India's top court dismisses Novartis petition for Glivec patent

NEW DELHI, April 1 (Reuters) - India's highest court has dismissed Swiss drugmaker Novartis AG's petition seeking patent protection for its cancer drug Glivec, a serious blow to Western pharmaceutical firms which are increasingly focusing on India to drive sales.

In a landmark judgment that has the potential to change the direction of India's pharmaceutical business, the Supreme Court said on Monday that the drug failed to qualify for a patent according to Indian law.

Novartis has been fighting since 2006 to win an Indian patent for an amended form of Glivec. In 2009 it took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.

(Reporting by Suchitra Mohanty; Editing by Daniel Magnowski)

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India's Top Court Rejects Novartis Patent Protection

India's top court has dismissed Swiss drugmaker Novartis's attempt to win patent protection for its cancer drug Glivec, a serious blow to Western pharmaceutical firms who are increasingly focusing on India to drive sales.

The decision also sets a benchmark for several intellectual property disputes in India, where many patented drugs are unaffordable for most of its 1.2 billion people, 40 percent of whom earn less than $1.25 a day.

India's domestic drugs market is the 14th largest globally, but with annual growth of 13-14 percent and the world's second biggest population, it has massive potential at a time when traditional developed markets have slowed down.

The Supreme Court's landmark ruling is likely to affect several other companies and their branded medicines.

Pfizer's cancer drug Sutent and Roche Holdings hepatitis C treatment Pegasys lost their patented status in India last year, and Monday's ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognized in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.

Novartis has previously that said it needs legal certainty if it is to plan further investment in drug research in India.

The ruling is a boost for healthcare activists who want the government to make medicines cheaper in a country where patented drugs constitute under 10 percent of total drug sales.

Novartis has been fighting since 2006 to win a patent for an amended form of Glivec. In 2009 it took its challenge against a law that bans patents on newer but not radically different forms of known drugs to the Supreme Court.

India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

The Supreme Court decided that Glivec does not satisfy the "novelty" aspect, Pravin Anand, lawyer for Novartis, told reporters.

Shares in Novartis India Ltd, the Indian unit of the drugmaker, fell over 5 percent after the verdict. They were down 4.63 percent at 571.10 rupees by 0528 GMT.

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India hails "historic" Supreme Court drug patent ruling against Novartis

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Novartis lung cancer drug gets key FDA designation

NEW YORK -- Novartis AG said Friday that its experimental cancer drug LDK378 was designated as a breakthrough therapy by the Food and Drug Administration.

The Swiss drugmaker is studying LDK378 as a treatment for a rare type of metastatic non-small cell lung cancer. It is intended for patients whose cancer progressed during treatment with Pfizer Inc.'s drug Xalkori, or who could not tolerate treatment with Xalkori.

The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.

Novartis is running two mid-stage clinical trials of LDK378. It plans to start late-stage testing later in 2013 and to file for marketing approval in early 2014.

Shares of Novartis rose 96 cents to $69.91 in late morning trading. The stock has changed hands between $51.20 and $70.24 in the past 52 weeks.

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FDA seeks to fast track Novartis lung cancer drug

* LDK378 treats non-small cell lung cancer

* Compound seen as potential future blockbuster

* Novartis sees first regulatory filing in early 2014

ZURICH, March 15 (Reuters) - The U.S. Food and Drug Administration has designated a compound developed by Novartis AG to treat a type of non-small cell lung cancer for fast-track development and review, the Swiss drugmaker said on Friday.

Novartis said the FDA had given "breakthrough therapy" designation to its LDK378 compound, a process aimed at speeding up the review of drugs that treat life-threatening conditions if the therapy has demonstrated efficacy.

LDK378 - seen as a potential future blockbuster - is designed to treat anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC). Sufferers tend to be non-smokers and younger than other lung cancer patients.

Novartis said two Phase II trials were under way and it planned to launch several Phase III trials later this year with first regulatory filing expected by early next year.

"This breakthrough therapy designation will allow us to collaborate more closely with the FDA and potentially to expedite the availability of an important new treatment option for patients with ALK+ NSCLC," said Alessandro Riva, Novartis head of oncology development.

(Reporting by Emma Thomasson, editing by William Hardy)

((+41 58 306 7311)(Reuters Messaging: emma.thomasson.thomsonreuters.com@reuters.net))

Keywords: NOVARTIS/LUNGCANCER

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Novartis Scraps $78 Million Pay for Outgoing Chairman

Novartis said it would scrap a 72 million Swiss franc ($77.98 million) pay package for outgoing chairman Daniel Vasella, bowing to mounting anger in Switzerland before an investor meeting on Friday.

The move represents a victory for the drugmaker's Swiss shareholders such as Geneva-based Ethos Fund, which had campaigned against paying Vasella 12 million francs over six years to prevent him from working for competitors.

"We continue to believe in the value of a non-compete, however, we believe the decision to cancel the agreement and all related compensation addresses the concerns of shareholders and other stakeholders," Novartis vice chairman Ulrich Lehner said in a statement on Tuesday.

(More on CNBC.com: Novartis CEO: Our Innovation Will Be Rewarded)

Vasella, long a lightning rod for criticism of executive pay in Switzerland, said in the statement he understood that Swiss people found the compensation too high. Vasella earned 13.1 million francs for 2012, down slightly from 13.5 million francs the prior year.

Vasella's golden parachute attracted a raft of criticism from top-ranking Swiss politicians and members of the country's pro-business lobby, against the backdrop of a March 3 referendum to give shareholders a veto over excessive manager pay.

Polls published on Sunday showed almost two thirds of Swiss voters favored the initiative.

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FDA approves Novartis drug for rare iron disorder

WASHINGTON -- The Food and Drug Administration has approved a Novartis drug to treat a rare genetic disorder that causes an overload of iron in the blood.

The FDA cleared Novartis' drug Exjade to treat patients 10 and older with a form of thalassemia, which affects about 1,000 people in the U.S. The disorder can lead to internal organ damage.

Patients with traditional thalassemia often require red blood cell transfusions to replace the protein that carries oxygen throughout the bloodstream.

Novartis' drug is for patients with a milder form of the condition known as non-transfusion-dependent thalassemia. These patients do not require frequent blood transfusions.

The FDA approved the drug in combination with a diagnostic test that measures iron concentration in the liver.

Novartis is headquartered in Basel, Switzerland with U.S. offices in East Hanover, N.J.

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Novartis meningitis vaccine wins EU approval

European regulators have approved the first vaccine against meningitis B, made by Swiss drugmaker Novartis.

Novartis said Tuesday that the European Commission approved Bexsero for use in patients ages 2 months and older, and the company will make the vaccine available as soon as possible.

Meningitis mainly affects infants and children. The disease can be fatal or can leave patients with lifelong consequences such as brain damage or impaired hearing.

There are five types of bacterial meningitis, and while vaccines exist to protect against four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Novartis said a vaccination is the best defense against the rare disease, since its symptoms often resemble the flu, and it can be easily misdiagnosed.

The European Medicines Agency had said in November that it recommended the vaccine's approval. Novartis also is seeking to test the vaccine in the United States.

Its shares closed at $65.64 on Friday.

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