With fewer new drugs than previous years, the pharmaceutical market in 2007 showed signs of greater regulation and cautiousness, but it still had its breakthroughs. Daniel A. Hussar, PhD, Remington professor of pharmacy at USP’s Philadelphia College of Pharmacy, reflected on last year’s pharmaceutical marketplace by selecting the year’s five most significant new drugs and discussed the trends leading into the new year.
“2007 was a low year in terms of new drugs being marketed with just 17,” explained Dr. Hussar. “Typically, the number of new drugs going to market is in the 20s, and going back to the late 1990s the numbers were in the 40s.”
With several drugs recently having highly-publicized withdrawals from the market, 2007 saw a noticeable increase in preemptive measures. “The FDA is getting more rigorous in reviewing new drug applications,” said Dr. Hussar. “Additionally, companies are becoming more selective about what types of agents they’re going to do studies on.”
While this emphasis on regulation and selectiveness has resulted in less new drugs reaching the market, Dr. Hussar found five new drugs to have significant impacts and important implications. The New Drug Comparison Rating (NDCR) is a one-to-five point system created by Dr. Hussar to succinctly show a drug’s importance. A designation of “5” denotes the drug introduces an important advance or advances, while “1” signifies important disadvantages. Seven of the 17 new drugs earned a NDCR of three or lower, meaning they failed to introduce any significant advantages to patients or the pharmaceutical marketplace. The following five drugs, however, are the most significant of the year.
Generic Name/Trade Name, Manufacturer, NDCR
Lapatinib/Tykerb®, GlaxoSmithKline, 4
For patients with advanced or metastatic breast cancer who do not or no longer respond to other therapies, Tykerb® may prove effective. After prolonged use of a specific drug, it is common for a patient’s body to become refractory to the drug. Therefore, this new drug may offer an alternative for patients with breast cancer. It is administered orally, and is less likely than certain other therapies to cause hypersensitivity reactions. When used in combination with capecitabine, the time-to-tumor progression (or death related to breast cancer) was 27 weeks, compared with 19 weeks for capecitabine alone.
Raltegravir/Isentress®, Merck, 4
Isentress® is an antiviral agent used to treat HIV-1 infections in treatment-experienced adult patients who show evidence of viral replication and HIV-strains resistant to multiple antiretroviral agents. It has a unique mechanism of action, and used in combination with other therapies, it has proven to be effective when patients develop resistance to other medications. Although experience with the drug is still limited, it appears less likely than most other antiretroviral agents to cause serious adverse events, or to interact with other medications. This is important for patients who may be taking an array of medications.
Retapamulin/Altabax®, GlaxoSmithKline, 4
Altabax® is a topical ointment for adults and pediatric patients aged nine months and older for the treatment of impetigo. Impetigo is a highly-contagious skin infection common among children, and is caused by Staphylococcus aureus or Streptococcus pyogenes. While this condition is often treated with mupirocin, Altabax® may be beneficial to patients because it requires less-frequent administration than mupirocin (twice daily versus three times daily). It also has a shorter course of treatment (five days compared to at least eight days), and has a unique mechanism of action. Altabax® is the first of a new class of antibacterial agents designated as pleuromutilins.
Rotigotine/Neupro®, Schwarz Pharma, 4
Neupro® is not the only therapy for treating the signs and symptoms of early-stage idiopathic Parkinson’s disease, but it is the first to use a transdermal (patch) administration method. This allows patients to apply the patch once daily, rather than taking a similar medication orally three times daily. As an added benefit, the transdermal formulation results in a more gradual and consistent release of the medicine into the body than other delivery methods can achieve. This may reduce the occurrence of adverse events that may be associated with the peak concentrations experienced with other agents.
Sapropterin dihydrochloride/Kuvan®000, BioMarin, 5
With a NDCR of 5, Kuvan®111 introduces an important advance to the pharmaceutical marketplace. It is the first drug marketed to treat phenylketonuria (PKU), an inherited disorder in which the activity of the enzyme phenylalanine hydroxylase (PAH) is deficient. This genetic disorder is tested for in infants, and has previously been treated using a specialized diet low in phenylalanine and high in tyrosine. Patients following this diet must avoid consuming foods such as breast milk, meat, chicken, fish, nuts, cheese, and other dairy products, and closely monitor starchy foods such as potatoes, bread, pasta, and corn. In conjunction with this diet, Kuvan®222 can help keep blood phenylalanine concentrations at a safe level and decrease the risk of neurological problems in some patients with PKU.
“Over the past few years there have been many anticancer drugs approved,” reflected Dr. Hussar. “This is an area in which a number of pharmaceutical companies are actively engaged in research.” Of the 17 new drugs in 2007, four are cancer therapies. The prevalence of cancer has led many pharmaceutical companies to actively pursue anticancer drugs, but there are also incentives to develop therapies for less-common ailments.
Including Kuvan®333, six orphan drugs used to treat rare diseases were introduced this past year. “If a drug is designated by the FDA as an orphan drug, the company that develops it is granted a seven-year period in which they have exclusive marketing privileges, so that provides an incentive for some companies to develop those,” explained Dr. Hussar. He further noted that these specialized drugs are usually very expensive.
A new book written by Dr. Hussar will be available early this year featuring the most important information about each of the 142 new therapeutic agents marketed in the United States from 2002-2007. The approximately 300-page paperback will include comparisons between new and preexisting drugs, as well as specific advantages and disadvantages. To preorder this valuable reference call 1-800-634-5463, extension 2000.