Teva CFS Book English

32 Hurvitz gave an instruction to start building. He always believed that eventually there would be a product and said that “when we get approval - there’s no way that we will face patients that want to receive the drug and we can’t provide them with it”. Building the plant was a decision that was made under complete uncertainty. I don't know a lot of companies that would be willing to make such a decision. We joked amongst ourselves and said that in the worst case scenario we would make instant coffee using freeze drying technology. The crucial vote In September 1996, there was drama surrounding the FDA approval for Copaxone. The FDA conducted a hearing for the drug in front of a professional committee that had the authority to recommend whether to approve the drug. The discussion was conducted as a sort of open court and at the end a vote was held. Dr. Miki Zaife recounts: “Experience said that if the committee makes a majority decision, the FDA will approve, and if not - there won’t be a product. It was real drama. We sat at the Teva offices in Petach Tikva and watched a live broadcast of the vote. The tension after all the years we invested in development was thick. One of the committee members, a toxicologist by profession, requested to separate between safety and clinical efficacy for the vote. When they voted on the safety clause, that same woman decided to delay her vote. Regarding the issue of clinical efficacy, however, all the members voted unanimously in favor. That’s when we knew it was a done deal. We were ecstatic and popped open the champagne bottles that Aharon Schwartz prepared ahead of time. In December we already received the FDA’s approval”. For Copaxone production, the Kfar Saba site adopted a cutting edge technology in the mid nineties - the automatic lyophilizers. The bottles were inserted and unloaded by large automatic robots that were customized to Teva’s specifications for Copaxone production, and were considered a breakthrough in the field. Value-adding collaboration - marketing together with the Americans Teva acknowledged that it didn’t have any experience in marketing an innovative product. So right away it signed a collaboration agreement with an American company called Marion Merrell Dow (now Aventis) that specialized in marketing inventive drugs to the American market. According to the agreement, the American company took the marketing upon itself, while Teva was responsible for manufacturing the raw material and the actual drug, as well as for its distribution. This contractual agreement was forged even before receiving FDA approval. In 1995, the drug was already ready to be submitted for FDA registration and in late 1996, Copaxone was launched in the U.S. The numbers speak for themselves The financial investment in Copaxone turned out to be worthwhile. Teva’s first innovative drug is currently marketed in over 50 countries worldwide, and its global sales total around 4 billion dollars. This is the company’s biggest drug in terms of revenues and contribution to net profit and it is entirely the product of Israeli creativity. The failure of the clinical trial of oral Copaxone in 2001 demonstrates how using creativity, composure, and positive thinking you can emerge stronger and prosper. The late Eli Hurvitz’s creativity and vision and Teva’s management, which gave complete support to the lengthy process of developing Copaxone, were the key factors in the drug’s success.