友霖新藥 臨床試驗超進度【經濟日報╱記者黃文奇／台北報導】 2013.08.02 03:41 am 友霖生技（4166）昨（1）日宣布，攜手美國藥品研發公司DURECT共同開發的抗過動症新藥「ORADUR-ADHD」，因人體臨床數據良好，將跨過二期直接進入三期，年底前將向美國、國內食品藥物管理署（FDA、TFDA）申請三期臨床試驗，未來雙方將共同搶攻全球84億美元商機。友霖是國內老牌藥廠友華的子公司，前者專注新藥開發，旗下擁有符合國際藥品製造稽察規範（PIC／S GMP）標準的藥品生產廠，進度最快的新藥除了抑制過動新藥外，還有抗帕金森氏症口水溢流症狀藥物，目前也正積極規劃授權中。友霖為興櫃公司，昨日興櫃參考價格約50.7元。業界表示，近期原傳出友霖旗下兩項試驗進度較快的新藥，包括抗過動、抗口水溢流兩項藥物都有機會授權；友霖昨日證實，由於前者臨床結果具特殊性，因此未來將由友霖和伙伴DURECT繼續開發，並於下季申請進入美國、台灣人體臨床三期試驗。【2013/08/02 經濟日報】
Market Opportunity Attention Deficit Hyperactivity Disorder (ADHD) is a neurobehavioral condition that is estimated to affect over 5 million (approximately 9%) of U.S. children ages 3-17, according to the U.S. Department of Health and Human Services. The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition presents itself in childhood and can be life long as a significant number of children with ADHD continue to present symptoms as adults. Over 50% of children with ADHD are estimated to being treated by medication, with stimulants such as amphetamine or methylphenidate as first-line treatments. U.S. sales of ADHD treatments were approximately $7.3 billion in 2011. The 2010 National Survey on Drug Use & Health estimates that 1.1 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness.
Development Strategy We are developing a drug candidate (ORADUR-ADHD) based on DURECT's ORADUR Technology for the treatment of ADHD. This drug candidate is intended to provide once-a-day dosing with added tamper resistant characteristics to address common methods of abuse and misuse of these types of drugs. In August 2009, we entered into a development and license agreement with Orient Pharma Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, under which we granted to Orient Pharma development and commercialization rights in certain defined Asian and South Pacific countries to ORADUR-ADHD. DURECT retains rights to North America, Europe, Japan and all other countries not specifically licensed to Orient Pharma. Under our agreement with Orient Pharma, the parties will collaborate to perform a clinical development program through a Phase II study intended to produce a data package suitable for further development of the drug candidate by us as well as Orient Pharma in their respective territories. We will be responsible for formulation and study design of the Phase I and Phase II clinical program which Orient Pharma has agreed to fund and execute. Orient Pharma would be responsible for all remaining development and commercialization activities for ORADUR-ADHD in the licensed territory. If commercialized, we will be entitled to receive a royalty on sales of ORADUR-ADHD by Orient Pharma. Orient Pharma has committed to supply a portion of DURECT's commercial requirements for ORADUR-ADHD in all territories other than the U.S. In 2010,2011 and 2012, we conducted several Phase I clinical trials in this program with multiple formulations. Based on information from these trials, we are continuing to optimize the lead formulations and are planning next steps in our ORADUR-ADHD program.
DURECT Announces Selection with Orient PHARMA of Lead Formulation for ORADUR®-Methylphenidate DURECT's goal is to deliver the right drug to the right site in the right amount at the right time. (PRNewsFoto)DURECT Corporation (www.durect.com) is pioneering the development and commercialization of pharmaceutical systems for the treatment of chronic ...CUPERTINO, Calif., Aug. 1, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that it and its collaborator Orient PHARMA Co., Ltd., a diversified multinational pharmaceutical, healthcare and consumer products company with headquarters in Taiwan, have selected a lead formulation for the lead program in DURECT's ORADUR-ADHD program, ORADUR-Methylphenidate. This lead formulation was chosen based on its potential for rapid onset of action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a recent Phase 1 trial. In addition, this product candidate will utilize a small capsule size relative to the leading existing long acting products on the market and incorporates DURECT's ORADUR anti-tampering technology. Orient PHARMA is planning to meet with the Taiwan Food and Drug Administration (TFDA) later this year to discuss the Phase 3 program in that market and is developing its plans for further development in the defined Asian and South Pacific countries to which it has rights from DURECT. DURECT retains rights to all other markets in the world, notably including the U.S., Europe and Japan, and is initiating licensing discussions with other companies now that the lead formulation has been selected. "We're pleased with the PK profile that has been achieved with ORADUR-Methylphenidate, which suggests that this product candidate would be an attractive alternative for patients with ADHD and their physicians," stated James E. Brown, D.V.M., President and CEO of DURECT. Attention Deficit Hyperactivity Disorder (ADHD) is a neurobehavioral condition that is estimated to affect over 5 million (approximately 9%) of U.S. children ages 3-17, according to the U.S. Department of Health and Human Services. The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition presents itself in childhood and can be life long as a significant number of children with ADHD continue to present symptoms as adults. Over 50% of children with ADHD are estimated to be treated by medication, with stimulants such as amphetamine or methylphenidate as first-line treatments. U.S. sales of ADHD treatments were approximately $8.4 billion in 2012, a 15% increase over 2011. The 2010 National Survey on Drug Use & Health estimates that 1.1 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness. In addition, according to the Drug Enforcement Administration (DEA), serious methylphenidate abusers often snort or inject methylphenidate for its intense euphoric effects or to alleviate the severe depression and craving associated with a stimulant withdrawal syndrome.
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