Notícies sobre Spherium

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  • 29 DE MAIG 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 MARÇ 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 DESEMBRE 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 MAIG 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 MARÇ 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 DESEMBRE 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 FEBRER 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 FEBRER 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 NOVEMBRE 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 FEBRER 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, Senior Project Manager, and Dr. Wilmar Castillo Ávila, Project Manager at Spherium Biomed.

12 DE FEBRER 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 GironaICO BadalonaMiguel 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 NOVEMBRE 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 GENER 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 NOVEMBRE 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 D'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 GENER 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 NOVEMBRE 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 D'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 SETEMBRE DEL 2016

    El desenvolupament de nous fàrmacs: “from push to pull”

    Article d'opinió escrit per 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 SETEMBRE DEL 2016

    Cyclatop estudi per a la dermatitis atòpica s'inicia el reclutament de pacients

    Spherium Biomed ha obert el primer de vuit hospitals a Espanya, que participen en l'estudi Cyclatop, per avaluar la seguretat i eficàcia d'un aerosol cutani propi de ciclosporina A (codificat SP14019-F1) per al tractament dermatitis atòpica...

  • 27 DE SETEMBRE DEL 2016

    Spherium Biomed a BIO-Europe 2016

    Després d'assistir a Biospain, Spherium Biomed participarà a la BIO-Europe 2016, la conferència d'associació més gran d'Europa per a la indústria biotecnològica global que tindrà lloc del 7 al 9 de novembre a Colònia (Alemanya).
    BIO-Europe...

27 DE SETEMBRE DEL 2016

El desenvolupament de nous fàrmacs: “from push to pull”

Article d'opinió escrit per 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 SETEMBRE DEL 2016

Cyclatop estudi per a la dermatitis atòpica s'inicia el reclutament de pacients

Spherium Biomed ha obert el primer de vuit hospitals a Espanya, que participen en l'estudi Cyclatop, per avaluar la seguretat i eficàcia d'un aerosol cutani propi de ciclosporina A (codificat SP14019-F1) per al tractament dermatitis atòpica (AD) de lleu a moderada, cubriint tots els grups d'edat, incluida la població pediàtrica. S’inclouran 36 pacients (amb un disseny ceg d'esquerra-dreta, de tal manera que cada pacient és el seu propi control) amb edats compreses de 2-75  anys  en tres cohorts (pediàtrics, juvenils i adults).

 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 SETEMBRE DEL 2016

Spherium Biomed a BIO-Europe 2016

Després d'assistir a Biospain, Spherium Biomed participarà a la BIO-Europe 2016, la conferència d'associació més gran d'Europa per a la indústria biotecnològica global que tindrà lloc del 7 al 9 de novembre a Colònia (Alemanya).
BIO-Europe atrau més de 3.500 negociadors de la biotecnologia, la indústria farmacèutica i les finances. A més, que el 2015 havia 4.358 oportunitats de llicències publicats. BIO-Europe és especialment interessant per Spherium, una empresa que desenvolupa innovacions biomèdiques a partir de fonts acadèmiques per accelerar la seva transició a la cadena de valor i per al mercat. Veure la cartera aquí i sol·licitar una reunió amb el nostre equip executiu!

  • 27 DE SETEMBRE DEL 2016

    FROM OUR NEWSLETTER Spherium Biomed a Biospain 2016

    L'equip executiu de Spherium Biomed assisteix al 8º Trobada Internacional de Biotecnologia, Biospain 2016, organitzat per l'Associació Espanyola de Bioempreses (Asebio) i l'Agència de Desenvolupament de Negocis Basc del 28 al 30 de setembre...

  • 13 DE GENER DEL 2016

    Spherium inicia un assaig clínic per avaluar l’eficàcia d’un producte per tractar el dolor en l’articulació de la mandíbula

    Spherium ha iniciat la inclusió de pacients en un assaig clínic per avaluar l'eficàcia de SP12006 per al tractament del dolor agut associat als trastorns temporo-mandibulars. L'assaig inclourà 96 pacients provinents de cinc centres especialitzats...

  • 17 DE NOVEMBRE DEL 2015

    Inici de l’assaig clínic d’eficàcia de SP13004 en mucositis oral induïda per radio-quimoteràpia: primer pacient reclutat 17/11/2015

    La biofarmacèutica Spherium Biomed, que desenvolupa projectes que s'originen en entorns acadèmics, ha posat en marxa un assaig clínic sobre l’eficàcia i la seguretat del gel SP113004 per prevenir i tractar la mucositis, un dels efectes...

27 DE SETEMBRE DEL 2016

FROM OUR NEWSLETTER Spherium Biomed a Biospain 2016

L'equip executiu de Spherium Biomed assisteix al 8º Trobada Internacional de Biotecnologia, Biospain 2016, organitzat per l'Associació Espanyola de Bioempreses (Asebio) i l'Agència de Desenvolupament de Negocis Basc del 28 al 30 de setembre a Bilbao.

 La fira és un dels més importants en el món, a causa del nombre d'un-a-un reunions (més de 3.000 en cada edició), així com el nombre d'empreses participants (més de 850). Trenta-quatre per cent dels delegats provenen de fora d'Espanya. Estats Units és el país convidat.

 Spherium és una empresa que desenvolupa innovacions biomèdiques a partir de fonts acadèmiques per accelerar la seva transició a la cadena de valor i per al mercat.

 

13 DE GENER DEL 2016

Spherium inicia un assaig clínic per avaluar l’eficàcia d’un producte per tractar el dolor en l’articulació de la mandíbula

Spherium ha iniciat la inclusió de pacients en un assaig clínic per avaluar l'eficàcia de SP12006 per al tractament del dolor agut associat als trastorns temporo-mandibulars. L'assaig inclourà 96 pacients provinents de cinc centres especialitzats d'àmbit nacional. Els resultats es coneixeran durant 2016.

 Els trastorns temporo-mandibulars són un problema significatiu de salut pública i són la segona causa de dolor i incapacitat d'origen musculo-esquelètic després del dolor crònic d'esquena. La complexitat de l'articulació temporomandibular i la diversitat de causes que provoquen el trastorn explica que no hi hagi una medicació específica, amb tractaments simptomàtics que són poc satisfactoris.

 SP12006 ha estat íntegrament desenvolupat per Spherium a partir de la investigació realitzada per un assessor clínic de la seva xarxa internacional. Es tracta d'una combinació nova, patentada, de productes coneguts que s'adrecen als diferents agents causals del trastorn. Es preveu també iniciar el desenvolupament del producte per al tractament del dolor muscular associat a la pràctica esportiva intensa.

Si els resultats fossin positius, SP12006 podria arribar a ser el primer fàrmac disponible per al tractament del dolor agut associat als trastorns temporo-mandibulars. Gairebé 5 milions de persones a Europa i als Estats Units necessiten algun tipus de tractament. Només a Espanya el nou fàrmac podria beneficiar unes 200.000 persones. Els tractaments actuals es dirigeixen al maneig del dolor i restabliment de la funció, però no acaben de resoldre els problemes en un percentatge molt significatiu dels pacients. No hi ha pautes clares de tractament farmacològic. S'empren fèrules d'ús nocturn, analgèsics, antiinflamatoris, relaxants musculars, antidepressius, arribant-se a l'ús d'opioides i fins i tot cirurgia en els casos més greus. A més, SP12006 podria ser útil per evitar el dolor i malestar muscular associat a la pràctica esportiva intensa.

Per Luis Ruiz - Ávila , director general de Spherium , l'inici d'aquest assaig clínic , el segon assaig en pacients que comença l'empresa, és una fita important que demostra la validesa del seu model de negoci. Diu Ruiz - Avila : " amb l'inici d'aquest assaig clínic vam demostrar que és possible desenvolupar fàrmacs innovadors , que resolen problemes de salut importants , partint del coneixement generat en entorns acadèmics. Seguint el mateix model actualment estem desenvolupant altres projectes per entrar en fases clíniques d'eficàcia, consolidant així el treball de recerca realitzat en els últims anys tant per l'empresa com pels investigadors que van originar en el seu moment el coneixement de base per dissenyar els nous medicaments .

17 DE NOVEMBRE DEL 2015

Inici de l’assaig clínic d’eficàcia de SP13004 en mucositis oral induïda per radio-quimoteràpia: primer pacient reclutat 17/11/2015

La biofarmacèutica Spherium Biomed, que desenvolupa projectes que s'originen en entorns acadèmics, ha posat en marxa un assaig clínic sobre l’eficàcia i la seguretat del gel SP113004 per prevenir i tractar la mucositis, un dels efectes secundaris més severs que poden patir molts pacients amb càncer de cap i coll tractats amb quimioteràpia i radioteràpia. L’assaig es farà en quatre hospitals de Barcelona, l'Hospitalet de Llobregat i Girona, amb 84 pacients voluntaris que pateixen aquesta malaltia.

La mucositis és una inflamació aguda de les mucoses, que provoca ferides i llagues que poden arribar a bloquejar la capacitat de menjar o beure dels afectats. Actualment, afecta més de 600.000 persones als Estats Units i Europa.

Per al seu tractament, Spherium, a partir de la recerca realitzada per l’equip de la Dra. Germaine Escames de la Universitat de Granada, ha desenvolupat un gel en forma de col·lutori bucal que utilitza el mètode natural de les mateixes cèl·lules per protegir-se de l’estrès oxidatiu. Fins ara, els tractaments contra la mucositis es dirigien a reduir el dolor i la inflamació i la lubricació de la mucosa, però encara no existia cap fàrmac que ataqués les seves causes.

Luis Ruiz-Ávila, CEO d'Spherium ha explicat que “l’inici d’aquest assaig és una gran oportunitat per satisfer una necessitat mèdica sense alternatives farmacològiques eficaces”. També ha remarcat que “demostrem que és possible desenvolupar fàrmacs innovadors, que resolguin problemes de salut importants partint del coneixement generat en entorns acadèmics”.

 

 

  • 19 D'OCTUBRE DEL 2015

    Recta final del projecte INNPACTO “Apta4”

    Amb un estudi clínic que s’està duent a terme a diversos hospitals de la Comunitat de Madrid, el projecte Apta4 ha entrat en la seva recta final. El projecte s’inicià el 2011 com a una col·laboració publico-privada, en el marc del programa...

  • 6 D'OCTUBRE DEL 2015

    BIO-Europe® 2015

    Spherium assistirà al 21th Aniversari del Bio-Europe que tindrà lloc a Munich del 2 al 4 de Novembre 2015.

    Spherium te com a objectiu comercialitzar les tecnologies actuals i adquirir nou portfoli de projectes.

    BIO-Europe es la conferencia...

  • 14 D'ABRIL DEL 2015

    Troba’ns al BIO 2015 (booth #2301)

    La propera edició de la BIO tindrà lloc a Filadèlfia (Estats Units) del 15 al 18 de juny del 2015, àrea metropolitana que acull més de 1.200 empreses, que van des de grans multinacionals de la indústria biofarmacèutica a empreses nacionals...

19 D'OCTUBRE DEL 2015

Recta final del projecte INNPACTO “Apta4”

Amb un estudi clínic que s’està duent a terme a diversos hospitals de la Comunitat de Madrid, el projecte Apta4 ha entrat en la seva recta final. El projecte s’inicià el 2011 com a una col·laboració publico-privada, en el marc del programa INNPACTO 2011 del Ministerio de Economía y Competitividad, i té com a principal objectiu, desenvolupar un kit capaç de mesurar la mala absorció intestinal. En el consorci hi participen dos centres d’investigació (Universitat de Barcelona y Hospital Ramón y Cajal de Madrid) i quatres empreses (Spherium, Biosystems, Aptus i Ingen Biotech).

6 D'OCTUBRE DEL 2015

BIO-Europe® 2015

Spherium assistirà al 21th Aniversari del Bio-Europe que tindrà lloc a Munich del 2 al 4 de Novembre 2015.

Spherium te com a objectiu comercialitzar les tecnologies actuals i adquirir nou portfoli de projectes.

BIO-Europe es la conferencia d'associació mes gran d'Europa al servei de la industria mundial de la biotecnologia.

BIO-Europe trobada empresarial tornarà a treure mes de 3000 assistents de la industria i participació de 60 països, que representen mes de 1800 empreses durant tres dies.

Mes informació:

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

14 D'ABRIL DEL 2015

Troba’ns al BIO 2015 (booth #2301)

La propera edició de la BIO tindrà lloc a Filadèlfia (Estats Units) del 15 al 18 de juny del 2015, àrea metropolitana que acull més de 1.200 empreses, que van des de grans multinacionals de la indústria biofarmacèutica a empreses nacionals amb gran projecció i un alt ritme de creixement. Així doncs, els expositors de la BIO tenen la oportunitat d'arribar a alts executius i decision-makers que assisteixen a la convenció amb l'objectiu de descobrir nous actors de la indústria, forjar col·laboracions i avaluar les tecnologies emergents.

  • 14 D'ABRIL DEL 2015

    Spherium al Bioforum 2015

    Des dels seus inicis el 2000, Bio Forum s'ha convertit en un centre de bionegocis innovador que integra els empresaris relacionats amb les àrees de biotecnologia , farmàcia i veterinària , així com equips d'investigació científica. Donat...

  • 14 D'ABRIL DEL 2015

    Spherium al BioTrinity 2015

    BioTrinity és líder europeu BioPartnering i Conferència d'Inversió . Proporciona la millor oportunitat de conèixer als inversors , els executius d'alt nivell de les organitzacions de concessió de llicències farmacèutiques mundials i l'alta...

  • 14 D'OCTUBRE DEL 2014

    Aquilon guanya el premi Cinco Días

    Aquilon Cyl SL ha estat escollida com empresa mes innovadora per els premis Cinco Días a la innovació empresarial en la seva edició de l’any 2014. El premi reconeix el model de negoci de l’empresa, basat en la transformació del coneixement...

14 D'ABRIL DEL 2015

Spherium al Bioforum 2015

Des dels seus inicis el 2000, Bio Forum s'ha convertit en un centre de bionegocis innovador que integra els empresaris relacionats amb les àrees de biotecnologia , farmàcia i veterinària , així com equips d'investigació científica. Donat que la col·laboració a Europa central i oriental s'està accelerant, aquesta regió és cada cop més atractiva per als inversors i les empreses d'altres parts del món. A l’inici, Bio Forum era una plataforma de trobada entre científics i empresaris, i cada any ha anat creixent i reunint més i més participants.

14 D'ABRIL DEL 2015

Spherium al BioTrinity 2015

BioTrinity és líder europeu BioPartnering i Conferència d'Inversió . Proporciona la millor oportunitat de conèixer als inversors , els executius d'alt nivell de les organitzacions de concessió de llicències farmacèutiques mundials i l'alta direcció d'empreses innovadores amb desenvolupament de fàrmacs.

14 D'OCTUBRE DEL 2014

Aquilon guanya el premi Cinco Días

Aquilon Cyl SL ha estat escollida com empresa mes innovadora per els premis Cinco Días a la innovació empresarial en la seva edició de l’any 2014. El premi reconeix el model de negoci de l’empresa, basat en la transformació del coneixement acadèmic veterinari. La creació d’Aquilon, concedida i impulsada per Spherium Biomed al 2012 (abans Janus Developments)  per canalitzar el desenvolupament de tecnologies dirigides a millor la productivitat animal que havíem adquirit o detectat en diferents universitats, es un exemple d’èxit del model de negoci de Spherium biomed. Actualment Spherium dirigeix  l’empresa i participa en el seu capital. Gràcies a la creació d’Aquilon s’ha mobilitzat fins ara 1,7 milions d’euros de capital privat per completar el desenvolupament de tres productes innovadors amb elevat impacte potencial en la millora  de la productivitat en la industria porcina. 

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

  • 1 DE GENER DEL 2014

    Noves oficines de Spherium

    El 31 de gener 2014, donem per inaugurades les notres oficines de Spherium ubicades a Esplugues de Llobregat, dins de l'àrea metropolitana de Barcelona i a prop de l'aeroport del Prat.

  • 27 DE NOVEMBRE DEL 2013

    Janus i Ferrer creen Spherium

    Janus crea una aliança estratègica amb Ferrer per implementar un nou model de I+D dins de la indústria farmacèutica espanyola.

1 DE GENER DEL 2014

Noves oficines de Spherium

El 31 de gener 2014, donem per inaugurades les notres oficines de Spherium ubicades a Esplugues de Llobregat, dins de l'àrea metropolitana de Barcelona i a prop de l'aeroport del Prat.

27 DE NOVEMBRE DEL 2013

Janus i Ferrer creen Spherium

Janus crea una aliança estratègica amb Ferrer per implementar un nou model de I+D dins de la indústria farmacèutica espanyola.