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Glaxo, like other pharmaceutical companies facing severe competition from generics, aggressively marketed the treatment for Restless Legs Syndrome (RLS) with its drug Requip. Glaxo made a strong marketing push for Requip with advertising in medical journals even before approval of Requip by the FDA, sending specialists to discuss treatment with general practitioners, and advertising strongly to consumers. Half of Requip's sales come from treatment of Parkinson's disease for which it was originally designed, the other half comes from RLS. Are their pressures to treat an expanding array of diseases merely to increase sales.

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Analysts say Abbott has paid a steep price for India's Piramal Health Care. Abbott is buying the Indian drug company for $3.72 billion, which is 48% above Piramal's market cap. Going by Piramal sales of $500 million a year , this is 7 times expected sales. Daiichi Sankyo paid 4 times sales for Ranbaxy in 2008. Analysts say this will give Abbott a 7% market share in India's branded generics market. Yet this market is highly fragmented with the top 20 makers having 60% of the market and many small companies.

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Global sales growth will be from developing countries as US sales slow down to the rate of a 4-5% growth, losing 1 percentage point and be at the level growth is in Europe. This growth will mean U.S. sales of 305 billion dollars in 2009 for pharmaceuticals. Next year two thirds of prescriptions will be generics, increasing from 50% in 2003. Forecasts from IMS. Also FDA is taking a tougher line in regulation. Top seven emerging markets will grow at 12 to 13% a year in contrast- from improving economies and greater demands for spending on health care.

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Under a new program to increased spending on healthcare from 1.3% of GDP to 2.5% the Indian government plans to provide free pharmaceuticals at state run hospitals. This is expected to cost $5 billion over 5 years. Initially 350 drugs would be on a list of essential medicines and would be purchased from generics manufacturers in India. Dr. K. Srinath Reddy, heads the committee advising the Indian government on healthcare. He says this will help improve access to medicines for the vast majority of the people. Estimates show 70% of out of pocket medical costs for Indians come from spending on drugs. About 40 million people are pushed into poverty each year because of the high cost of medicines, says Dr. Reddy. He said that in 1984 31% of the medicines at government run hospitals were provided free to admitted patients, dropping to 9% in 2004. For outpatients this dropped from 18% to 5%. The free medicine program would be part of a larger universal health care program to be introduced over the next decade. India's large generics pharmaceutical industry makes the provision of free medicines on a large scale a feasible option in India because of the lower prices, with additional pricing advantages when purchased in larger volumes by the government. This would also have a major impact on the quality of healthcare in the country of 1.2 billion people for a relatively small investment. It also promotes a sense of fairness and equal access because the benefits of decades of modernization have been unevenly distributed and because of widespread poverty....

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The increase in the Nasdaq Composite Index to 4000 by November 2013. In contrast to the period in 1999 the Nasdaq Index now has companies in the Index in a broader number of tech fields including medical technology, pharmaceuticals and consumer. Tech companies in the Index now have reliable tested products and generate significant revenues and profits. Apple has 8.02% representation in the Nasdaq Composite Index. Other companies are Microsoft with 5.15%, Google 4.80%, Amazon 2.88%, Intel 1.95%, Qualcomm 2.09%, Gilead, 1.88%, Amgen 1.42%. The Index is more diversified in 2013. B/E Aerospace and First Solar are part of the Index. About 13.5% are in Health Care technologies, including Celgene and Myriad Genetics. And 7.1% in Telecom, including SBA Communications. Priceline, Amazon are part of consumer internet companies in the Index. Tech based companies make up only 45% on the Index Composite compared to 66% in 1999, with these companies on stronger revenue and profit footing and not bid up speculatively as they were in 1999....

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Adolf Merckle, a native of Dresden, left for West Germany after World War II and built up businesses RatioPharm a generics pharmaceutical maker, and Heidelberg Cement. After making a bad bet in shortselling of VW shares, just when the Prosche family moves ran up the price of VW shares from 210 euros to 1000 euros in 2 trading sessions to obtain majority control of VW, Merckle faced losses of several hundred million euros and possible loss of RatioPharm. A badly timed acquisition by Heidelberg Cement also created worsening finances for Merckle's business. When he failed to get a bridge loan Merckle committed suicide. A public outcry prevented the state government there to provide any loans to Merckle.

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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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Monsanto CEO Hugh Grant pursues a strategy of expansion in pesticides with the planned acquisition of Syngenta. He is a graduate of Glasgow University with a degree in molecular biology. Grant, CEO of Monsanto since 2003, sees higher growth in pesticides. Sales in Monsanto's seeds and genetic traits division, about 65% of its business, increased by 4% in 2014, with its herbicide division growing by 13%. Syngenta is the largest pesiticide manufacturer and Monsanto the leader in seed sales worldwide. Grant has used his Scottish humor to fend off criticism of its genetically modified seeds business, a business it started 20 years ago and which is slowing. This can be seen in the increasing frequency with which the label "No GMO" (no genetically modified) is seen on food products. Grant sees the new moves as a way to reinvent Monsanto's business one more time.

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Copies with slight changes to extend drug life with new brand names- Clarinex for Claritin, Nexium for Prilosec, Paliperidone for Risperdal being the latest in this new marketing strategy of drug companies to extend the life and sales of a successful drug. The drug companies try to market the copy drug as a significant improvement, which is what J&J is doing with Paliperidone. Experts are skeptical. Pricing of the generic versions of Risperdal or its copy will be much less expensive. Cost is a sensitive issue. About 15% of Risperdal's $1.35 billion sales were from Medicaid, generic substitutions offer potentially large savings. Meantime J&J did not do clinical tests between Risperdal and Paliperidone, the tests with 1600 patients compared Risperdal with a sugar pill. A psychiatry Professor at Duke and another professor at NYU are skeptical of J&J claims for Paliperidone. United Health shows savings of $150 million by using generics instead of Nexium, so managed care payors will tread carefully....

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Teva's at-risk-launches of generic versions including Wyeth's Protonix and taking about 60% of the prescriptions written for Protonix. Its a profitable strategy for Teva Pharmacetical.

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Chinese pharmaceuticals makers are getting ready to launch generics products in the US market and have obtained FDA approval of an AIDS drug once its patent expires.

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The story of the Pfizer BioNTech vaccine is the story of 2 chikdren of Turkish immigrants to Germany. Sahin the son of a engineer working at a Ford factory in Cologne, and Tureci the daughter of a surgeon working at a hospital in Mainz Germany. Sahin was born in 1965 on the Mediterranean coast in Iskerundun, Turkey and he went to Germany when he was 4 years old, his father being recruited in a new effort to rebuild Germany with foreign labour. Both are motivated by scientific research and the drive to come up with some method to tackle cancer for patients with new research and cures.  Both did their doctoral dissertation on experimental therapies at the Johannes-Gutenberg University of Mainz in Germany, and both joined the faculty there. Sahin spent years studying the mRNA , genetic instructions that can be delivered to the body to help it defend itself against viruses and other threats. Much of this mRNA research was already at an advanced stage in January 2020 when Sahin heard about the coronavirus in China. At that point he saw the potential of retargeting the mRNA research to tackling the coronavirus. By this time he already had his own company with over 200 million euros invested in it  by investors including Helmut Jeggle, now supervisory board chairman of BioNTech. This report says he sat down one Saturday, January 25, 2020 and working on his computer designed the template for 10 possible coronavirus vaccines, one of which would become BNT162b2, the vaccine now approved in Britain. On the same day he told a surprised Jettle that he would refocus the company on the new virus that had not yet hit Europe. Shain he says cited the Hong Kong flu that claimed 4 million lives. Why Pfizer. Pfizer had already been working with BioNTech on a new flu vaccine based on mRNA technology. A cooperation deal was signed with Pfizer in March for organizing clinical trials, manufacture globally, and distribute the vaccine. BioNTech then acquired a U.S. company and a German pharmaceutical factory in Germany. ...

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Abbott Labs will split into two publicly traded companies, with a medical products company including products such as Similac, Ensure and stent devices, and a pharmaceutical company that would have its Humira rheumatoid arthritis therapy Humira. Humira generates about $8 billion in sales, but faces patent expiration in 2016 and competition from a new drrug expected from Pfizer, as well as generics. Abbott's CEO sees the opportunities in the two products falling in different areas. The medical products business has greater potential in emerging markets, and will require a different focus from the slower growing pharmaceutical business facing competition and payor cost pressures. The medical product company includes a drug coated stent Xience, with $1.5 billion in sales, which has improved prospects as J&J is leaving the stent business. The medical products business sales are 40% from emerging markets, and 40% of revenue comes from patients not from cost conscious governments or insurers, according to CEO White. Its the emerging markets emphasis that convinced White to go with the split. Richard Gonzalez who runs the pharmaceutical business will head the pharmaceutical company, and CEO Miles White will run the medical products company....

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The difficulties in making profits from generic drugs because of intensifiying competition among the generic drug makers.

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AstraZeneca PLC showed a net profit decline of 8.3% in fourth quarter 2011, on sales that remained stable at $8.66 billion compared to $8.62 billion in the prior year quarter. AstraZeneca is facing competition from low cost generics and cuts in government health care spending similiar to the rest of the industry. The company has announced new job cuts of 7,300 job for 2012, which brings total job cuts to 30,000 for the last 5 years. Most of the job cuts are in the U.S. and Europe. Hiring has continued in emerging markets leaving the net job cuts over the last 5 years at 9,600. Of the 7,300 job cuts planned for 2012, 2,200 will be in R&D departments, 1,350 in manufacturing and 3,750 in sales. AstraZeneca is changing the way it will do research and development with these changes. It will close the neuroscience research laboratories in Sodertalje, Sweden and in Montreal. It will have in its place "virtual" neuroscience units, small groups of 40-50 researchers working with academic groups and scientists outside to utilize the best science in the field. This is one of the most radical changes in R&D practices among pharmaceutical companies. In marketing the approach has shifted from having full time sales people call doctors offices to using online marketing tools and telemarketers. This approach is also being adopted for emerging markets....

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On April 20, 1996 the story of the merger of Ciba Geigy with Sandoz was the first story in notes made that day for Lyrarc from the WSJ Europe. This was during a trip to Europe. Ciba Geigy and Sandoz had become part of the home medical kits in Asia and Latin America by the 1960's, and their story had to be told to millions of people in these countries bringing Basel, Switzerland, to the world. Sandoz was founded in Basel in 1886 as a chemical company in Basel, Switzerland, and entered pharmaceuticals business in 1900. Ciba Geigy was formed in the 1850's as a chemical company for dyeing silk fabrics and entered the pharmaceuticals business in 1930's. The two companies were merged in December 1996 to form Novartis. Today Sandoz is the generics manufacturing part of Novartis. As prices of generics have declined Novartis CEO Narasimhan is planning to sell or spinoff Sandoz. With this move Novartis will focus solely on innovative drugs, says this report in WSJ. CEO's have also shifted fin the 25 years since the merger of Ciba Geigy and Sandoz from one with family connections to one with a professional background from India.   ...

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Research on agricultural production and improving and protecting rice, wheat and other food crops has suffered in the last decade as budgets for research have been cut. The USA is in the middle of cutting its $59.5 million annual support for a global research network by 75%. This includes the funding for the International Rice Research Institute in the Philippines which has suffered from budget cuts for years. Its amazing that this Institute is the world's main repository of rice seeds as well as genetic and other information about rice, the staple food in Asian and many other countries. This includes the International Maize and Wheat Improvement Center in Mexico. Agricultural experts have warned about this neglect for many years but have been ignored as the pace of industrialization took off in many developing countries and agricultural production was taken for granted. With the current crisis in agricultural production one would expect this cutting of research aid to be reversed, as President Bush asked Congress on May 1, 2008, for an extra $770 million to pay for food aid and to help improve agricultural productivity in developing countries. Its ironic that growth of food supplies has suffered just when incomes are improving in the developing countries leading to greater demand for beter food and nutrition and resulting in soaring food prices which cuts into that very effort to improve the nutrition and diets in the developing countries. ...

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Research by Allen Roses, director of Duke University's Deane Drug Discovery Institute, and continuing research on the ApoEgene that has aclose link with Alzheimer's. In 1993, Dr Roses's research showed that people who have avariant of the ApoE gene have an unusually high risk of developing Alzheimer's. THese studies have been repicated by other scientists. In research presented at the international conference of Alzheimer's deisease in Vienna, Dr Roses and this team show that they have found a gene linked to ApoE called TOMM40. This gene had mutations that involved a small number of extra copies of aparticular building block of DNA in some individuals and alarge number of extra copies in others. Individuals with alarge number of extra copies- knownn as the "long repeat" version of TOMM40- coupled with ApoE3 develop ALzheimer's an average of seven years earlier- at about 70 compared to the individuals have the "short repeat" version.

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Daiichi Sankyo Company of Japan announced plans to take a majority stake in Ranbaxy Labs for $3.4 billion to $4.6 billion. A patent settlement with Pfizer for Ranbaxy to market a generic version of Lipitor after November 2011 may be part of the effort to give more clarity to Daiichi Sankyo for it to go ahead with the deal. Both Pfizer and Ranbaxy have extensive litigation on this issue. Pfizer could otherwise have seen Ranbaxy bring a generic version of Lipitor in March 2010. About 25% of Pfizer's $48 billion in revenues come from Lipitor and its stock price is at its lowest in a decade because of the uncertainty over Lipitor. Under the agreement Ranbaxy gets to be the only company to market a generic version of Lipitor for 180 days after Pfizer's patent expires. Ranbaxy also gets to market a generic version of Caduet, a pill that combines Lipitor and blood pressure medication Norvasc, in 2011 before the patent for Caduet expires in 2018. The FDA can question the terms of this agreement as it favors introduction of generics competition, and the Caduet portion of this deal may be seen as a payoff to Ranbaxy for settling with Pfizer....

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This important WSJ report shows how the CDC labs failed to come with the test after contamination of a component and failure of the third part of the three part test components. In the absence of a working test from CDC where delays cost three weeks of February the private labs all over the country and state labs could have developed their own test, yet HHS and FDA required approval for these labs to develop their own test and use it. From Feb. 8 when state and city public health labs detected problems with the CDC test to Feb 29 when solutions were developed including simply excluding the third part of the three component test, and letting labs around the country do their own test, were 3 crucial weeks that let the virus spread out of control. The CDC, HHHS, and the FDA and their managers and heads of departments bear responsibility for these errors. Week after week the delays continued, instead the two component test which detects if the genetic material in the sample is coronavirus material, could simply have been approved at the outset instead of the approval for this given weeks later. The third component of the test checks if the virus mutated, according to this report. There is no explanation why the labs all over the U.S. were not allowed to go ahead on February 9 itself or within a few days after that to develop their own tests once it was clear the CDC test did not work on that day. CDC officials failed to recognize that there was a possibility that they may not be able to fix the faulty third component of the test and the risks if they gave false reassurances. There is also no explanation of why a German designed test was not used once the CDC test failed on Feb. 9, which would be a proper way for action considering that this pandemic had already shutdown parts of China by this time. Alarming also is the mention in this report that on Feb. 22 a FDA official in charge of lab diagnostics  flies to Atlanta where the CDC Respiratory Diagnostic lab which developed the test is located. His boss FDA medical device center director is cited from later information as describing the lab as "filthy" meaning the lab had the potential to contaminate, and going so far as saying that if it had been any other lab it would have been shut down. Considering that investment in public health has deteriorated over the last two decades and that there has been a massive misallocation of capital in the country away from public infrastructure this is appalling. The thought of critical labs for emergency health needs as not being up to high quality standards in the U.S. as a result of two decades of misspending, that this shows, is very disturbing.  This WSJ report is based on interviews with people who know about the testing crisis, and undisclosed emails, correspondence on the issues involved. Community transmission began in January 2020 in the U.S. These delays were costly in February and could have been prevented either by going with the German design on Feb 10 or asking labs across the U.S. to develop their own test, and letting other labs immediately use the modified 2 component test of CDC that worked instead of doing this action weeks later. Mardi Gras on Feb 25 and other places where large crowds gathered in sports stadiums could have been stopped had testing gone forward and shown the true extent of the community transmission in these critical weeks.  First China delayed a U.S. team of experts coming into the country for weeks, and then the CDC, FDA, HHS, failed to get testing started, creating  a false sense of complacency. Two crucial errors outside and inside the country that caused so much damage to America and the world.   ...