Novartis milestones be proud ! Management take a bow !

Novartis’s Gilenya Loses Market Share After Safety Review

By Simeon Bennett - Mar 6, 2012 6:21 PM ET

Novartis AG (NOVN)’s Gilenya multiple sclerosis pill lost market share for the first time in January, following the deaths of some patients soon after taking the first pill available for the disease in the U.S.

Gilenya’s share of the U.S. market for so-called immunomodulatory drugs against MS fell to 6.1 percent from 6.2 percent in December, according to data from Wolters Kluwer NV (WKL), a market research company. The decline was the first after 15 months of growth.

 

http://www.swissinfo.ch/media/cms/images/keystone/2012/02/35233605-32209738.jpg

picture worth a thousand words

 

United Therapeutics sues Sandoz over hypertension drug
Thu Mar 15, 2012 7:59am EDT

(Reuters) - United Therapeutics Corp said it filed a lawsuit against Novartis AG's generic unit Sandoz, alleging infringement of the biotechnology company's patent on its pulmonary hypertension drug.

In January, Sandoz filed a marketing application with the Food and Drug Administration to sell a copycat version of United Therapeutics' pulmonary hypertension drug Remodulin.

Since United Therapeutics has responded within 45 days of the receipt of Sandoz's notice, the FDA will automatically stay approval for the generic version for up to 30 months under the Hatch-Waxman Act.

In the lawsuit, United Therapeutics alleged that Sandoz's generic version of Remodulin will infringe three of its patents on the drug.

United Therapeutics filed the lawsuit in the District Court for the district of New Jersey.

 

15:22, 16 March 2012 Friday

EU agency still probing safety of Novartis MS pill

European regulators are still probing the safety of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, delaying an expected update on the medicine until April.

European regulators are still probing the safety of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, delaying an expected update on the medicine until April.

The European Medicines Agency (EMA) initially aimed to give an update on the medicine by March 16 but a spokeswoman said on Friday that the review had not yet been finalised. As a result, an announcement is now due on April 19 or 20.

The delay leaves a question mark over the product, which has seen its prospects clouded by concern about serious heart problems.

At the end of 2011 as doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.

Those cases prompted the EMA to start its review in January, when it also advised doctors to continuously monitor patients for six hours after giving them a first dose. The U.S. Food and Drug Administration (FDA) is also looking into the drug.
Novartis said in a statement it was working with the EU regulator to finalise the label for Gilenya and was also liaising with the FDA on its review.

 

What a joke, this has been in the label already. Media ... totally clueless!

 

Say NO to Novartis!

From HIV Prevention Justice Alliance

March 19, 2012

Novartis, the Swiss-based pharmaceutical giant, continues its assault on India's generic pharmaceutical industry -- legally challenging India's patent law that allows the nation to supply nearly 80% of the developing world's access to high-quality, affordable, life-saving medications.

India's patent law effectively stops evergreening, a tactic used by pharmaceutical companies to make minor tweaks on medications to extend their stranglehold on a patent that is about to expire.

Should Novartis succeed on March 28th, a dangerous precedent will be set ...

With a chain-reaction of serious consequences.

The costs?

Crippling the generic pharmaceutical industry

Making essential medications even more cost-prohibitive

Cutting off the supply of medications used by NGO's worldwide

Millions of lives that are dependent on these drugs to fight diseases like HIV/AIDS.

Say NO to Novartis

Send the message to Novartis that no loss of human life can ever be tolerated for profits, by signing a petition here.

Learn more on how to Occupy Pharma by joining our working group.

 

Novartis challenges India's patent law


Drug company up for rematch against clause prohibiting indefinite extension of patents.
Priya Shetty

21 March 2012

Pharmaceutical giant Novartis goes to the Indian Supreme Court next week, aiming to weaken the country’s drug-patent law by challenging a clause that prevents ‘evergreening’, a practice in which pharma companies continuously extend the life of a patent by tweaking the drug slightly.

Evergreening keeps drugs out of the reach of generic manufacturers, and therefore, say critics, out of the hands of patients who cannot afford some brand-name drugs. Novartis is also seeking a 20-year patent on a new version of its 11-year-old anticancer drug imatinib mesylate (Gleevec), which costs roughly US$30 for one 100-milligram pill. A generic version of the drug sells for as low as one-tenth of that cost.

Novartis' attempts to change India's patent laws have met with protests in the country.

A win for Novartis would “have a chilling effect” production of generic drugs in India, affecting “all other essential and life-saving drugs, including those for AIDS and TB treatment,” says Leena Menghaney, an activist at the non-governmental organization (NGO) Médecins Sans Frontières (also called Doctors Without Borders), India, who is leading a public awareness campaign against the Novartis case.

When India signed up in 2005 to the World Trade Organization's agreement on trade-related aspects of intellectual property rights (TRIPS), designed to ensure patent protection, the country included a clause, 3(d), that states that a drug must show a marked difference in efficacy from previous versions to be patentable. “Whereas US patent offices often grant frivolous patents on routine pharmaceutical improvements to a drug, India's law is more stringent,” says Menghaney.

Renewed battle

In 2006, the Chennai patent board ruled that Novartis’s variation of Gleevec was not novel enough to be patentable, and in 2007, the Chennai High Court dismissed Novartis’s challenge that clause 3(d) did not fall in line with the TRIPS agreement. However, in 2009, India’s Intellectual Property Appellate Board overturned the 2006 ruling and deemed the drug to be novel and inventive, but said that because the new version didn’t meet the criterion of enhanced efficacy required by 3(d), it still did not merit a patent.

Now Novartis is challenging 3(d) once more and trying again for a new patent on Gleevec. Anand Grover, co-founder and project director for the Lawyers Collective HIV/AIDS Unit in Mumbai, which is battling Novartis alongside the Indian generic-drug manufacturer Natco, says that Novartis is now arguing that section 3(d) relates to “discoveries” (of things already in existence but not previously found) and so doesn’t apply to its patent application, which is an “invention” (the creation of something new) under the Indian patent law.

“Novartis would like the Supreme Court to adopt a low-threshold standard whereby slight improvements will count as significantly enhanced efficacy,” says Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northeastern University School of Law in Boston, Massachusetts. “If this low-hurdle standard is adopted, companies will be able to evergreen their patents in India much as they do in the United States.”

The pharmacy of the poor

A blow to India’s generic industry would also create a ripple effect throughout the developing world, says Baker. “India is a major exporter of generic medicines to developing countries, including 80% of the medicine now used to treat over 6.6 million people living with HIV/AIDS. India's status as the pharmacy of the poor and of the developing world is actually under attack.”

But Paul Herrling, head of corporate research at Novartis in Basel, Switzerland, insists that the case is “about the rewarding of innovation where markets exist, not about impeding access to medicines for poor patients”. He told Nature: “We think that Gleevec is a fundamental breakthrough in medicine. If 3(d) can be used to prevent the patenting of results of innovative biomedical research, it will certainly be a disincentive for both Indian research-based pharmaceutical companies and for foreign companies wanting to be active in India. This would be to the disadvantage of Indian patients.”

India’s defence of its generics industry remains strong — on 9 March it issued its first ‘compulsory licence’ of a patented drug, allowing local manufacturer Natco to produce a generic version of Bayer's sorafenib tosylate, a drug used against liver and kidney cancers. India’s patent controller decided that the company wasn’t selling the drug at a reasonable price for patients in India.

India is not the first to use this tool. In 2007 Brazil issued a compulsory licence on the AIDS drug efavirenz after failing to negotiate lower drug prices with Merck, the drug’s manufacturer.

Menghaney says that the compulsory licence is a victory for advocates of cheaper drugs. “This ruling puts companies on warning that patents are not granted merely to enable them to enjoy a monopoly; there is a consequence for excessive pricing and refusal to license.”

As India awaits the outcome of the Novartis case, Grover is aware that the stakes are high. “If we get knocked out, it’s game over, because there will be no difference between India’s patent law and that of any other country.”

 

SO HOW MUCH $$ FLUSHED DOWN THE DRAIN HERE ?

Accelr8's Q2 Revenues Drop Sharply As Novartis Deal Ends

March 21, 2012

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Accelr8 reported last week that its fiscal second-quarter revenues plummeted to $8,328 from $313,568 a year ago as a result of the expiration of an agreement with Novartis.

For the three months ended Jan. 31, technical development fees dropped to zero from $310,408 a year ago, Accelr8 said in its Form 10-Q filed with the US Securities and Exchange Commission. As reported last October by GenomeWeb Daily News, an agreement with Novartis to evaluate Accelr8's BACcel platform expired without Novartis renewing it.

 

bye bye exjade

Novartis Sues Actavis Over Exjade Iron-Control Drug Patents

By Phil Milford - Mar 22, 2012 10:00 AM ET
..
Novartis AG (NOVN) sued generic-drug maker Actavis Group hf in federal court in Delaware alleging infringement of two U.S. patents for the iron-control drug Exjade.

Novartis, based in Basel, Switzerland, contends Actavis, of Zug, Switzerland, is wrongly planning to market copies of Exjade in the U.S. before the patents expire.

In reply, Actavis, with operations in Iceland and the U.S., has told Novartis its patents “are invalid, unenforceable” and the generic tablets won’t infringe, according to a complaint filed yesterday in Wilmington.

Also yesterday, a person knowledgeable about merger negotiations said Watson Pharmaceuticals Inc. (WPI) is in talks to buy Actavis for as much as 5.5 billion euros ($7.3 billion), sending Watson shares soaring.

The case is Novartis v. Actavis, U.S. District Court, District of Delaware (Wilmington).

To see the patents, click: 6,465,504; 6,596,750.

 

15 years of Novartis. What a great book

 

I SUGGEST YOU CHECK YOUR FACTS FIRST.
NAOMI WAS TOTALLY INCOMPETENT FOR THAT ROLE AND SHE SHIULDNT HAVE BEEN THERE IN THE FIRT PLACE.
AND BRIAN WAS NOT IN CHARGE OF MANUFACTURING

QUOTE=Anonymous;4279239]BECAUSE HE DID SUCH A GOOD JOB AS KINCOLN NEBRASKA DEMONSTRATES
& AS USUAL ANOTHER NVS FEMALE BITES THE DUST

3/5/2012

Novartis has promoted Brian McNamara from region head of its European over-the-counter (OTC) business to head of its entire OTC division.

McNamara replaces Naomi Kelman who Novartis said had decided to leave the company. She had only been in the position since March 2011 after joining from Johnson & Jonson (J&J).

In a statement, Joseph Jimenez, CEO of Novartis, thanked Kelman for her work, and welcomed McNamara as someone who will “provide strong leadership, focusing on growing our priority brands, consistently meeting our quality standards, and improving performance in key emerging markets”.

McNamara has been at Novartis OTC since 2004, when he joined as senior VP and general manager of OTC North America.

He spent three years in the position before moving to Europe as president and region head of Novartis OTC Europe.

Prior to his time at Novartis, he spent 16 years at Procter and Gamble, working in both manufacturing management and brand management.

His appointment comes just two months after Novartis recalled batches of four OTC products in the US following complaints of chipped and broken pills as well as well as inconsistent clearance practices for bottle packaging at a its Lincoln, Nebraska, manufacturing plant.

Novartis temporarily suspended operations at the facility following a warning letter from the US Food and Drug Administration (FDA).

GlaxoSmithKline (GSK) has also been affected by issues at the plant, and was forced to recall nearly 400,000 bottles of its blood pressure treatment DynaCirc CR that made there.[/QUOTE]

 

MORE NVS CORRUPTION

Kentucky, Novartis reach $2.75M settlement in drug-price case
Date: Thursday, March 29, 2012, 4:58pm EDT

Kentucky Attorney General Jack Conway announced Wednesday that the state reached $2.75 million settlement with Novartis Pharmaceuticals Corp. over allegations that the company published false and inflated average wholesale prices for its drugs, according to a news release.

The Kentucky Medicaid program relied on published average wholesale prices to calculate Medicaid drug reimbursement rates, according to a news release.

The lawsuit Conway filed alleged that East Hanover, N.J.-based Novartis and the other defendants published false, inflated and deceptive AWPS for their drugs

 

all of pharma does this. corrupt to bone

 

"where your jobs are going "

Novartis to construct pharma plant in Turkey
4/2/2012
Novartis has selected Turkey as its headquarters for central Asia, the Middle East and Africa and intends to set up a new manufacturing facility in the country.

The Swiss pharma company made the announcement during the course of meetings between a Swiss trade delegation and members of Turkey's government, including Science, Industry and Technology minister Nihat Ergun.

Novartis board member Alexandre Jetzer-Chung said Turkey has emerged as a regional centre in recent years

 

JOE LOVES LAYOFFS !!!! (makes his heart smile)

Novartis's Joe Jimenez on Layoffs in Good Times

Posted on April 05, 2012

When I was named CEO of Novartis (NVS) in 2010, it raised some eyebrows. I wasn’t a scientist or a physician. I was an American. Most of my career had been in consumer packaged goods. Before I joined in 2007, I ran Heinz (HNZ) in Europe; .

It was clear we needed reductions. The business was performing well, but governments around the world were being significantly affected by the debt crisis and were cutting prices in health care. I felt we had to reduce our cost base, and I wanted to do it from a position of strength.

Instead of one big layoff, we had pockets of reduction in 2010. Earlier this year we announced we’d have to cut about 2,000 jobs as (the blood-pressure-lowering drug) Diovan goes off patent. We’re getting costs down to invest for the long term.

I want innovation, & cost reduction, to be the signature I have. Some decisions don’t pay off for years. — As told to Diane Brady

 

Novartis Gilenya patient has infection associated with Tysabri

By Bloomberg News
April 13, 2012

A patient taking Novartis AG’s Gilenya multiple sclerosis pill has been diagnosed with a potentially deadly brain infection.

The patient previously took Tysabri, an injection from Weston-based Biogen Idec Inc. and Elan Corp., Novartis said in an e-mailed statement. Tysabri increases the risk of the viral infection, known as progressive multifocal leukoencephalopathy, that usually leads to death or severe disability, according to a warning the drug’s label has carried since 2006.

“The current assessment is that Tysabri is the drug most likely associated with this case of PML,” Novartis said in the statement. “However, a contribution of Gilenya to the evolution of this case cannot be excluded.”

 

FRONTLINE
Volume 29 - Issue 08 :: Apr. 21-May. 04, 2012

Drug and duplicity

NOVARTIS has long been suing the Government of India to eliminate or weaken Section 3(d) of the Patents (Amendment) Act, 2005, which established strict standards of patentability in order to prevent the ever-greening of patent monopolies on medicines. Although Novartis lost in 2007 its initial efforts to have Section 3(d) declared unconstitutional and violative of international norms for national patent regimes, it has persisted in appealing and re-appealing the denial of its patent application on Glivec, a key anti-cancer medicine whose basic ingredient was invented in 1993, well before India was required to begin granting patents on pharmaceutical products.

Novartis' latest appeal before the Supreme Court of India is scheduled to be heard in July. In that hearing, Novartis will ask the court to eviscerate the existing interpretation of Section 3(d), which limits patents on new forms and versions of existing chemical entities to those rare circumstances when such routine modifications result in a significant improvement in efficacy in terms of treatment of human illness. Novartis wants minor improvements in absorption or stability of the medicine to justify an additional 20-year monopoly.

In previous press statements, Novartis India has said that it is merely seeking clarity on the unique provisions of the Patents Act and that it is not trying to undermine lawful flexibilities in India or elsewhere with respect to the promotion of more affordable medicines. It has specifically said that it respects India's rights under international and domestic law to issue compulsory licences (permission to a generic competitor to make and sell an equivalent product). That was until India actually issued its first compulsory licence on Bayer's cancer medicine, sorafenib, on March 12. There, the Patent Controller ruled that Bayer had neglected to meet the reasonable requirements of the public, that it had charged an unreasonable price ($66,812 per patient a year!) and that it had not worked the product in India by means of any local manufacture.

Following the issuance of the Bayer compulsory licence, Novartis's publicity machinery changed its tune. On March 14, in The Times of India, Novartis' local representative in India, Ranjit Shahani, wrote: “Compulsory licences are powerful rights granted to governments to deal with extraordinary circumstances such as a national health crisis and must hence be used with extreme prudence. As per TRIPS, WTO member states can grant a compulsory licence in case of national emergency, in case of public non-commercial use, in case of anti-competitive practices or in case of a dependent patent if additional criteria are met. If used injudiciously, compulsory licences will in fact work to the detriment of the patient through the negative impact they will have on future investment in innovative pharmaceuticals.”

This statement grossly misstates the operative legal standards for compulsory licences under Article 31 of the World Trade Organisation's (WTO) TRIPS Agreement, but it helps to bring to light Novartis' real position on India's right to issue compulsory licences. Compulsory licences, as made clear both in Article 31 and in the Doha Declaration on the TRIPS Agreement and Public Health, are not limited to “extraordinary circumstances”, let alone to the narrow set of national emergencies, government use, anti-competitive remedies, or dependent patents listed by Shahani. WTO member states, including India, are free to determine any and all grounds upon which compulsory licences may be issued, with explicit acknowledgement that they may do so to promote public health and access to medicines for all.

India's issuance of a compulsory licence on Bayer's sorafenib was not “injudicious”. The Patent Controller's findings were detailed and fully weighed all of the arguments advanced by Bayer. In the end, however, the conclusion was easy – pricing a medicine so that fewer than 200 cancer patients in India could access it, instead of the thousands who needed it, justified a licence to Natco, which could make and sell the same medicine at 3 per cent of the Bayer price while still making a profit and paying a 6 per cent royalty to Bayer. Health activists are hopeful that the sorafenib case will establish a strong precedent for more frequent compulsory licences on key HIV/AIDS, cancer, and psychiatric medicines, indeed, on medicines more generally.

Novartis's overzealous defence of intellectual property rights knows no bounds. It seeks to strengthen and lengthen patent monopolies and prevent the use of hard-fought flexibilities that ensure that poor people will not be left to die. Yet, it has issued pious statements in the past about its benign intentions with respect to the use of lawful TRIPS flexibilities. Now, the façade has been removed to reveal the naked greed that actually motivates Novartis' attack both on its lawful adoption of high standards for patents and on India's use of well-established flexibilities that have been recognised internationally for a century and a half.

Brook K. Baker

Professor Brook K. Baker is with Health GAP (Global Access Project), Northeastern University School of Law Program on Human Rights and the Global Economy, Boston. He is also Honorary Research Fellow, University of KwaZulu Natal, Durban, South Africa.

 

Novartis halts hepatitis drug trial after death
Apr 19, 2012 12:26pm

GENEVA (AP) — Swiss pharmaceutical company Novartis AG says it has halted clinical trials for a new drug to treat hepatitis after one patient died.


The Basel-based company says it has informed the U.S. Food and Drug Administration of "a small number" of reported cases of pancreatitis and one death in patients who were receiving the drug alisporivir and other medication to treat hepatitis C.

Pancreatitis is an inflammation of the pancreas.

Novartis said in a statement Thursday it was notified by the FDA that clinical trials of the drug will be put on hold.

The company reports its first-quarter results on Tuesday.

 

Trying to screw patients again ?

23 April 2012

NHS faces judicial review from Novartis over AvastinBy Branwen Jeffreys

Health correspondent, BBC News

The pharmaceutical company Novartis is challenging the use of a cheaper alternative to its drug Lucentis for a common cause of loss of vision.

The NHS in four areas in the south of England agreed last year that a drug called Avastin could be prescribed for the condition wet AMD.

Lucentis is recommended for use by the NHS drugs watchdog NICE.

Avastin is not officially approved for eye conditions, but is being widely used off licence.

Severe loss of vision
Wet age-related macular degeneration, or AMD, is a common cause of loss of vision in older people.

According to the NHS, around 70% of people with wet AMD will experience severe loss of sight within two years of being diagnosed.

Lucentis, which costs around £740 per injection, is the treatment officially recommended to the NHS in England by the independent advisor NICE.

It was developed for use in eye conditions and has been given a European licence, or safety approval, for treating wet AMD.

The NHS in Southampton, Hampshire, The Isle of Wight and Portsmouth decided last year that it would also pay for the use of Avastin, where it was prescribed by an opthamologist.

Avastin costs around £60 per injection, and has to be used off licence as it has not been formally approved for use in eyes.

'Safety at risk'

Novartis, which makes Lucentis, is seeking a judicial review of the policy to pay for Avastin on the NHS.

The company argues that systems put in place to safeguard patients are being undermined.

Novartis said: "It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available.

"It undermines the regulatory process that was introduced to safeguard patients."

But the four primary care trusts, now working together, which agreed to fund Avastin say it is offered as an extra option for clinicians. They will still pay for the more expensive Lucentis when its prescribed.

The PCTs say the cheaper alternative is safe and useful.

"Avastin is internationally recognised as an effective treatment for AMD, and for example over 50% of AMD patients in the United States are treated with Avastin."

Using a cheaper drug that seems to work well, even if it is not licensed for this condition, saves money.

 

This is from the company that pushed Diovan for Diabetes , The Whole Aliskren family for diabetes , Zelnorm as a prep ( among more recent transgressions ) & has been fined 1/2 a billion & counting for off lable marketing . What hypocritical clowns , the first to jump on any "class effect" story to boot.