K********g
发帖数: 9389 | 1 我挑选了几个：
AMRN
ARIA
BPAX
VRTX
CHTP
CRIS
AMLN
上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
50%+的有AMLN和ARIA
VRTX不好说
不过风险也很大的。要买可以趁低吸入，明年上半年估计药股不会太难过 | y*****l
发帖数: 5997 | 2 多谢，有段时间没关注生拉了。
http://finviz.com/screener.ashx?v=341&t=AMRN,ARIA,BPAX,VRTX,CHT
光头的文章：
22 Hot Drugs Facing FDA Approval in 2012
http://www.thestreet.com/_yahoo/story/11324723/1/22-hot-drugs-f
【在 K********g 的大作中提到】
: 我挑选了几个：
: AMRN
: ARIA
: BPAX
: VRTX
: CHTP
: CRIS
: AMLN
: 上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
: 50%+的有AMLN和ARIA
| y*****l
发帖数: 5997 | 3 22 Hot Drugs Facing FDA Approval in 2012
By Adam Feuerstein 11/29/11 - 08:55 AM EST
BOSTON (TheStreet) -- Here's your first look at the biotech and
pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S.
regulatory events -- FDA drug approvals and advisory panels -- expected
between December 2011 and July 2012. As every savvy biotech investor and
trader knows, the volatility in biotech and drug stocks ramps significantly
as U.S. regulators weigh whether to approve or reject new drugs.
Among the highlights from the 2012 FDA drug-approval calendar that should be
of most interest to bio-pharma investors: A first-quarter FDA advisory
panel that will once again tackle the thorny issue of obesity-drug safety,
including Vivus'(VVUS_) Qnexa; approval decisions for novel inhaled
medicines from Alexza Pharmaceuticals(ALXA_) and MAP Pharmaceuticals(MAPP_);
and the fifth (!!) attempt at approval for Discovery Labs'(DSCO_) lung
therapy for premature infants.
Biotech and drug stocks below are listed in chronological order based on the
closest regulatory catalyst.
Affymax(AFFY_)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
FDA advisory panel: Dec. 7, 2011
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's(AMGN_)
Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients
with chronic kidney disease, although peginesatide use would be limited to
sicker kidney dialysis patients only. Amgen recently signed long-term Epogen
supply contracts with the two largest kidney dialysis clinics in the U.S.
Pfizer(PFE_)
Drug/indication:Inlyta (axitinib) for kidney cancer
FDA advisory panel: Dec. 7, 2011
Approval decision date: Feb-April 2012
Alexza Pharmaceuticals(ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
FDA advisory panel: Dec. 12, 2011
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the
anti-agitation medicine loxapine directly into the lungs where it gets into
the bloodstream and begins to work quickly. The FDA advisory panel is
expected to focus much of its attention on the potential side effects and
safety issues related to delivering Adasuve into patients' lungs.
FDA initially rejected Adasuve in October 2010 due to concerns over lung
safety. Alexza resubmitted the drug to FDA last August.
Vivus(VVUS), Arena Pharmaceuticals(ARNA_) and Orexigen Therapeutics(OREX_)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: First quarter 2012 (exact date not yet disclosed.)
FDA held advisory panels to review all three of these controversial weight-
loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012,
Vivus and its obesity drug competitors are back for another shot, and FDA
will once again bring together a group of outside experts to weigh the pros
and cons of treating obesity with a pill.
Biogen Idec(BIIB) and Elan (ELN)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus
antibody status as a factor to help stratify the risk of progressive
multifocal leukoencephalopathy (PML). Doctors can use to test to determine
which multiple sclerosis patients are at low or high risk for PML, a serious
, potentially fatal brain infection caused by Tysabri.
Columbia Labs(CBRX) and Watson Pharmaceuticals(WPI)
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012
Amylin Pharmaceuticals(AMLN)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable
medicine for the treatment of Type 2 diabetes. Amylin recently split with
its long-time marketing partner Eli Lilly(LLY). Alkermes(ALKS) retains its
royalty split on Bydureon sales.
Bristol-Myers Squibb(BMY)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012
Pfizer(PFE) and Protalix Biotherapeutics(PLX)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control
issues. If approved this time around, Uplyso will compete against Sanofi/
Genzyme's(SNY) Cerezyme and Shire's Vpriv.
Teva(TEVA) and BioSante Pharmaceuticals(BPAX)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.
Corcept Pharmaceuticals(CORT)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.
Discovery Labs(DSCO)
Drug/indication: Surfaxin for respiratory distress syndrome in premature
infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.
Roche(RHHBY) and Curis(CRIS)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.
MAP Pharmaceuticals(MAPP)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it
intends to hold an advisory panel to review Levadex.
Chelsea Therapeutics(CHTP)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012
Pfizer(PFE) and Bristol-Myers Squibb(BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in
patients with atrial fibrilation.
Approval decision date: March 28, 2012
Onyx Pharmaceuticals(ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on
Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a
specific approval decision date. I'm assuming a six-month priority review
because carfilzomib is a cancer drug.
Vivus(VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.
Vertex Pharmaceuticals(VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis
in patients with a specific genetic defect.
Cell Therapeutics(CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone,
setting up the drug's second chance at U.S. approval.
Amgen(AMGN)
Drug/indication: Xgeva for prevention of bone metastases from prostate
cancer.
Approval decision date: April 26, 2012
VVUS(VVUS)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Merck(MRK) and Ariad Pharmaceuticals(ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012
Ironwood Pharmaceuticals(IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012
Amarin(AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012
Sources: Company reports, TheStreet research, BioMedTracker.com
--Written by Adam Feuerstein in Boston. | i*****1
发帖数: 670 | 4 风险怎么样
准备选择风险小的入手
【在 K********g 的大作中提到】
: 我挑选了几个：
: AMRN
: ARIA
: BPAX
: VRTX
: CHTP
: CRIS
: AMLN
: 上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
: 50%+的有AMLN和ARIA
| L*********n
发帖数: 1225 | 5 我准备选择风险大的入手.
为神马? 风险大的便宜吧, 呵呵. | y*****l
发帖数: 5997 | 6 高风险高收益
【在 L*********n 的大作中提到】
: 我准备选择风险大的入手.
: 为神马? 风险大的便宜吧, 呵呵.
| g***y
发帖数: 1025 | 7 cris，aria 一直在我的watch list上，看表现在决定吧。 | y*****l
发帖数: 5997 | | y*****l
发帖数: 5997 | 9 老牛还搞AMRN,BPAX？
BPAX CHTP有内部买入。
Insider Trading Relationship Date Transaction Cost #Shares Value ($) #Shares
Total SEC Form 4
ROSENOW EDWARD C III Director Nov 14 Buy 2.37 3,000 7,110 20,540 Nov 15 11:
15 AM
SULLIVAN LOUIS W Director Aug 15 Buy 2.67 10,000 26,700 47,898 Aug 29 12:40
PM
MANGANO ROSS J Director Aug 12 Buy 2.40 25,000 60,000 73,333 Aug 12 12:10 PM
DONENBERG PHILIP B Sr. VP of Finance, CFO & Secy Aug 08 Buy 2.23 1,000 2,230
44,322 Aug 09 10:51 AM
MANGANO ROSS J Director Aug 05 Buy 2.21 80,000 176,800 165,756 Aug 05 12:59
PM
Insider Trading Relationship Date Transaction Cost #Shares Value ($) #Shares
Total SEC Form 4
Schwieterman William D Chief Medical Officer Nov 23 Buy 4.46 45,141 201,329
130,592 Nov 28 04:43 PM
AUSTIN JOSIAH T 10% Owner Oct 17 Buy 4.37 2,100 9,177 8,243,149 Oct 19 11:09
AM
AUSTIN JOSIAH T 10% Owner Jun 14 Sale 4.89 20,018 97,818 8,241,049 Jun 15 01
:59 PM
AUSTIN JOSIAH T 10% Owner Jun 13 Sale 4.61 49,420 227,777 8,261,067 Jun 15
01:59 PM
Schwieterman William D Chief Medical Officer Mar 07 Buy 3.96 40,000 158,400
85,451 Mar 09 04:13 PM
【在 K********g 的大作中提到】
: 我挑选了几个：
: AMRN
: ARIA
: BPAX
: VRTX
: CHTP
: CRIS
: AMLN
: 上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
: 50%+的有AMLN和ARIA
| y*****l
发帖数: 5997 | 10 买了点AMRN,BPAX
Shares
40
PM
230
【在 y*****l 的大作中提到】
: 老牛还搞AMRN,BPAX？
: BPAX CHTP有内部买入。
: Insider Trading Relationship Date Transaction Cost #Shares Value ($) #Shares
: Total SEC Form 4
: ROSENOW EDWARD C III Director Nov 14 Buy 2.37 3,000 7,110 20,540 Nov 15 11:
: 15 AM
: SULLIVAN LOUIS W Director Aug 15 Buy 2.67 10,000 26,700 47,898 Aug 29 12:40
: PM
: MANGANO ROSS J Director Aug 12 Buy 2.40 25,000 60,000 73,333 Aug 12 12:10 PM
: DONENBERG PHILIP B Sr. VP of Finance, CFO & Secy Aug 08 Buy 2.23 1,000 2,230
| | | h*****8
发帖数: 4754 | 11 JAZZ咋样？
【在 K********g 的大作中提到】
: 我挑选了几个：
: AMRN
: ARIA
: BPAX
: VRTX
: CHTP
: CRIS
: AMLN
: 上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
: 50%+的有AMLN和ARIA
| t******g
发帖数: 462 | 12 11月初AMLN和LLY宣布合作终止, 有什么问题吗?
As part of the agreement, the parties will transition full responsibility
for the worldwide development and commercialization of exenatide to Amylin,
starting in the United States (U.S.) on November 30, 2011, and progressing
to all markets by the end of 2013.
【在 K********g 的大作中提到】
: 我挑选了几个：
: AMRN
: ARIA
: BPAX
: VRTX
: CHTP
: CRIS
: AMLN
: 上面可能翻倍的有AMRN, BPAX, CRIS, CHTP
: 50%+的有AMLN和ARIA
| K********g
发帖数: 9389 | 13 有问题，所以俺不敢买
,
【在 t******g 的大作中提到】
: 11月初AMLN和LLY宣布合作终止, 有什么问题吗?
: As part of the agreement, the parties will transition full responsibility
: for the worldwide development and commercialization of exenatide to Amylin,
: starting in the United States (U.S.) on November 30, 2011, and progressing
: to all markets by the end of 2013.
| b*****h
发帖数: 783 | 14 amln 的BYDUREON 和NVO 的Victoza head to head 对比试验输掉了,就注定amln 会失
宠。
【在 K********g 的大作中提到】
: 有问题，所以俺不敢买
:
: ,
| t******g
发帖数: 462 | 15 Thanks.
ALXA 如何? 马上12号有个FDA panel, 好象不是很positive
http://seekingalpha.com/article/311279-5-healthcare-companies-w
A few days later Alexza's (ALXA) Adasuve is slated to face the FDA's Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-004) citing adverse pulmonary reactions as well as a required human factors study to validate the product can be used successfully. Alexza states these issues are resolved, but the Advisory Committee has stated it will focus on pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD) Afrezza. Both are novel inhalation powders that have possible pulmonary reactions. Therefore we will likely see the Advisory Committee pick apart Adasuve, which means unless the Staccato system is perfect we will see a negative recommendation.
Adasuve is intended to treat agitation in patients with schizophrenia and/or bipolar disease. There are about 8 million patients diagnosed with schizophrenia or bipolar disease in the U.S. and agitation can be a violent side effect and/or symptom of these diseases. While this may sound fine and dandy, one issue that should be brought up is how a caregiver will give a severely agitated patient the treatment. The system may be simple, but if a patient is severely agitated it may become extremely difficult to get the patient to accept the Staccato system.
Nevertheless, the share price will be severely effected by the decision. Alexza's share price has already seen continuous declines and a shot in the arm from the Advisory Committee will send the stock tumbling. On the other hand, since a positive recommendation is not expected, the share price has the potential to fly 40% on a positive note from the Advisory Committee. Unfortunately this will not happen because Alexza did not address the pulmonary concerns the FDA cited. Everything else including the human factors study was a success, but the company more or less dismissed the FDA concerns toward pulmonary side effects.
【在 b*****h 的大作中提到】
: amln 的BYDUREON 和NVO 的Victoza head to head 对比试验输掉了,就注定amln 会失
: 宠。
| K********g
发帖数: 9389 | 16 这个垃圾不碰
Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-
004) citing adverse pulmonary reactions as well as a required human factors
study to validate the product can be used successfully. Alexza states these
issues are resolved, but the Advisory Committee has stated it will focus on
pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD)
Afrezza. Both are novel inhalation powders that have po: ssible pulmonary
reactions. Therefore we will likely see the Advisory Committee pick apart
Adasuve, which means unless the Staccato system is perfect we will see a
negative recommendation.
or bipolar disease. There are about 8 million patients diagnosed with
schizophrenia or bipolar disease in the U.S. and agitation can be a violent
side effect and/or symptom of these diseases. While this may sound fine and
dandy, one issue that should be brought up is how a caregiver will give a
severely agitated patient the treatment. The system may be simple, but if a
patient is severely agitated it may become extremely : difficult to get the
patient to accept the Staccato system.
Alexza's share price has already seen continuous declines and a shot in the
arm from the Advisory Committee will send the stock tumbling. On the other
hand, since a positive recommendation is not expected, the share price has
the potential to fly 40% on a positive note from the Advisory Committee.
Unfortunately this will not happen because Alexza did not address the
pulmonary concerns the FDA cited. Everything else includi: ng the human
factors study was a success, but the company more or less dismissed the FDA
concerns toward pulmonary side effects.
【在 t******g 的大作中提到】
: Thanks.
: ALXA 如何? 马上12号有个FDA panel, 好象不是很positive
: http://seekingalpha.com/article/311279-5-healthcare-companies-w
: A few days later Alexza's (ALXA) Adasuve is slated to face the FDA's Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-004) citing adverse pulmonary reactions as well as a required human factors study to validate the product can be used successfully. Alexza states these issues are resolved, but the Advisory Committee has stated it will focus on pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD) Afrezza. Both are novel inhalation powders that have possible pulmonary reactions. Therefore we will likely see the Advisory Committee pick apart Adasuve, which means unless the Staccato system is perfect we will see a negative recommendation.
: Adasuve is intended to treat agitation in patients with schizophrenia and/or bipolar disease. There are about 8 million patients diagnosed with schizophrenia or bipolar disease in the U.S. and agitation can be a violent side effect and/or symptom of these diseases. While this may sound fine and dandy, one issue that should be brought up is how a caregiver will give a severely agitated patient the treatment. The system may be simple, but if a patient is severely agitated it may become extremely difficult to get the patient to accept the Staccato system.
: Nevertheless, the share price will be severely effected by the decision. Alexza's share price has already seen continuous declines and a shot in the arm from the Advisory Committee will send the stock tumbling. On the other hand, since a positive recommendation is not expected, the share price has the potential to fly 40% on a positive note from the Advisory Committee. Unfortunately this will not happen because Alexza did not address the pulmonary concerns the FDA cited. Everything else including the human factors study was a success, but the company more or less dismissed the FDA concerns toward pulmonary side effects.
| b*****h
发帖数: 783 | 17 alxa 是小公司，没长期投资价值。
不过12号的panel 对短期炒作影响很大， 上下50％的幅度吧。
基本就像这个评论写的。
FDA 对它的安全性有疑问。
我感觉fda 态度还可以，而且这个是phase 1 trial 中出现的问题，placebo control
中也有，感觉不会太严重。
不过panel 结论不好预测，risk 挺大的。
Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-
004) citing adverse pulmonary reactions as well as a required human factors
study to validate the product can be used successfully. Alexza states these
issues are resolved, but the Advisory Committee has stated it will focus on
pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD)
Afrezza. Both are novel inhalation powders that have po: ssible pulmonary
reactions. Therefore we will likely see the Advisory Committee pick apart
Adasuve, which means unless the Staccato system is perfect we will see a
negative recommendation.
or bipolar disease. There are about 8 million patients diagnosed with
schizophrenia or bipolar disease in the U.S. and agitation can be a violent
side effect and/or symptom of these diseases. While this may sound fine and
dandy, one issue that should be brought up is how a caregiver will give a
severely agitated patient the treatment. The system may be simple, but if a
patient is severely agitated it may become extremely : difficult to get the
patient to accept the Staccato system.
Alexza's share price has already seen continuous declines and a shot in the
arm from the Advisory Committee will send the stock tumbling. On the other
hand, since a positive recommendation is not expected, the share price has
the potential to fly 40% on a positive note from the Advisory Committee.
Unfortunately this will not happen because Alexza did not address the
pulmonary concerns the FDA cited. Everything else includi: ng the human
factors study was a success, but the company more or less dismissed the FDA
concerns toward pulmonary side effects.
【在 t******g 的大作中提到】
: Thanks.
: ALXA 如何? 马上12号有个FDA panel, 好象不是很positive
: http://seekingalpha.com/article/311279-5-healthcare-companies-w
: A few days later Alexza's (ALXA) Adasuve is slated to face the FDA's Advisory Committee. Adasuve was rejected in October 2010 (under the name AZ-004) citing adverse pulmonary reactions as well as a required human factors study to validate the product can be used successfully. Alexza states these issues are resolved, but the Advisory Committee has stated it will focus on pulmonary safety. Adasuve may be in the same boat as Mannkind's (MNKD) Afrezza. Both are novel inhalation powders that have possible pulmonary reactions. Therefore we will likely see the Advisory Committee pick apart Adasuve, which means unless the Staccato system is perfect we will see a negative recommendation.
: Adasuve is intended to treat agitation in patients with schizophrenia and/or bipolar disease. There are about 8 million patients diagnosed with schizophrenia or bipolar disease in the U.S. and agitation can be a violent side effect and/or symptom of these diseases. While this may sound fine and dandy, one issue that should be brought up is how a caregiver will give a severely agitated patient the treatment. The system may be simple, but if a patient is severely agitated it may become extremely difficult to get the patient to accept the Staccato system.
: Nevertheless, the share price will be severely effected by the decision. Alexza's share price has already seen continuous declines and a shot in the arm from the Advisory Committee will send the stock tumbling. On the other hand, since a positive recommendation is not expected, the share price has the potential to fly 40% on a positive note from the Advisory Committee. Unfortunately this will not happen because Alexza did not address the pulmonary concerns the FDA cited. Everything else including the human factors study was a success, but the company more or less dismissed the FDA concerns toward pulmonary side effects.
| C*G
发帖数: 7495 | 18 amln去年10月没过后跳空，以为就是补点材料，就抢了一把，后来问过银杏后没信心就
跑了。
诺和诺德一直领跑，但这个市场太大了，天朝国力增长中不可避免的的富贵病。
hiahia
【在 b*****h 的大作中提到】
: amln 的BYDUREON 和NVO 的Victoza head to head 对比试验输掉了,就注定amln 会失
: 宠。
| b*****h
发帖数: 783 | 19 恩，国内这块市场潜力很大，，等mnkd快破产时把它的产品license回国开发。。。
【在 C*G 的大作中提到】
: amln去年10月没过后跳空，以为就是补点材料，就抢了一把，后来问过银杏后没信心就
: 跑了。
: 诺和诺德一直领跑，但这个市场太大了，天朝国力增长中不可避免的的富贵病。
: hiahia
| C*G
发帖数: 7495 | 20 糖尿病这一块的产品，配合移动监测和医疗才是未来三十年方向。
welldoc已经起步了，国内貌似也有，虽然商业盈利模型还争议不少，但方向应该还是
跑不了的,市场和利润可观。
我老野鸡认为，这比那些热炒的移动概念下的团购和社区等浮云强了N倍。
hiahia
【在 b*****h 的大作中提到】
: 恩，国内这块市场潜力很大，，等mnkd快破产时把它的产品license回国开发。。。
| | | b****t
发帖数: 442 | | t******g
发帖数: 462 | 22 Just for case study
Alexza Wins Panel’s Backing for Inhaled Antipsychotic Drug
Alexza Pharmaceuticals Inc. (ALXA) narrowly won a U.S. panel’s backing to
sell an inhaled antipsychotic drug that may put some patients at risk for
respiratory failure.
The Food and Drug Administration should approve a single daily dose of
Adasuve for schizophrenia and bipolar mania with a risk mitigation plan
proposed by the agency, outside advisers to the FDA said today in a 9-8 vote
in Adelphi, Maryland. The FDA isn’t required to follow the recommendation.
Adasuve would be the first product for Mountain View, California-based
Alexza. The therapy uses an inhalation device developed by the company to
deliver a vaporized form of the 36- year-old antipsychotic drug loxapine to
the lungs for rapid absorption into the bloodstream. The FDA aims to decide
on the product by Feb. 4.
“This product offers the potential to be a significant contributor to an
important need,” Andrew Winokur, director of psychopharmacology at the
University of Connecticut School of Medicine in Farmington, said before the
vote. The company presented “impressive efficacy data,” and the FDA’s
risk- mitigation proposal was “reassuring,” he said.
Sales of the drug, if approved, may reach $150 million, Jason Kantor, an
analyst at RBC Capital Markets in San Francisco, said Dec. 8 in a note to
clients.
Trading on Alexza was halted pending the outcome of today’s meeting. The
shares had declined 50 percent this year before today.
First Inhaled Antipsychotic
While loxapine was approved by the FDA in 1975, Adasuve would be the first
inhaled treatment for agitation associated with schizophrenia and bipolar
disorder. The product would compete with injectible forms of Eli Lilly & Co.
(LLY)’s Zyprexa, Bristol-Myers Squibb Co. (BMY)’s Abilify and Pfizer Inc.
(PFE)’s Geodon, part of a newer class of medicines known as atypical
antipsychotics.
If Adasuve gains FDA approval, Alexza “would still need a U.S. partner and/
or to raise substantial cash to fund the launch of Adasuve, which should
limit near-term upside,” Kantor said.
While Adasuve is effective as a fast-acting treatment for agitation among
patients with schizophrenia and bipolar disorder, it can cause bronchial
spasms that may be fatal in people with conditions such as asthma or chronic
obstructive pulmonary disorder, FDA staff said Dec. 7 in a report.
“No regulatory precedent exists for a product that has this degree of
bronchospasm as an adverse event,” Theresa Michele, a medical officer in
the FDA’s pulmonary products division, told the panel today.
Risk Mitigation
Adasuve failed to win approval in October 2010 because the agency was
concerned about the risks of pulmonary toxicity. Alexza resubmitted its
application in August with a proposed mitigation strategy that includes
screening patients for respiratory risks and monitoring people who take
Adasuve for an hour after treatment.
The company’s proposal didn’t resolve the FDA’s concerns because it may
be difficult for health-care providers to identify respiratory distress in
psychiatric patients who are “uncooperative and severely disorganized,”
Francis Becker, a medical officer in the FDA’s division of psychiatry
products, told the panel today.
“The scenario that all of us are worried about at FDA is that a patient,
whose asthma is not detected for whatever reason, gets treated in an
emergency setting, calms down, and is sort of put off to the side and not
carefully observed,” Thomas Laughren, director of the FDA’s Division of
Psychiatry Products, said at today’s meeting. “And they’re slowly getting
into trouble because no one’s monitoring them.”
Fast-Acting Drug
A company-funded study published in January in the British Journal of
Psychiatry found that Adasuve started to work within 10 minutes of
inhalation and was more effective than a placebo in cutting agitation levels
within two hours.
Alexza was able to recruit participants “very quickly” for the clinical
trials because “patients wanted to use this product,” James Cassella,
Alexza’s senior vice president for research and development, said today in
a presentation to the panel. Adasuve is “non-invasive, non-coercive and
helps maintain the patient-physician therapeutic alliance.”
There haven’t been any studies directly comparing Adasuve with other drugs
approved to treat agitation in patients with schizophrenia and bipolar
disorder, the FDA reviewers said.
While Lilly earned $5 billion from Zyprexa last year, sales may drop to $2.1
billion in 2012 amid generic competition. The FDA approved the first
Zyprexa copies in October. Bristol-Myers earned almost $2.6 billion from
Abilify last year, while Pfizer’s Geodon had $1 billion in revenue. | C*G
发帖数: 7495 | 23 铁牛的推荐的fda股第一炮不错哈
赞铁牛师傅
hiahia
【在 C*G 的大作中提到】
: amln去年10月没过后跳空，以为就是补点材料，就抢了一把，后来问过银杏后没信心就
: 跑了。
: 诺和诺德一直领跑，但这个市场太大了，天朝国力增长中不可避免的的富贵病。
: hiahia
| K********g
发帖数: 9389 | 24 不过BPAX的药效让人感到很意外，按道理药效大家估计都还行，但居然不行。
否则有一轮可搞的
【在 C*G 的大作中提到】
: 铁牛的推荐的fda股第一炮不错哈
: 赞铁牛师傅
: hiahia
| s**********9
发帖数: 846 | | K********g
发帖数: 9389 | 26 可以买了。在盘整，估计很快就要运动了，不过最好不要赌Priority Review. Review
前卖掉
【在 s**********9 的大作中提到】
: Chtp will run next?
| C*G
发帖数: 7495 | 27 您老推荐的这个amln的fda play算是本周像样盘子里涨幅表现最好的了.俱乐部里其他
大牛讨论得也很具体牛X的说.
hiahia.
【在 K********g 的大作中提到】
: 不过BPAX的药效让人感到很意外，按道理药效大家估计都还行，但居然不行。
: 否则有一轮可搞的
| n**********8
发帖数: 340 | | K********g
发帖数: 9389 | | C*G
发帖数: 7495 | |
|
