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Jan
25
Sandeep Singh Dhillon
Novartis Climbs Out of Its Growth Pit – Bloomberg Gadfly
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Its new CEO has challenges but is starting from a good place.

By Max Nisen

Incoming Novartis AG CEO Vas Narasimhan is taking over at the right time.

As it reported fourth-quarter earnings on Wednesday, the company predicted it will grow sales in 2018 after a multi-year slump. Departing CEO Joe Jimenez is leaving many difficult decisions for Narasimhan as he cedes control next week. But he is also leaving a company with an unusually rich set of assets and a pretty high margin for error.

One of Jimenez’s nicest parting gifts is a return to sales growth for the company’s troubled Alcon eye-care division. That makes the decision (delayed until 2019) to sell or spin off the unit less urgent; it’s no longer an obvious drag on the share price. And there’s real hope of increasing the return of an eventual divestiture by further improving results.

But generics unit Sandoz has emerged as a new problem child, hurt by a difficult pricing environment. U.S. sales fell 17 percent in the fourth quarter from a year ago, Novartis said Wednesday. Narasimhan on the earnings call outlined a strategy to help Sandoz, moving away from products most subject to pricing pressure and toward more-complex (read, expensive) alternatives. But several other generic drugmakers are pursuing the same strategy, and it won’t be an easy or quick fix.

Sandoz’s success depends largely on the progress of Novartis’s heavy investment in biosimilars — the equivalent of generics for complex drugs made in living cells. But it’s far from alone in that endeavor, and the lucrative U.S. market is proving highly difficult and time-consuming to crack.

On the novel drug side — the source of 67 percent of Novartis’s revenue in 2017 — Narasimhan will inherit a broad set of new medicines to help overcome sales declines of older stalwarts such as Gleevec. But heavy competition awaits. Cosentyx, the firm’s best recent launch, is fighting it out in psoriasis with both well-settled blockbusters such as Humira and newer drugs such as Taltz and Tremfya. Breast-cancer drug Kisquali and an upcoming migraine medicine are also in intensely competitive classes.

Pharmacy benefit managers will likely have a field day extracting big discounts on these drugs, and the marketing battles will be fierce.

Novartis’s heart failure drug Entresto has been dogged by payer restrictions since its 2015 approval due to its cost and large patient population. It’s still far from the company’s diminished $3 billion plus estimate of its potential peak sales.

Still, at least Novartis has new drugs. Some of its medicines are in less-competitive markets. And while I am constitutionally skeptical of Narasimhan’s claims that the company will boost productivity via investment in automation and AI, his pledge to prune the firm’s research pipeline more aggressively is promising.

Though Novartis hasn’t done much on the M&A front, it has the capacity to invest if pharma growth lags once more or if Sandoz proves tough to fix. Its balance sheet is strong. And it can generate a flood of cash by selling out of its consumer joint venture with GlaxoSmithKline PLC and its separate multi-billion-dollar equity stake in Swiss rival Roche Holding AG. It could also speed up its decision on what to do with Alcon.

But its financial position gives it the luxury of waiting for the best return on these disposals while enjoying a cheap boost to its income in the meantime.

There are pitfalls ahead for Narasimhan. But at least he’s not starting in one.

This article originally appeared at https://www.bloomberg.com/gadfly/articles/2018-01-24/novartis-earnings-climbing-out-of-a-growth-pit

Dec
23
Sandeep Singh Dhillon
5 Milestones Of 2017 In The War On Cancer – Forbes Healthcare
Pharma Extra
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By Arlene Weintraub,

An impressive 45 novel drugs have been approved by the FDA in 2017 so far — more than doubling last year’s total. A dozen of those new products were in oncology, as the year ushered in new choices for treating a range of cancers, including mantle cell lymphoma, Merkel cell carcinoma and follicular lymphoma.

But what’s notable about the FDA’s list of new chemical entities approved during the year is that it doesn’t include many of the other advances that were seen in the world of oncology research. That’s a separate list, which includes novel combinations of previously approved drugs, and the entry of personalized immune-cell therapies—CAR-T treatments—that have offered hope to thousands of patients who had run out of options for treating their cancers.

The bottom line is that it has been a banner year for cancer research. Here were some of the highlights:

May 23: The FDA approves the first cancer treatment that’s prescribed based on the genetic characteristics of the disease—not the tumour’s location. Merck’s immuno-oncology drug Keytruda won approval to treat patients whose tumors are defined as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). About 5% of colorectal tumors have one of these two characteristics, but the defects are also found in other solid tumors, such as breast cancer, gastrointestinal cancer and prostate cancer. MSI-H and dMMR tumors are unable to properly repair the DNA inside cells. Keytruda works by blocking “checkpoints” that would normally prevent the immune system from recognizing and attacking these defective cells. Merck tested Keytruda in 149 patients with 15 different MSI-H or dMMR cancer types and charted impressive results: More than 39% of patients had at least a partial response to the drug, and 78% of those people responded well for six months or longer.

August 30: The FDA approves the first CAR-T treatment, Novartis’s Kymriah, for some young people with leukaemia. When results from trials of CAR-T treatments first started emerging a few years back, it seemed too good to be true: Cure rates for previously untreatable blood cancers were 70% and higher. But the results held up, and Novartis took home the first FDA approval in this booming area of cancer research.

Kymriah is made by removing immune-boosting T cells from patients, engineering them to be able to recognize and kill their cancers and then re-infusing them. It’s a hugely complex process for a one-time treatment, and it’s priced at a whopping $475,000. But Novartis has proven to be a pioneer not just in the invention of CAR-T but also in its pricing: The company struck a deal with the Centers for Medicare and Medicaid Services (CMS) stipulating that the agency will only have to pay for the treatment when patients respond within the first month.

October 18: Kite Pharma wins approval for its CAR-T, Yescarta, just weeks after cementing its $11.9 billion purchase by Gilead. When Gilead announced its planned purchase of Kite in August—one of the biggest oncology deals of recent years—no one was surprised. Gilead had been under pressure to make a purchase that would boost its pipeline, and Novartis was on the verge of proving that personalized cell therapies can be embraced by regulators.

Yescarta was approved to treat some adult patients with large B-cell lymphoma. There have been some hiccups on the way to market, including reimbursement difficulties that have resulted in long waiting lists for the product. But analysts are optimistic about the $373,000 product, estimating it could bring in as much as $250 million next year.

December 10: Tiny Bluebird Bio stokes optimism for CAR-T in the third type of blood cancer. Shares of gene therapy startup Bluebird Bio shot up 18% to $201.80 in a day after the company announced results from a small trial of its CAR-T in multiple myeloma. The treatment, which is being co-developed by Celgene, is different from the two previously approved CAR-Ts in that it targets a protein on myeloma cells called BCMA. The 18 patients in the trial had failed multiple previous therapies, and 17 of them responded positively to Bluebird’s CAR-T. In 10 of those patients, the cancer seemed to disappear, the companies reported at the annual meeting of the American Society of Hematology (ASH).

Early successes with CAR-T have prompted researchers around the world to see if they can apply T-cell technology to multiple cancer types, including solid tumors. Novartis and Kite are among the companies that have been working on CAR-Ts for solid tumors.

December 20: The FDA approves its 12th cancer combination treatment of the year. The rise of immuno-oncology treatments brought with it a prediction that combining multiple drug modalities might make it possible to conquer previously untreatable cancers. Several companies succeeded this year in persuading the FDA that previously approved products, including immuno-oncology treatments and targeted drugs, work better in groups than do on their own. Hence 12 new cancer combinations were approved in 2017—way up from the five combos approved in 2016.

The most recent of these approvals was awarded to Roche unit Genentech, for its combination of Perjeta, a monoclonal antibody targeted at HER-2 positive breast cancer, with the similarly targeted drug Herceptin and chemotherapy, in patients who face a high risk of recurrence. Earlier in the year, the FDA granted an accelerated approval for Keytruda combined with Eli Lilly’s Alimta and carboplatin for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer.

No doubt 2018 will bring more immuno-oncology advances—and combination treatments designed to outsmart cancer from multiple sides.

This article first appeared at https://www.forbes.com/sites/arleneweintraub/2017/12/21/five-milestones-of-2017-in-the-war-on-cancer/?ss=pharma-healthcare#15a2a7b741de

Jul
3
Sandeep Singh Dhillon
Supply Chain Manager – Novartis
Pharma Job Portal
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Job Description

Job ID 214902BR
Position Title : Supply Chain Manager
Division Novartis Technical Operations
Business Unit NTO SUPPLY CHAIN
Country : Malaysia
Work Location : Petaling Jaya
Company/Legal Entity : NOV MALAYSIA
Functional Area : Technical Operations
Job Type : Full Time
Employment Type : Regular

•Responsible for implementation of global SCM processes and initiatives
•Facilitation and implementation of local S&OP process and forecasting with the Sales & marketing team
•Responsible for proper Net Requirement Planning and Order Management
•Review/evaluate demand data of active assortment items coming from the business units/product management vs. rules and assumptions
•Provide demand data to global demand and supply planning
•Planning and managing physical levels of stockholding.
•Controlling movement of each individual item closely to meet unexpected short term variations and deviations
•Up-to-date and accurate submission of demand files to SCM.
•SKUs reductions & pruning program
•Demand planning & tracking analysis on stock forecast requirement and accurate data and ensure timely submission
•Timely transmission of monthly sales & inventory reporting
•Establish & integrate local processes in alignment to GISC processes.
•Fine-tune and enhance if necessary the control parameters within the inventory system and all decision-related processes in the total logistic operation.
•Identifying areas of best cost trade-off for all inter-related activities within both our distributors’ networks which will optimize the efficiency of the total distribution process.
•Maintaining high level of inventory record accuracy
•Ensure all relevant data and documentation for both sales & inventory transactions are up-to-date and in-line for a smooth, accurate and fast month end closing
•Build and maintain supplier relationships to secure continuity of supply and support business goals
•Participate as part of a cross-divisional team to identify reliable, cost-effective, good quality suppliers for both new and existing products
•Product Lifecycle Management Launches: support new launches and make sure that all milestones are met.

Minimum requirements

•University degree in supply chain management, business administration or Commercial degree.
•Fluent in English
•3-5 years experience in supply chain management, and works independently
•Ability to lead and drive initiatives and projects with minimum supervision
•Excellent organizational, planning skills, and effectiveness in a complex environment, as well as ability to communicate throughout different cultures, functions and hierarchies.
•Good understanding of the (generic) pharmaceutical industry is preferred (awareness of regulatory procedures, Quality assurance, and patent issues)
•Sound knowledge of ERP

Apply here at 

https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?jobid=2488035&jobreqlang=140&jobsiteid=5260&jobsiteinfo=2488035_5260&gqid=0&partnerid=13617&siteid=5268&type=mail

Apr
7
ragupathyrenganathan
Novartis’ Revolade Approved for Pediatric Patients in the EU – Yahoo News
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Novartis NVS announced that the European Commission (EC) has approved Revolade for the treatment of pediatric patients (aged 1 year and above) suffering from chronic immune (idiopathic) thrombocytopenic purpura (ITP) who are refractory to other treatments such as corticosteroids and immunoglobulins.

Revolade is approved in both a tablet formulation as well as an oral suspension formulation which makes it easier to swallow for children who cannot swallow tablets.

As per the U.S. National Institutes of Health, ITP is a rare blood disorder that affects about five in 100,000 children every year, while chronic ITP affects 13–36% of those suffering from ITP.

We note that Revolade is already approved in Europe for the treatment of adults. The drug is marketed under the brand name Promacta in the U.S under a collaboration agreement with Ligand Pharmaceuticals, Inc. LGND. In Aug 2015, the FDA approved an oral suspension formulation of Promacta for younger children with chronic ITP who may not be able to swallow tablets.

Promacta is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy, and for the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy.

Sales of Revolade came in at $402 million in 2015. A label expansion of the drug will further boost its sales.

Approval of new drugs and label expansion of existing ones should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan of late. Additionally, its oncology drugs are facing competition in the form of immuno-oncology therapies.

Moreover, its Alcon segment is facing a decline in surgical equipment sales in the U.S. and emerging markets, while Ophthalmic Pharmaceuticals is grappling with issues like the threat of increased generic competition in the U.S.

Mar
29
ragupathyrenganathan
U.S. Seeks Records of 80,000 Novartis `Sham’ Events for Doctors – Bloomberg Business
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The U.S. is asking Novartis AG to provide records of about 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs to their patients.
The Swiss drugmaker and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed.
In a filing Friday, the U.S. said it needs Novartis to provide information to support its allegation that the company defrauded federal health-care programs of hundreds of millions of dollars over a decade by inducing doctors to prescribe its medications through sham speaker events.
“The requested documents go to the core issues in this case: whether educational materials were provided at these events; which doctors actually attended the events; how much money was spent on meals and honoraria; and indeed, most fundamentally, whether the underlying documentation shows that a particular event actually took place,” the government said in its court filing.

‘Exploded’ Case
That filing came in response to a March 22 request by Novartis to the judge, seeking a hearing because the company says the U.S. has “exploded” the size of the case by demanding information about as many as 80,000 promotional events set up by its salespeople.
Representatives of Basel-based Novartis didn’t immediately respond to an e-mail sent Saturday seeking comment on the government’s filing.
Last year Novartis agreed to pay $390 million to settle a lawsuit in which the U.S. government claimed the Swiss company paid kickbacks to pharmacies to boost sales of some of its prescription drugs. The company neither admitted nor denied liability.
The case is U.S. v. Novartis Pharmaceutical Corp., 11-CV-0071, U.S. District Court, Southern District of New York (Manhattan).

Mar
26
ragupathyrenganathan
Novartis and Pfizer join forces to upend oncology dogma
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For the past four years, the cancer research community has been acting on an accumulation of evidence suggesting that hard-to-treat tumors driven by mutations in a gene called KRAS have an Achilles’ heel. While KRAS itself seemed undruggable, these tumors appeared to be addicted to autophagy, a cellular recycling system that helps cells be thrifty in times of stress and starvation. The field had latched on to the idea that KRAS-mutant tumors could be shut down by inhibiting autophagy and researchers had begun acting on it, hoping to find new therapies for pancreatic cancer and other pernicious diseases.

The flurry of activity spurred by this idea, however, may be coming to a halt based on new findings from the Novartis Institutes for BioMedical Research (NIBR), and also, coincidentally, from Pfizer. Two independent industry labs found evidence that casts doubt on the hypothesis that autophagy inhibitors will shut down KRAS-driven tumors.

“The idea had become dogma in the field,” says Leon Murphy, a director in the Developmental and Molecular Pathways group at NIBR. “But in every case we probed, we found that the hypothesis was not valid.”

After a chance encounter at a conference led the industry researchers to learn of one another’s work, they joined forces to bring their data to light by publishing a paper (link is external) together in the Proceedings of the National Academy of Sciences. The paper is unusual because results that de-validate hypotheses often go unpublished.

“Jointly we have accumulated an enormous amount of negative validation data,” says Murphy. “We feel it’s important to release these data so that the community will not go off in the wrong direction and invest in areas that aren’t likely to lead to the development of a therapeutic.”

The need for new therapies for KRAS-driven tumors is strong. Approximately 90 percent of pancreatic cancer tumors involve KRAS mutations, and only 5 to 15 percent of patients survive the disease. 1So far, there are no approved drugs that inhibit mutant KRAS and there are no obvious ways to interfere with the mutant protein’s action.

“The idea of attacking KRAS-driven tumors by shutting down autophagy was super attractive,” says Beat Nyfeler, a NIBR investigator and autophagy expert who led the Novartis investigation. “An autophagy inhibitor would have met a huge unmet medical need.”

Gathering evidence
Acting on this potential, the team at NIBR screened a collection of 47 cell lines, including some with cancer-causing KRAS mutations and some with healthy (i.e., wildtype) KRAS. They used RNA interference to disable different components of autophagy. What they found was striking: Disabling autophagy had no effect on growth across all 47 cell lines.

In parallel, Christina Eng, a principal scientist at Pfizer and also an autophagy expert, had become interested in inhibiting autophagy to treat KRAS-driven tumors. “The first step is trying to validate the hypothesis,” she says. “But we couldn’t.”

Chance brought Eng and Nyfeler to the Keystone Autophagy Meeting in Austin, Texas in the spring of 2014. Eng sought out Nyfeler to say hello. She soon learned that they both would be presenting findings refuting the autophagy hypothesis.

“It was shocking,” says Eng. “But what was really beautiful was that it was a perfect complement of tests. He used one set of models, and I used another, but the data were identical.”

Nyfeler followed the screening experiment with another in which he used genome editing technology to delete autophagy in the cultured cell lines. Again he found no effects on cell growth. He ran the test again, this time growing the cancer cells in mice rather than in plastic dishes. The results remained the same.

At Pfizer, Eng had performed the same experiments, targeting the same genes contributing to autophagy. She, too, started in cultured cells and then moved to mouse models and consistently found no effects on growth.

A missing mechanism
The researchers also made an important discovery about the anti-malarial drug chloroquine. Recent research suggests that chloroquine might also work against cancer, ostensibly by inhibiting autophagy, and clinical trials are currently underway to test this hypothesis. But the Novartis-Pfizer team showed that chloroquine slows growth equally in cells whether autophagy is working or has been disabled. “Chloroquine does block autophagy, and it does inhibit cell proliferation, but these things have nothing to do with one another,” says Nyfeler.

The findings do not rule out chloroquine as a promising drug for use in combination with other therapies for cancer, says Eng. “But we need to focus on the mechanism by which it’s actually inhibiting the growth of those tumor cells, and it’s not through autophagy.”

Labs currently acting on the hypothesis that KRAS-mutant tumors are addicted to autophagy and vulnerable to its inhibition may need to re-evaluate this strategy given these findings. “That’s the point,” says Murphy. “Hopefully this will allow researchers to focus on finding different ways that autophagy is important in cancer.”

1S Eser, et. al. Oncogenic KRAS signaling in pancreatic cancer. British Journal of Cancer (2014) 111, 817-822.

Main image: HeLa cells by Paul Andrews/University of Dundee/Wellcome Images. Modified by PJ Kaszas.

Mar
21
ragupathyrenganathan
Immune Engineering
Drug Discovery, Pharma Notables
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Nov
17
ragupathyrenganathan
Novartis MS drug Gilenya could relieve painful side effect of chemo
Drug Discovery, Pharma News
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Aug
4
ragupathyrenganathan
Novartis divests influenza vaccine business to CSL for $275 million
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Jul
15
sandeepsd
Novartis’ Copaxone generic is off to a speedy start
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