Teva sues drug makers to protect Azilect patent

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) is taking three drug makers and their subsidiaries to court to defend its patent on Azilect, its drug to treat Parkinson's disease.

Teva claims that Watson Pharmaceuticals, Mylan, Orchid Chemicals and Pharmaceuticals, and their subsidiaries submitted requests to produce generic versions of the drug, based on its patent.

The claim, brought in New Jersey, states that the defendants infringed Teva's patent which is valid until 2017. The claim led to the halt of the approval process from the US Food and Drug Administration (FDA) until November 16, 2013, or earlier if a court rules in their favor.

Azilect already has sales of several tens of millions of dollars per year, and Teva hopes to increase the sales in hundreds of millions of dollars.

Teva shares fell 0.07% to $53.48 in midday trading on Nasdaq.

Pharma Can Double Sales in Two Years by Increasing Patient Adherence

Pharmaceutical product teams can recapture lost sales and even double sales if they can help patients stay in therapy over two years. What patients need from the pharmaceutical industry are education and information materials that they can understand and that motivate them to stay in therapy.

McLean, Virginia - A message from Dr. Dorothy L. Smith, President and CEO Consumer Health Information Corporation: "Patients can make or break the success of a product. Product teams that are able to meet the needs of their patients will not only survive these tough economic times but they will also recapture lost sales. A product team can double sales if they can help a patient stay in therapy over two years. Sales can easily triple if the patient stays in therapy three years. No other industry in the world has such a window of opportunity for increasing sales but also helping people receive a good therapeutic outcome. The challenge is to meet the needs of the patient."

Dr. Dorothy L. Smith, President and CEO Consumer Health Information Corporation (CHIC) and an expert in evidence-based patient adherence program development and REMS, spoke about the importance of the patient's role in successful therapeutic outcomes to an audience comprised of pharmaceutical industry executives, clinicians and researchers.

Dr. Smith stressed that, "In today's volatile economy, the number of patients who are cutting costs and not filling their initial prescriptions has doubled from 10% to 20%. As many as 50% - 85% are not refilling their prescriptions for a variety of reasons other than cost."

Currently, patients prescribed medications for the treatment of chronic conditions are making decisions to drop out of therapy at an alarming rate.

Recapture Lost Sales

When patients drop out of therapy unexpectedly, the monies invested to have a physician write the initial prescription are lost. The area above the curve represents lost sales due to patient nonadherence. Assuming 90% initial compliance, lost sales equal approximately 60% at two years and up to 80%-90% at three years depending on the specific product.

The key to recapturing lost sales is to educate and motivate patients to stay in treatment. It is a win-win situation. Patients will have improved treatment outcomes and decreased healthcare costs. When patient education is done correctly, product sales should at least double.

Help Patients Get Through the First Year

Research shows that when patients are able to manage their medications for one year, they are more likely to stay in therapy and not drop out.

Dr. Smith urged the pharmaceutical industry to develop more effective patient education programs during the first year of treatment. These programs must:

Teach patients how to integrate the dosage regimens into their daily lifestyles so that taking the medication stops being a hassle.

Teach patients how to manage side effects correctly so they do not become frightened and stop the drug suddenly.

Be evidence-based, practical, and motivational and meet patient comprehension requirements. The majority of patients are receiving information they cannot understand.

Give patients the information they need at the different stages in which they make decisions.This means that health professionals need different patient tools at each of these different stages. It is a waste of money for a pharmaceutical company to encourage health professionals to redistribute the same patient material at every clinic visit.

Teach patients how to recognize signs of progress. When patients are convinced that a medication is helping them, they will be more likely to decide to stay in therapy.

Dr. Smith summarized that, "Providing patients with information they can understand will lead to better health outcomes, decrease patient dropouts and boost product ROI."

Let Us Help You Develop Patient Education Programs That Increase ROI

Patient education programs work if they meet the needs of patients and health care professionals. We want to help you succeed in realizing the maximum untapped revenue of your product. Since 1983 Consumer Health Information Corporation has specialized in the development of FDA-approved patient labeling and innovative evidence-based patient education and REMS programs that increase patient adherence and retention. Our customized programs have made it possible for product teams to increase sales as well as meet the needs of patients, physicians, pharmacists, consumers and sales reps.

Drug Firms' Spending on Consumer Ads Fell 8% in '08, a Rare Marketing Pullback

The nation's pharmaceutical makers spent more than $2.9 million on Vermont's doctors, hospitals and universities to market their products in the last fiscal year, according to a report issued Wednesday by the state attorney general's office.

That's down slightly from the previous year, but Attorney General William Sorrell says he's not sure if the drug companies are tightening their belts or if they want to avoid public scrutiny for the payments, whose recipients aren't identified.

The report shows 78 companies spent the money in the year ending July 1, 2008. By law, the companies have to report their spending on consulting and speakers' fees, travel expenses, gifts and other payments to or for physicians, hospitals, universities and others authorized to prescribe drugs.

The cash payments are made directly to health care providers, Sorrell said.

"It's `I pay you money to give me feedback on how your patients react to my drugs,' `I give you free samples that you can prescribe to your patients,' `I'll pay you a consulting fee or take you to dinner or pay for you to take a trip someplace to hear lectures or presentations on how this drug works or how effective it is for various conditions,'" Sorrell said.

The Pharmaceutical Marketing Disclosure Law, adopted in 2002, requires drugmakers to report their spending by Dec. 1 and the attorney general to issue a report summarizing them. At least four other states have such disclosure laws, but the report released Wednesday dealt only with Vermont. The disclosures don't include money spent on advertising.

The industry says that the money helps pay for education programs about drugs for doctors and patients and that the drug companies develop some of their medicines using feedback from prescribers and users.

Among the findings of the report released Wednesday:

_Eli Lilly and Co., Pfizer Inc., Novartis Pharmaceuticals Corp., Merck & Co. and Forest Pharmaceuticals Inc. were the biggest spenders.

_25 doctors and nurses each got more than $20,000 in cash or benefits from the companies, 10 got more than $50,000 and one psychiatrist took in $112,000.

In the year ending July 1, 2007, 84 companies had reported spending $3.1 million, following a larger trend in which the number of companies spending the money increases but the overall amount decreases. From 2004 to 2008, the number of manufacturers reporting climbed 40 percent but the amount they spent dropped by 30 percent.

The report doesn't identify the recipients of the money, an exemption at the heart of a bill before the state legislature. The bill would eliminate the drug companies' ability to claim "trade secret" in providing the information to the state but barring the state from releasing it to the public.

Sorrell said more than 80 percent of the expenditures analyzed for the report claimed the trade secret designation. He said consumers would be better off if that weren't an option so people would know if a health care provider recommending a drug had been paid by its manufacturer.

"If I was a patient or one of my kids was a patient, and my doctor was telling me, `You ought to try drug X,' I would like to know that my doctor received $40,000 from the company that manufactures and markets this drug," he said.

The Vermont Medical Society, a physician advocacy group, and the Vermont Psychiatric Association, an organization of psychiatrists, endorse the bill. They say it would improve patient confidence if the information were public.

The Pharmaceutical Research and Manufacturers of America, which represents drug companies, says much of the money goes toward helping doctors know when to prescribe a certain medication.

"An individual who's prescribing, particularly a new medication, needs to know when it should be used, what patient populations it should be used for, for what conditions and when it should not be used," said Marjorie Powell, senior assistant general counsel for the group, a trade association.

The group opposes elimination of the exemption, saying it would allow competitors to know their trade secrets.

"The amount I'm spending on how to improve a product would be valuable information to a company that's considering making a competing product," Powell said.

She said the reason for the trade secret designation wasn't to hide anything from patients.