Novartis milestones be proud ! Management take a bow !

Former Novartis U.S. oncology head Bill Hinshaw jumps ship to metabolic startup
by Ben Adams |
May 31, 2018 9:00am

Hinshaw joins a stream of former Novartis cancer execs to end up in biotech roles.

Novartis continues its hemorrhaging of executives seeking new careers at smaller, younger biotechs as its EVP and head of U.S. oncology Bill Hinshaw takes the reins at Axcella Health.

Axcella Health is a very early-stage company (it expects to have data from several pre-IND human signal-seeking studies across a few disease indications “in the coming months”) that’s working on “a new class of products to rebalance patients’ metabolic state to address serious unmet medical needs,” the biotech says.

Specifically, Axcella is “combining endogenous metabolic modulators to develop powerful new medicines with the goal of addressing metabolic dysregulation by safely reprogramming cellular physiology with unprecedented multifactorial effects.”

Its so-called ‘AXA’ product candidates “leverage the diversity and synergy of metabolic modulators to restore health across a network of dysregulated pathways,” with early programs that include liver, muscle, CNS and other target indications.

The biotech has been quietly plugging away on its early-stage work, with much of its public face over the past year focused on hiring new faces, including another former Novartis cancer exec David Epstein in January as its chair, and a CMO in Manu Chakravarthy, M.D., Ph.D., coming from Eli Lilly as its global head of innovation strategy and external R&D.

So, what brought Hinshaw, who helped lead all aspects of Novartis’ $6 billion revenue U.S. oncology business, including products such as Tasigna, Gleevec, and CAR-T drug Kymriah, to this little-known company with much more risk, and much less money?

“I will be forever grateful for the significant experiences and great teams that I led at Novartis,” he told FierceBiotech. “At this stage of my career, I wanted to join a company as CEO where I could lead and work with the team in shaping a discovery and development program to bring real innovation forward to the market, and thus broader access to patients.

“Biotech is unique in that it provides the opportunity to fully integrate the life cycle and launch of truly impactful products. I was specifically attracted to biotech because it provides the opportunity for me to engage in the whole life cycle of development, and the launch of differentiated therapies that can provide clear benefit to patients and the healthcare system.

“Axcella fills all of these criteria and additionally, provides an opportunity for me to join a company at an inflection point in its life cycle where I can directly impact its growth and development as a company. At this stage of my career, I feel I have the relevant experience and personal circumstances that position me to pursue this approach and lead an organization passionate about that same vision.”

Why specifically Axcella, when presumably there were offers elsewhere? Did Epstein help tip the balance? “I was attracted to Axcella due to the science, the platform, the development model, the stage of the company, and the opportunity to lead a talented and passionate team,” Hinshaw explained.

“The science is fundamental to human health and offers the potential to restore the balance of health in a powerful and safe way. The platform allows for disease-matched design of AXA candidates, that could potentially address the many diseases that have multifactorial metabolic dysregulation at their core.

“The stage of company allows for tremendous learning and growth as a leader, individual, and for us as a management team. The people at Axcella are skilled, bright, committed to the vision, and fun. Of course, I am also very excited to work with David [Epstein] again; he is a vastly experienced leader with whom I have a strong working relationship. His own transition from big pharma to an entrepreneurial environment is an additional plus.”

“Bill joins Axcella’s leadership team at a key inflection point in the company’s strategic and clinical evolution with a proven track record of overseeing the successful clinical development and commercialization of numerous therapeutic franchises across multiple geographies,” said Epstein, also an executive partner at VC Flagship Pioneering.

“Axcella has made substantial progress in 2018 as we continue advancing our proprietary platform and expanding our pipeline of novel metabolic modulators. We are excited to have Bill on board to lead the company through its next phase.”

Ameet Mallik, who has been region head of Latin America and Canada for Novartis oncology, replaces Hinshaw as U.S. oncology head.

This follows a series of departures for senior Novartis execs over the last few years, which includes Epstein, who led Novartis Pharmaceuticals for six years, as well as Usman "Oz" Azam, who exited to take the CEO spot at Tmunity Therapeutics. Then there’s Alessandro Riva, who left for Gilead, where he is EVP of oncology therapeutics; Hugh O'Dowd, who ended up as chief of Neon Therapeutics; and Mahesh Karande, who signed on as president and CEO at Macrolide Pharmaceuticals recently and was formerly vice president and head of Novartis' breast and renal oncology unit in the U.S.

And at the start of the year Liz Barrett, former global president of oncology at Pfizer, became CEO of Novartis Oncology, and took over from Bruno Strigini, who was said by Novartis to have retired for “personal reasons.”
 






Funny Coming from the company that paid a QUARTER BILLION FINE for sexism & discriminationo_O
Oh & $6900? :eek: when you can get generic Maxalt for $10-25 bucks monthly as needed
Keep dreaming :D

HEALTH NEWS
JUNE 1, 2018 / 7:45 AM / UPDATED 9 HOURS AGO
Novartis readies anti-sexism message for migraine drug

John Miller


ZURICH (Reuters) - With women hardest hit by migraine headaches, Swiss drugmaker Novartis is gearing up its marketing message to counteract sexism that it worries might become a barrier to adoption of its new medicine Aimovig.

The injectable monoclonal antibody that Novartis has developed with Amgen won approval in the United States this month and on Friday bagged a recommendation from a key European panel, clearing the way for likely approval on the continent.

The drug is expected to be high priced, though countries negotiate their own terms with the company. In the United States, the drug is priced at $6,900 a year. Novartis is also considering new pricing models for Aimovig.
 






Merck and Novartis gender bias suits draw renewed attention, and New York is taking action
by Angus Liu |
Jun 28, 2018 12:45pm

New York is looking into allegations of pregnancy discrimination against Merck and Novartis. (Merck)
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As the #MeToo movement puts workplace sexual harassment at the front, Merck & Co. and Novartis, two of the largest pharma companies, find themselves entangled in a different kind of gender problem: alleged pregnancy discrimination.

A spokesman with law firm Sanford Heisler Sharp, which represents the women in the Merck lawsuit, told FiercePharma that about 700 people have opted in to the case, adding that the suit has a potential to include up to 3,500 plaintiffs. A trial date has not been set. Merck had eliminated about 40,900 positions by the end of 2016 through two major restructuring rounds since the Scherling-Plough megamerger.

Merck isn’t the only pharma company that has been under fire with gender-bias complaints. Novartis in 2010 agreed to pay $175 million to settle a similar suit. Christine Macarelli, a former Novartis saleswoman, said in that case that her supervisor told her “women who find themselves in my position—single, unmarried—should consider an abortion,” the NYT reported.

Now both Merck and Novartis are under scrutiny from the New York state government’s Division of Human Rights. The agency just sent the companies letters requesting information about the discrimination claims. Because New York has a law requiring employers to accommodate pregnant workers, the state could seek damages though administrative complaints, according to the NYT.

A Novartis spokesperson told FiercePharma that the 2010 settlement agreement came with a post-trial monitoring program “which concluded there were no disparities in pay or promotion for women in our sales organization.”

“Following the settlement, Novartis enhanced many of these ongoing commitments and added programs and initiatives to further strengthen its commitment to a diverse and inclusive environment,” the spokesperson said. He pointed to several external gender-equality awards the company has won, including being inducted into Diversity’s Hall of Fame this year and recognized as “100 Best Companies” by Working Mother Magazine. Merck's representative mentioned that the company earned the same title for the past 26 consecutive years.
 






File it under the Michael Cohen style investment

Novartis dumps Aveo drug as relationship sours
by Nick Paul Taylor |
Jul 3, 2018 9:38am


Novartis has walked away from Aveo Pharmaceuticals’ AV-380 three years after paying $15 million (€13 million) upfront for the asset. The action cuts short a relationship that was starting to sour amid the slow progress of the treatment for severe, cancer-related weight loss.

The fate of AV-380 changed quickly late last week. On Thursday, Aveo, frustrated by the slow progress of AV-380, sent Novartis a notice disputing the Swiss pharma’s compliance with the obligations set out in the 2015 agreement. The next day, Novartis told Aveo it is terminating the pact in 60 days and handing back the worldwide rights to AV-380.

That action will free Novartis from its ongoing obligations related to AV-380 but Aveo still plans to hold it to account for its earlier actions, or lack thereof. Having sent Novartis the notice last week, Aveo is now gearing up to talk to management at its former partner. If those talks fail to resolve the dispute, the case could go to arbitration.
 






Novartis to Drop Anti-Infectives Research Programs and Lay Off 140
Published: Jul 12, 2018 By Mark Terry

The Novartis Institutes for BioMedical Research (NIBR) is ending its early-stage anti-infectives research programs located in Emeryville, California. As a result, the company expects to lay off about 140 employees.

In a statement, Novartis said, “The groups that are impacted in their entirety are antibacterial and antiviral research. As a result, other groups are also affected including, Pharmacology, Protein Sciences, Project Management and global support functions in Global Discovery Chemistry, NIBR Informatics, Scientific Operations and Translational Medicine. About 150 employees will remain in the San Francisco Bay Area in support of NIBR and our drug discovery efforts.”

One of the programs being cut is LYS228, what was touted as a new agent to impact antibiotic-resistant strains of various bacteria, including Enterobacteriaceae, which includes Escherichia coliand Klebsiella pneumoniae. According to a 2017 brief on the Novartis website, LYS228 “was built with the tools of modern drug development. One major resource was a library of E. coli strains that were genetically identical except that each came with a different type of beta-lactamase enzyme. By testing compounds against these strains, Novartis scientists determined how each enzyme impacted the ability of the compounds to kill E. coli.”

Novartis reported in February that it was laying off 65 people at its Broomfield, Colorado location run by its Sandoz division. At that time, the company indicated it was because of double-digit price erosion caused by consolidation and increased competition in the U.S. generic market. This is the same site that announced in October 2017 that it was cutting 450 jobs over a two-year period.

And in May 2017, the company announced plans to cut 250 jobs in New Jersey and 500 jobs in Basel, Switzerland.

On the other hand, AveXis, a Novartis company based in Illinois, is currently building a new manufacturing plant in Durham, North Carolina that is expected to create 200 jobs. This will be used to make its first product candidate, AVXS-101, a gene therapy to treat three types of spinal muscular atrophy (SMA).

Novartis’ cutting in the anti-infectives area is a bit puzzling, although the company is working hard to restructure and cut costs. According to Informa, there are about 327 anti-infective vaccines in preclinical testing and 282 more in Phase I through pre-registration. But big pharma has been cautious about antibiotics for some time, largely because the competition from generics makes it difficult to eke out a profit. As a result, much of the research and development in the area has gone to smaller biotechs that are using new approaches. That includes companies such as Moderna, which focuses on anti-infectives and vaccines using messenger RNA, or Nabriva Therapeutics, who reported positive topline results in May from its Phase III clinical trial of oral lefamulin in adults with moderate community-acquired bacterial pneumonia. Nabriva expects to submit the drug to regulatory authorities in this year’s fourth quarter.

Novartis stated, “While the science for these programs is compelling, we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicine that will have a positive impact for patients. The need for these types of medicines is clear and to maximize the changes that these programs will one day help patients. We are actively engaged in out-licensing discussions with companies focused on developing medicines in these areas.”
 






MY MY WHAT A TANGLED WEB

Senate Democrats blast former Trump attorney for 'selling access' to White House

BENJAMIN SIEGEL, MATTHEW MOSK and KYRA PHILLIPS


Michael Cohen’s relationship with the Swiss drug company Novartis was more extensive than the company previously disclosed, as shown in newly uncovered emails exchanged by President Donald Trump’s former lawyer and the company’s former top executive.

In a report released by Senate Democrats on Friday morning blasting Cohen for “selling access” to the White House, senate investigators revealed that they have obtained dozens of emails between Cohen and former Novartis CEO Joseph Jimenez. These communications, shared exclusively with ABC News, shed new light on the services Cohen provided through Essential Consultants LLC, a shell company he formed shortly before Election Day.

Novartis paid $1.2 million to Essential Consultants, the same company Cohen used to make payments to the adult film star known as Stormy Daniels to keep quiet about her allegations of an affair with Trump.

In one exchange, Democrats say Cohen appeared to discuss drug pricing proposals with Jimenez after meetings between the administration and the pharmaceutical industry. In another, he appeared to encourage Novartis to consider investing in a pharmaceutical company tied to a firm linked to a Russian billionaire that Cohen also represented.


In an early version of their agreement, Novartis specifically asked Cohen to "provide access to key policymakers in the US Government" under the contract’s scope of work. Cohen deleted that reference, replacing it in the final version of the contract with an offer “to provide consulting and advisory services.”

Wyden told ABC News he believes Cohen’s intentions were clear, but said many questions remain and he and his colleagues will continue to investigate.

“What troubles me is that it sure looks like what Novartis got out of this deal was a direct line of access to the White House for their priorities,” Wyden said. “We still don’t know the kind of White House access Cohen was granting to undisclosed clients, or whether Cohen served as a foreign agent.”

Following the release of the report, a spokesperson for Novartis provided a statement to ABC News acknowledging those additional communications but disputing the conclusions drawn from them. Novartis executives “never asked Mr. Cohen to perform any services on our behalf after March 1, nor did he perform any,” a spokesperson said.

“We disagree with the report’s conclusion that we issued a misleading public statement regarding the extent of our engagement with Mr. Cohen,” the spokesperson said. “As we have already acknowledged, Novartis made a mistake in entering into the contract with Michael Cohen. And in hindsight – and certainly knowing everything we know now – we should have tried to terminate the contract with Mr. Cohen regardless of our views at the time of its legal enforceability.”

Novartis provided the documents to the Senate voluntarily, while Wyden said other clients of Cohen’s consulting company, including AT&T, have declined Senate requests to provide their records of communications with Essential Consultants.

The White House and the president’s personal attorneys declined to comment. Representatives for Jimenez, the former CEO, did not respond to a request for comment.

In a letter to employees in May after news of the agreement with Cohen became public, current Novartis CEO Vasant Narasimhan wrote that the company “made a mistake” in working with the longtime Trump insider but maintained that its contact with Cohen was brief and inconsequential.

Executives held only a single meeting with Cohen, the company said, before they realized the relationship would prove unhelpful and lamented that they were obligated under their contract to pay out the $1.2 million in fees they owed him. Cohen never lobbied the administration on behalf of Novartis, former CEO Jimenez told Bloombergand Forbes, and he never provided access to the Trump administration.

“Michael Cohen was somebody who was introduced to us, and he was unknown to us, but he was said to be somebody who could help,” Jimenez said in May. “After my team met with him individually, it was clear that he oversold his abilities.”

The newly disclosed emails show Cohen had multiple contacts with Jimenez on substantive matters, including federal drug pricing policy, over the course of six months.

In June 2017, Jimenez, replying to a request from Cohen, sent an email containing a six-point plan for the Trump administration entitled “Drug Pricing Cost Initiatives. In their response to the senators, Novartis said Cohen told Jimenez at the time that a "friend with experience in the pharmaceutical industry" was preparing ideas for a discussion with Trump administration officials.

Cohen responded that “the information you provided was a great beginning. I am expecting to receive in a few days their version and will scan to you under privileged and confidential communication.”

Novartis wrote in their letter to the Senate that Cohen "never told Mr. Jimenez the name of his friend or any other person his friend was working with." Novartis also said the discussion of drug policy was not part of their consulting agreement, but rather a discussion held as “a courtesy.”

Democrats claim several of those points were similar to proposals included in a report Trump released in May 2018 outlining the administration’s priorities on addressing the cost of prescription drugs, but it is unclear whether they were drawn from the company’s six-point plan -- a list including cost-lowering initiatives Novartis and other pharmaceutical companies had advocated for publicly.

According to Bryson Morgan, a Washington attorney who served as Investigative Counsel at the U.S. House of Representatives Office of Congressional Ethics, if Cohen made contact with President Trump or other federal officials, he would have been required to register as a lobbyist.

“That’s lobbying,” he said. “It’s the public’s right to know who is trying to influence the government, and through what means, and for what compensation. It’s an important mechanism for the public being able to hold their public officials accountable.”

It is unclear whether the Novartis arrangement has any connection to ongoing investigations into Cohen’s business activities or Special Counsel Robert Mueller’s ongoing investigation of Russian meddling in the 2016 election.

Novartis was contacted by Mueller’s team in November of 2017 about its agreement with Essential Consultants. In addition to contacts about drug pricing, Cohen also communicated with Novartis about an autism drug being developed by Yamo Pharmaceuticals, a company linked to investment firm Columbus Nova, which had also signed him to a hefty consulting contract.

Columbus Nova is run by Andrew Intrater, an American businessman whose cousin, Viktor Vekselberg, is a Russian billionaire with close ties to Russian president Vladimir Putin. Vekselberg was recently sanctioned by the U.S. Treasury alongside his company Renova Group.


Intrater is a minority investor in Hoffman Technologies LLC, the controlling shareholder of Yamo Pharmaceuticals, the company revealed in a letter to Democrats.

"Mr. lntrater appraised Mr. Cohen of the Varno project and asked him if he knew anyone who would be interested in partnering with the company, advocacy groups and/or attract pharmaceutical industry partners," the company wrote.

A spokesman for Columbus Nova has not responded to a request for comment.

Late last year, Vekselberg was stopped at a New York airport by federal agents working for Mueller and questioned, according to the New York Times. The Times also reported that Intrater was separately interviewed by the special counsel.

Last month, ABC News reported that guest lists show Vekselberg and Intrater attended the “Candlelight Dinner” in Washington’s Union Station on the eve of Trump’s inauguration, a perk for major contributors to the Presidential Inaugural Committee.

According to a source familiar with the arrangements, they were seated at the dinner next to Michael Cohen and his family.
 






MY MY WHAT A TANGLED WEB

Senate Democrats blast former Trump attorney for 'selling access' to White House

BENJAMIN SIEGEL, MATTHEW MOSK and KYRA PHILLIPS


Michael Cohen’s relationship with the Swiss drug company Novartis was more extensive than the company previously disclosed, as shown in newly uncovered emails exchanged by President Donald Trump’s former lawyer and the company’s former top executive.

In a report released by Senate Democrats on Friday morning blasting Cohen for “selling access” to the White House, senate investigators revealed that they have obtained dozens of emails between Cohen and former Novartis CEO Joseph Jimenez. These communications, shared exclusively with ABC News, shed new light on the services Cohen provided through Essential Consultants LLC, a shell company he formed shortly before Election Day.

Novartis paid $1.2 million to Essential Consultants, the same company Cohen used to make payments to the adult film star known as Stormy Daniels to keep quiet about her allegations of an affair with Trump.

In one exchange, Democrats say Cohen appeared to discuss drug pricing proposals with Jimenez after meetings between the administration and the pharmaceutical industry. In another, he appeared to encourage Novartis to consider investing in a pharmaceutical company tied to a firm linked to a Russian billionaire that Cohen also represented.


In an early version of their agreement, Novartis specifically asked Cohen to "provide access to key policymakers in the US Government" under the contract’s scope of work. Cohen deleted that reference, replacing it in the final version of the contract with an offer “to provide consulting and advisory services.”

Wyden told ABC News he believes Cohen’s intentions were clear, but said many questions remain and he and his colleagues will continue to investigate.

“What troubles me is that it sure looks like what Novartis got out of this deal was a direct line of access to the White House for their priorities,” Wyden said. “We still don’t know the kind of White House access Cohen was granting to undisclosed clients, or whether Cohen served as a foreign agent.”

Following the release of the report, a spokesperson for Novartis provided a statement to ABC News acknowledging those additional communications but disputing the conclusions drawn from them. Novartis executives “never asked Mr. Cohen to perform any services on our behalf after March 1, nor did he perform any,” a spokesperson said.

“We disagree with the report’s conclusion that we issued a misleading public statement regarding the extent of our engagement with Mr. Cohen,” the spokesperson said. “As we have already acknowledged, Novartis made a mistake in entering into the contract with Michael Cohen. And in hindsight – and certainly knowing everything we know now – we should have tried to terminate the contract with Mr. Cohen regardless of our views at the time of its legal enforceability.”

Novartis provided the documents to the Senate voluntarily, while Wyden said other clients of Cohen’s consulting company, including AT&T, have declined Senate requests to provide their records of communications with Essential Consultants.

The White House and the president’s personal attorneys declined to comment. Representatives for Jimenez, the former CEO, did not respond to a request for comment.

In a letter to employees in May after news of the agreement with Cohen became public, current Novartis CEO Vasant Narasimhan wrote that the company “made a mistake” in working with the longtime Trump insider but maintained that its contact with Cohen was brief and inconsequential.

Executives held only a single meeting with Cohen, the company said, before they realized the relationship would prove unhelpful and lamented that they were obligated under their contract to pay out the $1.2 million in fees they owed him. Cohen never lobbied the administration on behalf of Novartis, former CEO Jimenez told Bloombergand Forbes, and he never provided access to the Trump administration.

“Michael Cohen was somebody who was introduced to us, and he was unknown to us, but he was said to be somebody who could help,” Jimenez said in May. “After my team met with him individually, it was clear that he oversold his abilities.”

The newly disclosed emails show Cohen had multiple contacts with Jimenez on substantive matters, including federal drug pricing policy, over the course of six months.

In June 2017, Jimenez, replying to a request from Cohen, sent an email containing a six-point plan for the Trump administration entitled “Drug Pricing Cost Initiatives. In their response to the senators, Novartis said Cohen told Jimenez at the time that a "friend with experience in the pharmaceutical industry" was preparing ideas for a discussion with Trump administration officials.

Cohen responded that “the information you provided was a great beginning. I am expecting to receive in a few days their version and will scan to you under privileged and confidential communication.”

Novartis wrote in their letter to the Senate that Cohen "never told Mr. Jimenez the name of his friend or any other person his friend was working with." Novartis also said the discussion of drug policy was not part of their consulting agreement, but rather a discussion held as “a courtesy.”

Democrats claim several of those points were similar to proposals included in a report Trump released in May 2018 outlining the administration’s priorities on addressing the cost of prescription drugs, but it is unclear whether they were drawn from the company’s six-point plan -- a list including cost-lowering initiatives Novartis and other pharmaceutical companies had advocated for publicly.

According to Bryson Morgan, a Washington attorney who served as Investigative Counsel at the U.S. House of Representatives Office of Congressional Ethics, if Cohen made contact with President Trump or other federal officials, he would have been required to register as a lobbyist.

“That’s lobbying,” he said. “It’s the public’s right to know who is trying to influence the government, and through what means, and for what compensation. It’s an important mechanism for the public being able to hold their public officials accountable.”

It is unclear whether the Novartis arrangement has any connection to ongoing investigations into Cohen’s business activities or Special Counsel Robert Mueller’s ongoing investigation of Russian meddling in the 2016 election.

Novartis was contacted by Mueller’s team in November of 2017 about its agreement with Essential Consultants. In addition to contacts about drug pricing, Cohen also communicated with Novartis about an autism drug being developed by Yamo Pharmaceuticals, a company linked to investment firm Columbus Nova, which had also signed him to a hefty consulting contract.

Columbus Nova is run by Andrew Intrater, an American businessman whose cousin, Viktor Vekselberg, is a Russian billionaire with close ties to Russian president Vladimir Putin. Vekselberg was recently sanctioned by the U.S. Treasury alongside his company Renova Group.


Intrater is a minority investor in Hoffman Technologies LLC, the controlling shareholder of Yamo Pharmaceuticals, the company revealed in a letter to Democrats.

"Mr. lntrater appraised Mr. Cohen of the Varno project and asked him if he knew anyone who would be interested in partnering with the company, advocacy groups and/or attract pharmaceutical industry partners," the company wrote.

A spokesman for Columbus Nova has not responded to a request for comment.

Late last year, Vekselberg was stopped at a New York airport by federal agents working for Mueller and questioned, according to the New York Times. The Times also reported that Intrater was separately interviewed by the special counsel.

Last month, ABC News reported that guest lists show Vekselberg and Intrater attended the “Candlelight Dinner” in Washington’s Union Station on the eve of Trump’s inauguration, a perk for major contributors to the Presidential Inaugural Committee.

According to a source familiar with the arrangements, they were seated at the dinner next to Michael Cohen and his family.

I knew this issue was not over. It will probably get worst.
 












Novartis had ‘longer and more detailed’ relationship with Trump lawyer Michael Cohen, Senate report finds

Published: July 13, 2018 11:33 a.m. ET

Novartis’ then-CEO continued to communicate with Cohen even after the company said the relationship was over
By EMMACOURT REPORTER

Swiss drugmaker Novartis AG’s’ relationship with Michael Cohen, President Donald Trump’s longtime lawyer, was “longer and more detailed” than the company has said, a new Senate committee report has found.

Novartis NOVN, +0.28% has said that, a month after entering an one-year, $1.2 million contract with Cohen’s consulting company, the relationship was essentially over, as the consultants could not “provide the services that Novartis had anticipated.”

But then-Chief Executive Joe Jimenez and Cohen communicated multiple times after that and over the course of 2017, including an email exchange in which Jimenez sent Cohen Novartis’ “ideas to lower drug costs in the U.S.,” which were to be discussed with the Trump administration.

Several of the ideas later appeared in Trump’s drug pricing plan, released earlier this year, the report found. In spite of Trump’s harsh rhetoric about pharmaceutical companies, the plan largely leaves drugmakers unscathed, experts say.

The finding is one of several damning conclusions of the Friday report, “White House Access for Sale,” which was prepared by Democratic senators and based on documents provided by Novartis regarding its communications with Cohen.

Read: Novartis paid Trump ‘fixer’ Michael Cohen $1.2 mln to consult on ‘certain U.S. healthcare policy matters’

Novartis has said that the company could not end its contract with Cohen — and stop paying him $100,000 a month — “as the contract unfortunately could only be terminated for cause.”

The Democrats’ report, though, begs to differ.

“It appears in fact the company could have terminated Mr. Cohen’s contract,” the report found, with one such out in the contract stating that “satisfactory performance” was required.

MW-GM496_Cohen__20180713103602_NS.png
Congressional report
A draft version of Novartis’ contract with Michael Cohen’s consulting firm.
In a Friday statement, Novartis said that it disagrees with the report’s conclusions that it misled the public. The company said it met only once with Cohen, on March 1, 2017, and didn’t ask Cohen to do anything on its behalf after that. Cohen initiated the other communications with Jimenez, including the drug price ideas, which he solicited, the company said.

“As we have already acknowledged, Novartis made a mistake in entering into the contract with Michael Cohen,” the statement said. “And in hindsight — and certainly knowing everything we know now — we should have tried to terminate the contract with Mr. Cohen regardless of our views at the time of its legal enforceability.”

Novartis’ relationship with Cohen began in 2016. A few weeks after Trump was elected in November, Jimenez was eating dinner with Hain Celestial’s Irwin Simon, who called Cohen and introduced him to Jimenez, according to the report.

Jimenez would later set up a phone call with Cohen just days after pharmaceutical executives met with Trump in late January of 2017.

According to Novartis, Cohen told them that he “was knowledgeable about the individuals President Trump was likely to appoint and could provide the Company with information as to how these individuals would approach the healthcare-related issues Novartis was focused on.”

Novartis’ initial contract with Cohen similarly proposed that he provide “access to key policymakers” in the Trump administration, and that he “assess the reaction of the US Government to certain options to improve the affordability of medications,” according to the report. Cohen also represented himself as Trump’s lawyer when speaking with Novartis, according to the report, including through signature lines like “Personal Attorney to President Donald J. Trump.”

Later communications regarding drug pricing occurred around the same time as a report that Trump had drafted an executive order about drug pricing that was very industry friendly, and included several proposals that had come from industry.

Of the six drug pricing proposals that Jimenez sent Cohen, some are very like what was eventually included in Trump’s drug pricing blueprint, such as the criticism of “global freeloading” — or other countries paying lower prices for drugs — the promotion of value-based pricing for pharmaceuticals and point-of-sale rebates at pharmacies.

The proposals provided by Jimenez were “well-known ideas for lowering the cost of pharmaceuticals that had been discussed publicly in the industry,” Novartis said.

Because Novartis would not send the senators its own communications about Cohen and his role, there’s little information in the report about how the company discussed the consulting arrangement internally. But the report does state that current Chief Executive Vasant Narasimhan never spoke with Cohen.

Cohen also spoke with Jimenez about opioid lawsuits against pharmaceutical companies, according to the report, though there is little detail about precisely what was discussed. Hundreds of lawsuits have been filed in the U.S. against various drugmakers that manufacture opioids.

The report also opens a window into pharmaceutical industry wheeling and dealing.

Novartis had previously met with the privately held pharmaceutical company Yamo Pharmaceuticals, which is developing a therapy for autism, but decided not to invest in the company.

Cohen had a backdoor relationship with Yamo, which is connected to an investment firm called Columbus Nova that paid Cohen about $500,000, according to the report.

Columbus Nova encouraged Yamo to reach out to Cohen, who then asked Novartis’ Jimenez to “see if [the Yamo investment opportunity] was handled properly.” Jimenez said he would personally look into it.
 












Let's find out if there was any discussions of mitigating ongoing legal cases like the one in the SDNY for example . Since novaris hasn't provided documents , time for subpoena's to start flying & preservation notices to be issued
 






Novartis is the implied villain of the most popular film in China right now


By REBECCA ROBBINS @rebeccadrobbins

JULY 13, 2018
china-drugs-AdobeStock_169242797-645x645.jpeg


A new film about leukemia drugs opened in Chinese theaters last week, and it’s already become a blockbuster hit. The movie, called “Dying to Survive,” brought in $232 million in its first five days, a pace that gives it a chance to become China’s biggest-ever box-office success.

The dark comedy centers around a Chinese man who illegally smuggles cheap generic leukemia drugs from India to sell to Chinese patients who can’t afford the medication available through official channels — a pricey drug called Glinic sold by a greedy Swiss pharma company. Sound familiar?
 






FDA recalls heart, blood pressure medicines due to cancer-causing substance

Wednesday, July 18, 2018 08:11AM
SILVER SPRING, Maryland --
The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

This recall is due to an impurity, N-Nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled; only the generic ones made by Solco, Teva, and Major.

NDMA is classified as a probable human carcinogen - a substance that could cause cancer - based on results from laboratory tests.


These medications are being pulled off shelves. There is a voluntary recall - @US_FDA says meds may be tainted by carcinogen.

The presence of NDMA is thought to be related to changes in the way the active substance was manufactured.

"The FDA is committed to maintaining our gold standard for safety and efficacy," said FDA Commissioner Scott Gottlieb, M.D. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured. When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market."

-- Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

-- To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

-- If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company. This information has been posted to the FDA's website.

-- Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.
 






FDA recalls heart, blood pressure medicines due to cancer-causing substance

Wednesday, July 18, 2018 08:11AM
SILVER SPRING, Maryland --
The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

This recall is due to an impurity, N-Nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled; only the generic ones made by Solco, Teva, and Major.

NDMA is classified as a probable human carcinogen - a substance that could cause cancer - based on results from laboratory tests.


These medications are being pulled off shelves. There is a voluntary recall - @US_FDA says meds may be tainted by carcinogen.

The presence of NDMA is thought to be related to changes in the way the active substance was manufactured.

"The FDA is committed to maintaining our gold standard for safety and efficacy," said FDA Commissioner Scott Gottlieb, M.D. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured. When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we're committed to taking swift action to alert the public and help facilitate the removal of the products from the market."

-- Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

-- To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

-- If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company. This information has been posted to the FDA's website.

-- Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

This is good for NVS.
 












Novartis recruits new compliance head from Siemens after ethics stumbles
Reuters 4 hours ago

By John Miller

ZURICH, Aug 14 (Reuters) - Novartis has recruited a new chief ethics officer from Siemens after costly bribery scandals and a disputed $1.2 million contract with President Donald Trump's former lawyer that the Swiss drugmaker now calls a mistake.

Novartis said on Tuesday it had hired Klaus Moosmayer, 49, from Siemens, where he spent more than a decade helping oversee the German engineering company's efforts to build its compliance system after several of its own bribery scandals.

Novartis Chief Executive Vas Narasimhan, promoted on Feb. 1 to lead the Basel-based company, has promised to boost its reputation following settlements or fines in corruption cases in China, South Korea and the United States.

He has also faced U.S. lawmakers' criticism over the contract with former Trump lawyer Michael Cohen, something Narasimhan called a "mistake" that exposed Novartis to accusations it paid to gain influence within the administration.

Moosmayer, a German, replaces Shannon Thyme Klinger, who was appointed as Novartis's general counsel when Felix Ehrat resigned in May to take responsibility for the Cohen agreement.

"We must hold ourselves to (the) highest ethical standards and always aim to win and maintain the trust of society and our many stakeholders," Narasimhan said in a statement, while lauding Moosmayer's extensive experience in compliance matters.

Novartis has said neither Narasimhan nor Klinger knew of the contract with Cohen when it was signed in early 2017, shortly after Trump's inauguration.

In recent years, Novartis has paid hundreds of millions of dollars to resolve cases where employees were accused of flouting the law to accelerate sales. Units remain under scrutiny in Greece, Asia and Russia, and a trial is scheduled next year in another U.S. federal lawsuit.

SHORTCOMINGS

Novartis has acknowledged shortcomings amid what ex-CEO Joe Jimenez called a "results-oriented" culture, while insisting the Greek probe includes "many sensational and unfounded claims".

Moosmayer, a Siemens lawyer since 2000, played a central role in building up the company's policies governing internal investigations, disciplinary sanctions, remediation and compliance risk assessment.

In 2008, Siemens paid about $1.6 billion to resolve U.S. and European allegations it bribed officials around the world in exchange for business.

At Siemens, one of Moosmayer's main duties was to handle the remainder of what the company dubbed a “compliance crisis" that had once put the group's future in doubt.

His brief also included helping manage Siemens's response to the diversion of four turbines to Crimea, in breach of EU sanctions imposed after Russia annexed the region from Ukraine in 2014. Siemens's efforts to seize the turbines have been rejected by a Russian court.

Moosmayer, who joins the Novartis executive committee, said he hopes to build on Novartis's personal accountability focus.

"Society has high expectations of the pharmaceutical industry and rightfully so," Moosmayer said. (Reporting by John Miller in Zurich, Alexander Huebner in Munich; Editing by Adrian Croft)
 






Novartis says glaucoma stent setback will not derail Alcon spin-off
By John Miller,Reuters 7 hours ago


ZURICH (Reuters) - Novartis' eye care unit Alcon is withdrawing a surgical stent for glaucoma patients after clinical data showed it may damage the eye, but the Swiss drugmaker said the move would not affect plans to spin off the unit next year.

Novartis shares fell 0.6 percent by 0832 GMT on Wednesday, although one analyst said the company's swift reaction should help keep it out of the crosshairs of lawyers.

As part of its voluntary withdrawal of the CyPass Micro-Stent, Alcon advised surgeons treating glaucoma patients to stop implanting the stents immediately, the company said in a statement on Wednesday.

"We believe that withdrawing the CyPass Micro-Stent from the market is in patients' best interest and is the right thing to do," said Alcon's chief medical officer, Stephen Lane.

"Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labeling changes that would support the reintroduction of the CyPass Micro-Stent in the future."

The stent was designed to reduce pressure in the eye.

Based on two years of clinical data, the U.S. Food and Drug Administration had approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma.

But five-year post-surgery data showed patients experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. Endothelial cells are believed to help maintain visual function.

The Alcon eye care business has highlighted the stent's contribution to a recovery in sales. In the second quarter, Novartis said double-digit percentage growth of implantables including the CyPass stent helped drive an 8 percent surge in revenue from its surgical devices to $1.03 billion.

But a company spokesman said that CyPass sales were "immaterial" to Alcon's total sales of $3.6 billion in the first half, and there would be no change to its target of mid-single-digit percentage sales growth in constant currencies this year.

The spokesman said the withdrawal would not have an impact on Alcon's plans for a spin-off in the first half of 2019.

Zuercher Kantonalbank analyst Michael Nawrath estimated revenue from the stent at around $90-100 million.

Novartis's quick move to withdraw the device after five years of patient follow-up will give little leverage to any lawyers considering potential claims against Alcon, he said.

"A withdrawal is always negative, but if you react appropriately you can avoid becoming the potential target of litigation and legal costs," Nawrath said.
 






DOJ Says It Can Prove Novartis Dinners Were Kickbacks
By Dani Kass

(August 30, 2018, 8:04 PM EDT) -- The U.S. Department of Justice shot back against Novartis Pharmaceuticals Corp.’s claims that extensive discovery hasn’t turned up proof that the drugmaker bribed doctors to write prescriptions through its fraudulent speaker program, telling a New York federal court that the government will be able to win the case.

The DOJ on Wednesday asked the court to deny Novartis’ May request for summary judgment, saying it found at least 20 sales representatives and many internal documents that can back up the illegality of Novartis’ program
 






Novartis chief hints at job cuts in Switzerland
9/2/18

The president of pharmaceutical giant Novartis has announced job cuts in an interview with Swiss newspaper NZZ am Sonntag.


Jörg Reinhardt said the Basel-based company wants to streamline its production sites and administration worldwide.

"This will affect various plants globally and will also have an impact on Switzerland," Reinhardt was quoted as saying in the Sunday edition of the newspaper.

The impact will be felt not only at company headquarters in Basel but also probably in the Aargau plant in Stein, where 2,000 employees still produce many medicines using traditional methods, according to the newspaper.

Reinhardt justified the cost reduction plans citing the drop in net prices in the United States over the past year.

He said prices would be “one to two percent” lower than in the previous year due to discounts granted to major buyers.

Since the pharmaceutical industry generates on average half of its profits in the US, this decline is significant.

"We are preparing for something to happen in the US price system in the medium term that will have an impact on the entire pharmaceutical industry," Reinhardt said.
 






Novartis links bonuses to ethics in bid to rebuild reputation

John Miller

ZURICH (Reuters) - Swiss drugmaker Novartis (NOVN.S) has revealed its employees only get a bonus if they meet or exceed expectations for ethical behavior as it seeks to address past shortcomings that have damaged its reputation.

Chief Executive Vas Narasimhan has made strengthening the Swiss drugmaker’s ethics culture a priority after costly bribery scandals or legal settlements in South Korea, China and the United States.


Employees now receive a 1, 2 or a 3 score on their values and behavior. Receiving a 2, which Novartis said denotes meeting expectations, or a 3, for “role model” behavior, would make them eligible for a bonus of up to 35 percent of their total compensation.

Novartis said it began the scoring system in 2016 but details have not been widely reported. Company officials outlined the system on Monday on a call about its ethics efforts with analysts and journalists.

“Unless the sales representative scores a two or a three, they will not be eligible for their variable compensation,” Samir Shah, Novartis’s head of investor relations, said of the company’s values and behaviors scoring system.


“That’s how we’ve tried to make sure we’ve got the right balance between pay for performance and having the right behavior,” he added.

Shah, who said the standard applies in all countries where Novartis does business, did not immediately know how many employees will be ineligible for bonuses at their next appraisals in October or November.

Novartis said additional action may be taken where an employee falls short on their ethics score, or they could be dismissed.

The company was also this year embroiled in a political controversy over payments it made to U.S. President Donald Trump’s ex-attorney.

Narasimhan has said he did not learn of the $1.2 million payments to Michael Cohen, until well after his predecessor, Joe Jimenez, struck the deal in 2017. Narasimhan has labeled the Cohen contract a mistake but said the company did nothing illegal.

Basel-based Novartis recently hired a new ethics chief, Klaus Moosmayer, 49, from Siemens, where he spent more than a decade helping oversee the German engineering company’s efforts to build its compliance system.


Two years ago, Novartis was forced to pay $25 million to settle U.S. civil charges it had bribed Chinese healthcare professionals to boost sales in China. To remedy weaknesses in that country, the company now has a pilot project in China in which expense reports are scrutinized before money is reimbursed.

“This allows us to look at the behavior metric before any money leaves Novartis, and catch potential misconduct before there is any risk to our reputation,” said Novartis general counsel Shannon Klinger, promoted to the post this year after Felix Ehrat resigned to take responsibility for the Cohen contract.

“You can expect us to continue focusing on resolving the legacy issues that we read about in the press, ensuring we address any remaining underlying behaviors,” she added.