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News in brief, April 11, 2007

The latest news in brief

Mergers and acquisitions news

Cardinal Health completes Pharmaceutical Technologies and Services sale
US drug delivery and devices firm, Cardinal Health, has completed the sale of its Pharmaceutical Technologies and Services (PTS) segment to the Blackstone Group for around USD 3.3bn. Cardinal announced it plan to spin off PTS to focus resources on its four remaining segments serving health-care provider customers in November 2006. At the beginning of 2007, Cardinal announced the agreement with Blackstone. PTS develops, manufactures and packages pharmaceutical and other products for customers worldwide and employs nearly 10,000 staff, racking up more than USD 1.7bn (EUR 1.3bn/ GBP 860.2m) in annual sales. PTS develops and manufactures oral and sterile pharmaceuticals in various dosage forms and offers proprietary technologies used in ethical and OTC formulations.

Edelman acquires Karyo Communications
Edelman has acquired a majority interest in the Vancouver, Canada-based public relations and strategic communications firm Karyo Communications. The acquisition of the 25-person, 25-year-old firm expands the reach of EdelmanCanada, which already includes operations in Toronto and Montreal. In addition, the acquisition will give Edelman another gateway to the Asia-Pacific region and a northern terminus for the north-south flow of business along the Pacific Coast between B.C. and California, the company noted. The Vancouver firm will be known as Karyo Edelman and will continue to be led by principals Patti Schom-Moffatt and Paul Welsh. Edelman noted that it has an existing relationship with Karyo, having worked closely with the company on public relations counsel, integrated marketing and design capabilities for clients over the last two years.

Technology news

Burson data analysis tool
Burson-Marsteller has launched a new tool suite called B-M Business Intelligence, which is designed to help gather, track and analyse information, transforming raw data into practical solutions. The offering provides clients with the opportunity to "take a 360-degree look at their operations, issues and business needs to determine their precise place, opportunities and challenges in the competitive landscape," according to the firm. Specific services include: an opposition research tool to audit and analyse competitors' positioning in areas including business and marketing practices, executive positioning, corporate governance, corporate responsibility, and legal stance on business issues; a crisis and issues support tool that offers information and intelligence throughout the span of the crisis, including hourly or daily reports to identify new issues and other changes and analyse how they are being received by the public; and an opposition tracking tool that offers real-time monitoring of opponents' statements and positions.

Campaign news

Brand Create and KCI Medical team up for online advertising campaign
Appointed by KCI Medical UK, the award-winning agency, Brand Create is to promote a fully integrated risk management and therapeutic bed for obese patients for use in a variety of healthcare settings. The BariAir bed reduces the need for moving and handling of the obese patient by the carer. The online advertising campaign will use primary medical resources such as the key websites of the British Medical Journalís and the Royal College of Nursing. The online launch will help raise awareness of the benefits of the therapeutic bed through interactive banners. Users will click through to images of the BariAir therapy bed and its features. The online campaign has been specially designed to be one-click-banners, which ensures the user is greeted with an image of the therapy bed. The user is then educated and guided through the product's features and how these will provide benefits to both themselves and their patients, and then led to a direct response form, which will provide the data collection element. Brand Create will provide a fully integrated campaign to ensure that educational needs are met. A traditional direct marketing campaign will follow up with a mailout to members of the medical profession. The mailout will expand market reach again not only to nurses and doctors, but also to risk assessment managers, as well as moving and handling experts.

Partnership news

Porter-Novelli in Africa
Porter Novelli has entered a partnership with Corporate and Financial Communications Limited in Nigeria. The African company will become part of the Porter Novelli network and will be known as C&F Porter Novelli. The company is Nigeria's leading reputation-building and management consultancy, specialising in full-service marketing communications, including strategic counselling, media relations, crisis management, research, advertising, direct marketing, event management and interactive. C&F Porter Novelli has local and international clients in a range of sectors, including healthcare, Porter Novelli noted.

Regulatory news

Cox 2 inhibitors should not be approved if safer alternatives exist
Painkilling drugs in Cox 2 inhibitor class, which increase the risk of stroke and heart attack, must not be approved if safer alternatives are available, according to federal documents released on 2 April 2007. The announcement will not please US pharmaceutical company, Merck & Co, which is waiting for an FDA ruling on its Vioxx (rofecoxib) replacement, Arcoxia (etoricoxib). Merck took Vioxx off-market in 2004 after it was linked to a higher risk of stroke and heart attack. The FDA said its focus in evaluating Merck's application for Arcoxia, and all other drugs from that class, will be a risk assessment of cardiovascular system damage. NSAIDs will only merit approval if they fill an unmet need for a particular group of patients with no safer options available. The only Cox-2 inhibitor still on the US market is Pfizerís Celebrex (celecoxib). Merck wants FDA approval to sell Arcoxia to treat the signs and symptoms of osteoarthritis. Merck said the cardiovascular risk of Arcoxia was comparable with diclofenac, based on the results of a 35,000-patient study. Critics maintain that a fairer comparison would have been to use other NSAIDs, like naproxen, as diclofenac raises heart risks. Merck disputes the findings. The FDA, meanwhile, said data from smaller and shorter studies suggested the cardiovascular risk of Arcoxia was greater than either naproxen or placebo, but less that of other NSAIDs. Merck already sells Arcoxia in more than 60 other countries. The company expects a final FDA decision on the drug by the end of April 2007. For more information on the FDAís Unapproved Drugs Initiative click on the following link: http://www.fda.gov/cder/drug/unapproved_drugs.

FDA calls for halt of trimethobenzamide-based anti-nausea drugs
The FDA has asked manufacturers of suppository drug products which contain trimethobenzamide hydrochloride to halt their manufacture as they are not FDA-approved. The action is part of an ongoing agency effort to deal with prescription drugs which do not have FDA approval. Many of the drugs were on the market before certain federal laws governing approved drugs took effect. The FDA estimates that about two to three per cent of all prescription drugs on the US market lack agency approval. The FDA said there was no evidence that drugs containing trimethobenzamide in suppository form were effective at treating nausea and vomiting in children and adults. The agency said the products have been marketed as Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz. The FDA added that several oral capsules and injectable products which also contain trimethobenzamide were approved by the FDA to treat nausea and vomiting. Companies manufacturing or marketing trimethobenzamide suppository products must stop shipping them by 9 May 2007. Existing products still being sold in pharmacies can remain there until they are sold. The FDA said any company wishing to market a product containing trimethobenzamide in suppository form will need to submit an NDA and be in receipt of agency approval.

Clinical news

Novagali reveal positive phase III results for vernal keratoconjunctivitis treatment
French ophthalmic pharmaceutical company Novagali Pharma, has revealed positive data from the phase III clinical study of Vekacia (cyclosporine A) in children with orphan ophthalmic disease, Vernal Keratoconjunctivitis (VKC). The results showed that both symptoms and signs improved in patients receiving Vekacia. Tolerability of Vekacia was rated as "excellent". VKC is a severe form of chronic allergic conjunctivitis. Symptoms include ocular discomfort, pain, itching and intense photophobia. VKC is rare and affects mostly children and young adults living in warm climates. In March 2006, Novagali received an orphan drug designation from the EMEA for Vekacia in the treatment of VKC. The present study was conducted throughout Europe and lead by Professor David Ben Ezra of Hadassah Hebrew University Hospital, Israel, who first reported on the use and potential efficacy of cyclosporine A for the treatment of VKC. Vekacia is a topical cationic emulsion of cyclosporine A and will be the first therapeutic product available for this ocular condition. Novagali plans to file EU marketing authorisation mid-2007.

More stringent drug trial rules affecting UK R&D
A report in the Financial Times (FT) has revealed that more stringent UK regulations controlling human drug experiments, which were set up in response to the catastrophic trails held in March 2006 at Northwick Park Hospital in North-West London, according to pharmaceutical groups. The new data has shown that some companies have halted trials, or have contracted out research to foreign companies, adding that "longer and tighter scrutiny will see R&D in the UK diminish". The UK government has been trying to make the UK a more attractive destination for clinical trials to try to halt the increased trend in the pharmaceutical industry to use foreign contract research organisations (CROs). According to the FT, the Medicines and Healthcare products Regulatory Agency (MHRA) is to hold an expert committee established after the now defunct German drug company TeGeneroís monoclonal antibody TGN 1412 trial caused life-threatening reactions in six test subjects. The FT added that data provided by the MHRA demonstrated that from four trials for other drugs judged high-risk, already approved in March 2006 and re-reviewed after TGN1412, only one has been approved. Another drug is still pending approval and two were not carried out at all in the UK. Requests have been filed to approve trials for eight further high-risk drugs that were studied under interim measures introduced, but only one has so far been approved.

Markets news

Abbott to cut HIV/AIDS drug price for poor countries
Abbott is to cut the price of a key HIV/ AIDS drug by more than half in more than 40 poor countries. The US drug company added it would offer its drug Kaletra at an annual price of USD 1,000 (EUR 745/ GBP 506) per patient - lower than generic versions - to governments of more than 40 countries with low and low-middle income, as defined by World Bank criteria. Abbottís move is a possible answer to the criticism it has received from AIDS activist groups, charities and other organisations over recent patent disputes in India and Thailand over accessibility to HIV/ AIDS drugs. PMLive announced recently that Abbott said it would halt any launches of new drugs in Thailand as a reaction to the Thai government's January 2007 decision to ignore international laws regarding drug patents. The Abbott announcement sparked protests from AIDS advocates. Despite the announcement, Abbott said it would not launch Aluvia in Thailand. Aluvia is a heat-stable form of Kaletra and would eliminate the expense of refrigeration. Abbott also raised the price of HIV/ AIDS drug Norvir by 400 per cent in 2003 through a much-criticised marketing strategy.

Pulmonary drug delivery market could exceed USD 34bn by 2010
According to a new study published by market research firm Kalorama Information, the pulmonary drug delivery market could be worth USD 34.5bn (EUR 25.7bn/ GBP 17.5bn) in 2010. The report shows 2006 revenues for the total pulmonary drug delivery market reaching USD 25.5bn EUR 19bn/ GBP 12.9bn), an increase of 11.8 per cent since 2002. Sales of drug delivery technologies alone increased from USD 1.4bn to USD 1.6bn from 2002 to 2006. Also, the report adds that pharmaceuticals delivered through pulmonary means grew to USD 23.9bn, with the overall market showing a compound annual growth rate of nearly 10 per cent during the same time period. Sales of Pfizer's Exubera, have fallen short of the multi-billion dollar profit lines expected by analysts, but the report says that its very approval has made the prospect of inhaled delivery more acceptable. Inhalable delivery is used in wider variety of macromolecules, many of which are administered by injection or through oral means, both of which do not suit all patients. New agents currently under investigation for pulmonary delivery include interleukin-1 receptor, heparin, interferons, calcitonins and apomorphines. The report can be accessed by clicking on the following link: http://www.kaloramainformation.com/Drug-Delivery-Vol-1399440.

Approvals news

FDA licenses first biologic to combat HBV reinfection in transplant patients
The FDA has approved HepaGam B for the prevention of hepatitis B (HBV) reinfection in liver transplant patients. The immune globulin product is the first of its kind approved for this purpose. The Hepatitis B virus attacks the liver causing liver cancer, liver failure and death. Liver transplant patients exposed to the hepatitis B virus are at an increased risk of reinfection due to a weakened immune system. HepaGam B creates an immediate immune response to the virus, protecting patients previously exposed to HBV. Patients receive injections at the time of their liver transplant and throughout their lives. The product is derived from human plasma collected at licensed plasma centres in the US. The FDAís approval is based on clinical data in a study of HBV-infected patients undergoing full liver transplants. Results showed a reduction in the virus recurrence rate from 86 per cent to approximately 13 per cent. Adverse reactions were similar to other immune globulin products for other indications and included headache and hypertension. In early 2006, the FDA licensed HepaGam B for the prevention of HBV infection after acute exposure to blood or certain body fluids containing HBV, perinatal exposure of infants to mothers previously exposed to HBV, sexual exposure to persons previously exposed to HBV and household exposure to persons with acute HBV infection.

Contracts news

Shire chooses Rhythmyx for enhanced Intranet
UK-based pharmaceutical company Shire, has chosen Percussion Software's Web Content Management solution, Rhythmyx, to relaunch its company intranet. Shireís intranet was launched in 2002 will launch later in 2007 after a redesign. Rhythmyx 6 provides "a platform for the easy management of customer-focused content across multiple sites, multiple channels and multiple lines of business". The system also enables enterprises to build websites with frequently updated content that is engaging to multiple audiences. A key objective of the intranet project is that it will perform as a gateway to all sources of company information, while allowing personalisation of information. Shire is also looking for its intranet to support live two-way communication, password protected areas and blogs. By increasing the number of content contributors and editors, Shire says it will be able to generate content easily, re-use and refine content across departments and countries, reducing the number of internal processes and ensuring dynamic and engaging content. Shire, which is the UKís third largest pharmaceutical company, has a pipeline focused on attention deficit and hyperactivity disorder, human genetic therapies, gastrointestinal and renal diseases.

Financial news

Russian drugs group seeks London listing
According to a report in the Financial Times (FT), Pharmstandard, a Russian generic drug manufacturer, which is part-owned by multi-billionaire Roman Abramovich, is to sell shares through an IPO in London. Such a move would be the first made by a Russian pharmaceutical group to access international equity capital markets. The FT said that confirmation of the planned share sale came as the group reported an 86.8 per cent rise in annual pre-tax profit to RUB 2.7bn (USD 104m/ EUR 77.6m/ GBP 52.7m) on revenues which rose 49.9 per cent to RUB 8.5bn (USD 328m/ EUR 244.3m/ GBP 165.9m).

Biotechnology news

India and Australia sign biotechnology cooperation MoU
According to local media reports, India and Australia have signed a Memorandum of Understanding (MoU) to increase cooperation between the two countries in the field of biotechnology. Union Minister of Science and Technology and Earth Science, Kapil Sibal, was reported as saying that seven new projects and two workshops will be inaugurated to facilitate and support biotechnology research collaboration. The Australian Government has created a five-year fund worth AUD 6m (USD 5m/ EUR 3.7m/ GBP 2.5m), with a similarly valued Indian grant. The fund will also support public and private sector scientists of both countries, for collaborating and taking a leading edge in science and technology in order to contribute to the economic, social and environmental well being of India and Australia. Funding priority for the first round has been given to biomedical devices and implants, stem cells, vaccines/medical diagnostics, transgenic crops, nutraceuticals and functional foods and bioremediation.

11th April 2007

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