The Pharma Revolution Recalibrated - Pharmaceutical Executive

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The Pharma Revolution Recalibrated

Pharmaceutical Executive


True Pharmaceutical Productivity: 2000 to 2010




Considering combination product and DDEP approvals along with NME and BLA approvals provides quite a different view of pharmaceutical sector productivity (see chart). From a total of 52 combined approvals in 2000, the total approval numbers have remained largely consistent on a year-to-year basis through 2010. Even 2005 and 2007, which represented relative droughts for NME and BLA approvals, prove to be just about average when including combination product and DDEP approvals.

The figures reveal the increasing importance of drug-delivery-enhanced products in terms of the total creative output of the pharmaceutical sector. While annual DDEP approvals lagged behind NME/BLA approvals early in the last decade, the availability of more advanced technologies has pushed their total approvals closer to parity. At the same time, there has been a substantial increase in the number of approved combination products. Together, combination products and DDEPs now account for the majority of new therapeutic product approvals.

The State of Innovation

The real standard for pharmaceutical innovation should be whether a new therapeutic provides better patient outcomes through greater efficacy, safety, or tolerability. All three benefits can be provided by new molecules, new combination products, and DDEPs. While DDEPs are often considered most useful for improving convenience by reducing dosing requirements, this feature often translates into better efficacy by virtue of improved dosing compliance. Extended to new indications, DDEPs have also been able to deliver novel therapeutic solutions using new and previously approved active ingredients. Well-known examples include the treatment of chronic non-oral pain relief with a transdermal patch (Duragesic; fentanyl), the reduction of restenosis following angioplasty (Taxus; paclitaxel), and the inhalation treatment of asthma (Flovent; fluticasone).

Repurposing approved and validated pharmaceutical actives not only offers new therapeutic and commercial opportunities, but also enables companies to better manage risk. Combination and drug-delivery-enabled/enhanced pharmaceuticals may present development risks related to efficacy, but they're much less likely to present safety issues. These products are not without their own challenges, however; notably market exclusivity. Regulatory exclusivity in the US is limited to three years for a product incorporating a previously approved active. Even with the demonstration of improved safety or efficacy, securing durable patent protection can be difficult. Too often, it's a case of three years and out for DDEPs and combination products, despite providing innovation and improved therapeutic outcomes.

Inhalation DDEPs, both single active and combination, are an exception. Products such as Advair and Spiriva can expect to enjoy an extended period of exclusivity because there is no FDA-sanctioned abbreviated new drug approval pathway for inhalation products. This does not eliminate competitors incorporating the same active, but these products are required to go through a more demanding development program to demonstrate safety and efficacy. Furthermore, they are not substitutable for the innovator products.

A common criticism when comparing drug-delivery-enhanced and combination products to NME products relates to the relative degree of benefits they provide. There is no question that an NME able to treat an aggressive cancer for the first time is an innovative breakthrough product. But how innovative is the fifth SSRI antidepressant, or sixth proton pump inhibitor? These products incorporate NMEs, but are they any more innovative than a DDEP that enhances clinical outcomes by improving dosing frequency and patient compliance? Perhaps the criticism is unfounded; each product provides a benefit in its own way.

The Future of Innovation

The pharmaceutical industry, physicians, patients, and payers all depend on innovation to improve therapeutic and commercial outcomes. There is no room for intellectual snobbery. Rather than simply looking at DDEPs and combination products as part of lifecycle management, the industry can profit by embracing the innovation they deliver. With vision and creativity, these agents are able to deliver enhanced therapeutics along with improved profits—all at lower risk. And if companies can develop new strategies to extend market exclusivity, DDEP and combination product profits can help to fuel further discovery. Innovation can be defined in many ways, and the numbers for the last decade suggest that there is no lack of it in the pharmaceutical industry.

Josef Bossart is managing director, The Pharmanumbers Group. He can be reached at
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