Novartis milestones be proud ! Management take a bow !

Quote
Hurting Patients said:
Novartis Jury Awards $10.45 Million for Drug, Lawyer Says

By Christie Smythe - Nov 2, 2012 7:34 PM ET.

Novartis Pharmaceuticals Corp. (NVS) was found liable by a federal jury for jawbone damage in a woman who took the drug Zometa, and she was awarded $10.45 million, a lawyer for the plaintiff said.

A jury in Central Islip, New York, returned the verdict this afternoon, several hours after they began deliberations in the case, said John Vecchione, a lawyer for plaintiff Barbara Davids.

The verdict, which couldn’t be immediately confirmed in court records, is the second-largest among similar cases over Zometa, Vecchione said. It is the fourth win for plaintiffs out of eight Zometa-related jawbone cases that have gone to trial, he said. The jury in the Davids case awarded $450,000 in compensatory damages and $10 million in punitive damages, he said.

“What’s happening is these juries are seeing very bad behavior,” Vecchione said in a phone interview. “These juries are finding this evidence particularly egregious.”

A New York-based spokeswoman for Basel, Switzerland-based Novartis, Julie Masow, said in an e-mail statement that the company is reviewing its options for appeal.

“We are disappointed and disagree with the jury’s verdict,” she said.

2006 Complaint

In a complaint filed in February 2006, Davids alleged that she developed osteonecrosis, or bone death, in her jaw after taking Zometa, a drug she had been prescribed as part of her treatment for breast cancer. Zometa, a bisphosphonate, is a treatment for bone complications that can result from cancer, according to a Novartis website.

During the trial, which began Oct. 2, the attorneys for Davids showed the jurors a May 2003 e-mail in which a Novartis marketing employee described a proposed report linking Zometa to jawbone complications as “quite damaging.” In another e-mail from May 2003 used as evidence in the trial, the employee outlined a strategy to colleagues for “next steps,” including a public relations effort.

“In summary: we’ll try to avoid that the paper is ever published; we will be ready to react in case it gets published,” the employee said in the e-mail. The e-mails were provided to Bloomberg News by Vecchione.

The largest verdict in Zometa-related jawbone osteonecrosis cases was $12.8 million, awarded to a North Carolina woman’s family in November 2010. The award was later reduced to about $1.1 million under state law.

The case is Davids v. Novartis, 2:06-cv-431, U.S. District Court, Eastern District of New York (Central Islip).
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That's horrible , wait until the reclast folks start getting depositioned
 
























Drug caused osteonecrosis of jaw, plaintiff claimed

Verdict: (P) $10,450,000.00
Case Type: Design Defect, Products Liability - Failure to Warn, Products Liability - Breach of Warranty, Products Liability - Pharmaceutical
Case Name: Barbara Davids and Helene Deutsch v. Novartis Pharmaceuticals Corporation, No. 06 431
Venue: U.S. District Court, Eastern District, NY
Judge: Arthur D. Spatt
Date: 11-07-2012
Plaintiff(s):
Attorney(s):

John J. Beins; Beins, Goldberg & Hennessey, LLP; Chevy Chase, MD, for Barbara Davids
John J. Vecchione; Valad & Vecchione, PLLC; Fairfax, VA, for Barbara Davids

Expert(s):

Richard Kraut D.D.S.; Oral Surgery; Bronx, NY called by: John Vecchione, John Beins

Robert Marx D.D.S.; Maxillofacial Surgery; Miami, FL called by: John Vecchione, John Beins

Wayne Ray Ph.D.; Epidemiology; Nashville, TN called by: John Vecchione, John Beins

Suzanne Parisian Ph.D.; FDA New Drug Review/Approval Procedures; Phoenix, AZ called by: John Vecchione, John Beins

Salvatore Ruggiero D.M.D., M.D.; Oral Surgery; West Islip, NY called by: John Vecchione, John Beins

Defendant(s):
Attorney(s):

Bruce J. Berger; Hollingsworth LLP; Washington, DC, for Novartis Pharmaceuticals Corp.
Jacqueline Bushwack; Rivkin Radler LLP; Uniondale, NY, for Novartis Pharmaceuticals Corp.
Robert E. Johnston; Hollingsworth LLP; Washington, DC, for Novartis Pharmaceuticals Corp.

Expert(s):

Kenneth Fleisher M.D.; Maxillofacial Surgery; New York, NY called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston
Graham Russell M.D.; Skeletal Biology; Oxford, MA called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston

Janet Arrowsmith; FDA New Drug Review/Approval Procedures; Ruidoso, NM called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston

Facts:

In October 2003, plaintiff Barbara Davids, 56, a bank's teller, commenced use of a bisphosphonate: Zometa, which is manufactured by East Hanover, N.J.-based Novartis Pharmaceuticals Corp. Davids was suffering cancer of a breast, and the drug's administration was intended to suppress metastatic damage of her bones.

In January 2005, a doctor determined that Davids was suffering osteonecrosis of her jaw. The doctor opined that the condition was a by-product of Davids' use of Zometa. Davids' osteonecrosis ultimately necessitated the removal of portions of her jaw.

Plaintiff's decedent Helene Deutsch also suffered cancer of a breast. Her treatment included the administration of Zometa and another drug that Novartis Pharmaceuticals manufactured, Aredia. Deutsch also developed osteonecrosis of her jaw, and she also claimed that her osteonecrosis was a result of her use of Novartis Pharmaceuticals' drugs.

Davids and Deutsch sued Novartis Pharmaceuticals. They alleged that Aredia and Zometa were inherently dangerous drugs that caused osteonecrosis, that Novartis Pharmaceuticals was aware of the drugs' dangerous effects, that the company failed to provide warnings that adequately disclosed that danger, and that that failure constituted a breach of Zometa's implied warranty of merchantability.

Deutsch died after the suit had been filed. Her estate and Novartis Pharmaceuticals ultimately negotiated a pretrial settlement. Terms were not disclosed. The matter proceeded to a trial that addressed Davids' claims.

Plaintiffs' counsel claimed that Novartis Pharmaceuticals knew that Zometa caused osteonecrosis, and they contended that that knowledge dated to the initial testing of the product. They presented documents that had been written by employees of Novartis Pharmaceuticals. The documents' topics included Zometa's link to osteonecrosis, evaluations of studies that confirmed the link and potential preemptive responses to those studies. Some documents dated to May 2003. Plaintiffs' counsel also noted that Zometa's harmful effects were deeply explored in a May 2004 article that was published by the Journal of Oral and Maxillofacial Surgery. The article's author, Salvatore Ruggiero, agreed that Zometa caused Davids' osteonecrosis.

Plaintiffs' counsel further claimed that Zometa's label and instructions did not satisfy governmentally mandated guidelines that addressed the disclosure of potential hazards. They contended that the drug's original label and instructions did not mention osteonecrosis, and they claimed that revisions did not clearly warn that osteonecrosis could stem from the drug's use.

Defense counsel contended that evidence has not established that Zometa caused osteonecrosis, and they claimed that Davids' osteonecrosis was a result of her cancer. They also claimed that Zometa's label and packaging included warnings that adequately disclosed the drug's potential effects.

Injury:


In November 2004, Davids developed osteonecrosis of her jaw. The condition was diagnosed in January 2005.

Davids' jaw became infected and swollen, and her mouth emitted a foul odor. Her jaw's weakened condition caused the loss of several teeth. She claimed that her disfigurement caused anxiety, discomfort, embarrassment and fear, and she contended that she could not easily chew.

In 2006, Davids underwent the first of several procedures that involved the removal of necrotic portions of her jaw. The procedures continued until 2008, and they included the implantation of dentures that replaced teeth that had been lost.

Davids claimed that her disfigurement caused anxiety, discomfort, embarrassment and fear. She also claimed that she suffers permanent residual numbness of one side of her face.

Davids sought recovery of damages for past and future pain and suffering. She also sought punitive damages.

Defense counsel contended that Novartis Pharmaceuticals did not exhibit the reckless conduct that would have warranted an award of punitive damages.


Verdict Information:

The jury found that Novartis Pharmaceuticals did not adequately disclose the hazards that could stem from Zometa's use, that the company's failure constituted a breach of Zometa's implied warranty of merchantability, and that Davids' osteonecrosis was caused by her use of Zometa. It determined that Davids' damages totaled $10.45 million.


Barbara Davids

$10,000,000 Personal Injury: Punitive Exemplary Damages

$350,000 Personal Injury: Past Pain And Suffering

$100,000 Personal Injury: Future Pain And Suffering
Post Trial:

Defense counsel has moved for a mistrial.
 






6 hospitalized as Novartis manufacturing stumbles again

It has been a tough year for Swiss drugmaker


December 12, 2012 | By Nick Paul Taylor

In another black eye for the manufacturing side of Novartis ($NVS), 6 people had to be hospitalized after inhaling corrosive chemicals from a leak at a plant in Switzerland.

The leak occurred at a production plant near Basel where Novartis makes its blockbuster blood pressure drug Diovan. Police said a few liters of a caustic liquid chemical were spilt, The Local reports, and 13 people who inhaled the fumes needed medical attention. Three of the people who went to a hospital were released within hours. After the spill was reported, the affected areas were vented and returned to normal conditions. No areas outside the plant were affected, local police said.

Staff from an external cleaning company were on site at the time of the spill. Of the 6 people who were taken to a hospital, 5 were from the cleaning company. Novartis is yet to comment publicly on the incident, and is limited in what it can say by a local law that restricts who can report details of chemical spills. Local authorities wield that power exclusively.
 






Deutsche Bank Downgrades Novartis to “Hold” (NVS)


By Michael Flannelly
December 12th, 2012

On Wednesday analysts at Deutsche Bank downgraded pharmaceutical company Novartis (NVS) as it does not see the company keeping up with its past outperformance of consensus expectations.

The analysts downgraded NVS from “Buy” to “Hold.”
 






November 27, 2012


Novartis AG v. Kappos (D.D.C. 2012)

By Donald Zuhn --

In an opinion issued earlier this month, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia determined that Novartis AG and Novartis Vaccines and Diagnostics, Inc. had not satisfied the 180-day limitation of 35 U.S.C. § 154(b)(4)(A) for timely challenging patent term adjustment (PTA) determinations of the U.S. Patent and Trademark Office with respect to nineteen of twenty-three patents at issue, and further, that the 180-day limitation should not be equitably tolled. For three of the four patents for which Novartis had timely challenged the Office's PTA determinations, the District Court adopted the rationale in Exelixis, Inc. v. Kappos, and for the lone remaining patent, the Court determined that the Office erred in not applying the Federal Circuit's decision in Wyeth v. Kappos
 






Novartis' Exelon Patent Is Invalid, UK Appeals Court Says


By Jonathan Randles
Law360, New York (December 12, 2012, 4:56 PM ET) --

A U.K. appeals court on Wednesday affirmed a lower court's ruling invalidating a Novartis AG patent covering the company's Alzheimer's drug Exelon in a lawsuit brought by a subsidiary of generic-drug maker Mylan Pharmaceuticals Inc.
 






Merck, BMS/AZ, Novartis face 2013 German price cuts on DPP-4 diabetes drugs

By Surani Fernando and Kirsty Barnes in London

-----------------------------------------------

Merck (NYSE:MRK), Bristol-Myers Squibb (NYSE:BMY), AstraZeneca (LON:AZN) and Novartis (VTX:NOVN) are facing price cuts in Germany for their dipeptidyl peptidase-4 (DPP-4) inhibitors in diabetes, experts told BioPharm Insight.

Merck’s Januvia (sitagliptin), BMS/AZ’s Onglyza (saxagliptin) and Novartis’ Galvus (vildagliptin) have an upcoming pricing review by The Federal Joint Committee (G-BA), the German reimbursement regulatory body. These oral diabetes drugs were all approved prior to the new AMNOG law (German Act on the Reform of the Market for Medicinal Products), passed in January 2011. The law is to regulate the pricing of newly approved drugs relative to their benefit over already existing therapies and clamp down on potentially inflated drug prices set by drug companies back in Germany’s “free pricing” era.

In 2011, Merck reported global sales of USD 3.3bn for Januvia, BMS/AZ reported global sales of USD 684m for Onglyza, and Novartis reported global sales of USD 677m for Galvus.

All DPP-4s (gliptins) including combinations with generics are required to offer dossiers for an additional benefit assessment, a G-BA spokesperson said. The evaluation will begin on 1 January 2013. The combinations include generic metformin with Januvia and Galvus, according to a G-BA press release. The dossier submission is mandatory for all manufacturers, the G-BA spokesperson noted.

A spokesperson on behalf of BMS and AstraZeneca said the companies will not comment on competitor activity or pricing speculation. Novartis and Merck did not respond to request for comment.
 






Anonymous said:
Merck, BMS/AZ, Novartis face 2013 German price cuts on DPP-4 diabetes drugs

By Surani Fernando and Kirsty Barnes in London

-----------------------------------------------

Merck (NYSE:MRK), Bristol-Myers Squibb (NYSE:BMY), AstraZeneca (LON:AZN) and Novartis (VTX:NOVN) are facing price cuts in Germany for their dipeptidyl peptidase-4 (DPP-4) inhibitors in diabetes, experts told BioPharm Insight.

Merck’s Januvia (sitagliptin), BMS/AZ’s Onglyza (saxagliptin) and Novartis’ Galvus (vildagliptin) have an upcoming pricing review by The Federal Joint Committee (G-BA), the German reimbursement regulatory body. These oral diabetes drugs were all approved prior to the new AMNOG law (German Act on the Reform of the Market for Medicinal Products), passed in January 2011. The law is to regulate the pricing of newly approved drugs relative to their benefit over already existing therapies and clamp down on potentially inflated drug prices set by drug companies back in Germany’s “free pricing” era.

In 2011, Merck reported global sales of USD 3.3bn for Januvia, BMS/AZ reported global sales of USD 684m for Onglyza, and Novartis reported global sales of USD 677m for Galvus.

All DPP-4s (gliptins) including combinations with generics are required to offer dossiers for an additional benefit assessment, a G-BA spokesperson said. The evaluation will begin on 1 January 2013. The combinations include generic metformin with Januvia and Galvus, according to a G-BA press release. The dossier submission is mandatory for all manufacturers, the G-BA spokesperson noted.

A spokesperson on behalf of BMS and AstraZeneca said the companies will not comment on competitor activity or pricing speculation. Novartis and Merck did not respond to request for comment.
Click to expand...

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Current pricing for DPP-4 inhibitors could drop significantly after the negotiations, perhaps by 25%-40% from the current EUR 2/daily dose, one German endocrinologist estimated. It could potentially drop as low as EUR 1.50-1.20, the endocrinologist noted.

It is difficult to estimate the final pricing of these drugs without seeing the overall effects versus other products, said Stefan Walzer, a pricing and reimbursement adviser at MArS Market Access & Pricing Strategy, Germany. EUR 1.50 is a good estimation for the price drop, he noted.
 






AS TRUMP WOULD SAY .....YOU'RE FIRED !!!!!!!!!

Endo Pharma (ENDP), Novartis (NVS) End Development, Manufacturing Agreement
January 7th 2013

Effective as of December 31, 2012, Registrant's subsidiary, Endo Pharmaceuticals Inc. (Nasdaq: ENDP) and Novartis Consumer Health, Inc. (NYSE: NVS) mutually terminated Master Development and Toll Manufacturing Agreement dated May 3, 2001 between the parties.

Pursuant to the Manufacturing Agreement, Novartis Consumer Health manufactured certain of Endo's commercial products and products in development. The Manufacturing Agreement was to terminate effective February 2014. The termination did not give rise to any early termination penalties.
In December 2011, Novartis Consumer Health's Lincoln, Nebraska manufacturing facility was temporarily shut down to facilitate its implementation of certain manufacturing process improvements. As a result, throughout the first half of 2012, Endo experienced short-term supply constraints of certain Endo analgesic products which had been manufactured at this facility prior to the shutdown. Novartis Consumer Health has agreed to reimburse Endo for certain out-of-pocket charges incurred by Endo as a result of such supply constraints. Endo has made alternative arrangements for supply of certain of Endo's analgesic products which had been manufactured at the Nebraska facility prior to the shutdown.
 






Novartis CEO pay cited as Swiss weigh limits to exec compensation

Ballot initiative would give shareholders approval power, forbid some bonuses


January 9, 2013 | By Tracy Staton
CEO Joe Jimenez

The Swiss are up in arms over executive pay again and, once again, Novartis ($NVS) executives are key exhibits in their case. This time, a fair-pay initiative will go up for nationwide vote, giving citizens the chance to weigh in on executive compensation.

As Swiss Info reports, Novartis' lowest-paid employee would have to work 266 years to earn the $17.1 million (15.7 million Swiss francs) that CEO Joe Jimenez earned in 2011. That's the largest wage gap reported by the trade union Travail Suisse in an annual survey. In third place was Novartis Chairman Daniel Vasella, whose 2011 compensation was 229 times the lowest-paid employee's salary, the union says.

FiercePharma's own research put Jimenez's 2011 compensation at $15.7 million, just about in the middle of the pack of pharma's highest paid CEOs. Vasella had been a perennial entry on the CEO pay list, hitting No. 2 in 2010 with $27 million, which included his $12.8 million retirement payout.

Novartis executives and their paychecks have been in the spotlight for several years, with unions, investor groups and others decrying the numbers before each annual meeting. Last year, the shareholder group Ethos campaigned against compensation committee members as a way to object to Vasella's 2011 compensation. In 2011, about 38% of shareholders gave a thumbs down to Vasella's 2010 package. And the year before that, a Swiss proxy advisor questioned Vasella's 2009 bonus of about $6 million.

Now, the vote goes to the Swiss citizenry. A ballot initiative up for vote March 3 would give shareholders the right to decide on compensation for directors, executives and advisory board members, the news service says. Golden handshakes and buyout bonuses would be verboten. If the initiative fails, an already-approved proposal that adopts some of the initiative's provisions would take effect.

"There is no economic justification for exorbitant executive salaries," Jean-Jacques Friboulet, professor for economic ethics at Fribourg University, told Swiss Info. The fast growth in executive pay shows that the market can't properly regulate compensation, Fribulet said, and that's why shareholders need the power to give a thumbs-down to executive pay.
 






Jimenez Absurd Salary said:
Novartis CEO pay cited as Swiss weigh limits to exec compensation

Ballot initiative would give shareholders approval power, forbid some bonuses


January 9, 2013 | By Tracy Staton
CEO Joe Jimenez

The Swiss are up in arms over executive pay again and, once again, Novartis ($NVS) executives are key exhibits in their case. This time, a fair-pay initiative will go up for nationwide vote, giving citizens the chance to weigh in on executive compensation.

As Swiss Info reports, Novartis' lowest-paid employee would have to work 266 years to earn the $17.1 million (15.7 million Swiss francs) that CEO Joe Jimenez earned in 2011. That's the largest wage gap reported by the trade union Travail Suisse in an annual survey. In third place was Novartis Chairman Daniel Vasella, whose 2011 compensation was 229 times the lowest-paid employee's salary, the union says.

FiercePharma's own research put Jimenez's 2011 compensation at $15.7 million, just about in the middle of the pack of pharma's highest paid CEOs. Vasella had been a perennial entry on the CEO pay list, hitting No. 2 in 2010 with $27 million, which included his $12.8 million retirement payout.

Novartis executives and their paychecks have been in the spotlight for several years, with unions, investor groups and others decrying the numbers before each annual meeting. Last year, the shareholder group Ethos campaigned against compensation committee members as a way to object to Vasella's 2011 compensation. In 2011, about 38% of shareholders gave a thumbs down to Vasella's 2010 package. And the year before that, a Swiss proxy advisor questioned Vasella's 2009 bonus of about $6 million.

Now, the vote goes to the Swiss citizenry. A ballot initiative up for vote March 3 would give shareholders the right to decide on compensation for directors, executives and advisory board members, the news service says. Golden handshakes and buyout bonuses would be verboten. If the initiative fails, an already-approved proposal that adopts some of the initiative's provisions would take effect.

"There is no economic justification for exorbitant executive salaries," Jean-Jacques Friboulet, professor for economic ethics at Fribourg University, told Swiss Info. The fast growth in executive pay shows that the market can't properly regulate compensation, Fribulet said, and that's why shareholders need the power to give a thumbs-down to executive pay.
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Executives have become the aristocracy of these days. They do not earn the monies paid to them by corporations basically without approval by the owners, the shareholders. So it is just like in the medieval days when then nobility took whatever they wanted and beyond what they needed. Here we have these super greedy no good sons of beatches who managed to move up the corporate food chain, who use every means of BS to make themselves indespensible (which they never are) thus free to take whatever they want. 266 times the lowest paid Novartis slave? That in Switzerland where everyone is supposed to be paid well? Hope the referendum will stop this for the Swiss people although cultured and calm will do the right thing. Enough of these fuckers fucking everyone for their nerrow interest and greed.
Imagine that cock sucker Vasella has his own choper that Swiss police asks for sometimes to use in emergencies. How discussing is than? He is just another schmuck who learned the biz basics, married the chairs daughter and put in charge of Sandoz and then Novartis. Ever since he got on top, this company has become an criminal enterprise that uses all kinds of criminla practices to enrich the co to some degree but mainly these blood sucking fuckers. For every dollar, Swiss Frank and other currencies this Co makes (better terms; loots, steals, plunders) using legal means, they make another or more using their well established criminal means.
Someone has to stop the fuckers by legal, illegal and/or violent means. It will be a good and right thing to do.
 






Jimenez Absurd Salary said:
Novartis CEO pay cited as Swiss weigh limits to exec compensation

Ballot initiative would give shareholders approval power, forbid some bonuses


January 9, 2013 | By Tracy Staton
CEO Joe Jimenez

The Swiss are up in arms over executive pay again and, once again, Novartis ($NVS) executives are key exhibits in their case. This time, a fair-pay initiative will go up for nationwide vote, giving citizens the chance to weigh in on executive compensation.

As Swiss Info reports, Novartis' lowest-paid employee would have to work 266 years to earn the $17.1 million (15.7 million Swiss francs) that CEO Joe Jimenez earned in 2011. That's the largest wage gap reported by the trade union Travail Suisse in an annual survey. In third place was Novartis Chairman Daniel Vasella, whose 2011 compensation was 229 times the lowest-paid employee's salary, the union says.

FiercePharma's own research put Jimenez's 2011 compensation at $15.7 million, just about in the middle of the pack of pharma's highest paid CEOs. Vasella had been a perennial entry on the CEO pay list, hitting No. 2 in 2010 with $27 million, which included his $12.8 million retirement payout.

Novartis executives and their paychecks have been in the spotlight for several years, with unions, investor groups and others decrying the numbers before each annual meeting. Last year, the shareholder group Ethos campaigned against compensation committee members as a way to object to Vasella's 2011 compensation. In 2011, about 38% of shareholders gave a thumbs down to Vasella's 2010 package. And the year before that, a Swiss proxy advisor questioned Vasella's 2009 bonus of about $6 million.

Now, the vote goes to the Swiss citizenry. A ballot initiative up for vote March 3 would give shareholders the right to decide on compensation for directors, executives and advisory board members, the news service says. Golden handshakes and buyout bonuses would be verboten. If the initiative fails, an already-approved proposal that adopts some of the initiative's provisions would take effect.

"There is no economic justification for exorbitant executive salaries," Jean-Jacques Friboulet, professor for economic ethics at Fribourg University, told Swiss Info. The fast growth in executive pay shows that the market can't properly regulate compensation, Fribulet said, and that's why shareholders need the power to give a thumbs-down to executive pay.
Click to expand...


Joe I know that you read this stuff, say it ain't so Joe.
 












Accredo receives Justice Department subpoena for info on Novartis drug deal
By Toby Sells

Posted November 6, 2012 at 10:20 a.m


Accredo Health Group received a subpoena from the U.S. Department of Justice in October seeking information on a business arrangement with Novartis Pharmaceutical Corp

Express Scripts, the parent company of the Memphis-based specialty pharmacy, said in a regulatory filing Tuesday it received a subpoena duces tecum from the Justice Department's Southern District of New York last month. That type of subpoena orders people or companies to appear in court and produce documents or other evidence that can be used in a hearing or a trial.

The government wants more information about Accredo's arrangement with Novartis on its drug Exjade, a treatment for an overload of iron brought on by blood transfusions.

"The company is cooperating with the inquiry and is not able to predict with certainty the timing or outcome of this matter," the company said its filing with the U.S. Securities and Exchange Commission.
 






Exjade Subpoena said:
Accredo receives Justice Department subpoena for info on Novartis drug deal
By Toby Sells

Posted November 6, 2012 at 10:20 a.m


Accredo Health Group received a subpoena from the U.S. Department of Justice in October seeking information on a business arrangement with Novartis Pharmaceutical Corp

Express Scripts, the parent company of the Memphis-based specialty pharmacy, said in a regulatory filing Tuesday it received a subpoena duces tecum from the Justice Department's Southern District of New York last month. That type of subpoena orders people or companies to appear in court and produce documents or other evidence that can be used in a hearing or a trial.

The government wants more information about Accredo's arrangement with Novartis on its drug Exjade, a treatment for an overload of iron brought on by blood transfusions.

"The company is cooperating with the inquiry and is not able to predict with certainty the timing or outcome of this matter," the company said its filing with the U.S. Securities and Exchange Commission.
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any exjade reps care to comment ???? like wtf is going on here ????
 






Novartis: U.S. Probing Export of Alcon Products to Iran, Other Trade-Sanction Countries

Published January 23, 2013

Dow Jones Newswires

U.S. authorities are investigating the export of products made by Novartis AG's (NVS) Alcon eye-care unit to various countries subject to U.S. trade sanctions, including Iran, Novartis said Wednesday.

Alcon was notified during 2012 that the U.S. Attorney's Office for the Northern District of Texas is conducting the probe, Novartis disclosed in an annual report filed Wednesday with the U.S. Securities and Exchange Commission.

Alcon received a grand-jury subpoena seeking documents dating back to 2005, in connection with the investigation, Novartis said.

Novartis spokesman Eric Althoff said Alcon is cooperating with the investigation and the company can't comment further on the specifics of the investigation.

The U.S. has imposed sanctions that generally bar the export of goods and services to Iran from the U.S. or by Americans, with certain narrow exceptions, according to the U.S. Treasury Department's Office of Foreign Assets Control.

Switzerland-based Novartis acquired Alcon in a series of transactions over several years that were completed in 2011. Alcon, with U.S. headquarters in Fort Worth, Texas, had been majority-owned by Nestle SA (NSRGY).

In a separate disclosure in its annual report, Novartis said that non-U.S. affiliates within the company's vaccines division sold influenza and rabies vaccines to an entity believed to be affiliated with the Iranian Ministry of Health during 2012.
 






We hardly knew yee

Novartis withdraws marketing application for Ruvise

LONDON | Thu Jan 24, 2013 11:09am EST

(Reuters) - Swiss drugmaker Novartis has withdrawn a marketing application for its drug Ruvise, designed to treat arterial hypertension, the European Medicines Agency (EMA) said on Thursday.

The drug, known generically imatinib mesilate, was intended for use in adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH), the drug regulator said in a statement.

EMA reported that Novartis had said that the withdrawal was because it requires additional data to address the regulator's questions relating to its benefit-risk assessment.
 






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