Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

th

Year

Volume: 05

Number: 40

15th January 2012

Content Novartis to cut almost 2,000 US jobs this year MCI constitutes committee to probe Indore clinical trials Report finds Oxycodone prescriptions rose sharply in New York Analyst gauges financial loss from Novartis recall IDRI receives additional funds from Gates Foundation for novel TB drugs Status quo to continue on barcode implementation as case did not come up for hearing in Madras HC Forthcoming Event

Novartis to cut almost 2,000 US jobs this year Drug maker Novartis will cut 1,960 jobs in the United States this year in anticipation of lower sales for two of its hypertension drugs, the Swiss company said Friday. Basel-based pharmaceutical giant Novartis AG said the cuts will affect 1,630 sales positions in the field and 330 posts at its U.S. headquarters in New Jersey. The restructuring was necessary because of the expiry of its patent for the bestselling hypertension drug Diovan and the failure of a clinical study into another hypertension drug, Tekturna, Novartis said. "We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our

market position on our growth brands," the head of Novartis' pharmaceuticals division, David Epstein, said in a statement. "These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payers." Novartis said the job cuts would save $450 million a year from 2013 after an initial charge of $160 million, to be booked in the first quarter of 2012. Diovan contributed $1.43 billion to Novartis' net pharmaceutical sales of $8.16 billion in the third quarter. Its patent expiry is likely to markedly increase competition from generic products. Meanwhile, Novartis said a reassessment of the future sales potential of Tekturna, which is known as Rasilez outside of the

2 U.S., will result in an exceptional charge of $900 million in the fourth quarter. The company said last month at it had terminated a trial into the expanded use of Tekturna after it was found to cause increase complications in patients already taking other common hypertension drugs. Two other experimental drugs will also be dropped, leading to one-off charges of $160 million in the fourth quarter, Novartis said. In its statement Novartis made no mention of a recent announcement that it was recalling several over-the-counter drugs in the United States following reports of a possible mix-up with powerful prescription pain medications at a Nebraska manufacturing plant. Novartis shares closed at 53.35 Swiss francs ($56.61) on the Zurich exchange Thursday. The market was closed for trading Friday morning due to an unspecified technical problem, but is expected to open later in the day, said Stephan Meier, spokesman for SIX, the Swiss stock exchange.
Source: PharmaLive.com

doctors flagrantly violated minimum ethical standards on their patients.

[Source: ToI]

MCI constitutes committee to probe Indore clinical trials Medical Council of India (MCI) has constituted a committee under Prof Sneh Bhargava to probe the clinical trial issue, in which a group of doctors here subjected 233 patients to clinical trial, and submit its report to the MCI chairman Prof K K Talwar to take appropriate action against the erring doctors. Prior to this, CPM politbureau member Brinda Karat met Prof Talwar to bring into the notice of the council the misdeeds of the doctors and to take action against those involved in the drug trial in which

Report finds Oxycodone prescriptions rose sharply in New York The New York Times reports, "In a stark depiction of the rapid spread of prescription drug use and abuse in New York State, a new report shows that prescriptions for oxycodone, a widely prescribed narcotic painkiller, rose by 82 percent from 2007 to 2010." The Times adds that "the report, which the state's attorney general, Eric T. Schneiderman, issued on Wednesday, was offered in support of a drug-tracking system that Mr. Schneiderman proposed last year and hopes the Legislature will enact." In "the proposed legislation, the Health Department would put in place an Internet tracking system that goes beyond what most states employ." "Attorney General Schneiderman wants immediate online real-time tracking that would require physicians and pharmacists to report and review a patient's history prior to prescribing and distributing a controlled substance," WCBS-TV New York City reports. "Experts want to strengthen the narcotic database and go after the bad doctors. They also want to make treatment available for addicts before they become desperate and violent." Analyst gauges financial loss from Novartis recall Manufacturing problems at a Novartis factory that triggered the recall of four popular medicines could cost the company between $560 million and $750 million in lost sales and productivity, a Wall Street analyst estimated Tuesday. On Sunday the Swiss drugmaker announced the recall of 1,645 lots of Excedrin, NoDoz, Gas-X and Bufferin from the U.S. market due to reports of chipped

3 and broken tablets and inconsistent bottle packaging that could cause medicines to be mixed up. The company previously closed the Lincoln, Neb., facility where the products were manufactured and says it does not know when operations will resume. Novartis expects to take a $120 million charge for the fourth quarter of 2011 related to the recalls. Leerink Swann analyst Seamus Fernandez cut his 2012 sales forecast and full-year earnings estimate for the company by $560 million and 20 cents per share, respectively. According to an investment note from Fernandez, the figure reflects the loss of a year's worth of sales of the recalled products, roughly $390 million, plus $170 million in lost production from an expected three-month shutdown of the facility. The Food and Drug Administration is currently investigating manufacturing and quality-control problems at the plant and is expected to be involved in approving the restart of operations. "History suggests that few manufacturing challenges resolve quickly, but a partial resumption of manufacturing is certainly possible, although a resumption of manufacturing and a full recovery in the recalled brands are likely to take considerably longer to resolve, particularly given the FDA's involvement," Fernandez states. In a worst-case scenario, Fernandez expects Novartis would lose $750 million in income if all products manufactured at the Lincoln plant are suspended for one year. That would be a 30 to 35 cent cut in earnings per share. IDRI receives additional funds from Gates Foundation for novel TB drugs The Infectious Disease Research Institute (IDRI) announced the receipt of supplemental funds from the Bill & Melinda Gates Foundation, totalling over half a million dollars to augment the multi-million dollar award made last year as part of the Foundations Tuberculosis (TB) Drug Accelerator programme. The purpose of the original grant, titled Chemical genomics for the identification of targets and leads in tuberculosis, is to identify new leads and new drug targets suitable for further drug development, with the ultimate goal of producing new drugs to treat TB. The additional funding will allow IDRI to expand its activities and leverage increased participation by the pharmaceutical community in tuberculosis drug discovery. According to the World Health Organization, nearly two million people die of TB each year. Approximately 9 million people are newly infected with TB annually, and half a million cases are resistant to the multiple drugs that once effectively treated the disease. IDRI will use the additional funds to expand several areas of work in early drug discovery including increasing their capacity to screen for anti-tubercular compounds, evaluation of hit compounds and novel drug target identification. We are very pleased and thankful to be able to expand our efforts in drug discovery enabling progress towards our goal of developing new antibiotics for tuberculosis, said Prof. Tanya Parish, director of TB Drug Discovery at IDRI. The additional funding will allow us to screen a wider variety of compounds and progress them into drug candidates more rapidly. Dr Steven Reed, president, chief scientific officer and founder of IDRI, said, These additional funds will greatly help our drug

4 discovery efforts, enabling us to increase our interactions with the academic and pharmaceutical communities to find new treatments for tuberculosis. The IDRI is a not-for-profit organization committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty. Status quo to continue on barcode implementation as case did not come up for hearing in Madras HC The Madras High Court's December 19 order to maintain status quo on the issue of implementation of second phase of barcoding for the pharma exporters in the country will continue at least for another two weeks as the court did not take up the issue so far for hearing. According to CIPI general secretary B Sethuraman, who is spearheading the case against barcoding in Madras High Court, the case did not come up for hearing so far and the chances of coming up for another two weeks is bleak as the court is on leave till January 17 due to Pongal celebrations in Tamil Nadu. As there are several other pressing issues before the court, the chances of the case related to barcoding coming up in the next two weeks are dim, he said. Earlier on December 19, 2011, the Madras High Court had stayed the second phase of barcode implementation for the pharma exporters in the country till January 6, 2012. The court order came just less than two weeks before the union commerce ministry's mandatory implementation of barcoding on secondary level packaging was to come into force from January 1 this year. The court was to hear the issue on January 6, but it was not listed for hearing so far. The case against barcoding implementation was filed jointly by Confederation of Indian Pharmaceutical Industry (CIPI) and Indian Drug Manufacturers Association (IDMA). Delivering its order on December 19, the Madras High Court had ordered the union commerce ministry to maintain status quo on the issue of implementation of barcoding for the pharma exporters in the country till January 6. Even though the union commerce ministry had since then extended the implementation of the second and third phases of barcoding by six months, the court's intervention on the issue is significant as the court's directive will set the tone for the future course of action on the issue, on which both the industry and the government have locked horns for some time. Ever since the commerce ministry issued a notification on January 10, 2011 rolling out its plans to implement barcoding for pharma exports, the industry has been on warpath against the ministry's decision. In fact, the industry has been running from pillar to post to convince the commerce ministry officials to see reason as they argued that the implementation of barcoding on secondary level packaging will entail a string of regulatory, technical as well as cost issues which will harm the pharma exporters in the country. Burt, the industry's repeated pleas to defer the barcode implementation fell on the deaf ears of the officials of the commerce ministry, forcing the industry to turn to the last resort of moving court. Forthcoming Event

Fourth IPA-Students Congress

February 17-19, 2012 Venue: St. Peter's Institute of Pharmaceutical Sciences, Warangal in Feb 2012