Could you give us an introduction to yourself and the company?
My name is Philipp Karbach and I’m Chief Operating and Chief Financial Officer of AMW. AMW is a specialty pharmaceutical company focused on innovative drug delivery systems, for example the development and production of biodegradable implants used for the treatment of hormone sensitive tumors such as prostate cancer and breast cancer.
What class of drugs did Bachem help AMW to develop and how did they support that development?
In order to develop high-quality drug delivery systems, it is essential for AMW to cooperate in a trustful manner with long-term partners such as Bachem. The implants developed under this collaboration are primarily used for the treatment of prostate and breast cancer, common indications with a high unmet medical need. With Bachem’s APIs, we are able to scale up significantly and secure supply within Europe. This is a key advantage, especially throughout the pandemic, in terms of reliable supply chains throughout the whole calendar year.
What has Bachem enabled for AMW?
AMW was founded in 2008 and we launched our first implant in 2016, only eight years after development has started. From the beginning, we have been using Bachem’s API, and until today we have produced and sold more than 650,000 implants worldwide.
Bachem has always been a reliable production partner, who has helped us secure supply and also scale up significantly, which is key in generic markets where you can rapidly gain market share.
Throughout the development process, Bachem’s expert teams have supported us in any possible way and in a timely manner to answer open questions or to overcome challenges. When it comes to opening up new markets, especially those with high entry barriers, Bachem has been very supportive, using their experience in a straightforward manner throughout the process.
What are some of the challenges you face as a drug product developer? And what are the challenges in the filing of new drug formulations for generic peptide APIs?
The main challenges we are facing in developing innovative drugs are continuous changes in the regulatory framework and matching these changes with the progress in technology development. The most important challenge in filing the APIs into our technology platform, is achieving a sustained release that meets the requirements of the drug profile.
How did Bachem help to mitigate risk and maximize your chances for commercialization quickly?
Bachem is supplying us with two APIs for two of our key products. As we are in a situation where markets are growing very fast, we have to react to additional demand, sometimes even above prearranged quantities.
We could always count on Bachem to comply with our needs in supply to achieve our demand, during the pandemic and in other challenging situations. Thanks to the team supplying us with the requested quantities, we can ensure that adequate supply reaches the patients.
What was it like navigating regulatory milestones in partnership with Bachem?
Meeting regulatory requirements is a main aspect in AMW’s product development. Sourcing API from Bachem means that a significant part of the product is under our partner’s control – typically an aspect of high significance for the regulatory bodies.
By providing the appropriate documentation level and with the responsiveness of experts for additional questions, Bachem is the right partner for us to mitigate any risk within the regulatory process. The typical challenges throughout the regulatory process are questions being raised and additional data requested, which is usually to be supplied within a very short timeframe. Having response rates that are very short is therefore key in this process, and we could always count on Bachem to meet these timeframes imposed by the regulatory bodies.
How apparent was their industry expertise?
Since AMW is developing complex drugs / combination products, we come to a point where expert knowledge is key, especially when it comes to difficult technologies like biodegradable implants. Also, during the manufacturing of market goods, it is of great advantage for us to have access to Bachem’s experts.
What’s the biggest benefit of working with Bachem?
The biggest benefit of working with Bachem is the high level of trust in our relationship. It’s a true partnership in all areas of business. Also in difficult times, we can rely on our partners, and we can speak openly about any challenge ahead of us. Bachem has always been very supportive, and we are looking forward to our future collaboration, further expanding on both our existing products as well as upcoming development projects to be launched in the foreseeable future.
Would you recommend Bachem? If yes, to whom and why?
I definitely would recommend Bachem for drug developers like AMW. From the start, we found a very supportive environment, being invited to make use of Bachem’s expert knowledge, also in terms of regulatory documentation throughout the whole process, among others. We also experienced Bachem as a reliable partner you can count on for securing the supply of market goods, also in times of upscaling.
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