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Novartis Sticks With Heart Of Pipeline: Growth Is In Cardio-Metabolic Sector

Executive Summary

Novartis will continue to focus on the cardiovascular-metabolic segment in the near term with filings planned for new diabetes and hypertension therapies and line-extensions for its existing agents

Novartis will continue to focus on the cardiovascular-metabolic segment in the near term with filings planned for new diabetes and hypertension therapies and line-extensions for its existing agents.

"Our vision is straightforward: We are a leader in this space, and we want to continue to strengthen our leadership position in these categories, both with monotherapies and fixed combination therapies," Chief Marketing Officer & Global Head-General Medicine Kurt Graves said during a Sept. 20 R&D Day.

Novartis has scheduled filings for vildagliptin (LAF237) for the treatment of type 2 diabetes and aliskiren (SPP100) for the treatment of hypertension in the U.S. in the first half of 2006.

"The cardiovascular/metabolic marketplace is obviously a large and attractive marketplace," Graves said. By 2010, "between dyslipidemia, diabetes and hypertension, this market is expected to exceed over $100 bil.," he asserted.

Opportunities still exist in terms of unmet medical need, undiagnosed patients, diagnosed but untreated patients, undertreated patients and non-compliant patients, Graves maintained.

"The trends are clear that lower is better, and you will expect to see over the next five years treatment targets go even lower than they are today," he noted, citing guidelines for hypertension and diabetes.

Vildagliptin and aliskiren will initially be positioned as add-on therapies to existing medications, with the aim of helping patients reach their target blood pressure and blood sugar goals, the exec added.

Vildagliptin is a potentially first-in-class DPP-IV inhibitor that demonstrated sustained efficacy and good tolerability in treating patients with type 2 diabetes in Phase IIb/III studies, Novartis reported.

"Diabetes is fundamentally pancreatic islet dysfunction and insulin resistance, and we think we have the breakthrough therapy that can revolutionize the treatment of pancreatic islet dysfunction, and by doing that, we will get more people to their treatment goals," Graves said.

Vildagliptin will be positioned as an add-on to metformin. "That's the space we really want to own positioning-wise, which means that we will be differentiating based on the profile," Graves said.

Phase IIb/III studies with the compound demonstrated its ability to improve and sustain pancreatic islet cell function and insulin sensitivity over one year.

Novartis presented 52-week data from an ongoing two-year Phase III study; the trial in 254 treatment-naïve type 2 diabetes patients compared vildagliptin to metformin as monotherapy. Results showed a sustained reduction in HbA1c of 1% after 52 weeks in patients treated with vildagliptin compared to a 1.4% reduction in patients treated with metformin.

Although the trial narrowly missed its primary endpoint of non-inferiority versus metformin, Novartis maintained that the interim data demonstrated that LAF237 was better tolerated than metformin, particularly in its gastrointestinal tolerability profile.

Aliskiren is the first in the renin inhibitor class of anti-hypertensives. The company plans to file the drug in early 2006 based on data from two Phase III studies supporting its efficacy as a once-daily oral treatment for lowering blood pressure, both as a monotherapy and in combination with the diuretic hydrochlorothiazide.

"Where we see this drug fitting, especially at launch, is clearly as an add-on therapy," Graves said. "People are only treated with an average of two [antihypertensive] drugs a day. They need to be on four or five mechanisms, and we intend to make SPP the next add-on mechanism to existing treatment to get people to those goals."

In a clinical trial in 672 patients with mild-to-moderate hypertension, aliskiren demonstrated a statistically significant reduction in systolic and diastolic blood pressure across all doses compared to placebo after 10 to 12 weeks of treatment, Novartis said. Mean ambulatory blood pressure also showed a significant and sustained reduction over a full 24-hour period.

A second trial in 2,776 patients with mild-to-moderate hypertension demonstrated aliskiren in combination with HCTZ provided additional blood-pressure lowering benefits and improved responder rates relative to placebo.

Data from clinical trials combining aliskiren with two additional antihypertension agents, an ACE inhibitor and a calcium channel blocker, will be presented in 2006, Novartis said.

Three major morbidity/mortality outcome studies are also planned to start in 2006 "to ensure an extensive profiling program of aliskiren compared to other anti-hypertensives," the company added. Those data are not anticipated until at least 2011.

Novartis is also counting on the introduction of new cardiovascular and metabolism fixed-dose combinations as another near-term growth strategy.

The company plans to build on the strength of the Diovan (valsartan) franchise with a 2006 filing for a combination of the angiotensin receptor blocker with the CCB amlodipine. The filing would mark the first combination of a CCB and an ARB, offering once-daily hypertensive therapy with a dual mechanism of action, Novartis said.

"It will obviously punch all the entry ticket criteria to compete in this category, but more importantly it will raise the bar on differentiation because both drugs together will have an excellent morbidity/mortality track record," Graves stated.

The company also is planning to seek approval for the L-nucleoside antiviral telbivudine (LDT600) for the treatment of hepatitis B in the U.S. and EU and Lucentis (ranibizumab) for the treatment of age-related macular degeneration in the EU.

A number of other regulatory milestones are on track to be achieved over the next year, Novartis reported.

The company is anticipating FDA approval of the iron chelator Exjade (deferasirox) for patients with chronic iron overload in November. FDA's Blood Products Advisory Committee is due to review the drug Sept. 29 (1 'The Pink Sheet' Sept. 5, 2005, In Brief).

Novartis also is awaiting approval from FDA for Aclasta (zoledronic acid) for the treatment of Paget's disease of the bone after responding to an "approvable" letter from the agency earlier this year. Femara (letrozole) also was filed in July in the U.S. and EU for the treatment of breast cancer in an adjuvant setting.

Overall, Novartis has 75 projects in clinical development, including 52 in Phase II, Phase III or registration and 46 of which are new molecular entities, the company reported.

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