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News in brief, April 25, 2007

The latest news in brief

Financial news

Flat profits for GSK in Q1 FY06
The UKís largest pharmaceutical firm, GlaxoSmithKline (GSK) has published flat Q1 FY07 net profits due to the continuing growth of Sterling against the US dollar. The company revealed a GBP 1.5bn (USD 3.1bn), or GBP 0.27 pence a share net profit, almost flat on its GBP 1.5bn, or GBP 0.26 a share profit, in Q1 FY06. Turnover fell four per cent to rest at GBP 5.6bn from GBP 5.8bn in the same quarter of FY06. Earnings before tax of GBP 2.1bn was slightly down on the GBP 2.2bn recorded in Q1 FY06. The figures exceeded analyst forecasts of GBP 2bn, however. After gaining more than two per cent, the company's shares settled back to trade down 0.3 per cent in London trading on 25 April 2007. Despite the glitches, GSK maintained its FY07 earnings per share guidance range for growth of between eight and 10 per cent at constant exchange rates. The companyís Seretide/Advair (salmeterol/ fluticasone) and Avandia (rosiglitazone) respiratory products performed well in Q1 FY07, due to augmented prescription growth in the US. GSK added that its five key launches for 2007 were on track. These include breast cancer treatment, Tykerb (lapatinib), Coreg CR (carvedilol) for cardiovascular conditions and Cevarix for cervical cancer.

Schering-Plough reveals big Q1 FY07 profit
US pharmaceutical company Schering-Plough has announced a 55 per cent jump in earnings for Q1 FY07, exceeding analyst estimates due to greater than anticipated sales of prescription drugs, including two cholesterol lowering drugs sold in partnership with Merck & Co. Profit increased to USD 543m, or USD 0.36 per share, from USD 350m, or USD 0.24 per share in Q1 FY06. Excluding charges of USD 96m from three upfront licensing payments included in R&D, the company earned USD 0.42 per share in the quarter. Analyst expected Schering to report on average USD 0.29 per share. Q1 FY07 revenues rose 17 per cent on Q1 FY06 figures to reach USD 3.0bn. Counting revenue from cholesterol lowering drugs Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe), which the company markets with Merck, revenues rose 21 per cent including the co-marketed medicines. Schering also saw increased sales for its anti-inflammatory medicine, Remicade (infliximab), which rose 34 per cent to reach USD 373m, while allergy nasal spray Nasonex (mometasone) posted a 24 per cent rise in sales to USD 284m. On 18 April, Schering-Plough shares closed at USD 28.55, a rise of over 50 per cent over the last 12 months, outperforming the American Stock Exchange pharmaceutical index rate by 12 per cent over the same period.

Falling core sales force Pfizer to lower FY07 forecast
Pfizer, the world's largest pharmaceutical company, had to lower its FY07 forecast after an 18 per cent drop in sales for two of its major treatments: antihypertensive Norvasc (amlodipine) and antidepressant Zoloft (sertraline). Net income in Q1 FY07 fell to USD 3.4bn, or an EPS of USD 0.48 a share, from USD 4.1bn, or EPS of USD 0.56, in Q1 FY06. Despite the fall, profit excluding certain costs was USD 0.68 per share, which exceeded analyst estimates. Pfizer reported that FY07 revenue would be USD 1.2bn down on its forecast, mainly because of an unfavourable court ruling giving the green light to the manufacture of generic copycats of Norvasc. Zoloft is also facing generic competition. The sales results of novel, inhaled insulin treatment, Exubera, failed to reach target over concerns regarding safety data in lung studies and lack of market penetration. Pfizer added it will begin advertising Exubera to consumers by the beginning of H1 2007. Earlier in 2007, Pfizer revealed it was to slash 10 per cent of its workforce by 2008 to offset the lost revenue. Global sales of Lipitor (atorvastatin) were USD 3.4bn in Q1 FY07 and represented growth of eight per cent. Lipitor benefited primarily from price increases, lower rebates, a stronger US statin market growth and the impact of foreign exchange rates. Sales of neuropathic pain treatment, Lyrica (pregabalin), increased more than 50 per cent to rest at USD 395m, while sales of smoking-cessation drug, Chantix (varenicline), were USD 162m. Pfizer's bladder drug fesoterodine, which it hoped would receive FDA approval in January 2007, is now unlikely to reach the US market until 2009. Pfizer is partnering with Schwarz Pharma on the development of the drug.

Alliance Boots bidding war continues
The bidding war over Alliance Boots continues as two rival parties, Terra Firma Capital Partners and Kohlberg Kravis Roberts make rival offers for the company. Terra Firma Partners, which is supported by the Wellcome Foundation, raised its bid for Alliance Boots to GBP 10.9bn (USD 21.8bn), which was only three hours after Alliance Bootsí board had agreed to a revised offer of GBP 10.6bn (USD 21.2bn) from a consortium made up of Kohlberg Roberts & Co and Italian billionaire, Stefano Pessina, who is Alliance Boots' deputy chairman and biggest shareholder. Alliance Boots stock increased GBP 0.76, or 7.2 per cent to a record GBP 11.25 when the counter bid was revealed. Alliance Boots has 3,100 shops and a wholesale company which supplies drugs to more than 125,000 pharmacies and hospitals. Any takeover of the firm would be the largest leveraged buyout to date in the EU.

Adventis FY06 turnover up 62 per cent
UK marketing and advertising agency, Adventis Group, which includes healthcare subsidiaries Affiniti, Roundhouse and LeapFrog, has revealed FY06 results with group turnover up 62 per cent to reach GBP 35.5m. With further investment in the company of more than GBP 1.5m by Morgan Stanley, UBS and Oceanwood Capital Management, Adventis told PMLive it would continue to build on the success of existing services and new acquisitions. Adventisí primary strategy is to invest in and explore the Internet as a new conduit for healthcare professionals and broader audiences to engage with advertisers in more selective way. Charles Phillpot, CEO of Adventis, added that marketing solutions required a blend of on and offline tools: "We are focusing on developing our online services in a variety of areas including podcasts, search engine optimisation and key word click-throughs."

BioProgress reduces FY06 deficit
BioProgress, the speciality pharmaceutical and healthcare company, narrowed losses following a series of acquisitions. Last year the company made three purchases, including AirPharma, a US speciality pharmaceutical group, for USD 8m (GBP 4m) in cash and shares.

Baxter raises full-year outlook on strong Q1 FY07 results
Net income at US pharmaceutical company, Baxter, in Q1 FY07 increased 43 per cent to USD 403m, compared with USD 282m in Q1 FY06. Earnings per diluted share of USD 0.61 increased 42 per cent, compared with the USD 0.43 per diluted share in the same period in FY06. Strong sales, improved margins, and lower interest expense drove the company's financial performance, which matched the companyís guidance of USD 0.54 to USD 0.56 per diluted share. Baxter's worldwide sales increased 11 per cent to reach USD 2.7bn in Q1. US sales were USD 1.1bn, up eight per cent over Q1 FY06, while sales elsewhere rose eight per cent (excluding the impact of foreign exchange) to USD 1.5bn. The rise exceeded Baxterís guidance range of five to six percent. In the reporting period, Baxter's BioScience business brought in revenues of USD 1.1bn, up 22 per cent. The increase was driven by strength across all product lines, including recombinant products used in the treatment of haemophilia A, antibody therapy products for the treatment of primary immuno-deficiencies, and other specialty plasma therapeutics and biosurgery products. The company also posted strong vaccine results due to shipments of its candidate H5N1 vaccine for government stockpiles around the world, as well as strong demand in Europe for encephalitis and group C meningococcal meningitis vaccines. BioScience results exclude the Transfusion Therapies arm, which was divested in the reporting period. Medication Delivery revenues increased eight per cent to USD 990m as a result of strong international performance and sales of anaesthesia products. Renal revenues increased six per cent to USD 525m as the company continued to post strong gains in peritoneal dialysis patients, primarily in developing countries.

Health economics news

UK drug prices lower than EU average
A survey conducted by the EUís statistical office, Eurostat, has revealed that prices of medicines in the UK are seven per cent lower than the average for the EU, while in Switzerland they are a 87 per cent above average. The study looked at the prices of 181 top pharmaceutical products in 33 EU countries on prices as of November 2005 in the EU 25 member nations. Around 75 per cent of the medicines were branded products, while 25 per cent were generic in nature. Five member states had prices between 15 and 30 per cent above the average: Germany (28 per cent), Denmark (21 per cent), Norway (20 per cent), Ireland (19 per cent) and Italy (18 per cent), France, (11 per cent), the Netherlands (nine per cent), Austria (seven per cent), Malta and Belgium (six per cent), Luxembourg (three per cent) and Cyprus (two per cent). The next group were slightly below the average: Sweden (five per cent), Portugal (six per cent) and the UK (seven per cent). France was nine per cent under the average, while Slovakia was 14 per cent below. The countries where prices are between 21 and 72 per cent below the average are: Bulgaria; the Czech Republic; Estonia; Greece; Spain; Latvia; Lithuania; Hungary; Poland; Romania; Slovakia; Croatia; and Turkey. The lowest prices were found in the Former Yugoslav Republic of Macedonia, at 42 per cent under the average price. Pharmaceutical spending was 1.5 per cent of GDP for the 33 countries studied for the report, while for households the median was 1.3 per cent, according to Eurostat. The 33 countries also included three candidate countries: Croatia, Macedonia, Turkey and the European Free Trade Area (EFTA) nations Iceland, Norway and Switzerland.

R&D and drug delivery news

Avastin study reveals new safety data
Genentech and the FDA have warned healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC). The phase II clinical trial study combined chemotherapy and radiation plus Avastin (bevacizumab) and revealed two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled. A third, fatal event was also reported, in which TE fistula was suspected but unconfirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Also, six additional cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone, or with concurrent radiation treatment. Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin. Read the complete MedWatch 2007 Safety Alert with links to the Genentech Dear Healthcare Professional Letter and the most recent Avastin labelling, at:

HIV inhibitor in blood reveals potential new drug class
A research team at the University of Ulm in Germany has identified a component of human blood which blocks HIV-1, the dominant virus type which leads to AIDS, from infecting CD4 cells and replicating. The results revealed that a virus blocker might prevent the progression of HIV to AIDS and, because it works in a different way than existing antiretroviral inhibitors, could lead to a new class of drugs. The study, which was reported in the 20 April issue of the journal Cell, found that fragments of a blood molecule, which the research team has called a virus-inhibitory peptide (VIRIP) acts as a broad-based inhibitor of HIV-1. Results also demonstrated that a few amino acid changes in the fragment enhanced its antiretroviral potency twice over. The researchers said that VIRIP and its derivatives remained effective against drug-resistant HIV strains, making them highly promising for further clinical development. The group also demonstrated that HIV-1 did not easily develop resistance to VIRIP in vitro. An associated group of researchers led by Wolf-Georg Forssmann of IPF Pharmaceuticals and Hanover Medical School found preliminary evidence showing that some derivatives of the peptide are highly stable in human blood plasma and are non-toxic, even at high concentrations.

New dental drug delivery system
The EU's Sixth Framework Programme, which promotes cooperation between EU nations and Israel, is supporting an international project based on a drug delivery device inserted in the patient's tooth. Dr Andy Wolff, CEO of Israeli device firm, Saliwell, revealed that the Intellidrug system could be placed in a tooth, while the drug is delivered into the bloodstream through the mucosal lining of the mouth. The released drug is either swallowed by the patient or mixes with saliva, which consistently delivers the drug into the buccal lining. Intellidrug is an electronically controlled, intra-oral drug delivery system, which will provide an alternative approach to the treatment of addiction and chronic diseases. Wolff says he has recruited partners and is managing a consortium of 14 other companies and organisations involved in the development of the device, including universities, research institutes, hospitals and companies, such as German microelectronics institute HSG-IMIT, and Spanish telephone company Telefonica. The Intellidrug device is the size of two teeth and consists of a unit containing a pump and valves, a microprocessor, batteries and a reservoir for the drug pill. The consortium is working to miniaturise the system, so it may be used as a replacement tooth. The unit can be removed for refill and battery replacement.

Regulatory news

FDA approves first H5N1 virus vaccine in US
The FDA has announced the first US approval for Sanofi-Pasteurís human vaccine against the virus responsible for bird flu, H5N1. The vaccine would be used if the H5N1 avian virus strain mutated into a form which could be transmitted between humans, resulting in the rapid worldwide spread of the disease. If a pandemic occurred, the vaccine could offer limited protection in the months before a vaccine tailored to the particular pandemic strain of the virus could be developed and produced. The H5N1 virus is one version of the influenza A virus found in birds. The disease caused by H5N1 is far more aggressive and the onset of the disease is rapid, with pneumonia and multi-organ failure causing most fatalities. The vaccine was obtained from a human strain and will be used to inoculate people aged between 18 and 64 years at increased risk of exposure to the H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine immunisation consists of two intramuscular injections, given approximately one month apart. The manufacturer, Sanofi Pasteur, has sold the vaccine to the US federal government for inclusion within the National Stockpile for distribution by public health officials, and it will be manufactured at Sanofi Pasteur's facility. For more information on the government's preparedness efforts, click on the following link:

New laws to limit drug advertising limits under debate in US
Lawmakers in the US are debating legislation which would compel the drug industry to delay advertising for two years for newly approved prescription drugs. According to local media reports, the legislation is intended to give doctors time to review new drug safety and effectiveness before consumers see advertisements. Pharmaceutical firms say that if the legislation went ahead, it would impact their First Amendment free-speech rights. Spending on direct-to-consumer advertising has increased 500 per cent to more than USD 5bn on an annual basis, since the FDA released drug-ad restrictions in 1998. A Senate committee which steers the FDA voted 15-5 in favour of the legislation on 18 April, while similar legislation is under discussion by the House of Representatives.

Collaborations news

BTG signs with Novacea and KuDOS for AQ4N
BTG, the UK-based medical innovations company, has signed an agreement with Novacea and AstraZeneca (AZ) subsidiary, KuDOS Pharmaceuticals, regarding the anti-cancer pro-drug AQ4N. AQ4N is novel, tumour-selective pro-drug of topoisomerase, which include the marketed drugs Novantrone (mitoxantrone) and Adriamycin (doxorubicin), and has the potential applicability to multiple tumour types, both in combination with a number of chemotherapeutic agents and as a monotherapy for haematological malignancies. In November 2006, Novacea initiated a multi-centre phase Ib/IIa open-label clinical study of AQ4N in combination with radiotherapy and temozolomide in patients who were newly diagnosed with glioblastoma multiforme (GBM). Under the terms of the agreement, BTG will receive a signature fee, while Novacea gains exclusive worldwide rights to develop and commercialise AQ4N. BTG is also entitled to future milestone and royalty payments. In 2002, BTG licensed AQ4N to KuDOS, which in 2003 licensed North American rights to AQ4N to Novacea.

Schering-Plough and Bayer to co-market anti-cholesterol drug in Japan
German pharmaceutical company, Bayer, and US pharmaceutical firm, Schering-Plough, have received approval to co-market the latter firmís anti-cholesterol drug, Zetia (ezetimibe) in Japan. Bayer said in a statement that the Japanese Ministry of Health, Labour and Welfare had approved Zetia for launch in Japan. The drug will be co-marketed by Bayer Yakuhin and Schering-Plough's Japanese arm, the statement explained. The co-marketing agreement was part of an alliance announced by Bayer and Schering-Plough in 2004. The total number of patients in Japan suffering from high cholesterol is estimated to be around 30m.

Antisoma signs licensing deal with Novartis
Shares in UK-headquartered biotechnology company Antisoma rose 15 per cent after the cancer drug company revealed it had signed a licensing agreement with Swiss pharmaceutical company, Novartis, for late-stage tumour-shrinking treatment, AS1404. Antisoma will receive an upfront payment of USD 75m (GBP 37.5m) and a further USD 25m when the drug, AS1404, enters a phase III trial for lung cancer in Q1 2008.

China agrees to share bird flu samples
China has agreed to share human bird flu samples after the World Health Organisation said it was concerned that the countryís reluctance to send samples of the virus could slow global efforts develop a vaccine. China last released human samples of the H5N1 virus over to WHO laboratories in 2006, but since then five more cases have been reported, with the organisation repeating its request to receive new samples. WHO says that virus samples must be shared, as H5N1 mutates. The rate of mutation is linked to drug resistance and also possible transmission between humans. The sharing of viral samples is entirely voluntary and WHO has no power to force a country to cooperate. Indonesia and Thailand are among a number of countries protesting against drug companies using samples from developing countries to make expensive vaccines they cannot afford. China has already complained that the samples it sent to WHO laboratories in 2004 were used in research which failed to recognise the contribution of Chinese scientists. WHO has apologised for this and local media reported that a Ministry of Health official said it was about to share new samples. Another official, Wang Lin, a press officer at the Chinese Centre for Disease Control and Prevention, was quoted as saying the handover of samples was a long process because of the extreme caution with which dangerous viruses are handled.

NHS news

MPs say public role in NHS being undermined
At a Commons Health Committee meeting on 20 April, MPs have said that proper public consultation on the National Health Service will be undermined by "vague and woolly" legislation passing through parliament. The committee criticised government proposals to limit public consultation on healthcare changes to "significant" proposals and decisions. The proposed changes are part of the Local Government and Public Involvement in Health Bill, which is nearing the end of its passage through parliament. The committee added that the consultation on NHS changes, such as the closure of maternity wards, was already a sham in some cases, adding: "Elsewhere, NHS bodies have sought to evade their duty to consult entirely. The Department of Health needs to take a lead and make it clear that such behaviour will not be condoned.î MPs said the planned replacement of the country's 400 Patient Forums by 150 "Local Involvement Networks" (LINks) only four years after the volunteer-run health watchdogs were created was unnecessarily disruptive, and might push volunteers to leave. Uncertainty about the role of the new LINks would create "confusion and inactivity", the MPs added. The government said the forums, which themselves replaced the 30-year-old network of Community Health Councils, have too narrow a membership. But the Health Committee warned the forums should have been allowed to merge to form the new LINk bodies. The Conservative party have commented that the Labour government was wrong to abolish patient forums.

Health news

More links between HRT and cancer revealed
News in the last week has highlighted that hormone replacement therapy (HRT) to alleviate the symptoms of menopause should be used only if no other treatment options are available, as prolonged use has lead to the development of ovarian cancers. Investigators at the MD Anderson Cancer Center in the US have revealed that the gradual decline in national breast cancer diagnoses correlates with a steady drop in the use of HRT. A connection between HRT and cancer had been established in 2002, when a study the top-selling menopause drug of the time, Prempro (estrogen/ progestin) which is manufactured by Wyeth, showed that risks of both heart disease and breast cancer fell when patients stopped taking the drug. As a consequence, sales of Prempro fell considerably, as did a total decline in HRT product sales and a general fall in the female hormone market. The main feature of the drop in use was the concomitant fall in breast cancer rates. A report from the UK's Million Woman Study also revealed that HRT-caused ovarian cancers killed 1,000 British women between 1991 and 2005. When used, HRT drugs should be taken at the smallest possible dose for the shortest possible time, according to doctors.

Entrepreneur launches health website
Internet entrepreneur Steve Case launched a health website and hopes to attract consumers with free services, such as online medical records, doctor ratings and disease information. The co-founder of AOL and the architect of AOLís uneasy merger with Time Warner has christened the venture ìRevolution Healthî and invested USD 100m of his own money in the project. The website aims to reorganise a fragmented and bureaucratic healthcare system which Case said left patients and caregivers frustrated. A test site ran in January 2007 and drew more than one million visitors, according to Case. The site officially launched on 19 April and includes calculators for user to assess their chances of developing a heart attack, stroke or diabetes, as well as a symptom checker and an option to create a customised page of health topics. Most of Revolution Health's offerings are free of charge, but users also can pay for premium telephone services, such as answers to health questions and help settling insurance claims.

Medical education news

AstraZeneca clinical trial awareness
AstraZeneca (AZ) has entered into a partnership with the National Medical Association (NMA) and the Interamerican College of Physicians and Surgeons (ICPS) in an effort to raise awareness about the importance of ethnically diverse physician investigator participation in clinical trials. The programme will include educational and clinical trial investigator certification opportunities to encourage physicians from diverse backgrounds to become investigators. The partners said the programme is a key step toward getting more diverse patients enrolled in clinical trials, as these physicians are more likely to treat patients from minority backgrounds and will be able to educate them about trial participation and encourage them to enrol. NMA represents more than 30,000 African-American physicians, while ICPS has a membership of 39,000 Hispanic physicians in the US and Puerto Rico. AZ will provide "significant grants" to both groups over the next five years to fund the project.

Patent news

Generex granted patents in Canada and Mexico
Generex Biotechnology, which develops buccal drug delivery products for metabolic diseases, has expanded its patent portfolio with newly issued patents in Canada and Mexico issued by the Canadian Intellectual Property Office and the Mexican Institute of Intellectual Property, respectively. The Canadian patent titled "Pulmonary Drug Delivery" contains claims to an aerosol pharmaceutical formulation, metered dose dispenser, and use thereof. The patent discloses an improved delivery system for the administration of large molecule pharmaceuticals which can be administered by means of an aerosol into the mouth for buccal or pulmonary application. The Mexican patent titled "Micellar Pharmaceutical Compositions for Buccal and Pulmonary Application" is an extant US Patent held by the company containing claims to pharmaceutical compositions comprising a macromolecular pharmaceutical agent in mixed micellar form. The patent also discloses methods for making and using the pharmaceutical compositions. The Company currently holds an aggregate of 84 patents worldwide (20 of which are US Patents) and has an aggregate of 58 patent applications pending in various jurisdictions.

People news

AstraZeneca UK appoints new head of communications
AstraZeneca (AZ) has announced the appointment of Amie Malkin as Head of Communications for AZ UK. Malkin will be joining the pharmaceuticals company mid-June 2007 with accountability for internal and external communications. Currently, she is Managing Director and Chair of Burson-Marstellerís London Healthcare practice where she is responsible for clients such as GlaxoSmithKline, UCB, sanofi-aventis and Lundbeck. Malkin has worked for Burson-Marsteller for nearly twelve years and began her career with the company in their New York office, prior to relocating to San Francisco and London.

New CFO for ProStrakan
UK-based pharmaceutical company, ProStrakan, has hired Paul Garvey as its new CFO, replacing Adrian Gardner. Garvey was finance director at Scottish company, Axis Shield. In March 2007, ProStrakan obtained a GBP 50m debt facility when it revealed narrowing losses in its FY06 results.

25th April 2007


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