as of 3/31
Increased Positions: 76 | 24,604,493
Decreased Positions: 67 | 19,862,094
Wednesday, March 31, 2010
Friday, March 12, 2010
Ariad
Ariad股价大涨,其试验药被FDA指定为罕见病用药 2010-03-01
Ariad Pharmaceuticals(ARIA.O: 行情) 称,其治疗癌症的试验药品AP24534被美国食品药物管理局(FDA)指定为治疗慢性粒细胞白血病(CML)的罕见病用药(orphan drug),此外,亦被欧洲医药管理局(The European Medicines Agency)指定为治疗上述病症和急性淋巴细胞白血病(ALL)的罕见药.
该公司股价周一盘前大涨5.1%至2.67美元.
Ariad在研药治疗白血病效果好 2010-02-26
Ariad制药公司近日对外宣称，一项早期临床实验结果显示，其在研的一种抗癌药用于晚期血癌患者之后抗癌活性显著，这些受试患者已对其他药物产生抵抗性。这个最新研究成果促使该公司的股价大幅上涨了50%。
参加这次早期临床实验的受试者当中，有23名慢性髓性白血病(CML)患者，此前他们均采用过当今一线/二线CML药物，这些患者在实验中被分成4组，使用最高剂量的在研药进行治疗，结果显示他们当中有19人病情保持稳定，无恶化倾向，这表明了药物在控制病情方面的效果。
Ariad计划在这项实验中共招募50名受试者，目前已招募到30人。CML与染色体异常有关，这会使患者体内的骨髓过多地并无节制地制造白细胞，最终致病。
美ARIAD公司研制成功新的抗“骨质疏松症”小分子药物 2009-11-12
美国ARIAD制药集团近日研制成功一种新的抗“骨质疏松症”药物。这种小分子药物能够有效地防止由骨质疏松引起的骨骼崩解的发生。
骨质疏松是一种进展缺乏症状而无性别差异的广泛性疾病，在美国，每年有一千万人患有该病。
在8月号的《美国科学院学报》上，ARIAD公司的科学家著文称：他们在动物试验中借助于该公司独有的药物设计模型通过小分子药物抑制Src酪氨酸激酶的活性，成功地控制了“骨质疏松症”的病情。
ARIAD公司研制的Src抑制剂是一种通过抑制再吸收而治疗骨质疏松的新型药物。该种小分子药物通过抑制Src酪氨酸激酶的活性，进而选择性地抑制破骨细胞的活性，减少了骨质的重吸收。
Wednesday, March 10, 2010
UPDATE 2-U.S. FDA panel backs InterMune lung drug
2010年 3月 10日 星期三 06:36 BJT
* FDA advisers vote 9-3 to back drug
* Final FDA decision expected by May 4
* Shares rise 63 percent after hours (Adds comments from panel member, company)
By Susan Heavey
SILVER SPRING, Md., March 9 (Reuters) - U.S. medical advisers backed InterMune Inc's (ITMN.O) experimental drug to treat lung scarring on Tuesday, saying it should be approved for patients with the rare fatal condition, and the shares rose 63 percent in after-hours trading.
In a 9-3 vote, the Food and Drug Administration's outside experts said the company's data were strong enough to support use of the drug, pirfenidone, for patients with idiopathic pulmonary fibrosis (IPF).
"It's not a perfect therapeutic intervention, but it helps fill the void," said panelist Dr. Michael Foggs, a Chicago-based physician.
InterMune shares rose 63 percent in after-hours trading to $38 on Tuesday after being halted during normal trading hours while the advisory panel met. The shares closed Monday at $23.30 on Nasdaq.
On March 5 after the FDA released documents related to Tuesday's meeting, InterMune's shares rose nearly 80 percent in premarket trading. The shares reached a year high of $25.37 that day. They traded at $10.48 on Nov. 27.
InterMune is seeking FDA approval of pirfenidone to help mitigate worsening lung function in patients with IPF, in which the lungs scar with no apparent cause.
Analysts have said the drug's approval could be key for the company, making it a possible takeover target.
The FDA will weigh the panel's recommendation and is expected to make a final decision by May 4. The agency usually approves drugs that win advisory panel support.
The panel was more divided over how well pirfenidone worked than over potential side effects. Members voted 7-5 that InterMune's data provided "substantial evidence" of a meaningful benefit.
Jerry Krishnan, a panelist who voted against approval, echoed others in stating that the drug appeared to work in certain patients but it was not clear who might benefit from treatment.
"I worry a little bit about potentially opening the possibility of widespread use" that could expose the larger population of IPF patients to risks without benefits, said Krishnan, a medical professor at the University of Chicago.
Panelists, including those who backed the drug, called for a patient registry to collect more data.
FDA reviewers had expressed concern that just one of InterMune's two clinical trials showed any benefit while more pirfenidone than placebo patients dropped out over possible complications. Problems seen in the study included gastrointestinal issues, liver abnormalities and rash.
The committee voted 9-3 that InterMune adequately assessed the drug's safety.
Representatives for the biotech company told the panel that pirfenidone was the only tested option for patients with IPF and that it could help improve patients' quality of life.
"Pirfenidone did not cure IPF," said Paul Noble, a medical professor at Duke University who spoke on behalf of InterMune. But, he said, it was "an important first step in IPF treatment."
Roughly 90,000 to 100,000 Americans have IPF and currently either go untreated or use risky, unapproved therapies, company officials said.
InterMune's Chief Medical Officer Steven Porter told the panel that complications were manageable by lowering the dose or stopping use of the drug.
InterMune said in a statement that it welcomed the panel vote and would work with the FDA. The company is planning a 5 p.m. teleconference to discuss the meeting.
InterMune has proposed selling the drug under the brand name Esbriet. (Reporting by Susan Heavey; Editing by Gary Hill)
* FDA advisers vote 9-3 to back drug
* Final FDA decision expected by May 4
* Shares rise 63 percent after hours (Adds comments from panel member, company)
By Susan Heavey
SILVER SPRING, Md., March 9 (Reuters) - U.S. medical advisers backed InterMune Inc's (ITMN.O) experimental drug to treat lung scarring on Tuesday, saying it should be approved for patients with the rare fatal condition, and the shares rose 63 percent in after-hours trading.
In a 9-3 vote, the Food and Drug Administration's outside experts said the company's data were strong enough to support use of the drug, pirfenidone, for patients with idiopathic pulmonary fibrosis (IPF).
"It's not a perfect therapeutic intervention, but it helps fill the void," said panelist Dr. Michael Foggs, a Chicago-based physician.
InterMune shares rose 63 percent in after-hours trading to $38 on Tuesday after being halted during normal trading hours while the advisory panel met. The shares closed Monday at $23.30 on Nasdaq.
On March 5 after the FDA released documents related to Tuesday's meeting, InterMune's shares rose nearly 80 percent in premarket trading. The shares reached a year high of $25.37 that day. They traded at $10.48 on Nov. 27.
InterMune is seeking FDA approval of pirfenidone to help mitigate worsening lung function in patients with IPF, in which the lungs scar with no apparent cause.
Analysts have said the drug's approval could be key for the company, making it a possible takeover target.
The FDA will weigh the panel's recommendation and is expected to make a final decision by May 4. The agency usually approves drugs that win advisory panel support.
The panel was more divided over how well pirfenidone worked than over potential side effects. Members voted 7-5 that InterMune's data provided "substantial evidence" of a meaningful benefit.
Jerry Krishnan, a panelist who voted against approval, echoed others in stating that the drug appeared to work in certain patients but it was not clear who might benefit from treatment.
"I worry a little bit about potentially opening the possibility of widespread use" that could expose the larger population of IPF patients to risks without benefits, said Krishnan, a medical professor at the University of Chicago.
Panelists, including those who backed the drug, called for a patient registry to collect more data.
FDA reviewers had expressed concern that just one of InterMune's two clinical trials showed any benefit while more pirfenidone than placebo patients dropped out over possible complications. Problems seen in the study included gastrointestinal issues, liver abnormalities and rash.
The committee voted 9-3 that InterMune adequately assessed the drug's safety.
Representatives for the biotech company told the panel that pirfenidone was the only tested option for patients with IPF and that it could help improve patients' quality of life.
"Pirfenidone did not cure IPF," said Paul Noble, a medical professor at Duke University who spoke on behalf of InterMune. But, he said, it was "an important first step in IPF treatment."
Roughly 90,000 to 100,000 Americans have IPF and currently either go untreated or use risky, unapproved therapies, company officials said.
InterMune's Chief Medical Officer Steven Porter told the panel that complications were manageable by lowering the dose or stopping use of the drug.
InterMune said in a statement that it welcomed the panel vote and would work with the FDA. The company is planning a 5 p.m. teleconference to discuss the meeting.
InterMune has proposed selling the drug under the brand name Esbriet. (Reporting by Susan Heavey; Editing by Gary Hill)
Friday, March 5, 2010
InterMune新藥通过FDA审核可能性增大 股价上涨56%
【财经日报 3月5日 综合电】联邦药物监管机构在对InterMune的抗炎藥吡非尼酮(pirfenidone)的审查时措辞并不像投资者担心的那样苛刻，提升了该药物获得通过的可能性，使得该公司股价周五大幅上涨。
投资者们在发现联邦食品和药物管理局(FDA)的报告并不像预期的那样严厉后，焦虑情绪得到缓解，使其股价猛涨56%至22.82美元。
FDA在官方网站上发布的报告质疑，关于吡非尼酮对IPF(idiopathic pulmonary fibrosis)病人的一份正面研究和负面研究报告是否足以为其疗效提供足够证据，支持其通过审核。
然而FDA的报告并没有再提出对吡非尼酮疗效或者使用安全性的新疑问，这是出乎投资者意料的。FDA承认IPF是一种致命的疾病，目前还没有办法找到有效的治疗物。
吡非尼酮将在下周二再次由一个FDA召集的外界专家小组进行审核。
目前InterMune的股价上涨8.20美元或56.13%至22.81美元。
投资者们在发现联邦食品和药物管理局(FDA)的报告并不像预期的那样严厉后，焦虑情绪得到缓解，使其股价猛涨56%至22.82美元。
FDA在官方网站上发布的报告质疑，关于吡非尼酮对IPF(idiopathic pulmonary fibrosis)病人的一份正面研究和负面研究报告是否足以为其疗效提供足够证据，支持其通过审核。
然而FDA的报告并没有再提出对吡非尼酮疗效或者使用安全性的新疑问，这是出乎投资者意料的。FDA承认IPF是一种致命的疾病，目前还没有办法找到有效的治疗物。
吡非尼酮将在下周二再次由一个FDA召集的外界专家小组进行审核。
目前InterMune的股价上涨8.20美元或56.13%至22.81美元。
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