300億氣喘抗體市場 泉盛新藥IND 授權金值150億元 !!!

泉盛新藥 授權金衝150億【經濟日報╱記者黃文奇／台北報導】 2014.03.18 03:16 am抗體新藥公司泉盛昨（17）日宣布，將完成旗下抗體新藥Anti-cemX 對美國食品藥物管理局（FDA）人體臨床（IND）審查送件及啟動國際授權，已有國際前十大藥廠徵詢，下半年將有成果。業者預估，僅前期授權金（Upfront Payment）就有機會達5億美元（約新台幣150億元）。 泉盛指出，該藥物是目前唯一能和國際大廠羅氏（Roche）旗下抗體新藥「Anti-M1'」相抗衡的技術，最快今年5月送件美國FDA，若順利則今年7月有機會取得核准函進入IND，並已經同步啟動國際授權，正和全球前十大藥廠進入實質談判程序。泉盛為中天集團旗下子公司，為國內少數具備抗體新藥開發能力的新藥公司之一，主要競爭力除了自建「全人類抗體庫、抗體篩選技術」外，2011年起和中研院合作開發抗體新藥，更與中研院院士、抗過敏專利新藥發明人張子文攜手合作，開發在抗過敏領域具破壞性的新藥Anti0cemX、Xoliar蛋白質相似藥。據悉，張子文為羅氏抗過敏（氣喘）新藥Xoliar主要發明人之一，該藥物專利將在2016年到期，平均每年為羅氏帶來逾10億美元（約新台幣300億元）收入，去年更成長至12億美元，值得注意的是，泉盛的Anti-cemX就是Xoliar的新一代藥物，更具競爭力。泉盛表示，公司的Anti-cemX和羅氏的Anti-M1'雖系出同源，但各有擅長，且專利權互不侵犯，去年美國專利商標局（PTO）首階段已經判定泉盛專利合法，更值得注意的是，泉盛在該產品申請的另一項核心專利，近日將有機會被PTO核准，屆時Anti-cemX形同對羅氏產品產生更大威脅。

中天子公司 「藥」創新猷 中天集團昨（17）日表示，集團旗下子公司今年總共將送四個新藥，進美國食品藥物管理局（FDA）進行人體臨床試驗（IND）核准，除了泉盛的抗體藥anti-cemX、Xoliar蛋白質相似藥，另外包括合一抗肝癌新藥、中天C肝新藥，將刷新國內新藥公司紀錄。中天集團表示，今年除了規劃送四個新藥進入IND，旗下已經獲衛福部核准在台上市的二項新藥，也將同步啟動國際授權，因此今年國內外市場都將有機會看到實質業績。據悉，中天集團去年第3季才和大陸石藥集團簽署新藥合作開發協議，其中即包括具備競爭力的八個藥物，並包括中天開發的C肝新藥MB110、合一生技的抗肝癌牛樟芝小分子新藥ON318及泉盛進度最快的兩項抗體藥。【2014/03/18 經濟日報】

Handa Pharma搶先 !法德 跟進Paragraph 4 挑戰1.2 billion 市場 (Seroquel XR(R))

法德藥精神病用藥申請FDA 中央社 (2014-03-02 18:03)（中央社記者羅秀文台北2014年3月2日電）法德藥(4191)今天宣布，抗精神分裂症用藥Quetiapine Fumarate ER Tablet已向美國食品藥物管理局(FDA)提出第4類學名藥(P IV)上市審查申請。法德生技藥品成立於2008年，主要從事特殊學名藥的研究與開發工作，尤其是困難學名藥(Difficult-To-Formulate)及挑戰美國FDA第4類(Paragraph IV, P IV)和首仿(First-To-File)學名藥(ANDA)的上市申請。法德藥表示，Quetiapine Fumarate ER Tablet是一種長效型抗精神分裂症(Schizophrenia)用藥產品，商品名稱為Seroquel XR，原開發廠是阿斯利康製藥(AstraZeneca)。根據2012年的銷售資料顯示，原廠藥在美國市場年銷售額約12億美元，是一個重量級產品。此外，法德藥表示，去年12月下旬已接獲美國通路商對長效降血壓藥MetoprOLol Succinate ER Tablet產品的訂單，預計今年獲得FDA最終上市核准函後，產品將在美國上架銷售，正式邁入營收階段。

拚P4！法德藥長效抗精神分裂症學名藥向FDA遞件 鉅亨網新聞中心　(來源：精實新聞)　2014-03-03 07:59:18精實新聞 2014-03-03 記者 蕭燕翔 報導法德藥(4191)宣布，長效抗精神分裂症學名藥Quetiapine  Fumarate(150mg,200mg,300mg,400mg ER Tablet)向美國食品藥物管理局(US FDA)提出第四類學名藥(P IV)上市審查申請(遞件)，這也是該公司繼長效型降血壓用藥後的另一P4代表作。 Quetiapine Fumarate ER Tablet是一種長效型抗精神分裂症(Schizophrenia)用藥產品，商品名為Seroquel XR，其原開發廠為阿斯利康製藥(AstraZeneca)。根據2012年的銷售資料顯示，原廠藥在美國市場年銷售額約12億美元，屬年銷10億美元以上的Blockbuster。且這也是法德藥繼2011及2012年成功開發長效型降血壓用藥Metoprolol Succinate ER Tablet產品(商品名：Toprol XL)後，又一成功力作。法德生技藥品成立於2008年，主要從事特殊學名藥的研究與開發工作，尤其是困難學名藥（Difficult-To-Formulate）及挑戰美國FDA第四類（Paragraph IV, P IV）和首仿（First-To-File）學名藥（Abbreviated New Drug Application, ANDA）的上市申請。該公司創業核心成員在製藥產業已累計超過三十年藥品研發經驗，專精在長效固體劑型產品(Extended-Release Dosage From)開發領域，更是國內少數具實際成功開發美國學名藥產品(ANDA)經驗的專業團隊，該公司2011年及2012年即成功開發極具市場潛力長效降血壓用藥及抗糖尿病用藥等產品，分別向美國FDA申請ANDA送件。2013年7月美FDA針對法德100%轉投資的中國廣東佛山里水廠進行產品上市前的查廠（Pre-Approval Inspection,PAI），獲得零缺失（No Observation）的高標評價通過。法德藥於2013年12月下旬已接獲美國通路商對長效降血壓藥Metoprolol Succinate ER Tablet產品的訂單，預計今年(2014)接獲FDA最終上市核准函後，產品即同步在美上架銷售，正式邁入營收階段。

Par Pharmaceutical Acquires Rights to Market and Distribute Generic Seroquel XR® in the U.S. WOODCLIFF LAKE, N.J., Oct. 29, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC to acquire Handa's Abbreviated New Drug Application (ANDA) for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca's Seroquel XR®. Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes a 400 mg dosage strength. Under the terms of the agreement, Par has made a payment for the ANDA and for exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Par will receive a share of profits from the sales of the product. Under the terms of a prior settlement agreement with AstraZeneca, which has been assigned to Par, Par has a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company.  Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. SOURCE Par Pharmaceutical Companies, Inc.

AstraZeneca in patent settlement deal with Handa over Seroquel XR

30-09-2011 Anglo-Swedish drug major AstraZeneca (LSE: AN) yesterday revealed that it has entered into a settlement agreement in its US Seroquel XR (quetiapine) patent infringement litigation against California, USA-based Handa Pharmaceuticals, regarding Handa's proposed generic version of the blockbuster drug, which is indicated for the treatment of depression and bipolar disorder. Handa was the first company to file an Abbreviated New Drug Application with the US Food and Drug Administration, gaining tentative approval on December 13, 2010, for 50, 150, 200 and 300mg tablets of Seroquel XR and said it believed it was the first to file a Paragraph IV containing certification under the provisions of the Hatch-Waxman Act, which would give the copy drugmaker 180 days of marketing exclusivity for these tablet strengths on receipt of final regulatory approval. AstraZeneca is still pursuing patent law suits against five other generic drugmakers, including Mylan, over Seroquel XR, US sales of which were around $750 million last year. Total turnover of Seroquel reached $5.3 billion last year, with around $4 billion coming from the USA.

Handa can now launch generic on November 1, 2016 Under the agreement, also referred to as a pay-for-delay deal, Handa does not dispute that both patents asserted by AstraZeneca in the US patent litigation are valid and enforceable. As part of the accord, AstraZeneca has granted Handa a licence to enter the US market with generic Seroquel on November 1, 2016 or earlier upon certain circumstances. Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017. AstraZeneca and Handa will file a proposed Consent Judgment with the US District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining Seroquel XR patent infringement litigations remain on-going. "We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time. Seroquel XR remains an important part of our company's portfolio benefiting patients and physicians throughout the world,"said David Brennan, chief executive of AstraZeneca. This settlement will have no impact on the company's full year 2011 financial guidance, AstraZeneca noted.

 

"OPEN MIND" for stem cell research

Scientist urges withdrawal of his own 'breakthrough' stem cell research BY KIYOSHI TAKENAKA AND KATE KELLAND TOKYO/LONDON Mon Mar 10, 2014 1:03pm EDT(Reuters) - A Japanese scientist called on Monday for his own headline-grabbing study on stem cells to be withdrawn from publication, saying its findings had now been thrown into too much doubt. The research - hailed when it came out in January as a breakthrough that could herald a new era of medical biology - was covered widely in Japan and across the world after it was published in the highly reputable science journal Nature. But since then, there have been reports that other scientists have been unable to replicate the Japanese team's results and that there may have been problems with its data and images."It is no longer clear what is right," Teruhiko Wakayama, a professor at Japan's University of Yamanashi who was part of the researcher team, told public broadcaster NHK. The study, described as game changing by independent experts asked to comment on it when it was published, appeared to show a simple way to reprogram mature animal cells back into an embryonic-like state that would allow them to generate many types of tissue. The results appeared to offer a promise that human cells might in future be simply and cheaply reprogrammed back into embryonic cell-like cells - in this case cells dubbed Stimulus-Triggered Acquisition of Pluripotency, or STAP, cells - suggesting a simple way to replace damaged cells or grow new organs for sick and injured people."When conducting the experiment, I believed it was absolutely right," Wakayama said."But now that many mistakes have emerged, I think it is best to withdraw the research paper once and, using correct data and correct pictures, to prove once again the paper is right. If it turns out to be wrong, we would need to make it clear why a thing like this happened."A Nature spokesperson said "issues relating to this paper" had been brought to the journal's attention and it was conducting an investigation, but made no further comment.

"OPEN MIND"Robin Lovell-Badge, a stem cell expert at Britain's National Institute for Medical Research, cautioned against premature assumptions on whether the research was flawed."I have an open mind on this," he told Reuters. "I'm waiting to hear from several serious stem cell labs around the world on whether they have been able to reproduce the methods. "Wakayama's co-researcher Haruko Obokata, became an instant celebrity in Japan after she spoke during a Nature media briefing to science reporters all over the world about her eye-catching findings.The Japanese researchers, joined by others from Brigham and Women's Hospital and Harvard Medical School in the United States, took skin and blood cells, let them multiply, then subjected them to stress "almost to the point of death", they explained, by exposing them to various events including trauma, low oxygen levels and acidic environments. One of these "stressful" situations was simply to bathe the cells in a weak acid solution for around 30 minutes. Within days, the scientists said they had found that the cells had not only survived but had also recovered by naturally reverting into a state similar to that of an embryonic stem cell. Yet no other research team has yet been able to replicate the findings, and the RIKEN Center for Developmental Biology in Japan, where Obokata works, said last week it had "launched an independent inquiry into the content of the paper.That inquiry would be conducted by a panel of experts from within and outside RIKEN, it said, and would be published as soon as it was concluded.A RIKEN spokesman declined to comment on Wakayama's call for the paper to be withdrawn.