Thursday, August 28, 2014

SciClone and BTG Announce That DC Bead(R) Has Been Approved by China Food and Drug Administration

FOSTER CITY, CA -- (Marketwired) -- 08/28/14 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN), and its partner BTG plc (LSE: BTG), today announced that the China Food and Drug Administration has approved the registration of DC Bead® for the embolization of malignant hypervascularized tumors.
BTG and SciClone previously entered into an agreement granting SciClone exclusive licensing and distribution rights to DC Bead® in China. Under the agreement, SciClone will purchase product from BTG at a specified price for sale in China. Commercial launch plans are now underway.

Friedhelm Blobel, SciClone Chief Executive Officer commented: "Together with our partner BTG, we will now focus our efforts on preparing for the introduction of the product in the Chinese market. Oncology is a core business focus for SciClone, and our sales team and academic marketing liaisons have established high quality relationships with the medical professionals and institutions that specialize in cancer treatment. We believe DC Bead® has the potential to be a valuable addition to SciClone's oncology product portfolio."

Louise Makin, Chief Executive Officer at BTG, said: "Approximately half of the world's liver cancer patients are in China and there is a great interest among Chinese physicians to offer new, differentiated treatment options. Today's news marks an important step toward bringing our first interventional oncology product, DC Bead®, to the Chinese market where we can help address this need."

DC Bead® is a novel treatment for liver cancer which is currently approved in 40 countries worldwide, including Europe. DC Bead® is an embolic bead delivered through a minimally invasive, non-surgical procedure to block the blood flow to tumors.

DC Bead® is registered in China for the embolization of malignant hypervascularized tumors such as hepatocellular carcinoma ("HCC"), the most common form of primary liver cancer. The majority of people with HCC have cirrhosis, usually from chronic hepatitis B or hepatitis C infection, or chronic alcoholism. Because of the country's high incidence of hepatitis, China accounts for approximately one-half of the world's liver cancer cases. More than 350,000 people dying from primary liver cancer in China annually1.

DC Bead® and/or all indications may not be available in all territories. DC Bead® is not currently cleared by the FDA for sale or distribution in the USA.

About BTG
BTG is an international specialist healthcare company that is developing and commercializing products targeting acute care, cancer and vascular diseases. The company has diversified revenues from sales of its own marketed products and from royalties on partnered products, and is seeking to acquire new programmes and products to develop and market to specialist physicians. For further information about BTG please visit our website at www.btgplc.com.

About SciClone
SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN® (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Through its promotion business with pharmaceutical partners, SciClone markets multiple branded products in China which are therapeutically differentiated. The Company has successfully in-licensed products with the potential to become future market leaders and to drive the Company's long-term growth. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.
1http://www.ncbi.nlm.nih.gov/pubmed/21144900

Read complete press release here:

Tuesday, August 26, 2014

1 in 10 foreign-born Asian Americans has hep-B; most don’t know it

NEW YORK, New York — As many as 1 in 10 foreign-born Asian Americans is affected by hepatitis-B,  a rate over 20 times higher than that of the overall U.S. population, reports Gilead Sciences.

Chronic hepatitis B is a potentially fatal liver disease caused by the hepatitis B virus (HBV). HBV is up to 100 times more easily transmitted than the AIDS virus.

Chronic hepatitis B can slowly destroy the liver over many years – even decades – without producing symptoms. It may cause life-threatening complications including liver cancer or cirrhosis (severe liver scarring).

Thursday, August 21, 2014

Tulsa dentist accused of unsanitary practices to give up his license

A Tulsa oral surgeon found to have possibly exposed up to 5,000 patients to HIV, hepatitis B and hepatitis C may be permanently barred from practicing as of Friday.

An agenda item for the regular meeting of the Oklahoma State Board of Dentistry states “discussion and possible action to accept permanent surrender of license and agreed order” in the case against Dr. W. Scott Harrington. The meeting is at 9 a.m. Friday in Oklahoma City.


In September last year, genetic testing confirmed that at least one patient contracted hepatitis C from a visit to Harrington’s office. It was the first documented report of patient-to-patient transmission of hepatitis C in a dental setting in the United States.

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Tuesday, August 12, 2014

Arrowhead Reports Fiscal 2014 Third Quarter Financial Results and Provides Update on ARC-520

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced financial results for its fiscal 2014 third quarter ended June 30, 2014 and provided an update on the Phase 2a study of ARC-520, its RNAi-based candidate for the treatment of chronic hepatitis B infection. The company is hosting a conference call at 4:30 p.m. EDT to discuss results. Conference call and webcast details can be found below.

ARC-520 Phase 2a Study Update
  • Completed dosing of 1 mg/kg and 2 mg/kg dose cohorts
  • Initial blinded data suggest that the magnitude of HBsAg knockdown is similar to non-human primate studies, including the chronically infected chimpanzee reported on previously
  • Duration of knockdown appears to be substantially more sustained than in non-human primates, with patients in the 2 mg/kg group still demonstrating substantial knockdown after 8 weeks, which is the most recent time point available
  • HBsAg levels appear to continue to decline in a number of patients at the 8 week time point in the 2 mg/kg group
  • Based on initial review, dosing less frequent than once monthly will be explored in Phase 2b
  • ARC-520 continues to be well tolerated, with no dropouts or serious adverse events reported
  • The overall rate of AEs has been lower in the Phase 2a than in the Phase 1 normal volunteer study and safety labs continue to show no indication of end organ toxicity
  • Enrolled and dosed additional subjects at 3 mg/kg in the still open normal volunteer study and the dose performed well, without detected differences from safety and tolerability results at the other doses. Overall AEs do not appear to be increasing in frequency or severity with dose
  • Received IRB and DSMB approvals to proceed and began enrolling an additional dose cohort at 3 mg/kg in the Phase 2a patient study

About ARC-520
Arrowhead's RNAi-based candidate ARC-520 is designed to treat chronic HBV infection by reducing the expression and release of new viral particles and key viral proteins. The goal is to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s-antigen negative serum with or without sero-conversion. The siRNAs in ARC-520 intervene at the mRNA level, upstream of where nucleotide and nucleoside analogues act. In transient and transgenic mouse models of HBV infection, a single co-injection of Arrowhead's Dynamic Polyconjugate (DPC) delivery vehicle with cholesterol-conjugated siRNA targeting HBV sequences resulted in multi-log knockdown of HBV RNA, proteins and viral DNA with long duration of effect. The company is conducting a single dose Phase 2a study in chronic HBV patients, and expects to follow with a multi-dose, multi-national Phase 2b program. Approximately 350 million people worldwide are chronically infected with the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers globally.

About ARC-AAT
Arrowhead has developed ARC-AAT for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease that severely damages the liver and lungs of affected individuals. ARC-AAT employs a novel unlocked nucleobase analog (UNA) containing RNAi molecule designed for systemic delivery using the Dynamic Polyconjugate delivery system. ARC-AAT is highly effective at knocking down the Alpha-1 antitrypsin (AAT) gene transcript and reducing the hepatic production of mutant AAT (Z-AAT) protein. Reduction of inflammatory Z-AAT protein, which has been clearly defined as the cause of progressive liver disease in AATD patients, is important as it is expected to halt the progression of liver disease and allow fibrotic tissue repair. The Company plans to file for regulatory permission in the fourth quarter of 2014 and to commence clinical studies.

Read complete press release here

Sunday, August 10, 2014

Taiwan: Liver disease foundation vows to step up efforts

Liver disease, dubbed the “national disease” of Taiwanese for decades, continues to take the lives of an average of 35 people in the nation each day, and nearly 85 percent of liver cancer cases are caused by hepatitis B and hepatitis C, the Liver Disease Prevention and Treatment Research Foundation said.

The foundation made the remarks at a ceremony in Taipei on Saturday celebrating its 20th anniversary, during which it vowed to step up its decades-long effort to eliminate the cancer that has been the second-leading cause of cancer-related deaths in the country.

“If every patient with hepatitis B and hepatitis C is willing to receive regular screening tests and treatments before their condition turns into cirrhosis, we will be able to put an end to liver cancer within 20 years,” foundation chief executive officer Yang Pei-ming (楊培銘) said.

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Viral hepatitis more deadly than HIV, but unfunded

Haves and have nots

Existing hepatitis B drugs suppress viral replication, which stops progressive liver disease, allowing the liver to recover. The antiviral drugs can reverse cirrhosis, and reduce the incidence of liver cancer by 50-70 per cent. But the vast majority of the 350 million people worldwide with chronic hepatitis B do not receive treatment.

One of the antiviral drugs, tenofovir, is also used in the treatment of HIV, and funding support from international financing organisations such as the Global Fund and the US President's Emergency Plan for AIDS Relief has made it available for people living with HIV in extremely resource-challenged settings in the Asia-Pacific region.

“But the tragedy is that tenofovir is not made available for people living with hepatitis B. So, you can have the dichotomy whereby someone living with HIV is readily able to access free tenofovir for the treatment of their HIV, but his next-door neighbour who is dying of cirrhosis or has progressive liver disease and is at significant risk of liver cancer is unable to access the drug,” Cowie says.

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