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Press Release Source: GTC Biotherapeutics, Inc.
http://biz.yahoo.com/bw/060803/20060803005416.html?.v=1
GTC Biotherapeutics Reports Second Quarter 2006 Financial Results
Thursday August 3, 8:00 am ET
EMEA Provides Scientific Advice on the Study of ATryn(R) In DIC
FRAMINGHAM, Mass.--(BUSINESS WIRE)--Aug. 3, 2006--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the second quarter ended July 2, 2006, as well as receipt of the Scientific Advice of the European Medicines Agency, or EMEA, on a planned clinical program to study ATryn® as a treatment for disseminated intravascular coagulation, or DIC, associated with severe sepsis.
The total net loss for the quarter was $9.1 million, or $0.15 per share, compared with $7.1 million, or $0.15 per share, in the second quarter of 2005. The total net loss for the first six months of 2006 was $17.6 million, or $0.29 per share, compared to $15.2 million, or $0.33 per share, for the first six months of 2005.
"In early June, GTC reached an historic milestone in successfully obtaining a positive opinion from EMEA on our submission of ATryn® for marketing approval in Europe. Based on this positive opinion, the European Commission yesterday approved ATryn® for use throughout the European Union in patients with a hereditary antithrombin deficiency undergoing surgical procedures. We look forward to working with our European partner, LEO Pharma A/S, on the steps necessary to make the initial launch of this product on a country by country basis, currently planned to start in the second quarter of 2007. Importantly, we are also working with LEO to establish the European clinical program to examine the therapeutic potential of ATryn® as a treatment for DIC associated with severe sepsis," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "To ensure that we can expeditiously move forward to take advantage of being the first company to obtain a transgenic approval, we recently closed a registered equity placement with a group of investors. This has strengthened our balance sheet and prepares us to progress to additional milestones in our commercial development plans."
European Scientific Advice and U.S. Clinical Progress
LEO Pharma has recently obtained Scientific Advice from the EMEA on the DIC clinical program. Scientific Advice is a non-public document that provides guidance that will be used to evaluate the data submitted in any subsequent application for market authorization. In accordance with this guidance, LEO plans to commence a phase II study by the end of 2006 to explore safety and efficacy, and establish appropriate dosing in preparation for a phase III study. The phase II study will be a comparative study performed in at least 200 patients with anticipated patient recruitment to occur over a period of twelve months starting from when the first patient enrolls.
DIC is the widespread formation of clots within blood vessels and is often associated with severe sepsis. In this indication, the infection and resulting septic condition consume much of the patient's own antithrombin. This antithrombin deficiency then results in DIC. In addition to a number of research studies that support the potential therapeutic value of antithrombin for this indication, DIC is an approved indication for plasma-derived antithrombin in Japan. DIC occurs in an estimated 220,000 severe sepsis cases in the European Union each year, of which approximately 50% are fatal, representing a major unmet medical need of significant interest in critical care.
The design of the hereditary deficiency phase III study with ATryn® for the planned U.S. regulatory submission follows a review with the FDA of the clinical data generated for the European market authorization submission. There will be a total of 17 additional patients with hereditary antithrombin deficiency undergoing high risk procedures such as surgery and childbirth recruited for this phase III study. The results of this study will be combined with the 14 patients in the European study and compared to historical data from at least 35 patients that were previously treated with antithrombin derived from plasma sources.
Antithrombin is used in patients with hereditary deficiency to reduce the risk of the formation of a blood clot known as a deep vein thrombosis, or DVT, during high risk procedures. The primary endpoint of the U.S. study is based on the observation of clinical symptoms of a DVT together with the comparison to historical data.
The data on childbirth patients gathered in this phase III study for the U.S. is planned to be used in a subsequent filing with the EMEA in 2007 to request expansion of the approved label to include childbirth procedures in the European Union. Based on current estimates, enrollment of the last patient in this study is projected to occur before the end of the first quarter of 2007. A Biologics License Application in the U.S. is planned for submission within approximately six months of completion of enrollment in the phase III study.
Financial Results
Cash and marketable securities at July 2, 2006 totaled $19.4 million, a $16.8 million decrease compared to $36.2 million at January 1, 2006. The decrease includes a $2.4 million final repayment on a promissory note to Genzyme Corporation which was financed by the expanded term loan from GE Capital at the end of 2005. Exclusive of the effects of the promissory note repayment, $14.4 million of net cash and marketable securities was used in the first six months of 2006. The registered direct placement of stock and warrants, which was completed July 21, 2006, has subsequently provided approximately $16.2 million of additional cash, net of offering costs. After giving effect to the placement, the pro forma cash and marketable securities starting the third quarter would have been $35.6 million. The cash use for the remainder of 2006 is anticipated to be in the range of $7 million to $11 million, consistent with previous guidance. The rate of net cash use for the second half of the year is expected to be lower primarily due to anticipated payments from LEO for product that is being supplied to support the clinical program for the DIC indication as well as the $2 million milestone payment to be received as a result of European Commission approval.
Revenues for the second quarter were $0.4 million, a 59% decrease from the $1 million in the second quarter 2005. During the second quarter of 2006, approximately $1.4 million of cash received from Merrimack Pharmaceuticals for work in its MM-093 program and a $1 million milestone payment from LEO for obtaining the positive opinion were recorded to deferred revenue in accordance with our revenue recognition policy for multiple element arrangements. Revenues totaled $2.6 million for the first six months of 2006 compared to $2.3 million in the first six months of 2005, an increase of 12%. Reported revenues are expected to vary on a quarter-to-quarter basis due to the nature and timing of milestone-based research and development revenues.
Costs of revenue and operating expenses totaled $9.5 million in the second quarter, approximately 19% higher than the $8 million total in the second quarter 2005. Costs of revenue and operating expenses totaled $20.2 million in the first half of 2006, approximately 18% higher than the $17.2 million for the first half of 2005. The increases in the year to year comparisons were primarily driven by increased expenses in the ATryn® program associated with the manufacture of clinical material and execution of the US clinical trial, expansion of activities on our external program with Merrimack Pharmaceuticals, expenses associated with the implementation of SFAS 123R, which is the accounting guidance for "Share Based Payments", and increased legal costs. These increases in the year to year comparison were partially offset by reduced expenses for the EMEA regulatory activities for ATryn®, lower expenses in the CD137 development program and reduced expenses on the external programs with Elan and Centocor, which were successfully completed in 2005.
The results per share were affected by an increase in the weighted average number of shares outstanding from 46.8 million shares for the second quarter 2005 to 61.4 million shares in the second quarter 2006. The weighted average number of shares outstanding increased from 45.8 million shares for the first six months of 2005 to 61.1 million shares in the first six months of 2006. The increases in the weighted average shares outstanding primarily reflect the issuance of approximately 21.4 million shares of common stock in three offerings during 2005. The gross proceeds to GTC from those offerings totaled approximately $35 million. GTC had approximately 61.4 million shares outstanding as of July 2, 2006. After giving effect to the July 2006 registered direct placement, GTC has approximately 73.4 million shares outstanding.
Conference Call Information
GTC Biotherapeutics will discuss these results and expectations with financial analysts in a web cast conference call at 10:00 a.m. (Eastern) today. The dial-in number from inside the United States is 1-800-599-9816. The dial-in number from outside the United States is 1-617-847-8705. The participant passcode is 24504992. The webcast may be found at www.gtc-bio.com.
About GTC Biotherapeutics, Inc.
GTC Biotherapeutics is a leader in the development, production, and commercialization of therapeutic proteins through transgenic animal technology. GTC's lead program is ATryn®, its recombinant form of human antithrombin. The European Commission has granted market authorization for the use of ATryn® in patients with a hereditary antithrombin deficiency undergoing surgical procedures. In addition to the ATryn® program, GTC is developing a recombinant human alpha-1 antitrypsin, a recombinant human albumin, a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors, and a malaria vaccine. In its external programs, GTC's technology is used to develop transgenic production of its partners' proprietary products, including both large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. One of the external programs is in clinical trials with a transgenically produced product. Additional information is available on the GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing and scope of the DIC clinical program, the anticipated timing for a European market launch of ATryn®, the planned submission for label expansion in Europe, the progress and prospects of ATryn® in the United States, and the expected cash to be used in 2006. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports as filed with the Securities and Exchange Commission, including the uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of partners and regulatory agencies, the uncertainties associated with intellectual property, and the uncertainty that the Company will be able to obtain additional revenues and financial resources, including through continuing and new external programs and marketing and strategic partners for some of its internal programs and additional equity financings. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.
GTC BIOTHERAPEUTICS, INC.
Selected Financial Information
(Unaudited, in thousands except per share amounts)
Three months ended Six months ended
------------------ ------------------
July 2, July 3, July 2, July 3,
2006 2005 2006 2005
-------- -------- -------- --------
Revenue $ 416 $ 1,017 $ 2,617 $ 2,339
Costs of revenue and
operating expenses:
Cost of revenue 1,214 906 2,437 2,279
Research and development 5,854 5,188 13,332 10,605
Selling, general and
administrative 2,425 1,901 4,462 4,296
-------- -------- -------- --------
9,493 7,995 20,231 17,180
-------- -------- -------- --------
Loss from operations $ (9,077) $ (6,978) $(17,614) $(14,841)
Other income (expense): (20) (142) 14 (312)
-------- -------- -------- --------
Net Loss $ (9,097) $ (7,120) $(17,600) $(15,153)
Net loss per common share
(basic and diluted) $ (0.15) $ (0.15) $ (0.29) $ (0.33)
======== ======== ======== ========
Weighted average number of
shares outstanding (basic
and diluted) 61,397 46,835 61,085 45,836
======== ======== ======== ========
July 2, January 1,
2006 2006
-------- --------
Cash and marketable
securities $ 19,445 $ 36,169
Other current assets 2,137 2,754
Property and equipment, (net) 15,683 16,735
Other assets 10,527 11,061
-------- --------
Total assets $ 47,792 $ 66,719
======== ========
Current liabilities $ 18,735 $ 20,322
Long-term debt 4,919 7,005
Other liabilities 3,997 2,683
Stockholders' equity 20,141 36,709
-------- --------
Total liabilities and
stockholders' equity $ 47,792 $ 66,719
======== ========
POZN Partnership... Anyone own any POZN?
http://biz.yahoo.com/bw/060802/20060801006259.html?.v=1
Press Release Source: POZEN Inc.
POZEN and AstraZeneca Announce Global Collaboration to Co-Develop and Commercialize Fixed Dose Combinations of Naproxen and Esomeprazole for the Treatment of Pain
Wednesday August 2, 2:00 am ET
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 2, 2006--POZEN Inc. (NASDAQ: POZN - News) announced today that it has signed an exclusive global collaboration agreement with AstraZeneca for the co-development and commercialization of proprietary fixed dose combinations of the proton pump inhibitor (PPI) esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen, in a single tablet. The product will be indicated for the management of pain and inflammation associated with conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers.
Under the terms of the agreement, AstraZeneca will pay POZEN an upfront fee totaling $40 million with potential aggregate milestone payments of $160 million for certain development and regulatory milestones; and $175 million of potential sales performance milestones, if certain thresholds are achieved. Royalties will be paid on net sales on a tiered royalty structure that ranges from mid-single digits to mid-teens. POZEN will be responsible for the development and filing of the New Drug Application (NDA) in the United States, while AstraZeneca will have full responsibility for development activities outside of the U.S. as well as all aspects of manufacturing, marketing, sales and distribution on a worldwide basis. AstraZeneca will also be responsible for all non-U.S. regulatory filings. The collaboration is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
POZEN's proprietary PN drug candidates are being developed for the management of pain and inflammation associated with conditions such as osteoarthritis, one of the most frequent causes of physical disability among adults, affecting an estimated 20 to 30 million people in the United States. Estimates from the National Institutes of Health show that by 2030, 20 percent of Americans--about 70 million people--will have passed their 65th birthday and will be at risk to develop osteoarthritis. POZEN received a United States patent for the PN technology in 2005 which expires in 2023.
In short-term proof-of-concept studies conducted by POZEN, two other PN drug candidates produced significantly less gastric mucosal injury compared to a similar regimen of enteric coated naproxen. Earlier this year, POZEN announced that it had reached agreement with the U.S. Food and Drug Administration (FDA) on a New Drug Application program for PN 200, which included a Special Protocol Assessment (SPA) for the pivotal phase 3 trials. POZEN and AstraZeneca expect to meet with the FDA during the next few months to confirm that the core development program and the SPA already agreed upon will apply to this new product.
"This collaboration is further evidence of the progress we are making in strengthening our pipeline of new products," said Dr. John Patterson, Executive Director, Development, for AstraZeneca. "We believe that the combination of esomeprazole and POZEN's proprietary PN technology has the potential to address one of the key unmet medical needs for patients with chronic pain; namely, good pain relief coupled to a low risk of gastrointestional ulcers and good tolerability."
John R. Plachetka, Pharm.D., POZEN's Chairman, President and Chief Executive Officer said, "One of our goals in developing our PN technology has been to collaborate with a large pharma company that has the commercial resources necessary to drive products based on our PN technology into a leadership position amongst all NSAID products. AstraZeneca has consistently shown that it is one of the best pharmaceutical companies in the world, and we are especially pleased to be utilizing esomeprazole in this product."
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection product sales. AstraZeneca is listed on the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN's efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has a development and commercialization alliance with GlaxoSmithKline in addition to this agreement with AstraZeneca. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN". For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
ENCY...
Does anyone hold any shares? If so, what do you think the probability is that ENCY can resolve the final issue and get FDA approval? Thinking about buying a completely speculative position.
TIA,
10nis
PHARM.AS
Pharming was up 10+% today on 2 million shares.... I haven't seen any news today, has anyone else seen any?
TIA,
10nis
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