Pharma Marketletter articles from August 2008

Pharma Marketletter archives from August 2008

Pfizer recovers from patent expiry slump with strong international sales in 2nd qtr.(Financial report)
August 4, 2008... Global pharmaceutical giant Pfizer more than doubled its second-quarter 2008 profit, recovering from a poor first quarter (Marketletter April 28), due to an 18% rise in international sales, offsetting costs from loss of patents. Net income...

Wyeth profit down due to staffing cuts and generic competition for Protonix.(Financial report)
August 4, 2008... USA-based Wyeth Pharmaceuticals reported a 6.5% drop in net profit for the second quarter of 2008 compared to the same period in 2007, due to severance costs relating to ongoing staffing cuts. Net revenue was up to $5.95 billion, a 5%...

CHMP OKs Novartis' Aclasta for at-risk men.
August 4, 2008... Novartis' once-yearly Aclasta (zoledronic acid) 5mg has been recommended for European Union approval to treat osteoporosis in men who are at increased risk of fractures. Commonly regarded as a female disorder, an estimated one out of five men...

Bayer/J&J's Xarelto gets nod from CHMP.
August 4, 2008... The European Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the novel anticoagulant Xarelto (rivaroxaban) for the prevention of venous blood clots in patients undergoing elective hip...

BiovaxID improves 80-month DFS 60%.(Brief article)
August 4, 2008... USA-based Biovest International has reported strong data from a fast-tracked, randomized, controlled, pivotal Phase III trial of BiovaxID for indolent follicular non-Hodgkin's lymphoma, an often fatal blood cancer. In patients followed up...

Strong 52-week safety data for naproxcinod.
August 4, 2008... French drugmaker NicOx SA says that top-line results from a 52-week, open-label safety extension trial, following the completion of the 301 Phase III study for naproxcinod, revealed no unexpected safety findings. Efficacy was maintained for the...

B-MS' profit accelerates on good exchange rate.(Financial report)
August 4, 2008... US drug giant Bristol-Myers Squibb reported an 8% jump in profit in the second quarter of 2008, exceeding Wall Street expectations on a boost from the weak dollar. Net income for the company rose 20% to $706.0 million. GAAP earnings from...

Simplify drug taxes, French Senate tells govt.
August 4, 2008... The French Senate's health task force has published a report calling for a reform of the fiscal aspects of the country's drug sector. It describes the current system as lacking in transparency and clarity as well as damaging to the country by...

US report studies drug reimbursement options.(Brief article)
August 4, 2008... The New England Journal of Medicine has published a perspective piece looking at the health insurance coverage structure for biologic drugs. The report, titled, Tier 4 Drugs and the Fraying Social Compact, examines the approach taken by some...

California court examines Rx price cuts.(Brief article)
August 4, 2008... The California Courts are considering the effects of Medicaid fee reductions for pharmacists with the Ninth US Circuit Court of Appeals in San Francisco hearing arguments from pharmacists and California health officials about the potential...

ABPI joined by 16 new members in 1H 2008.
August 4, 2008... The Association of the British Pharmaceutical Industry has announced that, for the first half of 2008, 16 firms have joined its ranks. The new members include three pharmaceutical companies taking up full membership and 13 general affiliate...

GPhA presses for US biogeneric pathway.
August 4, 2008... The Generic Pharmaceutical Association (GPhA) has continued its campaign to get a workable pathway from the US Food and Drug Administration for follow-on biotechnology drugs, by arguing that "timely patient access to safe, affordable and...

AGI revises enrolment target on US Rezular Ph III trial.(AGI Therapeutics)(Brief article)
August 4, 2008... Dublin, Ireland-based AGI Therapeutics has met with the US Food and Drug Administration's Division of Gastroenterology Products to finalize a number of aspects of the ARDIS Phase III program for Rezular (arverapamil, AGI-003) in...

Cobra signs MOU to form JV with Viromed.(ViroMed Inc.)(Cobra Biomanufacturing PLC)(Brief article)
August 4, 2008... UK-listed Cobra Biomanufacturing has extended its manufacturing agreement and intends to form a joint venture with South Korea's ViroMed, a specialist in the development of DNA and protein-based therapeutics. The extended collaboration...

Exelixis initiates US Phase III registration trial of XL184.(Clinical report)
August 4, 2008... US drugmaker Exelixis has initiated a Phase III registration trial of XL184 as a potential treatment for medullary thyroid cancer. XL184 is a small-molecule cancer drug targeting the MET, RET, and vascular endothelial growth-factor 2 receptor...

Tabebuia extract can reduce triglyceride levels.
August 4, 2008... Scientists from Germany have recently discovered that extracts of a traditional herbal remedy, derived from Tabebuia impetiginosa, can delay the absorption of dietary fat in animal models. They believe that the extract could be incorporated...

Resveratrol could help prevent breast cancer.
August 4, 2008... Early laboratory research has shown that resveratrol, a common dietary supplement, suppresses the abnormal cell formation that leads to most types of breast cancer, suggesting a potential role for the agent in prevention. Published in the...

Greater LDL drop with "naturopathic" therapy.
August 4, 2008... Daily fish oil and red yeast rice supplements can help reduce low-density lipoprotein cholesterol, according to data published in the July issue of Mayo Clinic Proceedings. Researchers from Pennsylvania followed 74 patients with high blood...

Vitamin A can cut infant death risk in LDCs 15%.
August 4, 2008... A single, oral dose of vitamin A, given to infants shortly after birth in the developing world, can reduce their risk of death 15%, according to a study conducted by researchers at the USA's Johns Hopkins Bloomberg School of Public Health,...

Antisoma/Novartis to conduct second Ph III ASA404 trial this year.
August 4, 2008... London, UK-headquartered cancer drug developer Antisoma says its tumour-vascular disrupting agent, ASA404, will enter a second Phase III trial this year. The ATTRACT-2 trial, conducted by Antisoma's partner, Novartis, will be a randomized,...

Canadian Bio Med Systems gains license for Ocular Thera drugs.
August 4, 2008... Canadian Bio Med Systems has signed a preliminary agreement for the licensing rights to two new ophthalmic drugs from California, USA-based Ocular Therapeutics for the treatment of wet age related macular degeneration. The first is a...

BioSante gains new FDA SPA for Libigel.
August 4, 2008... US firm BioSante Pharmaceuticals has reached an additional agreement with the US Food and Drug Administration under the Special Protocol Assessment process for its LibiGel (transdermal testosterone gel) program in the treatment of female sexual...

Tibotec starts two Phase III trials for HIV drug candidate.
August 4, 2008... Tibotec Pharmaceuticals, a division of US health care giant Johnson & Johnson, has initiated two Phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor, in treatment-naive adults with...

Sanofi-Aventis in agreed bid to acquire UK vaccines maker Acambis for L276M.
August 4, 2008... Confirming the attraction of the vaccines sector to Big Pharma, French drug major Sanofi-Aventis - through its Sanofi Pasteur Holdings subsidiary, has entered into an agreement with UK biotechnology company Acambis, to acquire the firm in an...

Sanofi-Aventis buys Symbion of Australia.(Brief article)
August 4, 2008... France-based pharmaceutical major Sanofi-Aventis revealed that it has entered into a binding agreement with Primary Health Care Limited to acquire Symbion CP Holdings Pty Limited in Australia. Symbion Consumer manufactures, markets and...

Bayer/Onyx' Nexavar cleared for HCC in China.
August 4, 2008... Germany's Bayer HealthCare and the USA's Onyx Pharmaceuticals say that the State Food and Drug Administration of China has approved Nexavar (sorafenib) for unresectable or metastatic hepatocellular carcinoma. According to the firms, their drug...

EMEA proposes limiting use of Bayer's moxifloxacin.
August 4, 2008... Finalizing a review of the safety of Bayer's moxifloxacin for oral use, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that it should only be prescribed for acute bacterial...

Levitra benefits prostatectomy patients.(Clinical report)
August 4, 2008... A study published in the European Urology journal shows that Bayer's Levitra (vardenafil HCI) is highly effective in men with erectile dysfunction even shortly after radical nerve-sparing prostatectomy. This landmark study was a double-blind,...

CHMP expected to reject Santhera's FA drug.(Santhera Pharmaceuticals)(Committee for Medicinal Products for Human Use)(Brief article)
August 4, 2008... Santhera Pharmaceuticals, a Swiss specialty drugmaker focused on neuromuscular diseases, says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has informally advised that it would not...

Sinclair predicts sales up 30% in full-year i08.(Financial report)(Brief article)
August 4, 2008... Godalming, UK-based Sinclair Pharma has provided a pre-close period update ahead of its preliminary full-year results, which will be announced at the end of September. Revenues for the year ended June 30, 2008, are expected to be around...

Actelion recovers from poor first quarter.
August 4, 2008... Swiss biotechnology firm Actelion reported improved results for the first six months of 2008 on the recovery of its lead product, Tracleer (bosentan). The pulmonary arterial hypertension drug earned 12% more, like-for-like in the second quarter...

bioMerieux results up on expectations.(Financial report)
August 4, 2008... France-based in vitro diagnostics group bioMerieux has impressed Lehman Brothers' analysts by exceeding their expectations for the first six months of 2008. The firm posted an increase of 1.9% in first-half net sales compared to the like...

Genzyme's 2nd qtr profit hit by license cost.(Financial report)
August 4, 2008... US biotechnology major Genzyme's second-quarter 2008 GAAP net income fell to $69.6 million, or $0.25 per diluted share, from $83.8 million, or $0.31 per share, in the like period the year before, due to the $175.0 million it paid last month for...

Amylin's 2nd-qtr 2008 loss widens to $64.8M.(Financial report)
August 4, 2008... The USA's Amylin Pharmaceuticals says that second-quarter 2008 product sales totaled $200.3 million versus $167.3 million in the same period last year. Lead drug, diabetes injection Byetta (exenatide), earned $177.5 million vs $152.1 million,...

Biogen's 2nd-qtr 2008 revenue up 28%.(Financial report)
August 4, 2008... USA-based Biogen Idec's second-quarter 2008 revenues rose 28% year-on-year to $993.0 million, driven by sales of its multiple sclerosis drugs. Avonex (interferon beta-1a) revenues jumped 14% to $527.0 million, whle Tysabri (natalizumab),...

Forest's EPS falls to $0.79 in 2nd-qtr 2008.(Financial report)(Brief article)
August 4, 2008... US drugmaker Forest Laboratories says that fully-diluted earnings per share in the three months ended June 31, 2008, totaled $0.79 versus $0.83 in the like, year-ago period. During the reporting quarter, which represents the first quarter of...

Lilly's 2nd-qtr rise hides coming challenges.
August 4, 2008... US drug major Eli Lilly has reported solid financial results for the second quarter of 2008, but still decreased its financial guidance due to plant closure and staff lay-offs in preparation for the loss of patent for key drug, Zyprexa...

Germany's drug R&D regains ground.(Clinical report)
August 4, 2008... Germany's drug industry R&D has recovered some of the ground it lost over recent years in Europe. An analysis of the most recent data by the Handelsblatt business daily indicates that, in the three years since 2004, 3,900 clinical studies were...

Germany's drug spend up 9.8%, includes tax.
August 4, 2008... The annual drug report from Germany-based health fund Gmuender ErsatzKasse (GEK) reveals an increase of 9.8% in drug spending in 2007 over the previous year. The sharpest climb was in the area of prescribed daily-dose drug volumes, which saw...

Germany's VFA claims big life expectancy gain.
August 4, 2008... The life expectancy of German citizens will rise by six years in 2050, according to data published by the Federal Statistical Office, to 88 years for women and 84 for men. The German Association of Research-Based Pharmaceutical Companies (VFA)...

"Fall" in Austrian drug prices, says Pharmig.
August 4, 2008... The Austrian drug industry association, Pharmig, has disputed media reporting of an 8.3% rise in drug costs. Jan Oliver Huber, the group's general secretary, admitted that gains in life expectancy and new drugs push up spending. However, he...

Duska files Ph III ATPace protocol with FDA.(Clinical report)
August 4, 2008... California, USA-headquartered Duska Therapeutics has submitted for comment a synopsis of a proposed Phase III clinical study for its lead drug, ATPace (adenosine triphosphate) injection, to the Food and Drug Administration's Division of...

Dynavax in flu vaccine deal with Novartis.
August 4, 2008... US firm Dynavax Technologies has announced an agreement with Novartis Vaccines and Diagnostics, a US unit of the Swiss drug major, for the supply, development, and possible commercialization of the former's novel universal influenza vaccine....

Medarex gets milestone from Centocor.
August 4, 2008... Medarex says that it has received a milestone payment of an undisclosed amount from its licensing partner, fellow USA-based Centocor R&D, for the acceptance of an Investigational New Drug application to the Food and Drug Administration for an...

UK's MHRA clears Chelsea's droxidopa Ph II study.
August 4, 2008... US drug developer Chelsea Therapeutics International, has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase II trial of droxidopa, alone and in combination with carbidopa, for the...

AMA ups national fats awareness campaign.
August 4, 2008... Fewer than half of Americans know that the "better" fats (monounsaturated and polyunsaturated) can help reduce their risk of heart disease, according to a recent survey by the American Heart Association. "Heart disease remains the number...

IoM reports on supps use by US military.
August 4, 2008... The development of an information-sharing and educational forum comprised of military and non-military government and non-governmental organizations and industry is one of 12 recommendations the Institute of Medicine has made to the Department...

New data highlights potential new role for ARBs and statins in treatment of dementia.
August 4, 2008... A study published in the July 29 on-line issue of Neurology showed that statin users were half as likely as those who did not use them to develop dementia or cognitive impairment without dementia. Led by Mary Haan, epidemiology professor at...

Basilea's 2nd-qtr net loss widens 5.4%.(Financial report)
August 4, 2008... Basilea Pharmaceutica's second-quarter 2008 net loss widened 5.4% to 67.9 million Swiss francs ($66.6 million), or a loss of 7.11 francs per basic and diluted share. The biopharmaceutical firm, based in Basel, Switzerland, saw revenues increase...

Tysabri sales improve Elan's 2nd-qtr loss 49%.(Financial report)
August 4, 2008... Irish biotechnology firm Elan's second-quarter 2008 net loss narrowed 49% year-on-year to $71.5 million, boosted by higher sales of Tysabri (natalizumab). Co-developed with partner US drugmaker Biogen Idec (see page 6), the multiple sclerosis...

Restructing costs hit Biovitrum's first half.(Financial report)(Brief article)
August 4, 2008... Swedish drugmaker Biovitrum's net revenues in the first half of 2008 amounted to 287.9 million Swedish kronor ($48.2 million), a 28.7% decline on the comparable period last year. Profit before restructuring costs fell 60.8% to 23.4 million...

NicOx' 1st-half net loss widens to 33.1M euros.(Financial report)
August 4, 2008... NicOx' revenues for the first half of 2008 were 2.2 million euros ($3.5 million), an 80.3% decline on the like period last year, due to less payments received from the French drug developer's partners, Merck & Co and Pfizer. Operating...

GSK's abacavir gets HSR warning from US FDA.
August 4, 2008... US regulators have warned health care professionals that serious and sometimes fatal hypersensitivity reactions caused by GlaxoSmithKline's abacavir are significantly more common in patients with a particular human leukocyte antigen allele,...

Celgene pulls satraplatin MAA; weakening GPC.
August 4, 2008... The European Marketing Authorization Application for satraplatin is to be withdrawn. US drugmaker Celgene will not seek approval for the oral platinum-based cancer drug in combination with prednisone for hormone-refractory prostate cancer where...

US FDA rejects Eisai's fospropofol.(Food and Drug Administration)
August 4, 2008... Japanese drugmaker Eisai has received a "not approvable" letter from the US Food and Drug Administration, delaying the potential approval of fospropofol disodium for use by appropriately trained physicians. The injection has been under review...

Vanda's shares halve on US iloperidone setback.
August 4, 2008... Shares in Vanda Pharmaceuticals lost half their value after US regulators rejected its schizophrenia drug iloperidone. The Food and Drug Administration issued a "not approvable" letter for the atypical antipsychotic, expressing concern about...

Lonza profit up 83% on sale of stake in Polynt.(Financial report)(Brief article)
August 4, 2008... Switzerland-based custom peptide manufacturer Lonza has posted strong financial results for the first half of 2008, due to the sale of the firm's stake in Polynt SpA. Revenue was 1.46 billion Swiss francs ($1.43 billion), up 6.5% from the...

Retail drug sales in year to May 2008.
August 4, 2008... Retail pharmacy drug sales in 13 major markets during the 12 months to May 2008 have reached $431.8 billion, reports IMS Health's Retail Drug Monitor. Since the April report (Marketletter July 28), the UK and Italy have held a small lead over...

CombinatoRx presents update on pipeline.
August 4, 2008... USA-based firm CombinatoRx provided an update on several key drug development programs in its annual R&D day presentations at its headquarters in Cambridge, Massachusetts. During the presentation, the firm presented new data suggesting...

Gilead recruits for Ph III elvitegravir HIV trial.
August 4, 2008... California, USA-based Gilead Sciences has started the enrollment of patients in a Phase III clinical trial of elvitegravir, an investigational oral integrase inhibitor that is being evaluated for the treatment of HIV-1 infection. The...

Introgen reports more Advexin data at AACR.(Brief article)
August 4, 2008... The USA's Introgen Therapeutics, a developer of targeted molecular therapies for cancer, has reported additional efficacy data from recent regulatory filings seeking approval of Advexin (contusugene ladenovec). These findings resulted from...

Genentech convenes c'tee to assess Roche offer.
August 4, 2008... US biotechnology giant Genentech says that it has formed a special committee of its board of directors, composed of the company's three independent directors, to assess the proposal from Roche to acquire all of the outstanding shares of the...

Indian biotech firm Biocon ranked among world's top 10.
August 4, 2008... A recent report released by Med Ad News ranked Biocon (Bangalore, Karnataka), India's pioneer in the biotechnology sector, among the world's top 25 biotechnology companies. The report, which listed drug-based firms by revenue and by income,...

Homeopathy prescriptions plummet in the UK.
August 4, 2008... General Practitioner prescriptions for homeopathy in the UK have almost halved in two years, figures obtained by the UK GP journal Pulse reveal. The number for homeopathic preparations dropped from 83,000 in 2005 to 49,300 in 2007, statistics...

Strong Ph III data for Titan's opioid addiction implant.(Clinical report)
August 4, 2008... The USA's Titan Pharmaceuticals has reported positive, statistically-significant results from a Phase III trial of Probuphine, a subcutaneous implant designed to deliver six months of buprenorphine, a compound which is currently marketed as a...

Sucampo enrolls first patient in Ph II cobiprostone trial.(Clinical report)
August 4, 2008... The USA's Sucampo Pharmaceuticals has enrolled the first patient in a single-center Phase II trial evaluating cobiprostone for portal hypertension in patients with liver cirrhosis. The double-blinded, randomized, placebo-controlled study...

Kinaxo gets $914K grant for proteomics development.
August 4, 2008... Germany's Kinaxo Biotechnologies GmbH has been awarded a 575,000-euro ($914,075) grant by the Bavarian Ministry of Economic Affairs, Infrastructure, Transport and Technology to help expand the applications for its chemical proteomics platform,...

JPMA think-tank views China's appeal.
August 4, 2008... Japan's Office of Pharmaceutical Industry Research, the think-tank of the Japan Pharmaceutical Manufacturers Association, pointed out that China has become more attractive in terms of global R&D sites compared to Japan, in its recent report....

Australian drugmakers ethics code.
August 4, 2008... The pharmaceutical industry trade body Medicines Australia has published its Code of Conduct Annual Report, which documents all determinations made by the independent Code of Conduct Committee during 2007-08. The report includes the...

Australia considers more pediatric medicines.
August 4, 2008... In response to the Australian federal Ministry of Health announcement that it is considering methods of providing more drugs on the Pharmaceutical Benefits Scheme especially formulated for children, a spokesman for the trade group Medicines...

IFPMA sees "big picture" cost of failed WTO talks.
August 4, 2008... The International Federation of Pharmaceutical Manufacturers and Associations considers the breakdown of the Doha Development Round at the World Trade Organization's negotiations in July as bad news for the long-term access to medicines for...

Mid-stage data show unprecedented effectiveness for tau-targeting AD drug.(Conference news)
August 4, 2008... Mid-stage data presented this week has shown unprecedented effectiveness for an Alzheimer's disease drug candidate. Findings reported at the International Conference on Alzheimer's Disease, held in Chicago, USA, show that a novel drug called...

Wyeth/Elan shares drop on discouraging side effect profile of AD drug in mid-stage study.
August 4, 2008... Brain-swelling side effects have tarnished investor confidence in Alzheimer's disease drug candidate bapineuzumab. Shares in US drug major Wyeth fell over 10% to $40.50 in after-hours trading on July 29, after detailed Phase II study results...

Merck Serono to grow Japanese business.
August 4, 2008... Merck Serono, a division of Germany's Merck KGaA, says it will expand its Japanese business following the launch of Erbitux (cetuximab) before the end of 2008. The drug was approved by the Japanese Ministry of Health, Labor and Welfare...

Sanofi plans to appeal German Plavix copies.
August 4, 2008... French drug major Sanofi-Aventis says that a German administrative court has allowed two firms to continue marketing generic versions of its anticoagulant Plavix (clopidogrel), despite Sanofi claiming German marketing authorizations for the...

Teva targets Japanese market, says CEO.(Industry overview)
August 4, 2008... The world's biggest generic drugmaker, Israel's Teva Pharmaceutical Industries is eager to increase its Japanese market share, Shlomo Yanai, the firm's chief executive, told the UK Financial Times. Mr Yanai told the FT that, "right now,...

Rx cuts to balance France's budget.(Brief article)
August 4, 2008... The French government has announced new measures to cut the health budget deficit to below 3.0 billion euros ($4.72 billion). The main measure will see a sales tax of at least 3% applied to the complementary health funds from January 2009. The...

Italian university pharma ties renewed.
August 4, 2008... Italy's pharmaceutical industry association, Farmindustria, has renewed its convention with the Conference of the Italian University Chancellors (CRUI), which was originally signed in 2006, on graduate training programs in the drug sector. The...

UK Viagra smuggler targeted USA.
August 4, 2008... A Surrey, UK-based pharmacist has been fined L3,000 ($5,974) and faces the confiscation of L200,000 after being sentenced under the 1968 Medicines Act and the 2002 Proceeds of Crime Act over a major medicines smuggling scheme. Hitendra Patel...

25% "confused" by OTC drug status in Italy.
August 4, 2008... In first-quarter 2008, 92 million non-prescription drug packages, with a turnover of 588.0 million euros ($925.0 million), were sold in Italy, nearly 75% of which were over-the-counter. However, 25% of Italians are "still confused" about...

ImClone R&D offsets Erbitux sales in 2nd qtr.(Financial report)
August 4, 2008... USA-based ImClone Systems' net income dropped 21% in the second quarter of 2008 due to escalating costs as it tries to expand its product portfolio. The firm posted an 11% increase in revenue for the period ending June 30, 2008, versus the...

Amgen earnings down but outlook still up.
August 4, 2008... US biotechnology major Amgen has raised its full-year financial outlook, despite an 8% drop in earnings in the second quarter as, excluding restructuring and other charges, it beat Wall Street expectations. Net income for the three months...

Revised monograph for levothyroxine to be issued in USA.
August 4, 2008... The US Pharmacopeial Convention is in the process of revising its monograph for levothyroxine sodium, a commonly-prescribed synthetic thyroid hormone branded as Synthroid in the USA and Eltroxin in Asia, Europe and Oceania. The revised...

Barr confirms Sensipar patent challenge.
August 4, 2008... US generics group Barr Pharmaceuticals, which is the subject of an agreed $7.46 billion takeover offer from Israel's Teva Pharmaceutical Industries (Marketletter July 28), has confirmed that its subsidiary, Barr Laboratories, has initiated a...