Seeking Alpha Biotech Research stocks 'Biotech Research' Tag RSS Syndication from SeekingAlpha.com SeekingAlpha.com http://seekingalpha.com/tag/biotech-research 2009 Fortune 40 Best Stocks for Retirement: Part II http://seekingalpha.com/article/146570-2009-fortune-40-best-stocks-for-retirement-part-ii?source=feed 146570 This is part 2 of a 4 part series looking at each of the companies selected and listed by Fortune in their 2009 Fortune 40: The Best Stocks to Retire On list.

Part 1 | Part 2

]]> Thu, 02 Jul 2009 04:20:34 -0400 Jae Jun Jae Jun submits:

This is part 2 of a 4 part series looking at each of the companies selected and listed by Fortune in their 2009 Fortune 40: The Best Stocks to Retire On list.

Part 1 | Part 2


Complete Story »]]> ACN BDX BHI BMY CSCO CSL GILD MA MCK MMM MSFT PH TMO WAG Jae Jun Comparing Medicine’s Cost and Effectiveness http://seekingalpha.com/article/146468-comparing-medicines-cost-and-effectiveness?source=feed 146468

Two important reports Wednesday offer early hints of the potential impact of a $1.1 billion federal program to compare the medical benefit and the cost-effectiveness of surgeries, medicines and medical devices. The reports — by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research – suggest priorities for spending $700 million of the research funds set aside under the American Recovery and Reinvestment Act of 2009.

The reports don’t name particular products or companies, but many of the suggested projects would scrutinize expensive products and services sold by identifiable companies, to wit: biologics for treating auto-immune such diseases as arthritis, now sold by the likes of Abbott Laboratories (ABT), Johnson & Johnson (JNJ) and Bristol-Myers Squibb (BMY); home health programs to prevent falls by older adults, now promoted by the likes of Amedisys (AMED); heart arrhythmia treatments marketed by Medtronic (MDT) and St. Jude Medical (STJ); tests for drug-resitant staph germs, as sold by Cepheid (CPHD); prostate cancer treatment with the Intuitive Surgical (ISRG) robot; drug treatments for attention deficit hyperactivity disorder, as sold by Shire (SHPGY).

]]> Wed, 01 Jul 2009 10:37:49 -0400 Eric Savitz Eric Savitz (Barron's) submits:

Two important reports Wednesday offer early hints of the potential impact of a $1.1 billion federal program to compare the medical benefit and the cost-effectiveness of surgeries, medicines and medical devices. The reports — by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research – suggest priorities for spending $700 million of the research funds set aside under the American Recovery and Reinvestment Act of 2009.

The reports don’t name particular products or companies, but many of the suggested projects would scrutinize expensive products and services sold by identifiable companies, to wit: biologics for treating auto-immune such diseases as arthritis, now sold by the likes of Abbott Laboratories (ABT), Johnson & Johnson (JNJ) and Bristol-Myers Squibb (BMY); home health programs to prevent falls by older adults, now promoted by the likes of Amedisys (AMED); heart arrhythmia treatments marketed by Medtronic (MDT) and St. Jude Medical (STJ); tests for drug-resitant staph germs, as sold by Cepheid (CPHD); prostate cancer treatment with the Intuitive Surgical (ISRG) robot; drug treatments for attention deficit hyperactivity disorder, as sold by Shire (SHPGY).


Complete Story »]]> ABT AMED BMY BSX CPHD CVD DNA ISRG JNJ MDT SHPGY STJ VAR Eric Savitz Lilly's Free Compound Screening Will Draw Many Takers http://seekingalpha.com/article/146018-lilly-s-free-compound-screening-will-draw-many-takers?source=feed 146018

Not long ago, I wrote about a Pfizer (PFE) program for smaller companies to come screen their targets against Pfizer's compound bank. Now Eli Lilly (LLY) has flipped that around. In an initiative to bring other people's compounds out of the stockrooms and off the shelves, they'll screen them for free.

These aren't single-target assays. The company has four phenotypic screens going (for Alzheimer's, diabetes, cancer, and osteoporosis) and will look for improvement by any mechanism that comes to hand. No chemical structure information is shown to Lilly (I assume that they just know the molecular weight so they can run a dilution series). If something looks interesting, the company and the owners of the chemical matter have 120 days to come to terms for any further development deal - if not, then all rights revert to the submitter, and they can publish the data from the screens.

]]> Mon, 29 Jun 2009 13:12:48 -0400 Derek Lowe Derek Lowe submits:

Not long ago, I wrote about a Pfizer (PFE) program for smaller companies to come screen their targets against Pfizer's compound bank. Now Eli Lilly (LLY) has flipped that around. In an initiative to bring other people's compounds out of the stockrooms and off the shelves, they'll screen them for free.

These aren't single-target assays. The company has four phenotypic screens going (for Alzheimer's, diabetes, cancer, and osteoporosis) and will look for improvement by any mechanism that comes to hand. No chemical structure information is shown to Lilly (I assume that they just know the molecular weight so they can run a dilution series). If something looks interesting, the company and the owners of the chemical matter have 120 days to come to terms for any further development deal - if not, then all rights revert to the submitter, and they can publish the data from the screens.


Complete Story »]]> LLY Derek Lowe Genomic Health Inc. Needs Label Expansion http://seekingalpha.com/article/145536-genomic-health-inc-needs-label-expansion?source=feed 145536 By Grant Zeng, CFA

Oncotype DX for Breast Cancer is Growth Engine

Genomic Health Inc. (GHDX) is an oncology-based biotech company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions. The company’s first product, Oncotype DX, is used for early stage breast cancer patients to predict the likelihood of cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit.

]]> Fri, 26 Jun 2009 06:23:58 -0400 Zacks.com Zacks.com submits:

By Grant Zeng, CFA

Oncotype DX for Breast Cancer is Growth Engine

Genomic Health Inc. (GHDX) is an oncology-based biotech company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions. The company’s first product, Oncotype DX, is used for early stage breast cancer patients to predict the likelihood of cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit.


Complete Story »]]> GHDX Zacks.com GlaxoSmithKline Thinks It's Turning Things Around http://seekingalpha.com/article/145286-glaxosmithkline-thinks-it-s-turning-things-around?source=feed 145286

There are some interesting statements from GlaxoSmithKline (GSK) CEO Andrew Witty here at Reuters. He admits that morale was completely in the scupper around the place a few months ago, which certainly seems to be true, but says that they're turning things around. To that point, remember all that stuff a few years ago about how GSK's research structure exemplified pretty much everything that a drug company needed to have? Well. . .

"We've really thrown into reverse much of the trend of research organisation that had developed over the last 15 years," Witty said.

]]> Thu, 25 Jun 2009 06:22:48 -0400 Derek Lowe Derek Lowe submits:

There are some interesting statements from GlaxoSmithKline (GSK) CEO Andrew Witty here at Reuters. He admits that morale was completely in the scupper around the place a few months ago, which certainly seems to be true, but says that they're turning things around. To that point, remember all that stuff a few years ago about how GSK's research structure exemplified pretty much everything that a drug company needed to have? Well. . .

"We've really thrown into reverse much of the trend of research organisation that had developed over the last 15 years," Witty said.


Complete Story »]]> GSK Derek Lowe Isis Generating Impressive Oncology, Diabetes Data http://seekingalpha.com/article/145019-isis-generating-impressive-oncology-diabetes-data?source=feed 145019 By Jason Napodano, CFA

At perhaps the two biggest industry trade conferences of the year, the American Society of Clinical Oncology ((ASCO)) and the American Diabetes Association ((ADA)), Isis Pharmaceuticals (ISIS) and/or its partners presented encouraging pre-clinical and early-stage clinical data showing the potential power of antisense technology as a new paradigm for treating cancer and diabetes -- two of the most widespread diseases in the U.S. and worldwide.

]]> Wed, 24 Jun 2009 03:59:29 -0400 Zacks.com Zacks.com submits:

By Jason Napodano, CFA

At perhaps the two biggest industry trade conferences of the year, the American Society of Clinical Oncology ((ASCO)) and the American Diabetes Association ((ADA)), Isis Pharmaceuticals (ISIS) and/or its partners presented encouraging pre-clinical and early-stage clinical data showing the potential power of antisense technology as a new paradigm for treating cancer and diabetes -- two of the most widespread diseases in the U.S. and worldwide.


Complete Story »]]> ISIS Zacks.com Is Medarex's Prostate Cancer Drug a Success? Too Early to Tell http://seekingalpha.com/article/144879-is-medarex-s-prostate-cancer-drug-a-success-too-early-to-tell?source=feed 144879

What's really going on with Medarex (MEDX) and ipilimumab? The company made news over the weekend with a press release from the Mayo Clinic, detailing what appears to be a substantial response in two prostate cancer patients. But the more you look at the story, the harder it is to figure out anything useful.

As this WebMD piece makes clear, this study is not a trial of ipilimumab as a single agent. The patients are undergoing prolonged androgen ablation, the testosterone-suppressing therapy that's been around for many years and is one of the standard options for prostate cancer. The trial is to see if ipilimumab has any benefit when it's added to this protocol - basically, to see if it can advance the standard of care a bit.

]]> Tue, 23 Jun 2009 13:01:45 -0400 Derek Lowe Derek Lowe submits:

What's really going on with Medarex (MEDX) and ipilimumab? The company made news over the weekend with a press release from the Mayo Clinic, detailing what appears to be a substantial response in two prostate cancer patients. But the more you look at the story, the harder it is to figure out anything useful.

As this WebMD piece makes clear, this study is not a trial of ipilimumab as a single agent. The patients are undergoing prolonged androgen ablation, the testosterone-suppressing therapy that's been around for many years and is one of the standard options for prostate cancer. The trial is to see if ipilimumab has any benefit when it's added to this protocol - basically, to see if it can advance the standard of care a bit.


Complete Story »]]> MEDX Derek Lowe FDA Calendar Updates: Amgen, Amicus, Oncothyreon and Medarex http://seekingalpha.com/article/144756-fda-calendar-updates-amgen-amicus-oncothyreon-and-medarex?source=feed 144756 Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA.
With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter ((CRL)) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
Eurand (NASDAQ:EURX): On 6/22/09, EURX announced that the FDA advised the company that it has extended the PDUFA action date for its pending New Drug Application ((NDA)) for Zenpep (pancrelipase capsules) by three months for a new estimated decision deadline of 9/23/09. The FDA did not request that the company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.
Zenpep is a proprietary pancreatic enzyme product developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The product was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. Zenpep is a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion.
Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen’s experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09.
The FDA Advisory Panel will discuss the company's proposed uses of
  1. treating and preventing osteoporosis in post-menopausal women and
  2. treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
Amicus Therapeutics (NASDAQ:FOLD): On 6/22/09, FOLD announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal (migalastat hydrochloride) for the treatment of Fabry disease. The company has reached agreement with the FDA on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of 2009 (2H09). The trial will consist of a six-month double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60 subjects (at about 30 clinical sites worldwide) who are naive to enzyme replacement therapy ((ERT)) or who have not received ERT for at least six months prior to the start of treatment with Amigal.
Oncothyreon (NASDAQ:ONTY): On 6/22/09, ONTY announced that Merck KGaA (MKGAY.PK) has initiated a global Phase 3 trial of Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with ONTY. The Phase 3 trial, named STRIDE (STimulating immune Response In aDvanced brEast cancer), is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries - including North America, Europe, Asia and Australia. Patients with estrogen receptor-positive and/or progesterone receptor-positive, non-resectable locally advanced, recurrent or metastatic breast cancer receiving hormonal therapy will be randomized to receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study. Stimuvax is also being evaluated in a 1300-patient Phase 3 START trial in patients with non-small cell lung cancer with data anticipated in 2011.
Medarex (NASDAQ:MEDX) and Bristol-Myers (NYSE:BMY) expect to report top-line Phase 3 clinical trial results for ipilimumab in the treatment of metastatic melanoma during 1Q10 after reaching the targeted number of events during 4Q09, based on guidance provided at a presentation on 6/17/09. On 6/22/09, shares of MEDX gained 12.5% following a Mayo Clinic press release at its Discovery’s Edge online research magazine that reported on a prostate cancer study with ipilimumab, which is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4 is a molecule on T-cells that plays a critical role in regulating natural immune responses).
Two Mayo Clinic patients whose prostate cancer had been considered inoperable have no evidence of disease thanks in part to an experimental drug therapy (ipilimumab) that was used in combination with standard hormone treatment (androgen ablation) and radiation therapy. In these two cases, physicians say the approach initiated the death of a majority of cancer cells and caused extensive tumor shrinkage, allowing surgery. Both men experienced consistent drops in their prostate specific antigen ((PSA)) counts over the following weeks until both were deemed eligible for surgery, which was successful and both men have resumed their normal lives.
Disclosure: No positions.
]]> Tue, 23 Jun 2009 04:38:39 -0400 Mike Havrilla Mike Havrilla submits:
Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA.
With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter ((CRL)) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
Eurand (NASDAQ:EURX): On 6/22/09, EURX announced that the FDA advised the company that it has extended the PDUFA action date for its pending New Drug Application ((NDA)) for Zenpep (pancrelipase capsules) by three months for a new estimated decision deadline of 9/23/09. The FDA did not request that the company provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.
Zenpep is a proprietary pancreatic enzyme product developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The product was developed in response to the 2004 FDA initial guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. Zenpep is a highly stable formulation of a porcine pancreatic extract that is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion.
Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen’s experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09.
The FDA Advisory Panel will discuss the company's proposed uses of
  1. treating and preventing osteoporosis in post-menopausal women and
  2. treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.
Amicus Therapeutics (NASDAQ:FOLD): On 6/22/09, FOLD announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal (migalastat hydrochloride) for the treatment of Fabry disease. The company has reached agreement with the FDA on the key protocol design elements of the pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. The company has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of 2009 (2H09). The trial will consist of a six-month double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60 subjects (at about 30 clinical sites worldwide) who are naive to enzyme replacement therapy ((ERT)) or who have not received ERT for at least six months prior to the start of treatment with Amigal.
Oncothyreon (NASDAQ:ONTY): On 6/22/09, ONTY announced that Merck KGaA (MKGAY.PK) has initiated a global Phase 3 trial of Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Stimuvax is an investigational therapeutic cancer vaccine being developed by Merck KGaA under a license agreement with ONTY. The Phase 3 trial, named STRIDE (STimulating immune Response In aDvanced brEast cancer), is anticipated to enroll more than 900 patients at approximately 180 sites in over 30 countries - including North America, Europe, Asia and Australia. Patients with estrogen receptor-positive and/or progesterone receptor-positive, non-resectable locally advanced, recurrent or metastatic breast cancer receiving hormonal therapy will be randomized to receive either Stimuvax or a placebo in a 2:1 ratio. The primary endpoint of STRIDE is progression-free survival. Overall survival, quality of life, tumor response and safety will also be assessed in this study. Stimuvax is also being evaluated in a 1300-patient Phase 3 START trial in patients with non-small cell lung cancer with data anticipated in 2011.
Medarex (NASDAQ:MEDX) and Bristol-Myers (NYSE:BMY) expect to report top-line Phase 3 clinical trial results for ipilimumab in the treatment of metastatic melanoma during 1Q10 after reaching the targeted number of events during 4Q09, based on guidance provided at a presentation on 6/17/09. On 6/22/09, shares of MEDX gained 12.5% following a Mayo Clinic press release at its Discovery’s Edge online research magazine that reported on a prostate cancer study with ipilimumab, which is a fully human antibody that binds to CTLA-4 (cytotoxic T lymphocyte-associated antigen 4 is a molecule on T-cells that plays a critical role in regulating natural immune responses).
Two Mayo Clinic patients whose prostate cancer had been considered inoperable have no evidence of disease thanks in part to an experimental drug therapy (ipilimumab) that was used in combination with standard hormone treatment (androgen ablation) and radiation therapy. In these two cases, physicians say the approach initiated the death of a majority of cancer cells and caused extensive tumor shrinkage, allowing surgery. Both men experienced consistent drops in their prostate specific antigen ((PSA)) counts over the following weeks until both were deemed eligible for surgery, which was successful and both men have resumed their normal lives.
Disclosure: No positions.

Complete Story »]]> AMGN BMY EURX FOLD MEDX MKGAY.PK ONTY Mike Havrilla The Bug in Genzyme's Side http://seekingalpha.com/article/144708-the-bug-in-genzyme-s-side?source=feed 144708

We organic chemists have it easy compared to the cell culture people. After all, our reactions aren't alive. If we cool them down, they slow down, and if we heat them up, they'll often pick up where they left off. They don't grow, they don't get infected, and they don't have to be fed.

Cells, though, are a major pain. You can't turn your back on 'em. Part of the problem is that there are, as yet, no cells that have evolved to grow in a dish or a culture bottle. Everything we do to them is artificial, and a lot of it what we ask cultured cells to do is clearly not playing to their strengths. Ask Genzyme (GENZ): they use the workhorse CHO (Chinese Hamster Ovary) cells to produce their biologics, but they've been having variable yield problems over the past few months. Now it turns out that their production facilities are infected with Vesivirus 2117 - I'd never heard of that one, but it interferes with CHO growth, and that's bringing Genzyme's workflow to a halt. (No one's ever reported human infection with that one, just to make that clear).

]]> Tue, 23 Jun 2009 02:59:04 -0400 Derek Lowe Derek Lowe submits:

We organic chemists have it easy compared to the cell culture people. After all, our reactions aren't alive. If we cool them down, they slow down, and if we heat them up, they'll often pick up where they left off. They don't grow, they don't get infected, and they don't have to be fed.

Cells, though, are a major pain. You can't turn your back on 'em. Part of the problem is that there are, as yet, no cells that have evolved to grow in a dish or a culture bottle. Everything we do to them is artificial, and a lot of it what we ask cultured cells to do is clearly not playing to their strengths. Ask Genzyme (GENZ): they use the workhorse CHO (Chinese Hamster Ovary) cells to produce their biologics, but they've been having variable yield problems over the past few months. Now it turns out that their production facilities are infected with Vesivirus 2117 - I'd never heard of that one, but it interferes with CHO growth, and that's bringing Genzyme's workflow to a halt. (No one's ever reported human infection with that one, just to make that clear).


Complete Story »]]> GENZ Derek Lowe Lilly Offers Free Compound Testing in Collaboration with Lab Researchers http://seekingalpha.com/article/143625-lilly-offers-free-compound-testing-in-collaboration-with-lab-researchers?source=feed 143625 Eli Lilly (NYSE: LLY) has taken another step in implementing its transformation from a fully integrated big pharma to a partnership arrangement, which it now calls a Fully Integrated Pharmaceutical Network (FIPNet). The goal is to foster open collaboration between Lilly and global laboratory researchers.

Lilly calls its new program the Phenotypic Drug Discovery Initiative, or PD2 (pronounced PD-squared). Lilly is offering a free-of-charge use to outside researchers of its disease-state assays, complete with a secure web portal, which will evaluate the therapeutic potential of externally-developed synthesized compounds.

]]> Wed, 17 Jun 2009 04:26:59 -0400 ChinaBio Today ChinaBio Today submits:

Eli Lilly (NYSE: LLY) has taken another step in implementing its transformation from a fully integrated big pharma to a partnership arrangement, which it now calls a Fully Integrated Pharmaceutical Network (FIPNet). The goal is to foster open collaboration between Lilly and global laboratory researchers.

Lilly calls its new program the Phenotypic Drug Discovery Initiative, or PD2 (pronounced PD-squared). Lilly is offering a free-of-charge use to outside researchers of its disease-state assays, complete with a secure web portal, which will evaluate the therapeutic potential of externally-developed synthesized compounds.


Complete Story »]]> LLY ChinaBio Today 6 Healthcare Stocks to Watch http://seekingalpha.com/article/143429-6-healthcare-stocks-to-watch?source=feed 143429 The market experienced broad declines on Monday, hurt by weak economic data - a sharp contrast to last week when the Dow industrials rallied to turn positive for the year, increasing hopes that the economy is starting to turn around. Some key reports issued on Monday helped underscore the fact that the economy is still struggling. At mid-month, a New York state manufacturing survey (which often indicates where the country is headed) showed a decline in orders from just thirty days ago. In addition, more than half of the manufacturing respondents said that they had pared capital spending this year. Adding to the mix, the National Association of Home Builders housing-market index fell in June as higher mortgage rates damped demand. That didn't help set the table for a good week, but we'll see how things play out for the beaten bulls as the week goes on.

In the healthcare sector, Jazz Pharmaceuticals, Inc (NASDAQ:JAZZ), which had a good day last week, is off to another good start. The stock closed up +1.92 (72.73%) to $4.56 after the company's Sodium oxybate or JZP-6 demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase III data presented at the 2009 Associated Professional Sleep Societies meeting in Seattle, WA. The company said that these data have not been evaluated by the FDA or other regulatory authorities for use of sodium oxybate in the treatment of fibromyalgia. Assuming positive results for the second study, the company anticipates submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009.

]]> Tue, 16 Jun 2009 05:51:56 -0400 M. E. Garza The market experienced broad declines on Monday, hurt by weak economic data - a sharp contrast to last week when the Dow industrials rallied to turn positive for the year, increasing hopes that the economy is starting to turn around. Some key reports issued on Monday helped underscore the fact that the economy is still struggling. At mid-month, a New York state manufacturing survey (which often indicates where the country is headed) showed a decline in orders from just thirty days ago. In addition, more than half of the manufacturing respondents said that they had pared capital spending this year. Adding to the mix, the National Association of Home Builders housing-market index fell in June as higher mortgage rates damped demand. That didn't help set the table for a good week, but we'll see how things play out for the beaten bulls as the week goes on.

In the healthcare sector, Jazz Pharmaceuticals, Inc (NASDAQ:JAZZ), which had a good day last week, is off to another good start. The stock closed up +1.92 (72.73%) to $4.56 after the company's Sodium oxybate or JZP-6 demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase III data presented at the 2009 Associated Professional Sleep Societies meeting in Seattle, WA. The company said that these data have not been evaluated by the FDA or other regulatory authorities for use of sodium oxybate in the treatment of fibromyalgia. Assuming positive results for the second study, the company anticipates submitting a New Drug Application for sodium oxybate for the treatment of fibromyalgia to the U.S. Food and Drug Administration by the end of 2009.


Complete Story »]]> ABT AEZS ARNA BIOD CHDX JAZZ JNJ KNDL KV.A MRGE MRK PFE WYE M. E. Garza Life Science Looks to Big Pharma for Funding as Caution Still Reigns http://seekingalpha.com/article/143121-life-science-looks-to-big-pharma-for-funding-as-caution-still-reigns?source=feed 143121 By MARIE DAGHLIAN

Last week's flurry of public-share offerings must have been a blip on the radar screen, as most life sciences companies look to private investors for much needed cash. And while the number of PIPEs and venture-capital financings continues at a fairly good clip, the data reveal that individual deals are smaller and smaller. Partnering with pharma, another important avenue to sustainability, has been improving and can be quite lucrative, but deals remain few. Pharma companies are taking on less risk through smaller upfront fees and more option agreements.
Privately held San Mateo, California-based Bayhill Therapeutics gave up the idea of going public. Instead, it opted to leverage its pipeline through an exclusive worldwide collaboration with Genentech (DNA) (now a division of pharma giant Roche (RHHBY.PK)) to develop and potential commercialize Bayhill's BHT-3021. The compound is a DNA-based antigen specific immunotherapy currently in a phase I/II clinical trial in patients with type 1 diabetes.
Bayhill will get an upfront payment of $25 million in cash and equity from Genentech, with additional development, regulatory and sales milestone payments that could exceed $325 million. Bayhill will also get royalties on any sales of an approved therapy. Bayhill remains responsible for completing the on-going phase I/II trial, and Genentech will be responsible for all future research, development, manufacturing and commercialization efforts. Genentech will reimburse Bayhill the remaining costs of the phase I/II trial and will fund all future expenses. Bayhill retains rights to opt in on future development as well as an option to co-promote in North America.
Interim results for BHT-3021, a plasmid encoding proinsulin, were presented at the recent American Diabetes Association meeting in New Orleans and showed that the drug is safe and well-tolerated. Bayhill develops novel and targeted treatment candidates for autoimmune diseases that are designed to restore patient’s immunological “tolerance” to self antigens to a normal state by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact.
Vancouver, Canada-based Xenon entered into a strategic alliance with Merck (MRK) to discover and develop novel small molecule candidates for cardiovascular disease. From the start, privately held Xenon has followed a strategy of select partnering of parts of its pipeline in order to continue ownership and development of other programs. In collaboration with Merck, Xenon will perform validation studies using its clinical genetics platform, as well as drug discovery and select preclinical development of small molecule compounds for those targets selected by a joint steering committee.
Under the terms of the agreement, Merck has the option to exclusively license targets and compounds from Xenon for development and commercialization. In return, Xenon receives research funding and is eligible for option exercise fees, research, development and regulatory milestone payments of up to $94.5 million for the first target and up to $89.5 million for each subsequent target selected for drug discovery. Xenon will also receive royalties on sales of products resulting from the collaboration and retains the right to develop and commercialize certain compounds for which Merck does not exercise its option.
Pharmaceutical companies have been active investors of late through their corporate venture funds. Aileron Therapeutics closed a $40-million Series D financing. Investors included several venture arms of big pharma: SR One, the independent corporate venture fund of GlaxoSmithKline (GSK), Novartis (NVS) Venture Fund, Lilly Ventures (LLY), and Roche Venture Fund. New investor Excel Medical Fund and founding investor Apple Tree Partners also participated. The Cambridge, Massachusetts-based company is developing a novel class of therapeutics called Stapled Peptides as a technology platform for historically undruggable targets. Proceeds from the financing will be used to advance Aileron’s lead Stapled Peptide program toward clinical trials in 2010 and to further advance the Stapled Peptide platform and programs in oncology, immune/inflammation, metabolic disease, and infectious disease. Stapled Peptides are synthetically locked, or “stapled”, into an alpha-helical shape to create drug compounds that are uniquely effective for targets that are “undruggable” with currently available drug approaches. In previous financings, Aileron has raised $20 million in funding.
Alios BioPharma, based in South San Francisco, California, also relied on pharma money, closing its $32-million Series A preferred stock financing with $8 million from new investor SR One, the corporate venture fund of GlaxoSmithKline. The first closing was completed in December 2008, led by Novo A/S and Novartis Venture Fund with participation from the Roche Venture Fund. Alios is developing small molecule and protein therapeutics to treat viral diseases by activating pathways in the innate immune system.
Seattle, Washington-based NanoString Technologies closed a $30-million Series C equity financing to accelerate commercialization of its leading expression profiling nCounter Analysis System in the research tools and diagnostics arenas. The round was led by Clarus Ventures, and was joined by existing investors OVP Venture Partners and Draper Fisher Jurvetson.
In Minneapolis, medical device company Inspire Medical Systems completed a Series B financing of $17 million, which was led by Synergy Life Science Partners and included participation from existing investors Kleiner Perkins Caufield & Byers, US Venture Partners, Medtronic (MDT), and Dr. Glen D. Nelson through GDN Holdings. Earlier in 2009, Inspire announced the first human implant of its Inspire II system designed to treat Obstructive Sleep Apnea. Since this announcement, Inspire continued to implant patients into parallel clinical trials being conducted in the United States and in Europe with several implants in each location to date. The Series B financing is over two phases with the primary purpose to fund the on-going clinical activity.
While the tide toward economic recovery is slowly turning positive and consumer confidence is rising, many investors remain skittish, worrying that weakening demand for government debt may force Washington to raise interest rates to attract buyers, but at the same time slow the economic recovery. Caution still reigns. Raising capital in the public market continues to remain difficult especially for companies without any revenue generating products. Geneara called it quits after 22 years of failing to bring a product into the market.


]]> Mon, 15 Jun 2009 03:23:42 -0400 The Burrill Report The Burrill Report submits:

By MARIE DAGHLIAN

Last week's flurry of public-share offerings must have been a blip on the radar screen, as most life sciences companies look to private investors for much needed cash. And while the number of PIPEs and venture-capital financings continues at a fairly good clip, the data reveal that individual deals are smaller and smaller. Partnering with pharma, another important avenue to sustainability, has been improving and can be quite lucrative, but deals remain few. Pharma companies are taking on less risk through smaller upfront fees and more option agreements.
Privately held San Mateo, California-based Bayhill Therapeutics gave up the idea of going public. Instead, it opted to leverage its pipeline through an exclusive worldwide collaboration with Genentech (DNA) (now a division of pharma giant Roche (RHHBY.PK)) to develop and potential commercialize Bayhill's BHT-3021. The compound is a DNA-based antigen specific immunotherapy currently in a phase I/II clinical trial in patients with type 1 diabetes.
Bayhill will get an upfront payment of $25 million in cash and equity from Genentech, with additional development, regulatory and sales milestone payments that could exceed $325 million. Bayhill will also get royalties on any sales of an approved therapy. Bayhill remains responsible for completing the on-going phase I/II trial, and Genentech will be responsible for all future research, development, manufacturing and commercialization efforts. Genentech will reimburse Bayhill the remaining costs of the phase I/II trial and will fund all future expenses. Bayhill retains rights to opt in on future development as well as an option to co-promote in North America.
Interim results for BHT-3021, a plasmid encoding proinsulin, were presented at the recent American Diabetes Association meeting in New Orleans and showed that the drug is safe and well-tolerated. Bayhill develops novel and targeted treatment candidates for autoimmune diseases that are designed to restore patient’s immunological “tolerance” to self antigens to a normal state by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact.
Vancouver, Canada-based Xenon entered into a strategic alliance with Merck (MRK) to discover and develop novel small molecule candidates for cardiovascular disease. From the start, privately held Xenon has followed a strategy of select partnering of parts of its pipeline in order to continue ownership and development of other programs. In collaboration with Merck, Xenon will perform validation studies using its clinical genetics platform, as well as drug discovery and select preclinical development of small molecule compounds for those targets selected by a joint steering committee.
Under the terms of the agreement, Merck has the option to exclusively license targets and compounds from Xenon for development and commercialization. In return, Xenon receives research funding and is eligible for option exercise fees, research, development and regulatory milestone payments of up to $94.5 million for the first target and up to $89.5 million for each subsequent target selected for drug discovery. Xenon will also receive royalties on sales of products resulting from the collaboration and retains the right to develop and commercialize certain compounds for which Merck does not exercise its option.
Pharmaceutical companies have been active investors of late through their corporate venture funds. Aileron Therapeutics closed a $40-million Series D financing. Investors included several venture arms of big pharma: SR One, the independent corporate venture fund of GlaxoSmithKline (GSK), Novartis (NVS) Venture Fund, Lilly Ventures (LLY), and Roche Venture Fund. New investor Excel Medical Fund and founding investor Apple Tree Partners also participated. The Cambridge, Massachusetts-based company is developing a novel class of therapeutics called Stapled Peptides as a technology platform for historically undruggable targets. Proceeds from the financing will be used to advance Aileron’s lead Stapled Peptide program toward clinical trials in 2010 and to further advance the Stapled Peptide platform and programs in oncology, immune/inflammation, metabolic disease, and infectious disease. Stapled Peptides are synthetically locked, or “stapled”, into an alpha-helical shape to create drug compounds that are uniquely effective for targets that are “undruggable” with currently available drug approaches. In previous financings, Aileron has raised $20 million in funding.
Alios BioPharma, based in South San Francisco, California, also relied on pharma money, closing its $32-million Series A preferred stock financing with $8 million from new investor SR One, the corporate venture fund of GlaxoSmithKline. The first closing was completed in December 2008, led by Novo A/S and Novartis Venture Fund with participation from the Roche Venture Fund. Alios is developing small molecule and protein therapeutics to treat viral diseases by activating pathways in the innate immune system.
Seattle, Washington-based NanoString Technologies closed a $30-million Series C equity financing to accelerate commercialization of its leading expression profiling nCounter Analysis System in the research tools and diagnostics arenas. The round was led by Clarus Ventures, and was joined by existing investors OVP Venture Partners and Draper Fisher Jurvetson.
In Minneapolis, medical device company Inspire Medical Systems completed a Series B financing of $17 million, which was led by Synergy Life Science Partners and included participation from existing investors Kleiner Perkins Caufield & Byers, US Venture Partners, Medtronic (MDT), and Dr. Glen D. Nelson through GDN Holdings. Earlier in 2009, Inspire announced the first human implant of its Inspire II system designed to treat Obstructive Sleep Apnea. Since this announcement, Inspire continued to implant patients into parallel clinical trials being conducted in the United States and in Europe with several implants in each location to date. The Series B financing is over two phases with the primary purpose to fund the on-going clinical activity.
While the tide toward economic recovery is slowly turning positive and consumer confidence is rising, many investors remain skittish, worrying that weakening demand for government debt may force Washington to raise interest rates to attract buyers, but at the same time slow the economic recovery. Caution still reigns. Raising capital in the public market continues to remain difficult especially for companies without any revenue generating products. Geneara called it quits after 22 years of failing to bring a product into the market.



Complete Story »]]> DNA MRK The Burrill Report Celgene: Solid Balance Sheet and Promising Pipeline http://seekingalpha.com/article/142176-celgene-solid-balance-sheet-and-promising-pipeline?source=feed 142176 I have been looking for a solid pharmaceutical company to add to my stock portfolio. I had owned Pfizer (PFE) previously but Pfizer appears to be a drug company with a dearth of drugs in its pipeline.

The days of growth appear over and I am looking for a drug company with a brighter future. One of the stocks that has piqued my interest is Celgene (CELG). Celgene is a biotechnology company that discovers and produces therapies to treat cancer and other diseases. Celgene has a solid balance sheet and a promising pipeline of cancer drugs such as Vidaza, Revlimid and Thalomid.

]]> Tue, 09 Jun 2009 08:01:13 -0400 Mark Riddix I have been looking for a solid pharmaceutical company to add to my stock portfolio. I had owned Pfizer (PFE) previously but Pfizer appears to be a drug company with a dearth of drugs in its pipeline.

The days of growth appear over and I am looking for a drug company with a brighter future. One of the stocks that has piqued my interest is Celgene (CELG). Celgene is a biotechnology company that discovers and produces therapies to treat cancer and other diseases. Celgene has a solid balance sheet and a promising pipeline of cancer drugs such as Vidaza, Revlimid and Thalomid.


Complete Story »]]> CELG Mark Riddix Merck's Heart Failure Drug Candidate Hits the Skids http://seekingalpha.com/article/141977-merck-s-heart-failure-drug-candidate-hits-the-skids?source=feed 141977

There is no good way to spin a Phase III failure. By then you've made it past the main reasons for a drug to wipe out (PK and total mechanistic failure). A breakdown at this stage is a more subtle affair (well, except for the money involved, which is not subtle at all). For example, a drug might show efficacy in a carefully constructed Phase II trial, but can't perform under the wider (and more realistic) conditions of Phase III.

That's what appears to have happened to Merck's (MRK) MK-7418 (rolofylline, formerly KW-3902). This adenosine A1 antagonist, which Merck picked up by buying NovaCardia a couple of years ago, was being developed for acute heart failure. That's a tough indication, and this isn't going to improve that reputation. (This Forbes piece has a tour of the pile of discards that this area has become over the years. Rolofylline looked as if it might work in Phase II, but (from what I can tell from the press releases) missed every endpoint in Phase III.

]]> Mon, 08 Jun 2009 11:35:29 -0400 Derek Lowe Derek Lowe submits:

There is no good way to spin a Phase III failure. By then you've made it past the main reasons for a drug to wipe out (PK and total mechanistic failure). A breakdown at this stage is a more subtle affair (well, except for the money involved, which is not subtle at all). For example, a drug might show efficacy in a carefully constructed Phase II trial, but can't perform under the wider (and more realistic) conditions of Phase III.

That's what appears to have happened to Merck's (MRK) MK-7418 (rolofylline, formerly KW-3902). This adenosine A1 antagonist, which Merck picked up by buying NovaCardia a couple of years ago, was being developed for acute heart failure. That's a tough indication, and this isn't going to improve that reputation. (This Forbes piece has a tour of the pile of discards that this area has become over the years. Rolofylline looked as if it might work in Phase II, but (from what I can tell from the press releases) missed every endpoint in Phase III.


Complete Story »]]> MRK Derek Lowe Insmed Stock Rising on High Volume, But Still a Good Buy http://seekingalpha.com/article/141947-insmed-stock-rising-on-high-volume-but-still-a-good-buy?source=feed 141947 Based on the volatility of the stock that has been accompanied by days of high trading volume, I've been predicting for weeks now that Insmed (INSM) was gearing up to release some significant news, most likely regarding the preliminary data collected from a Phase II trial measuring IPLEX's effectiveness in treating Myotonic Muscular Dystrophy ((MMD)).

After the stock closed Friday at near the high of the day on over two million shares traded, that news could be imminent.

]]> Mon, 08 Jun 2009 07:09:53 -0400 VFC's Stock House VFC submits:

Based on the volatility of the stock that has been accompanied by days of high trading volume, I've been predicting for weeks now that Insmed (INSM) was gearing up to release some significant news, most likely regarding the preliminary data collected from a Phase II trial measuring IPLEX's effectiveness in treating Myotonic Muscular Dystrophy ((MMD)).

After the stock closed Friday at near the high of the day on over two million shares traded, that news could be imminent.


Complete Story »]]> INSM VFC's Stock House Life Science Companies Get Boost from Capital Markets http://seekingalpha.com/article/141784-life-science-companies-get-boost-from-capital-markets?source=feed 141784 by MARIE DAGHLIAN

During the first week in June, small biotech companies continued to struggle, doing what they must to conserve cash and keep their most promising programs alive and on track. The capital markets, though, were starting to show signs of a shifting tide as public financings of life sciences companies took center stage, alongside some interesting collaborations. Pfizer's (PFE) private European offering of $10.5 billion in senior unsecured notes in four separate issues turned it into a big fundraising week. The company said it would use the money to terminate the credit agreement it had taken out to fund the $68-billion buyout of Wyeth. As a backdrop to this activity, the unemployment rate in the United States reached 9.4 percent, the highest figure in the past 25 years, but the U.S. Department of Labor released figures that showed an easing of job losses.
Valeant Pharmaceuticals (VRX), an international specialty pharma company developing treatments in neurology and dermatology, announced a private placement of $365 million. The principal amount was increased from the previously announced $300 million.
Two healthcare service companies also issued large debt offerings. US Oncology, an oncology services company, raised $465 million and Express Scripts (ESRX), one of the largest pharmacy benefit management companies in North America, raised $2.5 billion in debt and $1.4 billion through the sale of 23 million shares of its common stock through a public offering. The money will be used to finance a portion of its previously announced $4.7-billion purchase of WellPoint's (WLP) pharmacy benefit management business.
With its coffers of cash, Big Pharma still dominates the partnering arena and seems to be less averse to doing earlier stage deals. For its first partnership deal, Massachusetts biotech Concert Pharmaceuticals signed an agreement with GlaxoSmithKline (GSK) that could be worth up to $1 billion for the company over the next few years.
The companies will collaborate to develop and commercialize deuterium-containing medicines. The deal includes three of Concert’s research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV, expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound for chronic renal disease, and a third research product in Concert’s pipeline. Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.
For its part, Concert will receive $35 million in upfront payments, including a $16.7-million equity investment by GSK. Concert is also eligible to receive milestones and tiered, double-digit royalties based on deuterium-containing products arising from both the Concert pipeline programs and the GSK pipeline compounds.
Concert will be responsible for research and development for each of its three programs, with GSK maintaining the option to obtain an exclusive, worldwide license to product candidates within the program and assuming responsibility for development and commercialization. Concert retains full rights to further develop and commercialize its product candidates in any program GSK chooses not to license.
GSK is already a strong player in the HIV arena, and recently formed a partnership with Pfizer to develop and market HIV drugs. For Concert, the partnership could be the first of many, a strong boost for its chemistry technology that can exchange some of the hydrogen in existing drug molecules with deuterium. Deuterium is a hydrogen-relative that can result in drugs with unique chemical composition that are potentially more effective than the original versions.
A chance meeting in an airport security line in Dublin led to an unusual agreement to investigate a novel combination anticancer regimen between pharmaceutical powerhouses AstraZeneca (AZN) and Merck (MRK). The companies will collaborate to research the combination of two investigational compounds, MK-2206 from Merck and AZD6244 from AstraZeneca to see if the combined administration can enhance their anticancer properties. Both compounds are designed to inhibit a protein known to be abnormally activated in human cancers. All development costs will be shared equally through the Phase I trial, after which the companies will consider opportunities for further clinical development.
Microsoft (MSFT) stepped further into the life sciences arena with its purchase of Rosetta Biosoftware, a business unit of Rosetta Inpharmatics, which is owned by Merck. The deal will allow Microsoft to incorporate genetic, genomic, metabolomic, and proteomics data management software into the Microsoft Amalga Life Sciences platform for enhanced translational research capabilities. Merck also agreed to become a customer of the Amalga platform. This deal gives Microsoft a bioinformatics platform that is already developed and profitable, an existing customer list of almost 100 names in academia and industry.
Not all the news was positive, as small companies continue to struggle to maintain viability. Two San Diego biotech companies are shutting down. Nanogen will lay off all 89 employees based in San Diego by July 14, as the company moves forward with the sale of its assets to French firm Elitech for $25.7 million. The molecular diagnostics company filed for Chapter 11 bankruptcy protection, saying it was "unable to secure sufficient working capital or alternative corporate transactions to enable the company to service its debt obligations and fund its operations." The company's Italian affiliate will also be acquired by Elitech.
TorreyPines Therapeutics' board voted to liquidate the company’s assets after failing to find a buyer or to negotiate other alternatives allowing it to remain in business, even as it said it “continues to seek and will consider any reasonable alternative strategic or financing proposals presented to the company.” The company had laid off all but three employees in March. The company had been in trouble since October 2007 when it revealed unimpressive data on its acute migraine headache drug.
StemCells (STEM) decided to close its Australian division, Melbourne's Stem Cell Sciences, which had been the country's first dedicated stem cell biotech firm. Palo Alto-based StemCells had already acquired all of SCS intellectual property that included a portfolio of more than 20 patent families.
Finally, with no partner at hand, Anadys Pharmaceuticals (ANDS) raised money and cut staff so that it could move its hepatitis C drug candidate ANA598 into mid-stage clinical trials. The company reduced its work force by 40 percent and suspended development of its second drug candidate for cancer. It also raised $17.5 million through private offering of common stock and warrants.
]]> Sun, 07 Jun 2009 06:53:05 -0400 The Burrill Report The Burrill Report submits:

by MARIE DAGHLIAN

During the first week in June, small biotech companies continued to struggle, doing what they must to conserve cash and keep their most promising programs alive and on track. The capital markets, though, were starting to show signs of a shifting tide as public financings of life sciences companies took center stage, alongside some interesting collaborations. Pfizer's (PFE) private European offering of $10.5 billion in senior unsecured notes in four separate issues turned it into a big fundraising week. The company said it would use the money to terminate the credit agreement it had taken out to fund the $68-billion buyout of Wyeth. As a backdrop to this activity, the unemployment rate in the United States reached 9.4 percent, the highest figure in the past 25 years, but the U.S. Department of Labor released figures that showed an easing of job losses.
Valeant Pharmaceuticals (VRX), an international specialty pharma company developing treatments in neurology and dermatology, announced a private placement of $365 million. The principal amount was increased from the previously announced $300 million.
Two healthcare service companies also issued large debt offerings. US Oncology, an oncology services company, raised $465 million and Express Scripts (ESRX), one of the largest pharmacy benefit management companies in North America, raised $2.5 billion in debt and $1.4 billion through the sale of 23 million shares of its common stock through a public offering. The money will be used to finance a portion of its previously announced $4.7-billion purchase of WellPoint's (WLP) pharmacy benefit management business.
With its coffers of cash, Big Pharma still dominates the partnering arena and seems to be less averse to doing earlier stage deals. For its first partnership deal, Massachusetts biotech Concert Pharmaceuticals signed an agreement with GlaxoSmithKline (GSK) that could be worth up to $1 billion for the company over the next few years.
The companies will collaborate to develop and commercialize deuterium-containing medicines. The deal includes three of Concert’s research and development programs; namely, CTP-518, a protease inhibitor for the treatment of HIV, expected to enter Phase I clinical trials in the second half of 2009, a preclinical compound for chronic renal disease, and a third research product in Concert’s pipeline. Concert will also provide GSK with deuterium-modified versions of three GSK pipeline compounds for GSK to develop.
For its part, Concert will receive $35 million in upfront payments, including a $16.7-million equity investment by GSK. Concert is also eligible to receive milestones and tiered, double-digit royalties based on deuterium-containing products arising from both the Concert pipeline programs and the GSK pipeline compounds.
Concert will be responsible for research and development for each of its three programs, with GSK maintaining the option to obtain an exclusive, worldwide license to product candidates within the program and assuming responsibility for development and commercialization. Concert retains full rights to further develop and commercialize its product candidates in any program GSK chooses not to license.
GSK is already a strong player in the HIV arena, and recently formed a partnership with Pfizer to develop and market HIV drugs. For Concert, the partnership could be the first of many, a strong boost for its chemistry technology that can exchange some of the hydrogen in existing drug molecules with deuterium. Deuterium is a hydrogen-relative that can result in drugs with unique chemical composition that are potentially more effective than the original versions.
A chance meeting in an airport security line in Dublin led to an unusual agreement to investigate a novel combination anticancer regimen between pharmaceutical powerhouses AstraZeneca (AZN) and Merck (MRK). The companies will collaborate to research the combination of two investigational compounds, MK-2206 from Merck and AZD6244 from AstraZeneca to see if the combined administration can enhance their anticancer properties. Both compounds are designed to inhibit a protein known to be abnormally activated in human cancers. All development costs will be shared equally through the Phase I trial, after which the companies will consider opportunities for further clinical development.
Microsoft (MSFT) stepped further into the life sciences arena with its purchase of Rosetta Biosoftware, a business unit of Rosetta Inpharmatics, which is owned by Merck. The deal will allow Microsoft to incorporate genetic, genomic, metabolomic, and proteomics data management software into the Microsoft Amalga Life Sciences platform for enhanced translational research capabilities. Merck also agreed to become a customer of the Amalga platform. This deal gives Microsoft a bioinformatics platform that is already developed and profitable, an existing customer list of almost 100 names in academia and industry.
Not all the news was positive, as small companies continue to struggle to maintain viability. Two San Diego biotech companies are shutting down. Nanogen will lay off all 89 employees based in San Diego by July 14, as the company moves forward with the sale of its assets to French firm Elitech for $25.7 million. The molecular diagnostics company filed for Chapter 11 bankruptcy protection, saying it was "unable to secure sufficient working capital or alternative corporate transactions to enable the company to service its debt obligations and fund its operations." The company's Italian affiliate will also be acquired by Elitech.
TorreyPines Therapeutics' board voted to liquidate the company’s assets after failing to find a buyer or to negotiate other alternatives allowing it to remain in business, even as it said it “continues to seek and will consider any reasonable alternative strategic or financing proposals presented to the company.” The company had laid off all but three employees in March. The company had been in trouble since October 2007 when it revealed unimpressive data on its acute migraine headache drug.
StemCells (STEM) decided to close its Australian division, Melbourne's Stem Cell Sciences, which had been the country's first dedicated stem cell biotech firm. Palo Alto-based StemCells had already acquired all of SCS intellectual property that included a portfolio of more than 20 patent families.
Finally, with no partner at hand, Anadys Pharmaceuticals (ANDS) raised money and cut staff so that it could move its hepatitis C drug candidate ANA598 into mid-stage clinical trials. The company reduced its work force by 40 percent and suspended development of its second drug candidate for cancer. It also raised $17.5 million through private offering of common stock and warrants.

Complete Story »]]> ANDS AZN ESRX GSK MRK MSFT PFE STEM TPTX VRX The Burrill Report Stock Watch: Biodelivery Sciences Has Nearly Tripled Over Past Months http://seekingalpha.com/article/141071-stock-watch-biodelivery-sciences-has-nearly-tripled-over-past-months?source=feed 141071 BDSI Sets 52-Week HighStock Watch: BDSI
Stocks on the Move: BDSI
VFC's 2009 Stock Picks, Part III

Biodelivery Sciences (BDSI) set a new 52-week high of six dollars during trading on Tuesday and closed not too far off that mark at $5.93.

]]> Wed, 03 Jun 2009 07:07:13 -0400 VFC's Stock House VFC submits:

BDSI Sets 52-Week HighStock Watch: BDSI
Stocks on the Move: BDSI
VFC's 2009 Stock Picks, Part III

Biodelivery Sciences (BDSI) set a new 52-week high of six dollars during trading on Tuesday and closed not too far off that mark at $5.93.


Complete Story »]]> BDSI VFC's Stock House Epicept Still Searching for Partner to Help Launch Its Latest Drug http://seekingalpha.com/article/141069-epicept-still-searching-for-partner-to-help-launch-its-latest-drug?source=feed 141069 Epicept Corporation (EPCT) announced on Tuesday that a partner has been found for Ceplene, the company's drug that is approved in the European Union for maintenance therapy for adult patients with AML in first remission. However, the partnership agreement is not in preparation for the commercial launch of Ceplene in Europe that is to take place later this year, but one for a named patient program that will make the drug available for compassionate use in most worldwide markets, excluding the United States.

For nearly a year now, Jack Talley, CEO of Epicept, has stated that the company is in advanced negotiations with a prospective marketing partner for Ceplene in Europe, but one has yet to emerge. As the search continues, the UK-based private firm IDIS will be the exclusive supplier of Ceplene for a named patient program that will allow Epicept to draw revenue while still preparing for the commercial launch.

]]> Wed, 03 Jun 2009 06:50:08 -0400 VFC's Stock House VFC submits:

Epicept Corporation (EPCT) announced on Tuesday that a partner has been found for Ceplene, the company's drug that is approved in the European Union for maintenance therapy for adult patients with AML in first remission. However, the partnership agreement is not in preparation for the commercial launch of Ceplene in Europe that is to take place later this year, but one for a named patient program that will make the drug available for compassionate use in most worldwide markets, excluding the United States.

For nearly a year now, Jack Talley, CEO of Epicept, has stated that the company is in advanced negotiations with a prospective marketing partner for Ceplene in Europe, but one has yet to emerge. As the search continues, the UK-based private firm IDIS will be the exclusive supplier of Ceplene for a named patient program that will allow Epicept to draw revenue while still preparing for the commercial launch.


Complete Story »]]> EPCT VFC's Stock House Burgeoning Bioplastics: Metabolix's Breakthrough http://seekingalpha.com/article/140599-burgeoning-bioplastics-metabolix-s-breakthrough?source=feed 140599 Despite my career in finance, in college I was studying biology in order to enter the Biotech industry, mainly due to Biotech's potential for manufacturing materials (rather than in regards to drugs). While I am confident that fields of plants commercially creating complete plastics will be a reality, we still have some time. Yet a more basic form of plant-based plastics, those made from vegetable products such as vegetable oil or corn starch, is starting to peek its head out. This bioplastics industry has increased its optimism lately since the technology is continuing to develop well, despite remaining challenges and false hopes in the past.

The polymer’s time may have come at last, as early performance problems have been addressed, and manufacturing has become more efficient.

]]> Mon, 01 Jun 2009 04:44:02 -0400 Vincent Fernando Vincent Fernando submits:

Despite my career in finance, in college I was studying biology in order to enter the Biotech industry, mainly due to Biotech's potential for manufacturing materials (rather than in regards to drugs). While I am confident that fields of plants commercially creating complete plastics will be a reality, we still have some time. Yet a more basic form of plant-based plastics, those made from vegetable products such as vegetable oil or corn starch, is starting to peek its head out. This bioplastics industry has increased its optimism lately since the technology is continuing to develop well, despite remaining challenges and false hopes in the past.

The polymer’s time may have come at last, as early performance problems have been addressed, and manufacturing has become more efficient.


Complete Story »]]> DOW MBLX MZDAF.PK Vincent Fernando Long Term Results of Oncothyreon's Stimuvax Look Promising http://seekingalpha.com/article/140514-long-term-results-of-oncothyreon-s-stimuvax-look-promising?source=feed 140514 Oncothyreon's (ONTY) stock has been on the rise for months now, and Saturday's press releases, one each by Oncothyreon and Merck KGaA (MKGAY.PK), gave us some insight as to why.

The press releases coincided with a presentation at the American Society of Clinical Oncology ((ASCO)) Annual Meeting where representatives of Oncothyreon provided updates on three of the company's pipeline candidates, most notably Stimuvax.

]]> Sun, 31 May 2009 08:14:59 -0400 VFC's Stock House VFC submits:

Oncothyreon's (ONTY) stock has been on the rise for months now, and Saturday's press releases, one each by Oncothyreon and Merck KGaA (MKGAY.PK), gave us some insight as to why.

The press releases coincided with a presentation at the American Society of Clinical Oncology ((ASCO)) Annual Meeting where representatives of Oncothyreon provided updates on three of the company's pipeline candidates, most notably Stimuvax.


Complete Story »]]> MKGAY.PK MRK ONTY VFC's Stock House