Biotech Daily Review: Regeneron Up On AMD Data
by Richard Daverman, PhD
Centient Biotech Investor
Regeneron (REGN) was up 15% on news that its drug for age-related macular degeneration, partnered with Bayer (BAY), produced positive interim data in a Phase II trial. The drug is VEGF Trap-Eye that is being given to patients with neovascular or wet AMD. In the first half of the patients who will be enrolled, the drug reduced retinal thickness after 12 weeks and increased the ability of patients to read an eye chart by a mean of 5.9 letters. Regeneron rose $2.85 to $22.00.
Also higher was CV Therapeutics (CVTX). On March 7, CV Therapeutics took a 24% hit after it announced that Ranexa did not meet its endpoints in a Phase III trial. The company was attempting to prove that Ranexa would decrease the overall incidence of heart attacks, death and recurrent ischemia in patients with heart disease. Today, in an expanded discussion of the trial results, officials from CV Therapeutics showed that Ranexa was effective against ischemia, where the heart muscles do not receive enough oxygen because of blocked blood flow, even though it did not meet its primary endpoint. Ranexa was approved in January 2006 to treat angina. CV Therapeutics climbed $1.21 to $7.96.
BioCryst (BCRX) fell after the company put a hold on a Phase IIb trial using the IV formulation of Fodosine in patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). The material was found to contain particulate matter. Trials of an oral form of the drug (a tablet) were not affected. BioCryst proffered the explanation that the material seemed to come from the stoppers of the vials that hold the drug, perhaps caused by a reaction between Fodosine and the material in the stopper. The company also said that the response rate in the Phase IIa trial of IV Fodosine in this population was lower than originally reported, which was 18%. Final data are not in, but the company expects they will be below 18%. BioCryst fell $1.58 to end at $8.00.
CombinatoRX (CRXX) reported that CRx-139 failed a Phase II test for rheumatoid arthritis. However, the drug did achieve statistical significance on some of the secondary endpoints. CombinatoRX slipped 24 cents lower to $7.02.
The FDA commented on Provenge from Dendreon (DNDN), the vaccine for prostate cancer, ahead of an advisory panel meeting that will discuss the drug on Thursday. As expected, the staff report stated that Provenge increased median survival, but missed other measures of effectiveness. Dendreon edged up 8 cents to $4.62.
AtheroGenics (AGIX) commented more fully on the failure of AGI-1067 to meet its Phase III trial endpoint, which was time to first incidence of a composite of major adverse cardiovascular events. The company stressed that, on the positive side, the drug met several “hard” secondary endpoints, all of which were predefined. These included cardiovascular death, myocardial infarction (heart attack) and stroke, as well as improvement in the key diabetes parameters of new onset diabetes and glycemic control. AtheroGenics dropped 28 cents to $3.30.
Seattle Genetics (SGEN) received $4.5 million from Genetech (DNA) to extend their partnership, under which Genentech has rights to certain targets and two companies collaborate to develop antibody-drug conjugates. Seattle Genetics moved up 9 cents to $8.15.
Adams Respiratory (ARXT) signed a deal with MonoSolRx LLC to use the latter company’s thin film technology to develop rapid dissolve oral prescription and OTC drugs. Although specific terms were not disclosed, MonoSolRx will receive milestone payments and a royalty on any marketed products. Adams has the right to develop two or more respiratory products in North America. An initial target has been defined, though the information was not released. Adams was off by 7 cents at $34.02.
Isis Pharma (ISIS) summarized data from three Phase II trials presented this week on ISIS 301012, an anti-cholesterol drug. Without any deleterious effect on HDL (good) cholesterol, a 400 mg dose of ISIS 301012 caused 100% of patients to achieve their LDL cholesterol and triglyceride targets. There was no sign of liver side effects, and the drug was effective as a single agent and when added to treatment with statins. Isis traded 24 cents lower to $9.62.
CuraGen (CRGN) and TopoTarget A/S began treating patients in a Phase II trial of belinostat, a small molecule histone deacetylase (HDAC) inhibitor. The drug will be given as an adjunct to Velcade (a Millenium (MLNM) drug) in patients with multiple myeloma as a second-line treatment. CuraGen edged up a penny to $3.86.
Myriad Genetics (MYGN) initiated a Phase II trial of Azixa in patients with melanoma that has spread to the brain. The trial has three arms: Azixa, temozolomide and a combination of Azixa plus temozolomide. Myriad dropped 48 cents to end at $34.58.
Barrier Therapeutics (BTRX) reported positive data from a Phase IIb trial of its oral antifungal pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of treating tinea (pityriasis) versicolor, a common fungal-caused rash. It also met the secondary endpoints of complete cure and mycological cure. Barrier shot 72 cents higher to $6.89.
Biotech traded lower all day and closed at its lows for the session. The Centient Biotech 200™ fell 25 points to 3868, a loss of .65%. The S&P 500 was off by .62% and Nasdaq was down .74%.
Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: Biosite Takes $85 Offer From Beckman Coulter
- Biotech Weekly Review: Biotech Recovers Some Lost Ground
- China Biotech Review: Simcere Pharma Files for American IPO
______________________
Centient Biotech Investor
Regeneron (REGN) was up 15% on news that its drug for age-related macular degeneration, partnered with Bayer (BAY), produced positive interim data in a Phase II trial. The drug is VEGF Trap-Eye that is being given to patients with neovascular or wet AMD. In the first half of the patients who will be enrolled, the drug reduced retinal thickness after 12 weeks and increased the ability of patients to read an eye chart by a mean of 5.9 letters. Regeneron rose $2.85 to $22.00.
Also higher was CV Therapeutics (CVTX). On March 7, CV Therapeutics took a 24% hit after it announced that Ranexa did not meet its endpoints in a Phase III trial. The company was attempting to prove that Ranexa would decrease the overall incidence of heart attacks, death and recurrent ischemia in patients with heart disease. Today, in an expanded discussion of the trial results, officials from CV Therapeutics showed that Ranexa was effective against ischemia, where the heart muscles do not receive enough oxygen because of blocked blood flow, even though it did not meet its primary endpoint. Ranexa was approved in January 2006 to treat angina. CV Therapeutics climbed $1.21 to $7.96.
BioCryst (BCRX) fell after the company put a hold on a Phase IIb trial using the IV formulation of Fodosine in patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). The material was found to contain particulate matter. Trials of an oral form of the drug (a tablet) were not affected. BioCryst proffered the explanation that the material seemed to come from the stoppers of the vials that hold the drug, perhaps caused by a reaction between Fodosine and the material in the stopper. The company also said that the response rate in the Phase IIa trial of IV Fodosine in this population was lower than originally reported, which was 18%. Final data are not in, but the company expects they will be below 18%. BioCryst fell $1.58 to end at $8.00.
CombinatoRX (CRXX) reported that CRx-139 failed a Phase II test for rheumatoid arthritis. However, the drug did achieve statistical significance on some of the secondary endpoints. CombinatoRX slipped 24 cents lower to $7.02.
The FDA commented on Provenge from Dendreon (DNDN), the vaccine for prostate cancer, ahead of an advisory panel meeting that will discuss the drug on Thursday. As expected, the staff report stated that Provenge increased median survival, but missed other measures of effectiveness. Dendreon edged up 8 cents to $4.62.
AtheroGenics (AGIX) commented more fully on the failure of AGI-1067 to meet its Phase III trial endpoint, which was time to first incidence of a composite of major adverse cardiovascular events. The company stressed that, on the positive side, the drug met several “hard” secondary endpoints, all of which were predefined. These included cardiovascular death, myocardial infarction (heart attack) and stroke, as well as improvement in the key diabetes parameters of new onset diabetes and glycemic control. AtheroGenics dropped 28 cents to $3.30.
Seattle Genetics (SGEN) received $4.5 million from Genetech (DNA) to extend their partnership, under which Genentech has rights to certain targets and two companies collaborate to develop antibody-drug conjugates. Seattle Genetics moved up 9 cents to $8.15.
Adams Respiratory (ARXT) signed a deal with MonoSolRx LLC to use the latter company’s thin film technology to develop rapid dissolve oral prescription and OTC drugs. Although specific terms were not disclosed, MonoSolRx will receive milestone payments and a royalty on any marketed products. Adams has the right to develop two or more respiratory products in North America. An initial target has been defined, though the information was not released. Adams was off by 7 cents at $34.02.
Isis Pharma (ISIS) summarized data from three Phase II trials presented this week on ISIS 301012, an anti-cholesterol drug. Without any deleterious effect on HDL (good) cholesterol, a 400 mg dose of ISIS 301012 caused 100% of patients to achieve their LDL cholesterol and triglyceride targets. There was no sign of liver side effects, and the drug was effective as a single agent and when added to treatment with statins. Isis traded 24 cents lower to $9.62.
CuraGen (CRGN) and TopoTarget A/S began treating patients in a Phase II trial of belinostat, a small molecule histone deacetylase (HDAC) inhibitor. The drug will be given as an adjunct to Velcade (a Millenium (MLNM) drug) in patients with multiple myeloma as a second-line treatment. CuraGen edged up a penny to $3.86.
Myriad Genetics (MYGN) initiated a Phase II trial of Azixa in patients with melanoma that has spread to the brain. The trial has three arms: Azixa, temozolomide and a combination of Azixa plus temozolomide. Myriad dropped 48 cents to end at $34.58.
Barrier Therapeutics (BTRX) reported positive data from a Phase IIb trial of its oral antifungal pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of treating tinea (pityriasis) versicolor, a common fungal-caused rash. It also met the secondary endpoints of complete cure and mycological cure. Barrier shot 72 cents higher to $6.89.
Biotech traded lower all day and closed at its lows for the session. The Centient Biotech 200™ fell 25 points to 3868, a loss of .65%. The S&P 500 was off by .62% and Nasdaq was down .74%.
Disclosure: Centient management holds a position in Genentech shares and does consulting work for Genentech.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: Biosite Takes $85 Offer From Beckman Coulter
- Biotech Weekly Review: Biotech Recovers Some Lost Ground
- China Biotech Review: Simcere Pharma Files for American IPO
______________________
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