Replies to post #43519 on Biotech Values

[robgera]

I read that adding an ARB to an Ace Inhibitor (at the appropriate dose) doesn't increase the effect on BP on average. I will search for the article or label.

>In fact, it's been shown that when you combine various drugs that act on the renin -angiotensin system, you can get additional BP reductions. That is to say, you can put an ACE with an ARB, or a direct renin inhibitor with an ARB, and get additional BP-lowering efficacy. Why? I won't get into all the reasons for all of the steps, but one example is that there are non-ACE pathways for the conversion of angiotensin I to angiotensin II.<

[DewDiligence]

NVS’ ultimate goal in the hypertension market is
clear: to combine the blockbuster ARB, Diovan, with
the recently approved Tekturna in a single pill (once
Diovan goes off-patent). This PR provides evidence
that the two drugs have additive efficacy. Never mind
that both drugs operate on the same pathway—rfj1862
did a fine job of debunking the idea that this is bad
thing (#msg-18166885).

http://biz.yahoo.com/prnews/070326/nym040.html?.v=85

>>
Tekturna®, First New Type of High Blood Pressure Medicine in a Decade, Provides Additional Blood Pressure Reduction When Used With Diovan®

Monday March 26, 10:39 am ET

* New study results show more patients receiving both Tekturna and Diovan reached target blood pressure goal compared to those taking either agent alone

* Tekturna approved in the U.S. as first direct renin inhibitor, works by directly targeting an enzyme which triggers a process that can lead to high blood pressure

* Tekturna provides significant blood pressure reductions for a full 24 hours and is generally well tolerated

* Urgent need for new therapies like Tekturna since nearly 70% of patients with high blood pressure still not achieving treatment goals

EAST HANOVER, N.J., March 26 /PRNewswire/ -- Results from a new study have shown patients taking two Novartis cardiovascular medicines -- the recently U.S.-approved drug Tekturna® (aliskiren) and the leading therapy Diovan® (valsartan) -- experienced greater reductions in blood pressure levels than those using either agent alone.

The study also found more patients receiving both Tekturna, which received U.S. approval in March and represents the first type of new high blood pressure medicine in a decade, and Diovan reached their treatment goal compared to either drug alone (ACC presentation #405).

Data from this trial involving 1,800 patients -- the first large-scale study to assess the potential benefits of combining these medicines -- were presented for the first time at the American College of Cardiology 56th Scientific Session in New Orleans.

Half of the patients in the eight-week trial taking both Tekturna and Diovan saw a reduction in blood pressure to the target of 140/90 mmHg (systolic/diastolic pressure), higher levels than seen in patients taking either of the medicines alone.

Tekturna and Diovan work in different ways to target the renin angiotensin system, one of the body's key regulators of blood pressure. Tekturna targets renin, an enzyme responsible for triggering a process that can lead to high blood pressure. Diovan, an angiotensin receptor blocker (ARB) and one of the world's most-prescribed cardiovascular medicines, works later in this system by blocking the action of angiotensin II, which causes narrowing of blood vessels.

"These study results are exciting because they suggest the value of different mechanisms of action when Tekturna and Diovan are used together," said Suzanne Oparil, MD, Director of the Vascular Biology and Hypertension Program and Professor of Medicine at the University of Alabama at Birmingham in Alabama. "In addition to important blood pressure lowering, the combination of Tekturna and Diovan maintained a tolerability profile similar to that seen with either agent alone," said Dr. Oparil.

Tekturna received U.S. regulatory approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. In an extensive clinical trial program involving more than 6,400 patients, Tekturna provided significant blood pressure reductions for a full 24 hours. This once-daily oral therapy is expected to be available by the end of March in U.S. pharmacies as 150 mg and 300 mg tablets.

A second study presented at the meeting compared Tekturna (150 mg or 300 mg alone or 300 mg in combination with HCTZ) to ramipril (5 mg or 10 mg alone or 10 mg in combination with HCTZ), another high blood pressure medicine in a class known as angiotensin converting enzyme (ACE) inhibitors (ACC presentation #1014). Results showed 61.4% of patients treated with the Tekturna-based therapy reached their blood pressure goal vs. 53.1% of patients treated with the ramipril-based therapy.

…"We are very encouraged by these results since they show Tekturna and Diovan are effective when used together," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Through our portfolio of high blood pressure medications, Novartis is committed to providing physicians with a wide range of tools to help patients lower their blood pressure."
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[robgera]

>I read that adding an ARB to an Ace Inhibitor (at the appropriate dose) doesn't increase the effect on BP on average. I will search for the article or label.<


It's reflected in Diovan's label

[DewDiligence]

NVS receives FDA approval for Exforge (Diovan+Norvasc). However, NVS has previously stated that it will wait until September (when PFE’s pediatric exclusivity runs out on Norvasc) before launching and today’s PR says nothing to contradict that.

http://biz.yahoo.com/prnews/070621/nyth035.html?.v=98

Given that Teva has launched a generic Lotrel (Lotensin+Norvasc), which has been one of NVS’ biggest-selling branded drugs, I figured NVS might get more aggressive on launching Exforge to offset the Lotrel losses. But evidently they won’t.