藥華 引進 Src/Pretubulin Inhibitor;KX01 (KX2-391) 用於psoriasis !!

PharmaEssentia Acquires Certain Asian Rights for Dermatology Preparations of Kinex Pharmaceuticals' Promising Novel Dual Src/Pretubulin Inhibitor, KX01  By Kinex Pharmaceuticals, LLC Published: Monday, Dec. 3, 2012 - 6:09 am BUFFALO, N.Y., Dec. 3, 2012 -- BUFFALO, N.Y., Dec. 3, 2012 /PRNewswire/ -- Kinex Pharmaceuticals, LLC and PharmaEssentia Corporation announced today the execution of a licensing agreement granting PharmaEssentia exclusive rights in certain Asian territories for the dermatology preparations of Kinex's dual Src/Pretubulin Inhibitor, KX01. KX01 (KX2-391) is a potent small molecule Src kinase/Pretubulin dual mechanism inhibitor discovered by Kinex Pharmaceuticals using its proprietary technology platforms Mimetica™ and Opal™. KX01 differentiates itself as an inhibitor that targets the kinase substrate pocket and, therefore, offers an excellent efficacy as well as safety profile. KX01 has been shown to be very effective against a broad range of cancers in both in vitro experiments and in animal cancer models. Importantly, the compound has synergistic/additive activities with most first line chemotherapeutic agents. A completed Phase study, in patients with end-stage cancer, showed a desirable safety profile and clinical response in approximately 25% of the patients. Phase II studies are ongoing.The composition of matter of KX01 is covered by issued patents.In further experiments, KX01 was found to show great potency in inhibiting the growth of keratinocytes as well as suppression of neo-angiogenesis. In addition, the compound was shown to down-regulate the production of interleukin 2. These data support KX01's potential utility in the treatment of skin conditions like psoriasis.Preliminary research conducted by PharmaEssentia showed that KX01 can be easily formulated for dermatology indications.Under the terms of the agreement, PharmaEssentia will acquire the rights for the development and commercialization of the dermatologic preparations for all indications in greater China and some other Southeast Asian countries. Korea, Japan, Australia and New Zealand are not included in this agreement. PharmaEssentia plans to file for an Investigational New Drug (IND) Application to initiate clinical studies in the near future.Kinex Pharmaceuticals will assist PharmaEssentia in the filing and will collaborate with PharmaEssentia in Phase II and III global registration studies. PharmaEssentia will provide Kinex Pharmaceuticals with an up-front payment. There will also be milestones and royalties associated with product sales. A joint development team will be established to foster the collaboration.Dr. Ko-Chung Lin, Founder and Chief Executive Officer of PharmaEssentia, former co-founder of the discovery chemistry team at Biogen, and the inventor of P1101 at PharmaEssentia stated, "KX01's unique mechanism of action affords great promise in treating psoriasis. Our internal expertise in chemistry and formulation will allow us to advance this program in an expedited way.Psoriasis is a disease that needs better treatment and we believe that we will be in a good position to provide an effective novel therapy for these patients in Asia."Dr. Ching-Leou Teng, Chairperson of the Board, Chief Scientific Officer, and also a former United States Food and Drug Administration reviewer added, "We were impressed by the experience of Kinex's management team. Our due diligence process indicated the strong potential value of KX01 in the dermatologic setting and we are delighted to partner with Kinex Pharmaceuticals to explore these indications.Kinex Pharmaceuticals has had excellent success with their regulatory filings in the United States and we are confident that we will be able to file our IND application for dermatology indications very soon.""We are pleased to collaborate with PharmaEssentia to develop KX01 for dermatology preparations and indications. We are highly confident in the accomplished PharmaEssentia management team and their strong commitment to research and development," said President Emeritus of Kinex Pharmaceuticals, Dr. Allen Barnett, who was credited for his effort in the discovery and development of Claritin when he was working at the Schering-Plough Research Institute. His team in Schering-Plough also developed Clarinex and Zetia.Dr. David Hangauer, Chief Scientific Officer, added, "We are impressed by the ability of the PharmaEssentia team to quickly explore the dermatology formulation of KX01. Based on comparing the profile of KX01 to the various pathogenetic mechanisms involved with psoriasis, I am confident that KX01 will find a niche in dermatology. I look forward to working together with PharmaEssentia to explore the full potential of KX01 for dermatology indications."Dr. Jinn Wu, a Director of Kinex's Board and President and CEO of Xenobiotic Laboratories and XBL-China, concludes, "PharmaEssentia is one of the leading biotechnology companies in Taiwan and their management consists of seasoned executives.I am confident that their know-how will foster the success of this partnership. As a native Chinese citizen who grew up in Taiwan, I am gratified to see PharmaEssentia taking the lead in the dermatology field to further foster biotechnology development in Taiwan."

About Kinex Pharmaceuticals, LLCKinex Pharmaceuticals, headquartered in Buffalo, New York, USA, is using its proprietary technologies Mimetica and Opal to discover and develop novel drugs for oncology and immune-modulatory diseases. More information of Kinex Pharmaceuticals can be found at www.kinexpharma.comKinex Pharmaceuticals, LLC - Caution Regarding Forward-looking Information Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, Kinex Pharmaceuticals cautions investors that any forward-looking statements or projections made by Kinex Pharmaceuticals, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected.

About PharmaEssentia CorporationPharmaEssentia Corporation, based in Taipei, Taiwan and founded by seasoned former executives from US biotechnology companies and US Food and Drug Administration, is a biotechnology corporation with expertise in both small molecules and biologics. More information of PharmaEssentia can be found at www.pharmaessentia.comKinex Inquiries: Patrick Gallagher Vice President, Business Development and Investor Relations Kinex Pharmaceuticals 701 Ellicott Street Buffalo, NY 14203 pgallagher@kinexpharma.com 716-898-8626SOURCE Kinex Pharmaceuticals, LLC

 

Pharma leader wants closer R&D ties

 Updated: 2012-12-01 09:23 By Liu Jie ( China Daily) China 'must maintain innovative climate, do more to ensure fair medicine pricing' China's medical innovation sector should focus on intellectual property protection, fair medicine pricing, and transparent, predictable regulations aligned with global frameworks, according to one of the US pharmaceutical industry's leading figures.John C. Lechleiter, chairman of the Pharmaceutical Research and Manufacturers of America, said his association expects R&D cooperation between its member companies and Chinese counterparts to increase in coming years. [Photo/Agencies]John C. Lechleiter, chairman of the Pharmaceutical Research and Manufacturers of America, said his association expects R&D cooperation between its member companies and Chinese counterparts to increase in the coming years. He said: "It is important that China should maintain a climate for innovation, for the innovative medicines and innovative medical solutions that can be developed for the better lives of people."The association is a body in the global industry, representing leading US pharmaceutical research and biotechnology companies.Its members invested an estimated $49.5 billion in 2011 in discovering and developing new medicines, according to its website.Lechleiter - who is also chairman, president, and chief executive officer of the international pharmaceutical giant Eli Lilly and Company - said China was improving in intellectual property protection, both in terms of patents and data protection. He added "a fair and transparent pricing system that recognizes the value of medicines" is also needed.In the pharmaceutical industry, highly innovative medicines with patents are priced higher, given the huge R&D costs involved, while generic drugs are generally priced cheaper.A major focus of China's medical reform, which is aiming to provide universal healthcare for its 1.3 billion population, is to cut the prices of medicine.But any price reduction requires some degree of squeezing of drugmakers' profit margins.Lechleiter said that price policy had "really impacted" on his members, explaining that innovative drugs usually take 10 to 15 years to develop, and cost an average of $1.2 billion in R&D costs.According to a recent report China's medical reforms, international market research firm McKinsey & Co said that despite affordable medicine being a government policy, enterprises still need profit to pay for the necessary R&D.It added that finding a balance between the two is a challenge to both the country's decision makers and the main businesses involved.Lechleiter urged that a regulatory system should be introduced in China to allow foreign companies "to undertake clinical trials, to achieve regulatory approval for new medicines in a way that is more harmonized with other countries, and which will enable Chinese patients to access new medicines, sooner".Multinational drugmakers, including those from the United States, have been fighting hard to be allowed to introduce their latest products to emerging markets in recent years.China is now the world's third-largest pharmaceutical market, and is expected to become the second after the US by 2017.China has strict market-access regulations due to medical safety concerns, so many new products don't end up being sold in the country until two to three years later than they become available in developed markets, such as the US, Europe and Japan.The preferred route for many multinationals has been to carry out R&D in cooperation with Chinese drugmakers.Guo Fanli, a senior pharmaceutical researcher with local market research institute China Investment Consulting Co Ltd, said: "Cooperation not only helps foreigners develop locally tailored products, but also facilitate their market access, by using the resources of local partners."Lechleiter said cooperation can take many forms, including R&D partnerships, license or equity agreements, or joint ventures."Chinese companies are growing up, and we expect the number of these kinds of agreements to increase," he said.The environment in China is favorable for Chinese R&D-oriented drugmakers.The biopharmaceutical sector was set by the central government as one of the seven key developing industries during the 12th Five-Year Plan (2011-15), with tens of trillions of yuan earmarked for R&D support to the sector.

 

 

黃秀美(GSK) 組行銷團隊 !!! 台灣浩鼎~~~

浩鼎轉大人 「藥」打台灣品牌【經濟日報╱記者黃文奇／台北報導】 2012.12.06 02:58 am台灣浩鼎生技將在本月12日登錄興櫃，這家公司結合了中研院研發能量、潤泰集團資金及跨國臨床經驗，創辦人張念慈昨（5）日表示，將透過台灣浩鼎將台灣的新藥產業，從研發層次提升到自創品牌的新地位，且不排除在台灣設立生產基地。台灣浩鼎成立於2002年，為張念慈創辦，目前資本額約13.82億元，據浩鼎內部表示，潤泰集團占整個台灣浩鼎股權比重近五成，為最大法人股東；其餘法人股東還包括玉山金、永豐餘、富邦金等集團。由於新藥潛力大，浩鼎預定於本月12日登興櫃，興櫃參考價雖僅45元，未上市交易價格早已奔向90元以上。張念慈昨天參加永豐證召開的閉門法說會，吸引近百家法人。浩鼎所發明的治療乳癌疫苗OBI-822，技術源自於中研院，已於今年8月進入新藥臨床三期階段，並預計招募第4期轉移性乳癌患者342名。浩鼎表示，預計在2014年第2季完成收案，再啟動期中分析。業界分析，OBI-822可望於2015年申請藥證，搶攻全世界每年130億美元商機。張念慈特別強調，台灣浩鼎要打造新藥領域的「台灣品牌」。為此目標，台灣浩鼎已邀請前葛蘭素史克大中華區總裁黃秀美出任營運長，要協助公司建立國際行銷團隊。張念慈指出，台灣新藥發展不少已發展到臨床二、三期，已到了發展「新藥自有品牌」的時機，估計目前有10家生技公司有發展自主品牌的條件，相對於歐美大藥廠，台灣小型藥廠爆發力、靈活度都更優，只要掌握專利及藥證就可以掌握大部分的利潤。近期張念慈已前往工業局洽談有關事宜，業界評估，台灣浩鼎未來應不排除再台投資設廠，並把第一個藥證留給台灣。【記者黃文奇／台北報導】台灣浩鼎生技創辦人張念慈是台灣藥界一則傳奇，曾經兩度創業，在事業經營上也面臨過挑戰，如今他透過台灣浩鼎生技，要重新在國際市場上搶回原有的地位，在台灣浩鼎將走向資本市場之際，他卻一派悠閒表示，馬上要帶老婆到南半球度假。

生技中心(DCB) 引介Big Pharma(s) 技轉 !!!!

八大藥廠技轉 台5廠中選 2012-12-06 01:16 工商時報 【記者杜蕙蓉／台北報導】全球一片尋找新藥荒中，包括羅氏、默克、嬌生等國際知名八大藥廠來台尋求技轉，浩鼎、中裕、太景、安成和泉盛等5新藥公司入選，預定下周(10-11日)進行二天技術洽談，生醫業界認為此舉將推波產業新能量和投資亮點。備受矚目的國際大藥廠羅氏、嬌生、賽諾菲安、Janessen、Amgen、默克、葛蘭素、禮來等8大藥廠和知名的KPCM創投公司，是透過生技中心和國家型國際合作辦公室安排，來台尋求技轉合作廠商。據了解，此次技轉的項目鎖定新藥，適應症則排除牙科，而國內藥廠頗為擅長的新劑型和藥物傳輸，儘管也入列，但不是優先選擇。生技中心董事長李鍾熙表示，該中心自九月進行組織全面大改組後，已啟動五年營運策略規劃，除了積極扮演新藥研發關鍵第二棒外，也做為國內藥廠和國際大藥廠策略聯盟的重要橋接角色。中裕新藥執行長張念原認為，與國際藥廠的合作有很多種模式，技轉、行銷和生產授權都可以，甚至共同進行臨床到新藥的申請上市，都能創造雙贏的契機，而新藥公司在逐步找到定位，加上有國際經驗的生技專家和國內生醫公司的結合，兩岸目前對生醫產業的合作也是空前的積極下，都有助於產業的發展。就初步統計，目前入選的五家藥廠各具特色，太景治療社區型肺炎的奈諾沙星，由於早在2005年即進行符合中國ICH與美國FDA規範所要求的新藥人體試驗，而有機會成為第一個獲得符合美國FDA與中國1. 1類新藥標準的新藥。該藥目前已授權上海A股上市公司浙江醫藥集團，在大陸地區的製造、銷售與行銷權利。安成、浩鼎都有國際授權經驗，且兩家公司選題精確，經營團隊對美國市場的行銷和布局也有心得。中裕的愛滋新藥原本就備受看好，目前除了TMB355外，也投入研發蛋白質抑制劑的領域，由於屬於長效型的產品，後市相當被看好。至於泉盛 ，除了FB301（Anti-CemX過敏抗體新藥），已提出全球18個國家地區專利申請外，目前也篩選優化出FB704（抗第六型介白素IL6抗體新藥），該產品是目前全球最熱門的抗體標的。

健亞/石家莊 歷經一年 終攜手上路 (中國市場) !!

健亞攜手中奇製藥，共同開發新陳代謝新藥 2012-12-07 【時報-台北電】健亞(4130)宣布與中國石藥集團旗下的中奇製藥正式簽署技術授權與開發合約，共同在中國市場開發治療新陳代謝異常的新成份新藥。健亞表示，為引進策略開發夥伴，開拓大陸市場、強化區域競爭力，已與石藥集團旗下的中奇製藥技術（石家莊）有限公司，就健亞研發中的治療新陳代謝異常新成份新藥，正式簽署技術授權與開發合約，以便在中國共同進行該藥品的研究、註冊、推廣、銷售和生產等事宜。此舉將有助於積極加速研發進度、分擔研發經費，進而降低研發風險、蓄積研發動能，增進公司價值。

 

健亞出技術 石藥出市場!!

健亞與石藥集團合作開發行銷代謝新藥