Biotech Daily Review: Novartis Gets Approval For Hypertensive Drug
by Richard Daverman, PhD
Centient Biotech Investor
Novartis (NVS) received FDA approval for Tekturna, a renin inhibitor that is a first-in-class blood pressure treatment. Renin is the key enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure. Tektura is the first new type of blood pressure drug to be approved in 10 years, and the US is the first country to approve it. The once-daily oral medication is said to work well alone and as an adjunct to other blood pressure drugs. All of this gives every indication that Tekturna will become a blockbuster billion-dollar seller for Novartis. In the blood-pressure market, Novartis currently sells Diovan, the single biggest contributor to its revenues at $4.2 billion annually. The patent on Diovan expires in 2012. The shares of Novartis ran up $3.31 to $56.85, an increase of 6.2%.
BioCryst (BCRX) out-licensed the Japanese rights for peramivir, its flu drug, to Shionogi. BioCryst will receive $14 million upfront and milestones of up to $95 million, plus a royalty of between 10% and 20%. Because the drug is injected, peramivir is not usually administered unless the patient is very ill. Peramivir, a neuraminidase inhibitor, is being tested as a drug for avian flu. BioCryst was 73 cents higher at $9.77, an 8.1% gain.
InterMune (ITMN) stopped its Phase III trial of Actimmune in patients with idiopathic pulmonary fibrosis because the data committee said the compound could not meet its efficacy goal. In fact, the Actimmune cohort had a morality rate of 14.5%, while mortality in the placebo arm was 12.7%. The drug was given to IPF patients with mild to moderate impairment in lung function. Intermune fell 21%, dropping $5.90 to end at $22.15.
Replidyne (RDYN) reported faropenem medoxomil met its Phase II trial endpoints. The drug is a treatment for infection of the middle ear or acute otitis media (AOM) in children. Fluid was tapped from the patients both before and after treatment to show that the drug eradicated bacteria. Replidyne rose 28 cents to $5.42.
Sunesis (SNSS) began dosing patients with advanced B-cell malignancies in a Phase I trial of SNS-032. The compound inhibits cyclin-dependent kinases 2, 7 and 9, and it has been shown to deplete cells of MCL-1, which is associated with cell survival in lymphomas and B-lymphoid malignancies. Senesis was 12 cents higher at $4.42.
Alkermes (ALKS) completed enrollment in a Phase I/II test of ALKS 29, a drug candidate that targets alcohol dependence. Alkermes has not disclosed the drug’s mechanism. Results from the trial are expected in the first half of 2007. Alkermes rose 50 cents to $15.81.
Pozen (POZN) reported its coated aspirin drug candidate passed a proof of concept test. PA325 coats 325 mg of aspirin with a proton pump inhibitor to prevent gastrointestinal damage. In the trial, the drug reduced the incidence of GI damage from 57% in the placebo to 10% in the active drug cohort. No ulcers were seen among the active drug recipients, but 20% of the placebo arm developed a gastric ulcer. Pozen climbed 10%, adding on $1.46 to end at $15.70.
EntreMed (ENMD) began a Phase II trial of Panzem in patients with metastatic renal cell carcinoma who have failed a treatment with Pfizer’s (PFE) Sutent, or are showing signs of disease progression. The drug will be administered alone and in combination with Sutent. The goal of the trial is to determine whether Panzem restores tumor response by blocking HIF- 1alpha, and also to test if it inhibits tumor progression. EntreMed moved up 10 cents to $1.53.
Amgen (AMGN) received some bad news when one of the administrators of a Medicare program decided it would no longer pay for use of anemia drug Aranesp in cancer patients. The use of Aranesp in cancer is an off-label use of the drug, but fairly common. Amgen was only 14 cents higher at $62.30.
Like the broad market, biotech enjoyed a steadily rising market in today’s session. The Centient Biotech 200™ climbed 45.5 points higher to 3834, an increase of 1.20%. The S&P 500 was up 1.55% and Nasdaq jumped 1.90%.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: Lilly Buys Insomnia-Focused Hypnion
- Biotech Weekly Review: Rough Week, IPOs Bright Spot
- Biotech Daily Review: Hopeful Results From HIV Conference
____________________
Centient Biotech Investor
Novartis (NVS) received FDA approval for Tekturna, a renin inhibitor that is a first-in-class blood pressure treatment. Renin is the key enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure. Tektura is the first new type of blood pressure drug to be approved in 10 years, and the US is the first country to approve it. The once-daily oral medication is said to work well alone and as an adjunct to other blood pressure drugs. All of this gives every indication that Tekturna will become a blockbuster billion-dollar seller for Novartis. In the blood-pressure market, Novartis currently sells Diovan, the single biggest contributor to its revenues at $4.2 billion annually. The patent on Diovan expires in 2012. The shares of Novartis ran up $3.31 to $56.85, an increase of 6.2%.
BioCryst (BCRX) out-licensed the Japanese rights for peramivir, its flu drug, to Shionogi. BioCryst will receive $14 million upfront and milestones of up to $95 million, plus a royalty of between 10% and 20%. Because the drug is injected, peramivir is not usually administered unless the patient is very ill. Peramivir, a neuraminidase inhibitor, is being tested as a drug for avian flu. BioCryst was 73 cents higher at $9.77, an 8.1% gain.
InterMune (ITMN) stopped its Phase III trial of Actimmune in patients with idiopathic pulmonary fibrosis because the data committee said the compound could not meet its efficacy goal. In fact, the Actimmune cohort had a morality rate of 14.5%, while mortality in the placebo arm was 12.7%. The drug was given to IPF patients with mild to moderate impairment in lung function. Intermune fell 21%, dropping $5.90 to end at $22.15.
Replidyne (RDYN) reported faropenem medoxomil met its Phase II trial endpoints. The drug is a treatment for infection of the middle ear or acute otitis media (AOM) in children. Fluid was tapped from the patients both before and after treatment to show that the drug eradicated bacteria. Replidyne rose 28 cents to $5.42.
Sunesis (SNSS) began dosing patients with advanced B-cell malignancies in a Phase I trial of SNS-032. The compound inhibits cyclin-dependent kinases 2, 7 and 9, and it has been shown to deplete cells of MCL-1, which is associated with cell survival in lymphomas and B-lymphoid malignancies. Senesis was 12 cents higher at $4.42.
Alkermes (ALKS) completed enrollment in a Phase I/II test of ALKS 29, a drug candidate that targets alcohol dependence. Alkermes has not disclosed the drug’s mechanism. Results from the trial are expected in the first half of 2007. Alkermes rose 50 cents to $15.81.
Pozen (POZN) reported its coated aspirin drug candidate passed a proof of concept test. PA325 coats 325 mg of aspirin with a proton pump inhibitor to prevent gastrointestinal damage. In the trial, the drug reduced the incidence of GI damage from 57% in the placebo to 10% in the active drug cohort. No ulcers were seen among the active drug recipients, but 20% of the placebo arm developed a gastric ulcer. Pozen climbed 10%, adding on $1.46 to end at $15.70.
EntreMed (ENMD) began a Phase II trial of Panzem in patients with metastatic renal cell carcinoma who have failed a treatment with Pfizer’s (PFE) Sutent, or are showing signs of disease progression. The drug will be administered alone and in combination with Sutent. The goal of the trial is to determine whether Panzem restores tumor response by blocking HIF- 1alpha, and also to test if it inhibits tumor progression. EntreMed moved up 10 cents to $1.53.
Amgen (AMGN) received some bad news when one of the administrators of a Medicare program decided it would no longer pay for use of anemia drug Aranesp in cancer patients. The use of Aranesp in cancer is an off-label use of the drug, but fairly common. Amgen was only 14 cents higher at $62.30.
Like the broad market, biotech enjoyed a steadily rising market in today’s session. The Centient Biotech 200™ climbed 45.5 points higher to 3834, an increase of 1.20%. The S&P 500 was up 1.55% and Nasdaq jumped 1.90%.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: Lilly Buys Insomnia-Focused Hypnion
- Biotech Weekly Review: Rough Week, IPOs Bright Spot
- Biotech Daily Review: Hopeful Results From HIV Conference
____________________
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