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Vaccines and Anti-Infectives

Leading the fight against global pandemics and local infections

Infectious diseases are a substantial health threat and a leading cause of death worldwide. Hospital-acquired infections with multi-drug resistant microbes have become increasingly common, with about 9 million cases worldwide and a mortality rate of around 4.5%, creating a risk for patients and a burden on healthcare systems.

Offering solutions to combat the increasing worldwide spread of dangerous pathogens, a number of highly innovative Austrian companies are transforming the world of antibiotic therapy or working on novel vaccines and therapeutics, including those that deal with the threat of pandemic flu.

Contents

  1. Challenging the global threat of influenza
    1. Influenza vaccines
    2. Influenza therapeutics
  2. Therapeutic vaccines
  3. Bacterial Infections
    1. Marine biotechnology
  4. Regenerative medicine
    1. Recombinant proteins
    2. Biological implants

Challenging the global threat of influenza

Influenza vaccinesInfluenza is a highly contagious viral disease. According to the World Health Organisation, 15% of the world’s population suffers from a seasonal influenza infection each year, leading to 250,000 to 500,000 deaths per year. At least four Austrian companies including Baxter, Valneva, Marinomed Biotechnologie and Savira Pharmaceuticals are developing innovative ways to combat this debilitating viral infection and to prepare for possible future pandemics.

Influenza vaccines


A world leader in the all-important area of development of new influenza vaccines is found within the Austrian operations of the global pharmaceutical company Baxter. For influenza, Baxter, does not use eggs to produce its vaccines. Instead, it uses a unique Vero cell technology platform which is one of the most advanced cell culture systems employed for the large-scale production of both seasonal and pandemic influenza vaccines. This approach also benefits from being faster and more flexible than traditional egg-based methods.

Valneva – the first, and until now only, Biotech company to IPO in Austria – is working on a new approach against pandemic influenza. It involves the use of Valneva’s adjuvant patch (Vaccine Enhancement Patch). The VEP has the potential to enhance the immune response of existing injected pandemic influenza vaccines.

Influenza therapeutics


It is not just vaccines that matter in the fight against influenza. Broad spectrum antiviral therapeutics can also play a part, and Austria has two companies with breakthroughs in this area. Marinomed Biotechnologie already has an anti-viral nasal spray against the common cold on the market. This remarkable cold therapy is unique in having an active ingredient, called Carragelose® which has clinically proven antiviral activity against common cold. In fact, Marinomed has discovered that this polymer derived from red seaweed is an effective inhibitor of around 200 respiratory viruses including Influenza A infections.

Novel structure-based influenza therapeutics are being developed by Savira pharmaceuticals. Among its pipeline of potential products are fully rationally designed polymerase inhibitors targeting the unique influenza cap snatching mechanism. In June 2012 Savira signed a cooperation agreement with Rocheto to develop its small molecule polymerase inhibitors for the treatment of influenza virus infections. Savira will receive milestone payments that could total EUR 240 million. In addition, Savira will receive upfront payments, research and development support, and royalties on product sales.

Therapeutic vaccines


On the basis of the company’s own patent positions, AFFiRiS develops tailor-made peptide-based vaccines for Alzheimer’s disease, atherosclerosis, Parkinson’s disease, hypertension, diabetes and several other conditions with unmet medical need and attractive market sizes. Alzheimer’s is the current lead indication. For the Alzheimer’s vaccine programme, a license and option agreement with GlaxoSmithKline was closed in October 2008, triggering an upfront payment of €22.5 million. The contract envisages milestone-dependent payments of up to €430 million. A first milestone payment of €10 million was made in October 2009 followed by €3.5 million. AFFiRiS currently employs 85 highly qualified staff at the Campus Vienna Biocenter in Vienna, Austria.

Hookipa Biotech is a start-up biotech company founded in Vienna in summer 2011. The company’s mission is to develop innovative vaccines for the prevention and treatment of various diseases, based on its proprietary VaxwaveTM technology. The technology presents a novel vaccine platform based on non-replicative viral vectors. It has been validated in different disease models and has become recognised as one of the most promising new strategies for next generation vaccines as it stimulates both long lasting and potent cellular and humoral immune responses. In October 2011 Hookipa raised €7 million from internationally renowned venture capital investors. The company currently focuses on the development of its lead vaccine candidate HB101 and plans to further industrialise the VaxwaveTM technology and build a robust pre-clinical product pipeline.

Bacterial Infections


With the development of penicillin, many people believed that the worldwide fight against bacterial infections was over. How wrong they were! Today we are confronted with the fact that antibiotic resistant pathogenic bacteria are emerging everywhere with no new therapeutic tools at hand.

Nabriva Therapeutics is one of few biopharmaceutical companies developing a new class of antibiotics called pleuromutilins, specifically to address serious infections in humans caused by antibiotic resistant pathogens. Recent clinical Phase II data for Nabriva’s lead pleuromutilin, BC-3781, have demonstrated proof of concept for the treatment of serious skin infections and bacterial pneumonia. In June 2012 Nabriva entered a cooperation with Forest Laboratories. Pursuant to the agreement, Forest will provide Nabriva with $25 million, and fund and conduct in collaboration with Nabriva, certain development activities related to BC-3781 over the next 12 months. During the 12-month period, Forest has the exclusive right to acquire Nabriva.

Another pioneering Austrian company is taking a different approach to traditional antibiotics. Arsanis Biosciences is developing cocktails of highly potent human monoclonal antibodies which are involved in targeting multiple microbial antigens. The company’s major focus is on life-threatening infections caused by antibiotic resistant pathogens, or which are associated with high mortality.

Valneva has a vaccine in clinical trials against Pseudomonas aeruginosa which is responsible for as much as 10% of hospital-acquired bacterial infections. In 2012 it is undergoing a Phase II/III trial which, if successful, could lead to another valuable weapon in the fight against killer infections in the hospital setting.

Marine biotechnology


Finally, natural substances, particularly those sourced from a marine environment, are an increasingly popular source of products with real utility as antibacterial or antiviral therapeutics. SeaLife Pharma® is an innovative marine biotechnology company focusing on the discovery and development of new bio-active compounds. Their research is based on the chemical diversity of unexplored marine microbes and broad experience in the anti-infective area at all relevant levels. At the moment SeaLife is pre-clinically developing its first lead group of 16 novel compounds against nosocomial bacterial infections.

The Vienna-based AlgOss Biotechnologies was founded at the end of 2002 and since then has been focusing on the research, development and production of medical devices using marine red algae. The company is the first and only manufacturer of bioactive, completely absorbable bone forming materials of plant origin.

Regenerative medicine


One consequence of severe bacterial infections can be damaged tissue in the form of wounds, ulcers or necrotic lesions around muscle or bone. Repairing that damage is one of the challenges of modern medicine and Austria has a few companies that stand out in this field.

Biological implants


Cartilage damaged by injury or infection can lead to crippling joint problems that until recently, could only be remedied through synthetic joint replacement. However, there are regenerative approaches in development. Arthro Kinetics researches, develops, manufactures and markets biological implants for the treatment of the human musculoskeletal system. The company’s products to regenerate articular cartilage are CaReS – a patented collagen type I matrix colonised with cells of the patient – and CaReS-One Step – a cell-free, CE-marked implant based on the same collagen matrix as CareS.

Baxter is one of the world leaders in Biosurgery and pioneers regenerative medicine through the use of stem cells in life-threatening chronic diseases. Building on more than 30 years of experience interdisciplinary approaches have led to the development of innovative therapies with higher safety and efficacy profiles and improved ease-of-use characteristics.

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