Nam Institute 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. Between the years 1987 and 2002, the number of Americans suffering from obesity doubled while the cost of treating diseases associated with obesity almost tripled. In an attempt to curb the menace, individuals and companies have rushed to cash in on the possible $2 billion dollar industry. 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 involved in the manufacture of natural products providing ingredients and science based solutions to dietary supplement, pharmaceutical, food, beverage, and cosmetic industries. Currently, the company has pending patent rights to Pterostilbine. The company launched its Bluescience dietary products whose key ingredient is Pterostilbine. This component treats obesity by lowering lipid levels and reducing the risk of dyslipidemias in an individual at risk of cardiovascular disease. Pterostilbine is a Blueberry Fruit Extract. Blueberries promote the way the body processes fats and sugars.
The component also has a longer half-life in the body lasting 105 minutes and higher than cellular uptake because of its lipophilic nature. Pterostilbine also has a positive effect on cognitive decline and cardiovascular diseases. These beneficial properties guarantee the product and ultimately the company huge market potential within the human nutrition industry. Prior to the formal launch scheduled in September 2010, the company held a soft launch in April 2010 where the key ingredient was incorporated in some of the products from nutraceutical industry.
However, after the formal launch in September, the component was included in all of its products before the second launch in summer of 2011. The product has received positive market acceptance, a strong indication of the product and ingredient growth potential. 3. Vivus (NASDAQ: VVUS) Qnexa has completed Phase III clinical trials for obesity and Phase II clinical trials for diabetes and obstructive sleep apnea. The advisory committee originally turned down the drug in 2010. However, in February this year, FDA gave the company the green light.
However, the company will have to wait for the final review, which will be revealed in July 17 this year. VVUS was hoping to beat its competitor Arena by launching the product in April. However, with FDA pushing the review date to July; it loses the chance of establishing itself in the market ahead of its competitor who receives its review in June. Qnexa is made of a combination of topiramate and Phentermine. The combination of these compounds gives the drug an edge with regard to weight loss over other drugs.
Topiramate acts on the nervous system as an antagonist to brain receptor. In shutting down the receptors, topiramate suppresses addiction and food cravings hence decreasing overall food cravings. Phentermine on the other hands works to suppress appetite and suitable in short-term obesity treatment. According to studies, Qnexa reduces body weight by 5 percent in one year with an average weight loss of 9 percent after two years. This is according to research carried out on a sample of patients. The drug has side effects including constipation, dryness of mouth, headache, respiratory tract infection and tingling.
However, these are considered common in other drugs and should not be grounds for FDA to deny its approval. Generally, Qnexa has a good chance of gaining approval from FDA. 4. Roche (PINKSHEETS: RHHBY) Roche is a Switzerland drug manufacturing company responsible for the production of Orlistart. This is a dietary pill sold by Roche under the name Xenical. This is an obesity-treating pill prescribed to overweight or obese patients and received FDA nod back in 1999. Xenical works by inhibiting the gastrointestinal secretion reducing the amount of digested calories hence preventing digestion of some fats.
According to the manufacturing company, the drug is not absorbed into the blood stream hence has no negative impact on internal organs. The company also claims that Xenical does not bring about drug habituation. However, the drug has been criticized with users claiming the drug is not impressive. The drug has also been linked to liver damage in 2010. This has greatly reduced its selling power, as people no longer want to buy it.
5. GlaxoSmithKline (NYSE: GSK) GlaxoSmithKline is one of the leading manufacture and distributor of drugs worldwide. The company sells Orlistart as a treatment for obesity under the name Alli. GlaxoSmithKline introduced Alli as a treatment for weight loss in 2007. Alli is a lower-strength version of Xenical by the Swiss company. After the drug was linked to severe lung damage in 2010, it meant the deathblow to the drug with decreased sales. Since then, GlaxoSmithKline announced its intentions to offload the less performing products including Alli. Currently, there are no potential buyers for the drug as companies view it as a sinking ship.
Conclusion Obesity is declared an epidemic all over the world with more people being considered overweight. Following the move by FDA to come up with dietary pills that will solve the problem, it is clear indication that obesity is a problem needing immediate but careful solutions. Some of the pills introduced in the past have proven to be less fit for human health. Regardless of the monetary benefits that the dietary pills promise, care has to be taken by conducting clinical trials on the drug to certify that it is sufficient for human consumption. References http: //seekingalpha. com/article/509591-vivus-qnexa-will-outpace-competition-from-alli- boost-stock