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发帖数: 2056 | 1 10 Biotech Stocks On the Line
By Adam Feuerstein
http://www.thestreet.com/_yahoo/story/10700109/1/10-biotech-stocks-on-the-line.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
十檔受到重大研究影響的生技股 ZT
InterMune (ITMN: 報價, 研究資料) 股價上漲五暴漲180%，擁有該檔股票的投資人，
上週的投資價值就翻漲一倍。 由於美國食品藥物管理局核准藥物，對生技股的影響非
常大，往往導致個股大漲大跌，因生技股投資人必須非常留意這些個股事件的波動。
以下十檔個股未來幾個月就有新藥正在等待核准。通過的業者就可望像InterMune大漲
，如果失敗，就很可能大跌。
1. Affymax (AFFY: 報價, 研究資料) ：研發慢性腎疾病導致之貧血藥物Hematide。預
估期間：第二季。 Hematide是每月一次的注射藥物，用來治療慢性腎病導致至貧血。
這款藥物的開發包括四次大型的階段三研究，將對Amgen的貧血藥物是一大競爭威脅。
2. Allos Therapeutics (ALTH: 報價, 研究資料) 研發非小細胞肺癌藥物Folotyn。預
估期間為第一或第二季。 Allos正在進行第二階段研究，以證實Folotyn治療有非小細
胞肺癌的特定病患。這項非小細胞肺癌的礦究很重要，因為可能擴展Folotyn開發為更
大規模、明確的腫瘤癌症指標。
3. Amylin Pharmaceuticals (AMLN: 報價, 研究資料) 和Alkermes (ALKS: 報價, 研
究資料) 研發每週一次治療糖尿病的Exenatide。預估時間為3月12日？ Exenatide是由
Amylin和Eli Lilly (LLY: 報價, 研究資料) 銷售的每週一次的糖尿病注射藥物，並和
Alkermes的長效給藥技術，一旦開始銷售，該公司即可收取權利金。
4. Cell Therapeutics (CTIC: 報價, 研究資料) 研究非何杰金氏淋巴癌藥物
Pixantrone。FDA顧問日期：3月22日。 Pixantrone 終於將面臨FDA的癌症專家顧問的
表決。FDA將於4月23日做出最後核准與否的決定。
5. Delcath Systems (DCTH: 報價, 研究資料) 研發肝轉移癌症的肝臟灌注(PHP)藥物
Percutaneous。預估期間為第二季。 PHP是一套系統，可讓醫生隔離肝臟對身體的供給
，以便以高劑量化療治療肝臟腫瘤，而不會嚴重毒害身體。初次第三階段研究採用化療
藥物melphalan以治療具有特定類型皮膚癌並擴散至肝臟的病患。
6. Dendreon (DNDN: 報價, 研究資料) 研發治療前列腺癌的Provenge藥物。核准決策
日期：5月1日。 食品藥物管理局(FDA)並未公開表示計畫召開審核此藥物申請的顧問會
議。2007年曾召開類似的建議會議，表決結果為建議核准。
7. GenVec (GNVC: 報價, 研究資料) 研發治療胰臟癌的TNFerade藥物。預期時間為第
一季底/第二季初。 GenVec正在進行核心第三階段研究的第二次審查期間分析，比較對
罹患胰臟癌的病患採取TNFerade搭配準備照護對整體存活的影響，以及僅採取標準照護
程序之間的差異。
8. Mannkind (MNKD: 報價, 研究資料) 研發治療糖尿病的Afrezza藥物。核准決策日期
不明。 FDA原本於1月16日將進行Afrezza核准決策的會議延後，因為審查一家胰島素生
產廠尚未完成。尚不確定FDA何時會完成審查及發給Afrezza核准。
9. Somaxon Pharmaceuticals (SOMX: 報價, 研究資料) 研發治療失眠的藥物Silenor
。 FDA於去年12月發出Silenor的完整回應函(CRL)。Somaxon與FDA的會議上提交額外的
資訊，是有關此藥物對非年長病患的效用，公司並表示FDA已擁有審查藥物及發給核准
的所有所需資料。Approval decision date: March 21 ？
10. Vertex Pharmaceuticals (VRTX: 報價, 研究資料) 研究C型肝炎藥物Telaprevir
，預估時間為第二季。 Telaprevir是第一個，也是到目前為止最有效的新型藥物，可
直接對抗C型肝炎病毒。Vertex與合作夥伴嬌生 (JNJ: 報價, 研究資料) 正在進行一系
列第三階段研究，針對telaprevir對於新疹斷出且對藥物反應不佳的C型肝炎患者的效
果。目標在於2010下半年申請藥物核准。
10 Biotech Stocks On the Line
By Adam Feuerstein
http://www.thestreet.com/_yahoo/story/10700109/1/10-biotech-stocks-on-the-line.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
BOSTON (TheStreet) -- Shares of InterMune(ITMN) are up almost 180% since
last Friday. For investors who owned the drug company's stock last week,
that means their investment more than doubled in value in just four trading
sessions.
Only in biotech can such volatility generate huge windfalls for investors --
those armed with a simple calendar of stock-moving events. FDA advisory
panels (in the case of InterMune), drug approval decision dates and clinical
trial results move biotech stocks -- a lot. Keeping close tabs on these
stock-moving events is an essential task for every successful biotech
investor.
Not all biotech stocks rocket like InterMune. Some crash to earth like
Medivation(MDVN), which lost 70% of its value after the failure of pivotal
phase III drug study. But even here, investors who knew approximately when
the Medivation data were to be released could have booked profits in advance
or used options to hedge their investment and cushion the blow from a bad
outcome. Either way, investors caught unaware by the timing of biotech
events either miss a moneymaking opportunity or get blindsided by a blowup.
Here are ten biotech and drug companies with stock-moving events in the next
few months. Some of these stocks might be the next InterMune; others might
end up more like Medivation. Either way, it pays to keep a biotech events
calendar handy.
1. Company: Affymax(AFFY)
Drug/indication: Hematide for anemia due to chronic kidney disease
Estimated timing: Second quarter
Hematide is a once-monthly injectable drug designed to treat anemia in
patients with chronic kidney disease. The drug's development, including four
, large phase III studies, represents a significant competitive threat to
Amgen's bedrock anemia drug franchise.
2. Company: Allos Therapeutics(ALTH)
Drug/indication: Folotyn in non-small cell lung cancer.
Estimated timing: First or second quarter.
Allos is conducting this phase II study to demonstrate the feasibility of
using Folotyn to treat certain patients with non-small cell lung cancer.
Folotyn was recently launched commercially as a treatment for peripheral T-
cell lymphoma, a relatively small blood cancer indication. The study in non-
small cell lung cancer is important because it potentially expands Folotyn's
development to larger, solid tumor cancer indications
3. Companies: Amylin Pharmaceuticals(AMLN) and Alkermes(ALKS)
Drug/indication: Exenatide once weekly for diabetes
Approval decision date: March 12 ？
A potential billion-dollar drug, Exenatide once weekly is a long-acting
version of Exenatide, a once-daily injectable diabetes drug marketed by
Amylin and Eli Lilly(LLY). Exenatide once weekly was developed with Alkermes
' long-acting drug delivery technology, and the company will receive
royalties on the drug's sales.
4. Company: Cell Therapeutics(CTIC)
Drug/indication: Pixantrone for non-Hodgkin's lymphoma
FDA advisory panel: March 22
Pixantrone finally gets its day in front of a panel of FDA-picked cancer
experts after the original Feb. 10 panel meeting was cancelled due to severe
winter weather. Following the panel's vote to recommend pixantrone's
approval (or not), the FDA is expected to make the final approval decision
on April 23.
5. Company: Delcath Systems(DCTH)
Drug/indication: Percutaneous Hepatic Perfusion (PHP) for cancer-related
liver metastases.
Estimated timing: Second quarter
PHP is a system that lets doctors isolate the liver from the rest of the
blood supply so that tumors in the liver can be treated with high doses of
chemotherapy without causing significant toxicity in the rest of the body.
The first phase III study of the PHP system uses the chemotherapy drug
melphalan to treat patients with certain forms of skin cancer that has
spread to the liver.
6. Company: Dendreon(DNDN)
Drug/indication: Provenge for prostate cancer
Approval decision date: May 1
The FDA has given no public indication that it plans to hold an advisory
panel meeting to review the Provenge application. (Contrary to recent
published reports.) A similar panel meeting was held in 2007, which voted to
recommend the drug's approval.
7. Company: GenVec(GNVC)
Drug/indication: TNFerade for pancreatic cancer
Estimated timing: End of first quarter/early second quarter
GenVec is conducting a second interim analysis of a pivotal phase III study
comparing the effect on overall survival of TNFerade plus the standard of
care versus standard of care alone in patients with pancreatic cancer.
8. Company: Mannkind(MNKD)
Drug/indication: Afrezza for diabetes
Approval decision date: Unknown
The Jan. 16 FDA approval decision date for Afrezza was extended because
inspections at an insulin manufacturing facility were not yet completed,
according to Mannkind. How long FDA will take to complete its inspection and
issue an approval decision for Afrezza, an inhaled insulin device, is not
known. In January, Mannkind executives expressed confidence that FDA would
be able to complete its review within weeks, but that timeline is already
past due.
9. Company: Somaxon Pharmaceuticals(SOMX)
Drug/indication: Silenor for insomnia
Approval decision date: March 21
FDA issued a complete response letter for Silenor last December. Somaxon met
with the FDA, ted additional information about the drug's effect in non-
elderly patients, and now says the agency has all the data it needs to
review the drug and issue an approval decision.
10. Company: Vertex Pharmaceuticals(VRTX)
Drug/indication: Telaprevir for hepatitis C.
Estimated timing: Second quarter
Telaprevir is the first -- and so far, most potent -- in a new class of
drugs that works directly against the virus that causes hepatitis C. Vertex
and partner Johnson & Johnson(JNJ) are running a series of phase III studies
of telaprevir in newly diagnosed and treatment-resistant Hep C patients,
with the goal of filing for the drug's approval in the second half of 2010. | B*D
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