Healthcare Industry News:  besylate 

Biopharmaceuticals FDA

 News Release - December 22, 2006

Exforge(R) Receives US Regulatory Approval as a New and Highly Effective Treatment Option for Patients with High Blood Pressure

Exforge offers in one tablet the complementary actions of valsartan and amlodipine besylate, two of the most prescribed branded antihypertensive medicines

Approval based on clinical data showing improved efficacy and side effect profile compared to amlodipine alone

Clinical trials show Exforge helped up to 9 out of 10 patients get to goal*

US Food and Drug Administration grants tentative approval pending expiration of market exclusivity and patent protection for amlodipine besylate in September 2007

EAST HANOVER, N.J., Dec. 22 (HSMN NewsFeed) -- Novartis announced today the US regulatory approval of Exforge as a new treatment option for patients with high blood pressure. Exforge combines in one tablet the two most commonly prescribed hypertension medicines in their categories -- DiovanĀ® (valsartan) and NorvascĀ®** (amlodipine besylate).

The US Food and Drug Administration (FDA) issued this tentative approval because Exforge has met all the required standards for safety, efficacy and manufacturing quality. Exforge is expected to be available to patients in the US in late September 2007, pending the expiration of market exclusivity and patent protection for amlodipine besylate.

In an extensive clinical program involving over 5,000 patients, Exforge helped up to nine out of 10 patients reach their treatment goal (diastolic blood pressure under 90 mmHg or more than a 10 mmHg reduction in diastolic blood pressure from baseline).

"The combination of these two well-known and powerful antihypertensive medications in one tablet will now give patients additional blood pressure control with favorable tolerability," said Bertram Pitt, MD, FACC, Professor of Medicine Emeritus at the University of Michigan School of Medicine Division of Cardiology in Ann Arbor, Michigan, USA.

The need for new antihypertensive medicines is urgent, as seven out of 10 patients are not at their target blood pressure goal. High blood pressure is a leading risk factor for cardiovascular disease, which is the world's leading cause of death.

Exforge is appropriate for patients whose blood pressure is not adequately controlled on any dihydropyridine calcium channel blocker (CCB) or angiotensin receptor blocker (ARB). Also, it is appropriate for patients who experience dose-limiting side effects on either component, such as amlodipine-induced edema, dizziness and flushing.

Diovan blocks angiotensin II, a hormone that causes blood vessels to tighten and narrow, while amlodipine blocks the entrance of calcium into the blood vessel walls. Both allow blood vessels to relax so blood can flow more easily. Exforge also provides the convenience of a single once-daily tablet, which could reduce the overall number of pills a patient may need to take.

"Most patients need two or more medicines to control their blood pressure and achieve guideline targets," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Exforge promises to be an attractive therapy option because it brings together two of the most powerful mechanisms of action in a single pill."

In November, Exforge was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the regulatory agency that reviews European Union submissions for new medicines. Novartis expects to receive approval from the European Commission and to make Exforge available in the EU during the first half of 2007.

About Exforge

Exforge is indicated for the treatment of hypertension. Exforge is not indicated for initial therapy. An extensive clinical trial program involving more than 5,000 patients showed that Exforge significantly lowered blood pressure compared to placebo, or amlodipine besylate or valsartan alone. In the Exforge clinical trials, adverse events were generally mild and transient in nature. Side effects that occurred more frequently with Exforge than placebo in clinical trials were peripheral edema, nasopharyngitis, upper respiratory tract infections, and dizziness. Exforge has not been shown to reduce the risk for cardiovascular disease resulting from high blood pressure. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Exforge (amlodipine and valsartan) should be discontinued as soon as possible.


The foregoing release contains forward-looking statements which can be identified by the use of terminology such as, "tentative approval," "pending expiration," "expected," "will," "could," "promises to be," or similar expressions, or by express or implied discussions regarding the potential final marketing approvals of Exforge, or potential future revenue from Exforge. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Exforge will be approved for any indications in the European Union, the United States or any other market, that Exforge will be brought to market in the EU, the US or in any other country, nor that Exforge will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Exforge could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected intellectual property issues involving the expiration of market exclusivity of amlodipine besylate; competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of clinical data, or new clinical data; our ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis AG (NYSE: NVS ) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low- cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 people and operate in over 140 countries around the world. For more information, please visit

* Diastolic blood pressure under 90 mmHg or more than a 10 mmHg reduction in diastolic blood pressure from baseline.

** Norvasc is a registered trademark of Pfizer Inc

Source: Novartis

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