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Tuesday, July 28, 2015

逸達 (Foresee ) 生攜手神隆(ScinoPharm) 開發 緩釋leuprolide injectable

台北生技獎 創新能量露鋒芒 20150727 04:10 黃台中 協助生技產業快速發展,台北市政府主辦的2015台北生技獎24日舉行頒獎典禮,副市長周麗芳揭曉各獎項得主,讚許獲獎單位的創新技術內容,展現台灣生技產業豐沛優越的創新能量外,多項技術更應用在生活與醫療,實現守護民眾的用心。因應生技產業發展逐步成熟,研發成果漸顯露光芒,2015台北生技獎以「新創技術」、「國際躍進」、「技轉合作」3大獎項,呈現在生技「國際化」、「創新價值」及「技術承接」的研發成就,73件參賽標的在技術、財務、智財等面向之水準均相當優異,在激烈的競爭評比後,出線的13件獲獎標的成為生技產業界「創新價值」、「國際布局」、「產學銜接」絕佳典範。新創技術獎金獎:台灣浩鼎生技公司,銀獎台灣生醫材料公司,銅獎台睿生物科公司,國際躍進獎金獎:雃博公司,銀獎台耀化學公司,技轉合作獎金獎:財團法人國家衛生研究院,銀獎清華大學,銅獎成大醫學院生化暨分生所。精專生醫公司、安盛生科公司、逸達生物科技公司、陽明大學、台北醫學大學分獲新創技術與技轉合作類優等獎。

 2015臺北生技獎得獎名單  2015-07-24 16:40:25 經濟日報 曹松清  「新創技術獎」:金獎是台灣浩鼎生技公司,標的名稱是「癌症免疫療法-OBI-822 抗癌疫苗新藥」;銀獎是台灣生醫材料公司,標的名稱是「創新泡沫式人工腦膜」;銅獎是台睿生物科技公司,標的名稱是「口服抗癌新成分新藥 TRX-818 暨多重標靶作用與獨特抑癌細胞類管道形成之開發計畫」。優等獎有精專生醫公司的「自動化線性排列式膜管核酸(DNARNA)純化系統」、安盛生科公司的「結合智慧型手機之創新血糖量測系統」、逸達生物科技公司的「新型緩釋藥物輸送平臺技術及其快速產品商業化的應用」。「國際躍進獎」金獎是雃博公司的「智慧型減壓氣墊床組系列」;銀獎是台耀化學公司的「膽固醇暨磷酸鹽結合劑原料藥之銷售」。「技轉合作獎」金獎是財團法人國家衛生研究院的「新穎抗糖尿病DPP4抑制劑DBPR108-從新藥探索到產業發展的歷程」、銀獎是國立清華大學的「球面型人工視網膜晶片系統」、銅獎是成大醫學院生化暨分生所的「專一性拮抗組合蛋白之新穎蛋白質藥物及其醫藥用途」。優等獎有:國立陽明大學的「低氧間葉幹細胞的臨床應用:異體移植及其衍生物效用」、臺北醫學大學生醫器材研發暨產品試製中心的「3D列印技術」。

逸達 / Foresee is capitalizing on the wealth of opportunities afforded by its proprietary platform technologies and new chemical entities (NCEs). FP is developing promising products based on its technologies internally and partner some of its product opportunities with development and/or commercialization companies at appropriate stages along the development process.

FP-001:Prostate Cancer  Prostate cancer is the most common non-skin cancer and the second leading cause of cancer death among men in the United States. According to National Cancer Institute, about 240,890 new cases of prostate cancer will be diagnosed and about 33,720 men will die of prostate cancer in 2011. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime. Hormonal therapy is the standard palliative treatment in men with advanced prostate cancer. Long-acting gonadotropin releasing hormone (GnRH) agonists have greatly contributed to physician use of and patient compliance with this therapy. However, the current commercially available depot products must be supplied in complicated dosage forms, i.e., microparticles and double syringe packages separating active ingredient from carriers. Reconsititution or mixing immediately prior to administration is required, which is not user friendly and may result in inaccurate doses. Needle clogging has been frequently encountered in some cases with microparticles. FP-001 is designed to overcome the drawbacks of the commercial depot products containing GnRH agonists. By using a proprietary delivery system, the stability of the depot formulation is significantly improved, resulting in a much longer shelf-life. Therefore, the final drug product can be manufactured and supplied in a ready-to-use syringe. This product is less expensive to manufacture and is user friendly, which leads to better patient compliance and treatment outcome. It has been shown that FP-001 depot can deliver GnRH agonist and suppress testosterone below castrate levels for at least 6 months in rats. FP has initiated a Phase 3 clinical study of FP-001 for the treatment of advanced prostate carcinoma. For more information, please visit the study detail page at http://clinicaltrials.gov/ct2/show/NCT02234115?term=foreseeacer&rank=1.

FP-025: Asthma and COPD  COPD is the fourth leading cause of death in America, claiming the lives of 120,000 Americans in 2002. An estimated 10.7 million U.S. adults have COPD, but there may be many more undiagnosed cases. The costs associated with COPD are staggering, with in excess of $30 billion spent annually. The average Medicare expenses for patients with the disease are 2.5 times greater than for those without the disease. COPD is currently the Fourth leading cause of death in the United States and is expected to move to the number-three position by the year 2020. Smoking is the primary risk factor for COPD-approximately 80 to 90% of COPD deaths are caused by smoking. In spite of declining tobacco use in the United States, prevalence of COPD is expected to increase because of the lag time between tobacco exposure and disease development. Over the next 20 years, medical costs related to COPD will total approximately $832.9 billion in the United States, according to a study that presented at the American Thoracic Society International Conference on May 2006. FP-025 is a novel oral, highly potent and selective non-hydroxamate, matrix metalloproteinase-12 (MMP-12) inhibitor for the treatment of asthma and COPD. In preclinical studies, FP-025 has demonstrated a profile that suggests the potential for oral dosing and a unique pharmacological and favorable toxicological profile. The favorable characteristics of FP-025 is likely due to its direct action via inhibition of MMP-12 enzyme with much greater selectivity over other MMP's. FP has initiated a "Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers". For more information, please visit the study detail page at http://www.clinicaltrials.gov/ct2/show/NCT02238834?term=Foresee+pharmaceutical&rank=1.

FP-002: Acromegaly and Carcinoid Tumors  Acromegaly is a disabling and rare hormonal disorder that is associated with a reduction in life expectancy if left untreated. Carcinoid tumor is a rare and slow-growing form of cancer that may develop anywhere in the body where neuroendocrine cells exist, but primarily in the gastrointestinal tract and lungs (~99%). The standard treatments for both acromegaly and carcinoid syndromes are using somatostatin peptide analogues, including octreotide and lanreotide, to inhibit the production of growth hormones. The long-acting depots, Sandostatin LAR and Somatuline Autogel (monthly injection), are preferred for better patient compliance. The combined world market was approaching $1.5 billion in 2009. The chronic, life-long treatment with the current leading treatment, Sandostatin LAR, which consists of intramuscular injections every 4 weeks, is costly. Difficult reconstitution prior to and needle clogging during injection is also an issue. Less frequent and more convenient administration will be highly desirable. FP-002 is designed to overcome the drawbacks of the commercial depot products. Needle clogging is eliminated by formulating somatostatin analog as a liquid. Stabilized somatostatin analog formulation is obtained by preventing interaction between the analog and polymer using a novel proprietary delivery system. The final drug product can be manufactured at a lower cost and supplied in a ready-to-use syringe. It can be administered subcutaneously instead of intramuscularly and is more user-friendly, which leads to better patient compliance and treatment outcome. The stability of the fill-finished product has been shown to be stable for at least two years under controlled storage conditions. FP-002 has also been shown to deliver and maintain therapeutic levels of somatostatin analog for at least 3 months in rats and rabbits.

FP-004: Substance Abuse and Pain Relief  Drug abuse and addiction is a growing worldwide problem, including addiction to heroin and opiate analgesics. According to the National Institute of Health, about 8.3% percent of Americans aged 12 or older were current illicit Opiate users in 2006. Statistics show that Opiate abuse and Opiate addiction cost Americans over $484 billion annually. This figure includes healthcare costs (and abuses of that system), lost job wages, traffic accidents, crime and the associated criminal justice system costs. It has clearly been demonstrated that drug addiction treatments result in reductions in drug use and crime, and improvements in health and social functioning. FP-004 is a novel, subcutaneously injectable formulation of an opioid receptor agonist designed to deliver one to three months of medication following a single treatment. It is expected to provide more consistent therapeutic levels of the opioid receptor agonist with less variability between administrations and over time. This long acting formulation will improve patient compliance and prevent from misuse. This product is in discovery development stage for opioids detoxification. It will also be indicated for chronic pain conditions such as low back, osteoarthritis, and neuropathic pain.

FP-005: Type 2 Diabetes  Diabetes affects an estimated 23.6 million people in the US (90 percent to 95 percent have type 2 diabetes) according to the American Diabetes Association. Statistics showed diabetes was the fifth leading cause of death from diseases in 2007. Diabetes costs $116 billion annually in direct medical costs and costs $58 billion annually in indirect costs (loss of work, disability, loss of life)1 . Despite the introduction of new medications over the last decade, many diabetic patients are unable to control their blood sugar.2 Exenatide is the first in a new segment of anti-diabetic agents called incretin mimetics and is dosed subcutaneously twice daily. An extended-release formulation of exenatide, BYDUREON, has been shown to be administered once weekly and demonstrated superior blood sugar control compared to common diabetes medications such as sitagliptin, pioglitazone and insulin glargine. FP-005 is a novel, subcutaneously injectable formulation of GLP-1 analog designed to deliver one to three months of medication following a single treatment. It is expected to provide more consistent therapeutic levels of the GLP-1 analog to better control blood sugar levels over time. This long acting formulation will improve patient compliance and may slow the disease progression. It will provide a substantial advantage over BYDUREON and other injectable GLP-1 analogs currently in development.

FP-008: Diabetic Retinopathy  FP-008 has been demonstrated to be a promising candidate for the treatment of diabetic retinopathy (DR) which affects more than 4 million US adults 40 years and older. Presently, there is no FDA approved drug for the treatment of DR despite a large market opportunity. To date, only laser treatment to the retina is approved. The off-label use of intravitreal injections of Avastin or Lucentis or steroids are the only acceptable alternative to the laser treatment. This is indeed an unmet medical need. FP-008 has been shown to inhibit the IGF-1 signal transduction pathway in RPE cells, resulting in decreased VEGF production in conditions such as DR. In the past, the problem lied in the difficulties in delivering a high enough effective dose of medications to the retina by systemic administration and in formulating a stable intravitreal injection of FP-008. Foresee believes FP-008 will provide a new, safe and effective option for the treatment of DR with bioavailability for at least six months to one year.

Other Research Projects  FP is also conducting studies to evaluate the feasibility of applying SIF to several other compounds. Use of SIF platform for these compounds is expected to improve their delivery profiles and to achieve better efficacy. Once preclinical proof-of-concept is demonstrated, the compound will be selected to enter development phase.

ScinoPharm & Foresee  30th, 2013 - Foresee Pharmaceuticals, Inc. entered into joint venture agreement with ScinoPharm Taiwan, Ltd., a public traded Taiwan based leading process R&D and API manufacturing service provider to the global pharmaceutical industry. To maximize the potential for our products to make a difference in patients' lives, Foresee has entered into joint venture agreements with ScinoPharm Taiwan, Ltd., a leading process R&D and API manufacturing service provider based in Taiwan. The strategic partnership between Foresee and ScinoPharm will enable Foresee to expedite the development of sustained release drug products to benefit patients. ScinoPharm's expertise and leadership in active pharmaceutical ingredient manufacturing and drug product development will play a critical role for the Joint Venture to successfully develop the leuprolide injectable drug products.• The joint venture will focus on the development of leuprolide injectable drug products for the treatment of advanced stage prostate Cancer. This long-acting release formulation has the potential to provide important therapeutic benefits.• ScinoPharm will be the exclusive provider of the leuprolide active pharmaceutical ingredient ("API") for the joint venture.

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