Cambrex was the sole supplier to the innovator of a key intermediate through the entire clinical development program of a drug.
When the Phase II clinical readout showed that the company
needed to increase the dosage ten-fold, this presented a significant CoG issue as the intermediate was a major cost driver in the
whole process. The customer therefore wanted to see whether
it was possible to achieve a major reduction in the price of the
intermediate; if not, the entire clinical program would have to be
terminated. The company was looking to pay a commercial price
of between $300 and $400/kg (at a scale of greater than 50 metric
tons), which represented a reduction of up to 87% from the current price of $2450/kg.
Cambrex’s technical team looked at both the process and the
capacity of facilities, and examined eight key variables that would
enable it to put together a realistic scenario that would see an
achievable price of approximately $640/kg. Presented with the
simulation and supporting documentation, the customer decided
to proceed with the clinical trial program. Over the course of five
subsequent delivery periods, the price was reduced by between
$150/kg to $500/kg.
By reviewing the plant capacity and throughput, Cambrex en-
gineers demonstrated that an investment of $2.3 million would
enable the weekly throughput to be increased from the current
500kg, to 2000kg, which would give significant cost improve-
ments. This allowed a long-term projection to be offered to the
customer of $320/kg, based on a commercial supply agreement
that included an investment payback.
Unfortunately, however, this investment was not made due
to the termination of the project by the customer in the wake of
poor Phase III clinical trial data.
In conclusion, there are a number of aspects to managing the
API life cycle to take advantage of the growing opportunities in
the market. However, there are certain factors that are crucial if
the benefits are to outweigh the risks; the first and foremost of
these is initial project selection. Clear project goals should be es-
tablished at the outset and referred to frequently, and existing
patent landscapes should be investigated and understood.
To achieve process improvements, a good understanding of
the process and the facilities is important, as well as looking to
reduce waste costs by good waste management. Parallel process-
ing and process telescoping give significant benefits with regard
to capacity utilization and product throughput.
Both process and capacity should also be considered when looking to improve the cost of goods. The identification of the key drivers
is critical to ensure that valuable development time is focused on
where the most significant cost savings can be realized. CP
JONATHAN KNIGHT is vice president of new product development at Cambrex.