US Human Microbiota firms need not fear the seeming complexity of the European market0

Whether it’s a carburetor, a silicon chip or a new type of yogurt, throughout industry “Speed to market” is the major focus of a timely product development project and a successful business. Nowhere is this more crucial than in the Pharmaceutical industry where drug development takes around 12 years with average overall costs including marketing of around $2.25 billion per drug.

The right regulatory strategy is a key element in optimizing “speed to market” and planning your development with regulations in mind.

The PRI was formed 7 years ago to help its members navigate the regulatory situation for medicinal probiotics in Europe. In Europe the regulatory pathway for LBPs or “Medicinal Probiotics” is confusing. Whether you are marketing your product as a food supplement (companies and EFSA are constantly debating the validity of health claims for probiotics) or a medicine – there is little clarity about how to access the market with a probiotic product.

There’s clearly strong science that validates the taking of probiotics as a food supplement; at the PRI we fully support the work of our friends at the IPA. However, the PRI was created 7 years ago because the founders believed that the real future of these products is that of a medicine. Although our principal long term goal is to drive the creation of a new category at the European level for LBPs which will facilitate the future development of Microbiotic Medicinal products, we have already assisted several of our members to reach Stage III clinical trials.

The market outlook for Microbiome therapeutics is said to exceed $2.2 billion by 2025, and much of the investment we’ve seen so far has been in the US through companies such as Seres, Vedanta, Rebiotix, just to name a few.

Some important points to consider for American companies looking to gain a foothold in Europe:

  • There are several established LBP developers with GMP pharma manufacturing status
  • There already exist several pre-2001 products authorized as medicines
  • there is a full supply chain already in place which would allow you to develop, manufacture and bring your product to market

The PRI is one of the few organizations in Europe that helps its members to navigate this difficult regulatory situation as well as discover the ever-expanding Microbiota & Human Health Industry, thanks to the continuous Partnering Platform and the annual can’t-miss event, Pharmabiotics 2018.

If you represent a US company in the Human microbiota industry looking to develop your European presence, the PRI can provide determinant expertise and insight for the European market.

Contact Richard Ellis, Business Developer, for more information.

Mobile phone: +33 661 245 717


Bugs Drugs & Beyond: Janssen Focused Microbiome-based Health Solutions0

Johson & Johnson’s Janssen Pharmaceutical Companies – the human microbiota and health

As soon as he is born, man becomes the habitat of a very rich microbial flora. The skin, the mucous membranes and the gastrointestinal contents become stocked with such a flora, but a very small number of these microorganisms have up to the present been recognised or described…For long it was thought that in healthy individuals all these micro-organisms were inoffensive and sometimes even useful.”

– Elie Metchnikoff, 1901, The Prolongation of Life

Unprecedented healthcare opportunity

The microbiome refers to the complex community of microbial organisms that live in, on and around us. In the early twentieth century, Metchnikoff proposed a scientific rationale for the beneficial effects of bacteria, hypothesizing their importance in health for the first time. Today, we understand that bacteria and the microbiome play a crucial role in both sickness and health, with the potential to maintain health, as well as prevent, intercept and cure disease.

Driving Innovation

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we’re interested in the human microbiome and the role ‘bugs’ play in impacting the health of consumers and patients, alike. We established the Janssen Human Microbiome Institute (JHMI) in 2015 to bring focus to microbiome expertise and innovations across Janssen and Johnson & Johnson. Headed by Dr. Dirk Gevers and headquartered in Cambridge, Massachusetts, the JHMI is a “one-stop shop” for microbiome innovators, offering experience and expertise to deliver microbiome-based health solutions to market.

The JHMI is working alongside researchers to deepen the understanding of host-microbe interactions, develop tools for standardized analytics, define regulatory pathways, and partner with the scientific community to advance translation of the science. Within the JHMI and across the J&J enterprise, our goal is to help innovators advance and bring about meaningful microbiome-based medicines, diagnostics, and solutions to individuals in order to improve and promote health and well-being.

IPSEN enters the field of probiotics with ‘Smebiocta®’0

Big Pharma & Microbiota together make for great innovation!

April 26th 2016, Probi and IPSEN officially announced the signature of a license and supply agreement for the commercialization of Probi’s probiotic strain Lactobacillus plantarum 299v (LP299V®). The agreement covers 18 countries, primarily within EU and emerging markets. One year after, IPSEN enters the field of probiotics by launching Smebiocta® – LP299V®, its first food supplement. Smebiocta® – LP299V® contains 10 billion of Lactobacillus plantarum 299v (LP299V®) per capsule, a unique Lactobacillus strain scientifically studied and rigorously selected. The product has strong medical endorsement that perfectly fits with Ipsen’s gastroenterology expertise and leverages Ipsen’s capabilities towards physicians and pharmacists in many countries. Read the full press release here.

This launch strengthens Ipsen’s Consumer Healthcare portfolio and fits with Ipsen’s strategy to bring this business unit back to growth, In early 2017, two other major announcements were made for acquisitions of new products and entities, particularly in France, Italy and Eastern Europe. This launch will help sustain Ipsen’s Consumer HealthCare growth and accelerate transition to the OTx (mix of physicians’ prescriptions, recommendations by pharmacists and patients’ demand originated through direct communication) model.
Learn more about Smebiocta® here (French market product website).