Where our team of editors discuss what they think about the current NGP US Issues.

Biovitrum had a very good year last year. It successfully integrated a number of acquisitions and broadened its pipeline, which contains both projects for large as well as niche indications. The success of a company depends on various factors, one of which is an effective business strategy. “Collaborations are the prerequisite for our business model,” says Mats Pettersson, CEO of Biovitrum. “We have collaborations both in the early stages with smaller biotech companies or academia but also in the later stages with the big pharmaceutical companies. We see ourselves as a bridge between smaller and bigger companies. This is why research collaboration is extremely important to us.”
Biovitrum collaborate with, amongst others, smaller biotech companies such as Danish Symphogen and Syntonix in the US. They also have an outlicensing agreement with Amgen and an extensive collaboration with Wyeth.
Collaborate to innovate
The importance of research collaborations goes back to the simple fact that no company will ever have all groundbreaking ideas on their own. Furthermore, a research project combines competences and resources of two parties. Pettersson nods: “It is an advantage to have a common goal, to be able to align your processes and your willingness to achieve the goal, because you reach the objective a lot quicker.”
Biovitrum will not rely only on its own discoveries. “Besides,” Pettersson adds, “we are a mid-size biopharmaceutical company, which means that we will not be able to launch and finance launches for large indication areas like obesity and diabetes. We depend on big pharmaceutical partners.”
Challenge
As promising as research collaborations sound, there are challenges and problems that come with working together with external partners. Pettersson lists important aspects that need consideration: “You have to be sure that you and your partner have agreed upon your different roles in the collaboration. The company culture and background are very important and so are alignment of long-term objectives and what you want to achieve. You also have to know how to deal with situations when things don’t go according to plan, for example when you enter into different views on the project.”
In these situations, it is vital to have agreed upon how to handle conflicts and, ultimately, termination clauses.
For the future, Biovitrum see other collaborative projects, licensing agreements and commercialisation partnerships on the horizon. Pettersson: “I am confident that in five to 10 years, we will be fully integrated like a pharma company. We will have several own developed products on the market but we will also have substantial royalty income from Big Pharma partners allowing us to further build our base business.”
He also sees his company developing into Asia, especially China and India, who, Pettersson believes, will play a much larger role in the pharmaceutical industry both as markets and research and development sites. “I trust that we will be able to be a very important player in the pharmaceutical and the biopharma industry in the years to come.”
Mats Pettersson: “It is an advantage to have a common goal, to be able to align your processes and your willingness to achieve the goal, because you reach the objective a lot quicker”
Does collaboration really work?
Boehringer Ingelheim and Ablynx have entered into a worldwide collaboration and licence agreement to discover and develop new therapies for Alzheimer’s disease. Here Klaus Wilgenbus, Corporate Senior Vice President Licensing for Boehringer Ingelheim, and Edwin Moses, CEO of Ablynx, offer NGP their thoughts on the importance of collaboration projects and their benefits and challenges.
NGP. How important is this collaboration project for you and why?
KW. We entered into this partnership with Ablynx because we considered the nanobody technology a unique and powerful technology platform to develop new biological entities. Nanobodies possess the affinity and selectivity of conventional antibodies yet are only a fraction of their size. Because of their unique structure and high stability, they can access targets and opportunities that are beyond the reach of conventional drugs, such as the case may be in Alzheimer’s disease. We have a long-standing interest in neurodegenerative CNS diseases, including Alzheimer’s and Parkinson’s.
EM. This is a very important collaboration for us. The nanobody technology platform is a very powerful one. It has the ability to develop potential drugs against a whole range of targets. To maximise and exploit this platform most effectively, in addition to the work that we do in our own research projects within Ablynx, it is important that we look for very strong partners externally to help us leverage the technology.
Boehringer Ingelheim are an example of a company that has a very strong reputation and a lot of knowledge, particularly in this area of Alzheimer’s disease. They have animal models, accessories and expertise, which allow us to test our new nanobody potential drugs and determine how effective they might be very quickly. So really, this collaboration will help us to advance these programmes much more quickly than we could have done on our own.
NGP. Generally, how important are collaboration projects for you and why? Do you have other ongoing research collaborations?
KW. Partnerships and collaboration projects are a very important component of our R&D and product development activities. External alliances supplement our strong internal research and development, and accelerate research activities. They also broaden our portfolio of development compounds and expand current franchises. Many innovative ideas are being pursued in academic institutes and biotech companies. We therefore strongly believe that cooperation creates a mutually successful situation for both parties involved.
While we anticipate a steady increase in our R&D activities for the next year, we very much welcome any cooperation that involves innovative approaches for either technology or compounds to meet unmet medical needs. Within the last couple of years we have intensified our partnering efforts in the area of innovative technology platforms as well as early product opportunities. Recent examples include deals with AbGenomics, Ajinomoto, Biolipox, Biota, Evotec, FivePrime and Vectura.
EM. We have existing arrangements with Novartis and also Procter&Gamble as well as Centocor, which is part of Johnson & Johnson. These are collaborations that began earlier in the life of the company. They are arrangements where some of the companies came to us with particular biological targets and we produced nanobodies against them.
More recently, in addition to the Boehringer Ingelheim deal, we also announced a deal with Wyeth Pharmaceuticals. This is actually a licensing deal. We licensed access to our nanobodies against the biological target called TNF-alpha, which is interesting and has many applications such as rheumatoid arthritis. So this is another one of our very important collaborations.
NGP. Accelerating time-to-market of new drugs is, of course, a major objective for the pharmaceutical business. What are the advantages of research collaborations in achieving this?
EM. For us, research collaborations combine the strengths of two parties to make an even stronger force going forward. In the example with Boeheringer Ingelheim, we have expertise in nanobody technology and develop those nanobodies against targets very effectively. Boehringer Ingelheim has considerable expertise in the actual testing of those nanobodies in vitro and in vivo. They also have a lot of experience in actual production scale-up.
We combine the skill sets. In the same way as with the collaboration with Wyeth, we bring the core nanobody technology and know-how while Wyeth, who are a leader in the field of antibodies and therapeutics in the areas such as rheumatoid arthritis, bring huge knowledge of the actual market and disease. It’s a combination of skills and knowledge helping us to get the product to the market quicker.
KW. The advantages are access to innovative technologies, specific biotech knowledge and true scientific exchange for mutual benefit. Many synergistic effects can be derived from combining knowledge about a particular technology and large expertise in preclinical and clinical development. Applying the financial resources and expertise of a pharmaceutical company such as Boehringer Ingelheim is needed to overcome the many challenges in a competitive pharmaceutical environment.
NGP. What are the challenges and problems of collaboration?
EM. One of the challenges that always comes with collaboration is communication. This is quite simply making sure that the scientists and the individuals on both sides talk constantly and communicate effectively. Clearly, if the partner company is physically closer, it is easier to have meetings in which people are actually present rather than video conferences or telephone conferences. Having said that, international pharmaceutical businesses are very much used to communicating across large distances.
KW. Importantly there are challenges and opportunities: the challenges involve collaborating with a smaller partner who does not necessarily have the expertise at all levels of the value chain. The opportunity is the ability to tap into specific know-how with respect to the licensor’s project, which the licensee may not have. Our goal is to manage this successfully during the entire process of development and commercialisation.
NGP. How important is IT in a collaboration project, for example in data management and sharing? Likewise, what emphasis is placed on standardisation of practices?
KW. As with any modern high-tech industry, IT is extremely important. I can think of three examples to support this statement. Firstly, companies should collect and process data and reports to allow for careful review in an e-room during due diligence. Secondly, electronic data storage of ongoing collaboration results is important for tracking exchange of information and ensuring rapid dissemination within the organisations. Thirdly, information and reports should be available in electronic form to facilitate the modern electronic drug registration process.
EM. In terms of data sharing, and in research collaborations we generate huge amounts of very confidential data. It is important that we set up secure links between our partners and ourselves so that we can ensure that they receive the new information as soon as it is generated and can then plan further experiments based on that. We prepare these IT links immediately on entering into a collaboration.
Standardisation of practises is also important. We, as an organisation, can learn a lot from our partners. They are mostly very much larger than us and have been in business a lot longer. So we look at their practices and we will conform with them wherever that is possible and makes sense.
NGP. Where do you see your company in the next five to 10 years? Do you have any other collaborative projects at the horizon?
EM. Our organisation is growing very quickly. In 2006, we began with 50 people and ended it with close to 100. We will have about 150 by the end of 2007. In the future it is important for us to gain continued financing, so we made it clear that we wish to be IPO ready by the middle of 2007. It is one of our choices of gaining access to further capital to develop the company.
This year we will see our first product enter Phase I clinical trials. Over the next few years we will be developing an ever-growing pipeline, driving products into the clinic and towards the marketplace. We will continue to look for partners at the appropriate time.
There are some products and some applications that we may take all the way through to marketing but many of them we will wish to partner at various stages of pre-clinical and clinical trials. So we are constantly looking for people who have the skills, which are complementary to the ones we bring to the development of nanobody technology.
KW. We will always be open for collaborations, which we always regard as mutually beneficial partnerships, whenever innovative approaches are promising to eventually treat diseases that are either not or only unsatisfactorily treated so far. Rather than developing another “me-too” product in an area where many treatment options already exist, we foster truly new approaches.
Klaus Wilgenbus steers and coordinates global partnering activities at Boehringer
Ingelheim, one of the world’s 20 leading pharmaceutical companies
In March 2006, Edwin Moses became CEO of Ablynx, a biopharmaceutical company engaged in the discovery and development of nanobodies