~ Uncle Russ

January 20, 2010

Karen Langhauser, Editor-in-chief

While waiting to close on our house, my fiancé and I have spent the last month living with my parents (insert jokes about how uncool we are here). It’s not all bad. Laundry is free, my parents have 900+ cable channels, and we don’t have to listen to our neighbor learn to play the guitar at 1:00 am like we did in our apartment. Perhaps the most amazing part of living at home is that every night when I get home from work (usually around 6:30), my mom, who has always been an awesome stay-at-home mom, has a home-cooked meal waiting for me.

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~ Uncle Russ

The U.S. Food and Drug Administration said Jan. 15 that the safety of bisphenol A (BPA) found in some baby bottles, children’s drinking cups, and other food containers merited further study but did not warrant immediate restrictions on its use. The FDA said studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA. However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and the FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

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~ Uncle Russ

Issue Date: January 20, 2010
Virus-like particles could speed response to pandemics

A method of producing vaccines from insect cells instead of chicken eggs may allow increased speed and safety in responding to pandemics, according to researchers. The technique avoids problems such as contamination, slow growth of isolates, and allergies to egg proteins, one researcher said.

“Pandemic influenza vaccines can theoretically be produced within weeks after the first isolation of the RNA sequence of a new emerging influenza strain,” said Florian Krammer, MSc, a researcher at the Vienna Institute of BioTechnology, part of the University of Natural Resources and Applied Life Sciences in Vienna, Austria. Dr. Krammer is first author of a paper describing the technique (Krammer F, Nakowitsch S, Messner P, et al. [Published online ahead of print December 29, 2009.] Biotechnol J).

Krammer and colleagues worked under senior author and lead researcher Reingard Grabherr, PhD, to produce H1N1 influenza recombinant virus-like particles (VLPs) in insect cells. They showed that these VLPs, which lack viral nucleic acid, induced an immune response in mice.

Dr. Krammer outlined potential advantages of VLP vaccine production in an e-mail to PFQ. He said VLP vaccines bypass disadvantages of egg-produced flu vaccines such as yield problems, high contamination risk, a limited specific pathogen-free egg supply in case of a pandemic, the need for process upscale, and problems with allergies to egg proteins.

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The September 2009 newsletter of the Vitamin D Council weighs the scientific evidence pointing to a connection between the use of statin drugs (prescribed to lower cholesterol) and vitamin D deficiency.

John Jacob Cannell, MD, of the Vitamin D Council and a number of other medical experts, including Michael Holick, MD, and Robert Heaney, MD, cite approximately 2,900 studies that illuminate the relationship between prohormone vitamin D levels and many aspects of human health. According to Dr. Holick, vitamin D is critical for metabolizing minerals and is linked to the expression of 200 different genes. Vitamin D deficiency is associated with chronic pain, Parkinson’s disease, 17 different cancers, heart disease, cognitive dysfunction, autoimmune disorders, and muscle and bone ailments. In fact, low levels of vitamin D are linked to higher rates of mortality.

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan 19, 2010 – Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon initiation of a Phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux®) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Under the terms of the agreement, the Company is entitled to receive a payment of ‚¬3.0 million (approximately $4.3 million) from Merck KGaA.

“We are very pleased with Merck KGaA’s initiation of this randomized Phase 2 clinical trial of EMD 1201081 in combination with cetuximab in patients with head and neck cancer,” said Alice Bexon, MBChB, Vice President of Clinical Development. “Under our collaboration with Merck KGaA, the use of EMD 1201081 with cetuximab is an important step forward in the development of our novel TLR9 agonists in combination with selected targeted agents for the treatment of solid tumors.”

The Company expects that it will receive the milestone payment of ‚¬3.0 million (approximately $4.3 million based on the currency exchange rate on January 18, 2010) from Merck KGaA during the first quarter of 2010. The clinical trial is being conducted in eight countries, including the U.S.

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Texan supplements manufacturer, Mannatech has settled a patent dispute with two companies that will see the companies pay $250,000 and cease making the glyconutrient products that infringed Mannatech’s patents.

Glyconutrients are those that deliver functional levels of carbohydrates.

The settlement was reached and finalised by a US District Judge who issued final judgment and permanent injunction against Techmedica Health and Ionx Holdings for their breaches.

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~ Uncle Russ

GENEVA (AP) — A panel of directors at eye-care company Alcon Inc. on Wednesday rejected as “grossly inadequate” a $39 billion takeover bid by Swiss pharmaceutical giant Novartis AG.

The rejection by the committee — made up of three independent board members — follows a similar response from minority shareholders to Novartis’ Jan. 4 announcement that it plans to pay $38.5 billion for the 77 percent stake in Alcon it does not already own.

“The committee has determined that the Novartis merger proposal is grossly inadequate,” the panel said in a letter to Daniel Vasella, chairman and CEO of Novartis.

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~ Uncle Russ

By Stephen Daniells, 20-Jan-2010

In the second part of our focus on weight management, NutraIngredients looks at the science behind the claims – from boosting fullness to energy burning.

The slimming ingredients market can be divided into five groups based on the mechanisms of action: increasing energy expenditure; modulating carbohydrate metabolism; increasing satiety or suppressing appetite; increasing fat oxidation or reducing fat synthesis; and blocking dietary fat absorption.

With the World Health Organization estimating that by 2015, there will be more than 1.5 billion overweight consumers, incurring health costs beyond $117 billion per year in the US alone, the opportunities for a scientifically-substantiated weight management food product are impressive.

The market for food, beverage and supplement weight management products is already valued at $3.64bn (2009 figures) in the US, according to Euromonitor. In Western Europe, the market was worth $1.3bn in 2009.

Two of the biggest areas are satiety – or boosting the feeling of fullness – and boosting heat generation, which means people burn more energy.

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~ Uncle Russ

By Guy Montague-Jones and Shane Starling, 20-Jan-2010

Danisco and Arla are taking part in a €2.5m+ business/academia research project to isolate and develop some of the oligosaccharides naturally present in human breast milk for use in infant formulas.

Specifically, the project seeks to develop an enzymatic process that will permit breast milk oligosaccharides to be produced outside the breast, i.e. in a lab.

Oligosaccharides are complex sugars naturally present in breast milk and are of interest to infant formula makers because they are present in relatively high concentration in breast milk and can help protect babies from infections and diarrhea.

“It’s a major challenge technically, but it is also a significant opportunity,” said Danisco’s UK-based chief scientific officer, Dr Andrew Morgan.

The project has received seed funding of DKK 20 million (€2.7m) from the Danish Council for Strategic Research – an initiative that runs under the Danish Ministry of Science, Technology and Innovation.

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