Noticias sobre Spherium

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  • 29 DE MAYO DEL 2017

    Spherium to scout for partners at BIO San Diego 2017

    From 19 to 22 June, the Spherium Biomed team will be at the BIO International Convention 2017 in San Diego, the largest biotechnology convention in the world that brought together 16,000 executives and decision makers from 76 countries...

  • 6 DE MARZO DEL 2017

    An Astronaut’s guide…. to biotech Project Management

    It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be...

  • 9 DE DICIEMBRE DEL 2016

    Let’s keep it simple

    Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed...

29 DE MAYO DEL 2017

Spherium to scout for partners at BIO San Diego 2017

From 19 to 22 June, the Spherium Biomed team will be at the BIO International Convention 2017 in San Diego, the largest biotechnology convention in the world that brought together 16,000 executives and decision makers from 76 countries for more than 35,000 business meetings last year. This year, Spherium will be part of the Biocat delegation along with other innovative companies and organisations from the healthcare and life sciences sector in Barcelona.

For four intense days, “We will scout for international partners to license our clinical and pre-clinical projects and we will continue our systematic work to assess and acquire portfolios from universities and research centres around the world,” explains Maribel Bergés, managing partner and CBDO of the company.

The Spherium product pipeline includes innovative drugs in clinical stage like SP13004, with a unique disease-modifying mechanism of action to prevent and treat mucositis caused by cancer therapy (phase IIa results in 2018); SP14019, to treat atopic dermatitis and psoriasis with an innovative, proprietary Cyclosporine topical formulation (clinical PoC results by the end of 2017); and SP12006, used to treat mild to moderate muscular pain associated with sport or temporomandibular joint disorder (clinical PoC results in 2017).

Schedule a meeting with us

6 DE MARZO DEL 2017

An Astronaut’s guide…. to biotech Project Management

It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be a good idea for them to license out their projects to Spherium Biomed and how we could help them to test their inventions and eventually increase their value.

Having taken the Gatwick express too early, I was now just wandering around the airport and waiting for my flight. I realized I still had 20 pounds in my pocket, and I was trying to invest them in something worth to before my return to the Euro space, when I entered the newspapers shop and saw this paperback edition with an astronaut picture on the front page. It came to me like an old dream from some years ago, when I was young, I had this idea of becoming an astronaut myself, an idea that had to be abandoned for a more down-to-earth professional plan when I learned about the extremely demanding vision requirements. So I bought the book. An astronaut’s guide to life on earth by Canadian astronaut Chris Hadfield and I started to discover the secrets of this profession that most of us will never get to really know, and learn about the lights and shadows that are so surprisingly close to our own.

As commander Hadfield describes his profession, it takes years to become an astronaut, since they need to keep always learning about the prospects of out of earth missions and getting their minds to think like astronauts: “No matter how competent or how seasoned, every astronaut is essentially a perpetual student forever cramming for the next test”. It takes hours of simulations, debriefing, courses, reading, and homework for an astronaut to be ready to take a mission, and yet we only know about them when a new record is achieved or something epic or sometimes even disastrous happened in their last mission. Another important advice from Hadfield is to prepare previously to each mission, even a single recognition flight, to check every potential problem that may come up and be ready for the unexpected events, as he puts it, you need to “sweat the small stuff” so you know ahead of a situation all the potential trouble you may find.

It turns out that it is very similar when you come to biotech Project Management. We will never have the thrill of actually leaving the ground to come higher than the 50 miles that it takes to be an astronaut, but a Project Manager is also a lifetime student that invests an incredible amount of time learning about the very specifics of a new mechanism of action, the properties or a complex biological system, or the clinical needs in a particular indication. Before starting a new experiment, may it be a murine model or a clinical trial, there are a number of small decisions to be taken in order to learn the most from the experience: how to administer the product, how many doses, how often, which are the readouts that are going to be collected and reported, and then we need to debrief to understand what happened, what went right and what went wrong, and start to plan for our next experiment again.

So what makes us good as Project Managers and, in a word, why should anyone want to partner with us? It is not so much about how good or exceptional are our successes, but it is about how long our hours have been in this field and how deep and extended is our experience. It is about how many experiments we have seen, how many right or wrong decisions we have made, how many projects we started and how many failed and how our team has learned from all that to bring it to any new development we start.

Since we incorporated Spherium Biomed, we have reviewed in depth more than 500 projects, we have started almost 70 new preclinical developments after closing as many licenses, and we are now conducting three phase II clinical trials. This is the real value that we can bring to an academic research organization: the experience and time it has taken to our team to be developing projects continuously for the last eight years. Or to say it in the words of Michael Jordan: “I've missed more than 9000 shots in my career. I've lost almost 300 games. 26 times, I've been trusted to take the game winning shot and missed. I've failed over and over and over again in my life. And that is why I succeed”.

In the next months we will learn the results of our first three clinical trials, we may succeed or we may fail, but no matter what we will debrief and learn to bring the best of our experience to our technological partners (worldwide universities and hospitals) and to the patients that deserve the best of our efforts to develop biomedical innovations for the improvement of their health.

Now the countdown is ready for our first results, in a way, our first lift-off. 5…4...3…2…1…

Maribel Berges, Managing Partner and CBDO of Spherium Biomed

9 DE DICIEMBRE DEL 2016

Let’s keep it simple

Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed in less than 6.000 characters and one drawing to describe the double helix of DNA and to suggest how its information could be copied and transmitted from one generation to the following.

“Distrust the idea that does not fit in a sentence”, says Jorge Wagensberg in his marvelous short aphorism book If Nature is the answer, what was the question? Simplicity is a key to understanding problems and to make others understanding the problems, also a key to propose solutions to problems. Simplicity helps in any kind of communication. However, sensible simplification is probably the most challenging effort for anyone with communication responsibilities, from the community manager in the Linkedin page to the CFO talking to investors; from the bench scientist telling the CEO how important the new program is for the company, to the University Professor explaining the tech transfer guys her last discovery (which by the way could be the next Watson & Crick thing…).

Ever heard of the elevator pitch concept?

Counter-example: I remember one honest and hard-working man going all over Spain explaining a full range of public financing options for science projects. He had 30 slides and his concept of adaptability was this: if he had 30 minutes, his presentation was OK, normal pace. If he had 45 minutes, then he explained his 30 slides at a slower, mindfulness-style rhythm. If he had only 10 minutes, then he was really fast, still showing the 30 slides.

We started Spherium Biomed in 2009. Our name was Janus at the time, after the bi-faced Roman divinity taking care of the transitions (January…), looking at the same time to the past and to the future. We thought of Janus because we wanted to look at the academic research and the unmet needs in the biomedical market and bridge the gap (our first catchy motto). Simultaneously we defined our mission as to turn biomedical knowledge into social and economic value. We spent infinite hours trying to find a sentence to define our company, a simple, easy-to-remember and true statement fitting in a short sentence that even my mum could understand.

During our first four years we tried several adaptations of known concepts: hands-on biomedical incubator; accelerator, a company specialized in maturing projects originated in academia; or cost-efficient de-risk incubator of biomedical technologies. All that time we spoke a lot with different local journalists who were interested in the evolution of the company. A symptom of us not communicating well was that one of them systematically defined us as a consulting firm giving strategic advice to research institutions, no matter how nice our pipeline started to look or how many licensing-in deals we had closed with academia.

Seven years have gone-by already, and we are still looking for that sexy and informative short sentence that defines as better. As of today we are a clinical stage biopharmaceutical company that sources its pipeline from academic research. Perhaps it is a good definition. For sure we will have another one in a couple of years.

Yes, I’ve checked already. The post has 566 words including this sentence. 3414 characters including spaces. No drawings.

It may work.

Dr. Luis Ruiz-Ávila, CEO of Spherium Biomed

  • 14 DE FEBRERO DEL 2017

    Advances in Spherium's clinical portfolio

    Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and...

  • 12 DE FEBRERO DEL 2017

    Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

    Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background...

  • 16 DE NOVIEMBRE DEL 2016

    Dr Pawel Zajdel receives recognition under the auspice of prestigious Prix Galien

    Dr Pawel Zajdel, a specialist in medicinal and organic chemistry from Jagiellonian University (Kraków), has been awarded a fellowship from the French Embassy under the auspices of the Prix Galien Poland for his innovation in academic research.

14 DE FEBRERO DEL 2017

Advances in Spherium's clinical portfolio

Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and hard work of the internal and external collaborators involved in these projects.

Most relevant goal was reached by SP12006, the program in Temporo-Mandibular Joint Disease (TMJD). In this project, the phase II clinical trial successfully completed the recruitment of 96 patients in 4 different centers: the Universitary Dental Clinic (UIC), the Hospital Odontológico of the University of Barcelona, the Universitary Hospital Rey Juan Carlos I in Madrid and the University Hospital de la Fe in Valencia. This exploratory trial is a randomized, double blind, placebo controlled study designed to evaluate safety and efficacy of a triple combination (ibuprofen, magnesium and vitamin C) for the treatment of acute pain in TMDJ. 

Another relevant milestone was reached by SP14019, the program in Atopic Dermatitis (AD). In this case, the phase II clinical trial successfully completed the recruitment of the adult cohorts, which allows Spherium Biomed to start the recruitment of children under 18 years. AD is a major unmet need in the children, so testing in this population is a critical objective of the project.

Finally, the program in Oral Mucositis (OM) SP13004 also has shown important advances: phase Ib-II clinical trial (reached the recruitment of 2/3 of the target patient population, and is actively recruiting at a steady pace.

'In summary we had a very busy clinical year, but we expect 2017 to be even busier.
Next milestone ahead: top line results of our clinical TMJD program, expected in the coming weeks' explain Dr. Benjamín Santos and Dr. Wilmar Castillo Ávila, Project Managers at Spherium Biomed.

12 DE FEBRERO DEL 2017

Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background and the design of the ongoing trial Mucomel®.

In the phase IB-II clinical trial, Spherium Biomed investigates the safety and efficacy of a proprietary oral gel for the prevention and treatment of severe oral mucositis in 84 patients with head and neck cancer undergoing radio/chemo therapy. At present, the trial is actively recruiting patients in seven leading hospitals in Spain (ICO L’Hospitalet, Vall d’Hebron University Hospital and Hospital Sant Pau in Barcelona, ICO Girona, ICO Badalona, Miguel Servet University Hospital in Zaragoza and La Paz University Hospital in Madrid). Recruitment pace forecasts that last patient will be included by June 2017.

Severe oral mucositis is a major adverse event of the oncologic treatment with a large incidence: 95% of head and neck cancer patients, 78% of haematological cancer patients, 40% of patients with solid tumors, among others. It is recognized by experts as one of the major unmet medical needs in cancer supportive care, since at present only partial symptomatic treatments are available (anesthesic washes, hygiene procedures and anti-inflammatories) and consequences of the disease can led to breaks in oncologic treatment, parenteral feeding and oral chronic toxicities. Mucomel® represents a unique opportunity to improve the quality of life for these patients.

During the 6th ICHNO, five posters related to melatonin, mucositis and cancer will be presented. The design of Spherium Biomed's clinical study will be summarized in the poster entitled Melatonin oral gel for the prevention of oral mucositis H&N cancer undergoing chemo/bio radiation, presented by the principal investigator Dra. Alicia Lozano. The preclinical in vivo results of the use of melatonin in prevention of oral mucositis will be summarized in two posters, Effects of melatonin oral gel to prevent radiation-induced mucositis model in rat and A melatonin gel protects the mitochondria from radiation damage preventing radiotherapy-induced mucositis, that will be presented by the originator of the Mucomel® technology, Dra. Germaine Escames. She will also present two posters summarizing her ongoing research work on melatonin at the University of Granada: Oncostatic effect of Melatonin in H&N cancer: role of mitochondrial function and Melatonin enhances the toxicity of Radio- and Chemotherapy in H&N cancer cells.

Meet Spherium Biomed at the 6th ICHNO! Please contact in advance our representatives Dr. Cristina Tarragó and Dr. Pedro Grima in order to arrange a meeting during the conference.

16 DE NOVIEMBRE DEL 2016

Dr Pawel Zajdel receives recognition under the auspice of prestigious Prix Galien

Dr Pawel Zajdel, a specialist in medicinal and organic chemistry from Jagiellonian University (Kraków), has been awarded a fellowship from the French Embassy under the auspices of the Prix Galien Poland for his innovation in academic research. Specifically, the award acknowledges the merit of the Polish-French initiative that has led to the discovery of preclinical candidate SP14040, a first-in-class small molecule for cognitive impairment in patients with Alzheimer or schizophrenia licensed by Spherium Biomed. Dr Zajdel is one of the owners of the patent on this compound, licensed to Spherium.

The awards ceremony took place at the Hilton Warsaw Hotel in Poland on 16 November 2016.

Considered the Nobel Prize of the pharmaceutical industry, Prix Galien was created in France in 1970 by a pharmacist named Roland Mehl with the aim of recognising and promoting significant advances in pharmaceutical research that improve the human condition by developing novel, high-value medicines. The Prix Galien are the only independent awards of their kind across the global industry and winners are chosen by eminent healthcare leaders and specialists. Nowadays, it is a global brand with fifteen national awards in Belgium-Luxemburg, Canada, Germany, Greece, Israël, Italy, Morocco, Poland, Portugal, Russia, Spain, Switzerland, The Netherlands, USA and United Kingdom.

  • 15 DE ENERO DEL 2017

    BIO-Europe Spring 2017: Getting collaborations at home

    Spherium Biomed will participate on next BIO-Europe Spring 2017. This year, winter is over and spring is coming to Barcelona. From 20th to 22nd March, Spherium Biomed team will join company presentations and partnering meetings with other...

  • 6 DE NOVIEMBRE DEL 2016

    Spherium’s key patent achievements in 2016

    2016 has been a productive and positive year for the patent portfolio behind Spherium Biomed’s active projects. Strategic intellectual property (IP) management is a key element for any company focused on drug development. 'We are no exception,'...

  • 2 DE OCTUBRE DEL 2016

    Spherium expands its pipeline with new preclinical program for autoimmune diseases

    Spherium Biomed has added PeMTADiV (SP15008) to its pipeline. This patented preclinical candidate for autoimmune diseases was discovered by Professor David Naor, a renowned immunologist from Israel. The aim is to reach the clinical phase...

15 DE ENERO DEL 2017

BIO-Europe Spring 2017: Getting collaborations at home

Spherium Biomed will participate on next BIO-Europe Spring 2017. This year, winter is over and spring is coming to Barcelona. From 20th to 22nd March, Spherium Biomed team will join company presentations and partnering meetings with other participants in our city.

As part of its regular business, Spherium Biomed is seeking in-licensing opportunities from academic sources, preferably therapeutically oriented projects with solid preclinical POC and repurposing (repositioning) opportunities of molecules that have reached the market or discontinued during development because of lack of efficacy.

On the other side, the company will look for out-licensing ongoing projects in clinical proof-of-concept stage (mucositis, psoriasis and atopic dermatitis, muscular soreness and acute kidney injury) and also in non-clinical stage (a local intramuscular treatment for muscle injury, a safe biomolecule that is a modulator of the immune response with proof-of-concept in lupus nephritis and rheumatoid arthritis and a preclinical candidate for cognitive deficit and negative symptoms in schyzophrenia).

See you soon in Barcelona!

6 DE NOVIEMBRE DEL 2016

Spherium’s key patent achievements in 2016

2016 has been a productive and positive year for the patent portfolio behind Spherium Biomed’s active projects. Strategic intellectual property (IP) management is a key element for any company focused on drug development. 'We are no exception,' says Maribel Berges, Managing Partner and CBDO of Spherium Biomed.

Spherium Biomed sources most of its projects from academic institutions, which are usually public. The company takes full responsibility not only for regular, reactive maintenance and defence of the IP licensed from universities, “but also for prospective, proactive generation of data to support the evaluation process. And sometimes, we produce experimental results that allow us to generate new IP, always in coordination with the original inventors,' explains Berges.

So, it’s time to look at what happened on the IP front in 2016:

* For the patent that protects MUCOMEL (SP 13004), a product to treat mucositis, Spherium Biomed has received notice of allowance from China, Japan, Mexico, Russia and Australia, a nice collection to add to the patents already issued in the US and Spain.

* In January, Spherium Biomed filed a composition of matter application for CYCLATOP (SP14019), a topical Cyclosporine solution for atopic dermatitis and psoriasis. The product is also covered by an umbrella patent granted for the US, Japan and Australia in 2016.

* Concerning COMBOPROFEN (SP12006), a product to treat mild muscle pain, Spherium received a very positive written opinion from the EPO and the company will push this application forward to then widen protection on a national and regional level in July 2017.

* One of the patents covering SP15016, a product to prevent iatrogenic acute kidney injury, was granted in the US and two more applications were filed based on exciting new data to broaden the IP protection and the project scope.

* Cognition deficit product SP14040, whose inventor has just been given an award under the auspices of the Prix Galien Poland, has seen its 2014 application proceeding to the national/regional phase with very good prospects, confirming the high scientific level of the research and the quality standards of the tech-transfer team at Jagiellonian University in Poland.

* Part of the broad patent application covering SP12008, a preclinical biological candidate for autoimmune diseases, received a notice to grant from Europe in 2016. Spherium Biomed expects to file new patents in the near future, to comprehesively cover the IP space for this breakthrough product.

* PeMTADiV (SP15008), for rheumatoid arthritis and other autoimmune diseases, licensed from Yissum, the tech-transfer company of the Hebrew University of Jerusalem. The technology is covered by patent applications from 2014 and by an additional one filed in July of this year on the basis of the molecule’s unexpected therapeutic attributes discovered in preclinical models.

So, 2016 has been a very good year. However, none of these achievements would have been possible without a strong foundation. Spherium Biomed works very closely with more than 50 research and tech-transfer teams all over the world, having closed deals with several Universities and Research Centers in Spain, France, Poland and Israel.

Such commitment translates into an ever-growing investment from our side as the IP portfolio reaches maturity: in 2016 Spherium invested €250,000 in patent management (up 60% from the previous year). 'That shows the continuous commitment to protect and increase the value of our licensors’ inventions,' concludes Maribel Berges.

2 DE OCTUBRE DEL 2016

Spherium expands its pipeline with new preclinical program for autoimmune diseases

Spherium Biomed has added PeMTADiV (SP15008) to its pipeline. This patented preclinical candidate for autoimmune diseases was discovered by Professor David Naor, a renowned immunologist from Israel. The aim is to reach the clinical phase within two years.

This drug is a 5-mer peptide (MTADV) derived from a CD44 variant expressed only in the inflammatory cells of the joints of rheumatoid arthritis patients. It inhibites substantially joint inflammation in a RA-CIA mouse model, as well as strongly inhibiting limb paralysis in a multiple sclerosis mouse model. The peptide has a novel, targeted mechanism of action directed at key pathways of the immune response and inflammatory cascade.

Yissum, tech transfer from Hebrew University of Jerusalem

The technology is covered by patent applications from 2014 and 2016. Spherium Biomed acquired an exclusive option to license PeMTADiV from Yissum, the technology transfer company of the Hebrew University of Jerusalem. Ranked among the top tech transfer companies, Yissum has registered over 9,300 patents, out-licensed 800 technologies and spun off 110 companies. Products that are based on Hebrew University technologies and commercialised by Yissum now generate over $2 billion in sales each year.

Spherium Biomed is closing out 2016 with a pipeline consisting of ten active projects in the field of human and animal health (four in the preclinical phase and six in the clinical phase). Furthermore, Spherium is a partner in one of them (veterinary vaccines for respiratory diseases) with the company Aquilon Cyl.

  • 27 DE SEPTIEMBRE DEL 2016

    El desarrollo de nuevos fármacos: “from push to pull”

    Artículo de opinión escrito por Luis Ruiz-Ávila, PhD CEO de Spherium:

    Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific...

  • 27 DE SEPTIEMBRE DEL 2016

    Cyclatop estudio para la dermatitis atópica se inicia el reclutamiento de pacientes

    Spherium Biomed ha abierto el primero de ocho hospitales en España, que participan en el estudio Cyclatop, para evaluar la seguridad y eficacia de un aerosol cutáneo propio de la ciclosporina A (codificado SP14019-F1) para el tratamiento...

  • 27 DE SEPTIEMBRE DEL 2016

    Spherium Biomed en BIO-Europe 2016

    Después de asistir a Biospain, Spherium Biomed participará en la BIO-Europe 2016, la conferencia de asociación más grande de Europa para la industria biotecnológica global que tendrá lugar del 7 al 9 de noviembre en Colonia (Alemania).

    BIO-Europe...

27 DE SEPTIEMBRE DEL 2016

El desarrollo de nuevos fármacos: “from push to pull”

Artículo de opinión escrito por Luis Ruiz-Ávila, PhD CEO de Spherium:

Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific instructions to deliver a new plane in 10 years. They most probably will deliver the new plane according to specifications. Take thousand biomedical scientists and do the same asking them to deliver an HIV vaccine, and they most probably won’t get it.

Applied biomedical research, particularly new drug development, is a pay per view business and the quintessence of the scientific method: no matter how good is your science, the only way to know if your hypothesis is right is to test it experimentally in the right model. And, in biomedicine, key experiments are outrageously expensive (the right model is a human and the experiments are called clinical trials) and surprises (unexpected results) are more the norm than the exception. Anybody in applied biomedical research has to learn to cope with technical failure. Actually, the real challenge of an R&D executive in the biopharma industry is to be able to minimize the cost of failures while performing sufficient number of attempts to get at least one drug to the patients once in a while, without being fired along the way because of incompetence or budgetary restrictions. 

 

There are two basic approaches to deliver a new drug: pull and push. The pull approach follows a very institutionalized path in the biopharma industry: define a medical unmet need, find a new therapeutic target, discover a molecule that acts on the target, show it works in preclinical models of the predefined unmet need, make the molecule industrial and regulatory compliant, define the clinical and market access strategy, take a deep breath and start formal development. It is a problem-driven approach. The key element is to find the right technology to solve a predefined problem. The driver of the process is the dedicated industry, that expends enormous amount of resources in understanding and predicting unmet medical needs, payer trends and, sometimes, even defining new diseases or disease sub-classifications. 

The push, by contrast, is technology-driven. One team of scientists makes a seminal discovery, then the key is to find the right problem where the new discovery can be used. Mechanistic research often leads to great discoveries sitting there waiting for somebody to find a way to use them. By far, most of the new knowledge is generated because of the mechanistic motivations of scientists exploring new explanations to understand better the basis of life. In fact, in general scientists do not care too much about market access and the likes. However, mechanistic research is probably the only effective path to real breakthroughs, something that was recognized in 1945 in Science, the endless frontier, a document that lead to the creation of the National Science Foundation, the National Institutes of Health  and the Defense Advanced Research Projects Agency  in the US. The idea-force behind this landmark document was the following (quoted literally): “To discover is to obtain for the first time sight or knowledge of some fact or principle hitherto unknown. Discovery cannot be achieved by directive. New products and new processes do not appear full-grown. They are founded on new principles and new conceptions, which in turn are painstakingly developed by research in the purest realms of science.”  

 

While the pull approach has been the main driver of the biopharma industry over the last fifty years, its perceived increasing lack of productivity combined with the massive amount of mechanistic knowledge that is permanently being generated in academic institutions are the basis of a very clear trend that permeates modern pharma. Big or small, almost everybody in the industry is trying to fish in the open innovation space, adding the push strategy to their business models with more or less fortune.

 

When we started Spherium Biomed we decided to stay in the push side. Our key assumption was that academic research was mechanistically driven, and that even when the results were presented as a consequence of a problem-solving process, in the great majority of cases the problem itself was badly defined and that just the right definition of the problem to solve lead to a significant improvement (or refutation) of the potential value of the research from the applied point of view.

 

Defining the right problem (in our process, the right Target Product Profile, TPP) is the very first step in our company when we start the evaluation of an academic technology. If we are able to define the TPP we have the most important thing that any new project can have: a defined goal (in engineering language, the specifications of the product). Then we can start thinking in a development plan (basically a development plan should aim to fill the gaps between the technology at time zero and the technology at TPP stage). If we can deliver a development plan, that means that have identified all the required providers and collaborators, so we have budgets and calendars. If those fit our budgetary and time constrains, then we have a project and we try to negotiate a license to be able to develop and commercialize the technology. If not, we don’t go for it. As simple and as complex as that.  

 

27 DE SEPTIEMBRE DEL 2016

Cyclatop estudio para la dermatitis atópica se inicia el reclutamiento de pacientes

Spherium Biomed ha abierto el primero de ocho hospitales en España, que participan en el estudio Cyclatop, para evaluar la seguridad y eficacia de un aerosol cutáneo propio de la ciclosporina A (codificado SP14019-F1) para el tratamiento de leve dermatitis atópica (AD) de leve a moderada, cubriendo todos los grupos de edad, incluida población pediátrica. En él se incluirán 36 pacientes (con un diseño cegado de izquierda-derecha, de tal manera que cada paciente es su propio control) con edades comprendidas de 2 a 75 años en tres cohortes (pediátricos, juveniles y adultos).

Systemic Cyclosporine A is an efficacious and well established treatment for moderate to severe atopic dermatitis. Its use is limited to short term because of the risk of adverse events, in particular nephrotoxicity. The topical formulation is expected to have a much better safety profile since it reduces dramatically the systemic exposure. “In our view it represents a unique opportunity to extend the well-established benefits of cyclosporine in the indication, both in time (allowing for longer treatment periods) and in patient base (broadening the scope of treatment to milder cases and pediatric populations)” explains Dr. Benjamín Santos, Senior Project Leader of Spherium Biomed.

20% of Spanish children suffer from atopic dermatitis

Atopic dermatitis , also called atopic eczema, is a chronic and relapsing inflammatory skin disease affecting up to 20% of children and up to 3% of adults depending on the country. Its prevalence is still on the rise. The disease is characterized by itchy skin lesions and rashes. It is primarily managed in primary healthcare settings and often is considered a minor condition, but it has a significant impact in quality of life and in costs for the health-care systems and families. When its first manifestations appear early in life it often precedes other allergic diseases such as asthma or allergic rhinitis.

The global market is in the 4 billion dollar range worldwide, with an estimated target population of 54 million people for the next decade. The long lasting nature of AD and the multiple etiologies underlying the disease are the basis for the existence of many therapeutic options and, simultaneously, of an intense research activity focused in niche unmet needs in severe, refractory cases, and in expanding the current armamentarium, especially topical alternatives for infants.

Presentation at the 25th EADV Congress

Spherium Biomed high-load formulation of Cyclosporine A is compatible with cutaneous spray administration. “We have already shown that the formulation delivers appropriate amounts of Cyclosporine to the target layers in the skin, with a parallel, dose dependent efficacy in preclinical models of atopic dermatitis,” says Dr Santos. The key aspect of SP14019 development has been solving the pharmaceutical challenge of obtaining a high-load, skin penetrating, scalable, stable and regulatory compliant formulation of CsA, a technical milestone that we couldn’t have achieved without the close collaboration with Bionanoplus, a Navarra University spin-off from which we licensed the technology in exclusive for this project. Dr. Benjamin Santos will present the project at an oral poster (Stable, high-load topical formulation of Ciclosporin for the treatment of Psoriasis and Atopic Dermatitis) at the 25th EADV Congress in Vienna  on 1st October .

This is the third project of Spherium Biomed's portfolio that reaches clinical efficacy stage over the last year. Exciting times ahead, since the three of them are expected to deliver top line results before the end of 2017. Keep you posted! 

 

27 DE SEPTIEMBRE DEL 2016

Spherium Biomed en BIO-Europe 2016

Después de asistir a Biospain, Spherium Biomed participará en la BIO-Europe 2016, la conferencia de asociación más grande de Europa para la industria biotecnológica global que tendrá lugar del 7 al 9 de noviembre en Colonia (Alemania).

BIO-Europe atrae a más de 3.500 negociadores de la biotecnología, la industria farmacéutica y las finanzas. Además, que en 2015 había 4.358 oportunidades de licencias publicados. BIO-Europe es especialmente interesante para Spherium, una empresa que desarrolla innovaciones biomédicas a partir de fuentes académicas para acelerar su transición a la cadena de valor y para el mercado. Ver la cartera aquí y solicitar una reunión con nuestro equipo ejecutivo!

  • 27 DE SEPTIEMBRE DEL 2016

    FROM OUR NEWSLETTER Spherium Biomed en Biospain 2016

    El equipo ejecutivo de Spherium Biomed asiste al 8º Encuentro Internacional de Biotecnología, Biospain 2016, organizado por la Asociación Española de Bioempresas (Asebio) y la Agencia de Desarrollo de Negocios Vasco del 28 al 30 de septiembre...

  • 13 DE ENERO DEL 2016

    SPHERIUM INICIA UN ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA DE UN PRODUCTO PARA TRATAR EL DOLOR EN LA ARTICULACIÓN DE LA MANDÍBULA

    Spherium ha iniciado la inclusión de pacientes en un ensayo clínico para evaluar la eficacia de SP12006 para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. El ensayo incluirá 96 pacientes provenientes de...

  • 17 DE NOVIEMBRE DEL 2015

    Spherium ensaya un fármaco contra la mucositis, uno de los efectos secundarios más severos de la quimio y la radioterapia

    Spherium pone en marcha un ensayo clínico sobre la eficacia y seguridad del gel SP13004 para la prevención y tratamiento de la mucositis, una dolorosa inflamación de las mucosas, efecto secundario que padecen muchos pacientes con cáncer...

27 DE SEPTIEMBRE DEL 2016

FROM OUR NEWSLETTER Spherium Biomed en Biospain 2016

El equipo ejecutivo de Spherium Biomed asiste al 8º Encuentro Internacional de Biotecnología, Biospain 2016, organizado por la Asociación Española de Bioempresas (Asebio) y la Agencia de Desarrollo de Negocios Vasco del 28 al 30 de septiembre en Bilbao.

 La feria es uno de los más importantes en el mundo, debido al número de uno-a-uno reuniones (más de 3.000 en cada edición), así como el número de empresas participantes (más de 850). Treinta y cuatro por ciento de los delegados provienen de fuera de España. Estados Unidos es el país invitado.

 Spherium es una empresa que desarrolla innovaciones biomédicas a partir de fuentes académicas para acelerar su transición a la cadena de valor y para el mercado.

 

13 DE ENERO DEL 2016

SPHERIUM INICIA UN ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA DE UN PRODUCTO PARA TRATAR EL DOLOR EN LA ARTICULACIÓN DE LA MANDÍBULA

Spherium ha iniciado la inclusión de pacientes en un ensayo clínico para evaluar la eficacia de SP12006 para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. El ensayo incluirá 96 pacientes provenientes de cinco centros especializados de ámbito nacional. Los resultados se conocerán durante 2016.

Los trastornos temporo-mandibulares son un problema significativo de salud pública y son la segunda causa de dolor e incapacidad de origen musculo-esquelético tras el dolor crónico de espalda. La complejidad de la articulación temporo-mandibular y la diversidad de causas que provocan el trastorno explica que no exista una medicación específica, con tratamientos sintomáticos que son poco satisfactorios.

SP12006 ha sido íntegramente desarrollado por Spherium a partir de la investigación realizada por un asesor clínico de su red internacional. Se trata de una combinación novedosa, patentada, de productos conocidos que se dirigen a los diferentes agentes causales del trastorno.  Se prevé también iniciar el desarrollo del producto para el tratamiento del dolor muscular asociado a la práctica deportiva intensa. 

Si los resultados fueran positivos, SP12006 podría llegar a ser el primer fármaco disponible  para el tratamiento del dolor agudo asociado a los trastornos temporo-mandibulares. Casi 5 millones de personas en Europa y en Estados Unidos necesitan algún tipo de tratamiento. Sólo en España el nuevo fármaco podría beneficiar a unas 200.000 personas. Los tratamientos actuales se dirigen al manejo del dolor y restablecimiento de la función, pero no acaban de resolver los problemas en un porcentaje muy significativo de los pacientes. No existen pautas claras de tratamiento farmacológico. Se emplean férulas de uso nocturno, analgésicos, anti-inflamatorios, relajantes musculares, antidepresivos, llegándose al uso de opioides e incluso cirugía en los casos más graves. Además, SP12006 podría ser útil para evitar el dolor y malestar muscular asociado a la práctica deportiva intensa.

Para Luis Ruiz-Ávila, Director General de Spherium, el inicio de este ensayo clínico, el segundo ensayo en pacientes que comienza la empresa, es un hito importante que demuestra la validez de su modelo de negocio. Dice Ruiz-Avila: “con el inicio de este ensayo clínico demostramos que es posible desarrollar fármacos innovadores, que resuelven problemas de salud importantes, partiendo del conocimiento generado en entornos académicos. Siguiendo el mismo modelo actualmente estamos desarrollando otros proyectos para entrar en fases clínicas de eficacia, consolidando así el trabajo de investigación realizado en los últimos años tanto por la empresa como por los investigadores que originaron en su momento el conocimiento de base para diseñar los nuevos medicamentos.

17 DE NOVIEMBRE DEL 2015

Spherium ensaya un fármaco contra la mucositis, uno de los efectos secundarios más severos de la quimio y la radioterapia

Spherium pone en marcha un ensayo clínico sobre la eficacia y seguridad del gel SP13004 para la prevención y tratamiento de la mucositis, una dolorosa inflamación de las mucosas, efecto secundario que padecen muchos pacientes con cáncer de cabeza y cuello tratados con quimio y radioterapia.

• El ensayo se realiza en cuatro hospitales de Barcelona, Hospitalet de Llobregat y Girona, con 84 pacientes voluntarios que padecen cáncer de cabeza y cuello

 

• La novedad del SP13004 está en su mecanismo de acción, que utiliza el método natural de las células para protegerse del estrés oxidativo.

 

Barcelona, 17 de noviembre de 2015. La mucositis oral es un efecto secundario de la quimio y la radioterapia en forma de inflamación aguda de la mucosa, que provoca heridas y llagas, y que puede llegar a bloquear la capacidad de comer o beber de los afectados. En los casos más severos, puede llevar incluso a la suspensión del tratamiento.

Revolucionario enjuague bucal

El gel SP13004 ha sido desarrollado por Spherium a partir de la investigación realizada por el equipo de la Dra. Germaine Escames de la Universidad de Granada. La novedad reside en su mecanismo de acción, que utiliza el método natural de las propias células para protegerse del estrés oxidativo.Spherium ensaya un fármaco para prevenir y tratar la mucositis

El SP13004 es un gel en forma de enjuague bucal que se administra varias veces al día, cuya seguridad y eficacia ha sido comprobada ya en ensayos preclínicos. Ahora se prueba en pacientes con la autorización de la Agencia Española del medicamento.

Atacar las causas de la mucositis

Hasta hoy, los tratamientos contra la mucositis se dirigían al manejo del dolor, la reducción de la inflamación y la lubricación de la mucosa. Pero todavía no existía ningún fármaco que atacara sus causas.

El modo de acción del SP13004 es restablecer el mecanismo natural de defensa de la integridad de la mucosa que emplea el organismo y que suele verse seriamente afectado en muchos tratamientos oncológicos.

Cientos de miles de afectados

La mucositis afecta a más de 600.000 personas en Estados Unidos y Europa, con especial incidencia en los pacientes de cáncer de cabeza y cuello (el 95%) o en los pacientes de cánceres hematológicos sometidos a trasplante (80%).

La base científica del SP13004 fue descubierta y patentada por científicos de la Universidad de Granada liderados por la Dra. Germaine Escames.

Spherium adquirió licencia para el desarrollo y comercialización del fármaco. En caso de comercializarse, la Universidad de Granada recibiría parte de los ingresos, que redundarían en la investigación universitaria.

No es el primer fármaco que se prueba, existen otros productos, pero son muy poco eficaces. Según Luis Ruiz-Ávila, Director General de Spherium, el inicio de este ensayo clínico es un hito importante que representa una gran oportunidad para satisfacer una necesidad médica sin alternativas farmacológicas eficaces. “Con el inicio de este ensayo clínico demostramos que es posible desarrollar fármacos innovadores, que resuelven problemas de salud importantes, partiendo del conocimiento generado en entornos académicos”, afirma Ruiz-Ávila.Spherium ensaya un fármaco para prevenir y tratar la mucositis

Más sobre Spherium

Spherium Biomed es una empresa biofarmacéutica que desarrolla proyectos originados en entornos académicos. La empresa establece acuerdos de licencia con universidades o centros de investigación de todo el mundo. A partir de ahí, Spherium lidera y coordina el proyecto, definiendo su estrategia y planificación y llevando a cabo los experimentos necesarios para avanzar en el desarrollo del producto.

En caso de completar con éxito el desarrollo, Spherium busca socios que puedan hacerlos llegar al mercado, inversores que apoyen la creación de una nueva empresa o bien empresas establecidas (normalmente farmacéuticas o biotecnológicas).

Parte del valor recibido por Spherium revierte en las instituciones originadoras en forma de participación en los beneficios futuros.

Spherium es una empresa del Grupo Ferrer. Cuenta con un equipo de 13 personas, en su mayoría doctores.

Para ampliar información y/o concertar entrevistas:

Jordi Trilla jordi.trilla@aportada.com 671.612.807

Jordi Benavente jordi.benavente@aportada.com 670.906.384

 

  • 19 DE OCTUBRE DEL 2015

    Recta final del proyecto INNPACTO “Apta4”

    Con un estudio clínico que se está desarrollando en varios hospitales de la Comunidad de Madrid, el proyecto Apta4 ha entrado en su recta final. El proyecto se inició en 2011 como una colaboración público-privada, en el marco del programa...

  • 6 DE OCTUBRE DEL 2015

    BIO-Europe® 2015

    Spherium asistirá al 21th Aniversario del Bio-Europe que tendrá lugar en Munich del 2 al 4 de Noviembre 2015.

    Spherium tiene como objetivo comercializar las tecnologías actuales y adquirir nuevo portfolio de proyectos.

    BIO-Europe es la...

  • 14 DE ABRIL DEL 2015

    Visítanos en BIO 2015 (booth #2301)

    La próxima edición de la BIO tendrá lugar en Filadelfia (Estados Unidos) del 15 al 18 de junio de 2015, área metropolitana que acoge más de 1.200 empresas, que van desde grandes multinacionales de la industria biofarmacéutica a empresas...

19 DE OCTUBRE DEL 2015

Recta final del proyecto INNPACTO “Apta4”

Con un estudio clínico que se está desarrollando en varios hospitales de la Comunidad de Madrid, el proyecto Apta4 ha entrado en su recta final. El proyecto se inició en 2011 como una colaboración público-privada, en el marco del programa INNPACTO 2011 del Ministerio de Economía y Competitividad, y tiene como principal objetivo desarrollar un kit capaz de medir la malabsorción intestinal. En el consorcio participan dos centros de investigación (Universidad de Barcelona y Hospital Ramón y Cajal de Madrid) y cuatro empresas (Spherium, Biosystems, Aptus e Igen Biotech). 

6 DE OCTUBRE DEL 2015

BIO-Europe® 2015

Spherium asistirá al 21th Aniversario del Bio-Europe que tendrá lugar en Munich del 2 al 4 de Noviembre 2015.

Spherium tiene como objetivo comercializar las tecnologías actuales y adquirir nuevo portfolio de proyectos.

BIO-Europe es la conferencia de asociación más grande de Europa al servicio de la industria mundial de la biotecnología

BIO-Europe encuentro empresarial con más de 3000 asistentes de la industria y con una participación de 60 países, que representan más de 1800 empresas durante tres días.

Más información:

http://www.ebdgroup.com/bioeurope/index.php

14 DE ABRIL DEL 2015

Visítanos en BIO 2015 (booth #2301)

La próxima edición de la BIO tendrá lugar en Filadelfia (Estados Unidos) del 15 al 18 de junio de 2015, área metropolitana que acoge más de 1.200 empresas, que van desde grandes multinacionales de la industria biofarmacéutica a empresas nacionales con gran proyección y un alto ritmo de crecimiento. Así pues, los expositores de la BIO tienen la oportunidad de llegar a altos ejecutivos y decision-makers que asisten a la convención con el objetivo de descubrir nuevos actores de la industria, forjar colaboraciones y evaluar las tecnologías emergentes.

  • 14 DE ABRIL DEL 2015

    Spherium en el Bioforum 2015

    Desde sus inicios en 2000, Bio Forum se ha convertido en un centro de bionegocios innovador que integra los empresarios relacionados con las áreas de biotecnología, farmacia y veterinaria, así como equipos de investigación científica. Debido...

  • 14 DE ABRIL DEL 2015

    Spherium en el BioTrinity 2015

    BioTrinity es líder europeo BioPartnering  y Conferencia de Inversión. Proporciona la mejor oportunidad de conocer a los inversores, los ejecutivos de alto nivel de las organizaciones de concesión de licencias farmacéuticas mundiales y...

  • 14 DE OCTUBRE DEL 2014

    Aquilon gana el premio Cinco Días

    Aquilón Cyl SL ha sido elegida como empresa más innovadora por los premios Cinco Días a la innovación empresarial en su edición de 2014. El premio reconoce el modelo de negocio de la compañía, basado en transformación de conocimiento académico...

14 DE ABRIL DEL 2015

Spherium en el Bioforum 2015

Desde sus inicios en 2000, Bio Forum se ha convertido en un centro de bionegocios innovador que integra los empresarios relacionados con las áreas de biotecnología, farmacia y veterinaria, así como equipos de investigación científica. Debido al hecho de que la asociación en Europa central y oriental se está acelerando, hace que esta región atractiva para los inversores y las empresas de otras partes del mundo. En el comienzo, Bio Forum  era una plataforma de encuentro entre científicos y empresarios. Cada año, fue creciendo y reuniendo más y más participantes.

 

14 DE ABRIL DEL 2015

Spherium en el BioTrinity 2015

BioTrinity es líder europeo BioPartnering  y Conferencia de Inversión. Proporciona la mejor oportunidad de conocer a los inversores, los ejecutivos de alto nivel de las organizaciones de concesión de licencias farmacéuticas mundiales y la alta dirección de empresas innovadoras en desarrollo de fármacos.

14 DE OCTUBRE DEL 2014

Aquilon gana el premio Cinco Días

Aquilón Cyl SL ha sido elegida como empresa más innovadora por los premios Cinco Días a la innovación empresarial en su edición de 2014. El premio reconoce el modelo de negocio de la compañía, basado en transformación de conocimiento académico veterinario en productos competitivos. La creación de Aquilón, concebida e impulsada por Spherium Biomed 2012 (el nombre de la compañía era Janus Developments) para canalizar el desarrollo de tecnologías dirigidas a la mejora de la productividad animal que habíamos adquirido o detectado en diferentes universidades, es un ejemplo de éxito del modelo de negocio de Spherium Biomed.  En la actualidad Spherium dirige la empresa y participa en su capital. Gracias a la creación de Aquilón se ha logrado movilizar hasta el momento 1,7 millones de euros de capital privado para completar el desarrollo de tres productos innovadores con alto impacto potencial en la mejora de la productividad en la industria porcina.  

http://cincodias.com/cincodias/2014/10/10/sentidos/1412971029_355536.html

  • 1 DE ENERO DEL 2014

    Nuevas oficinas de Spherium

    Spherium empieza sus actividades en sus nuevas oficinas en Esplugues de Llobrega, en el área metropolitana de Barcelona y cerca del aeropuerto de El Prat-BCN.
    Nuestras oficinas son accesibles desde el centro de la ciudad por transporte público.

  • 27 DE NOVIEMBRE DEL 2013

    Janus y Ferrer crean Spherium

    Janus establece una alianza estratégica con Ferrer para implementar un nuevo modelo de I+D en la Industria Farmacéutica Española.
    Con la creación de Spherium, Janus Developments valida su modelo de negocio y Ferrer diversifica sus actividades...

1 DE ENERO DEL 2014

Nuevas oficinas de Spherium

Spherium empieza sus actividades en sus nuevas oficinas en Esplugues de Llobrega, en el área metropolitana de Barcelona y cerca del aeropuerto de El Prat-BCN.
Nuestras oficinas son accesibles desde el centro de la ciudad por transporte público.
Por favor, consulte nuestra sección Contacto para más información.

27 DE NOVIEMBRE DEL 2013

Janus y Ferrer crean Spherium

Janus establece una alianza estratégica con Ferrer para implementar un nuevo modelo de I+D en la Industria Farmacéutica Española.
Con la creación de Spherium, Janus Developments valida su modelo de negocio y Ferrer diversifica sus actividades de I+D para adaptarse eficientemente a las necesidades actuales del mercado