BioBlogger - Seeking Alpha 'BioBlogger' Tag RSS Syndication from SeekingAlpha.com SeekingAlpha.com http://seekingalpha.com/author/bioblogger Encysive Pharmaceuticals Blind-Sided: Thelin Receives Approvable Letter from FDA http://seekingalpha.com/article/8237-encysive-pharmaceuticals-blind-sided-thelin-receives-approvable-letter-from-fda?source=feed 8237 Although the company is being tight-lipped on exactly what FDA’s issues are, the company stated in its press release that the “letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.]]> Tue, 28 Mar 2006 00:48:46 -0500 BioBlogger Although the company is being tight-lipped on exactly what FDA’s issues are, the company stated in its press release that the “letter contains concerns and observations that must be satisfied prior to achieving approval, including a request for additional clinical trial work.
Complete Story »]]> ENCY BioBlogger FDA Delay of Tysabri Verdict Not a Surprise (BIIB, ELN) http://seekingalpha.com/article/8153-fda-delay-of-tysabri-verdict-not-a-surprise-biib-eln?source=feed 8153 ELN) and Biogen Idec (ticker: BIIB) announced that the FDA has extended its review of Tysabri by three months, pushing the PDUFA date out to June 28th.

This was not entirely surprising given the complex risk management program that needs to be put in place before it is reintroduced; if anything, this is more favorable than an “approvable letter,]]> Fri, 24 Mar 2006 10:53:56 -0500 BioBlogger ELN) and Biogen Idec (ticker: BIIB) announced that the FDA has extended its review of Tysabri by three months, pushing the PDUFA date out to June 28th.

This was not entirely surprising given the complex risk management program that needs to be put in place before it is reintroduced; if anything, this is more favorable than an “approvable letter,
Complete Story »]]> BIIB ELN BioBlogger Nabi Biopharmaceuticals Continues Clinical Development of StaphVax (NABI) http://seekingalpha.com/article/8152-nabi-biopharmaceuticals-continues-clinical-development-of-staphvax-nabi?source=feed 8152 Fri, 24 Mar 2006 10:46:08 -0500 BioBlogger Complete Story »]]> NABI BioBlogger Tysabri Comes Out On Top At FDA Panel Meeting (BIIB, ELN) http://seekingalpha.com/article/7581-tysabri-comes-out-on-top-at-fda-panel-meeting-biib-eln?source=feed 7581 BIIB) and Elan (ticker: ELN) hit the lottery. The Panel not only voted unanimously to bring back the drug as a standalone treatment but also voted 7-5 in favor of allowing the drug to be used in first-line therapy. A final decision by the FDA is expected by the end of the month.

Now that the “big]]> Fri, 10 Mar 2006 00:01:36 -0500 BioBlogger BIIB) and Elan (ticker: ELN) hit the lottery. The Panel not only voted unanimously to bring back the drug as a standalone treatment but also voted 7-5 in favor of allowing the drug to be used in first-line therapy. A final decision by the FDA is expected by the end of the month.

Now that the “big
Complete Story »]]> BIIB ELN BioBlogger Tysabri To Be Discussed At FDA Advisory Committee Meeting: Findings From The Briefing Documents (BIIB, ELN) http://seekingalpha.com/article/7473-tysabri-to-be-discussed-at-fda-advisory-committee-meeting-findings-from-the-briefing-documents-biib-eln?source=feed 7473 several posts speculating on the fate of this drug. Over the next couple days we will be a lot closer to understanding that fate. I have endured a considerable amount of criticism for voicing my opinions that went against popular sentiment. Apparently, I have not had enough – I am going to opine on Tysabri one more time.

Yesterday, the FDA released the Briefing Information for the Advisory Committee Meeting occurring today and tomorrow regarding the reintroduction of Tysabri back into the market. The most illuminating information to come from the documents was comments made by the FDA’s Office of Drug Safety (ODS) that stated: “It is the opinion of ODS that the RiskMAP* in its current form does not adequately address the risk of PML.]]> Tue, 07 Mar 2006 08:04:42 -0500 BioBlogger several posts speculating on the fate of this drug. Over the next couple days we will be a lot closer to understanding that fate. I have endured a considerable amount of criticism for voicing my opinions that went against popular sentiment. Apparently, I have not had enough – I am going to opine on Tysabri one more time.

Yesterday, the FDA released the Briefing Information for the Advisory Committee Meeting occurring today and tomorrow regarding the reintroduction of Tysabri back into the market. The most illuminating information to come from the documents was comments made by the FDA’s Office of Drug Safety (ODS) that stated: “It is the opinion of ODS that the RiskMAP* in its current form does not adequately address the risk of PML.
Complete Story »]]> BIIB ELN BioBlogger Research Report Highlights Reality of Tysabri’s Prospects (ELN, BIIB) http://seekingalpha.com/article/7257-research-report-highlights-reality-of-tysabris-prospects-eln-biib?source=feed 7257

The survey conducted on 140 neurologists found that only 59% believed Tysabri should return to the market and that only 6% would use Tysabari as first-line therapy. The results were not all bad, however – 92% believe the drug could be useful therapy to patients and 57% believe the effectiveness is worth the risk of PML.

]]> Wed, 01 Mar 2006 00:01:46 -0500 BioBlogger

The survey conducted on 140 neurologists found that only 59% believed Tysabri should return to the market and that only 6% would use Tysabari as first-line therapy. The results were not all bad, however – 92% believe the drug could be useful therapy to patients and 57% believe the effectiveness is worth the risk of PML.


Complete Story »]]> BIIB ELN BioBlogger FDA Has Egg On Its Face…Again (NFLD) http://seekingalpha.com/article/7053-fda-has-egg-on-its-faceagain-nfld?source=feed 7053 The Polyheme study referred to in the WSJ article was a controlled study comparing Polyheme versus real blood in patients undergoing surgery to repair aortic aneurysms. In 2001, the company abruptly halted the study citing slow enrollment. This is a plausible reason given only 152 of the projected 600 patients had enrolled in the study during a four year period. However, the fact the data on the 152 patients where never reviewed or published and the data were never submitted to the FDA raises numerous questions. According to internal documents cited in the WSJ article, Polyheme not only resulted in an increase in heart attacks but patients treated with Polyheme also show increased incidences of heart arrhythmia and pneumonia.

Dr. Stephen Gould’s, Northfield’s Chairman and CEO, is of the opinion that some hospitals gave patients both Polyheme and real blood resulting in hypertension that led to the heart attacks. Some experts, however, disagree. Given the toxicity of hemoglobin outside the confines of the red blood cell – free hemoglobin is known to cause inflammation in blood vessels that in turn can lead to heart attacks – many physicians speculate that polymerized hemoglobin may still cause inflammation albeit at a lower level that free hemoglobin despite claims made by the company. The fact that heart attacks and pneumonia have a common denominator – inflammation – suggests something more than the excessive fluid claim made by Dr. Gould, and the fact the company did not come clean with this data implies they have something to hide.

]]> Thu, 23 Feb 2006 00:05:55 -0500 BioBlogger The Polyheme study referred to in the WSJ article was a controlled study comparing Polyheme versus real blood in patients undergoing surgery to repair aortic aneurysms. In 2001, the company abruptly halted the study citing slow enrollment. This is a plausible reason given only 152 of the projected 600 patients had enrolled in the study during a four year period. However, the fact the data on the 152 patients where never reviewed or published and the data were never submitted to the FDA raises numerous questions. According to internal documents cited in the WSJ article, Polyheme not only resulted in an increase in heart attacks but patients treated with Polyheme also show increased incidences of heart arrhythmia and pneumonia.

Dr. Stephen Gould’s, Northfield’s Chairman and CEO, is of the opinion that some hospitals gave patients both Polyheme and real blood resulting in hypertension that led to the heart attacks. Some experts, however, disagree. Given the toxicity of hemoglobin outside the confines of the red blood cell – free hemoglobin is known to cause inflammation in blood vessels that in turn can lead to heart attacks – many physicians speculate that polymerized hemoglobin may still cause inflammation albeit at a lower level that free hemoglobin despite claims made by the company. The fact that heart attacks and pneumonia have a common denominator – inflammation – suggests something more than the excessive fluid claim made by Dr. Gould, and the fact the company did not come clean with this data implies they have something to hide.


Complete Story »]]> NFLD BioBlogger Does Adolor’s Announcement of Positive Entereg Data Assure FDA Approval? (ADLR) http://seekingalpha.com/article/6637-does-adolors-announcement-of-positive-entereg-data-assure-fda-approval-adlr?source=feed 6637 Study 314 is the fifth Entereg Phase 3 trial conducted in POI. Previous studies gave confounding results with some (studies 302 and 308) missing the primary endpoint. The mixed Phase 3 results prompted the FDA to issue an approvable letter in July 2005. According to Adolor’s website:

“In the Letter, the FDA indicated that, before the application may be approved, it will be necessary to provide additional proof of efficacy to support use of Entereg following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and indicated that this could be addressed with positive results from Adolor's ongoing Study 314. The FDA also indicated that the company must provide justification that the median reduction in time to gastrointestinal (GI) recovery seen in bowel resection patients treated with Entereg is clinically meaningful.]]> Wed, 08 Feb 2006 16:30:52 -0500 BioBlogger Study 314 is the fifth Entereg Phase 3 trial conducted in POI. Previous studies gave confounding results with some (studies 302 and 308) missing the primary endpoint. The mixed Phase 3 results prompted the FDA to issue an approvable letter in July 2005. According to Adolor’s website:

“In the Letter, the FDA indicated that, before the application may be approved, it will be necessary to provide additional proof of efficacy to support use of Entereg following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and indicated that this could be addressed with positive results from Adolor's ongoing Study 314. The FDA also indicated that the company must provide justification that the median reduction in time to gastrointestinal (GI) recovery seen in bowel resection patients treated with Entereg is clinically meaningful.
Complete Story »]]> ADLR BioBlogger Barron’s Tepid Review of Amylin Pharmaceuticals (AMLN, PFE, NKTR, SNY, NVO) http://seekingalpha.com/article/6350-barrons-tepid-review-of-amylin-pharmaceuticals-amln-pfe-nktr-sny-nvo?source=feed 6350 AMLN). His conclusion: Amylin’s drug, Byetta, “…could emerge as a star in the war against diabetes despite competition and…a possible link to a rare cancer. But all the good news already appears to be in the stock price.]]> Wed, 01 Feb 2006 00:09:12 -0500 BioBlogger AMLN). His conclusion: Amylin’s drug, Byetta, “…could emerge as a star in the war against diabetes despite competition and…a possible link to a rare cancer. But all the good news already appears to be in the stock price.
Complete Story »]]> AMLN NKTR NVO PFE SNY BioBlogger Gilead Reports Another Solid Quarter (GILD, BMY) http://seekingalpha.com/article/6349-gilead-reports-another-solid-quarter-gild-bmy?source=feed 6349 GILD) beat expectations once again. The results were driven by strong Truvada sales and royalties on its anti-influenza drug Tamiflu. Gilead reported EPS of $0.54, excluding a one-time tax benefit, on total revenue of $609.3 million. According to Yahoo, The Street was expecting $0.52 per share on $585.1 million in sales. The company has exceeded expectations on both the top and bottom lines over the past five quarters.

Despite the strong results, Gilead traded down in the after market on concerns over Truvada’s future growth. In other words, we saw a little “selling on the news.]]> Tue, 31 Jan 2006 20:54:30 -0500 BioBlogger GILD) beat expectations once again. The results were driven by strong Truvada sales and royalties on its anti-influenza drug Tamiflu. Gilead reported EPS of $0.54, excluding a one-time tax benefit, on total revenue of $609.3 million. According to Yahoo, The Street was expecting $0.52 per share on $585.1 million in sales. The company has exceeded expectations on both the top and bottom lines over the past five quarters.

Despite the strong results, Gilead traded down in the after market on concerns over Truvada’s future growth. In other words, we saw a little “selling on the news.
Complete Story »]]> BMY GILD BioBlogger Upheaval at Imclone (IMCL, BMY, AMGN, ABGX) http://seekingalpha.com/article/6145-upheaval-at-imclone-imcl-bmy-amgn-abgx?source=feed 6145 piece discussing the merits of Amgen’s (ticker: AMGN) and Abgenix’s (ticker: ABGX) panitumumab in treating colorectal cancer and the negative implications for Bristol-Myers’ (ticker: BMY) and Imclone’s (ticker: IMCL) Erbitux. The post incited considerable emotion, and many people adamantly disagreed with the conclusion – “Erbitux is in big trouble.]]> Thu, 26 Jan 2006 00:01:59 -0500 BioBlogger piece discussing the merits of Amgen’s (ticker: AMGN) and Abgenix’s (ticker: ABGX) panitumumab in treating colorectal cancer and the negative implications for Bristol-Myers’ (ticker: BMY) and Imclone’s (ticker: IMCL) Erbitux. The post incited considerable emotion, and many people adamantly disagreed with the conclusion – “Erbitux is in big trouble.
Complete Story »]]> ABGX AMGN BMY IMCL BioBlogger Fate of Serono: J&J Hires Citigroup to Examine a Formal Bid (SRA, JNJ, GDT, STJ, ELN, BIIB) http://seekingalpha.com/article/6144-fate-of-serono-j-j-hires-citigroup-to-examine-a-formal-bid-sra-jnj-gdt-stj-eln-biib?source=feed 6144 JNJ) has hired Citigroup to evaluate a possible bid for Serono (ticker: SRA). Citing people close to the situation, the article states that Johnson & Johnson is weighing its options following its failed bid for Guidant (ticker: GDT).

I am surprised by this revelation, assuming it’s true. I believe Serono would undoubtedly be an accretive asset for a large pharma company like J&J; however, given their appetite to enter the cardiac rhythm management business, I expected to hear more chatter about a bid for St. Jude Medical (ticker: STJ) than for Serono. Given the Tysabri overhang and the impending FDA Panel and ultimate FDA decision in March, I do not think J&J or any other company is in a rush to put in a bid for Serono. I believe potential suitors will sit on the sidelines until the FDA provides more clarity on Tysabri’s future.

]]> Wed, 25 Jan 2006 23:21:40 -0500 BioBlogger JNJ) has hired Citigroup to evaluate a possible bid for Serono (ticker: SRA). Citing people close to the situation, the article states that Johnson & Johnson is weighing its options following its failed bid for Guidant (ticker: GDT).

I am surprised by this revelation, assuming it’s true. I believe Serono would undoubtedly be an accretive asset for a large pharma company like J&J; however, given their appetite to enter the cardiac rhythm management business, I expected to hear more chatter about a bid for St. Jude Medical (ticker: STJ) than for Serono. Given the Tysabri overhang and the impending FDA Panel and ultimate FDA decision in March, I do not think J&J or any other company is in a rush to put in a bid for Serono. I believe potential suitors will sit on the sidelines until the FDA provides more clarity on Tysabri’s future.


Complete Story »]]> BIIB ELN GDT JNJ SRA STJ BioBlogger Biotech Stocks Q4 2005 Earnings Scorecard http://seekingalpha.com/article/6048-biotech-stocks-q4-2005-earnings-scorecard?source=feed 6048 Earnings season has arrived. Below is a list of many of the largest biotech stocks, their reporting dates, consensus estimates, and actual results (for those that have already reported) for the fourth quarter. Details (click to enlarge):


]]> Tue, 24 Jan 2006 01:40:49 -0500 BioBlogger Earnings season has arrived. Below is a list of many of the largest biotech stocks, their reporting dates, consensus estimates, and actual results (for those that have already reported) for the fourth quarter. Details (click to enlarge):



Complete Story »]]> AFFX ALXN AMGN AMLN AZN BIIB BMRN BSTE CELG DNA ELN GILD GPRO IMCL INCY ISTA KOSP NABI NBIX ONXX PGNX PHRM TELK VRTX BioBlogger It’s Official: FDA Panel Will Review Tysabri On March 7th (ELN, BIIB) http://seekingalpha.com/article/6047-its-official-fda-panel-will-review-tysabri-on-march-7th-eln-biib?source=feed 6047 ELN) and Biogen Idec (ticker: BIIB) announced today that an FDA panel will convene on March 7th to discuss the fate of Tysabri. Information on the panel can be viewed here.

Comment: More on Tysabri here.

]]> Mon, 23 Jan 2006 20:10:49 -0500 BioBlogger ELN) and Biogen Idec (ticker: BIIB) announced today that an FDA panel will convene on March 7th to discuss the fate of Tysabri. Information on the panel can be viewed here.

Comment: More on Tysabri here.


Complete Story »]]> BIIB ELN BioBlogger BioCryst Receives Fast-Track Status for Peramivir, But Does It Justify The Stock's Appreciation? (BCRX) http://seekingalpha.com/article/5896-biocryst-receives-fast-track-status-for-peramivir-but-does-it-justify-the-stock-s-appreciation-bcrx?source=feed 5896 BCRX) influenza drug, peramivir. Investors were overjoyed by the news, sending the stock up 18% on the day. Was the market’s reaction to the news rational? Is a Fast Track designation worth $90 million? Investors seem to think so – that’s how much they added to BioCryst’s market capitalization on the news.

To address the question of the value of Fast Track designation, let’s first look at what “fast track]]> Wed, 18 Jan 2006 09:17:17 -0500 BioBlogger BCRX) influenza drug, peramivir. Investors were overjoyed by the news, sending the stock up 18% on the day. Was the market’s reaction to the news rational? Is a Fast Track designation worth $90 million? Investors seem to think so – that’s how much they added to BioCryst’s market capitalization on the news.

To address the question of the value of Fast Track designation, let’s first look at what “fast track
Complete Story »]]> BCRX BioBlogger Should Pfizer Acquire Kos Pharmaceuticals? (PFE, KOSP, MRK) http://seekingalpha.com/article/5470-should-pfizer-acquire-kos-pharmaceuticals-pfe-kosp-mrk?source=feed 5470 Merck’s (ticker: MRK) recent announcement that it is developing a drug to increase HDL poses a significant threat to Pfizer’s (ticker: PFE) cholesterol management franchise. Pfizer is developing torcetrapib as an HDL raising drug that will be used in combination with its market leading statin, Lipitor; however, torcetrapib is not projected to be on the market until 2009. Merck announced that it has a drug consisting of an anti-inflammatory and extended-release niacin that it is combining with its statin, Zocor, that is expected to be on the market in 2008, one year ahead of Pfizer’s torcetrapib. If Merck is successful getting to market first with its HDL raising drug, it would deal a serious blow to Pfizer. However, there is one way for Pfizer to protect its market leadership – acquire Kos Pharmaceuticals (ticker: KOSP).

The reasons Pfizer should acquire Kos are four-fold:

]]> Thu, 05 Jan 2006 10:01:53 -0500 BioBlogger Merck’s (ticker: MRK) recent announcement that it is developing a drug to increase HDL poses a significant threat to Pfizer’s (ticker: PFE) cholesterol management franchise. Pfizer is developing torcetrapib as an HDL raising drug that will be used in combination with its market leading statin, Lipitor; however, torcetrapib is not projected to be on the market until 2009. Merck announced that it has a drug consisting of an anti-inflammatory and extended-release niacin that it is combining with its statin, Zocor, that is expected to be on the market in 2008, one year ahead of Pfizer’s torcetrapib. If Merck is successful getting to market first with its HDL raising drug, it would deal a serious blow to Pfizer. However, there is one way for Pfizer to protect its market leadership – acquire Kos Pharmaceuticals (ticker: KOSP).

The reasons Pfizer should acquire Kos are four-fold:


Complete Story »]]> KOSP MRK PFE BioBlogger Nitromed Update: Cramer Re-Visited (NTMD) http://seekingalpha.com/article/5468-nitromed-update-cramer-re-visited-ntmd?source=feed 5468 On November 8th I posted a comment concerning Jim Cramer’s call on Nitromed (ticker: NTMD). Almost two months later the stock has failed to retain the “Cramer Spike.]]> Thu, 05 Jan 2006 09:49:20 -0500 BioBlogger On November 8th I posted a comment concerning Jim Cramer’s call on Nitromed (ticker: NTMD). Almost two months later the stock has failed to retain the “Cramer Spike.
Complete Story »]]> NTMD BioBlogger Amgen Makes Bid To Acquire Abgenix For $2.2 billion (AMGN, ABGX) http://seekingalpha.com/article/5122-amgen-makes-bid-to-acquire-abgenix-for-2-2-billion-amgn-abgx?source=feed 5122 Yesterday evening, Amgen (ticker: AMGN) announced its intention to acquire Abgenix (ticker: ABGX) for $22.50 per share plus assumption of debt, representing a 54% premium over Abgenix's closing stock price.

The acquisition of Abgenix by Amgen is not a surprise to most since they are partners in the development of panitumumab for colorectal cancer and AMG 162 in osteoporosis. Aside from future panitumumab and AMG 162 royalties, the deal provides Amgen with a solid platform for developing future products with Abgenix's monoclonal antibody technology.

]]> Thu, 15 Dec 2005 17:17:02 -0500 BioBlogger Yesterday evening, Amgen (ticker: AMGN) announced its intention to acquire Abgenix (ticker: ABGX) for $22.50 per share plus assumption of debt, representing a 54% premium over Abgenix's closing stock price.

The acquisition of Abgenix by Amgen is not a surprise to most since they are partners in the development of panitumumab for colorectal cancer and AMG 162 in osteoporosis. Aside from future panitumumab and AMG 162 royalties, the deal provides Amgen with a solid platform for developing future products with Abgenix's monoclonal antibody technology.


Complete Story »]]> ABGX AMGN AMLN BMY IMCL LLY MRK SEPR BioBlogger PAH Market Heats Up: Myogen Reports Positive Data of Ambrisentan (MYOG) http://seekingalpha.com/article/4992-pah-market-heats-up-myogen-reports-positive-data-of-ambrisentan-myog?source=feed 4992 Myogen (ticker: MYOG) announced positive top-line results today from the pivotal ARIES-2 trial comparing ambrisentan, a once-a-day oral endothelin receptor antagonist (ERA), in pulmonary arterial hypertension.

ARIES-2 enrolled 186 patients in a randomized, double-blind, placebo-controlled trial evaluating two doses (2.5mg and 5mg) of ambrisentan. The primary endpoint was exercise capacity, which was defined as placebo-corrected mean change in six-minute walk distance at 12 weeks. In the study, 2.5mg dose of ambrisentan improved the six-minute walk distance by 32.3 meters (p=0.0219) while the 5mg dose improved 59.4 meters (p=0.0002). These results compared favorably with other oral PAH therapies, including Encysive's (ticker: ENCY) Thelin, which showed a 31.4 meter improvement in STRIDE-2, and Pfizer's (ticker: PFE) Rovitio, which showed a 50 meter improvement in SUPER-1.

]]> Mon, 12 Dec 2005 17:07:54 -0500 BioBlogger Myogen (ticker: MYOG) announced positive top-line results today from the pivotal ARIES-2 trial comparing ambrisentan, a once-a-day oral endothelin receptor antagonist (ERA), in pulmonary arterial hypertension.

ARIES-2 enrolled 186 patients in a randomized, double-blind, placebo-controlled trial evaluating two doses (2.5mg and 5mg) of ambrisentan. The primary endpoint was exercise capacity, which was defined as placebo-corrected mean change in six-minute walk distance at 12 weeks. In the study, 2.5mg dose of ambrisentan improved the six-minute walk distance by 32.3 meters (p=0.0219) while the 5mg dose improved 59.4 meters (p=0.0002). These results compared favorably with other oral PAH therapies, including Encysive's (ticker: ENCY) Thelin, which showed a 31.4 meter improvement in STRIDE-2, and Pfizer's (ticker: PFE) Rovitio, which showed a 50 meter improvement in SUPER-1.


Complete Story »]]> ENCY MYOG PFE BioBlogger Tysabri Panel Meeting in March? (BIIB, ELN) http://seekingalpha.com/article/4922-tysabri-panel-meeting-in-march-biib-eln?source=feed 4922 On the FDA Center for Drug Evaluation and Research website, the list of tentative meeting dates includes a March 7-8, 2006 meeting of the committee on Peripheral & Central Nervous System Drugs. See here.

]]> Thu, 08 Dec 2005 09:31:27 -0500 BioBlogger On the FDA Center for Drug Evaluation and Research website, the list of tentative meeting dates includes a March 7-8, 2006 meeting of the committee on Peripheral & Central Nervous System Drugs. See here.


Complete Story »]]> BIIB ELN BioBlogger