Nestlé Health Science aims to develop nutritional therapies that change the way people approach the management of health. In this context, Nestlé Health Science has made several acquisitions, investments and partnerships.
The acquisition of Vitaflo – headquartered in Liverpool, UK – has enabled Nestlé Health Science to establish a foothold in the fast-growing market for uniquely formulated products that address various congenital metabolic disorders that become apparent only shortly after birth.
Metabolic disorders result when people lack the necessary enzymes to break down the fat, carbohydrates or protein in foods they have ingested, resulting in serious medical problems and often requiring a specialized diet and nutritional solutions for life.
Vitaflo’s nutritional solutions help patients maintain or recover metabolic homeostasis, often playing the most important role in the management of the disorder. Developing products that taste good, and that are easy and convenient to use, is an important factor in promoting compliance with these highly restrictive dietary management protocols, which are always administered under medical supervision.
In line with our intent to bring new science-based nutritional solutions to gastrointestinal (GI) patients with a compromised or dysfunctional gut, Nestlé Health Science acquired Prometheus Laboratories Inc., based in San Diego, California (USA).
The company is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care.
Prometheus is primarily focused on the detection, diagnosis and treatment of disorders within the fields of gastroenterology and oncology. Its strategy includes the marketing and delivery of pharmaceutical products and is complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Nestlé Health Science aims to provide physicians with more targeted solutions to optimize care for their patients.
Nestlé Health Science acquired the business of Pamlab, based in Covington, Louisiana (USA), which encompasses an innovative portfolio of medical food products for use under medical supervision in the nutritional management of patients with mild cognitive impairment, depression and diabetic peripheral neuropathy.
This acquisition has enhanced Nestlé Health Science capacity to deliver nutritional solutions in the areas of metabolic health and brain health.
Pamlab’s portfolio of prescription medical food products for use under medical supervision includes Metanx®, formulated to meet the distinct nutritional requirements of patients with diabetes to help restore the metabolic processes associated with peripheral neuropathy; Deplin®, a medical food specifically formulated to provide necessary nutritional support for certain people on prescribed antidepressant therapy for clinical depression; and CerefolinNAC®, a medical food that helps address the distinct metabolic nutritional needs associated with mild cognitive impairment. Please note that Pamlab’s portfolio is commercially available only in the USA.
KEY INVESTMENTS AND PARTNERSHIPS
Nestlé Health Science entered into a license agreement with Lipid Therapeutics GmbH (based in Heidelberg, Germany) for exclusive rights worldwide, except for Europe and Australia, to Lipid Therapeutics’ LT-02 compound (phosphatidylcholine). LT-02 is a novel barrier function therapy for patients with mild-to-moderate ulcerative colitis. Under this agreement, Nestlé Health Science will further develop and commercialize LT-02 upon marketing approval by the relevant authorities in the licensed geographies. Nestlé Health Science plans to start phase III clinical trials in the US in 2016.
Lipid Therapeutics’ European development partner, Dr. Falk Pharma GmbH, a pharmaceutical company specialized in gastroenterology, announced the start of phase III trials for LT-02 in Europe in October 2014. As part of a strategic development approach, Nestlé Health Science, Dr Falk and Lipid Therapeutics will collaborate to generate the required clinical evidence in support of LT-02’s beneficial effects in the treatment of ulcerative colitis in order to obtain drug regulatory approvals.
More than one million people worldwide are estimated to suffer from ulcerative colitis, a chronic and debilitating inflammatory condition of the large intestine. The most common treatment is 5-aminosalicylic acid (mesalazine), However it is estimated that 40% of patients receiving the recommended dose of 5-aminosalicylic acid continue to experience persistent disease activity flares. The Nestlé Health Science development program will primarily assess LT-02 as an add-on therapy to 5-aminosalicylic acid. LT-02 has a novel mode of action that restores the colonic barrier function in the gut mucosa or ‘wall’ and through anti-inflammatory signaling and represents a first-in-class therapy for those patients still suffering flares while being treated with mesalazine.
In line with an intent to take a leadership position in the developing microbiome therapy field, Nestlé Health Science has signed an exclusive agreement outside the United States and Canada for Seres Therapeutics’ novel class of microbiome therapeutics (Ecobiotics®) in the fields of Clostridium difficile infections (CDI, such as SER-109 and SER 262) and Inflammatory Bowel Disease (IBD; such as SER-287 and SER-301). The agreement follows Nestlé Health Science’s initial equity investments in US-based Seres Therapeutics announced in January and July 2015.
Through this agreement, Nestlé Health Science will support the potential future commercialization of the first ever microbiome therapy expected to be launched worldwide: SER 109 is in Phase 2 trials and targets multiple recurrent Clostridium difficile (C. diff), a bacterial infection that can affect the digestive system. An additional C. diff and two inflammatory bowel disease (IBD) pipeline candidates are also part of the collaboration, including SER-287, the innovative microbiome therapeutic currently in Phase 1 clinical development in IBD. Seres’ Ecobiotics® are first-in-field therapies, based upon microbial organisms and target the microbiome, the 100 trillion microorganisms that live within the human body. When unhealthy – or dysbiotic – the microbiome is increasingly understood to be causally related to a range of diseases.
Seres Ecobiotic® therapeutic product candidates are based upon microbial organisms, fundamentally different from traditional drugs. Advances in genomics are progressively revealing the importance of the microbiome, which comprise around 100 trillion microorganisms that live in the body, to various aspects of health.
Strategic Innovation Partnership with Flagship Ventures
Nestlé Health Science has entered into a strategic innovation partnership with Flagship Ventures, a leading venture capital and venture creation firm focused on innovations in healthcare and sustainability based in Cambridge, Mass., USA. Nestlé Health Science has invested in the Flagship Ventures Fund V. The partnership will focus on supporting start-up ventures working on nutritional health and therapy, and is intended to provide Nestlé Health Science with early exposure to Flagship’s innovative insights and technologies, which may be further exploited through minority direct investments, licensing, joint ventures or acquisitions by Nestlé Health Science. .AstraZeneca and Bayer CropScience are also strategic innovation partners in the fund. A significant portion of the partnership’s funding is dedicated to investing in entrepreneurial companies developing breakthrough technologies in the novel nutritional therapy arena relevant to Nestlé Health Science, including brain, gastrointestinal and metabolic health.
Much of Flagship’s successful 15-year track record of venture funding and creation has been built in the healthcare field, specifically in therapeutics. Through the partnership, Nestlé Health Science gains access to Flagship’s unique model of entrepreneurial innovation through acquisitions, minority stakes, licensing and joint-ventures. Cost effective, safe and clinically proven nutritional therapies – that realize the potential of nutrients to impact disease and health states at a physiological level – have a big role to play in addressing the intensifying healthcare challenges and unmet clinical needs. This fund creates multiple opportunities that can directly relate into the Nestlé Health Science pipeline and portfolio over time.
Nestlé Health Science has made a strategic investment in Axcella Health (previously: Pronutria Biosciences), a US-based company that is pioneering a pipeline of oral therapeutic and nutritional biologics, called Pronutrein® proteins. These target imbalances in amino acid profiles that are now understood to have underlying roles in a range of health conditions (e.g. neurological, muscle and liver disorders).
Amino acids (AA) are critical to life and work in tandem to provide the foundation for a healthy body. Disruption to that foundation has been linked to thousands of diseases and health conditions, all with varying levels and degrees of amino acid dysregulation. That is why addressing amino acid dysregulation has the potential to not only significantly impact the onset of devastating health conditions, but also the potential to regenerate cellular pathways damaged by AA dysregulation and restore health.
The proceeds from Nestlé Health Science’s financing will help fund further clinical development of Axcella's lead product candidates, including PN-107 for muscle wasting indications, as well as the advancement of the company's pipeline of therapeutics to treat many other diseases impacted by amino acid dysregulation.
Nutrition Science Partners Limited (NSP) is a new 50/50 joint venture between Nestlé Health Science and the pharmaceutical and healthcare group Chi-Med.
Nutrition Science Partners aims to research, develop, manufacture and market innovative nutritional and medicinal products derived from botanical plants.
In addition, Nutrition Science Partners gets access to Chi-Med’s traditional Chinese medicine library of more than 50,000 extracts from over 1,200 different herbal plants and its world-class expertise. This includes access to a gastrointestinal botanical research and development platform, which includes discovery research, nonclinical and pharmaceutical science functions, and information on botanical guidelines and regulations. Nutrition Science Partners will focus on gastrointestinal health and may in the future expand into the metabolic disease and brain health areas.
Nestlé Health Science acquired a minority stake in Accera, a privately held U.S. company based in Broomfield, Colorado (USA) that specializes in the research, development and commercialization of medical foods for neurodegenerative disorders like Alzheimer’s disease, which affects more than 30 million people worldwide.
The stake in Accera enabled Nestlé Health Science to make a strategic step forward in building up its brain health portfolio, which is fully aligned with our science-based nutrition vision.
Accera’s key brand, Axona®, a medical food that is already on the market in the USA, is intended for the clinical dietary management of mild to moderate Alzheimer’s disease. Please note that Axona® is commercially available only in the USA.
Addressing Gastrointestinal Conditions
In line with our intent to grow the area of nutrition in gastrointestinal disease management, Nestlé Health Science became a strategic partner of Vital Foods, based in Auckland New Zealand, and acquired a minority stake in this business that has a portfolio of natural products supporting general digestive health, particularly bowel functioning.
Vital Foods’ products – Kiwi Crush™, a functional drink,and Phloe®, a special kiwifruit extract that comes in a tablet and capsule formulation – are 100% naturally derived from New Zealand green kiwifruit, extracted using Vital Foods’ unique, proprietary process. Both Kiwi Crush and Phloe are well-established, widely used and recommended in New Zealand. Phloe is a leading OTC laxative product in the New Zealand pharmacy channel.