Folic Acid

The number of actions taken by FDA to enforce drug and medical device safety — such as warning letters and seizures of products — declined from 2000 to 2005, according to a report requested by House Government Reform Committee ranking member Henry Waxman (D-Calif.), the New York Times reports. Waxman in 2004 began the inquiry after congressional hearings suggested that FDA was partly responsible for the 2004 shortage of flu vaccine. According to the report, the number of warning letters issued to drug companies, medical device manufacturers and others by FDA declined from 1,154 in 2000 to 535 in 2005, a 54% decrease (Harris, New York Times, 6/27). Over that period, the number of violations reported by agency inspectors declined 1%, from 6,334 to 6,268 (Alonso-Zaldivar, Los Angeles Times, 6/27). Because the number of violations remained steady, investigators concluded that the reduced number of FDA actions did not indicate that manufacturers were safer but that the reports were less likely to result in warning letters or other enforcement. FDA’s Center for Devices and Radiological Health had the largest decline in warning letters, with 66% fewer letters issued in 2005 than in 2000. FDA’s Center for Drug Evaluation and Research had a 39% drop in warning letters (Kaufman, Washington Post, 6/27). Each of FDA’s five centers issued fewer warning letters in 2005 than in 2000. Waxman’s inquiry also identifies 138 cases in which FDA officials did not take enforcement actions recommended by inspectors. Many of those cases involved medium- or small-sized companies selling over-the-counter treatments (Los Angeles Times, 6/27). The seizure of defective, dangerous or mislabeled products fell 44%, according to the report (New York Times, 6/27). The report finds that the number of onsite inspections at manufacturing plants dropped nearly 50% from 2000 to 2005 (Washington Post, 6/27). The only increase noted in the report is the number of recalled products, which rose 44% (New York Times, 6/27). The report says lack of enforcement exposes the public to “dangerous products” and creates an unfair “playing field for companies with strong safety records” (Cohen, Newark Star-Ledger, 6/27).

Additional Findings
The report outlines specific cases in which FDA inspectors recommended actions that agency officials did not follow, including the following:
A recommendation from the Denver office in 2001 that a warning letter be sent to a company whose hangover treatment had a toxic level of caffeine. Three people who took the treatment were sent to emergency departments. FDA officials said the issue did not meet the “regulatory significance threshold of enforcement.”

A recommendation that a warning letter be sent to a company whose anti-itch treatment contained no active ingredient. After 11 months, FDA rejected the recommendation, saying the company was a “very small operation” (Schmit, USA Today, 6/26).

A recommendation that criminal proceedings be initiated against an Ohio medical supply company that sold a tank of nitrogen gas that was misidentified as oxygen. Four nursing home residents died as a result. FDA waited two and a half years before closing the case without taking action.

A recommendation that a warning letter be sent to Purdue Pharma after the company failed within the mandatory time period to report 12 “serious and unexpected adverse events,” including loss of consciousness and convulsions, caused by the epidural painkiller Chirocan. FDA rejected the call for a warning letter and instead sent a less severe letter.

A recommendation that a warning letter be sent to a blood bank in Puerto Rico after field investigators found “significant and objectionable conditions” that resulted in one death and multiple patients receiving incorrect blood products. FDA took no action, saying the death was a “single, isolated event.”

Comments
Waxman said, “Americans have relied on FDA to ensure the safety of their food and drugs for 100 years. But under the Bush administration, enforcement efforts have plummeted, and serious violations are ignored” (Newark Star-Ledger, 6/27). Waxman added, “The people who’ve been making decisions at the FDA have decided to favor industry.” Michael Wilkes, a professor at the University of California-Davis School of Medicine and former FDA enforcement official who reviewed documents at Waxman’s request, said FDA “systematically ignores District Office recommendations” (USA Today, 6/26). Sammie Young, a former FDA enforcement official who also reviewed the documents, said FDA officials frequently reject the “clear and thorough recommendations” of agency field offices. Young said FDA’s actions are often “inadequate or unreasonable” (Newark Star-Ledger, 6/27).

Response
David Elder, director of FDA’s Office of Enforcement, in a statement said, “FDA enforcement cannot be properly judged by counting the number of actions taken by the agency. FDA has increasingly used an enforcement strategy based on efficient risk management principles that focus on combating the greatest public health risks and maximizing our deterrent effect against potential violators.” Elder noted that the agency has won legal actions taken against companies that violated the law, bringing in more than $2.5 billion since 2000 in fines, penalties and settlements (Washington Post, 6/27). Elder said the agency has been focusing more on the most serious violations that “present the highest risk to consumers and public health.” Elder also said the agency “has taken prompt, targeted and aggressive action against firms that are in violation of law” (New York Times, 6/27). Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America, said he did not “see anything in the report that indicates a reason for patients to be concerned about the safety and effectiveness of the drugs they receive.” AdvaMed, an association of medical device manufacturers, in a statement said, “FDA vigorously enforces the law,” adding that fewer warning letters “could indicate better compliance on the part of manufacturers” (Newark Star-Ledger, 6/27).

Broadcast Coverage
NPR’s “Morning Edition” on Tuesday reported on the report. The segment includes comments from Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital; Michael McGarry, executive vice president for public affairs at AdvaMed; and Waxman (Silberner, “Morning Edition,” NPR, 6/27).

The complete segment is available online in RealPlayer.

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Ken Johnson, senior vice president of communications for the Pharmaceutical Research and Manufacturers of America, last week said that many of the 150,000 low-income Nevada residents could benefit from prescription drug assistance programs, the AP/Las Vegas Review-Journal reports (Riley, AP/Las Vegas Review-Journal, 6/23). Under the Partnership for Prescription Assistance program, PhRMA matches low-income individuals to one of 475 pharmaceutical industry and government prescription drug assistance programs. The program offers a call center and Web site through which individuals can directly apply for prescription drug assistance programs that offer discounted or no-cost medications to those with no prescription drug coverage and annual incomes less than 200% of the federal poverty level (Kaiser Daily Health Policy Report, 7/27/05). Johnson said that the no-cost medications provided under the program, which has helped more than two million low-income individuals to date, have a wholesale value of $5.3 billion. In addition, Johnson said that Nevada residents who purchase medications from Canadian online pharmacies under a new state program are “playing Russian roulette” with their safety. He also criticized a study recently released by AARP that found wholesale prices of brand-name medications increased by 3.9% in the first quarter of 2006 (AP/Las Vegas Review-Journal, 6/23).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

An article in the Journal of the Royal Society of Medicine examines the conduct of pharmaceutical companies in drug trials and urges changes to ensure their research is scientifically trustworthy.

Sir Iain Chalmers said stricter regulation is needed to curb biased under-reporting of clinical trials conducted by pharmaceutical companies.

“Research undertaken by pharmaceutical companies cannot be trusted. Their systematic under-reporting of negative results and lack of transparency is blatant scientific misconduct and unethical. Without radical change this will continue,” said Sir Iain.

“It is particularly disappointing that many doctors collude with the industry in this form of scientific misconduct. They have too often simply acquiesced in scientific misbehaviour driven by the marketing departments of pharmaceutical companies.”

The paper examines how policies of greater transparency, led by Glaxo Wellcome in the 1990s and adopted by the Association of the British Pharmaceutical Industry, were reversed following Glaxo Wellcome’s merger with SmithKlineBeecham.

“Guidelines for good publication practice, which were employees at Glaxo Wellcome, were dropped by GlaxoSmithKline and the employees who drafted them were dismissed,” said Sir Iain.

Sir Iain recently requested that a draft of his paper be presented for comment and criticism to a meeting of staff from the medical departments of member companies of the Association of the British Pharmaceutical Industry.

“No participant from the pharmaceutical industry challenged the contents of the paper. Rather they asked for suggestions about what could be done to improve the currently poor public image of the industry,” said Sir Iain.

“The first and most obvious step would be for all companies to publicly endorse the Good Publication Practice Guidelines for Pharmaceutical Companies. However, given industry’s reluctance to take voluntary steps to ensure the scientific integrity of their research, stricter government regulation is likely to be needed,” he said.

Sir Iain’s paper is published days after a study by Consumers International called for an end to the unscrupulous marketing practices by pharmaceutical companies, which spend US$60 billion annually on drug promotion.

From optimism to disillusion about commitment to transparency in the medico-industrial complex (PDF 77k)

Sir Iain Chalmers is editor of ‘The James Lind Library’ and co-author of ‘Testing Treatments: better research for better healthcare’ (British Library 2006).

Good Publication Practice Guidelines for Pharmaceutical Companies.

‘From optimism to disillusion about commitment to transparency in the medico-industrial complex’ by I Chalmers is published in the July 2006 issue (Vol. 99) of the Journal of the Royal Society of Medicine.

JRSM is the flagship journal of the Royal Society of Medicine. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi.

The article is available free at jrsm.

The European Commission has published its final evaluation (1) – following comments received from stakeholders (2) – on five years of the EU’s Orphan Medicines Regulation (EC 141/2000). The report confirms the tangible benefits of the Regulation for patients with rare diseases and its contribution to growth and jobs by stimulating increased investment in R & D to meet a high unmet medical need, which in turn has also led to new start-up companies.

The joint industry task force of EuropaBio – the European association for bioindustries – and of EBE – European Biopharmaceutical Enterprises – welcomes the Commission’s Report because it increases awareness about rare diseases in the EU and promotes the continuation and further support of the Orphan Medicines Regulation, an important piece of innovative legislation in Europe.

There are some 8000 rare diseases, many are life-threatening and/or seriously debilitating, and for most of them, there is no access to effective medical treatments. Given that 70-80% of these rare diseases have a genetic origin, biotechnology is an important tool to develop treatments for them. Another consequence of this genetic link is that these diseases affect children, who can thus benefit from more than half of the products developed.

So far the Regulation has delivered 22 approved therapies in the EU, and the portfolio of products in the pipeline, which have been designated as orphan medicines, may promise treatments for more than 200 different conditions (3). This Regulation is transforming the public health environment to the benefit of rare disease patients.

The Commission’s Report notes that the total cost of approved orphan medicines today in any given country typically accounts for less than 1% of the national healthcare budgets earmarked for medicines, but timely and equitable access for patients to the approved medicines remains an issue. The Report further notes that some member states are limiting patient access by delaying reimbursement. As of December 2004 only one Member State could demonstrate that all approved orphan medicines were reimbursed and available to patients. Eurordis, the umbrella patient organisation for rare disease patients in Europe, has published a report on the issue of access (4).

“The need for equitable and timely access for patients to innovative therapies, coupled with the need for more incentives by Member States to stimulate research, development and marketing of orphan medicines should be combined.” says Erik Tambuyzer, Chair of the Joint EuropaBio / EBE Task Force. “By generating a new set of incentives to tackle access issues to benefit patients, Member States would at the same time help the EU move towards the so-called Lisbon knowledge economy targets.” The industry is happy with the Comments from the Public Consultation published by the Commission (2), but misses reference to the access issue and to the suggestion above.

According to the Commission report in the absence of policies at Member State level to stimulate private sector research, the 10 years market exclusivity for an orphan medicine in respect of similar products remains the main industry incentive. However, industry is concerned that the delay in reimbursement and late access for patients cuts broadly into the 10 year market exclusivity, eroding the incentive quite a bit.

One year ago, the Joint EuropaBio / EBE Task Force on Orphan Medicines published a White paper (4) putting forward 9 suggestions for the full implementation of the Orphan Medicines framework in Europe. “We call on the Commission and the Member States to look again at these suggestions, and to consider them,” says Erik Tambuyzer. “The full implementation of the Orphan Medicines Framework should include Member States resolving the issues around patient access, and a predictable orphan medicines environment that will foster further R&D in the field, with the typical collaboration between researchers, clinicians, industry and patients which is so typical for this field. Industry is taking up its part of this responsibility, and is listening to other stakeholders as well.”

(1) The Commission Report – Review of five years of Orphan Medicines Regulation
ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/orphan_en_06-2006.pdf
Commission Press Release.
(2) Commission Report on the comments received for their Working Document: Commission’s 5 year review of Orphan Medicines Regulation.
pharmacos.eudra/F2/orphanmp/doc/2006/summarycomments.pdf
(3) Register of designated Orphan Medicinal Products (by number)
pharmacos.eudra/F2/register/orphreg.htm
(4) Eurordis – Improving patient access to orphan drugs in Europe
eurordis/article.php3?id_article=1013
(5) Joint EuropaBio / EBE White paper on Orphan Medicines
europabio/documents/Orphans_WhitePaper_printedversion.pdf

More about Rare Diseases

EuropaBio web page resource on Orphan Medicines
europabio/healthcare.htm#orphan

EBE web page resource
ebe-biopharma/Topics/Orphans.htm

About EuropaBio

EuropaBio, the European Association for Bioindustries, has 70 corporate members operating worldwide, 11 associate members, 5 BioRegions and 24 national biotechnology associations representing some 1500 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products. europabio

About EBE

EBE (European Biopharmaceutical Enterprises) is an association representing the needs and interests of biopharmaceutical companies. It has 65 member companies, which are engaged in research and development of new biotech healthcare products.
ebe-biopharma

BusinessWeek and the Arizona Republic on Monday examined the ongoing controversy involving Wyeth Pharmaceuticals and pharmacies that make plant-based compounded hormones. Compounded — also known as “bio-identical” — hormones are mixtures of estrogen and progesterone that are extracted from plants and usually customized for women by pharmacies based on the results of hormone tests (Kaiser Daily Women’s Health Policy Report, 5/2). According to BusinessWeek, makers of compounded hormones have “largely dodged the scrutiny” of FDA and are not subjected to clinical trials normally required for prescription medications. There are more than 3,000 compounding pharmacies that fill about 30 million prescriptions annually, according to FDA. Wyeth, which manufactures the hormone drugs Prempro and Premarin, has petitioned FDA to require bio-identical hormones to carry health warnings and be federally regulated (Weintraub, BusinessWeek, 6/26). Candace Steele, a Wyeth spokesperson, said the company does not oppose compounded hormones but says that some providers do not disclose the risks of taking their products. “FDA says all estrogens carry the same risks. We want women to understand that,” Steele said. Producers of compounded hormones say the products are safe and effective alternatives to federally regulated products. “This is quite unique, a frontal blast by Wyeth,” L.D. King, director of the International Association of Compounding Pharmacists, said, adding, “It’s the first time we’ve seen it. The FDA does a good job. We think the regulatory scheme works quite well” (Nolan, Arizona Republic, 6/26). FDA has said it needs more time to review Wyeth’s petition because it “raises complex issues requiring extensive review” (BusinessWeek, 6/26).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Premarin; Prempro.

Ketek (telithromycin) was approved by the FDA in 1994 for respiratory tract infections, sinusitis, community-acquired infections and bronchitis. There have been reports, since its approval, of patients who took the drug having severe liver problems – several died. The drug will now have a warning of liver failure and severe injury.

Sanofi-Aventis, the makers of Ketek, are also providing patients and doctors with information.

The new label warns to look out for signs of hepatitis – malaise, fatigue, jaundice, anorexia and nausea. Patients are told to stop taking Ketek immediately and see their doctor if they have signs or symptoms of hepatitis. The warning also contains revised recommendations for the use of Ketek in patients with myasthenia gravis.

Sanofi-Aventis, as well as the FDA, believe Ketek’s benefits are still greater than its risks.

During the month of April, 2006, 12 cases of acute liver failure were reported to the FDA, of which four died, one had to have a liver transplant. All the patients had been treated with Ketek. Experts believe Ketek was the link as no other association could be found. Two more cases have been reported since April.

Even though the number of deaths and liver failure are proportionally higher than would be expected with other antibiotics, experts say it is not yet possible to conclude that the risk of serious complications is higher for Ketek. This is because the cases of liver failure associated with Zetek stimulated other reports.

Zetek is a useful drug for patients who are infected with bacteria that have become resistant to other antibiotics, says Dr. Bruce Lavin, VP, Internal Medicine, Sanofi-Aventis.

The Senate Finance Committee is investigating fraud allegations related to the Ketek trials.

Sanofi-Aventis has halted the enrolment of children in Zetek trials.

About Ketek (telithromycin) tablets

Ketek is one of a new class of antibiotics called ‘ketolides’. It was designed specifically to treat community-acquire respiratory tract infections. It is also indicated for the treatment of acute exacerbation of chronic bronchitis; acute bacterial sinusitis; and mild to moderate CAP communityacquired pneumonia, including those infections caused by multi-drug resistant S. pneumoniae, in patients 18 and older.

Ketek unlike other antibiotics, binds strongly to two sites on the bacterial ribosome, stopping protein production and eradicating the targeted bacteria. This strong dual binding helps provide in vitro coverage against antibiotic-resistant strains of S. pneumoniae. Its spectrum of activity provides tailored coverage of common respiratory pathogens.

View drug information on Ketek.

SkyePharma PLC (Nasdaq: SKYE;
LSE: SKP) announces that it has completed negotiations with Mundipharma
International Holdings Limited (“Mundipharma”) the result of which is that
SkyePharma will reacquire the rights for the marketing and distribution of
DepoBupivacaine(TM) in Europe and other international markets excluding the
USA, Canada and Japan. SkyePharma will also obtain rights to the clinical
data from the Phase II trials of DepoBupivacaine(TM). This is expected to
simplify the ongoing divestment process of SkyePharma’s injectables unit.

SkyePharma’s Chief Executive Frank Condella said: “DepoBupivacaine(TM)
is the most important near-term product in the injectables pipeline and
therefore a key component of the value of this business unit. During our
negotiations to divest this unit we have identified the desirability of
clarifying the commercial rights to this key product and we are gratified
that we are now in a position to offer unrestricted global rights to
DepoBupivacaine(TM) (outside Japan) to parties interested in acquiring the
injectables unit. Mundipharma remains our valued marketing partner for
DepoCyte(R) in Europe.”

Under an agreement announced in April 2005, SkyePharma has received $10
million to date from Mundipharma, primarily to fund the Phase II clinical
trials for DepoBupivacaine(TM). SkyePharma will now pay $5 million for the
marketing and distribution rights and for data generated during the Phase
II clinical programme.

In November 2005 SkyePharma announced that it had entered into an
exclusive marketing and distribution agreement with Maruho Company Limited
(“Maruho”) for Japan. Maruho is funding the development of the product for
approval by the Japanese regulatory agency.

About SkyePharma

SkyePharma PLC develops pharmaceutical products benefiting from world-
leading drug delivery technologies that provide easier-to-use and more
effective drug formulations. There are now twelve approved products
incorporating SkyePharma’s technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation
capabilities. For more information, visit skyepharma.

About DepoBupivacaine(TM)

DepoBupivacaine(TM) is an extended-release injectable formulation of
the widely-used local anaesthetic bupivacaine. Local anaesthetics
temporarily block the transmission of pain signals along nerve fibres.
DepoBupivacaine(TM) employs SkyePharma’s proprietary DepoFoam(TM)
technology to release bupivacaine over a period of several days and is
supplied as a ready-to-use injectable suspension. DepoBupivacaine(TM) is
designed for administration by local infiltration at wound sites, as a
peripheral nerve block or by the lumbar epidural route. It is not suitable
for intrathecal, subarachnoid or intravenous administration.

DepoBupivacaine(TM) is designed for the prolonged control of pain after
surgery. SkyePharma expects that its main use will be in control of post-
operative pain in patients who have undergone ambulatory surgical
procedures under local or regional anaesthesia. However DepoBupivacaine(TM)
will also be suitable for use during surgery on hospital in-patients.

DepoBupivacaine(TM) has completed Phase II trials and is expected to
commence its Phase III trial programme later this year.

About DepoFoam(TM)

DepoFoam(TM) is SkyePharma’s proprietary sustained-release injectable
delivery technology. This is fully commercialised and approved by
regulatory agencies in both the USA and Europe. DepoFoam(TM) consists of
lipid-based particles containing discrete water-filled chambers dispersed
through the lipid matrix. The particles are 10-30 microns in diameter and
are suspended in saline. The suspension resembles skimmed milk and can be
injected through a fine needle. The water-filled chambers containing active
drug account for most of the weight of the particles. The lipids are
naturally occurring substances (or close analogues) such as phospholipids
and triglycerides. The small amount of lipid is cleared rapidly in the body
as the particles deliver their drug payload over a period that can be
modified from 1 to 30 days. For example in DepoCyt(R)/DepoCyte(R) the
circulating half-life of the drug cytarabine is increased from 3.4 hours to
141 hours.

Certain statements in this news release are forward-looking statements
and are made in reliance on the safe harbour provisions of the U.S. Private
Securities Litigation Act of 1995. Although SkyePharma believes that the
expectations reflected in these forward-looking statements are reasonable,
it can give no assurance that these expectations will materialize. Because
the expectations are subject to risks and uncertainties, actual results may
vary significantly from those expressed or implied by the forward-looking
statements based upon a number of factors, which are described in
SkyePharma’s 20-F and other documents on file with the SEC. Factors that
could cause differences between actual results and those implied by the
forward-looking statements contained in this news release include, without
limitation, risks related to the development of new products, risks related
to obtaining and maintaining regulatory approval for existing, new or
expanded indications of existing and new products, risks related to
SkyePharma’s ability to manufacture products on a large scale or at all,
risks related to SkyePharma’s and its marketing partners’ ability to market
products on a large scale to maintain or expand market share in the face of
changes in customer requirements, competition and technological change,
risks related to regulatory compliance, the risk of product liability
claims, risks related to the ownership and use of intellectual property,
and risks related to SkyePharma’s ability to manage growth. SkyePharma
undertakes no obligation to revise or update any such forward-looking
statement to reflect events or circumstances after the date of this
release.

SkyePharma PLC
skyepharma/

Initial marketing authorisation applications

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on initial marketing authorisation for Exjade (deferasirox), from Novartis Europharm Ltd. Exjade is indicated for the treatment of chronic iron overload due to blood transfusions. EMEA review began on 18 May 2005 with an active review time of 197 days.

Similar biological medicinal products

The Committee adopted a negative opinion for Alpheon (recombinant human Interferon-alfa-2a), from BioPartners GmbH, due to major quality concerns and to differences identified between Alpheon and the reference product Roferon-A in the quality and clinical comparability exercise. Alpheon was intended for the treatment of chronic hepatitis C. EMEA review began on 21 June 2004 with an active review time of 204 days.

A separate question and answer document is available.

Extensions of indications

The Committee adopted positive opinions on the extension of indication of medicinal products that are already authorised in the European Union:

– DatSCAN ([123I] ioflupane), from GE Healthcare Limited, to extend its indication to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease. DatSCAN, a diagnostic agent, was first authorised in the European Union on 27 July 2000. It is currently indicated in the diagnosis of patients with clinically uncertain Parkinsonian syndromes, to help differentiate essential tremor from Parkinsonian syndromes related to idiopathic Parkinsonґs disease, multiple system atrophy and progressive supranuclear palsy.

– Keppra (levetiracetam), from UCB S.A., to extend its indication to monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Keppra was first authorised in the European Union on 29 September 2000. It is currently indicated as adjunctive therapy in the treatment of partial onset seizures or myoclonic seizures in patients suffering from epilepsy.

Summaries of opinions for all these products are available and can be found here emea.eu.int/htms/human/opinion/opinion.htm.

Referral procedures concluded

The Committee finalised arbitration procedures for generic medicinal products containing doxazosin, concluding that the benefit-risk profile of these medicines is beneficial in the agreed indications and that a marketing authorisation should be granted.

Doxazosin-containing medicines are approved in a number of EU Member States for the treatment of essential hypertension and symptomatic treatment of benign prostatic hyperplasia. The medicinal products concerned were: Cardoreg 4 mg prolonged release tablets (doxazosin as mesylate), from Pharmcom Oy, Doxagamma 4 mg prolonged release tablets (doxazosin as mesylate), from Generics UK Limited, Doxastad 4 mg prolonged release tablets (doxazosin), from Stada Arzneimittel, Doxazosin Retard “Arrow” 4 mg prolonged release tablets (doxazosin as mesylate), from Arrow Generics Ltd, Doxazosin Retard “Winthrop” 4 mg prolonged release tablets (doxazosin as mesylate), from Winthrop Pharmaceuticals UK Ltd.

The procedures were initiated under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) due to concerns regarding differences in the release profile of the reference product and the generic versions.

Arbitrations under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) are initiated by one or more Member States in cases where an agreement cannot be reached in the context of the mutual recognition procedure.

Referral procedures started

The Committee started an arbitration procedure under Article 29 of the Community code on human medicinal products (Directive 2001/83/EC as amended) for the generic medicinal product Ciprofloxacine Kabi (ciprofloxacin hydrogen sulphate), from Fresenius Kabi. The procedure was initiated by the United Kingdom with a view to harmonise the summary of product characteristics across the European Union regarding the dosages used to treat complicated urinary tract infections.

A more detailed CHMP meeting report will be published shortly.

emea.eu.int

View drug information on Keppra.

30 October – 2 November 2006, Danubius Regents Park, London.

Offers real insight into the strategies, the industry has employed to, firstly, implement an eCTD and, secondly how to achieve a successful submission. The regulators are on hand to provide clarification of the latest guidelines.

Key expert presentations, an integral aspect of this conference will be the provision of both facilitated and informal discussion sessions to allow you to conduct extensive debate with colleagues and receive invaluable feedback from key regulators.

Two full-day practical workshops offer interactive opportunity to gain hands-on experience of eCTD procedures:

– Building the eCTD: from Strategy to Submission
– eCTD Lifecycle Management: a Practical Approach

To BOOK:

Online
Log on to wwwrma-ls/ectd to receive up-to-date information about this event

By Phone
CALL Customer Services: +44 (0)20 7915 5055

The Jack Miller Center for Peripheral Neuropathy at the University of Chicago will present its second biennial scientific symposium on the “Frontiers of Peripheral Nerve Research,” from 9 A.M. to 4:30 P.M. on Friday, April 28, 2006, at the University of Chicago’s Ida Noyes Hall, 1212 E. 59th Street, Chicago.

The seminar will focus on pain mechanisms and peripheral nerve development, repair and regeneration. Speakers include Rhona Mirsky of University College, London; Elior Peles of the Weizmann Institute, Israel; Jeff Milbrandt of Washington University in St. Louis; Stephen Waxman of Yale; Bill Snider of the University of North Carolina; and Clifford Woolf of Harvard.

Peripheral neuropathy is a common disorder, affecting about three percent of all those over age 60. The disease results from damage to the nerves and nerve processes that are located outside the brain and spinal cord. It has many causes, including diabetes, traumatic injury to the nerves, damage to or swelling of the sheaths around nerves, circulation problems, genetics, or a misdirected immune attack on nerve tissue. Symptoms include pain in the hands and arms, legs and feet–sometimes constant and quite severe-as well as progressive numbness and weakness in the arms and legs.

The Miller Center promotes multidisciplinary investigations into peripheral neuropathies, focusing on efforts to determine the cause, at the molecular level, and finding ways to use that knowledge to produce a cure for these disorders. The Center was founded in 1999 by a generous gift from Jack Miller of Lincolnshire, Illinois, founder and president of Quill Corporation. Miller, who suffers from peripheral neuropathy, was frustrated by the lack of information about the disease and decided to launch a concerted effort by neuroscientists at the University of Chicago to investigate the basic biology of the neuropathy and to search for better treatments and, eventually, a cure for this common nerve disorder.

Schedule — Friday, April 28, 2006

Ida Noyes Hall, the University of Chicago, 1212 E. 59th Street

8:15 – 9:00 Registration and Continental Breakfast

9:00 – 9:15 Opening Remarks:

James L. Madara, M.D., Dean, Biological Sciences Division and Pritzker School of Medicine and University of Chicago Vice-President for Medical Affairs,

Christopher Gomez, M.D., Ph.D., Chair, Department of Neurology, the University of Chicago,

Brian Popko, Ph.D., Jack Miller Professor in Neurological Diseases, Director, Jack Miller Center for Peripheral Neuropathy, the University of Chicago, and

Jack Miller, Founder, Jack Miller Center for Peripheral Neuropathy

9:15 – Noon Morning Session

Rhona Mirsky, Ph.D., Professor of Developmental Neurobiology at University College, London, UK, on “Signals that control Schwann cell development and myelination.”

Elior Peles, Ph.D., Associate Professor of Molecular Cell Biology at the Weizmann Institute of Science, Israel, on “Axon-glia interactions at the nodes of Ranvier.”

Jeffrey Milbrandt, M.D., Ph.D., Professor of Pathology and Immunology, Internal Medicine and Neurology at Washington University School of Medicine in St. Louis, on “Molecular insights into myelination and axonal degeneration.”

Noon – 1:30 Lunch

1:30 – 4:30 Afternoon Session

Stephen G. Waxman, M.D., Ph.D., Professor and Chairman of Neurology, and Professor of Neurobiology and Pharmacology at Yale Medical School, Neurologist-in-Chief at Yale-New Haven Medical Center, and Director of the Center for Neuroscience & Regeneration Research at the VA Medical Center, Connecticut, on “Sodium channels in axonal disease.”

William Snider, M.D., Professor of Neurology and Cell & Molecular Physiology, and Director, of the Neuroscience Center at the University Of North Carolina School of Medicine, on “The path from nerve growth factor to axon assembly.”

Clifford J. Woolf, M.D., Ph.D., the Richard Kitz Chair of Anesthesia Research at Harvard Medical School and Director of the Neural Plasticity Research Group at Massachusetts General Hospital, on “What the peripheral nervous system can tell us about promoting successful regeneration.”

4:30 – 5:30 Reception

Funding for the symposium came from the Brain Research Foundation and from grants from Pfizer, Takeda, Lilly, Athena Diagnostics and a generous patient.

University of Chicago Hospitals
MC 6063, 5841 S. Maryland Ave.
Chicago, IL 60637
United States
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