced product, Mycograb, is currently awaiting European approval for the treatment of invasive candidiasis -- a life-threatening form of thrush. It is also investigating using the medicine as a breast cancer treatment.
A second medicine, Aurograb, is in final Phase III tests for treating methicillin-resistant staphylococcus aureus (MRSA).
On Tuesday, Novartis unveiled a separate, $507 million deal to boost its antiviral-drug pipeline by buying rights to the hepatitis C drug Albuferon from U.S. biotech company Human Genome Sciences (HGSI.O: Quote, Profile, Research).
The deals -- which follow one in March worth $525 million with U.S. biotech company Idenix Pharmaceuticals for another experimental hepatitis C treatment -- underscore Novartis's reputation as an aggressive acquirer of medicines developed by other companies.
Major drugmakers are increasingly turning to licensed products to fill out their in-house portfolios. Albuferon is a long-acting form of interferon alpha created by HGS.
Why not reload (buy-back in)? GTCB is still cheaper today then it was before it announced rejection back in February are whenever. It seems like a steal after today's news, but that's just my stupid opinion (JMSO).
10nis
Dew, are you taking any new investor money? IDIX is up another 6% today trading at 9.85. I could use some consistent returns like this...
Thank you for all of your hard work and I hope you have a great weekend spending some of your new found wealth!!
OT...
Per CNBC, Hank Paulson (Goldman Sachs CEO) taking over for Treasury Secretary John Snow.
VRTX... Is this new information?
http://biz.yahoo.com/prnews/060521/nesu001.html?.v=8
Press Release Source: Vertex Pharmaceuticals Incorporated
Researchers Report Results for 28-day Phase II Study of VX-950 in Combination with Pegylated Interferon and Ribavirin in Hepatitis C Patients
Sunday May 21, 2:30 pm ET
- 12 of 12 (100%) patients HCV RNA undetectable with no evidence of viral breakthrough at end of 28 days VX-950 dosing -
- 92% (11 of 12) continued to have undetectable HCV RNA through 12 weeks of follow-on therapy -
LOS ANGELES, May 21 /PRNewswire-FirstCall/ -- Data to be presented this week at the Digestive Disease Week conference show that plasma HCV RNA was reduced to undetectable levels (less than 10 IU/mL) in all 12 of 12 (100%) patients with genotype 1 HCV infection treated with VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor being developed by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News), in combination with pegylated interferon alfa-2a (Pegasys®; peg-IFN) and ribavirin (RBV) for 28 days. No viral breakthrough was observed in any patient during 28 days of VX-950 dosing. All patients completed dosing with no serious adverse events; those adverse events reported are considered typical of peg-IFN and RBV combination therapy. All patients enrolled in the 28-day study subsequently received follow-on treatment with peg-IFN and RBV. Researchers reported for the first time today that 11 of these patients (92%) continue to have no detectable virus in their blood at the end of 12 additional weeks of follow-on peg-IFN+RBV dosing. The 12th patient was found to have detectable HCV RNA (less than 30 IU/mL) in the week 12 post-VX-950 follow-up sample, with continuing evidence of detectable HCV RNA in subsequent samples. All 12 patients are continuing to receive peg-IFN+RBV.
"With the combination of VX-950, pegylated interferon and ribavirin, we observed unprecedented antiviral activity, with all 12 genotype 1 patients reaching viral levels below the limits of detection at the end of dosing at 28 days," said Eric Lawitz, M.D., of Alamo Medical Research in San Antonio, the investigator presenting the study results. "In addition, no serious adverse events were reported, and those adverse events that were reported are similar to those observed in previous studies of pegylated interferon and ribavirin. These results are highly encouraging for the initiation of future VX-950 studies that seek to evaluate the potential for viral eradication with short duration therapy."
In addition, researchers reported the results of a viral sequencing analysis from patients in the 28-day study. These results showed that despite the detection of treatment-emergent viral variants in two patients early in the course of VX-950 dosing, combination treatment with VX-950 resulted in a continuous decline in HCV RNA to undetectable levels through the initial 28- day dosing period, and HCV RNA has remained undetectable in these patients through 12 weeks of follow-on therapy.
Study Design
The 28-day, Phase II clinical study enrolled 12 treatment-naive patients with genotype 1 HCV. Patients received VX-950 in a tablet formulation at a dose of 750 mg every eight hours (q8h) for 28 days in combination with standard doses of pegylated interferon alfa-2a (Pegasys®; peg-IFN) and ribavirin (Copegus®; RBV). At the end of 28 days, patients completed dosing with VX-950 and per study protocol were required to continue off-study treatment with peg-IFN and RBV. This 28-day, Phase II study was not designed to evaluate sustained viral responses (SVR) in patients receiving VX-950.
Antiviral Results at 28 days
At study entry, the median baseline plasma HCV RNA was 6.5 log10 (3.2 million) IU/mL. At the end of week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of quantitation (30 IU/mL; Roche Taqman® assay) in six of the 12 patients; and undetectable (less than 10 IU/mL; Roche Taqman® assay) in two of 12 patients. Preliminary HCV RNA results in patients for weeks 2-4 are as follows:
* At the end of week 2, plasma HCV RNA was below the limit of quantitation
(30 IU/mL) in 11 of the 12 patients; and undetectable (less than 10
IU/mL) in three of 12 patients.
* At the end of week 3, plasma HCV RNA was below the limit of quantitation
(30 IU/mL) in 12 of the 12 patients; and undetectable (less than 10
IU/mL) in nine of 12 patients.
* At the end of VX-950 dosing (end of week 4; day 28), plasma HCV RNA was
undetectable (less than 10 IU/mL) in all 12 patients.
* No patients showed evidence of viral breakthrough while receiving VX-950
treatment.
Follow-on Therapy
All 12 patients received follow-on treatment with peg-IFN+RBV therapy after completing 28 days of combination therapy with VX-950, peg-IFN and RBV. At week 12 of follow-on therapy, 11 patients had HCV RNA below the limit of detection (10 IU/mL). The patient with detectable viral levels at week 12 of follow-on dosing did not have undetectable HCV RNA (less than 10 IU/mL) until the 4th week of VX-950 dosing. While this patient's HCV RNA was again detectable (less than 30 IU/mL) two weeks after stopping VX-950 dosing, it was undetectable for the next 8 weeks, becoming detectable again after 12 weeks of follow-on peg-IFN+RBV dosing. At week 16 of follow-up, HCV RNA in this patient was 490 IU/mL. Blood samples from this patient are being collected for viral sequencing and this patient continues to receive peg-IFN+RBV treatment.
Safety
A complete safety review has been conducted. All patients completed dosing and no serious adverse events were reported. The most common adverse events observed in the study were flu-like illness, fatigue, headache, nausea, anemia, depression, itching and rash. All of these adverse events were mild to moderate in severity, except for one headache that was graded as severe. All of these adverse events were considered to be typical of peg-IFN and RBV combination therapy.
On-Treatment Viral Sequencing Analysis
Extensive viral sequencing analyses of the HCV protease catalytic domain were planned as part of the study, using blood samples collected at baseline (before VX-950 dosing) and during the 28-day dosing period. Baseline sequences obtained in all 12 subjects showed only wild-type RNA. Once dosing was initiated, sequences could be obtained in all 12 patients at the 24-hour time point, but only in two patients at the end of the first week of dosing (14 on- treatment samples total). In all other patients, and at all other time points, dosing with VX-950 in combination with peg-IFN and RBV suppressed plasma HCV RNA to levels below the limit of detection of the sequencing assays.
Using a highly sensitive clonal sequencing approach, 12 of the 14 samples contained 100% wild-type virus. In two samples, one collected from a patient at 24 hours of dosing and one in another patient at the end of the first week of dosing, viral variants consisting predominantly of a V36M amino acid sequence change were detected, with one sample also showing a low proportion of an A156T amino acid sequence change. In both these patients with detectable viral variants, HCV RNA was rapidly suppressed during continued dosing with VX-950, and both patients became HCV RNA undetectable by the end of the third week of dosing. HCV RNA remained undetectable in both of these patients after 12 weeks of follow-on treatment with peg-IFN and RBV. The results suggest that viral variants may exist at a low level in patients before VX-950 dosing is initiated, and that they are uncovered by the rapid reduction of the wild-type virus. However, in this study these variants were rapidly suppressed to below detectable levels with VX-950, peg-IFN and RBV combination therapy.
AMGN, DNA...
Anyone think the correction in biotech is almost over? IMO, AMGN and DNA look like a buy at current levels. Anyone else agree?
TIA,
10nis
IMCL...
David Faber (CNBC) just reported that IMCL has 3-4 bidders. He said that a winner could be announced at the end of June. Does anyone know anything about the bidders or what one would pay for IMCL?
TIA,
10nis
IDIX
http://biz.yahoo.com/prnews/060429/nesa002.html?.v=1
Press Release Source: Idenix Pharmaceuticals, Inc.
Favorable Antiviral Activity and Improved Tolerability Demonstrated by Valopicitabine 200 mg/day in Combination with Pegylated Interferon in an Ongoing Phase IIb Trial in Treatment-Naive Genotype 1 Patients
Saturday April 29, 11:30 am ET
-Data at 12 and 16 weeks show comparable activity to 800 mg/day dose-
VIENNA, Austria and CAMBRIDGE, Mass., April 29 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News) announced today that the 200 mg/day dose level of the investigational agent, valopicitabine (NM283), combined with pegylated interferon demonstrated comparable antiviral activity to the results obtained in the 800 mg/day-containing arms in a preliminary analysis of an ongoing phase IIb clinical trial in treatment-naive genotype 1 patients at 12 weeks of treatment. To date in this clinical trial the 200 mg/day dose has demonstrated improved tolerability compared to the 800 mg/day dose. These data are being presented in a late-breaker session on Saturday, April 29 at 5:15 p.m. Central European Time (CET) at the annual meeting of the European Association for the Study of the Liver.
"The antiviral activity and safety data observed in the 200 mg/day dose arm is encouraging," said Douglas Dieterich, M.D., Professor of Medicine at the Mt. Sinai School of Medicine, New York and an investigator in the study. "More than 70 percent of patients receiving this regimen achieved viral clearance at week 12 utilizing the Amplicor® assay's lower limit of quantification of 600 copies/mL, which is substantially higher than we generally see in clinical practice in HCV genotype 1 patients."
"We believe these data indicate that valopicitabine may provide significant viral suppression and may be well tolerated at the 200 mg/day dose," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix Pharmaceuticals, Inc. "We are planning a robust program to advance the development of valopicitabine and believe, if successfully developed and approved, it may become an important component of future HCV combination therapy to improve treatment for patients."
In the 200 mg/day arm (arm B*; n=31), 87 percent of patients achieved an early virologic response (EVR), defined as greater than or equal to 2 log10 (100-fold) reduction in virus after 12 weeks of treatment, compared to 88 percent in the pooled 800 mg/day arms (arms C, D and E*; n=92). At 12 and 16 weeks, 71 percent and 73 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 600 copies/mL compared to 73 percent and 74 percent in the pooled 800 mg/day arms. After 12 and 16 weeks, 45 percent and 62 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 20 copies/mL, compared to 56 percent and 61 percent in the pooled 800 mg/day arms. Mean reductions of HCV RNA of 3.93 log10 after 12 weeks of treatment were achieved among patients in the 200 mg/day dose group compared to 4.26 log10 in the pooled 800 mg/day dosing groups. Partial 16-week data indicated above includes 26 patients in the 200 mg/day arm and 74 patients in the pooled 800 mg/day arms.
Through 12 weeks of treatment, in the ongoing phase IIb clinical trial, discontinuations in the 200 mg/day arm occurred at a rate significantly less than the higher dosing regimens, at six percent and 22 percent, respectively. Through week 12, a total of 24 patients discontinued for adverse events (AEs), with two occurring in the 200 mg/day arm. To date, three serious adverse events (SAEs) were considered attributable to valopicitabine in the phase IIb clinical trial. These were dehydration with renal insufficiency and pancreatitis; hyponatremia/hypokalemia; and dehydration with acute gastroenteritis. Two of these SAEs occurred at doses of 800 mg/day and one occurred at a dose of 200 mg/day.
*Phase IIb Study Design
The 12-week analysis from this ongoing 48-week phase IIb clinical trial in treatment-naive patients included data from the following five randomized treatment arms, all involving dosing regimens of valopicitabine, administered once-daily, in combination with pegylated interferon alfa-2a (Pegasys®) 180 µg per week: (A) pegylated interferon beginning on Day 8 plus valopicitabine ramping from 400 mg to 800 mg beginning at Day 29; (B) valopicitabine 200 mg beginning on Day 1 plus pegylated interferon beginning on Day 8; © valopicitabine ramping from 400 mg to 800 mg beginning on Day 1 plus pegylated interferon beginning on Day 8; (D) valopicitabine 800 mg beginning on Day 1 plus pegylated interferon beginning on Day 8; and (E) valopicitabine 800 mg plus pegylated interferon, both beginning on Day 1.
In March 2006, the protocol for this ongoing phase IIb 48-week clinical trial in treatment-naive patients was amended after gastrointestinal side effects related primarily to the higher dose arms (800 mg/day) of valopicitabine were observed. The amendment required that patients in the 800 mg/day dose arms who had virus levels below 600 IU/mL, be randomized to continue study treatment with either valopicitabine 200 mg/day plus pegylated interferon or valopicitabine 400 mg/day plus pegylated interferon. Twelve percent of the treatment-naive patients did not meet the criteria and were discontinued from the trial. Patients originally receiving the 200 mg/day dose have continued on that treatment regimen. The 12-week data discussed herein includes data prior to protocol modifications.
More About Valopicitabine
Valopicitabine is an investigational agent being evaluated in ongoing clinical trials for the treatment of hepatitis C. Based on preclinical evidence, it is believed that valopicitabine may block hepatitis C virus (HCV) replication by specifically inhibiting the HCV RNA polymerase. In initial clinical trials, valopicitabine, administered orally once a day, was shown to reduce HCV viremia in patients infected with the genotype 1 strain of HCV. The ongoing phase IIb clinical trials are evaluating the combination of valopicitabine and pegylated interferon in hepatitis C patients who previously failed to respond to antiviral treatment, as well as in patients who have not yet been treated for hepatitis C. Valopicitabine has dose-related gastrointestinal (GI) side effects, more common at higher dosing levels (e.g., 800 mg/day), which are typically mild-to-moderate, are transient in most patients, and are less common at lower dosing levels (200 mg/day and 400 mg/day). Moderate or severe intensity to the gastrointestinal side effects have been observed in some patients, particularly at higher dosing levels, which may result in treatment discontinuation.
About Hepatitis C
Hepatitis C is an infectious liver disease caused by the hepatitis C virus.(1) Chronic HCV infection inflames the liver, causing progressive liver damage that can lead to cirrhosis (liver scarring), hepatocellular carcinoma (liver cancer), liver failure and death.(1) Hepatitis C is a severe and progressive disease, with 70 percent to 85 percent of patients infected with HCV developing chronic infection,(2) and of whom 10 percent to 20 percent develop cirrhosis.(1) Worldwide, the World Health Organization estimates that 170 million individuals carry chronic HCV infection, with 3 to 4 million new infections each year.(1)
HCV infection is the most common chronic blood-borne infection in the United States.(3) The Centers for Disease Control and Prevention estimates that 4 million Americans have been infected with HCV, and 2.7 million of these carry chronic HCV infections.(2) Hepatitis C related liver failure is the most common indication for liver transplantation in the United States.(2) As the prevalence of severe liver disease attributable to hepatitis C rises, deaths due to complications from hepatitis C infection, currently 8,000 to 10,000 per year in the United States, are increasing and are expected to triple by 2010.(4)
Idenix/Novartis Collaboration
Idenix is developing its hepatitis B and hepatitis C product candidates, telbivudine, valtorcitabine and valopicitabine, in collaboration with Novartis Pharma AG. The collaboration arrangement provides that Novartis and Idenix will co-promote in the United States, France, Germany, Italy, Spain and the United Kingdom those product candidates that are approved for marketing, which Novartis has licensed. Novartis holds the exclusive license to these product candidates in the rest of the world.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statement
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as "is encouraging", "believe", "may", "planning", or similar expressions or by express or implied discussions regarding the ongoing and planned clinical trial development of valopicitabine, regarding potential future marketing approvals for valopicitabine or potential future sales of valopicitabine. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that valopicitabine will successfully complete phase IIb clinical evaluation in both or either patient population in which it is currently being evaluated or that valopicitabine will proceed to phase III clinical trials in any patient population. Neither can there be any guarantees that valopicitabine will be approved by regulatory authorities in any markets, or that the company will earn any revenues from valopicitabine. In particular, management's expectations may be affected by the results of clinical trials, including additional data relating to the ongoing phase IIb clinical trial evaluating valopicitabine; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; competition in general; government, industry and general public pricing pressures; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for valopicitabine. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" in the company's annual report on Form 10-K for the year ended December 31, 2005 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Pegasys® and Amplicor® are registered trademarks of Hoffmann-La Roche, Inc.
(1) World Health Organization. Hepatitis C Fact Sheet accessed online at
http://www.who.int/mediacentre/factsheets/fs164/en/print.html
(2) Center for Disease Control. Hepatitis C Fact Sheet accessed online at
http://www.cdc.gov/ncidod/diseases/hepatitis/c/fact.htm
(3) Center For Disease Control National Prevention Strategy
(4) Davis, G. et al., Projecting Future Complications of Chronic Hepatitis
C in the United States. Liver Transplantation, April 2003
Idenix Pharmaceuticals' Contacts:
Media: Teri Dahlman 617-995-9905 or cell: 857-234-8816
(Please call cell number from 04/29/06-04/30/06)
Investors: Amy Sullivan 617-995-9838
UNH
Dew, do you have any opinion on United Health (UNH)? UNH has fallen from 64 and change in December 2005 to the current 47 and change. The fall looks pretty similar to the fall in MDT. I'm tempted to pick up both, however, just wanted to see what people thought here. Thank you for the great posts and diligence.
Take care,
10nis
Dramatic Rebound...
You can thank me for selling my last shares at 1.09. =)!!
Good Luck all,
10nis
10nis
I actually ended up buying back at 1.69 and sold half on the way up (2.10 and 2.30) and just sold the last half just now at(1.09). So, I ended up almost flat on the last few shares. So, net-net I think I ended up flat on the previous shares and the current shares.
I wish the best to everyone!!
GTCB....
Interesting to see no selling pressure before tomorrow's news. Maybe it'll come in the last hour. Looking forward to the next 24 hours. Good luck everyone!!
10nis
Dew,
What is your best guess on when GTCB will announce EMEA news? Thursday or Friday of next week? I ask only because there's a good probability that I won't be around a computer and want to make sure I find someone to mind my account.
TIA,
10nis
Cougar...
Am I the only person getting annoyed with your posts? Why do you say that the CFO's of GE and Xerox need to take some of those accounting classes? I personally think you need to stop posting and actually go back to school, as I've yet to see the reason for your posts.
You first claimed that no MNC company just keeps money in foreign lands to avoid paying U.S. taxes. I think the CFO article in your last post showed very clearly that is true. Dell doesn't have any reason to repatriate billions of dollars to the U.S. since they prefer to invest in high growth emerging markets (foreign lands) vs. slower-growth U.S.. (Note: MNC's spend billions of dollars on tax consulting projects/fee's to reduce or keep their effective tax rates as low as they legally can.)
Also, on the other hand, repatriation makes complete sense for a PFE because they have billions of dollars in earnings that they want to invest in the U.S. (partnerships, acquisitions, research centers, etc.) and they can do that at a reduced tax rate. Its a no-brainer for PFE.
Last, I never said it made sense for all MNC's to repatriate foreign earnings. It only makes sense for MNC's to repatriate the amount of earnings they plan to invest in the U.S..
Take care and good luck,
10nis
Cougar3,
PFE files consolidated financial statements. Therefore, the cash balance on its financials statements includes all cash held w/in domestic and foreign entities. Thus, you will not find any new cash holdings that weren't include in previous financial statement filings.
It was mentioned by a number people on this board that the benefit of the repatriation was to give PFE and the other MNC's a tax break (taxing them only 5.25% on repatriated earnings vs. 35%) in order to stimulate investment in the U.S.. I don't understand why this is so hard to understand.
Since you are a retired 62 year stockbroker, why don't you go back to school and take some accounting and tax classes. Its never too late to learn something new.
Good luck,
10nis
Repatriation.......
Shark Attack? I wasn't attacking anyone and I don't think anyone else was either. I'm a CPA and a Level III Candidate in the CFA Program. I have spent the majority of my career working on tax consulting, audit and financial restatement projects for MNC's.
I want to congrat you on being a successful stockbroker with two major Wall Street I-Banks and all of that stuff. I don't know why it matters how much money you have sitting in unrealized capital gains, however, you are a stockbroker so I shouldn't be too surprised by that comment.
With respect to the topic at hand repatriation of earnings, here's a little overview of the HIA related to repatriation of earnings......
The foreign repatriation incentive provision of the American Jobs Creation Act, IRC §965 (a.k.a. the Homeland Investment Act or "HIA"), was enacted to encourage U.S. based multinational corporations ("MNCs") to repatriate certain foreign earnings for the purpose of stimulating investments and job creation in the U.S. The provision temporarily reduces U.S. federal income tax assessed on certain offshore earnings by allowing MNCs an 85% dividends received deduction for certain "qualified dividends." Consequently, MNCs who elect to apply this provision would be subject to a 5.25% U.S. income tax rate on "qualified dividends" repatriated back to the U.S., rather than the regular statutory 35% rate.
MNCs wanting to benefit from §965 face various challenges. Various requirements of the provision are unclear, and currently lack relevant guidance. In fact, currently there is ambiguity even around the definition of a "qualified dividend". Failure to meet any one of the requirements will cause the dividend to be taxed at the full 35% rate. Because many MNCs are expecting to repatriate billions of dollars in cash under this provision, the cost of failing any one of the requirements may be huge for a company.
Second, the calculation of "extraordinary dividends" and "base period amounts" may require significant quantitative analysis. In fact, foreign subsidiaries from which extraordinary and base dividends will be paid may require earnings and profits (e&p) and tax pool calculations. Consequently, MNCs who expect to be repatriating from many or tiered subsidiaries may require numerous e&p and tax pool calculations, in addition to the calculations needed under §965.
Third, implementation of the §965 strategy may be complex as there are many steps involving various corporate departments, beyond Tax. For example, the CEO and the Board will need to approve the reinvestment plan, Treasury will need to fund the dividend, the CFO will need to assess the financial statement disclosures, and the legal department will need to work with the foreign offices to resolve any foreign legal restrictions on the cash.
Fourth, insufficient planning could add nondeductible tax costs to the repatriation. In addition to the disallowance of 85% of the foreign tax credits (FTCs) associated with
the repatriated dividend, § 965 also disallows 85% of any withholding taxes that would otherwise be creditable as FTCs. Consequently, MNCs may wish to restructure some of their global operations to limit their withholding tax liabilities. Similarly, there may be some detrimental state tax impact if the states do not adopt the provision in the same manner and timing as the federal statute.
New §965 is intended to attract money away from offshore jurisdictions and encourage U.S. based multinationals to repatriate surplus foreign profits, ultimately helping to stimulate business investment in the United States. This provision temporarily reduces the U.S. federal income tax assessed on offshore earnings, for a one-year period, by allowing U.S. based multinational corporations an 85% dividends received deduction for certain "qualified dividends" repatriated from controlled foreign corporations (CFCs) in excess of the "base amount." The "base amount" would be determined by a combined average of all distributions from all CFCs to the U.S. taxpayer over the previous five years ending on or before June 30, 2003 excluding the high and low years.
"Qualified dividends" under §965 are expressly limited to cash dividends. Deemed dividends described in IRC sections 956, 1248, and generally in section 951, among others, generally, will not qualify for HIA benefits. However, certain CFC-to-CFC dividends that constitute subpart F income may qualify for the HIA benefit. The qualified dividend must meet a variety of other tests.
(1) The qualified dividend is limited to the greater of (a) $500 million or (b) the earnings reported on the company’s financial statement certified on or before June 30, 2003, as permanently reinvested outside the United States, or, in the case of a financial statement that fails to show such an earnings amount and which shows a specific amount of U.S. tax liability attributable to such earnings, the amount of such tax liability divided by 35%;
(2) The amount of the dividends must be invested in the United States under a domestic reinvestment plan approved by company management; and
(3) As mentioned above, the dividends must exceed the average repatriation level from all CFCs over a five-year base period. The base period is the five most recent tax years of the U.S. company ending on or before June 30, 2003. The two tax years in this five-year period with the highest and lowest repatriation amounts are disregarded in computing the base period average.
Repatriated earnings.....
Cougar3,
What are you getting at with your link? I don't have time to read the article. What do you do for a living?
Thanks,
10nis
Repatriated Earnings....
Cougar3,
<<< Multi-national companies don't keep billion in cash sitting around in foreign countries simply to avoid US taxes. They do move their cash around the world as needed to fund their domestic and foreign needs just as they borrow monies whereever in the world their borrowing costs are most favorable. >>>
I disagree. I think you need to take an International tax class at your local university. MNC's do not just move cash generated from earnings around the world anyway they want, unless they like to pay very high tax rates. I'll try and write more on this topic when I get a chance.
10nis
ymi - back by popular demand - up 11%
Now back down to even for the day. It looks like its topping short-term, but what do I know. I hope it goes through the roof for whomever is holding it (I unfortunately am not).
Have a great weekend,
10nis