Pharmaceutical News

Gene E. Burleson, Healthcare Industry Executive and Director of Several NYSE-Listed Companies, Joins Vyteris Board of Directors

FAIR LAWN, N.J.–(BUSINESS WIRE)–Vyteris, Inc. (OTCBB: VYTR), an innovator in alternative drug delivery technology, announces that Gene E. Burleson (age 69) has been appointed to the Company’s Board of Directors effective December 1, 2010. Mr. Burleson is the first of two MediSync BioServices Directors to be named to the Vyteris Board under the September 2010 merger agreement.

“We are delighted to welcome Gene to the Vyteris Board of Directors, and are confident his experience in building and consolidating healthcare services companies over a career spanning more than 30 years will be invaluable as we integrate MediSync BioServices with our active transdermal drug delivery business”

“We are delighted to welcome Gene to the Vyteris Board of Directors, and are confident his experience in building and consolidating healthcare services companies over a career spanning more than 30 years will be invaluable as we integrate MediSync BioServices with our active transdermal drug delivery business,” stated Haro Hartounian, Ph.D., President and CEO of Vyteris. “Gene’s vast experience in the healthcare industry will be instrumental in achieving our strategic and operational goals in the rapidly expanding contract drug development industry.”

Mr. Burleson served as Chairman (1989-1997) and CEO and President (1990-1997) of GranCare, Inc., which, under his management, grew from under $10 million in revenue to become one of the nation’s largest publicly-traded long-term healthcare providers with revenues in excess of $1 billion. Following the merger of GranCare’s pharmacy operations with Vitalink Pharmacy Services, he served as CEO and a Director of Vitalink a provider of pharmacy services to skilled nursing facilities. Both GranCare and Vitalink were NYSE-listed companies.

He has an extensive and successful track record of consolidation within the healthcare industry. In 2006, along with other established life science executives, Mr. Burleson joined MediSync, a consolidator of complementary, high-value, niche contract research organizations, site management organizations and related businesses.

Mr. Burleson currently serves on the Board of Directors of SunLink Health Systems. Previously he served as Chairman and CEO of Pet DRx Corporation, as Chairman of Mariner Post-Acute Network and Alterra Healthcare Corporation, and as a Director of Deckers Outdoor Corporation and Prospect Medical Holdings, among others. He holds a BS in Accounting and an MBA from East Tennessee State University.

About Vyteris

Vyteris, Inc. is the maker of the first active, ready-to-use drug delivery patch (LidoSite®) to receive marketing clearance from the U.S. Food and Drug Administration. Vyteris’ proprietary active transdermal smart patch technology delivers drugs comfortably through the skin using low-level electrical energy (iontophoresis). This smart patch technology is intended to allow precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that may result in considerable therapeutic, economic, and lifestyle advantages over existing methods of drug administration. Vyteris has successfully delivered a peptide non-invasively using its system, where the Company demonstrated achievement of therapeutic levels of a peptide without using any needles. For more information, please visit www.vyteris.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “would,” “should,” “believes,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, statements concerning the potential impact of the new marketing agreement and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others, the competitive environment and competitive responses to the new marketing arrangement. The Company has described other important risks and uncertainties under the caption “Risk Factors” in its most recent Annual Report on Form 10-K and in various filings made with the SEC. Actual results may differ materially from those contained in the forward-looking statements in this press release.

Nixon accepts pharmaceutical industry’s offer to track pseudoephedrine sales

Gov. Jay Nixon announced today that a new computerized system will help combat methamphetamine labs by blocking illegal sales of a decongestant at the pharmacy counter.

Legislators passed a law in 2008 requiring pharmacies to report sales of pseudoephedrine products electronically, but the mandate was never funded. Pseudoephedrine is meth’s main ingredient.

The Consumer Healthcare Products Association, a trade association representing pharmaceutical companies that make the over-the-counter product, volunteered to pay for the system.

Nixon accepted the industry’s offer, saying it will allow pharmacists and law enforcement to determine at the point of sale whether a buyer has bought large amounts of pseudoephedrine at various stores to skirt the legal limits.

Nixon said the system would allow people who legitimately need the cold medicine to purchase it, but will block sales to people trying to build an inventory to make methamphetamine.

Jim Acquisto, Product Manager at Appriss Inc., the company building the database, said the system likely will be up and running in about 90 days, and will connect Missouri’s database to those in Kentucky, Illinois and Louisiana.

Kansas and Iowa likely will be the next states to link to Appriss’ system, called Nplex.

Pharmacists will enter the buyer’s name into the database and get an immediate record of how much pseudoephedrine the person has bought along with a record of where and when the purchases were made. If the new purchase would put the buyer above daily or monthly limits, the purchase will be denied.

A buyer who is denied would receive a receipt with Appriss’ phone number asking the person to call Appriss for an explanation of the denial. The system is also able to spot fake identification cards, flag multiple purchasers living at the same address and track other suspicious patterns.

Appriss also will provide free training to pharmacy staff on how to use the system as well as law enforcement personnel on how to track suspicious purchases.

Local police agencies in Missouri are skeptical the new system will have an impact. They point to Kentucky, which had an increase in meth labs during the database’s first year of operation. They say Kentucky’s experience shows that the electronic system doesn’t stop meth labs.

Instead, police in Missouri have lobbied for prescription laws, saying electronically tracking sales won’t stop meth addicts from paying others to buy boxes of pseudoephedrine for them or shopping in groups.

So far, eight local governments have passed prescription laws, including Washington, Union, Poplar Bluff, Gerald, Kennett, Eureka, Potosi, Jefferson County and Farmington.

Happy holidays? Not necessarily in the pharmaceutical sector

Pharmaceutical manufacturers looking to cut costs need to keep focus on manufacturing/packaging to prevent product quality problems.

‘Tis the season to be jolly, right? Not necessarily in the pharmaceutical industry. A recent article from The Economist’s Intelligence Unit, for example, reported that Roche and Bayer were slashing thousands of jobs globally, attributing the cuts in part to industry consolidation, patent expires, and moving dollars to emerging markets.

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It’s unclear if such job cuts will reach packaging staff at pharmaceutical companies, but one respected packaging veteran expressed concern to this editor that cutbacks could potentially affect packaging development (both new packages and packaging procedures), and operations (upgrades, safety, efficacy, recalls, etc.). This expert wondered if some of Johnson & Johnson’s problems could be traced to packaging and labeling errors resulting from cutbacks.

A recent Wall Street Journal online article noted, “Johnson & Johnson, which has been recalling a number of popular over-the-counter medicines, said it is withdrawing more Tylenol because of a labeling problem.” The recall of more than 9 million bottles, WSJ said, was being made “because the bottles’ front labels didn’t show they contain small amounts of alcohol from ingredients that flavor the medicine. …The recalls are costing the company hundreds of millions of dollars in lost sales and prompted the temporary shutdown of a key manufacturing plant and a revamp of manufacturing. The company has also shuffled management.”

The article said the labeling problem “doesn’t threaten the health of consumers, who don’t need to take action and can continue to take the product.” An unnamed contract manufacturer was said to have made the recalled products, according to the article.

The Economist’s piece concluded, “Job cuts that accompany a recession are understandable, and they are also reversible when better times come. But the shift into emerging markets, and away from the old sales and marketing routines, is more permanent. The jobs that are disappearing now will probably not reappear, though that may help to save other jobs by shoring up pharma company profits.”

Economic factors and strategic planning give a pharmaceutical industry veteran enough to be concerned about, but cutbacks in personnel that result in product quality issues could damage a company’s reputation and negatively impact the bottom line..

PhRMA Statement on Department of Homeland Security Efforts to Crack Down on Counterfeiting Crimes

WASHINGTON, Dec. 15, 2010 /PRNewswire-USNewswire/ — Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John Castellani released the following statement regarding the Department of Homeland Security stepping up efforts to combat counterfeit drugs:

“The Department of Homeland Security’s (DHS) decision to step up efforts to eliminate counterfeit medicines should not only be applauded but should also serve as a warning sign to criminals selling fake and harmful counterfeit pharmaceuticals to unsuspecting consumers.

“No country is immune to the worldwide counterfeit medicine threat. A growing web of criminal networks around the globe are selling dangerous counterfeit drugs to innocent victims – people who might think they’re getting a good deal but in reality are receiving medicines that are fake, substandard and in some cases lethal. Make no mistake: criminals are not only targeting ‘lifestyle’ drugs but also vital medicines that treat cancer, diabetes, malaria and high blood pressure.

“The most common mechanism for counterfeit drugs to enter the U.S. drug supply is through purchases made on illegal online pharmacy sites that are operated by criminals in other countries with known counterfeiting problems. Cracking down on these illegal sites can help protect patient safety and help ensure that the closed U.S. drug supply system is not compromised.

“In most cases, criminals caught selling counterfeit medicines in the U.S. face lighter jail sentences and penalties than criminals selling illicit drugs such as heroin. For this reason, PhRMA will continue to advocate for stricter sentencing guidelines for counterfeiters – the average jail time for a counterfeiting crime is 3 years but we believe that 20 years is a better fit for such a potentially deadly crime.

“In the meantime, America’s biopharmaceutical research companies will continue to work with key government agencies – such as DHS and the Food and Drug Administration – as well as members of Congress to help safeguard patient health and the U.S. drug supply system.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $45.8 billion in 2009 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.3 billion in 2009.

Pharmaceutical technology transfer growing rapidly in past decade: IFPMA

Technology transfer in medicines and vaccines were growing rapidly in the past decade, benefiting both pharmaceutical companies and the health of recipient countries’ population alike, said the International Federation of Pharmaceutical Manufactures and Associations (IFPMA) here on Tuesday.

According to IFPMA spokesperson Guy Willis, today a majority of medicines reaching people in fact came from technology transfer.

On the transferring chain, most of the technology providers are research and development based companies from developed countries, such as Germany, Switzerland and Japan, while the recipients are mainly in middle and low-income countries.

IFPMA studies suggested that the middle-income countries caught more opportunities of pharmaceutical technology transfer, in comparison to the low-income countries who were hindered by lacking many of the enabling conditions.

To facilitate the process, IFPMA has issued a research paper titled “Technology Transfer: a Collaborative Approach to Improve Global Health — the R&D Pharmaceutical Industry Experience,” with over 50 case studies illustrating successful practices.

The paper also identified favorable conditions that contribute to successful transfers, such as market access, sound economic governance, clear development priorities, effective regulations, sufficient skilled workers, and adequate capital market.

IFPMA called on middle- and low-income countries to create “a welcoming policy environment” to boost pharmaceutical technology transfer, and high-income country to increase aid funding for health and healthcare in the developing world.

Big Pharma’s Big Headache

We may be witnessing a slowly developing economic recovery, but that’s little consolation to the pharmaceutical industry. This year, according to the New York Times, drug companies will see annual sales of almost $50 billion evaporate. Why? Because the patents for more than 10 major drug brands will expire.

It’s a reality that has lingered for years. A drug company invests huge amounts of money in R&D and finally wins approval to bring a drug to market under a brand name.

But that drug can only be protected by a patent for a certain number of years; when the patent expires, generic versions of the drug can be sold, almost always at a cheaper price. Take Tylenol, for example, one of the brand names for acetaminophen.

Today, consumers can buy the generic version of acetaminophen, which often sits on a store shelf right next to Tylenol. By law, the generic version must contain the same active ingredients as the brand name, but the generic drug costs less.

While consumers may exhibit some amount of brand loyalty, there aren’t many compelling reasons to keep buying the name brand if a generic works just as well at a lower price. Typically, the price difference in prescription drugs versus generics is even greater, so when a brand name prescription medication “goes generic,” the impact on a drug company can be enormous.

Part of the reason consumers may be less loyal to a brand name drug could be the fact that, oftentimes, the name is nonsensical. This is largely due to regulators, particularly in the United States, who restrict names from being too promissory or suggestive of what the drug can accomplish.

Coming up with a distinctive, easily remembered name — such as a Prozac or Viagra — isn’t as easy as the consumer might think. There are also so many drug names in the marketplace that it is difficult to come up with anything new.

As a result drug companies are likely to propose brand names that are less than meaningful. As Bill Flook commented in Washington Business Journal, “The Food and Drug Administration subjects proposed drug names to intense scrutiny, and drugmakers take pains to make sure a product’s name doesn’t end up delaying its trip to the market.”

Patent expirations and nomenclature are two of the many problems facing a pharmaceutical industry “that just a few years ago was the world’s most profitable business sector but is now under pressure to reinvent itself and shed its dependence on blockbuster drugs,” writes Duff Wilson in the New York Times.

Drug companies are also feeling the heat from insurance companies and the government who, in an effort to control health care costs, want them to keep drug prices reasonable. Recent health care legislation in the US was supported by the pharmaceutical industry, but calls for government price controls.

In addition, the drug companies are not having the kind of success with major drug introductions that they had in the past; the cost associated with testing new drugs is sometimes prohibitive and, in the US, fewer new drugs are being approved. And there’s also some consumer uncertainty in the wake of recalls.

Kenneth I. Kaitin, director of the Center for the Study of Drug Development at Tufts University in Massachusetts, told the New York Times, “This is panic time, this is truly panic time for the industry. I don’t think there’s a company out there that doesn’t realize they don’t have enough products in the pipeline or the portfolio, don’t have enough revenue to sustain their research and development.

What’s the answer? For now, drug companies seem to be trying to solve the problem by buying their way out of it, “essentially paying cash for future revenue as their own research was flagging.” That explains the industry consolidation that has taken place in recent years. Examples include Merck buying Schering-Plough, Pfizer buying Wyeth, Roche buying Genentech, and Sanofi-Aventis buying Genzyme.

Still, “75 percent of all prescriptions in the United States are now low-price, low-profit generic drugs,” and drug companies are under pressure globally to lower the prices of their name brand medications.

This year seems to be just the beginning of a long-term migraine for the pharmaceutical industry.

Supreme Court declines to hear ‘pay-to-delay’ pharma case

The federal government’s decade-long quest to limit pharmaceutical manufacturers’ actions to keep generic medications off the market for a specified time–through deals called “pay-to-delay”–ran into a new challenge Monday: The U.S. Supreme Court, without comment, declined to hear a federal appeals court decision from a year ago that had upheld the practice.

In that earlier ruling, the New York-based appeals court dismissed a legal challenge regarding Bayer AG to pay a potential generic competitor, Teva Pharmaceutical’s Barr Pharmaceuticals, in a 1997 deal to delay introduction of a generic version of Cipro, a popular antibiotic.

However, in an unusual move, the appellate court encouraged the plaintiffs in this case–including pharmacy chains CVS and Rite Aid–to petition for a rehearing en banc, in which all of the appellate judges would hear the case. However, that petition was denied last fall, which lead to attempts for a review from the Supreme Court.

The Federal Trade Commission (FTC) has strongly opposed such “pay-to-delay” deals, which it has estimated to cost consumers as much as $3.5 billion a year in higher prescription drug prices.

The Obama administration also is against these settlements. In the President’s recent budget request, according to a report from The Pharma Letter, he has proposed giving the FTC powers to block these types of agreement between brand-name drug companies and generic drug companies.

Restrictions on “pay-to-delay” were included last year in the initial House healthcare reform bill, but they were excluded in the final healthcare reform law passed last March.

Patents for 11 drugs end, pharma firms brace for loss of sales to generics

Patents of 11 drugs sold in the U.S. are about to end this year. Pharmaceutical companies are bracing for loss of sales to generics on the 11 drugs, which have combined yearly sales of almost $50 billion.

By November, Pfizer’s patent for cholesterol drug Lipitor ends, placing at risk the company’s $10 billion yearly sales on the drug. Pfizer filed for a reissue of Lipitor’s calcium salt patent in January 2007, but the Patent Office rejected the application.

To fill in the anticipated sales gaps, some of the large drug firms bought their competitors during the last 24 months. Pfizer purchased Wyeth for $68 billion, Merck bought Schering-Plough for $41 billion, Genentech sold out to Roche for $46 billion and Sanofi-Aventis bought Genzyme for $20 billion.

An industry expert said that it is now panic time for the pharmaceutical industry on realization that drug firms do not have enough products in their pipeline or portfolio or enough revenue to sustain research and development. They also have to deal with research failures, such as the failed clinical trials of the replacement for Lipitor.

As a consequence, the drug firms reduced 53,000 jobs in 2010, on top of the 61,000 jobs they cut in 2009.

Pfizer, with up to 30 percent reduction on R & D in the next two years, will refocus its efforts on smaller niches in cancer, inflammation, neuroscience and branded generics, according to new Pfizer president Ian Read.

The drug firms’ biggest competitors continues to be generic drugs, which now account for 75 percent of all prescriptions in the U.S.

Hospitals grapple with drug shortage

A nationwide shortage of key drugs has forced local hospitals to get creative in their treatments of some diseases, including cancer.

“We haven’t run out of anything crucial,” said Becky Caswell, assistant director of pharmacy at Southwest Washington Medical Center.

But the hospital has had to ration, opt for more expensive alternatives to preferred drugs, and work carefully to plan cancer treatments and surgeries with doctors.

Drugmakers say the shortage is the result of tougher federal safety rules, which have prompted them to review manufacturing processes and take some drugs off the market. Consolidation and competitive pressures within the pharmaceutical industry have exacerbated the shortage.

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The result: area hospitals have become increasingly vigilant over their use of medication, as they watch to make sure that essential drugs don’t run out.

So far, that has not happened, said Kathy Stoner, pharmacy services director for Legacy Health, which operates Legacy Salmon Creek in Vancouver. But doctors and nurses have been forced to use second-choice medications.

For example, when a preferred anti-convulsant became scarce, Legacy began to use another effective treatment — phenytoin — that can cause tissue damage when it escapes from an intravenous tube.

“We have nurses who weren’t practicing last time phenytoin was in use,” Stoner said. “There was some education needed about the right dose for the drug and how to give it so it’s safe for patients.”

When shortages spur a substitution, patients usually do not even know there was another option.

While local hospital officials say they are unaware of postponed or canceled treatment linked to unavailable drugs, vaccine shortages have affected preventive health. Southwest Washington Medical Center has not had the shingles vaccine in stock since December, and does not expect the next order to arrive until June — despite six pending prescriptions from patients who would like the shot.

Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies as they respond to the federal government’s crackdown on drug safety. The quality issues can range from finding toxins and “particulate matter” in medicines to workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.

Even after a company restarts production of a drug, it takes time for a plant to catch up to the back orders. And injectable drugs in particular, unlike pills and tablets, tend to require long lead times to produce.

There are about 150 drugs — triple the number from just five years ago — that are in short supply, according to the American Society of Health-System Pharmacists, a trade group that works with hospital pharmacists on ways to deal with the shortage. About 60 of those are considered by federal health officials as “medically necessary,” and they include prescription medicines used to treat or prevent a serious disease or medical condition.
Challenging climate

Legacy Salmon Creek has experienced difficulties in obtaining about 75 drugs that it has ordered over the past year.

It’s a challenge to know which drugs will be available, despite industry efforts to publicize supply problems.

“Sometimes we find out when we go to order something, sometimes we know sooner,” said Caswell of Southwest Washington Medical Center. Several times the hospital has had to implement immediate changes to its formulary, or guide to preferred drugs.

Changing a formulary can be a complex process because it requires communication among doctors, nurses and pharmacists.

Drugmakers say they are obeying tougher safety rules put in place by the U.S. Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market. The FDA came under fire for its role in monitoring the blockbuster pain pill Vioxx, which was pulled off the market in 2004 by its manufacturer, Merck & Co., after the drug was linked to heart attacks and strokes.

The drug shortage is being exacerbated by consolidation in the pharmaceutical industry, which leaves fewer companies making drugs.

In addition, some drug companies have exited the business of making older, generic injectable drugs, which typically aren’t as profitable as newer brand-name medicines. That puts additional production pressure on the remaining makers of these generic treatments.

Take propofol, a popular anesthetic for surgeries and other medical procedures. Teva Pharmaceuticals Ltd. decided to exit the propofol business last year following a quality issue with the drug in 2009. In a statement, the company said it believed its “existing, approved technology is not suitable to ensure that we can consistently produce the product to Teva’s high quality standard.”

Teva’s decision came around the time another propofol maker, Hospira, had to stop shipping the drug due to quality issues in its production process. Last summer, the FDA allowed Hospira to begin production again. But the company said it needed time to ramp up production and fill back orders.

Teva also makes generic forms of certain cancer medications. When quality issues temporarily closed its plant in Irvine, Calif., in April, medical professionals were faced with limited supplies of an array of cancer drugs.

The drug shortages have gained the attention of members of Congress. Earlier this month, Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Pa., introduced legislation that would require drugmakers to give the FDA an early notification “when a factor arises that may result in a shortage,” according to a joint statement.

“Several major hospitals in our state have experienced shortages that are jeopardizing patient care, and this bill will provide the knowledge required to help address and prevent future shortages,” Casey said. “Knowledge is one of the most important tools for combating problems associated with drug shortages, which are a growing threat to public health in Pennsylvania and across the U.S.”

Hospitals are finding ways to deal with the lack of availability.

Legacy, which has five hospital campuses and a number of clinics, has moved products in short supply from one hospital to another, Stoner said. The hospital has also ordered some medications direct from the manufacturer at greater price than buying through a wholesaler, in order to guarantee shipment.

Turning to secondary suppliers when a primary source for drugs runs out has caused some hospitals to pay double or more for certain drugs.

In Illinois, Advocate Health Care pharmacists had to buy certain dosages of the drug neostigmine, used to reverse the effects of “paralyzing agents” commonly used in surgeries, for $11.50 per vial compared with the usual price of $1.50 to $6.50 per vial from their primary wholesaler, which ran out of the medicine.

Escalating prices are of major concern for those watching the nation’s ever-rising cost of health care, but pharmacists say they’re just relieved that so far their ability to offer treatments has not been substantially altered.

“I’m not worried at this time,” Caswell said, “but you never know.”

Ontario Liberals gear up to battle Shoppers Drug Mart again

Less than a year after trouncing Shoppers Drug Mart in a public fight over prescription costs, Dalton McGuinty’s government is gearing up to do battle again. This time it’s over the pharmacy giant’s attempt to establish its own line of generic drugs.

Last week, the government sought leave to appeal a court ruling that overturned its ban on “private labels” – a ban aimed most obviously at Shoppers, though it would also thwart similar efforts by Rexall. The Liberals are buying time while they decide whether to go back to court or write new legislation that trumps the ruling.

Even among many of those familiar with the issue, the government’s motivation for bothering with either option is a minor mystery. Health Minister Deb Matthews got what she wanted last year – a much lower price for generic drugs, achieved by eliminating the “professional allowances” paid by manufacturers to pharmacies in return for stocking their products. Why would she begrudge efforts by the chains to recoup some of the revenues they lost through those reforms, since their private-label drugs would still be sold under the new set price?

Little credence is given to the argument, made previously by the government, that it would be dangerous for pharmacies to have vested interests in which drugs are dispensed. Generics are by their nature the same, so it really doesn’t matter which are used to fill prescriptions.

Neither is the government all that concerned with protecting independent pharmacies, even though private labels would enhance Shoppers’ (and Rexall’s) already considerable competitive advantage. Ms. Matthews made plain last year that she thinks the province has more pharmacies than it needs, and there’s no indication she’s changed her mind.

The real worry, it seems, is about the future of a domestic industry that on its face seems less sympathetic: generic-drug manufacturers.

The private-label strategy hinges on chains striking (possibly exclusive) deals to get drugs at a wholesale price that’s only a fraction of the sale price, which has been capped at 25 per cent the cost of the brand equivalent. For now, those deals would be with domestic suppliers. But it’s widely believed that, to get the best deals, the chains would soon outsource overseas – likely to India.

A cynic would suggest the Liberals are looking out for Bernard (Barry) Sherman – the chairman and CEO of Apotex, the largest domestic manufacturer. Mr. Sherman cuts an influential figure, and it’s not been lost on some observers that Apotex is a political donor.

A more charitable explanation is that the government is worried about jobs. Combined, the province’s generics companies employ about 8,000 Ontarians, and many of them could wind up out of work.

Then there’s costs. Particularly with the lower prices, the government – which foots the bill for prescriptions bought on its public plan – wants generics to replace brands as quickly as possible. And if the domestic industry declines, that could take longer.

Mr. Sherman is extremely aggressive in challenging patents, and willing to pay the very large legal costs. If he’s out of the picture, it remains to be seen if the chains themselves will step into the void. And it’s also uncertain whether generics manufactured in India or elsewhere would take longer to get regulatory approval.

If generics take longer to come to market, the extra year or two of paying for brand drugs could wipe out some of the savings achieved through last year’s reforms.

A final factor is the availability of the small number of generics that offer minimal profit, because they’re more expensive to produce. There’s already concern that the price cap is affecting that supply. And with a shrinking industry, it could become even more scarce.

That, at least, is what some insiders argue. Of course, there’s a much simpler explanation for the Liberals’ eagerness for renewed hostilities: getting even.

Although they won the last war, Liberal MPPs still hold a grudge over the massive public relations campaigns that Shoppers waged against them in their ridings. So there’s a certain degree of enthusiasm for scorched earth.

If last year showed anything, it’s that picking on the poster child for aggressive retail expansion makes for good politics. But one would like to think the government has something a little nobler in mind.

Report: 50% of pharma serializing in 2011

IDC is bullish on drug serialization. The market researcher says in a report that it expects about 50 percent of the industry to have fully serialized at least one product line to the item level by the end of 2011.

The driver will be big pharma companies preparing for the 2015 deadline of the California Board of Pharmacy serialization mandate and similar upcoming regulations worldwide, says Pharmaceutical Commerce. A U.S. national serialization and pedigree program remains an FDA discussion item. The agency held a public workshop on system attributes for drug track and trace in mid-February. The effort is in line with similar activities in Europe, reports the Association for Automatic Identification and Mobility (AIM).

Many companies are encoding data matrix symbology on preprinted labels, says AIM. And several are embedding RFID tags in labels and encoding them on-the-fly. Mechanics aside, however, housing, managing and securing these data remain challenges. And some non-manufacturing parts of the drug supply chain, including retailers, maintain resistant.

Caraco to merge with Sun Pharma

Caraco Pharmaceutical Laboratories today said it has entered into a merger agreement with Sun Pharmaceutical Industries, which has increased its offer price per share by 10.52%.

“The merger agreement provides that all shareholders of Caraco, other than Sun Pharma and Sun Global, will receive a cash payment of $5.25 per share upon the closing of the transaction,” Caraco said in a statement on its website.
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The company had earlier announced that Sun Pharma and Sun Global had proposed to delist the NYSE listed firm, under which Sun Pharma, Sun Global and/or one or more of their affiliates would acquire all of the outstanding shares of Caraco common stock for a per share consideration of $4.75 cash.

Sun Pharma and its subsidiary Sun Global collectively own 75.8% of Caraco common stock.

“Upon completion of the transaction, Caraco will become a privately held company and its common stock will no longer be traded on the NYSE Amex,” it said.

Caraco entered into the merger agreement based upon the recommendation and approval of the Independent Committee of Caraco’s Board of Directors and the approval of the Board of Directors, the statement said.

The closing of the transaction is subject to regulatory and shareholders approval, it added

Detroit-based Caraco develops, markets and distributes generic pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.

Pharma sector ‘ill-equipped’ to cope with new demands

Manufacturers and chemical processors in the UK’s pharmaceutical industry are ill-equipped to meet the sector’s future needs, it has been claimed.

Most companies lack the infrastructure to produce and distribute the kind of complex treatments that will soon be required, according to a report from PricewaterhouseCoopers (PwC).

PwC global pharmaceutical and life sciences leader Simon Friend explained that the global pharmaceutical industry will need to develop a new supply chain model, to meet the sector’s shifting demands.

He added: “Companies must now work hard to get closer to their patients as by 2020, there is little doubt that the data behind a product will as valuable as the product itself.”

Earlier this month, the Association of the British Pharmaceutical Industry called on ministers to take action to improve sector trading processes, particularly to continue with tackling medical supply shortages.

In particular, the organisation pointed to issues within the NHS procurement process that need addressing by the government.

Typical Guttridge equipment used in the pharmaceutical industry includes; Feeders – metering screw feeders – weighing systems

UPDATE 1-Paladin wins Canada approval for cancer-pain drug

* Drug treats bouts of severe pain in cancer patients

* To acquire additional 10 percent stake in Pharmaplan

TORONTO Feb 22 (Reuters) – Paladin Labs Inc (PLB.TO: Quote) said it received Health Canada’s approval to market a cancer-pain drug.

The specialty pharmaceutical company owns the Canadian rights for Abstral, a formulation of fentanyl used to treat sudden bouts of severe pain in cancer patients. Abstral is manufactured by ProStrakan (PSK.L: Quote), a Scottish pharmaceutical company.

The approval boosts Paladin’s pain line-up, which includes Tridural and analgesic Metadol.

The Montreal-based company is also looking to accelerate its purchase of shares in South Africa’s Pharmaplan. It plans to acquire an additional 10 percent of Pharmaplan in 2011, compared with its earlier plan to buy 5 percent. This will increase its stake to 44.99 percent, effective March 1. (Reporting by S. John Tilak)

Themis Medicare

Themis Medicare Ltd has informed BSE that the Company have for the First Time entered into an altogether new pharmaceutical marketing segment – COSMETO – DERMATOLOGY with the launch of the brand LUMIXYL.

LUMIXYL incorporates a new technology called Peptide that addresses a skin disorder called Hyper-pigmentation i.e., darkening of skin. The product is being introduced in India through the Company’s new Division ‘LUMINOUS’ that has been launched for this very range of products.

Themis Medicare is the First and Only Company to market LUMIXYL in India.

LUMIXYL is being introduced in a ‘Hamper’. Each Hamper will contain a Lumixyl Skin Brightening Cream for Hyper-pigmentation and a Lumixyl Sunscreen with SPF30.

Global consolidation hits Indian contract drug manufacturing cos

NEW DELHI: Mergers & acquisitions in the global pharmaceutical industry that have led to reduction in outsourced research work have hit Indian contract drug manufacturing and research services or CRAMS companies.

The impact is being felt by both large firms such as Jubilant Life Sciences as also mid-sized firms such as Dishman Pharmaceuticals and Shasun Pharmaceuticals. Analysts say global consolidation poses a challenge for Indian CRAMS firms revenues for the future.

“When global drugmakers cut cost, the pre-clinical and early phase drug development outsourced to Indian firms are among the easy targets,” said a Mumbai-based pharma analyst with a global brokerage firm.

The impact is visible in the financial performance of handful of CRAMS firms. Ahmedabad-based Dishman Pharmaceuticals & Chemicals scrip sank to its 52-week low at the Bombay Stock Exchange on Wednesday after its profit for the quarter ended December 2010 was almost wiped from 33 crore a year ago.

Another large CRAMS company Shasun Pharmaceuticals that also has bulk drug business saw consolidated loss increase almost fivefold to 9.7 crore for the third quarter.

The country’s largest CRAMs firm Jubilant Life Sciences saw its revenues from its research services drop almost by a third shrinking its profit more than half to 44 crore for the third quarter. The services business segment which constitutes 20% of its total revenue fell to 167 crore due to consolidation in global pharma space and delay in certain milestone linked payments, executive director finance R Sankaraiah said.

There has been several M&A deals in the pharma sector in the past two years as global companies have chosen to merge their operations to compensate for an imminent loss of revenues as their patent for their top-selling drugs expire.

These include Pfizer’s $60-billion buyout of Wyeth and Merck’s acquisition of Schering Plough for $41 billion. On Wednesday, Sanofi Aventis announced it is buying American biotech firm Genzyme Corp for $20 billion.

Hitesh Gajarai, pharma analyst at consultancy firm KPMG said after a mergerm where two firms consolidate their independent activities, the new company may stop research on molecules in same therapeutic area, rejig its research portfolio or re-negotiate contract suppliers with their preferred firms.

Many global research firms, such as Pfizer , GSK and Merck , have announced massive cost-cutting measures, including expenses in R&D. For instance, Pfizer, that has the biggest research expenditure in the pharma industry, plans to cut R&D spends in 2012 by as much as $2 billion from a planned $8-8.5 billion.

J R Vyas , managing director at Dishman, said since these are huge companies it takes a long time to integrate and outsourcing takes a back seat. “But this does not mean they will stop outsourcing. We expect to maintain a 15-20% growth next year onwards,” he said.

Ranjit Kapadia, VP Institutional Research at brokerage firm HDFC Securities , said those Indian companies that have larger contract manufacturing business and less exposure to clinical research services are better off.

“We do little contract research work and most of our business revolves around manufacturing,” said Swati Piramal , director at Piramal Healthcare . The Mumbai-based company’s sales from its CRAMs business grew 23.7% to 233 crore even as its research services revenues which accounts for about a 10th of its total CRAMs revenues remained flat.

Quebec creates seed fund for biotechnology

The Quebec government announced Friday the creation of a seed fund for the biotechnology sector.

The fund, called AmorChem, consists of $41.25 million from Investissement Québec, FIER Partners and the FTQ’s solidarity fund. There’s also an $8.25-million investment from the private sector, of which $6.8 million has come from pharmaceutical giant Merck.

This is the last of three new venture capital funds the Quebec government has created. Late last year, the government announced the creation of Real Ventures, a $50-million fund that will invest in high-tech startups, and last month, Cycle Capital was launched with $41.5 million dedicated to develop new companies in the clean tech sector. The government hopes the investments will boost Quebec’s sagging venture capital industry.

Louis Lacasse, who will serve as president of AmorChem, said this new seed fund will follow an unconventional method he believes will reduce risk: Rather than funding individual companies that are each based on research projects, the fund will finance several pressing projects at the same time, and they will share research facilities. Projects that continue to show promise will either be grouped with similar ones and formed into a company, or the work will be licensed to investors from pharmaceutical companies.

Lacasse explained this is a far less risky way of creating companies than in the past. However, there is still much risk investing in the industry.

“Most projects fail, that’s just the nature of the business,” he said. “You have to be very good, and you have to be very lucky to have a project that becomes successful.”

Shares of KV Pharmaceutical Get a Boost, Up 10.8% (KV.A)

KV Pharmaceutical (NYSE:KV.A) is one of today’s notable stocks on the rise, up 10.8% to $9.51. The S&P is currently trading fractionally higher to 1,343 and the Dow Jones Industrial Average is trading 0.3% higher to 12,355.

KV Pharmaceutical is in SmarTrend’s Drug Manufacturers- Generic industry and this industry is currently in an Uptrend according to our research. We are monitoring many other stocks on the move within this industry.

In the last five trading sessions, the 50-day MA has climbed 16.92% while the 200-day MA has risen 6.45%.

In the past 52 weeks, shares of KV Pharmaceutical have traded between a low of $0.60 and a high of $8.73 and are now at $9.51, which is 1472% above that low price.

SmarTrend currently has shares of KV Pharmaceutical in an Uptrend and issued the Uptrend alert on February 04, 2011 at $3.42. The stock has risen 151.2% since the Uptrend alert was issued.

Loyer’s Pharmacy closes

York, PA – Katie Rexroth came out from behind the counter at Loyer’s Pharmacy in Red Lion and wrapped her arms around Bernard “Nard” Bacon.

The 82-year-old from Chanceford Township had been a Loyer’s regular for about 60 years and friends with Rexroth’s grandparents. Still, Rexroth’s hug seemed to puzzle him.

“We’re closing today, Nard,” said pharmacist Jim Loyer. Only the top of his head was visible above the high counter where he worked to fill prescriptions. “It’s our last day.”

“You’re kidding,” Bacon said. “That ain’t true, is it? Huh? Oh my.”

After Loyer locked the door Monday night, Bacon and the regulars like him will have to go to nearby Lion Pharmacy to fill prescriptions. Loyer sold Lion his inventory and the arranged for it to fill his customers’ prescriptions.

Loyer is closing because business has become too hectic and too much for him to handle by himself. He blames York County’s aging population. The 58-year-old said wants to spend time with his two grandkids and one on the way.

For the time being, he’ll go to work as a part-time pharmacist at Lion.

After hearing the news, Bacon scratched the gray tufts poking from under his ball cap. He’d been patronizing Loyer’s since the 1930s, when it was known as Strock’s Drug Store. Otto Strock was the first druggist to hang out his shingle at 66 North Main Street in 1911.

Where will Bacon go now to swap stories and sip a complimentary birch beer — his favorite — while waiting at the marble counter of the soda fountain?

Charles Loyer, Jim Loyer’s father, had been a pharmacist in the Philadelphia suburbs when he bought the business from Harry Gruver in 1961. Jim Loyer was 9 at the time.

The drug store had always sold soft drinks and ice cream. Back then, every town in America had at least one drug store with a soda fountain in it, Loyer said. By 1961, the drug store was just beginning to disappear as a local hangout.

“I think it was always procrastinated, and it’s a good thing he did.”

As of Monday, 10 to 20 customers each day were still buying Coca-Cola products. People awaiting prescriptions got a free soda or coffee. Loyer’s also served PennSupreme ice cream and made milkshakes.

Time hasn’t changed much at Loyer’s. The original stained-wooden shelves and apothecary drawers still line the walls beneath ancient signs advertising Rexall Drugs. Jars of penny candy are piled on the counter.

“I have a lot of mixed feelings” about closing, Loyer said.

He’ll miss Beanie Babies and Smurfs — the little trinkets he sold customers that made them laugh. He’ll miss conversations. Customers like Bacon and  employees like Kilgore have known him all his life.

“I don’t want to say we’re all one big happy family,” he said, “that’s going a bit far, maybe.”

“Close,” Kilgore said.

Loyer nodded.

THE FOUNTAIN

While Loyer’s Pharmacy has closed, its soda fountain might see some business yet.

The Red Lion Borough Council recently awarded Lion Pharmacy conditional approval to expand, said owner Bethany Miller.

Part of the expansion could include a coffee bar.

“We would love to have it,” she said.

Lynn men indicted on drug, rape charges

SALEM – Two Lynn men were indicted last week by an Essex County Grand Jury on separate cases involving child rape and narcotic crimes.

Jose J. Minaya, 45, of 761 Summer St., is charged with rape of a child with force and three counts of indecent assault and battery on a child under the age of 14.

The allegations arise out of an incident on Nov. 28 when he allegedly raped and sexually assaulted a 9-year-old girl.

Minaya, who works at General Electric, was arrested following a police investigation. Bail of $5,000 was set during his arraignment in Lynn District Court, where he pleaded innocent. If bail is posted, District Court Judge Albert Conlon ordered that Minaya stay away from his accuser, have no contact with her and abide by any restraining order.

A conviction on the rape of a child carries a potential life sentence and indecent assault and battery on a child each carry up to 10 years in state prison.

Sean M. Driscoll, 42, of 76 Verona St., is charged with possession of Hydrocodone with the intent to distribute, subsequent offense, possession with the intent to distribute Hydromorphine with the intent to distribute, subsequent offense, possession with the intent to distribute amphetamine, subsequent offense, possession with the intent to distribute Methylphenidate, subsequent offense, and breaking and entering in the nighttime, larceny in a building, larceny

of property over $250. On Oct. 30 Driscoll is alleged to have

burglarized Connolly’s Pharmacy, located at 44 Bay Road in Hamilton, where he allegedly stole a number of prescription drugs.

Lynn Police arrested Driscoll at a third-floor apartment at South Street Court, where they found him sitting in a recliner surrounded by hundreds of stolen prescription drugs and pill bottles labeled Connolly’s Pharmacy.

Police then searched his red Cadillac and reportedly found two, two-way hand-held walkie talkies and a police scanner.

Indictments are not an indication of guilt, rather it is a legal process that allows a case to be transferred from District Court to Superior

Court, allowing for a more serious penalty.

Radical reform needed in pharmaceutical industry

A research centre funded by the Economic and Social Research Council (ESRC) has shown that radical reform of the drugs industry regulatory system must be an important part of the solution to ensure a productive and profitable pharmaceutical sector, both globally and in the UK.

Researchers from the ESRC’s Innogen centre, in Edinburgh, UK, have studied the innovation models in the pharmaceutical industry and how the industry has been able to remain sustainable for so long.

The results of their research show that the lengthy and expensive regulatory system that now applies to most products for the life sciences is causing innovation failure.

Regulation has a large impact on the kinds of product that are developed by any industry sector: it is designed to ensure that products are safe, effective and of high quality.

Innogen’s research demonstrates that the impacts of regulation in pharmaceuticals are especially far reaching.

They determine overall company strategies; which types of companies succeed; and ultimately the structure and dynamism of the sector as a whole.

Under current circumstances, regulation prevents the development of the radically innovative technologies that could provide opportunities for the sector to become more effective in developing innovative products.

Innogen research has predicted that the industry is approaching a tipping point in the not too distant future.

Professor Joyce Tait said: “We do not need less regulation, but smarter regulation that can deliver expected standards of safety and efficacy, is flexible enough to respond to new scientific discoveries and can do so more efficiently than our current systems within a shorter time frame.”

Innogen research also shows that policymakers and governments need an understanding of all the major causes and relevant options available.

Radical regulatory reform for the life science industries needs to be a priority in discussions regarding the future of the industry.

Reform could provide the lever to profitably unleash the creativity that has been so effectively generated from public funding of basic science, leading to something closer to the innovative performance that we have seen in information and communication technologies over the past twenty years.

Why Investors Like Potato Chips More Than Pharmaceuticals

Why have the share prices of major pharmaceutical companies been dropping for years? I asked Sanofi-Aventis chief executive Christopher Viehbacher to chat following his company’s full-year earnings call. Here’s an edited transcript of our conversation about layoffs, the future of drug industry research, and why his company is trying to acquire Genzyme.

How much can you cut R&D? How much can other companies cut R&D? You were first out of the box to say that costs can actually be reduced. Now Ian Read, Pfizer’s CEO, is saying very much the same thing, even closing down his Sandwich labs. How far do you think that can go?

We’ve cut about 30%, that’s where we are. I don’t know where Ian is. There’s two ways of looking at cost. One is the fixed running cost of your R&D, you’ve got buildings, you’ve got maintenance, you’ve got security guards, you’ve got people with salaries and benefits. That actually accounts for most people for about two-thirds of the R&D budget. The other third is your development costs which are essentially clinical trial costs. Most people have very limited discretionary spending on R&D.

You really have to put your portfolio through the R&D equivalent of a bank stress test. Most companies have not really been as tough as they should be in figuring out what products should be in there. And then you go back and look at your fixed costs. Once you have too many R&D facilities you essentially have to keep your money in those facilities. If there’s not a lot coming out of it and you want to bet on a new team it becomes pretty difficult – because you already have all these teams.

So to me the question is how to make this variable. There is no correlation between how much you spend and how successful you are. To a degree this becomes risk management.

You made a bet to bring research in from the outside by buying BiPar Sciences, which was developing a drug for triple-negative breast cancer. But the first phase III study of that drug turned out negative. This was supposed to be Sanofi’s entry into innovative cancer research. What happened?

Just because it’s external doesn’t mean it’s a guarantee. If it were that easy, we’d all have much higher share prices.

We did have a setback. The phase III results did not meet their primary endpoint. However, you’ve got a drug that has had such extraordinary phase II results you’ve got to ask yourself what went wrong. I can’t give you a complete answer to that, partly because we are presenting the data at ASCO and partly because we’ve got an external swat team on it. But I can tell you that the top experts in breast cancer outside the company are not concerned. [Viehbacher argued that the trial looked at too broad a swath of patients, and that this is common with new cancer drugs because patients are so excited to enroll in the trial.—M.H.]

What does bringing in former NIH chief Elias Zerhouni to run your labs mean for your R&D organization?

Elias brings a number of interesting skill sets. What that really brought it is an understanding of the science that is going on around the world. Second, he’s an entrepreneur. He’s founded five companies and been able to sell three of them. But Elias can’t be a one-person R&D organization. What Elias does is make sure that we have the best people working in the organization, and be a lot better at finding the opportunities. I think Elias can really help us to up the scientific horsepower in the company.

As you’re going through the patent cliff [the expiration of patents on major drugs] what kind of levers do you actually have to maintain sales and earnings?

Essentially we know that between 2010 and 2012 we lose 25% of sales and a little more than that on profits. We have one of the most concentrated patent cliffs. A lot of companies have them spread out over a five to seven year period, ours are over a three year period. All those things are basically cash, they’re not the future of the company. If it stays an extra six months, it really just represents an extra six months of cash flow. But it’s not something that has any particular impact on the underlying value of the company. We have very few levers, really, but you have to just say that’s going to happen.

What you can do is look inside the company and say, I need to find stuff that grows, I need to find stuff that has some level of competency, and I need to build on those things. It’s a bit of a race against time.

What I’ve seen over the last ten years is we sweat every quarter and watch the share price slide. Only because people tend to look forward in terms of valuation, and unless they can see some kind of sustainability, people are not going to give you any value for that. You’re not getting any value for pipelines. So you need some businesses like vaccines and consumer health and emerging markets where people can say yeah, I can do a ten year sales forecast on that and it’s not going to disappear.

You know the whole industry is at a 25%, 30% discount to the S&P 500, whether you’re Pfizer, you’re Merck, you’re J&J even. If you make potato chips and soft drinks you’re going to have a higher P/E than we do, but it’s because potato chips and soft drinks are a more sustainable business.

Can we talk a bit about the decision to go after Genzyme? Why do you want to buy them?

Certainly I’m happy to talk about the strategic rationale. Without anything of substantial size in acquisitions, we could basically make these growth platforms offset what we lose. If we have stabilized the business, we can use our cash flow, which is about 4 billion euro after dividends, to go after growth opportunities.

We identified Genzyme because it really accelerated our push into biotechnology, and also because of the history of our company we also weren’t as present as we wanted to be in the U.S. in research. I’m not sure it’s going to be the case in ten years, but still today the hot research is going on in the U.S. and you need to have a presence. Third, we thought the company was under-managed and we could do a better job running the company and therefore deliver value to our shareholders.

Zogenix Receives 2011 Drug Delivery Partnerships Innovation Award for SUMAVEL(R) DosePro(TM)

Zogenix, Inc. (“Zogenix”) (Nasdaq:ZGNX) today announced that it has received the 2011 Drug Delivery Partnerships™ (“DDP”) Innovation Award in the Industry Achievement category for SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System. Winners of this year’s DDP Awards, which recognize success within the drug delivery industry, were selected by attendees at the 15th annual DDP conference, held in Miami, Florida.

SUMAVEL DosePro is the first drug product approved by the U.S. Food and Drug Administration (FDA) using the Zogenix DosePro needle-free drug delivery technology, which allows for the subcutaneous delivery of medication. SUMAVEL DosePro is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. During the first year of production over 1,000,000 commercial units have been produced establishing the viability of a single-use, disposable, pre-filled needle-free technology for use in other important therapeutic applications.

Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, “The DDP Industry Achievement Award is a significant honor at one of the pharmaceutical industry’s largest drug delivery conferences. We believe it reinforces SUMAVEL DosePro as an innovative treatment for the migraine market and further validates our DosePro technology platform.”

Stephen J. Farr, Ph.D., President and Chief Operating Officer said, “We believe this award recognizes the importance of our DosePro technology for the biopharmaceutical industry. The commercial experience of 2010 showed that physicians and patients alike are willing to use treatment administered subcutaneously instead of orally if it is available in an easy-to-use needle-free system like DosePro. The competitive advantage offered by the DosePro technology is now available for licensing to other biopharmaceutical firms. Clinical studies suggest that DosePro will have significant versatility in delivering various types of therapeutic compounds, including biologic products.”

Zogenix and its co-promotion partner, Astellas Pharma US, Inc., launched SUMAVEL DosePro in the United States in January 2010. Zogenix has a partnership with Desitin Arzneimittel GmbH to develop and commercialize SUMAVEL DosePro in the European Union (EU). Desitin plans to launch SUMAVEL DosePro in Germany and Denmark in early 2011. Desitin is responsible for pursuing MAA approvals and broader commercialization on a country-by-country basis under the EU decentralized procedure in territories in the EU for which Desitin elects to undertake such activities.

About SUMAVEL DosePro

SUMAVEL DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of SUMAVEL DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.

IMPORTANT SAFETY INFORMATION

SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.

Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer SUMAVEL DosePro if a headache being experienced is atypical.

SUMAVEL DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with SUMAVEL DosePro, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). SUMAVEL DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.

In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.

Pharmacy law ‘doesn’t match’ industry technology, say healthcare lawyers

Pharmacy law “doesn’t match” the technological developments in pharmacy, leaving “grey areas” for pharmacists, healthcare law firm Charles Russell has warned.

Charles Russell associate Noel Wardle criticised current legislation for not adapting to innovations such as remote dispensing machines, collection points and pharmacy websites. “The legislation just doesn’t match what people would like to do with their pharmacies,” he explained.

Mr Wardle said this left “grey areas” in pharmacy law. He referred to the current laws on supervision, which do not take into account possible modern methods of supervising through remote devices.

“The legal definition of supervision is ‘in a position to intervene’ but this has a very different meaning in 2011 than it did when the law was created,” he said. Mr Wardle said this created confusion over the legal position of devices such as remote dispensing machines, where pharmacists communicate with patients by telephone.

He added that he felt these machines contradicted pharmacies’ NHS Terms of service, which say that services must only be provided on registered pharmacy premises.

Remote collection points were also cited as a source of confusion, because of discrepancies between the relevant legislation and guidance. Although it is legal for collection points to operate outside pharmacy premises, Royal Pharmaceutical Society guidance stipulates that remote collection points should only operate in remote areas after consultation locally.

Mr Wardle warned the wider introduction of remote machinery would have considerable legal implications for the sector.

He was speaking at a Charles Russell conference on pharmacy law, held in London on February 2.

Tennessee legislators introduce legislation to help fight meth production

Senator Mae Beavers (R – Mount Juliet) and Representative Debra Maggart (R – Hendersonville) introduced legislation [SB 325/HB 234] today that calls for the adoption of a statewide, industry-funded electronic tracking system, called NPLEx (the National Precursor Log Exchange), to monitor and stop illicit purchases of over-the-counter cold and allergy products containing pseudoephedrine (PSE), an ingredient sometimes used to illegally manufacture methamphetamine. The bill provides an alternative, less-intrusive solution to the prescription-only bill (HB 181) introduced last week.

“This kind of government intrusion in our lives is not the solution we need to attack the meth problem in Tennessee,” Sen. Beavers, the bill’s sponsor in the Senate said. “We should not punish the tens of thousands of innocent Tennesseans who need this over-the-counter medication to get at the criminals who are using the drug illegally to produce meth when there is another approach which is very effective. Our legislation offers a proven, effective, non-governmental solution to the problem, without pushing up the cost of the medication on consumers by requiring them to visit a physician to obtain a prescription.”

There is currently no mechanism in place in Tennessee to block illegal sales in real time, as many pharmacies and retailers rely on handwritten, paper logbooks to track purchases. As a result, criminals have learned to circumvent the current system. SB 325/HB 234 would provide a secure, interconnected electronic logbook that allows pharmacists and retailers to refuse an illegal sale based on purchases made elsewhere in the state or beyond its borders. Most importantly, SB 325/HB 234 preserves access to the PSE medicines consumers rely on and trust for cold and allergy relief.

“For all law-abiding Tennesseans, the experience of buying cold and allergy medicines containing pseudoephedrine at the local pharmacy will not change,” Rep. Maggart, the bill’s sponsor in the House of Representatives said. “However, for those looking to purchase more than their legal limit, this system will immediately deny the sale, and law enforcement will possess a powerful tool to track down these individuals when they attempt to do so.”

In the four states that have fully implemented e-tracking technology, nearly 40,000 grams of illegal PSE sales per month are blocked. The system, which provides local law enforcement officials with precise data on who is attempting to buy illegal amounts of PSE, also helps law enforcement find meth labs.

“NPLEx is effective because it prevents the illegal sale of pseudoephedrine from ever happening in the first place,” Carlos Gutierrez, a state government relations consultant at the Consumer Healthcare Products Association said. “Electronic blocking technology gives law enforcement the ability to identify meth cooks, not only in Tennessee, but across state lines and in real time.”

The leading manufacturers of over-the-counter medicines containing PSE, represented by the Consumer Healthcare Products Association, are working closely with state legislators and law enforcement to help implement NPLEx technology to pharmacies and retailers in Tennessee free of charge.

SB 325/HB 234 is supported by the Tennessee Pharmacists Association, the Asthma and Allergy Foundation of America, and the Tennessee Chamber of Commerce & Industry. If passed into law, SB 325/HB 234 would make Tennessee the 13th state to pass legislation requiring a statewide e-tracking system to block illegal sales of medicines containing PSE. The NPLEx system would be fully integrated into Tennessee pharmacy systems by January 1, 2012.