Zadaxin - SciClone Pharmaceuticals - Charting A New Course?

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http://www.tradingmarkets.com/.site/news/TOP%20STORY/2396491/

SciClone Pharmaceuticals - Charting A New Course?

Mon. June 29, 2009; Posted: 10:51 AM

(RTTNews) - Shares of SciClone Pharmaceuticals Inc.opened Monday's trading

session at $2.65, setting a new 52-week high. Now that it is re-entering the

U.S. broad-market 3000 index, the stock is slated to get a higher

profile among investors.

SciClone has an established business in China and the country accounted for

about 94% of the company's product sales last year. Zadaxin (Thymalfasin),

approved for the treatment of hepatitis B, hepatitis C, certain immune-sensitive

cancers and as a vaccine adjuvant, is the company's only marketed drug and is

approved for sale in over 30 countries, primarily in Asia, Eastern Europe, the

Middle East and Latin America.

SciClone sells Zadaxin in various international markets through its wholly owned

subsidiary, SciClone Pharmaceuticals International Ltd.

Thanks to SciClone's increased marketing efforts, Zadaxin sales have continued

to rise year-over-year -- $32.4 million in 2006; $37 million in 2007 and $54.1

million in 2008. Despite competition from generic brands in China, Zadaxin has

been able to achieve consistent double-digit sales growth. According to the

company, Zadaxin has a strong brand recognition and is positioned as a

high-quality, imported, premium-priced product.

However, the drug has yet to be approved in key markets of the United States,

Europe and Japan. Last November, a phase III trial evaluating Zadaxin in

combination with pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin as a

treatment for patients with hepatitis C virus who have not responded to prior

therapy consisting of peg-IFN and ribavirin alone failed to achieve statistical

significance for the primary endpoint of sustained virological response.

In the U.S., Zadaxin is under development as a potential treatment for stage IV

melanoma. In late 2008, SciClone and the FDA reached an agreement on the design

of a phase III registration trial for Zadaxin for stage IV melanoma. The company

is in active discussion with several parties to establish a partnership for its

phase III study of Zadaxin in stage IV melanoma.

In a phase II study, Zadaxin in combination with dacarbazine, or 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 has patent protection through 2021 in the United States and Europe for

the HCV treatment approach using the triple therapy of Zadaxin, pegylated

interferon, and ribavirin. Italy-based Sigma-Tau retains the European rights to

Zadaxin, while SciClone has the rights to the drug in all other regions of the

world, including the United States.

According to SciClone, Zadaxin has a potential to generate global sales of $200

million for stage IV melanoma indication and over $500 million if the targeted

patient group is extended to include earlier stage patients in the adjuvant

setting.

Other drugs under development include SCV-07, a phase II drug for oral mucositis

and hepatitis C and RP101, a phase II drug for pancreatic cancer. The company's

DC Bead product, a drug-eluting agent, is awaiting approval in China for the

treatment of liver cancer.

The results of a proof-of-concept phase IIa clinical trial using SCV-07 as a

sole agent administered to patients chronically infected with HCV (hepatitis C

virus), released last September, demonstrated activity in some treated patients

in the higher dosage groups. Additionally, SCV-07 was shown to be generally safe

and well-tolerated with no dose limiting toxicities or serious adverse events

reported. SciClone is planning to initiate a phase IIb trial for SCV-07 in HCV

this year.

Another indication for which SCV-07 is being tested as a potential treatment is

oral mucositis in subjects receiving chemoradiation therapy for the treatment of

cancers of the head and neck. SCV-07 is under phase II testing for this

indication. The company plans to complete enrollment of this trial before the

end of 2009 and expects to report results in the first half of 2010.

SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the

molecule was recently approved for stimulation of depressed immune systems and

commercialization was just started. The worldwide rights, outside of Russia, to

commercialize SCV-07 were acquired by SciClone from Verta Ltd., a biotechnology

company in St. sburg in 1999.

Early in the month of March, the company announced that it has completed

enrollment of unresectable stage III and IV pancreatic cancer patients in a

phase II trial evaluating RP101 in combination with gemcitabine chemotherapy

ahead of the schedule. Results of the trial are expected in the first half of

2010.

In early studies, RP101 has demonstrated a more than 3-month survival benefit

over standard of care, according to the company. SciClone sees a market

opportunity of $350 million for RP101 as an additive pancreatic cancer therapy.

SciClone acquired the exclusive rights in the United States and Canada to

develop and commercialize RP101 from Resistys, Inc., a wholly owned subsidiary

of Avantogen Oncology, Inc. in April 2007.

DC Bead, which is awaiting regulatory approval in China for the treatment of

liver cancer, is already approved in Europe for use in the treatment of

malignant hypervascularized tumors. In 2006, SciClone acquired the rights to

distribute the DC Bead in China from Biocompatibles International plc.

China accounts for one-half of the world's liver cancer cases and more than

300,000 people die annually from this disease in China, making this an important

unmet medical need. SciClone expects to obtain approval for DC Bead in China

this year. But, given the complexity in the approval process in China, it

remains to be seen whether the company will be able to get DC Bead approved this

year.

[Guest guest]

http://www.tradingmarkets.com/.site/news/TOP%20STORY/2396491/

SciClone Pharmaceuticals - Charting A New Course?

Mon. June 29, 2009; Posted: 10:51 AM

(RTTNews) - Shares of SciClone Pharmaceuticals Inc.opened Monday's trading

session at $2.65, setting a new 52-week high. Now that it is re-entering the

U.S. broad-market 3000 index, the stock is slated to get a higher

profile among investors.

SciClone has an established business in China and the country accounted for

about 94% of the company's product sales last year. Zadaxin (Thymalfasin),

approved for the treatment of hepatitis B, hepatitis C, certain immune-sensitive

cancers and as a vaccine adjuvant, is the company's only marketed drug and is

approved for sale in over 30 countries, primarily in Asia, Eastern Europe, the

Middle East and Latin America.

SciClone sells Zadaxin in various international markets through its wholly owned

subsidiary, SciClone Pharmaceuticals International Ltd.

Thanks to SciClone's increased marketing efforts, Zadaxin sales have continued

to rise year-over-year -- $32.4 million in 2006; $37 million in 2007 and $54.1

million in 2008. Despite competition from generic brands in China, Zadaxin has

been able to achieve consistent double-digit sales growth. According to the

company, Zadaxin has a strong brand recognition and is positioned as a

high-quality, imported, premium-priced product.

However, the drug has yet to be approved in key markets of the United States,

Europe and Japan. Last November, a phase III trial evaluating Zadaxin in

combination with pegylated interferon alpha-2a (peg-IFN-2a) and ribavirin as a

treatment for patients with hepatitis C virus who have not responded to prior

therapy consisting of peg-IFN and ribavirin alone failed to achieve statistical

significance for the primary endpoint of sustained virological response.

In the U.S., Zadaxin is under development as a potential treatment for stage IV

melanoma. In late 2008, SciClone and the FDA reached an agreement on the design

of a phase III registration trial for Zadaxin for stage IV melanoma. The company

is in active discussion with several parties to establish a partnership for its

phase III study of Zadaxin in stage IV melanoma.

In a phase II study, Zadaxin in combination with dacarbazine, or 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 has patent protection through 2021 in the United States and Europe for

the HCV treatment approach using the triple therapy of Zadaxin, pegylated

interferon, and ribavirin. Italy-based Sigma-Tau retains the European rights to

Zadaxin, while SciClone has the rights to the drug in all other regions of the

world, including the United States.

According to SciClone, Zadaxin has a potential to generate global sales of $200

million for stage IV melanoma indication and over $500 million if the targeted

patient group is extended to include earlier stage patients in the adjuvant

setting.

Other drugs under development include SCV-07, a phase II drug for oral mucositis

and hepatitis C and RP101, a phase II drug for pancreatic cancer. The company's

DC Bead product, a drug-eluting agent, is awaiting approval in China for the

treatment of liver cancer.

The results of a proof-of-concept phase IIa clinical trial using SCV-07 as a

sole agent administered to patients chronically infected with HCV (hepatitis C

virus), released last September, demonstrated activity in some treated patients

in the higher dosage groups. Additionally, SCV-07 was shown to be generally safe

and well-tolerated with no dose limiting toxicities or serious adverse events

reported. SciClone is planning to initiate a phase IIb trial for SCV-07 in HCV

this year.

Another indication for which SCV-07 is being tested as a potential treatment is

oral mucositis in subjects receiving chemoradiation therapy for the treatment of

cancers of the head and neck. SCV-07 is under phase II testing for this

indication. The company plans to complete enrollment of this trial before the

end of 2009 and expects to report results in the first half of 2010.

SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the

molecule was recently approved for stimulation of depressed immune systems and

commercialization was just started. The worldwide rights, outside of Russia, to

commercialize SCV-07 were acquired by SciClone from Verta Ltd., a biotechnology

company in St. sburg in 1999.

Early in the month of March, the company announced that it has completed

enrollment of unresectable stage III and IV pancreatic cancer patients in a

phase II trial evaluating RP101 in combination with gemcitabine chemotherapy

ahead of the schedule. Results of the trial are expected in the first half of

2010.

In early studies, RP101 has demonstrated a more than 3-month survival benefit

over standard of care, according to the company. SciClone sees a market

opportunity of $350 million for RP101 as an additive pancreatic cancer therapy.

SciClone acquired the exclusive rights in the United States and Canada to

develop and commercialize RP101 from Resistys, Inc., a wholly owned subsidiary

of Avantogen Oncology, Inc. in April 2007.

DC Bead, which is awaiting regulatory approval in China for the treatment of

liver cancer, is already approved in Europe for use in the treatment of

malignant hypervascularized tumors. In 2006, SciClone acquired the rights to

distribute the DC Bead in China from Biocompatibles International plc.

China accounts for one-half of the world's liver cancer cases and more than

300,000 people die annually from this disease in China, making this an important

unmet medical need. SciClone expects to obtain approval for DC Bead in China

this year. But, given the complexity in the approval process in China, it

remains to be seen whether the company will be able to get DC Bead approved this

year.