Roche Leads Pack for Upcoming FDA Approvals
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Several drugs that could be used to treat cancer patients are slated for approval by the U.S. Food and Drug Administration (FDA) during the first half of the year. Some of the manufacturers of these treatments are touting the medicines as being the next break through in treating the various forms of the deadly disease. This gives them the chance to continue to expand their presence in the multi-billion dollar cancer treatment market.
According to the National Cancer Institute, cancer has the highest per-person costs than any other condition. The total cost of treating cancer in the U.S. is estimated to have risen from roughly $100 billion in 2000 to more than $125 billion now. On that same note, the number of cancer-related deaths has decreased. That’s partly due to the myriad of drugs that pharmaceutical companies are developing that must receive FDA approval before they can be sold.
One of the more dominant players in the cancer pharmaceutical space is Roche Holdings (NASDAQOTH:RHHBY). The Swiss-based pharmaceuticals and diagnostics company has partnered with ImmunoGen (NASDAQ: IMGN) in developing a breast cancer drug. Called, T-DM1, the drug is slated for a yea or nay vote from the FDA on Feb. 26.
This drug has been found to significantly extend survival rates in people who have aggressive forms of breast cancer. Observers say Roche will receive FDA approval of the drug based on the encouraging results from its clinical trials.
This latest drug should further establish Roche as a formidable player in the oncology space. Decision Resources, a pharmaceutical research group, forecasts the breast cancer market to grow to $10.9 billion in 2018 due to new premium-priced drugs like those from Roche.
Fellow Fool Blogger Anh Hoang pointed out two advantages that the company has over its competitors: its low threat from patent expirations and its strong pipeline and R&D investments. Also, Hoang noted that many of Roche’s products still have several years for their patents to expire in the U.S.
On July 28, AVEO Pharmaceuticals (NASDAQ: AVEO) is looking for the FDA to approve its kidney cancer treatment drug called tivozanib. Specifically, it is used in the treatment of renal cell carcinoma and it is a potential first-line treatment for the disease.
Recognizing the potential impact of the drug, the company has taken steps to shore up its finances so that it can effectively market it if it is approved. The goal is to save $100 million over the next three years, which could do wonders for investor confidence in the company. Observers note that the renal cell carcinoma space is getting crowded, although it is still considered relatively large. Pfizer had the largest share of the space in 2011, capturing about $1.2 billion of the sales worldwide.
Delcath Systems (NASDAQ: DCTH) hopes for approval of a chemotherapy drug that treats liver metastases caused by ocular melanoma. Called ChemoSat, it is slated for FDA approval on June 14.
I need to give you a word of caution about this company. It originally applied to the FDA’s approval of ChemoSat for the treatment of skin cancer that had spread to the liver. However, in December, it amended that application so that the treatment is for ocular melanoma that has metastasized to the liver.
According to Bloomberg Businessweek, Delcath would only be allowed to market ChemoSat to treat patients with inoperable ocular melanoma that has spread to their livers. However, doctors would be able to treat patients with other conditions if they want, which could lead to the drug still being used as intended.
Investors didn’t’ take well to the application being amended. The stock had traded as high as $1.61 at the beginning of December. However, it began to tank after the announcement was made. It closed Monday at $1.23 on Monday.
One of the most common and debilitating complaints from cancer patients stems from the nausea they experience from chemotherapy. A.P. Pharma aims to eliminate that with its drug called APF530. It is slated for FDA approval on March 27.
Navidea Biopharmaceuticals has developed lymphoseek, a radioactive tracing agent that can help find lymph nodes in cancer patients. Last fall, the FDA failed to approve it because of issues related to a third party contract manufacturer. The mapping agent is slated for FDA approval on April 30.