New blockbusters to fuel growth through 2012.(new drugs to dominate the market)
From Drug Store News (September 9, 2006)
While lack of innovation may have contributed to the industry s slow growth of late, according to IMS (product,search) Health's Doug Long, there are some promising drugs on the horizon. Looking forward, some of the hot disease-state sectors for pharmaceutical drug development include heart disease, diabetes and cancer. "Currently today, cardiovascular is the largest therapeutic class in the United States, [in] 2009 it will be oncology," Long said. According to published reports, there are some 566 compounds currently in development for the treatment of various types of cancer—the largest class in terms of drug development.
Following is a brief overview of the potential blockbuster medicines that are expected to gain approval over the next two years.
- Pfizer recently gained approval for Exubera (product,search), the first inhaled insulin to reach the market, and will begin shipping the first supplies to pharmacies in September. The introduction marks a significant innovationthe first non-injectible insulin to reach the marketpotentially revolutionizing how insulin is delivered to diabetics. Analysts have been cautious about getting too excited, however. "While patients love the Exubera, glycemic control by Exubera has been disappointing when compared to the glycemic control obtained from short-acting insulin," commented Al Rauch, an analyst with A.G. Edwards. "Type 1 diabetics would need to inhale six to 10 pounds of Exubera a year to control their diabetes and Type 2 diabetics would need to inhale 12 to 20 pounds a year," he noted.
"Although Exubera may prove to be a successful product for Pfizer, we believe that its peak market potential may be more modest than current Pfizer or consensus analysts' estimates suggest," he reported. "While the market potential for this drug could be over $1 billion, a large part of its success will be dependent on Exubera's ability to penetrate the Type 2 market."
- Pfizer also has the top drug in the area of heart disease, the torcetrapib/Lipitor (product,search) compound, which is expected to reach the U.S. market as early as 2008. It is expected that a key piece of research will presented at the American College of Cardiology conference in March 2007. Analysts have expressed some concern surrounding the potential approvability of torcetrapib; higher dosing in phase I and phase II trials, while effective, raised concerns over hypertension risks. It is expected that phase III trials will employ lower dosing, which may potentially impact the drug's efficaciousness.
However, a combination pill that both increases high-density lipids (the good cholesterol) and lowers low-density lipids (the bad cholesterol) would certainly rival the $12.2 billion in worldwide sales generated last year by Lipitor, which could face generic competition in March 2010 thanks to a recent court decision. Analysts only project as much as $5 billion in torcetrapib/Lipitor (product,search) sales by 2010.
Pfizer announced last month it would develop torcetrapib as a stand-alone drug as well, following criticism from doctors that the proposed combination drug precluded the use of rival statins.
- AstraZeneca gained approval for its asthma medicine Symbicort last month. Symbicort is a twice-daily asthma therapy combining budesonide, an inhaled corticosteroid, and formoterol, a rapid and long-acting beta2-agonist into one inhaler that is expected to give GlaxoSmithKline's Advair (product,search) ($2.9 billion worldwide for the six months ending June) a run for its money. Still, despite last month's approval, AstraZeneca isn't launching the inhaler until mid-2007. "It is not uncommon for inhaled agents such as this one to have a gap between the NDA being approved and the first launch because manufacturing of these is not a simple matter, and it takes a while to make sure you have adequate launch stock available," explained John Patterson, executive director of development at AstraZeneca.
In addition, the company is submitting new stability data to FDA in an effort to gain an extended shelf life and hopes to add indications for COPD and for pediatric use in 2008. Points of differentiation for the inhaler include a faster-acting active, AstraZeneca executives reported in a recent conference call.
- Sanofi-Aventis' Acomplia (product,search) received an approvable letter for an obesity indication from the FDA in February. And although obesity drugs historically have not done wellRoche's Xenical (product,search), which GlaxoSmithKline is attempting to switch to over-the-counter status as Alli, only generated $296 million worldwide sales for the six months ending JuneAcomplia is expected to generate more than 18 times that by 2010, according to analysts, due to Acomplia's relatively fewer unpleasant side effects. Despite potential launch delays in the United States, Acomplia has already successfully launched in the United Kingdom and expects approval in Germany soon.
- Earlier this month, Pfizer began distribution of its smoking cessation product Chantix, which is expected to achieve blockbuster status by 2010. According to Pfizer, approximately 7 out of every 10 smokers want to quit—suggesting there are more than 30 million potential patients. And unlike smoking cessation products of the past, third-party payers are more likely to place Chantix on their formularies.
"The history … is that [this] has primarily always been a cash market," commented Peter Brandt, senior vice president with Pfizer Global. "There has not been much reimbursement for smoking cessation products or programs in the past. One of the advantages that we have is that society is putting a huge amount of pressure on the payers, and payers themselvesled by their customers, the employersare changing even without any introduction of a novel, innovative product such as Chantix.
"So our timing is wonderful … in terms of going [after] higher levels [of reimbursement] for smoking cessation products," he said. "We still don't expect that this is going to come anywhere near the type of reimbursement or formulary levels that you see with a product such as Lipitor. On the other hand, it's going to be, we think, higher than we have seen previously with smoking cessation products."
- After having been largely absent from the U.S. vaccine market, GlaxoSmithKline is becoming a force in influenza. The company last month reported that a very low dose of active ingredient has proven effective versus the avian flu strain and could be mass-produced by next year. Analysts expect GlaxoSmithKline to generate $7.4 billion from its overall vaccine division by 2010.
It's difficult, however, to pinpoint sales projections on an avian flu vaccine. "[Analysts] don't have the elements to really assess the potential of this vaccine," said GlaxoSmithKline chief executive officer Jean-Pierre Garnier last month. "The one element that is missing is, first of all, the yield of the production process. We are industrializing the production process, and we will be able to say more about the quantities of vaccines we can produce by early next year. And that will, of course, narrow the range of opportunities for the company," he said.
"The second point is demand from the governments," Garnier added. "Clearly the data is of interest, but exactly at what pace governments will commit to order the product is uncertain at this point but will be firmed up over the next six months."
Top prospects in the pipeline
Medicine Company Indication
Acomplia Sanofi-Aventis Obesity
torcetrapib/Lipitor Pfizer High cholesterol
Paliperidone Johnson & Johnson Schizophrenia
Symbicort AstraZeneca Asthma
Galvus Novartis Diabetes
TAK-390MR Abbott Gastrointestinal
Exubera Pfizer Diabetes
Rasilez Novartis High blood pressure
Actemra Roche Rheumatoid arthritis
Chantix Pfizer Smoking cessation
Medicine Current stage Sales projections
by year
Acomplia NDA filed $5.4 billion by 2010
torcetrapib/Lipitor Phase III 5.0 billion by 2010
Paliperidone Phase III 2.5 billion by 2010
Symbicort Approved 2.5 billion by 2012
Galvus NDA filed 2.1 billion by 2012
TAK-390MR Phase III 2.0 billion by 2009
Exubera Approved 1.8 billion by 2010
Rasilez NDA filed 1.4 billion by 2011
Actemra Phase III 1.4 billion by 2012
Chantix Approved 1.1 billion by 2010
Source: Drug Store News research, company reports
