The biggest shock to the branded drug industry in the past year has been the withdrawal of Pfizer’s drug torcetrapib from the market last December. The drug was taken out of clinical trials, just two months before the pharmaceutical company was planning to submit it for Food and Drug Administration approval, because the trial showed too many deaths.
Following the announcement of the halting of torcetrapib clinical trials, Pfizer’s market value fell by $21 billion overnight, and 10,000 jobs hit the floor soon afterward. This was particularly bad news for a company that can see the patent expiration of its top-selling drug, Lipitor, on the horizon. When that drug loses patent protection around 2010, along with it will go most of the $10 billion it brings to Pfizer’s coffers.
Despite this, Pfizer’s chief executive officer, Jeffrey Kindler, said that the company will be “capitalizing on the largest pipeline in its history,” and will place increased focus and emphasis on its business development and licensing efforts. “As a result, Pfizer continues to target the introduction of about six new products a year starting in 2010,” he added.
Pfizer is pinning some hope on its drug Sutent (sunitinib), a targeted anti-cancer treatment for patients with gastrointestinal stromal tumors, a rare stomach cancer, and advanced kidney cancer. This is the first oncology drug to be approved by the FDA for two indications simultaneously. According to the American Cancer Society, about 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year.
Late last year, the FDA approved Invega (paliperidone) extended-release tablets, to treat schizophrenia. The once-daily oral medication specifically is designed to deliver paliperidone—the active ingredient derived from risperidone—through Oros
extended-release technology. Invega is marketed by Janssen (a division of Johnson & Johnson) and became available in January of this year. It is the first new prescription treatment for schizophrenia to be approved by the FDA since 2003.
Another drug to treat schizophrenia is in the works, and approval is expected this month. Wyeth will market Bifeprunox in the United States, in collaboration with the drug’s developer, Solvay of Belgium. It is a partial dopamine agonist/antagonist, as well as a serotonin receptor agonist. It is expected that partial dopamine agonist action will have beneficial effects for positive, negative and cognitive symptoms, while the serotonergic agonist action will help alleviate some side effects and possibly combat the depression and anxiety that can accompany schizophrenia treatment.
Also for mental health, Wyeth’s Pristiq (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor to treat major depressive disorder, was approved by the FDA in January.
Indications for the drug were extended last month when the agency issued an approvable letter for Pristiq to treat hot flashes and night sweats associated with menopause.
For the former approval, several conditions need to be met before full approval is granted. These included a satisfactory FDA inspection of the Wyeth’s Guayama, Puerto Rico, facility and several post-marketing commitments.
For the latter, Wyeth must provide additional data on Pristiq’s risk for serious cardiovascular adverse events and hepatic effects before the application can be approved. The FDA also requested a randomized, placebo-controlled clinical trial of postmenopausal women lasting at least one year.
One drug that’s holding the industry’s attention is Sanofi-Aventis’ Acomplia (rimonabant). The drug has been approved in Europe and some Scandinavian countries as a weight-loss and smoking-cessation product, and in Mexico with a diabetes indication, but it has not yet been approved in the United States.
Unfortunately for Sanofi-Aventis, even if Acomplia is approved in the United States (where it would be known as Zimulti), it’s now up against a powerful competitor: In June, GlaxoSmithKline’s weight-loss drug Alli was approved as an OTC product, and sales mushroomed to $150 million in less than a month.
Diabetes drugs are proliferating—no surprise given the increasing numbers of people suffering from the disease. Last October, the FDA approved Januvia (sitagliptin) from Merck. The drug is the first to be approved in a new class called dipeptidyl peptidase IV inhibitors.
DPP-4 inhibitors enhance the body’s levels of a protein called GLP-1, which stimulates the pancreas to produce more insulin and prevents the liver from producing glucose. Because of this, DPP-4 inhibitors are less likely to cause hypoglycemia than some older diabetes drugs that are on the market.
Brand Generic Manufacturer Indication Patent expiration
|Coreg||carvedilol||GlaxoSmithKline||high blood pressure||Sept. 5, 2007|
|Meridia||subutramine||Abbott||weight loss||Dec. 11, 2007|
|Mavik||trandolapril||Abbott||high blood pressure||Dec. 12, 2007|
|Tequin||gatifloxacin||GlaxoSmithKline||antibiotic||Dec. 25, 2007|
|Zyrtec||cetirizine||Pfizer||allergies||Dec. 25, 2007|
|Fosamax||alendronate||Merck||osteoporosis||Feb. 6, 2008|
|Camptosar||irinotecan||Pfizer||colon cancer||Feb. 20, 2008|
|Effexor||XR venlafaxine||Wyeth||depression||June 13, 2008|
|Zymar||gatifloxacin||Allergan||bacterial conjunctivitis||June 25, 2008|
|Dovonex||calcipotriene||Bristol-Myers||Squibb psoriasis||June 29, 2008|
|Kytril||granisetron||Roche||cancer/chemotherapy||June 29, 2008|
|Risperdal||risperidone||Janssen||antipsychotic||June 29, 2008|
|Depakote||divalproex sodium||Abbott||bipolar, epilepsy, migraines||June 29, 2008|
|Advair||fluticasone & salmeterol||GlaxoSmithKline||asthma||Aug. 12, 2008|
|Serevent||salmeterol||GlaxoSmithKline||asthma||Aug. 12, 2008|
Despite the steep price of Januvia (about $4.86 per day, or $145 per month), sales have been high—about $144 million per quarter. These figures are only expected to grow, and Jami Rubin, an analyst with Morgan Stanley, forecasted 2007 sales of $350 million worldwide and $1.6 billion by 2010.
Another possible diabetes blockbuster could be Galvus (vildagliptin) from Novartis, another DPP-4 inhibitor (to be used both as a monotherapy and in use with other anti-diabetic medicines.) The drug maker announced six months ago that it had received an approvable letter from the FDA. Under the terms of the letter, the FDA has requested additional data, including a clinical study to demonstrate the safety and efficacy of Galvus in specific patient groups with renal impairment.
It is expected that Galvus soon will be approved in Europe. Last month, Novartis received a positive opinion from the Committee for Medicinal Products for Human Use, recommending the approval of the drug as a once-daily oral medication for type 2 diabetes. The European Commission generally follows the CHMP’s recommendations and is expected to issue a decision on Galvus within three months. The decision will apply in all 27 EU member states, as well as Iceland and Norway.
Also awaiting approval from the FDA is Rasilez (aliskiren), a hypertension drug from Novartis. This drug was submitted for approval in April 2006, and according to Novartis, would represent the first new treatment approach for people with high blood pressure in more than a decade.
Symbicort from AstraZeneca also is awaiting FDA approval. This drug is meant to be an alternative to Seretide and has been shown in trials to reduce the risk of a severe asthma attack by 25 percent, and the total number of severe asthma attacks by 22 percent, when compared with Seretide.
Clinical trials showed that patients using Symbicort experienced fewer severe asthma attacks and required less rescue medication compared with patients taking Seretide.
Symbicort combines two key components of asthma therapy in one inhaler: Formoterol, a unique rapid and long-lasting bronchodilator, which can be used both as maintenance and reliever medication, and budesonide, an inhaled corticosteroid that provides an additional anti-inflammatory effect.