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SciClone Pharmaceuticals to Report First Quarter 2010 Results on May 6
Press Release Source: SciClone Pharmaceuticals, Inc. On Monday April 26, 2010, 5:30 pm EDT
FOSTER CITY, CA--(Marketwire - 04/26/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today announced that it plans to report first quarter 2010 results on Thursday, May 6, 2010. SciClone will host a conference call to give a business and product update at 4:30 pm ET that day. The call will be hosted by Friedhelm Blobel, Ph.D., President and CEO, and Gary Titus, Senior Vice President and CFO.
LIVE CALL: 866-713-8395 (U.S./Canada) 617-597-5309 (International) Passcode: 25943363REPLAY: 888-286-8010 (U.S./Canada) 617-801-6888 (International) Passcode: 79254016 (Replay available from Thursday, May 6, 2010, at 8:00 pm ET until 11:59 pm ET on Thursday, May 13, 2010)
The conference call will contain forward-looking statements. Interested parties who wish to listen to the webcast should visit the Investor Relations section of SciClone's website at http://www.sciclone.com/. The information provided on the teleconference is only accurate at the time of the conference call, and SciClone will take no responsibility for providing updated information except as required by law.
4:05PM SciClone Pharma announces study shows signal of delay to onset of severe OM in higher dose group (SCLN) 3.71 -0.09 : Co announces topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis-- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies. Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM, an expanded measure of OM
"SCLN News" SciClone Announces Topline Results From Phase 2 Clinical Trial of SCV-07 for Prevention of Oral Mucositis
Study Shows Signal of Delay to Onset of Severe OM in Higher Dose Group
http://www.marketwatch.com/story/sciclone-announces-topline-results-from-phase-2-clinical-trial-of-scv-07-for-prevention-of-oral-mucositis-2010-03-30?reflink=MW_news_stmp
FOSTER CITY, CA, Mar 30, 2010 (MARKETWIRE via COMTEX) -- SciClone Pharmaceuticals, Inc. /quotes/comstock/15*!scln/quotes/nls/scln (SCLN 3.71, -0.09, -2.37%) today announced topline results from the company's phase 2 clinical trial of SCV-07 for the prevention of severe oral mucositis (OM) (World Health Organization, WHO scale, grades 3 to 4) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. This proof of concept study was intended to provide an estimate of SCV-07's treatment effect and guide further studies of SCV-07 in addressing this serious unmet medical need. Patients receiving the study's higher dose (0.1 mg/kg) of SCV-07 showed a trend towards delay to onset of severe OM, the study's primary endpoint. Patients in the low dose treatment arm (0.02 mg/kg) appeared to do worse than placebo, suggesting that the treatment effect is sensitive to dose. Additionally, SCV-07 was safe and well tolerated with no drug-related serious adverse events reported, indicating that there is potential to administer higher doses of SCV-07 in future clinical studies.
Additional data analysis showed a more pronounced clinical benefit for patients in the high dose treatment arm when evaluating the delay to onset of ulcerative OM (WHO scale, grades 2 to 4), an expanded measure of OM. In this analysis, the low dose treatment arm appeared similar or slightly better than placebo.
"We are encouraged that the trial provides an indication of a biological signal, in the high dose arm, for the pre-specified primary endpoint of the study," said Stephen T. Sonis, DMD, DMSc, Senior Physician, Brigham and Women's Hospital, Professor of Oral Medicine, Harvard School of Dental Medicine, and a leading expert in oral mucositis. "The finding that extends this signal to ulcerative OM is important, as ulceration is the major cause of the morbidity associated with OM."
Based on these study findings, SciClone intends to initiate discussions with the United States Food and Drug Administration regarding the design of a second phase 2 study of SCV-07 for the prevention of OM, which would involve higher doses. SciClone has also submitted a late-breaking abstract on results of this study for the 2010 American Society of Clinical Oncology Annual Meeting.
"We believe these findings support the concept that SCV-07 could provide a clinically meaningful benefit in the prevention of OM for patients with head and neck cancer being treated with chemoradiotherapy by stimulating the immune system through critical signaling pathways," said Israel Rios, MD., Chief Medical Officer and Senior Vice President of SciClone.
The phase 2 multicenter, randomized, double-blind, placebo-controlled, dose ranging proof of concept study was designed to assess the safety and tolerability of SCV-07 as well as provide an indication of efficacy in delaying the onset of severe OM, as assessed by the WHO scale, in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. The study was not designed to demonstrate statistical significance and the results are not statistically significant. The study was conducted at 21 centers in the United States and included 59 patients. Patients received either placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at the higher dose of 0.10 mg/kg. The treatment period was approximately seven weeks depending on the patient's prescribed radiation plan, with a follow-up visit approximately 30 days following the last day of radiation therapy.
About Oral Mucositis OM is a painful, debilitating and costly toxicity of many of the drug or radiation regimens used to treat cancer. OM is a condition in which the sensitive cells lining the mouth and throat are damaged by cancer treatments such as chemotherapy (with or without radiation) and become painful mouth sores. Severe OM has been reported to occur in about 50% of patients who receive chemoradiation for the prevention of cancers of head and neck (Sonis, Core Evidence, 2009). Importantly, radiation to the head and neck, especially when it includes the tissues of the mouth, pharynx and hypopharynx, results in significant ulcerative OM in greater than 90% of patients (Manas et al, Clinical Translational Oncology, 2009) and can compromise the patient's ability or willingness to accept a complete course of therapy. Symptoms can include painful ulcers in the mouth and throat, redness and swelling of the gums, dryness and overall soreness in the mouth, and difficulty eating, swallowing, talking and drinking. In addition to the symptoms of OM and its impact on quality of life and continued therapy, mucositis can cause adverse affects on a variety of other health and economic outcomes, such as a risk of serious infection, the need for parenteral nutrition and narcotic analgesia, and increased hospitalization and feeding-tube placement. The National Cancer Institute estimates that 400,000 patients in the U.S. suffer from OM during cancer therapy.
WHO OM Scale The WHO OM Scale is the standard, validated instrument used in clinical trials to measure OM.
Grade 0 = None Grade 1 = Erythema and soreness; No ulcers Grade 2 = Ulcers; Able to eat a solid diet Grade 3 = Ulcers; Requires a liquid diet Grade 4 = Ulcers; Not able to tolerate a solid or liquid diet; Requires IV or tube feeding.
About SCV-07 SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including OM prevention, treatment of viral infections and cancers, and in the enhancement of response to vaccines.
Additionally, SciClone is currently running a multicenter, multidose, open label phase 2 clinical trial of SCV-07 as a monotherapy and in combination with ribavirin to treat patients infected with hepatitis C virus, who have relapsed after the last treatment. SCV-07 has shown a good safety profile in several early stage clinical trials in healthy volunteers and subjects with HCV infection at various doses. SciClone expects to provide initial results from this trial in the second half of 2010.
SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has recently been approved for stimulation of depressed immune systems.
7:11AM SciClone Pharma announced the European approval of ondansetron RapidFilm (SCLN) 3.69 : Co announced the European approval of ondansetron RapidFilm , co-developed by APR Applied Pharma Research and Labtec GmbH and licensed to BioAlliance Pharma s.a. for European Union countries. BioAlliance was granted approval under the EU decentralized procedure in 16 major EU countries. SciClone has acquired the commercialization and distribution rights for ondansetron RapidFilm from APR for the People's Republic of China, Vietnam, Hong Kong, and Macau and believes that these approvals in Europe will support SciClone's efforts to secure regulatory approval for the product in these countries. Based on the European approvals, SciClone plans to file for product registration with the regulatory authorities in China, Vietnam, Hong Kong, and Macau. SciClone expects to introduce the product through its existing sales organization.
SciClone Reports Financial Results for the Fourth Quarter and Year End 2009 and Provides Commercial and Pipeline Updates
Full Year Revenues, EPS and Year End Cash Balances Increased
Press Release Source: SciClone Pharmaceuticals, Inc. On Tuesday March 2, 2010, 4:05 pm EST
FOSTER CITY, CA--(Marketwire - 03/02/10) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) today reported results for the fourth quarter and year ended December 31, 2009. Revenues for the fourth quarter of 2009 grew to $18.1 million, or 18% compared to the fourth quarter of 2008. Net income for the fourth quarter of 2009 was $2.4 million or $0.05 per share, compared with a net loss of $3.1 million or $(0.07) per share in the fourth quarter of 2008, both on a basic and diluted basis.
For the year ended December 31, 2009, total revenues increased by 34% to $72.4 million, compared with revenues of $54.1 million for the year ended December 31, 2008. For the year ended December 31, 2009, net income was $11.9 million, or $0.26 and $0.25 per share on a basic and diluted basis, respectively, compared with a net loss of $8.3 million or $(0.18) per share for the year ended December 31, 2008, both on a basic and diluted basis.
"We are proud of our financial and operational success after one year of executing on our strategy as a profit-focused specialty pharmaceutical business. Our net income of $2.4 million for the fourth quarter and $11.9 million for the full year truly is a testament to this strategy," commented Friedhelm Blobel, Ph.D., SciClone's President and Chief Executive Officer. "We have achieved full year profitability, an important goal for 2009, and expect to build on this success in 2010. We plan to continue to focus on expanding our efforts in China, where we already have a well-established name and reputation, and we complement this effort with our promising biotechnology pipeline, for which we expect to reach several key milestones this year."
Financial Results
For the fourth quarter of 2009, total revenues from the sale of ZADAXIN increased by 18% resulting in total revenue of $18.1 million, compared with revenues of $15.3 million in the fourth quarter of 2008. For the year ended December 31, 2009, total revenues increased by 34% to $72.4 million, compared with product revenues of $54.1 million for the year ended December 31, 2008. The increase in product revenues for the fourth quarter and year ended December 31, 2009 was primarily attributable to an increase in the quantity of ZADAXIN sold to China.
Research and development expenses for the fourth quarter of 2009 totaled $4.0 million compared with $6.5 million in the fourth quarter of 2008. For the year ended December 31, 2009, research and development expenses were $16.5 million, compared with $22.9 million for the year ended December 31, 2008. The decrease was primarily related to lower clinical trial-related expenses as a result of the discontinuation of SciClone's RP101 clinical trial for the treatment of pancreatic cancer in October of 2009, and was offset partially by increased expenses related to the Company's SCV-07 phase 2 clinical trials for the treatment of severe oral mucositis and HCV. This decreased expenditure reflects SciClone's strategy of limiting its research and development costs and the Company expects to further reduce its research and development spending in 2010.
Sales and marketing expenses for the fourth quarter of 2009 were $5.3 million, compared with $4.9 million in the fourth quarter of 2008. For the year ended December 31, 2009, sales and marketing expenses were $18.8 million, compared with $16.9 million for the year ended December 31, 2008. The increase in sales and marketing expenses in the fourth quarter and year ended December 31, 2009 was primarily due to increased marketing activities, including conferences and employee-related costs associated with the expanding sales efforts for SciClone's lead product ZADAXIN in China.
General and administrative expenses for the fourth quarter of 2009 were $3.4 million, compared with $3.8 million for the fourth quarter of 2008. For the year ended December 31, 2009, general and administrative expenses were essentially flat at $12.5 million compared with $12.5 million in 2008. In 2009, the Company incurred increased expenses related to business development efforts in China which were offset by decreased accounting and legal fees.
Net income for the fourth quarter of 2009 totaled $2.4 million, or $0.05 per share, compared with a net loss of $3.1 million, or ($0.07) per share for the fourth quarter of 2008, both on a basic and diluted basis. For the year ended December 31, 2009, net income was $11.9 million, or $0.26 and $0.25 per share, on a basic and diluted basis, respectively, compared with a net loss of $8.3 million or ($0.18) per share, both on a basic and diluted basis for the year ended December 31, 2008.
The fourth quarter 2009 expenses included $0.6 million of non-cash stock-based compensation charges, which were comparable to $0.4 million for the same period last year. Excluding non-cash stock-based compensation charges, on a pro-forma basis, net income was $3.0 million or $0.06 per share, compared with a net loss of $2.7 million or ($0.06) per share for the fourth quarter of 2008, both on a basic and diluted basis. For the year ended December 31, 2009, expenses include $1.9 million of non-cash stock-based compensation charges, compared with $1.8 million in 2008. Excluding non-cash stock-based compensation charges, on a pro-forma basis, net income was $13.8 million, or $0.30 and $0.29 per share on a basic and diluted basis, respectively, compared with a net loss of $6.5 million or ($0.14) per share for the year ended December 31, 2008, both on a basic and diluted basis.
Cash, cash equivalents and short and long-term investments totaled $31.8 million at December 31, 2009, compared with $29.7 million at December 31, 2008. The increase in cash for the year ended December 31, 2009 is primarily a result of SciClone's operating net income and proceeds from issuances of common stock offset partially by an increase in accounts receivable and an increase in inventory levels to meet expected sales demands.
Financial Outlook for 2010
As announced in the SciClone press release dated January 11, 2010, the Company anticipates 2010 revenues of between $82 and $85 million, an increase of approximately 15% over 2009. SciClone expects its revenue growth to be driven by the sales of ZADAXIN, principally to China. The Company also anticipates earnings per share for the full year 2010 to be between $0.31 and $0.35. SciClone cash, cash equivalents and short- and long-term investments at December 31, 2010 are projected to be greater than $35 million.
2010 Corporate Milestones
SciClone Pharmaceuticals expects to achieve the following significant milestones in 2010:
?
-- Provide topline results in the phase 2 trial of SCV-07 in severe oral
mucositis in the first quarter of 2010;
-- Announce duration of response data in the late-stage trial of ZADAXIN
as an enhancer of the H1N1 vaccine in the first half of 2010;
-- Provide topline results in the phase 2 trial of SCV-07 in HCV in the
second half of 2010;
-- Receive regulatory approval for DC Bead in China by the end of 2010;
-- Achieve 2010 revenues of $82 to $85 million and EPS of $0.31 to $0.35
for the full year 2010.
Fourth Quarter and Recent Pipeline Updates
In November 2009, SciClone completed enrollment ahead of schedule for its phase 2 trial of SCV-07, a small molecule synthetic peptide with immunomodulating properties, for the treatment of oral mucositis. SciClone's multicenter, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of oral mucositis in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. Topline results from this trial are expected to be announced during the first quarter of 2010.
In February and also in January, SciClone and its partner, Sigma-Tau S.p.A., announced two data points from the study of ZADAXIN as an enhancer of H1N1 flu vaccines. ZADAXIN treatment given with the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria? from Novartis, led to a statistically significant increase in the percentage of patients who seroconverted, when evaluated at 21 days and also 42 days after vaccination, compared to those who received the H1N1 vaccine alone. In addition, the improvement in titers seen in ZADAXIN-treated patients was maintained at the later timepoint. The Company will announce further data on the study after all patients have reached 168 days post vaccination and final topline results are available.
Fourth Quarter 2009 Results Conference Call Information
SciClone will host a conference call on Tuesday, March 2, 2010 at 4:30 pm ET to give a business and product update and guidance for 2010. The call will be hosted by Friedhelm Blobel, Ph.D., President and CEO, and Gary Titus, CFO and Senior Vice President.
?
LIVE CALL: 800-706-7749 (U.S./Canada)
617-614-3474 (International)
Passcode: 95315467
REPLAY: 888-286-8010 (U.S./Canada)
617-801-6888 (International)
Passcode: 29781029
(Replay available from Tuesday, March 2, 2010 at
7:30 p.m. ET until 11:59 p.m. ET on Tuesday,
March 9, 2010)
The conference call will contain forward-looking statements. Interested parties who wish to listen to the webcast should visit the Investor Relations section of SciClone's website at www.sciclone.com. The information provided on the teleconference is only accurate at the time of the conference call, and SciClone will take no responsibility for providing updated information except as required by law.
6:15AM SciClone Pharma and Sigma-Tau announce additional positive results in clinical study examining ZADAXIN's ability to enhance response to H1N1 vaccine (SCLN) 2.68 : The co and its partner Sigma-Tau S.p.A., announced additional topline results in a clinical study evaluating the potential of ZADAXIN to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis. According to investigators, ZADAXIN treatment given with the H1N1 vaccine led to a statistically significant (p value=0.04) increase in the percentage of subjects who seroconverted, also when evaluated 42 days after vaccination, compared to those who received the H1N1 vaccine alone. In addition, the improvement in titers seen in ZADAXIN-treated patients was maintained at this later timepoint. "The seroconversion results that we have seen to date in this study are very encouraging and continue to demonstrate the value that ZADAXIN may have in offering the public a more powerful vaccine regimen against the H1N1 virus," said Friedhelm Blobel, Ph.D., SciClone's president and chief executive officer. "It is our hope that ZADAXIN will ultimately provide the enhancement benefits to H1N1 vaccines for patients with compromised or weakened immune systems. If this study continues to show positive data, we may also explore the potential of ZADAXIN to improve the response to vaccines with other flu or virus strains."
here and accounted for ! ready to rock and roll !
It's amazing this price shares!!. CTIC is a bull$hit and it's trading very high!.
Don't understand why
6:03AM SciClone Pharma and Sigma-Tau announce positive preliminary results in clinical study examining ZADAXIN'S ability to enhance response to H1N1 vaccine (SCLN) 2.77 : The co and its partner Sigma-Tau S.p.A. have received initial topline results in a clinical study evaluating the potential of ZADAXIN to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria from Novartis (NVS). According to investigators, ZADAXIN treatment given with the H1N1 vaccine led to a highly statistically significant increase in the percentage of subjects who seroconverted at 21 days after vaccination, when compared to those who received the H1N1 vaccine alone.
6:07AM SciClone Pharma provides 2009 financial update and initial 2010 sales revenue guidance (SCLN) : Co issues guidance for FY09 (Dec), sees FY09 (Dec) revs of 72.4 mln vs. $72.30 mln First Call consensus. Co issues upside guidance for FY10 (Dec), sees FY10 (Dec) revs of $82.85 mln vs. $73.57 mln consensus. Cash, cash equivalents, short and long-term investments are anticipated to be approx $31.8 mln (unaudited) at December 31,
2009, compared with $29.7 million at December 31, 2008. Co says "During 2009, we executed on our corporate strategy of managing the company as a profit-driven specialty pharmaceutical business with a strong pipeline to fuel future growth. We expect to achieve significant full year operating profitability during 2009 and are very pleased with both our commercial sales growth and cash position... Given the strong performance of our international commercial operations and careful expense management, we expect profits to continue to grow in 2010. We look forward to providing full 2010 financial guidance as well as an update on our pipeline later this quarter."
Where is everyone?? This stock poised to explode and nary a poster in sight...
Great sales of Zadaxin in China.
$2.35 was a gift and I hope you all got in below $3.00
Heading back to $5.00 easy.
Flu season and H1N1 still in its infancy.
Expect a huge increase in Q4 earnings.
cheers,
SJ
Hope people got in at $2.35..... won't see that again.
cheers,
SJ
Getting to a new entry point for the next rise to $5.00
cheers,
SJ
Everyone still feeling good about SCLN? what about VICL Kei?
Thanks.
$heff, this is an excellent play both for short term bumps on the swing
as well as an excellent long term investment.
Zadaxin sells in China... major revenue source.
Swine Flu is going to boost sales to easily $60 million by end of December.
Cheers,
SJ
my scln is popping again!
thanks again io_io !!!
did i tell you i just got another flu-stock vicl?
many many thanks!
kei
nothing was easy.....
did you take profit?
me?.....just holding all
any bad news...?
didnt find any...
just noticed that we are having pre-market trading!
and we are up again!
just keep going up since i purchased....amazing stock.
(^^)/
happy thursday day to you.
btw, dilution on gnvc...shocked (>_<)' but i'm going to hold all my position.
<<<"thank you, ioio for this stock!!! ">>>
hi Kei.....
no, thank you for listening ...... we were seriously looking for another one there, and we found it...... it was good timing OK
it is not in a hurry (unless this swine flu media image gets out of control), so it may go back down ......who knows ?
anyway, SCLN is profitable......and they say the dollar will be weak which wil mean strong China sales......even without any swine flu issues over there......
:o)
thank you, ioio for this stock!!!
amazing stock!
from 2.50 to 3.70 in 2 weeks!!!
yeahoooooooooooooooo$$$$$$$$$$$
SCLN - Adjuvants for Swine Flu Vaccines
Any list of Swine Flu companies should contain SCLN - its adjuvant (Zadaxin) is approved in 12 countries - including Italy and China - and saw increased sales (about $6m) in q2. SCLN is now running trials to make its adjuvant more available - although in the USA, it may not used this winter for reasons you will read below. However, Europe & China are a different story.
http://abcnews.go.com/Health/SwineFluNews/story?id=8296948&page=1&cid=yahoo_pitchlist
Swine Flu Vaccine: What The Heck Is an Adjuvant, Anyway?
Booster May Extend Vaccine Supplies; Some Have Safety Concerns
By JOSEPH BROWNSTEIN
ABC News Medical Unit
Aug. 11, 2009—
While drug makers prepare a swine flu vaccine in anticipation of a possible outbreak this fall, one of the issues yet to be resolved is whether the shots will contain an adjuvant.
"It's something that allows the immune system to respond with higher levels of effectiveness," said Dr. David Fedson, formerly a professor of medicine at the University of Virginia and former medical director for the pharmaceutical company Aventis Pasteur.
Adjuvants can include various forms of aluminum and are typically used with other vaccines in the United States, including vaccinations for hepatitis A and B, diphtheria-tetanus-pertussis and Haemophilus influenzae type b (Hib). In a flu vaccine, the adjuvant would be a water-oil mixture.
By using them in various vaccines, doctors hope to reduce the amount of the vaccine itself that is needed.
"Hopefully, in the future, they're going to lead to the ability to get a better immune response with much less vaccine," Dr. Andrew Pavia, chair of the public health committee of the Infectious Diseases Society of America and a professor of professor of pediatrics at the University of Utah, said in an interview with ABC News last September.
The ability to stretch a supply of swine flu vaccine -- and an adjuvant's ability to help to do that -- is not trivial. Fears have arisen about whether there will be enough swine flu vaccine available. Adjuvants can allow dosing to be much smaller.
For example, Fedson points to trials for a bird flu vaccine in which 90 micrograms of an antigen -- a flu virus's "signature" that allows for an immune response -- could be reduced to 3.75 micrograms when an adjuvant was introduced, effectively enabling 24 times more doses.
"By adding an adjuvant, you gain what is known as an antigen sparing effect," Fedson said.
While flu vaccine doses typically use 15 micrograms of antigen, adjuvants could increase that significantly.
"Being able to produce four times as many vaccines is a huge advantage in terms of public health," Fedson said.
At the same time, vaccines have long been plagued by safety concerns -- whether legitimate or not -- and the use of adjuvants is only likely to add to that. No flu vaccine approved for use in the United States has ever contained an adjuvant.
"It wasn't felt to be necessary, because the flu vaccines that have been used for decades in this country & were rather broadly protective," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "We felt that the immune response of the vaccine was pretty good to begin with."
Safety and Availability Fears May Clash
Fears surrounding the swine flu vaccine are often attributed to the vaccine for the 1976 swine flu epidemic when a few hundred people came down with Guillain-Barré syndrome after receiving the swine flu vaccine.
While the bad publicity led to the halting of the vaccine program after 40 million Americans had received the vaccine, no link has ever been proven between the vaccine and Guillain-Barré.
But concerns about what might happen with the vaccines remain, and the addition of adjuvant is likely to add more fuel to the fire.
The initial trials of the swine flu vaccine for the United States will be with the unadjuvanted form, while later trials with an adjuvanted form may take place if deemed necessary.
"We'll probably be looking at that in a few weeks in case we don't get as good a response with the unadjuvanted vaccine," Fauci said. "We don't plan to start any trials on adjuvants at least until we get a bit into the adjuvanted trials."
He said that a mild flu season would likely mean the trials of a vaccine with an adjuvant would not get started. But a swine flu that returned quickly and spread quickly might force their usage.
"It's something that we're keeping as a contingency in case we need to use them," Fauci said. "Right now, the main priority is to test the unadjuvanted vaccine."
Should an adjuvant be needed, however, Fauci said there is little question that it would be safe.
"We're more cautious than when we use something that we've used every year for decades," he said, noting, however, "the Europeans have used these same adjuvants for a long period of time with a & reasonable safety record."
But if adjuvants were to be used, they would likely be used in older people, where they have been tested, rather than children.
"There's not a lot of data on adjuvants in young kids -- even from the Europeans," Fauci said.
Good Domestic Public Health, Bad International Public Health?
Officials do not expect a shortage of swine flu vaccine. "We don't anticipate that we will run out, but it's possible," Fauci said.
But while Americans may not face a shortage, Fedson said that not using adjuvants is a problem from an international perspective, although it makes getting the vaccine approved in the United States easier.
"From the regulator point of view, this will be the least onerous pathway to follow to get it approved," he said. "I think that's the path of easy regulatory approval, but whether it meets the public health needs of the world and the nation is another matter."
The problem, he said, is that the concerns for approval are for the individual. But even if the United States has enough, failure to use adjuvants means that doses for developing countries -- who don't have their own vaccine production capacity -- are unavailable.
Even more, said Fedson, because the swine flu virus has not been experienced by many Americans, they will need two doses of vaccine instead of one to develop immunity.
Describing the distribution methods for swine flu vaccine "a boutique approach to global public health," Fedson called them "an approach which will not make much difference for the people in 90 percent of the world, who will not have access to vaccines or antivirals."
<"i just love this stock, my man!">
I like it too, ma belle !
i just love this stock, my man!
did i tell you that i now own 2000 shares instead of 1000?
thank you for ordering me to buy this gem!
Japanese soccer player hospitalized with swine flu
- this is on front page of Yahoo news - seems to be a benign case, but making headlines - another one closer to home is the famous USA player Landon Donovan -http://www.baltimoresun.com/sports/bal-sp.pressboxlede.new14aug14,0,2589528.story - but he was not hospitalized -
http://sports.yahoo.com/sow/news;_ylt=AlqNVxnupck7S44hIbphEZImw7YF?slug=ap-japan-swineflu&prov=ap&type=lgns
A member of the Japanese women’s under-19 soccer team has been hospitalized with swine flu following a recent trip to China.
Ryoko Takara returned to Japan on Thursday after playing in a tournament in Wuhan, China. The Nikkan Sports daily reported on Saturday that she was quarantined in a Kobe hospital a day later after showing symptoms of the virus.
Takara’s temperature has dropped since being hospitalized and her condition has improved.
The Japan Football Association said none of Takara’s teammates have shown symptoms of the virus.
A Japanese man infected with swine flu died Saturday, becoming the country’s first fatality linked to the virus. The health ministry said on Saturday that more than 7,300 Japanese have been infected with swine flu.
<"Sure Looks Healthy">
Am interested in SCLN which is on the berge of becoing a year-round profitable biotech. And i think a compelling acquisition target for some big phrma needing to get on the ground in China.
Curious to know why this seems to be your only biotech ?
<"from $.80 to $4.40.... that's enough for me....">
Very good. I have been blind to this one. I owned it 3 years ago and it mysteriously ran to $8; I was frozen in place and only sold half. And am still making the same mistakes.
So back to $3.70 - and I am buying. Yourself ?
<"excellent conference call">
Yes it was. When China comes out of the downturn, and as modern medicine makes more inroads, SCLN will be nicely placed.
finally.... but it's too much too soon...
from $.80 to $4.40.... that's enough for me....
way overbought this AM.
But a nice handy profit....
Trade wisely, invest better!
cheers,
SJ
SciClone swings to $7.3M Q2 profit
SciClone Pharmaceuticals Inc. on Tuesday reported second quarter net income of $7.3 million, or 16 cents a share, compared to a loss in the same period last year of $300,000, or a penny a share.
Foster City-based SciClone (NASDAQ:SCLN) said revenue grew 59 percent to $22 million compared with the same period in 2008.
"We are very pleased with the exceptional results in this quarter, which allow us to increase our revenue and earnings guidance for the full year," said CEO Friedhelm Blobel.
The company said it anticipates full year 2009 revenue of between $69 and $71 million, an increase of approximately 28 percent to 31 percent over 2008. SciClone anticipates earnings per share for the full year 2009 to be between 10 cents and 14 cents a share.
Research and development expenses for the second quarter totaled $3.7 million, compared with $4.5 million for the same period last year.
The company focuses on therapies for cancer and infectious diseases.
From $1.60 to $2.75 on very strong stats
Gotta love biotech cycles.
cheers,
SJ
geez... It only took 9 months to make this statement
a reality...
SCLN back to strength at $1.60
cheers,
SJ
showing strength and above support lines...
excellent chart technically.
Revenues increasing...
This one is a winner in the biotech field.
Cheers,
SJ
$1.25 entry to $1.60 and up from here
excellent conference call. All good
cheers,
SJ
SciClone and Sigma-Tau Report Promising Interim Results From Phase 3 Hepatitis C Trial
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A today reported promising blinded interim data from a large, randomized phase 3 clinical trial evaluating ZADAXIN® (thymalfasin) in combination with pegylated interferon alpha and ribavirin as a treatment for patients with hepatitis C virus (HCV) who have not responded to prior therapy with pegylated interferon alpha and ribavirin. Full unblinded data from the trial will be available in the third quarter of 2008.
48 Week End of Treatment Response
The interim blinded HCV data show that at the end of 48 weeks of therapy, 171 out of 553 total patients, including both treatment and control group patients, responded to treatment. A response to treatment is defined as having no detectable HCV RNA circulating in the blood at the end of 48 weeks of therapy.
72 Week Sustained Virologic Response
Of the 171 patients who responded after 48 weeks of therapy, 150 patients have completed the 24-week follow up period (72 week observation) and 54 patients have achieved a sustained virologic response (SVR). Of the remaining 21 patients who responded at the end of therapy, 12 were HCV negative at week 60 (12-week follow-up observation period), and two had yet to reach the week 60 follow-up point. All patients will complete the observation period by the end of the second quarter 2008. While these data include both treatment and control group patients, SciClone and Sigma-Tau believe the trend is promising in light of other recent clinical trial results in non-responder HCV patients retreated with only pegylated interferon alpha and ribavirin which demonstrated SVR rates of 3 to 8% at the 72 week observation point. If the final results of this trial are positive, SciClone and Sigma-Tau plan to meet with the regulatory authorities in the United States and Europe to determine the most expeditious process to bring this therapy to the market.
"These interim HCV data are promising because, although we do not know the breakdown between thymalfasin treated and control group patients who have achieved an SVR, this is already a strong overall response for nonresponder patients. We look forward to reporting full data from this trial in the third quarter of 2008," said Mario Rizzetto, M.D., Professor of Gastroenterology, San Giovanni Battista Hospital, University of Torino, Italy, and lead investigator of the trial. "Thymalfasin's mechanism of action as an immune stimulator may prove to be ideal in the treatment of chronic hepatitis C, where the immune system is suppressed and cannot effectively fight the disease on its own."
"We believe that thymalfasin could represent an important advance in the treatment of hepatitis C patients and address a growing and acute unmet need. We estimate that nearly 1 million HCV patients in the United States alone have failed or will fail currently approved therapy, particularly those who have not responded to prior therapy," stated Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "The treatment approach for HCV using a combination of thymalfasin together with pegylated interferon plus ribavirin is patent protected by SciClone in most major markets including the United States and Europe until 2021."
Thymalfasin Phase 3 Programs
"The information from these interim data is important in determining the optimal phase 3 development pathway for thymalfasin," noted Dr. Blobel. "In light of the promising interim data, we and Sigma-Tau are analyzing the many factors relative to our thymalfasin HCV and malignant melanoma programs."
In June 2007, SciClone reported positive phase 2 clinical trial results from Sigma-Tau's 488 patient study demonstrating thymalfasin met its primary endpoint in tumor response and, more importantly shows promise in extending survival for patients diagnosed with stage IV malignant melanoma. The companies are planning the design of a phase 3 melanoma trial and their regulatory strategy including a Special Protocol Assessment (SPA) to be filed with the Food and Drug Administration. Thymalfasin phase 3 clinical development and commercialization plans for HCV and melanoma have potentially significantly different timelines, costs, sizes of prospective addressable markets, competitive products and other factors. Consequently, before proceeding further with the melanoma trial, SciClone and Sigma-Tau will review the final 72 week results for the current HCV clinical trial in the third quarter of 2008 in order to determine the next steps for an optimal thymalfasin development program for the HCV and malignant melanoma indications.
Today, Israel Rios, M.D., Chief Medical Officer of SciClone Pharmaceuticals, will participate in a panel discussion on "HCV: Beyond Coin Toss SVRs" at the BIO CEO and Investor Conference 2008 in New York City. Dr. Blobel will present a corporate overview at the conference tomorrow, February 12, 2008, at 4:15 p.m. ET. To access the live audio webcast of the corporate presentation, log on through a link located in the Investor Relations section of SciClone's website at www.sciclone.com. A replay of the webcast will be available until March 14, 2008.
Thymalfasin Triple Therapy for HCV
The ongoing phase 3, multi-center, double-blinded, randomized study enrolled 553 predominately genotype 1 HCV patients who have not responded to previous treatment with pegylated interferon alpha and ribavirin. Patients were randomized, in a one-to-one ratio, to receive either thymalfasin or a placebo, and all patients received pegylated interferon alpha and ribavirin. After completing 48 weeks of treatment, patients are monitored twice during a 24-week observation period at week 60 and week 72.
The primary endpoint of the trial is sustained virological response (SVR), defined as the absence of HCV RNA measured at week 72, which is the end of the 24-week observation period. The secondary endpoints are normalization of ALT (an enzyme that when present in increased levels is an indicator of inflammation or damage of the liver) measured at the end of weeks 48 and 72, absence of HCV RNA measured at week 48, and an improvement in liver biopsy. Details of the study design and preliminary blinded safety data were reported by Professor Rizzetto at the 'Thymosins in Health and Disease First International Symposium' held last year in Washington, D.C. and also were published in September 2007 in a special edition of the Annals of the New York Academy of Sciences.
The design of this phase 3 clinical trial is derived from the positive results from a 2005 pilot study conducted by a team led by Jorge L. Poo, M.D., Chief Scientific Officer of CIF-Biotech at the Medica Sur hospital in Mexico City. This study evaluated the use of thymalfasin in combination with pegylated interferon alpha 2a and ribavirin to treat 40 patients who had not responded to prior therapy with the non-pegylated form of interferon and ribavirin. Measured on an intent-to-treat basis, this small study demonstrated a 22% SVR for the most difficult to treat genotype 1 patients.
Triple therapy, the addition of another agent to the combination of pegylated interferon alpha and ribavirin, is now an accepted approach in efforts to develop a new therapeutic regimen that may provide HCV patients with a potentially better chance to reach a sustained virological response. SciClone was a pioneer in developing the triple therapy approach, and today several drug developers are combining their drug in a triple therapy regimen for HCV clinical trials, typically after discovering that their drug alone or in combination with only pegylated interferon alpha did not provide satisfactory results in comparison to the standard therapy of pegylated interferon and ribavirin. In 2005 and 2006, SciClone completed two phase 3 clinical trials using thymalfasin in combination with pegylated interferon without ribavirin. Although those trials did not show statistical significance in the thymalfasin treatment arm, a positive thymalfasin-related trend was observed in SVR.
About Hepatitis C Virus
HCV is a blood-borne viral disease which causes inflammation of the liver. The World Health Organization estimates that 170 million people worldwide are infected with HCV, and the Centers for Disease Control estimates that approximately 8 to 10 million people are infected with HCV throughout the U.S. and Europe. Of these patients, approximately 85% are chronically infected, and the persistent liver inflammation in chronically infected patients can develop serious complications including cirrhosis of the liver, liver failure and hepatocellular carcinoma or liver cancer. Only about half of all naïve patients treated with current therapy achieve an SVR, and SciClone estimates nearly 1 million HCV patients in the United States alone have failed or will fail current therapy. The markets for HCV therapeutics in the three major economic regions of the United States, Europe and Japan are estimated to total approximately $3 billion currently and are expected to grow to approximately $10.6 billion by 2014.
About Thymalfasin
ZADAXIN, scientifically referred to as thymalfasin or thymosin alpha 1, is SciClone's synthetic preparation of thymalfasin, a thymic peptide which circulates in the blood naturally, and is instrumental in the immune response to certain cancers and viral infections. Published scientific and clinical studies have shown that thymalfasin helps stimulate and direct the body's immune response to eradicate infectious diseases like HCV and HBV, as well as certain cancers. Thymalfasin appears to be well tolerated with few reports of significant side effects or toxicities associated with its use.
Thymalfasin elicits a variety of immune system responses against viruses. One such response is an increase in production of certain subsets of white blood cells and their differentiation into CD-4 helper-cells, specifically towards differentiation into the Th1 subset of CD-4 helper cells (Th1 cells secrete cytokines such as interleukin-2 (IL-2) and gamma interferon that can help the immune response). Moreover, as thymalfasin increases differentiation into Th1 cells, it also results in decreased CD-4 cell differentiation into the Th2 subset of CD-4 helper cells that produce cytokines, such as IL-4, which are associated with persistence of viral infection. In addition, thymalfasin stimulates several other components of the immune response that help the body attack and kill virally-infected cells.
The shorts are getting jerked around SCLN on low volume, these boys will keep a bid under the stock until $3 or more.
SciClone Reports Third Quarter 2007 Results
Tuesday November 13, 6:30 am ET
FOSTER CITY, CA--(MARKET WIRE)--Nov 13, 2007 -- SciClone Pharmaceuticals, Inc. (NasdaqGM:SCLN - News) today reported results for the third quarter ended September 30, 2007. For the third quarter 2007, product revenues from the sale of ZADAXIN® (thymalfasin), SciClone's lead product, increased by 14% to $9,421,000, compared with revenues of $8,270,000 for the third quarter 2006. For the nine months ended September 30, 2007, product revenues increased by 13% to $27,020,000, compared with product revenues of $23,969,000 for the same period of 2006. The increase in product revenues for the third quarter and nine months ended September 30, 2007 is primarily attributable to an increase in the quantity of ZADAXIN sold in China, which accounted for approximately 92% of total ZADAXIN sales for the quarter.
"Our revenues from the sales of ZADAXIN to China continue to grow as we expand our reach in this important and growing pharmaceutical market," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Simultaneously, we continue to advance our clinical-stage pipeline of products targeting approvals in the United States and Europe as we are on track to begin a phase 2 clinical trial using RP101 to treat pancreatic cancer patients in the fourth quarter of 2007 and a phase 3 clinical trial using thymalfasin to treat malignant melanoma patients in the first quarter of 2008."
Net loss for the third quarter 2007 totaled $3,055,000, or $0.07 per share, compared with $1,306,000, or $0.03 per share, for the third quarter 2006. A higher level of research and development expenditure associated with the initiation of the RP101 clinical trial accounted for the majority of the increase in net loss for the 2007 period. For the nine months ended September 30, 2007, net loss was $6,336,000, or $0.14 per share, compared with net income of $2,230,000, or $0.05 per share, for the same period of 2006. Net income for the nine months ended September 30, 2006 included an $8,000,000 settlement received in April 2006; there was no similar income received during the corresponding periods of 2007.
Research and development expenses for the third quarter 2007 totaled $4,793,000, compared with $3,167,000 for the third quarter 2006. For the nine months ended September 30, 2007, research and development expenses were $11,928,000, compared with $10,897,000 for the same period of 2006.
Cash, cash equivalents and short-term investments totaled $37,516,000 at September 30, 2007, compared with $37,481,000 at June 30, 2007 and $42,073,000 at September 30, 2006.
Financial Guidance for Full Year 2007
SciClone now expects to exceed its previous revenue guidance of $35,000,000 to $36,000,000 driven primarily by the continued growth in sales of ZADAXIN to China. With the planned initiation of the RP101 clinical trial in the fourth quarter SciClone increases its 2007 estimates for research and development expenses from approximately $19,000,000 to $22,000,000 for the full year 2007, and net loss estimate increases from approximately $13,000,000, or $0.28 net loss per share, to $14,000,000, or $0.31 net loss per share for the full year 2007. The guidance for cash, cash equivalents and short-term investments at December 31, 2007 is maintained at approximately $26,000,000.
Recent Highlights
-- SCV-07 demonstrated positive results in preclinical animal models of
mucositis, lung cancer and malignant melanoma.
-- SciClone appointed Eric Hoechstetter Vice President of Legal Affairs.
Mr. Hoechstetter brings to SciClone 16 years of legal experience with a
majority focused on international business. At Chiron Corporation he was
Senior Corporate Counsel at the UK headquarters and oversaw all legal
affairs of the Biopharmaceutical Division's European activities as well as
the company's corporate governance activities ex-United States. From 1995
to 2003 he served in legal capacities of increasing responsibility in
Europe for three rapidly growing communications companies, Wanadoo S.A.,
Level (3) Communications Ltd., and Global One Communications S.A. He began
his legal career with White & Case in New York. He earned a Bachelor of
Business Administration from the University of Michigan and a law degree
from Columbia University School of Law.
-- SciClone presented at the UBS Global Healthcare Conference in
September and will present at the BIO Europe Partnering Conference on
November 14, 2007.
http://biz.yahoo.com/iw/071113/0327676.html
August 7, 2007 - 5:30 AM EST
SCLN 2.06 -0.08
SciClone Reports Second Quarter 2007 Results
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today reported results for the second quarter ended June 30, 2007. For the second quarter 2007, product revenues from the sale of ZADAXIN® (thymalfasin), SciClone's lead product, increased by 13% to $8,955,000, compared with revenues of $7,910,000 for the second quarter 2006. For the six months ended June 30, 2007, product revenues increased by 12% to $17,599,000, compared with product revenues of $15,699,000 for the same period of 2006. The increase in product revenues for the second quarter and six months ended June 30, 2007 is primarily attributable to an increase in the quantity of ZADAXIN sold in China, which accounts for over 90% of total ZADAXIN sales.
"During the second quarter, we continued to grow our sales of ZADAXIN to China, hired key regulatory and business development personnel and further expanded our well established sales organization in China," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "Broadening our capabilities while adding sales representatives to our strong sales and marketing base are key parts of our strategy to build a leading pharmaceutical business in this rapidly growing market."
Dr. Blobel continued, "We are making significant progress in advancing our product development portfolio for the U.S. and European markets. Most notably we reported that the primary endpoint in a large phase 2 study of thymalfasin for malignant melanoma was achieved and we acquired the U.S. and Canadian rights to RP101, a clinical compound for the treatment of pancreatic cancer. Both of these cancer indications present markets with significant unmet medical needs. Moving forward, we expect to initiate a phase 2 pancreatic cancer clinical trial for RP101 by the fourth quarter of this year. We also will be meeting with the FDA early next quarter to discuss our multinational phase 3 melanoma clinical trial for thymalfasin, which we expect to commence in the first quarter of 2008. In addition, we look forward to analyzing and reporting final results from our European phase 3 hepatitis C clinical trial using thymalfasin in triple therapy in the second half of 2008."
Net loss for the second quarter 2007 totaled $2,657,000, or $0.06 per share, compared with net income of $5,960,000, or $0.13 per share, for the second quarter 2006. For the six months ended June 30, 2007, net loss was $3,281,000, or $0.07 per share, compared with net income of $3,536,000, or $0.08 per share, for the same period of 2006. Net income for the second quarter and six months ended June 30, 2006 included an $8,000,000 settlement received in April 2006; there was no similar income received during the corresponding periods of 2007.
Research and development expenses for the second quarter 2007 totaled $4,712,000, compared with $3,901,000 for the second quarter 2006. For the six months ended June 30, 2007, research and development expenses were $7,135,000, compared with $ 7,730,000 for the same period of 2006.
Cash, cash equivalents and short-term investments totaled $37,481,000 at June 30, 2007, compared with $38,986,000 at March 31, 2007, and $44,091,000 at June 30, 2006.
Financial Guidance for Full Year 2007
For the full year 2007, SciClone is maintaining its current guidance. SciClone maintains its revenue estimate of approximately $35,000,000 to $36,000,000, driven primarily by continued growth in sales of ZADAXIN to China. Also, SciClone is maintaining its estimates for research and development expenses of approximately $19,000,000 for the full year 2007, net loss of approximately $13,000,000, or $0.28 net loss per share, for the full year 2007, and cash, cash equivalents and short-term investments at December 31, 2007 of approximately $26,000,000. Second quarter 2007 highlights included:
-- To further expand SciClone's capabilities in China, SciClone hired
Annie Qi-man Yin as the Head of Regulatory Affairs and Clinical Operations
in China and Asia and Horace Hao Wu as the Head of Marketing and Business
Development in China. Mrs. Yin joined SciClone in July 2007 from Shanghai
Roche Pharmaceuticals Ltd. where she was Medical Manager of the
Medical/Pharma Development Department. Prior to Roche, Mrs. Yin was with
Eli Lilly Asia where she was the Regulatory Affairs Team Leader. Mrs. Yin
has been involved with 23 new product approvals in China over the span of
her career. Mr. Wu will join SciClone in August 2007 and has 13 years of
experience in marketing and sales with Schering-Plough (China), Shanghai
Roche Pharmaceuticals Ltd., and most recently with Eisai China. At Eisai
he was Head of Marketing Division, Shanghai and in charge of business
development to introduce new products and enhance the product portfolio of
Eisai China.
-- In June 2007, SciClone initiated a proof-of-concept phase 2 clinical
trial using its proprietary compound SCV-07 as a sole agent to treat
patients infected with the hepatitis C virus. SciClone expects to report
data in the first quarter of 2008.
-- In June 2007 at the Annual Meeting of the American Society of Clinical
Oncology, SciClone and its European partner Sigma-Tau S.p.A reported that
thymalfasin (ZADAXIN, thymosin alpha 1) achieved its primary endpoint in a
phase 2 clinical trial treating patients diagnosed with stage IV malignant
melanoma. Results showed that thymalfasin in combination with dacarbazine
(DTIC) chemotherapy tripled the overall response rate and extended overall
survival by nearly 3 months compared to patients treated with DTIC, the
current standard of care, and interferon alpha. SciClone plans to initiate
a phase 3 clinical trial in melanoma in the first quarter of 2008.
-- In April 2007, SciClone acquired the exclusive rights in the United
States and Canada to develop and commercialize RP101, a clinical-stage
compound for the treatment of cancer. In a previous phase 1 clinical trial
evaluating RP101 in combination with gemcitabine, the current standard of
care, to treat late-stage pancreatic cancer patients, the median survival
for the RP101 treated group was 9.3 months, compared to the historical
control of approximately 6 months for patients treated with gemcitabine
alone. SciClone expects to initiate a phase 2 pancreatic cancer trial for
RP101 by the fourth quarter of 2007.
Conference Call
SciClone will host a conference call at 10:30 a.m. ET (7:30 a.m. PT) today, Tuesday, August 7, 2007. The call will contain forward-looking statements. Financial and statistical information to be discussed in the conference call will be posted on the Investor Relations section of SciClone's web site at www.sciclone.com prior to the commencement of the conference call.
DATE: Tuesday, August 7, 2007
TIME: 10:30 a.m. ET (7:30 a.m. PT)
WEBCAST: Live call and replay accessible at www.sciclone.com
LIVE CALL: 800-289-0533 (U.S./Canada)
913-981-5525 (International)
REPLAY: 888-203-1112 (U.S./Canada)
719-457-0820 (International)
Passcode: 4316600
(Replay available from 1:30 p.m. ET on August 7, 2007
through 12:00 a.m. ET on September 7, 2007)
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead™. For the U.S. market, SciClone's clinical-stage drug development candidates are SCV-07 for the treatment of hepatitis C virus and RP101 for the treatment of pancreatic cancer. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding future sales and financial results for 2007, and progress and results of our clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, goals, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including changes in demand for ZADAXIN, the progress or failure of clinical trials, our actual experience in executing on our objectives, the performance of our partners, maintenance of the sufficiency and eligibility of the enrolled patient population, unanticipated delays or additional expenses incurred during our clinical trials, our future cash requirements, delays in analyzing and synthesizing data obtained from clinical trials, the performance and future actions of our strategic partners, unexpected delays in clinical trial enrollment, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and the fact that experimental data and clinical results derived from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission. Further, although our financial guidance is based on our current estimates, factors such as the actual timeline and design of the phase 3 melanoma clinical trial and final decisions regarding expense sharing arrangements for the trial could alter the estimates of our research and development expenses, net loss and year end cash balance for 2007.
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2007 2006 2007 2006
=========== =========== =========== ===========
Product sales $ 8,955,000 $ 7,910,000 $17,599,000 $15,699,000
Contract revenue - 54,000 - 144,000
----------- ----------- ----------- -----------
Total revenues 8,955,000 7,964,000 17,599,000 15,843,000
Cost of product sales 1,687,000 1,373,000 3,315,000 2,939,000
----------- ----------- ----------- -----------
Gross margin 7,268,000 6,591,000 14,284,000 12,904,000
Operating expenses:
Research and
development 4,712,000 3,901,000 7,135,000 7,730,000
Sales and marketing 3,139,000 2,843,000 6,163,000 5,675,000
General and
administrative 2,444,000 2,294,000 5,054,000 4,681,000
----------- ----------- ----------- -----------
Total operating
expenses 10,295,000 9,038,000 18,352,000 18,086,000
----------- ----------- ----------- -----------
Loss from operations (3,027,000) (2,447,000) (4,068,000) (5,182,000)
Interest and investment
income 419,000 446,000 873,000 798,000
Interest and investment
expense (10,000) (22,000) (20,000) (63,000)
Other (expense) income,
net (11,000) 7,983,000 (17,000) 7,983,000
----------- ----------- ----------- -----------
(Loss) income before
provision for income
tax (2,629,000) 5,960,000 (3,232,000) 3,536,000
Provision for income tax 28,000 - 49,000 -
----------- ----------- ----------- -----------
Net (loss) income $(2,657,000) $ 5,960,000 $(3,281,000) $ 3,536,000
=========== =========== =========== ===========
(Loss) earnings per share:
Basic net (loss)
income per share $ (0.06) $ 0.13 $ (0.07) $ 0.08
Diluted net (loss)
income per share $ (0.06) $ 0.13 $ (0.07) $ 0.08
Weighted average shares
used in computing:
Basic net (loss)
income per share 46,093,452 45,899,646 46,083,777 45,895,784
Diluted net (loss)
income per share 46,093,452 46,090,981 46,083,777 46,076,921
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
ASSETS
June 30, December 31,
2007 2006
============ ============
(unaudited)
Current assets:
Cash and cash equivalents $ 27,385,000 $ 25,615,000
Restricted short-term investments 700,000 698,000
Other short-term investments 9,396,000 16,279,000
Accounts receivable, net of allowance of
$15,000 at June 30, 2007 and $50,000 at
December 31, 2006 13,353,000 13,277,000
Inventories 4,504,000 3,232,000
Prepaid expenses and other current assets 2,332,000 1,640,000
------------ ------------
Total current assets 57,670,000 60,741,000
Property and equipment, net 239,000 297,000
Intangible assets, net 367,000 402,000
Other assets 1,088,000 1,144,000
------------ ------------
Total assets $ 59,364,000 $ 62,584,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,000,000 $ 963,000
Accrued compensation and employee benefits 1,206,000 1,813,000
Accrued professional fees 995,000 754,000
Other accrued expenses 1,780,000 2,487,000
Accrued clinical trials expense 1,436,000 1,803,000
Deferred revenue 36,000 62,000
------------ ------------
Total current liabilities 6,453,000 7,882,000
Other Long-term liabilities 126,000 68,000
Commitments and contingencies
Stockholders' equity:
Preferred stock; $0.001 par value;
10,000,000 shares authorized; no shares
outstanding in 2007 and 2006 - -
Common stock; $0.001 par value; 75,000,000
shares authorized; 46,114,562 and
46,001,249 shares issued and outstanding at
June 30, 2007 and December 31, 2006,
respectively 46,000 46,000
Additional paid-in capital 214,497,000 213,064,000
Accumulated other comprehensive income 77,000 78,000
Accumulated deficit (161,835,000) (158,554,000)
------------ ------------
Total stockholders' equity 52,785,000 54,634,000
------------ ------------
Total liabilities and stockholders' equity $ 59,364,000 $ 62,584,000
============ ============
SCICLONE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six months ended
June 30,
2007 2006
============ ============
Operating activities:
Net (loss) income $ (3,281,000) 3,536,000
Adjustments to reconcile net (loss) income to
net cash (used in) provided by operating
activities:
Non cash expense related to employee stock
options 1,158,000 1,231,000
Depreciation and amortization 109,000 118,000
Loss from disposal of property and equipment - 1,000
Changes in operating assets and liabilities:
Accounts receivable, net (76,000) (779,000)
Inventories (1,222,000) 101,000
Prepaid expenses and other assets (636,000) 249,000
Accounts payable and other accrued expenses (670,000) (212,000)
Accrued compensation and employee benefits (607,000) (829,000)
Accrued clinical trials expenses (367,000) (111,000)
Accrued professional fees 241,000 301,000
Deferred revenue (26,000) (150,000)
Long-term liabilities 58,000 (58,000)
------------ ------------
Net cash provided by (used in) operating
activities (5,319,000) 3,398,000
------------ ------------
Investing activities:
Purchases of property and equipment (16,000) (26,000)
Sales (purchases) of short-term investments,
net 6,880,000 (161,000)
------------ ------------
Net cash (used in) provided by investing
activities 6,864,000 (187,000)
------------ ------------
Financing activities:
Proceeds from issuances of common stock 225,000 44,000
Repayment of notes payable - (1,600,000)
------------ ------------
Net cash (used in) provided by financing
activities 225,000 (1,556,000)
------------ ------------
Net increase in cash and cash equivalents 1,770,000 1,655,000
Cash and cash equivalents, beginning of period 25,615,000 25,845,000
------------ ------------
Cash and cash equivalents, end of period $ 27,385,000 $ 27,500,000
============ ============
Corporate Contact
Richard Waldron
Executive Vice President and Chief Financial Officer
SciClone Pharmaceuticals, Inc.
650-358-3437
Source: Market Wire (August 7, 2007 - 5:30 AM EST)
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SciClone Initiates Phase 2 Clinical Trial Using SCV-07 to Treat Hepatitis C Patients
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced it has initiated a proof-of-concept phase 2 clinical trial using its proprietary compound SCV-07 as a sole agent to treat patients infected with the hepatitis C virus (HCV). The trial is designed to evaluate the therapeutic effect of SCV-07 on patients with HCV.
"SCV-07 has shown broad applicability in viral diseases, and we are eager to determine the therapeutic benefit of this compound for patients with HCV," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "The objective of this trial is to demonstrate SCV-07's effect on hepatitis C viral load as well as on other measures of immune response, and we expect to report data in the first quarter of 2008. If we are able to determine that SCV-07 stimulates the immune system in a method similar to that of interferon alpha, but without side effects, this could be a significant treatment advance for patients suffering from HCV."
The randomized, placebo-controlled trial plans to enroll 30 patients infected with the difficult to treat genotype 1 strain of the HCV virus who previously responded to treatment with interferon alpha and ribavirin, but subsequently relapsed. Patients will be randomized into three cohorts of escalating doses, and will receive daily subcutaneous injections of SCV-07 or placebo. After completing seven days of therapy, all patients will be monitored for 14 days. The primary endpoint of the trial will be a single-log reduction in the hepatitis C viral load.
About SCV-07
SciClone's proprietary drug candidate SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects. SCV-07 has shown efficacy in treating various viral and bacterial infections. SCV-07 specifically stimulates the immune system through its effects on T-helper 1 cells, which are essential for clearance of viral infections. In June 2007, SciClone reported that SCV-07 also inhibits melanoma tumor growth, a cancer know to be sensitive to immune modulation, in an animal model study. Additional preclinical studies with SCV-07 are ongoing.
About Hepatitis C Virus
HCV is a viral disease which attacks the liver and can lead to cirrhosis of the liver, liver cancer and death. According to the Centers for Disease Control and Prevention, approximately 3.2 million individuals in the United States are chronically infected with HCV. Approximately 75% of these chronically infected carriers are infected with the difficult to treat genotype 1 strain of the virus. Unfortunately, currently approved therapy, including the immunotherapy interferon alpha with or without the antiviral drug ribavirin, has significant side effects and is ineffective in treating most patients infected with HCV genotype 1.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN® is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC Bead(TM). For the U.S. market, SciClone's clinical-stage drug development candidates are SCV-07 for the treatment of hepatitis C virus and RP101 for the treatment of pancreatic cancer. For more information about SciClone, visit www.sciclone.com.
This press release contains forward-looking statements including our statement regarding timing and expectations for an SCV-07 Phase 2 clinical trial and because the experimental or clinical data described may imply certain actual results in larger patient populations. These statements are subject to risks and uncertainties and may. Actual outcomes may differ from our forward-looking statements because of the inherent uncertainties in the timing of clinical trial events including patient enrollment. Experimental data and clinical results derived from studies with animals or a limited group of patients may not be predictive of the results of larger studies and, therefore, such experimental or clinical data is not necessarily predictive of efficacy or safety or the results of larger studies and clinical trials.
Corporate Contact:
Richard Waldron
Executive Vice President and Chief Financial Officer
SciClone Pharmaceuticals, Inc.
650-358-3437
Source: Market Wire (June 27, 2007 - 6:30 AM EDT)
SciClone and Sigma-Tau Report Thymalfasin Meets Primary Endpoint in Phase 2 Malignant Melanoma Trial
Data Presented at Annual Meeting of the American Society of Clinical Oncology
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) and Sigma-Tau S.p.A today announced that SciClone's lead product candidate thymalfasin (ZADAXIN®, thymosin alpha 1) achieved its primary endpoint in a phase 2 clinical trial treating patients diagnosed with stage IV malignant melanoma, the most advanced form of skin cancer. Results showed that thymalfasin in combination with dacarbazine (DTIC) chemotherapy tripled the overall response rate and extended overall survival by nearly 3 months compared to patients treated with DTIC, the current standard of care, and interferon alpha.
"We are extremely pleased with the outcome of this trial, and are particularly excited that thymalfasin's therapeutic effect is demonstrated consistently through increased overall survival, the most important standard in oncology as well as tumor response in each treated group," commented Israel Rios, M.D., Chief Medical Officer of SciClone Pharmaceuticals, Inc. "Based on these results, we intend to meet with the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) in the third quarter of 2007. Our current goal is to begin our planned phase 3 registration trial in the fourth quarter of 2007 to treat stage IV malignant melanoma patients."
The phase 2 multi-center, randomized open-label study enrolled 488 patients with stage IV metastatic melanoma at 64 European clinical sites. The trial was designed to evaluate different dose levels of thymalfasin in combination with DTIC chemotherapy, with and without low-dose interferon alpha, as a first-line treatment for malignant melanoma. Most patients enrolled in the trial had liver and other metastases and the remaining patients had lung metastases and skin or lymph node metastases. Thymalfasin at all dose levels was well-tolerated in all treated patients, with no serious adverse events attributed to the drug.
These data were presented Sunday, June 3rd, 2007 at the Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois and were the subject of a poster presentation entitled 'A large first-line, randomized, dose-finding, phase II study on Thymosin alpha 1 (Tα1) plus Dacarbazine (DTIC) with or without Interferon alpha (IFNα) vs DTIC plus IFNα in stage IV melanoma. Tumor response and survival results' (ASCO abstract number: 8535).
Tumor Response Data
When measured for overall tumor response, including complete response (CR) and partial response (PR), all patients in the treatment arms containing thymalfasin showed a greater overall tumor response than those in the control arm. Patients treated with the 3.2 mg dose of thymalfasin in combination with DTIC without interferon alpha showed an overall tumor response of 12.1%, compared to 4.1% for patients in the control group treated with DTIC and interferon alpha.
Complete Partial Overall
Response Response Response
Treatment Arm N= (CR) (PR) Rate
(CR + PR)
DTIC + Interferon alpha 97 0 4 4 (4.1%)
(control)
Thymalfasin (3.2 mg) + DTIC 99 2 10 12 (12.1%)
Thymalfasin (1.6 mg) + DTIC + 97 2 5 7 (7.2%)
Interferon alpha
Thymalfasin (3.2 mg) + DTIC + 97 3 7 10 (10.3%)
Interferon alpha
Thymalfasin (6.4 mg) + DTIC + 98 2 4 6 (6.1%)
Interferon alpha
Overall Survival and Progression Free Survival Data
When measured for overall survival, all patients in the treatment arms containing thymalfasin reached a longer median survival than those in the control arm. Patients treated with the 3.2 mg dose of thymalfasin in combination with DTIC without interferon alpha reached a median survival of 9.3 months, compared to 6.6 months for patients in the control group treated with DTIC and interferon alpha. Median progression free survival was 1.87 months for the group of patients treated with the 3.2 mg dose of thymalfasin in combination with DTIC without interferon alpha, compared to 1.81 months for the control group treated with DTIC and interferon alpha. Even though the median progression free survival times were similar, the Hazard Ratio (HR) comparing 3.2 mg of thymalfasin together with DTIC versus patients treated with DTIC and interferon alpha was 0.74, which translates into a 26% reduction of the risk of disease progression for patients treated with 3.2 mg of thymalfasin.
Intent to treat analysis (includes all patients enrolled in the trial):
Median Median Median
Treatment Arm N= Survival Progression Follow-up
Free Period
Survival
DTIC + Interferon alpha 97 6.6 months 1.81 months 31.9 months
(control)
All Thymalfasin Arms 391 9.4 months 1.84 months 26.8 months
Thymalfasin (3.2 mg) + DTIC 99 9.3 months 1.87 months 32.1 months
Thymalfasin (1.6 mg) + DTIC + 97 9.3 months 1.84 months 28.5 months
Interferon alpha
Thymalfasin (3.2 mg) + DTIC + 97 8.5 months 1.84 months 28.5 months
Interferon alpha
Thymalfasin (6.4 mg) + DTIC + 98 10.2 months 1.84 months 17.7 months
Interferon alpha
In a subset analysis excluding patients with elevated levels of the enzyme lactate dehydrogenase (LDH), a factor associated with poor prognosis, the group of patients with normal LDH levels treated with the 3.2 mg dose of thymalfasin in combination with DTIC without interferon reached a median survival of 14.4 months, compared to 10.8 months for the control group treated with DTIC and interferon alpha. Median progression free survival was 3.65 months for the group of normal LDH patients treated with the 3.2 mg dose of thymalfasin in combination with DTIC without interferon alpha, compared to 2.17 months for the control group treated with DTIC and interferon alpha (HR= 0.62).
Patients with normal lactate dehydrogenase (LDH):
Median
Treatment Arm N= Median Progression
Survival Free Survival
DTIC + Interferon alpha (control) 63 10.8 months 2.17 months
All Thymalfasin Arms 246 12.9 months 3.45 months
Thymalfasin (3.2 mg) + DTIC 62 14.4 months 3.65 months
Thymalfasin (1.6 mg) + DTIC + 62 12.9 months 3.33 months
Interferon alpha
Thymalfasin (3.2 mg) + DTIC + 58 12.6 months 3.38 months
Interferon alpha
Thymalfasin (6.4 mg) + DTIC + 64 12.8 months 3.38 months
Interferon alpha
How Thymalfasin Works in Melanoma
Suppression of the growth of immune-sensitive tumors such as melanoma have been shown to be dependent on a strong immune response, including a large number of activated effectors such as tumor-infiltrating lymphocyte cells (TILs) and specific anti-melanoma cytotoxic T lymphocytes (CTL). It is also important to increase the presentation of cancer-specific antigens to the immune system through sustained expression of these molecules along with MHC Class I, as cancers avoid the immune system by decreases in this presentation.
Thymalfasin's potential beneficial role in treatment of melanoma derives from its demonstrated activation of these various arms of the immune system, including increases in TILs, CTLs, and expression of MHC Class I and tumor-specific antigens. Thymalfasin's multiple activities arise through activation of Toll-like receptor 9 and signaling through increases in the nuclear factor NfKB through Myd88 and IKKb. Evaluation of thymalfasin's utility in melanoma animal models has confirmed effective anti-tumor activity.
About Malignant Melanoma
Skin cancer is the most common form of cancer in the United States. In 2007, The American Cancer Society estimates that approximately 8,110 deaths will occur from melanoma and another 59,940 cases of melanoma are expected to be diagnosed in this country. Melanoma is classified as stage IV, the most advanced form, once the cancer has spread beyond the skin to a distant site. DTIC and interleukin-2 (IL-2) are the only FDA-approved therapies for the treatment of malignant melanoma. However, these other therapeutic agents including alpha interferon, used alone or in combination, are ineffective at extending overall patient survival, which at this stage is typically only about six to nine months. Response to treatment largely depends upon the stage of melanoma, disease site and the extent to which the cancer has spread.
ZADAXIN received Orphan Drug Designation in the United States for stage IIb through stage IV malignant melanoma in March 2006.
About SciClone
SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage in China by in-licensing or acquiring the marketing rights to other products, such as the DC Bead, to broaden its portfolio in this rapidly growing pharmaceutical market. For the U.S. market, SciClone's clinical-stage drug development candidates are SCV-07 for the treatment of viral infectious diseases and RP101 for the treatment of pancreatic cancer. For more information about SciClone, visit www.sciclone.com.
The information in this press release contains forward-looking statements including our expectations and beliefs regarding timing, progress and results of our clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including the progress of ongoing and proposed trials and studies for thymalfasin, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in Europe and the fact that clinical results from one study may not be indicative of clinical results in other large trials, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.
Corporate contact:
Richard Waldron
Executive Vice President and Chief Financial Officer
SciClone Pharmaceuticals, Inc.
650-358-3437
Source: Market Wire (June 4, 2007 - 6:30 AM EDT)
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SciClone Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapeutics for the treatment of cancer and infectious diseases in China and internationally. It provides ZADAXIN for the treatment of hepatitis B and hepatitis C, and certain cancers, as well as for use as a vaccine adjuvant. The company?s products under development includes ZADAXIN, a thymalfasin, which is in Phase III clinical trials for the treatment of stage IV melanoma; RP101, which is in Phase II clinical trials for the treatment of pancreatic cancer; and SCV-07, which is in Phase II clinical trials for the treatment of hepatitis C virus and oral mucositis. It also holds Chinese marketing rights from Biocompatibles International plc. for DC Bead, a product for the treatment of liver cancer or hepatocellular carcinoma. The company was founded in 1989 and is headquartered in Foster City, California. |
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Products & Pipe-Line Details:
ZADAXIN Melanoma - http://www.sciclone.com/product/zadaxin_melanoma.php
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