These include diets, lifestyle changes and drugs that aim to reduce overweight and obesity. However, with the fall out of Fen Phen, a drug designed to treat obesity but found to cause serious heart conditions, any plans to develop new dietary drugs were thwarted. This changed when the FDA gave two dietary pill companies the go ahead to manufacture drugs. These companies include Arena Pharmaceuticals and VVUS. This move has created hope in the industry and in turn significantly affected the stock market. No other sector in the stock market moves as much as the biotechnological sector due to corporate development. A single FDA decision or drug trial can send stocks plunging or soaring. As a result, many investors trade their biotechnological stocks depending on FDA decisions or meetings and upcoming data releases. The decision by FDA regarding the dietary pills in February 2012 has thus caused a lot of movement in stock and changes in five biotechnology and drugs companies. 1. Arena Pharmaceuticals (NASDAQ: ARNA) Arena’s advanced drug candidate is lorcaserin hydrochloride meant for weight management. The rug has completed two pivotal Phase III clinical trials for lorcaserin. The drugs help patients to deal with overweight, obesity and have a weight-related co-morbid condition to lose weight and keep it off. Lorcaserin is one of the first drugs in more than a decade to have a real shot at gaining FDA final approval. The move by FDA and the company not only legitimizes Arena as a company, but it also favors other companies working to develop dietary pills. This announcement saw the company shares soar with a 74 percent increase. This was the company’s biggest increase since it first started trading publicly in July 2000. The advisory committee to FDA voted 18 to 4 indicating that the benefits of lorcaserin outweigh potential risks after long-term use among obese and overweight individuals. In December 2009, Arena presented the first NDA for lorcaserin to FDA but they were not approved. The company resubmitted in December 2011, and in March 2012, the company’s drug was approved. However, the drug will not hit the markets until the FDA recommends it. The agency will reveal its decision in June 27 2012 after completing its review. Arena has patent of lorcaserin not only in the US but also in most of European countries, which could continue until 2023. The company will granted exclusive marketing and distribution rights to the Japanese company, Esai, once FDA approves the lorcaserin in June. In Europe, the European medicine Agency has accepted the marketing authorization. According to the original agreements, arena would manufacture the diet pills in Switzerland. The finished products will then be sold to Esai for distribution and marketing. This will be done after attaining regulatory approvals in the various territories. The company however has faced several challenges in its quest including stiff competition from VVUS and its dietary drug Qnexa. The company has also received criticism with late-stage trials indicating that the drug only contributes 3.3 percent of weight loss after one year of treatment instead of the recommended 5 percent. Others have also claimed that the drug causes tumors in mice used for the study. However, the company has defended the drug saying the concentration of lorcaserin in human brain is significantly lower than that in mice. 2. Chromadex (OTC: CDXC) Chromadex is an innovative company
Nam Tutor Institute Course Date Public Companies Trying To Treat Obesity Introduction Currently, obesity is America’s leading healthcare problem consuming a big percentage of funds located to Medicaid and Medicare. Americans are prone to obesity regardless of social status, age or ethnic background…
Name: Title: Date: Professor: Personal Statement for Public Policy The area of public life that I have high interest of contributing in is the field of international business and regional development. This is informed by my previous personal experiences in the field of China-Latin America business relations and the challenges of cross-cultural trade.
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