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News in brief, March 27, 2007

Teh latest news in brief

Approvals news

GW Pharma and Otsuka win US antitrust clearance for Sativex in US
UK-headquartered GW Pharmaceuticals and Japanese pharmaceutical firm, Otsuka Pharmaceutical, have revealed that US antitrust authorities have approved the co-licensing and co-development agreement both firms have to market GW's cannabinoid-derived pain drug, Sativex, in the US, after receiving Hart-Scott-Rodino clearance. In February 2007, GW entered into an exclusive licensing agreement with Otsuka allowing it to develop and market Sativex in theUS. GW said it would manufacture and supply Sativex to Otsuka. The Hart-Scott-Rodino Antitrust Improvements Act of 1976 is a set of amendments to US antitrust laws, which requires parties to transactions over a certain dollar threshold to notify the government and observe waiting periods before closing. The two firms are still in talks on entering a cannabinoid research collaboration in the field of CNS disorders and cancer treatments in order to research, develop and commercialise a range of other early stage cannabinoid product opportunities, according to a GW press statement on 22 March. GW Pharmaceuticals recently also announced the appointment of Mr Richard Forrest as a non-executive director to its board. Mr Forrest replaces Mr David Morrison who stood down on that date. GW also revealed that James Noble, previously a senior independent director, assumed the newly created position of deputy chairman.

Collaborations news

Strategic collaboration for allergic ocular diseases and allergic rhinitis
Privately held, French-headquartered specialty biopharmaceutical company, Novagali Pharma, has initiated a strategic collaboration and cross-license agreement with Canadian development stage biopharmaceutical company, Topigen Pharmaceuticals. Per the agreement, Novagali will receive an exclusive worldwide license to develop and commercialise an ophthalmic product based on Topigen's multi-targeted, RNA-targeting platform technology for the treatment and prevention of allergic eye diseases. Topigen will receive an exclusive license to Novagali's Novasorb topical delivery technology for use in formulating and developing an RNA-targeted therapy for treating respiratory conditions such as allergic rhinitis. Both firms will collaborate to develop ocular and nasal forms of RNA-targeting product candidates using Novasorb and will develop formulations designed to improve the bioadhesion and efficacy of RNA-targeting therapeutics delivered to the nasal membrane and ocular surface. Novasorb technology improves retention time for therapeutic compounds in tissues such as the cornea and conjunctiva and other membrane surfaces including nasal and buccal. The terms in the agreement enable Novagali to develop its own ophthalmic product based on Topigen's technology for the treatment and prevention of allergic eye diseases and for Topigen to develop its own RNA-targeting products for allergic rhinitis based on the formulations developed using Novasorbís technology. Financial terms were undisclosed.

Financial news

Ranbaxy pulls of out Merck KGaA generic subsidiary bid
India ís third largest pharmaceutical company, Ranbaxy Laboratories, has pulled out of the bidding for the generics subsidiary of Merck KGaA. Ranbaxyís shares had dropped 24 per cent since CEO Malvinder Singh indicated in early January that he might make a bid for the Merck unit. Its shares had previously fallen further on news of an FDA warning letter issued in 2006 regarding a domestic pharmaceutical manufacturing facility which failed to meet the US Current Good Manufacturing Practice (CGMP) regulations. Indian media reports said that Ranbaxy continued onto the second round of the bidding process but decided not to go ahead because valuations for the generics business had exceeded USD 6bn. Ranbaxy shares rose 6.2 per cent on the Bombay Stock Exchange, closing at INR 336.4 (EUR 5.83/ GBP 4.00/ USD 7.70), on news that the company was withdrawing from the bid. Analyst reports have been favourable since the bid cancellation. The concerns were that a big acquisition could strain Ranbaxyís balance sheet and cash flows.

Capital Healthcare amends investment agreement with SkyePharma
US healthcare fund manager, Paul Capital Healthcare, have restructured its two investments in SkyePharma. Paul Capital has converted its royalty participation in 14 of SkyePharma's marketed and pipeline products into a USD 92.5m (EUR 69.3/ GBP 47.1m) secured note, with additional contingent payments linked to the future sales performance of DepoDur, a pain management product produced by SkyePharma's injectables arm. By restructuring its investments in the company, Paul Capital assisted SkyePharma's simultaneous divestiture of its US-based injectables business on 26 March 2007. SkyePharma says that the divestiture will allow it to focus on developing its inhaled and oral products, including its lead product, Flutiform, and will also reduce a significant source of cash burn for the company. Peter Grant, SkyePharmaís CFO said: "Paul Capital Healthcare has been a long-term financing partner to SkyePharma and has been flexible in restructuring its investments to support our future growth." Paul Capital's initial investments in SkyePharma, which were made in 2000 and 2002, funded the development of the company's lead development stage products. The 2002 investment also funded the acquisition of RTP Pharma, which provided SkyePharma with the drug delivery technology which allowed it to develop Triglide, which is marketed in the US by Sciele.

Amgen donates USD 1m for new biotech centre
Amgen, the US biotechnology company, has announced a USD 1m (EUR 748,816/ GBP 508,620) donation to the University of Rhode Island (URI) to help finance the construction of a USD 60m (EUR 44.9m/ GBP 30.5m) biotechnology and life sciences centre at the Kingston campus, the drug manufacturerís largest charitable gift in the state since it opened its plant there in 2002. The company added that its gift signalled its continued support for a campaign by URI to match its academic offerings to state economic development goals, particularly the expansion of the biotechnology sector. Amgen has created 1,700 jobs at its West Greenwich facility. URI has taken steps to guarantee a steady supply of labour to the company, and to help the state recruit similar firms. In 2003, Amgen helped URI establish a biomanufacturing program in Providence , donating USD 25,000 and guiding the development of the curriculum for a specialised BSc degree. To pay for the building, URI will use a USD 50m bond, approved by voters in 2004, and raise another USD 10m in private donations.

LIDDS' prostate cancer treatment funding progresses
LIDDS, a privately-held Swedish drug development company, has announced the successful completion of a SEK 40m (EUR 4.3m/ GBP 2.9m) financing round for the next phase of development of its drug delivery technology and lead product Liproca for local treatment of prostate cancer. LIDDS expects to begin a phase I clinical trial of the new product during Q2 2007 in order to establish tolerability, safety and efficacy. The financing round was provided by LIDDS shareholders, the PULS financial network, private individuals and investment companies. LIDDS' drug delivery concept is built on the principle of administrating a ceramic drug carrier locally to the target organ. The ceramic can be loaded with various active pharmaceutical drugs for release at the site of administration over weeks to several months, during which time the ceramic carrier material will be resorbed, leaving no residues. The ceramic material also makes it possible to increase the accuracy of dose-positioning since the injected material is visible with ultrasound. Liproca, which is LIDDS' first product, was designed to reach long-term antiandrogen effect locally in the prostate tumour, either as a repeated mono-treatment or in combination with current peroral and/or parenteral therapies or as neo-adjuvant to radiation therapy, for example. Commenting on the financing, LIDDSí chairman, Roland Bengtsson, said: "I am very pleased with the outcome of this funding process. During the course of development, the confidence that Liproca will add something of crucial value to the prostate cancer market has strengthened and the capital increase demonstrates shareholdersí confidence in LIDDSí ability to create value. With the proceeds of the capital increase, LIDDS will be able to accelerate and expand its development program. Our cash position also provides us with a unique opportunity to pursue various strategic options, including alliances with larger partners interested in taking over LIDDSí projects and technologies."

Turnover up 145 per cent at Sinclair Pharma
UK pharmaceutical company Sinclair Pharma has release its H1 FY07 interim results. Turnover was GBP 9.1m, up 145 per cent compared with H1 FY06. The high revenue increase was driven by contributions from acquired sales and marketing operations in France and the UK : CS Dermatologie and Ashbourne Pharmaceuticals, respectively. The Atopiclair revenues increased 130 per cent to GBP 1.3m. An operating loss of GBP 2.6m was recorded, compared with GBP 1.7m in H1 FY06. The company recorded a loss per share of GBP 0.031, compared with the H1 FY06 figure of GBP 0.03. Sinclair started H2 FY06 with its strongest ever order book and is seeking to migrate from AIM to the Official List in London in the near future, together with a secondary listing on Euronext Paris. Sinclair now has a marketing partner network that spans 67 countries including the main EU and Latin American territories, the US, China and Russia . New marketing agreements included one with Bayerís specialist dermatology division, Intendis, to sell Atopiclair in eight major territories. In some countries a co-marketing agreement means that Intendis will market the product alongside Sinclairís own sales and marketing teams.

FY06 sales at Bayer steam ahead
German research-based, healthcare, nutrition and high-tech materials company, Bayer, has revealed a FY06 sales increase of 17.2 per cent. Bayer HealthCare was highlighted as being particularly successful, with above-market growth across all divisions and additional momentum coming from the Schering acquisition. Sales at Bayer HealthCare rose by 46.6 per cent to reach EUR 11.7bn, with business in the pharmaceuticals segment rocketing 83.9 per cent to EUR 7.5bn. Sales at the Bayer Group rose in 2006 by 17.2 per cent to rest at EUR 28.96bn, compared with EUR 24.70bn for FY05. The figure includes EUR 3.1bn in revenues contributed by the recently acquired Schering business from 23 June 2006 to the end of FY06. Total earnings gleaned from Bayerís divested diagnostics division and subsidiaries, H C Starck and Wolff Walsrode, were omitted except for net earnings, which were included in Bayer Groupís net income. The company reported a 21.3 per cent rise in EBITDA before special items to rest at EUR 56bn. EBIT before special items advances rose 14.2 per cent to reach EUR 3.5bn. Bayer expects its sales and underlying EBITDA to grow more than 10 per cent in FY07, as well as targeting an underlying EBITDA margin of about 22 per cent for FY09. Bayer HealthCare aims for an underlying EBITDA margin of approximately 27 per cent in FY09. Werner Wenning, Bayerís Management Board Chairman and CFO Klaus K¸hn presented the company's Annual Report for 2006, saying: "Fiscal 2006 was an extraordinarily eventful and very successful year for Bayer, which had improved major performance indicators substantially compared to the previous year. Bayer decisively strengthened its pharmaceuticals business with the acquisition of Schering AG." Wenning forecast a further improvement in FY07 earnings.

Industry news

Abbott data show XIENCE stent superior to Boston's TAXUS
Abbott has presented data from its randomized Spirit III trial of 1,002 patients compared Abbottís next-generation XIENCE V everolimus-eluting coronary stent system with Boston Scientific's TAXUS paclitaxel-eluting coronary stent system met both its primary endpoint and major secondary endpoint. In its primary endpoint of in-segment late loss at eight months, XIENCE V demonstrated superiority to TAXUS with a statistically significant 50 per cent reduction in late loss, compared with TAXUS. In-segment late loss is a measure of vessel renarrowing. In its major secondary endpoint of Target Vessel Failure at nine months, XIENCE V demonstrated non-inferiority to TAXUS with an observed 21 per cent reduction in Target Vessel Failure for XIENCE V compared with TAXUS. Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack. Subsequent to SPIRIT III meeting its primary and major secondary endpoints, an analysis of nine-month Major Adverse Cardiac Events (MACE), such as cardiac death, heart attack or target lesion revascularisation (artery re-treatment due to lack of blood supply), was undertaken in which XIENCE V demonstrated superiority to TAXUS with a statistically significant 44 per cent reduction in MACE at nine months compared with TAXUS. Principal investigator of the SPIRIT III clinical trial, Dr Gregg W Stone of Columbia University Medical Centre and the Cardiovascular Research Foundation, said: "Not only did the SPIRIT III trial meet its primary and major secondary endpoints, but it showed a statistically significant reduction in major adverse cardiac events, favoring XIENCE V."

Inhaled insulin's long-term side effects worry prescribers
Pfizer's inhalable insulin product, Exubera, which was approved for marketing in the US in 2006 has disappointed market analysts, who say that while doctors appear to see Exubera as a new way to deliver insulin, some remain concerned about the drug's long-term pulmonary effects, cost and insurance coverage. Insurers in the US have said that Pfizer has not effectively demonstrated Exubera's value. For example, WellPoint, the largest US healthcare insurer, is either not covering Exubera or placing it in the most restrictive tier, with higher copays, depending on the plan. As a result, Exubera sales may not benefit when Pfizer expands the  sales effort to primary care doctors. Indeed, Exubera sales for FY06 were not reported. Pfizer, who co-developed Exubera with US drug delivery firm, Nektar Therapeutics, has not disclosed Exubera's development costs, but stresses that the product will improve adherence in those who are needle phobic. Susan Silberman, Pfizer's senior vice-president of worldwide commercial development, said: "I think we have to manage this product differently. Insulin is intuitive. What has changed is the approach to delivery, so (marketing) is about the education." Pfizer has around 900 part-time diabetes educators to explain the product to doctors and patients, with more proposed. A small, non-branded ad campaign for the drug which does not mention Exubera by name began recently and a bigger DTC marketing effort will start in Q2 2007. Analysts say that Exubera's poor introduction could hit Pfizer's profits, especially as Lipitor is to lose patent protection in 2010, while the development of a successor failed in 2006. Miller Tabek & Co analysts doubt Exubera will meet the FY07 sales target of USD 200m, adding that Exubera's market share and the number of patients on the drug is difficult to assess because of the way it is sold. Patients need to buy the inhaler, as well as regular repurchases of blister packs and release units, which help create the mist. However, Deutsche Bank analysts say that while the launch has been slow, Exubera still could reach USD 1bn in sales in the next few years.

Crestor fails to reverse arterial thickening
UK pharmaceutical company, AstraZeneca (AZ), has failed to show that its cholesterol-lowering drug, Crestor (rosuvastatin), failed to reverse thickening in the neck arteries of people at low risk for heart attacks and strokes, but did demonstrate the slowing of arterial thickening. Crestor is approved primarily to reduce levels of low-density cholesterol, but AZ had hoped US health regulators would approve expanding the product label to say it can improve atherosclerosis. The METEOR study thus will not support the wider use of Crestor and other statins in people assessed as low risk for heart attacks and cardiovascular events. AZ had already presented another Crestor study at a 2006 American College of Cardiology meeting for people with signs of heart disease who were at higher risk for future heart attacks and strokes. Crestor partially reversed the buildup of plaque in coronary arteries in these patients. AZ has submitted data from both studies to the FDA and expects to hear by the end of 2007. If a label change regarding atherosclerosis is warranted, according to James Blasetto, head of strategic development for Crestor. The 2006 study helped Crestor win a 60 per cent rise in FY06 sales to over USD 2bn. Crestor and Vytorin (ezetimibe/ simvastatin) have been eroding the market lead of Pfizer's Lipitor (atorvastatin), which racked up FY06 sales of USD 12.9bn. Vytorin is marketed by a jv of Merck & Co and Schering-Plough. There is currently aggressive competition to produce new clinical data demonstrating the superiority of each product.

NHS news

BCS develops new ECDL health unit for NHS
The British Computer Societyís (BCS) new European Computer Driving Licence Health Unit was launched on 23 March 2007 and is the first computer skills syllabus in the world specifically for users of healthcare systems. It will be made available by the NHS Connecting for Health (NHS CfH) to its staff later in March. The new ECDL Health Unit is the result of seven years collaborative work between the BCS and NHS CfH to develop a computer skills syllabus specifically for healthcare information systems users, providing them with skills sets necessary to use IT effectively when caring for patients. The unit, which has been trialled by 100 NHS staff across five NHS Trusts, covers the broad issues, challenges and benefits of using electronic patient information systems. It has been designed for all staff working with healthcare systems including clinical staff and administrative workers. Candidates do not need advanced computer knowledge to take the qualification, needing only the basic skills of using a computer keyboard and mouse. A pilot of the ECDL health unit proved successful, with candidates taking an average of ten hours to complete the learning section, with a pass rate of 90 per cent. Claire Adams, NHS Connecting for Health, said: ìThe outcome of the English NHS pilot has been highly successful in validating the appropriateness and the importance of the core syllabus.î

Regulatory news

NICE help for employers ahead of smoking ban
In the countdown to England becoming smoke-free, the National Institute for Health and Clinical Excellence (NICE) will issue public health guidance on the most effective ways to encourage and support employees to stop smoking. The guidance, due in late spring, is aimed at everyone responsible for ensuring that workplaces are smoke-free from 1 July 2007. This includes employers and those involved in providing smoking cessation help in the workplace. Professor Mike Kelly, Director, Centre for Public Health Excellence, said: ìThe guidance we will shortly issue will support employers by recommending effective methods to help their employees quit smoking. Although employers are not obliged to help employees stop smoking, providing support to help employees quit could help reduce the chances of falling foul of Julyís legislation. The guidance will highlight the benefits to businesses in terms of productivity and improvements to employeesí health. Smoking is a key public health priority as well as the principal cause of inequalities in death rates between rich and poor in this country. The forthcoming NICE guidance will support organisations and health professionals ahead of this major public health milestone.î The workplace smoking guidance is expected to be published in late April 2007. More information about the guidance is at http://guidance.nice.org.uk/page.aspx?o=350204

Quick US approval for generic biotech drugs 10 years off
The FDA has announced that it could be a decade or more before the necessary science is available to approve generic versions of biotech drugs safely in the it currently approves generic versions of branded ethicals. The FDA's deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen and Genentech, which have yet to face generic competition in the US for their products, some of which are the most complex and expensive on the market. The current lack of competition will eventually change under a bill introduced by Representative Henry Waxman. The bill charges the FDA with the approval of copycat versions of biotech medicines, which are made from living cells and proteins. The biotech industry has argued that because these proteins are more prone to minor differences when mass produced, it will be more difficult for generic drug companies to safely reproduce them. Others argue that the complexity of biotech drugs makes it necessary that generic biotech manufacturer conduct clinical trials of their products. Novo Nordisk's vice-president, Inger Mollerup, said that if Congress created a system to approve cheaper protein-based drugs it should be similar to the EU one, where generic biotech companies have to conduct extensive studies to show the safety of their versions. Despite the safety studies, the generic products are still not considered interchangeable with the original product,  which means that a patient must gain approval from a GP before switching from the branded drug. Waxman's bill would allow the FDA to require clinical safety studies, though whether or not this would be mandatory remains unclear. In February 2007, an Express Scripts report revealed that generic biotech drugs could save patients and insurance providers USD 71bn over 10 years

Technology news

LED array signals successful binding of drug-delivery molecules to DNA
Biology and chemistry researchers from Virginia Tech are creating molecular complexes to bind to and disrupt the DNA of diseased tissues, such as tumours or those infected with viruses. Testing the activity of each of the therapeutic molecule designs has been a time-consuming process. A J Prussin II, a second year student at Virginia Tech who is majoring in biochemistry and biology in chemistry, has created an LED system that glows blue when the special molecules successfully bind to DNA. ìIt allows us to do 100 tests per day, instead of one or two,î said Karen Brewer, professor of chemistry at Virginia Tech. The research will be presented at the 233rd national meeting of the American Chemical Society in Chicago, which is held between 25 and 29 March 2007. Pussin and chemistry graduate student David Zigler of Sterling, Illinois, plan next to build an array that will use different colors to signal different DNA interactions. ìThat capability is important in terms of what color of light you want to use to activate the molecules to bind to or cleave the DNA,î Brewer said. The research poster, ìValidation of an LED array for use in DNA photocleavage assaysî, was selected for both the Bioinorganic and for the special Sci-Mix session at the Hyatt Regency Chicago Riverside Center. Authors are Prussin, Zigler, chemistry graduate students Jared Brown and Avijita Jain, Biology Professor Brenda S J Winkel and Brewer. The research was supported by the National Science Foundation.

Health news

Study claims aspirin cuts cancer risk by a quarter in women
A longitudinal, US-based study of nurses has suggested that aspirin not only reduces the risk of heart attacks and strokes, but also has a protective affect against cancer. Published in Journal of the American Medical Association's (JAMA) 26 March issue of Archives of Internal Medicine, the study found that, even in healthy women, a daily dose can cut the risk of dying from cancer by 12 per cent and the risk of dying from heart disease by 38 per cent. Dr Andrew T Chan of the Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues examined the association between aspirin use and death in 79,439 women enrolled in the Nursesí Health Study, a large group of female nurses who have been followed since 1976. Beginning in 1980 and again every two years through 2004, the women were asked if they used aspirin regularly and, if so, how many tablets they typically took per week. At the beginning of the study, the women had no history of cardiovascular disease or cancer. There are several mechanisms by which aspirin could reduce the risk of death, the authors note. "Aspirin therapy may influence cardiovascular disease and cancer through its effect on common pathogenic pathways such as inflammation, insulin resistance, oxidative stress (damage to the cells caused by oxygen exposure) and cyclooxygenase (COX) enzyme activity," also linked to inflammation, they write. The controversy surrounding the study is that aspirin can also trigger internal bleeding in many patients, which makes doctors cautious about prescribing it, and warnings were issued that people should not take it without contacting their GP first.

27th March 2007

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