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German born Joerg Reinhardt, the new chairman of Novartis, is overseeing the plan to revitalize and strengthen its R&D operations. Reinhardt who has a doctorate in pharmaceutical sciences, spent 30 years working for Novartis and its predecessor company Sandoz, before leaving for Bayer in 2010 and returning to Novartis. He is leading the effort by setting up a board subcommittee setup to oversee the research and development effort. The new subcommittee's task is to review the R&D strategy and organization. The subcommittee will advise the board on scientific trends and activities critical to R&D success. Novartis has increased R&D budget to 5.6% in 2013, which will remain at that level in 2014. The pharmaceutical industry by contrast decreased spending by 2.2% in 2013 compared to the high point in 2011, according to PriceWaterhouseCoopers. Research activities will be concentrated in 4 cities- Shanghai, Basel, Boston and La Jolla, California, to take advantage of infrastructure already in place in these places. A review of Novartis's portfolio of business begun in 2013 will be completed in 2014. Reinhardt says acquisitions of upto $5 billion could be made to build scale for promising smaller units. The review also includes Novartis's one third stake in Roche built up since 2001, and conversations Reinhardt is having with Roche's new chairman Christopher Franz....

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Changes Novartis CEO Daniel Vasella is making in the pharmaceutical business. He has hired Joe Jimenez, who is running Novartis's consumer health care business to be the new pharmaceutical division chief. Jimenez previously worked at packaged goods companies including H.J. Heinz Company. Jimenez is cutting 25% of the jobs at pharmaceutical division's headquarters in Basel to reduce bureaucracy and costs. In March he promoted Trevor Mundel and Andrin Oswald, 2 young executives, to head the drug developmet group which puts drugs through human testing and submits them for regulatory approval. This group had become too bureaucratic and slow to move and take initiative. To improve its functioning Jimenez is organizing it into small teams with each team assigned an experimental drug in Novartis's pipeline. Each team of 8 people including physicians, experts in regulatory affairs and marketing and toxicologists work together to spot potential safety issues early and discuss them with regulators to determine whether to put the drug through expensive clinical trials. Each team takes the responsibility to take its drug to the market. The pharmaceutical unit is also being organized to be more nimble. It solicits health systems early on whether its willing to pay for drugs. And Jimenez has startd 4 pilot projects in tough markets to improve relationships with payers, including the Pacific Northwest where Novartis has offered to train an HMO's nurses in aspects of heart disease. Vasella supports the generics division of Sandoz because the growth is in generics, with generics commanding 60% of the prescription volume in Germany and USA, and sales for generics up 25% this year in the generics division. And Novartis paid $39 billion for Alcon, a eye care company. Its also working aggressively in the vaccines business, which like generics enjoys double digit growth. ...

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Novartis bought form Nestle SA a 25% stake in Alcon for $11 billion with an option to buy Nestles's remaining 52% holding in 2010 and combine its eye care operations with Alcon's. But there is uncertainty about how this will work out and at what price Nestle will sell as share price of Alcon has dropped. This leaves Novartis in a bind when it comes to other acquisitions as it has to raise and set aside capital to complete the Alcon acquisition. Novartis raised $5.5 billion in debt in February 2009, and $2.2 billion in a bond sale in June, and will raise more capital.

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A 41 year old doctor, Vasant Narasimhan, is the new CEO of Novartis in Feb. 2018. Under Narasimhan R&D is expected to get prominence. His predecesor Mr. Jimenez's focus was on developing new prescription drugs. Dr. Narasimhan sees a shift to new technology, improving data science and digital capabilities to discover new medicines. This shift raises the possibility of a spinoff of the Alcon eyecare business and the Sandoz generics business.   Narasimhan joined Novartis in 2005 from consultancy Mckinsey & Co. and becoming head of R&D. He is expected to push a series of tech based initiatives including artificial intelligence to be used for new biomarkers showing effectiveness of treatment, new sensor technologies developed with Microsoft. This shift is a result of the earlier effort under previous CEO's to make up for the loss of patent protection on profitable drugs by diversifying into consumer healthcare. During the period under Jimenez Novartis share price performance was mediocre, rising 41% over 8 years. Its business is stagnant with a 1% increase in 2017 for revenues, the first increase in 3 years.   ...

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Novartis CEO Dr Vasella will organize a restructuring designed to get rid of bueaucracy in Novartis operations. He has see more than six layers between senior management and the lower ranks in many situations inside Novartis. The goal is speedier decisionmaking. He will also look at the large expense of third party companies that oversee clinical trials.

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Research on the human genes by Novartis researcher Dr. Rappouli has helped develop a vaccine for Meningitis B. In a unique collaboration with Craig Venter, the scientist who decoded the human genome, Dr Rappouli, an Italian scientist working for Novartis unit, Chiron Corp., describes his research effort and results to Jeanne Whalen of the WSJ in 2007.

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Achieving a right balance between the needs for public health in developing countries- and the need for cost reduction in developed countries- with the need to keep innovation, is the challenge facing the Indian Supreme Court as it hears the Novartis case on its leukemia drug Gleevec. The efforts by Novartis and other western pharmaceutical companies to restrict the flow of low cost generic drugs from India. India stopped granting patents on drugs in 1970. It only resumed giving patents under a WTO agreement on patents. The Indian government denied the patent on Gleevec and the case is now coming up before the Supreme Court.

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Novartis is taking a new approach to drug research and drug discovery. The old one which was popular in the drug industry was to go directly for blockbuster drugs for large numbers of users, with a long time in the research pipeline because the area of research was largely an unknown. This was costly and becoming less and less productive. Dan Vasella who heads Novartis, is taking a different approach which comes from his understanding of medical science as a physician, in an industry run by accountants, lawyers and business people. This is to go after wellknown molecular pathways identified by Dr Fishman at Harvard in his research, and do this by taking on problems in diseases that afflict small numbers of people. These drugs have some established medical science to work with, and the research work takes a shorter period. Once the drug proves its effectiveness in one illness, it is tested for other illnesses that afflict a large number of people but which shares some of the same underlying phenomena that cause the disease in the two situations. Dr Vasella stumbled on this approach after the development of the drug Gleevec by Novartis. Gleevec was originally approved for a rare blood cancer, but has now shown to be effective against six other dieases. Gleevec brought 3.7 billion in revenues in 2008 for Novartis. In 2002 Vasella made a bold move to discard the old drug development model. The basis of this approach was to go after new drugs that were desperately needed and where the genetics of the illness were well understood. Whereas pursuing rare dieases is considered foolhardy by most drug company leaders, Vasella's idea is to use the common genetic underlying arrangements for that drug to go after other diseases that would be good prospects for the now proven drug. The known genetics makes it possible to complete the research in a shorter time. In 2009 Novartis has 93 drug candidates in the pipeline, 40% more than 3 years ago and 80% of Novartis' drugs last year made it from early testing to late stage development. This was a 60% improvement over 2005. The new approach fits the current regulatory climate, with regulators concerned more about safety, and Medicare and Medicaid and other payor less willing to pay for treatment with modest benefits or with uncertain outcomes. The approach had to be executed in terms of organization and staffing. Vasella moved the R&D global research operation from Basel to Cambridge, Massachusetts, and spent $4 billion on the move. He recruited a renowed researcher and cardiologist at Harvard University, Dr Mark Fishman, who had done research on the genetic mutations in the cardiovascular systems, to run the center and set the new direction for global research. Fishman convinced Vasella that medical research should focus on a small number of molecular pathways- the complex suquences of interactions among chemicals, proteins, and larger cell structures in the body that are behind all illnesses. Says Fishman, there are 24,000 genes in the genome, but only a few dozen pathways conserved through evolution. Fishman's theory is that you find all the links in a pathway and then locate the signals that can turn the genes on or off to develop medicines for illnesses. Bercause disease after disease share a common pathway, the knowledge gathered can then be applied across that region with more accuracy and directly, to address a range of illnesses. Fishman's approach means marketing and sales no longer make the decisions. There is a new method for doing things. Fishman focusses on clinical data and insists that commercial analysis comes after sufficient clinical data. A major restructuring in 2007 led to shedding 1260 sales and marketing jobs, as clinical science now takes precedence and medically trained scientists take senior leadership positions. The new approach is being used for a drug developed for Muckle-Wells syndrome. Computer simulations are shortening the time to late stage trials. The drug has applications for Type 2 diabetes and severe arthritis. The whole process will take many years, as its a sea change for the industry and for Novartis, a fresh approach when the approach used by the pharmaceutical industry for so long is failing. An oral drug treatment for multiple sclerosis is being developed along these lines. Afinitor. approved by the FDA for kidney cancer in March shows potential in six other diseases, including lymphoma where Afintor shrank tumors by 50% in one third of the patients in a trial. ...

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Sanofi will use its manufacturing plant in Ridgefield, New Jersey, in the US to fill vials and finish packaging of 200 million doses of Moderna vaccine, under a new agreement. This will supply the US under Moderna's US supply of vaccine agreements that run through April 2022. This is part of industry collaboration to expand supply of global vaccines, that includes Merck and Novartis.

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A $250 millon award by a jury to a group of employees of Novartis AG. The jury agreed that Novartis had discriminated against women in its sales force for pay and promotions, and discriminated against pregnant women.

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Novartis CEO, Joseph Jimenez, is interviewed by the WSJ's Marta Falconi. Jimenez sees the need to focus on patient outcomes and giving payers incentive by reducing total hospitalization cost through better drugs. One area he sees the pharmaceutical industry needing to change is to invest more in R&D, and less in sales and marketing.

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Glaxo's respiratory business sales decline by 18% in 2014 as it faces competitive pricing. After the asset swap with Novartis Glaxo is concentrated in respiratory, HIV, vaccines and consumer health and its business is now in a state of transition.

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FDA allows use of Zelnorm for irritable bowel syndrome under restricted conditions.

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Watson Pharmaceutical's acquisition of Swiss company Actavis in a 4.5 billion euros deal makes it the third largest generics manufacturer after Teva of Israel and Novartis AG's Sandoz unit. Actavis was owned by Icelandic billionaire Thor Bjorgolfsson's private equity firm and was taken over by Deusche Bank when the Icelandic bank Landsbanki Islands collapsed in 2008, leading to restructuring of debt.

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The 2.2 billion Swiss franc plan of pharmaceutical company Novartis to remake its production facility site in northern Basel near the Rhine river, with new buildings designed by famous architects. 14 new buildings with different architectural designs are part of the complex that is being built. This is giving new life to the area in St Johann, bringing in boutiques, showrooms and Art Basel. It is connected to France and Germany by a new tram line and a new Swiss underground highway.

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Lower demand for Tecfidera, Biogen's drug for multiple sclerosis led to a drop of 22% in the company's share price. Because of the lower demand the 2015 revenue growth for Biogen will be 6-8% instead of 14-16% predicted earlier for the Cambridge, Mass. company. The lower demand is because of a rare side effect, patients discontinuing treatment because it was not helping, and lower reimbursement price in Germany. Tecfidera sales were $2.9 billion in 2014. Another factor is the competition from Gilenya for MS by Novartis.

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How the Drug Industry and Drug Companies will go through a complete change and look nowhere near what it looks like today. Huge changes are overtaking the Drug industry and old ways of doing things will go out the window. Patent expirations for blockbuster drugs, safety issues, increased regulation, rise of generics drugs, cost issues, outsourcing of manufacture and testing and some R&D, changes in marketing practices, slimming down of marketing and sales force personnel, new approaches to R&D- Novartis emphasizing science, Glaxo breaking up into smaller teams, and the growth of emerging markets. All this happens as the public in the USA looks at healthcare in anew way and the demand for healthcare expands quickly in growing developing countries of Asia, Africa and Latin America and Eastern Europe.

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Nestle will create a new subsidiary called Nestle Health Science and a research organization Nestle Institute of Health Sciences, "to pioneer a new industry between health and pharma." Nestle sees disease prevention as a big part of healthcare in the future. The new company with an investment of 500 million euros over the next ten years will work to develop new nutritional products for diseases such as diabetes, obesity, cardiovascular and Alzheimer's. After sale of its stake in Alcon unit to Novartis for $28.3 billion, Nestle is almost debt free and can invest in developing new nutritional products without needing a return in the short term.

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Speaking for the Biden administration Anthony Blinken says that "on the current trajectory, if we don't do more, if the entire world doesn't do more, the entire world won't be vaccinated until 2024." What is needed he said is to "speed this up, and get that done, I think, in a much shorter time." Experts say the immediate impact of the Biden decision to give waivers on transfer of patents technologies is to get drug companies to cooperate with each other and for them to voluntarily join in the manufacture of vaccines globally. This would be done through global manufacturing alliances in major pharmaceutical manufacturing nations such as France, India and other countries that can quickly ramp up manufacturing if they have access to the technologies involved and the knowhow itself. The Biden decision is then the first of many decisions that would lead to voluntary action by pharmaceutical companies cooperating say Novartis and Sanofi in France and Switzerland with a Pfizer or Moderna in increasing manufacturing capacity or a Serum Institute or Reddy Labs in India working with Pfizer and Moderna or Novavax. These companies already have the basic structures to ramp up. This would take months yet the process has to start immediately. Today many companies such as Glaxo Smith Kline in UK and US are in a position to get involved in manufacturing but need access to the technologies and knowhow. Leadership by the US plays a huge part in making that happen.  ...

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The restructuring underway at Pfizer. Experts view the cut in R&D budgets, when more new drugs are needed, with skepticism. Pfizer and other drug manufacturers believe they can make up for this by working closer with universities. Pfizer is reducing the size of its Groton, Connecticut R&D facility and is moving research operations closer to universities in Boston and Cambridge, England. R&D budgets will be cut 30%, from $9.4 billon to $6.5- $7 billion. The emphasis now is to develop a new model for drug development by focussing on a few promising areas, collaborate closely with universities, and fill gaps with acquisitions, as a more efficient way to develop new drugs. In this new approach the infant nutrition business, even with its high growth rates, did not fit in. Cash from the operations sold to Nestle will be used to make share buybacks and be returned to shareholders. Other drug companies from Novartis to Bristol Myers are trying this approach.