It has long been known that elevated LDL cholesterol and reduced HDL cholesterol are major risk factors for developing cardiovascular disease. And while much ado has been made about a drug that can balance the level of both cholesterol types before—think Pfizer’s torceptrapib, which was found to increase deaths and heart disease events in a large clinical trial—Merck may be on to something with its new drug, anacetrapib.

Merck’s high hopes for the new compound could signal a revival of interest in the mass market primary care space, which has ceded ground in recent years to the perception that the industry’s future lies in high priced specialty medicines for small patient populations.

Because the drug not only lowers  “bad cholesterol” (LDL) but also raises “good cholesterol” (HDL), Merck hopes that where other drugs have failed, anacetrapib can “reduce patient risk and improve outcomes,” according to a story published by Forbes last week.

What we don’t know yet is whether the problems with Pfizer’s drug, torceptrapib, are inherent to the entire class of CETP inhibitor drugs—of which Merck’s compound is also a member—and if the same factors that caused Pfizer’s drug to lead to increased risks will turn up for Merck. So far, patients who used the drug showed no signs of raised blood pressure or any other safety risks that were present with Pfizer’s drug.

The study, titled Determining the Efficacy and Tolerability of CETP Inhibition with anacetrapib (DEFINE), for Merck’s anaceptrapib was presented last week to a plenary session at an American Heart Association meeting. Though the study was too small to detect modest harms or benefits, a small study to generate preliminary results was a milestone that needed to be passed in order for Merck to proceed with a large clinical trial.

While the new drug could mean potential big business for Merck, it could also eventually mean a big change in patients’ lives, and could lead to a time where medications, rather than cardiac stents, become the norm. In the 18-month, 1,623-person preliminary study, the drug diminished the number of such procedures in patients with (or at high risk for) coronary heart disease by 70 percent, and increased good cholesterol by more than 130 percent.

The next step for Merck is a five-year, 30,000 person study, led by Oxford University, to determine whether the drug can lower patients’ heart risks without causing other adverse effects.

Statins should be given to people with high blood pressure or diabetes, even if they don’t have heart disease, according to a study published in the British Medical Journal. While several studies have shown that statins benefit those with cardiovascular disease, this is the first large study which looked at statins as primary prevention in those who were otherwise healthy.

The international team of researchers looked at 10 trials, involving more than 70,000 patients, all of which compared statin therapy with placebo or a control group, and patients were followed for at least four years. They found that statins reduced deaths from all causes by 12 percent and—importantly—reduced the risk of major events such as stroke or heart attack by 30 percentin those without a history of heart disease. These risk reductions are similar to those seen previously in secondary prevention with patients who have established heart disease.

The data suggested that those over 65 with risk factors such as high cholesterol or diabetes were most likely to benefit from long-term statin use, although additional ways of predicting the risk would be useful in identifying those in greatest danger of developing cardiovascular problems. “Given the favourable effects of long term statin treatment, it would be wrong to deny these benefits to people at increased risk for cardiovascular disease,” the authors claimed.

Related articles:

• Statin Cuts Heart Attack Risk in Healthy Too (findmeacure.com)
• Statins ‘cut risk of dying by more than a tenth’ (telegraph.co.uk)
• Statins cut heart risks even in healthy patients (ctv.ca)

The winners this year:

For best branded program AstraZeneca Canada for a program in support of Arimidex (anastrozole), an adjuvant therapy for breast cancer. The program recruits patients through pharmacies (with the help of the e-health organization Rx Canada) and provides them with a series of timed newsletters throughout the five-year course of therapy.

For best integrated program Talecris Biotherapeutics for its health management program for patients with Alpha-1 Antitrypsin Deficiency, an extremely rare hereditary condition leading to chronic obstructive pulmonary disease.  The program is noteworthy both for its remarkable success rate and for its use of a not-for-profit patient support group to provide extensive peer counseling.

Best Disease State Adherence Program Novartis for “BP Success Zone” an education and adherence program for patients with high blood pressure. Patients enroll for a 12-month series of e-mails and mailings timed to known drop-off curves. The program focuses on knowing and reaching blood pressure goals; it offers patients blood pressure meters and has a feedback loop for healthcare providers.

Scientific Pursuit of Excellence in Adherence R&D Merck, for “The Adherence Estimator,” an elegantly researched tool for predicting which patients will display poor compliance by focusing on just three core issues: commitment to treatment, concerns over therapy, and cost.

We’ll have lots more on the individual programs and the people behind them in the June issue of Pharmaceutical Executive.

Gilead, the Foster City, CA, powerhouse will pay cash for the deal.

In A conference call, Gilead CEO John Martin, COO John Mulligan, and R&D wizard Norbert Bischogberger had to deal with a fair amount of skepticism from industry analysts, who poked and prodded with questions about the deal, aiming to find its vulnerable spots. And there are several.

From CV Therapeutics, Gilead gets two marketed products: Ranexa, a $100 million seller in chronic angina; and Lexiscan, a $50 million drug for mycocardial perfusion imaging—plus a pipeline including two Phase III molecules for atrial-fibrillation molecule and heart failure.

Analysts asked whether Gilead was placing too big a bet on two hopes: that Ranexa, with a new label for first line treatment, will grab a major piece of the angio market; and that the platform will indeed deliver. The biotech is also banking on its own Phase III compound, darusentan, for persistent hypertension. In addition, CV Therapeutics sales force nicely expands Gilead’s access to cardio specialists. If everything works out as planned, the innovative specialty drugmaker could find itself leading in the blockbuster-making primary-care market. That would be a truly remarkable accomplishment.

Under tough questioning, the Gilead team stuck to their guns, proclaiming complete confidence in both their planned relaunch of Ranexa and the approval of darusentan in the competitive hypertension field, where other brave new molecules have failed.

Is it all a bridge too far, analysts wondered. Based on Gilead’s track record, maybe not. Martin reminded them that “we didn’t have to do this acquisition” (unlike some pharmas, hint, hint). But rather than sit on their cash pile, Gilead chose to roll the dice in a new game. That’s biotech talking.

Update 3/16/09: Astellas announced Monday morning that it would not engage in a bidding war with Gilead and terminated its $16 per share offer.

“Astellas also intends to withdraw a related lawsuit in the Delaware Chancery Court against CV Therapeutics and its directors,” the company stated in a release. “Astellas is a disciplined acquirer and does not see value for Astellas stockholders in CV Therapeutics at the price level ofthe sale announced on March 12.”