EMD Millipore, the life science division of Merck, KGaA, recently announced plans surrounding the introduction of products and technologies for enhancing drug bioavailability. The company feels their history of successful pharmaceutical raw material handling and technologies can position EMD Millipore as a resource in helping others facing formulation challenges.
This new focus includes an offering to address solubility, as well as PK/PD modification and targeting, which must be taken into account for optimized bioavailability in the final drug. The company feels their enhancement options offer a unique blend of experience, application know-how, and GMP production support ranging from API development to registration of the final dosage form.
Another target of the program is ensuring high levels of bioavailability during the development of a therapeutic formulation. To assist in addressing this issue, EMD Millipore will provide solutions for formulators that help ensure the right amount of a drug is delivered, at the right time, to the right place in the body.
Additionally, EMD Millipore estimates that nearly 40 percent of drug candidates fail during early clinical trials due to poor bioavailability properties. So working with processors to avoid these failures could help control drug development costs and reduce wasted time and resources.
Roger Weibel, head of Bioavailability Enhancement – Global Marketing, recently took some time to discuss the new program and its potential impact on the pharmaceutical marketplace.
Pharmaceutical Processing: What do you feel are the most significant market factors influencing EMD Millipore’s focus on bioavailability enhancement?
Roger Weibel: This is the most widespread challenge facing the entire pharma industry today. About $6 billion of R&D spending are lost a year, a major portion due to inadequate bioavailability of the active.
90 percent of drug substances (large and small molecules) in development are BCS class 2 and 4, and in today’s drugs it is 40 percent. Meaning they have low solubility and/or low permeability. There is a clear market need for providers to offer comprehensive products and technologies to enhance bioavailability. Currently, single technology/solution providers dominate the industry.
Pharmaceutical Processing: What are some examples of how companies can cut costs during the development phase? For larger companies? For start-ups?
Roger Weibel: Supporting regulatory efforts leads to reducing the time to final drug approval. We strive to offer the most comprehensive portfolio of solutions to enhance bioavailability of the active in the final dosage form, therefore reducing development times and development costs.
Our functional excipients help to use cost effective processing technologies (e.g. direct compression). At the same time, this can increase throughput and increase yield.
Pharmaceutical Processing: Looking at the industry as a whole, what categories of pharmaceuticals do you see producing more API development work?
Roger Weibel: Large molecules. The major challenge is to formulate the active into a suitable, stable and effective formulation. The development work will move away from the API development to formulation development, as the number of new actives that can turn into commercial success and pay back their investment in breakthrough indications is declining.
So making known actives work better will become more and more important for the industry. The latter is also true for small molecule, where the major challenge is to find a lead substance that can be translated in a final drug and exhibit the necessary efficacy.
Pharmaceutical Processing: What do you feel will be the most significant trend impacting pharmaceutical processors in 2013?
Roger Weibel: The industry will move from a general focus on biopharm and pharm towards addressing indications, regardless of the type of the API. In addition, manufacturers will need to address the post-patent expiration market.