Editor’s note: Cutting Edge Information, a business intelligence firm based in Durham, contributes exclusive articles to Local Tech Wire.Big cardiovascular drugs want to do just that – stay big. Many leading pharma companies have discovered a way to do this, and are joining in on the new trend to extend patent life among cardiovascular drugs. The solution is a single pill combination drug that will extend product life for not one, but two cardiovascular drugs. These combination drugs are radically altering the prescription cardiovascular drug market.

Of the companies developing new combination therapies, many involve compounds containing a statin in order to adjust the evolving dyslipidemia sector that is expected to emerge over the next ten years. Among the companies who are leading the way with their combination drugs are Merck, Schering-Plough, and Pfizer.

Merck and Schering-Plough hope to release their single pill super-drug – Zocor and Zetia – to lower cholesterol in the near future. Currently, the two statins contend alone with Pfizer’s Lipitor and AstraZeneca’s recently launched Crestor, among other statins. According to Lehman Brothers estimates, the Zocor-Zetia fixed-dose combination therapy could generate $900 million in sales in 2004 for Zetia – $200 million of which would be derived from combination therapy sales.

Pfizer has recently received FDA approval for their single pill drug, Caduet, which is a combination of the statin market leader Lipitor and antihypertensive drug Norvasc. The combination is the first pill with established clinical results of two blockbusters in one dose. The treatment serves patients with both dyslipidaemia and hypertension.

Improving health, helping patents

These combination drugs are expected to be enhance the cardiovascular drug market and help achieve things a single drug cannot do without the help of the other. Combination drug collaborations help settle many patent issues as well as improve overall cardiovascular health.

One issue facing the Cardiovascular sector is that the next three to five years will see several key statins lose patent protection, most notably Pravachol and Zocor, whose patents expire in 2006. As generic competition threatens the maturing statin market, companies will be seeking ways to retain and build market share. Furthermore, the FDA may rule to allow companies to market statins over-the-counter, which would greatly affect not only the cardiovascular competitive landscape, but perhaps also the entire pharmaceutical industry as best-selling Lipitor would surely lose market share.

Combination drugs help alleviate some of these patent challenges. Merck hopes to extend the product life of Zocor through its combined therapy with Zetia. Officials at Merck hope the launch will strengthen Zocor’s presence in the US market before its patent expiration. Likewise, Caduet has the potential to give Pfizer a boost by compensating for Norvasc’s impending patent expiration in global markets, such as the US.

A single pill

Another major benefit of combination drugs is that they are produced as one single pill, which is key to patent protection. This single pill form helps the patent owner fight back against any impending generics. While each drug alone may have expiring or already expired patents, a combination pill allows entirely different patent rights. Therefore, generics could reproduce the drugs individually, but not as one single pill. The single pill combination is favorable for patients rather than dealing with two separate drugs, thereby increasing patient compliance. Furthermore, this single pill form benefits managed healthcare organizations that only have to tolerate prescriptions for one drug as opposed to two.

This trend of combination therapies is on the rise in part due to one simple reason-two drugs are more effective than just one. Combination therapy displays increased efficacy compared to standard statin treatments. Early results indicate combining blood pressure and cholesterol treatments, such as Pfizer’s Caduet, improves overall cardiovascular health by as much as 50 percent, by some estimates.

These results open a whole new window of marketing opportunities for companies who market these combination drugs. For example, Pfizer’s launch of Caduet reveals an opportunity for new ways to promote old drugs. While Lipitor alone is marketed for lowering cholesterol, and Norvasc is marketed as an antihypertensive, Caduet can be promoted as much more. Since high blood pressure and high cholesterol often trigger each other, Pfizer can market Caduet as a drug that improves overall cardiovascular health, not just one aspect.

Cutting Edge: www.cuttingedgeinfo.com