Teva CFS Book English

Leading the Way Including necessary changes in the computer system to “separate authorities” and setting up a new plant-wide entity. There were also interesting processes on the human resources front, since on one hand we hired and trained workers in a lengthy process that took about a year but on the other hand, we were waiting for the regulatory approvals from the FDA and from Europe and we didn’t have the work volume for the workers we trained. So, a group of dozens of workers moved to the OSD Plant and when we obtained approvals, they returned and started working at the Sterile Plant, for which they were originally hired and trained”. A decade of research and development Development and improvement of Copaxone took over a decade. The raw material was unknown and a very lengthy period was required to accurately identify it in order to determine the level of cleanliness and all the other parameters required in order to use it as a medicinal raw material. According to Dr. Miki Zaife “as professionals in R&D we wanted to develop the best product possible. We weren’t prepared to compromise on product quality at any stage because we knew that once the patent expired it would be to our benefit to have high entrance barriers that would be hard to pass. Which is what happened”. When Miki is asked what the secret to the Sterile Plant’s success was, he responds: “We’re not the no. 1 generic drug manufacturer in the world for nothing. We had a different mentality and didn't always work “by the book”, even vis-a-vis the FDA. I remember sitting across from someone who went by the nickname Horrible Ron from the FDA regarding Copaxone and I logically explained to him that there were things that didn’t work, and so we did other things. It turned out that the authorities also like “good science” and respect it. Only those who dare, succeed; And we undoubtedly were daring and paved the way”. “Leading the way” around the clock In 1997, the marketing of Copaxone in VAILS began and manufacturing volumes increased. Anat Goren, who was appointed as the Manager of the Sterile Plant in 2000, recalls: “When workloads increased, the need to work in three shifts emerged - morning, evening and night. At first, there was a concern that workers and mainly parents of children would oppose working in the evenings and at night, but when we discussed the fact that shift work was more rewarding and also a mother of young children could get a morning off to herself, we fortunately obtained full cooperation and the move went smoothly. It turns out that when you really believe in something, you can change the world”. The Sterile Plant as a center for excellence In recent years, the plant started manufacturing multiple products, due to the realization that sterile production capability is a valuable and important commodity, and the plant currently serves as a center for excellence and knowledge for product filling using syringe technology and for filling of biological products. In 2011, the first biological product was produced and packaged at the Sterile Plant. Around 150 employees currently work at the plant and it produces around 22 million sterile units per year. 1. Multiple Sclerosis is a chronic disease that attacks the central nervous system. Copaxone has a unique mechanism of action that protects the nervous system and also acts to regenerate it. The name comes from: COP- short for COPOLYMER, and AXONE - the myelin-coated nerve axon, which is damaged in MS patients. 2. Copaxone is the first original drug that was invented in Israel. It was jointly developed by scientists from the Weizmann Institute of Science and Teva. 3. In December 1996, the first prescription for Copaxone was written in Israel and since 2000, a million patient years have accumulated around the world. The drug was approved in the United States in 1997, and is currently marketed in around 51 countries worldwide, including throughout Europe, Canada, Mexico and Australia. 4. In 2007, Copaxone became the leading treatment in the world in the Multiple Sclerosis global market. It is a safe and convenient treatment that improves patients' quality of life. 5. A prospective long term study that examined the effect of Copaxone for 15 years of treatment, indicated a significant reduction of the severity of the disease (degree of disability) among patients that continued treatment compared to patients that discontinued treatment. Interesting facts about Copaxone - The most successful Israeli drug of all time: 5 23