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Bavarian Nordic publishes its annual report 2009
Today (9 March 2010) Bavarian Nordic published the company’s Annual Report 2009. The report is available on the company’s website. Below is an extract of the most significant matters in the report as well as important events after the balance sheet date.
The financial result for the year 2009 was in line with the company’s expectations and latest guidance. Revenue was DKK 75 million and the company recorded a loss before tax of DKK 331 million. At year-end 2009, net free cash and cash equivalents stood at DKK 185 million.
The net proceeds of almost DKK 300 million from the successful completion of a rights issue in the beginning of 2010 enables Bavarian Nordic to maintain momentum in the production of IMVAMUNE© and continue preparations for Phase III for PROSTVAC™.
For 2010, Bavarian Nordic maintains its financial expectations with revenues in the level of DKK 475 million, a pre-tax loss in the level of DKK 250 million and net free cash and cash equivalents in the range of DKK 225 to DKK 275 million at year-end. Bavarian Nordic expects to deliver and invoice 4-5 million doses of IMVAMUNE® to the US authorities, which is the primary source of revenue, which furthermore derives from the ongoing RFP-2 contract and the RFP contract for freeze-dried IMVAMUNE®.
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Action Pharma reports positive results in a proof of concept phase IB study in obese human volunteers treated with small molecule oral once-daily AP1030 targeted for type II diabetes associated with obesity
Action Pharma A/S has completed a proof of concept clinical phase IB study with AP1030 currently being developed for treatment of type II diabetes associated with obesity. In a phase IB study the effect of AP1030 on glucose metabolism in obese human volunteers was investigated. AP1030 administered orally once-daily for two weeks in obese human volunteers significantly improved glucose metabolism.
AP1030 is the first in a new drug class developed for oral once-daily treatment based on a new mode of action (a positive allosteric modulator through new pharmacological targets, the melanocortin receptors) and is part of Action Pharma’s small molecule program. The mode of action of AP1030 involves a hypothalamic melanocortin type 4 receptor mediated effect, thereby modulating appetite and central regulation of glucose metabolism. In addition, AP1030 exerts anti-inflammatory effects mediated through melanocortin type 1 receptors aimed at reverting low grade inflammation in fatty tissues and thereby reducing peripheral insulin resistance.
“The positive results obtained for AP1030 in the phase IB study is a major milestone for ActionPharma”, says Ingelise Saunders, CEO of Action Pharma, and continues: “In contrast to other weight reducing anti-diabetics, including GLP-1 analogues, AP1030 has the major advantage of being administered once-daily orally potentially making it very attractive for the anti-diabetes market.”
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Litesse® polydextrose scores high with Nutrafiles
Recently, Nutrafiles highlighted Litesse® polydextrose from Danisco as the “Ingredient of the Month” in their e-newsletter and gave it a high score of 35 for its market potential.
Nutrafiles is a newly launched web-based knowledge centre for health ingredients that provides detailed technical and marketing information to its food industry members. All ingredients in the Nutrafiles database are scored from a low value of 0 to high value of 7 in the following categories:

Novelty

Biology

Health

Intellectual

Market

Regulatory

Litesse® achieved a high score of 35 out of a possible 42. Litesse® was also the highest scoring ingredient for market potential in the fibres section of the database.
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Zealand Pharma Announces Augmentation of its Management Team as it Continues its Growth Strategy
Today (8 March 2010) Zealand Pharma A/S announces that Dr. Christian Grøndahl has been appointed Chief Scientific Officer, Mr. Mats Blom as Chief Financial Officer and Dr. John Hyttel as Senior Vice President for Operations.
“I am delighted to welcome Christian Grøndahl, Mats Blom and John Hyttel as new members of Zealand’s Management Team. Together they bring a wealth of experience, energy and skills to Zealand Pharma as we continue to advance our growth strategy to bring Zealand Pharma A/S to the next level,” said Dr. David Horn Solomon, President and CEO of Zealand Pharma A/S.
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NeuroSearch announces new findings from the MermaiHD Phase III study supporting potential disease modifying properties of Huntexil®
NeuroSearch today (8 March 2010) announced that further analysis of the data from the MermaiHD study with Huntexil® (pridopidine) for the treatment of Huntington's disease supports potential disease modifying properties of the drug.
Top line results from the MermaiHD study, a six months European Phase III study in 437 patients with Huntington's disease, was announced and presented in the beginning of February, showing that treatment with Huntexil® significantly improves patients' motor function with effects seen on both the voluntary and involuntary motor symptoms associated with the disease.
Additional analysis of results from the study shows that Huntexil® not only has symptomatic effect, but also appears to slow the underlying disease progression depending on the patients' disease-genotype. In line with recently published academic findings (Aziz et al., 2009, Ravina et al., 2008), data from the placebo treated patient group in the MermaiHD study confirm a strong correlation between the length of the Huntington's disease gene and the rate of symptoms progression.
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Vitamin D crucial to activating immune defenses
Scientists from the Department of International Health, Immunology and Microbiology at Copenhagen University have discovered that Vitamin D is crucial to activating our immune defenses and that without sufficient intake of the vitamin, the killer cells of the immune system - T cells - will not be able to react to and fight off serious infections in the body.
For T cells to detect and kill foreign pathogens such as clumps of bacteria or viruses, the cells must first be ‘triggered' into action and ‘transform' from inactive and harmless immune cells into killer cells that are primed to seek out and destroy all traces of a foreign pathogen.
The researchers found that the T cells rely on vitamin D in order to activate and they would remain dormant, ‘naïve' to the possibility of threat if vitamin D is lacking in the blood.
- We have discovered that the first stage in the activation of a T cell involves vitamin D, explains Professor Carsten Geisler from the Department of International Health, Immunology and Microbiology.
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Smoking tied to lung cancer in women with HIV
Women infected with HIV or at risk of becoming infected with HIV, the virus that causes AIDS, appear more likely to develop lung cancer than women in the general population, possibly because they are much more likely to smoke cigarettes, study findings hint.
People with HIV have a much higher risk for many cancers. Still, it is unclear whether HIV infection plays a role in the development of lung cancer, Dr. Alexandra M. Levine, at City of Hope National Medical Center in Duarte, California, and colleagues note in the Journal of Clinical Oncology.
To investigate, they compared lung cancer cases in 2,651 HIV-infected and 898 at-risk but uninfected women, who were 35 years old on average, with lung cancer cases estimated to occur among similarly aged women in the general population.
"We found a substantially increased risk of lung cancer among both HIV-infected and at-risk uninfected women compared with population-based expectations," the team reports.
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Appetite may be partly linked to germs in the gut
Germs in the gut may help drive appetite, says new research into the link between obesity and bacteria.
Previous studies have shown that overweight people and normal-weight people harbor different types and amounts of microbes that naturally live in the intestine. To determine why, scientists are peering into mice.
Emory University researchers noticed that mice with an altered immune system were fatter than regular mice, and had a collection of disorders — high blood pressure, and cholesterol and insulin problems — called metabolic syndrome, often a precursor of heart disease and diabetes.
Everyone is born with a sterile digestive tract that within days is flooded with bacteria from first foods and the environment. Altered immunity in these mice meant somewhat different bacteria grew in their intestines than in normal rodents — driving bigger appetites, metabolic syndrome and a low-grade inflammation believed key to obesity's illnesses, Emory associate pathology professor Andrew Gewirtz reported Thursday in the journal Science.
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Cambodia drug-resistant malaria stirs health fears
In a dusty village near the Thai-Cambodia border, 24-year-old Oeur Samoeun sits on a dark green hammock recovering from a strain of malaria that has resisted the most powerful drugs available.
Ravaged by days of fever and chills, he is considered lucky: the parasite has left his body. But for many others, the potentially deadly disease never quite disappears.
His province of Pailin is the epicenter of strains of malaria that have baffled healthcare experts worldwide, raising fears a dangerous new form of malaria could already be spreading across the globe.
"The fear is what we're observing right now could be the starting point for something worse regionally and globally," said Dr. Charles Delacollette, Mekong Malaria Program Coordinator at the World Health Organization.
A New England Journal of Medicine study last year showed that conventional malaria-fighting treatments derived from artemisinin took almost twice as long to clear the parasites that cause the disease in patients in Pailin and others in northwestern Thailand, suggesting the drugs were losing potency in the area.
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Researchers: AIDS virus can hide in bone marrow
The virus that causes AIDS can hide in the bone marrow, avoiding drugs and later awakening to cause illness, according to new research that could point the way toward better treatments for the disease.
Finding that hide-out is a first step, but years of research lie ahead.
Dr. Kathleen Collins of the University of Michigan and her colleagues report in this week's edition of the journal Nature Medicine that the HIV virus can infect long-lived bone marrow cells that eventually convert into blood cells.
The virus is dormant in the bone marrow cells, she said, but when those progenitor cells develop into blood cells, it can be reactivated and cause renewed infection. The virus kills the new blood cells and then moves on to infect other cells, she said.
"If we're ever going to be able to find a way to get rid of the cells, the first step is to understand" where a latent infection can continue, Collins said.
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