HIV Antibody Therapy Ibalizumab Inches Forward

September 27, 2011 Long-awaited results from a Phase II study of ibalizumab, an antibody-based therapy that has been in early stage development for several years, were reported at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on September 17 in Chicago. Though the results raise more questions than answers about the drug's efficacy, the presenting researchers conclude that ibalizumab holds potential for HIV treatment veterans in need of novel therapies. Ibalizumab is an experimental entry inhibitor being developed by TaiMed Biologics, a biotechnology company with research facilities in Taiwan and Irvine, California. The drug contains genetically engineered antibodies, known as monoclonal antibodies. These antibodies bind to the CD4 receptor on CD4 cells. Once ibalizumab binds to these receptors, HIV cannot successfully connect with the surface of CD4 cells, thus preventing the virus from infecting healthy cells. Because of ibalizumab's unique mechanism of action, researchers have long believed that the drug holds tremendous promise as an HIV treatment, particularly for people with multiple-drug-resistant strains of the virus. Ibalizumab is currently administered intravenously in an outpatient setting. To date, the drug has been given by researchers once weekly and every other week, using a dose that depends on body weight.  With the successful completion of a variety of early stage studies, including a 48-week Phase IIa study reported in 2006 demonstrating statistically significant viral load reductions compared with placebo, a Phase IIb study was started in August 2008. Twenty-four week data from the latest study were reported at ICAAC by Stanley Lewis, MD, PhD, of TaiMed. Unlike the weight-based dosing used previously, the Phase IIb study explored two fixed doses: 800 milligrams (mg) administered intravenously once every two weeks and 2,000 mg given every four weeks. The clinical trial enrolled 113 people living with HIV with resistance to multiple drugs, including at least one drug in the three major classes of antiretrovirals (the nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and the protease inhibitors). Both doses were combined with an optimized background regimen containing at least one drug the patients' viruses were sensitive to. Of note, no placebo for comparison purposes was used in the study. After 24 weeks, viral loads were reduced, on average, by 1.5 log in both treatment groups. Undetectable viral loads were documented in 44 percent of those in the 800 mg ibalizumab group and 28 percent in the 2,000 mg ibalizumab group. CD4 counts increased by 63 cells and 80 cells, respectively. Though these viral load reductions are notable, the lack of a placebo group in the study prevents firm conclusions about ibalizumab's potential. For example, it remains unclear how much of the viral load reductions seen in both treatment groups were attributed to the ARVs used in combination with ibalizumab. Encouragingly, Lewis reported that ibalizumab was well tolerated with no drug-related deaths, serious side effects or discontinuations. Though some laboratory abnormalities were reported, these were not associated with any "clinically meaningful" problems. The most common side effects were rash, diarrhea, headache and nausea, which appeared to be more common in the 2,000 mg dosing group. Going forward, TaiMed plans to use the lower dose of the drug to minimize the risk of side effects without compromising efficacy. The company is also experimenting with a subcutaneous version of the drug—administered using a hypodermic needle to deliver ibalizumab directly under the skin—to allow for once-weekly injections at home.

總經銷協議認定!!

美時與安生訟案將再上訴2011-09-27 【時報-台北電】美時製藥（1795）與大陸珠海安生公司訴訟案，美時昨（26）日收到大陸廣東省高級人民法院判決書，仍維持原判，美時應支付安生約470萬人民幣。美時副總經理洪堯樂表示，上述賠償金額，已在98年度財報中認列損失，且公司正與委任律師商議提起再審。　美時認為，安生公司違約拒付樂特仕推廣費，應對美時承擔違約責任，所以公司正與委任律師商議，將依法提起再審。　98年7月6日，廣東省珠海市中級人民法院判決美時應支付安生約470萬人民幣。經美時上訴後，廣東省高級人民法院，據「中華人民共和國合同法」及中華人民共和國民事訴訟法，認為安生拒付推廣費在一定程度上影響了「總經銷協議」，但未全部影響「總經銷協議」執行，因此維持原判。

台灣第4家藥品外銷美國 美時抗癲癇藥

美時打開美國市場，進補800萬元 2011-09-28 【時報-台北電】美時製藥（1795）接到美國知名藥品經銷商Trigen公司首批抗癲癇藥的訂單，昨（27）日正式出貨，成為公司第一張外銷美國的藥品訂單，也是繼永信、益邦、安成公司之後，台灣第4家藥品外銷美國市場的製藥業者。美時表示，已分別取得美國FDA查廠，及藥品查驗登記，是爭取到美商Trigen公司首批抗癲癇藥訂單的主因，首批訂單金額約800萬元。為乘勝追擊，美時主管昨晚在美國持續與Trigen公司洽談第2張採購訂單的價格與數量。美時說，等首批抗癲癇藥訂單，在美國鋪貨上市銷售後，若市場反應不錯，後續訂單粗估在今年底或明年初可發酵。此外，美時的抗癲癇藥，也將向台灣衛生署藥檢局申請藥品許可證，準備搶攻內銷市場。美時認為，美商藥廠在美國生產專利過期的學名藥因成本高，已沒有市場競爭力，不少美國學名藥大廠或知名藥品經銷商，分別赴台灣及印度等地，尋找合作藥廠，並釋出代工藥品訂單或採購案。尤其，台灣製藥業，因有原物料供應的優勢，加上製藥技術水準，遠比大陸及東南亞等地業者還高，使台灣製藥廠已成為美商製藥廠或藥品經銷商，釋出海外藥品訂單的首選。為抓住此商機，美時再向美國FDA送件，申請包括止痛藥的藥品許可證，最快明年可望有初步的成果。　總公司位於台中大甲的永信控股（3705），多年前也已進軍美國藥品市場。永信經理鍾威凱表示，台灣廠外銷美國的藥品清單，包括3種抗生素、1種止痛藥，及1種精神科用藥，1年訂單總金額約1億多元。為擴大產品上市的銷售規模，永信台灣廠最近已送件申請美國藥品許可證的藥品，還包括心血管用藥等產品。另永信旗下美國廠，生產約6種藥品在美國鋪貨上市銷售；旗下馬來西亞廠產製的藥品，則以銷往東協與中東市場為主，並沒有外銷美國市場。

洗腎與偽藥??!!

杜絕偽藥販售 吳揆：已有成效 中央社 2011-09-27 （中央社）行政院長吳敦義今天表示，各地方政府針對電台販賣偽劣禁藥都有進行勸導、處罰，已有一定成效。衛生署長邱文達說，電台廣告販賣偽藥的情形，近1年來違規減少了一半。中國國民黨籍立委林德福上午在立法院針對地下電台的查緝情形提出質詢。他說，地下電台販賣偽劣藥，有人誤信食用後造成必須洗腎，台灣變成洗腎王國，國內洗腎人口有6萬8000多人，健保給付洗腎1年高達新台幣500多億元，政府應強力掃蕩。吳敦義答詢時表示，播出偽藥廣告的不一定是地下電台，有的合法電台也有播出販賣偽藥廣告的情形，對此各地方政府都有進行勸導、處罰，情節嚴重的會將違法電台的發射器全部拆除。衛生署長邱文達指出，市面上販賣偽藥的情形已有改善，這1年來「違規的減少了一半」；至於腎臟病的防治方面，衛生署在前5年進行腎臟病末期防治；最近匡列新台幣4億元，將進一步做前期的防治，前期防治也就是還沒進入洗腎階段的預防。吳敦義補充說，目前還在播出偽藥廣告的不一定是地下電台，有的是合法電台，合法電台一般性節目基於尊重新聞自由，政府不能干擾，但如果合法電台廣告推銷的是違法偽劣禁藥，政府會加以取締。

美時製藥被中國醫藥公司反告賠償!!!

美時製藥：本公司與大陸安生公司訴訟案,高級人民法院判決之相關事宜  鉅亨網　2011-09-26美時製藥：本公司與大陸安生公司訴訟案,高級人民法院判決之相關事宜 第二條　第2款1.法律事件之當事人、法院名稱、處分機關及相關文書案號: 原告：珠海安生醫藥有限公司 被告：美時化學製藥股份有限公司 法院名稱：廣東省高級人民法院處分機關案號：（2009）粵高法民四終字第299號2.事實發生日:100/09/26  3.發生原委(含爭訟標的):原(98年)本公司之孫公司樂特仕生物科技諮詢(上海)有限公司控告珠海安生醫藥有限公司拒付推廣費人民幣1,292,582.50元，違反"總經銷協議"經珠市香洲區人民法院一審判決安生公司應支付樂特仕人民幣815,145.82元，安生反控本公司解除其"總經銷協議"之違約責任，經兩造上訴，(98/07/06)廣東省珠海市中級人民法院 (2008)珠中法民四初字第94號判決，本公司應支付安生公司人民幣4,707,092.52元，業經再上訴，(100/09/26)廣東省高級人民法院根據"中華人民共和國合同法""中華人民共和國民事訴訟法"認為安生公司雖拒付推廣費，在一定程度上影響了"總經銷協議"但並未致使"總經銷協議"的主要目的不能實現，故維持原判本公司應支付安生公司人民幣4,707,092.52元。4.處理過程:本公司認為安生公司違約拒付樂特仕推廣費，應對美時承擔違約責任，正與委任律師商議，將依法提起再審。5.對公司財務業務影響及預估影響金額:依據律師提供之法律意見，並洽會計師擬具之影響，業已於98年財報中認列損失。6.因應措施及改善情形:本公司與委任律師商議後，將依法提起再審。7.其他應敘明事項:無。