Pharma Marketletter articles from October 2007

Pharma Marketletter archives from October 2007

SkyePharma's 6-month loss reduced 11%.
October 1, 2007... A reduction in loss and progress made in the development of the asthma drug Flutiform (combined formoterol and fluticasone) were key to the positive market response received by UK drugmaker SkyePharma's half-year report. The firm's deficit for...

OncoMethylome's 1st half loss climbs 55%.(OncoMethylome Sciences revenue report)(Financial report)(Brief article)
October 1, 2007... Belgium's OncoMethylome Sciences, a molecular diagnostics company, says that, for the six months ended June 30, 2007, it recorded a net loss of 5.1 million euros ($7.2 million), a 54.5% increase on the deficit it saw in the first half of 2006....

ReGen's 1st half loss up 50% on R&D costs.(ReGen Therapeutics revenue report)(research and development)(Financial report)(Brief article)
October 1, 2007... UK-based biotechnology firm ReGen Therapeutics says that, for the six months to June 30, 2007, its loss after tax increased 50% to 1.5 million ($3.0 million). The company said that the results, which are the first announced under international...

PhRMA welcomes timely PDUFA renewal.
October 1, 2007... The Pharmaceutical Research and Manufacturers of America (PhRMA) president Billy Tauzin has welcomed the US Congress' passage of the Prescription Drug User Fee Act re-authorization legislation (Marketletters passim). "In passing the...

90% cure rate for MRSA cSSSI with J&J's ceftobiprole.
October 1, 2007... US health care major Johnson & Johnson's investigational antibiotic ceftobiprole was as effective as commonly-used combination therapy in treating patients with complicated skin infections caused by a broad spectrum of bacteria, according to...

Large data set supports safety of Mycamine in at risk patients.(Clinical report)
October 1, 2007... New data from a pooled analysis of 17 clinical studies demonstrate that Mycamine (micafungin sodium) for injection offers a favorable clinical safety profile in hospitalized patients of all ages with serious, underlying diseases with...

J&J's doripenem fares well vs NP and VAP.
October 1, 2007... US health care major Johnson & Johnson's investigational antibiotic doripenem was found to clinically cure 81% of patients with nosocomial pneumonia, and 68% of people with ventilator-associated pneumonia, according to new data presented at the...

Lilly Japan moves into GP market with Cialis.
October 1, 2007... In the wake of launching its erectile dysfunction drug Cialis (tadalafil) in Japan, US pharmaceutical major Eli Lily will enter the general practitioners' market for the first time, Newton Crenshow, president of Eli Lilly Japan, said at a press...

Intellect and CHDI to evaluate Oxigon for Huntington's disease.
October 1, 2007... Intellect Neurosciences, a New York, USA-based biopharmaceutical company focused on the development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and related disorders, and CHDI, a non-profit...

Tibotec files etravirine NDA with FDA.(Tibotec Pharmaceuticals)(Food and Drug Administration)(new drug application)(Brief article)
October 1, 2007... Ireland-headquartered Tibotec Pharmaceuticals says that its New Drug Application for TMC125 (etravirine), an investigational non-nucleoside reverse transcriptase inhibitor, has been accepted for priority review by the US Food and Drug...

Synova completes $3.3M notes sale.(Synova Healthcare Group)(Synova Healthcare Group)(Brief article)
October 1, 2007... Pennsylvania, USA-based Synova Healthcare Group has completed the sale of approximately $3.3 million in aggregate notional principal amount of its 6.5% senior convertible promissory notes, series B, due September 19, 2012, and related common...

FDA approves Campath as single agent for B-CLL.
October 1, 2007... Bayer Schering Pharma, the pharmaceutical arm of Germany's Bayer AG, and US biotechnology major Genzyme say that the Food and Drug Administration has approved a supplemental Biologics License Application for the anticancer agent Campath...

Lack of HbA1c testing increasing risk to diabetes sufferers.
October 1, 2007... According to the results of a survey of health care professionals, presented at this year's European Association for the Study of Diabetes in Amsterdam, the Netherlands, sub-optimal use of HbA1c testing is increasing the risk of long-term...

CHMP recommends Viracept reinstatement.
October 1, 2007... Swiss drugmaker Roche says that the European Medicines Agency's (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that marketing authorization for the HIV drug Viracept (nelfinavir) is re-instated. The committee said that it...

Health pros' personal dietary supp use study.
October 1, 2007... The USA-based Council for Responsible Nutrition has announced research to be published in November that addresses what it terms "a major knowledge gap in the $21.4 billion diet supplement industry." The campaign, titled "Life...supplemented" is...

FDA to phase out CFCs in metered-dose inhalers for epinephrine.
October 1, 2007... The US Food and Drug Administration has proposed a change to its regulation on the use of chlorofluorocarbons, or CFCs, in metered-dose inhalers (MDIs) for epinephrine. The rule would remove the "essential-use" designation that allows the use...

Pfizer backs diabetes research award program.
October 1, 2007... Global drug giant Pfizer and the European Foundation for the Study of Diabetes announced t at the European Association for the Study of Diabetes Annual Meeting, held in Amsterdam, the Netherlands, the development of a new awards program which...

Strong data for Prezista HIV regimen.(Clinical report)
October 1, 2007... Irish drugmaker Tibotec says that results from a new ongoing, randomized, controlled, open-label Phase III study showed that 84% of treatment-naive HIV-1 infected adults taking an investigational dose of Prezista (darunavir) 800mg (two 400 mg...

Strong Ph III data for telavancin in cSSSI.(complicated skin and skin structure infections)(Brief article)
October 1, 2007... Japanese-owned Astellas Pharma US and Theravance have reported strong results on their co-developed investigational compound telavancin from the largest subset of surgical-site-associated complicated skin and skin structure infections (cSSSIs)...

Merck & Co's Cancidas comparable to AmBisome in IFI.
October 1, 2007... US drug major Merck & Co's Cancidas (caspofungin acetate) demonstrated a safety and efficacy profile generally similar to Gilead Sciences' antifungal agent AmBisome (liposomal amphotericin B for injection) in a clinical study involving its...

Isentress plus OBT sustains HIV suppression.
October 1, 2007... USA-based Merck & Co says that data from an ongoing Phase II study showed that antiretroviral suppression was sustained after 48 weeks of treatment with its investigational integrase inhibitor Isentress (raltegravir), in combination with...

Internet pharmacy "made $126M" in illegal sales.
October 1, 2007... The US Department of Justice reports that a Florida pharmacy owner and a Kentucky physician have accepted a plea bargain over charges of operating an illegal on-line distribution network for prescription drugs. The Internal Revenue Service's...

$5M settlement over "improper" OxyContin marketing.
October 1, 2007... The Attorney General of the US state of Pennsylvania has announced a $5.1 million settlement with drugmaker Purdue Frederick over alleged improper marketing of the prescription painkiller OxyContin (oxycondone HCl). The deal forms part of a...

BIO honors pro-biotech Arizona Governor.
October 1, 2007... The Biotechnology Industry Organization has awarded Arizona Governor Janet Napolitano (Democrat) with its Governor of the Year award in recognition of "her passionate support of the biosciences," the group said. Jim Greenwood, president of...

B-MS in agreed deal to buy Adnexus for $430M.
October 1, 2007... US drug major Bristol-Myers Squibb says it has signed a definitive agreement to acquire privately-held Adnexus Therapeutics, developer of a new therapeutic class of biologics called Adnectins. The purchase will help advance B-MS' biologics...

Differential Rx drug pricing model queried.
October 1, 2007... A report in the scientific journal Nature has questioned the issue of one mechanism adopted by the pharmaceutical industry to balance access to drugs in developing countries with the maximization of profit in richer markets. Differential...

WHO event to consider drug R&D joint ventures in developing countries.
October 1, 2007... The Inter-Governmental Working Group of the World Health Organization has issued its provisional agenda for a session on a draft global strategy and plan of action on public health, innovation and intellectual property. The report, to be...

China's fake Viagra "would give overdose".
October 1, 2007... An undercover report by the UK's Sunday Times newspaper has revealed that a Chinese factory is allegedly producing counterfeit Viagra (sildenafil citrate) tablets with three times the permitted dose. A spokeswoman for global drug giant Pfizer,...

Merck drops HIV vacc candidate as it fails to demonstrate efficacy in DSBM review.
October 1, 2007... US drug major Merck & Co says it has discontinued development of its investigational HIV vaccine candidate V520, after it failed to demonstrate therapeutic efficacy. The decision follows an independent Data Safety Monitoring review of interim...

Pfizer's Celsentri gets European Commission approval for patients infected with HIV-1 CCR5-tropic virus.
October 1, 2007... US drug giant Pfizer says that the European Commission has approved its drug Celsentri (maraviroc) for treatment experienced HIV patients. Specifically, the drug has been cleared for use, in combination with other antivirals, by patients with...

PhRMA welcomes US Congress' timely PDUFA renewal, FDA budget crisis avoided.
October 1, 2007... The president of the Pharmaceutical Research and Manufacturers of America (PhRMA), Billy Tauzin, has welcomed the US Congress' passage of the Prescription Drug User Fee Act re-authorization legislation (Marketletters passim). "In passing the...

Novartis gets positive CHMP opinion for Eucreas; presents new data at EASD.
October 1, 2007... Swiss drugs major Novartis is expecting approval from the European Commission before the end of the year to market Eucreas, its fixed-dose oral combination of the DPP-4 inhibitor Galvus (vildagliptin) and the current gold-standard treatment for...

CHMP backs Bayer Schering's Nexavar.(Committee for Medicinal Products for Human Use)(Bayer Schering Pharma)(Brief article)
October 1, 2007... Berlin, Germany-based Bayer Schering Pharma, part of the Bayer group, has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for the use of its drug Nexavar (sorafenib) in the treatment of...

Celera to acquire Atria Genetics in $33M deal to enter HLA market.
October 1, 2007... Maryland, USA-based Celera, an Applera Corp business, and South San Francisco-headquartered Atria Genetics, a privately-held company, have signed a definitive agreement whereby the former will acquire substantially all of the assets of Atria...

Celgene invests $40M in Array BioPharma in deal that could bring the latter $500M.
October 1, 2007... US companies Array BioPharma and Celgene Corp have announced a worldwide strategic collaboration focused on the discovery, development and commercialization of novel therapeutics in cancer and inflammation. The move comes just two weeks after...

Bavarian Nordic strengthens commerical organization, updates on pipeline.
October 1, 2007... Denmark-headquartered Bavarian Nordic says it will establish a new separate sales and marketing functions in order to strengthen the company's commercial activities and increase the promotion for its third-generation smallpox vaccine, Imvamune...

WHO stresses the need to ensure the safety of children's medicines.
October 1, 2007... The lack of thorough and reliable clinical data on the way medicines affect children requires strengthened safety monitoring and vigilance of medicinal products, is the fundamental message of Promoting Safety of Medicines for Children, released...

Toricel gets CHMP nod as first-line RCC drug.
October 1, 2007... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for US drugmaker Wyeth's anticancer agent Torisel (temsirolimus) as a first-line therapy for renal...

Nordisk's NovoRapid gains EC clearance.
October 1, 2007... Danish insulin giant Novo Nordisk says that the European Commission has approved its rapid-acting insulin product NovoRapid (insulin aspart) for the treatment of elderly diabetics. The EC also cleared the product as a therapy for diabetic...

Lilly files Alimta with EMEA for NSCLC.
October 1, 2007... US drug major Eli Lilly & Co has submitted its anticancer agent Alimta (pemetrexed for injection) to the European Medicines Agency (EMEA), seeking approval for its use in the treatment of advanced cases of non-small cell lung cancer....

Biomax Informatics acquires data-mining business, eudaptics.(Brief article)
October 1, 2007... Aiming to enhance and broaden its technology and solution portfolio, Germany's Biomax Informatics AG has acquired the operative business of the Austrian data mining specialist eudaptics software gmbh. This extends the Biomax offering with...

ACT completes Mytogen acquisition.(Advanced Cell Technology)(Brief article)
October 1, 2007... Advanced Cell Technology says that it has completed the acquisition of all of the outstanding capital stock of Mytogen. In May 2007, the company announced that it had entered into a letter of intent to acquire Mytogen and its Myoblast Program...

Prana completes Ph IIa enrollment of PBT2 in AD.(Clinical report)
October 1, 2007... Melbourne, Australia-based Prana Biotechnology says it has completed patient enrollment in its Phase IIa clinical trial of PBT2 in patients with early Alzheimer's disease. This is a double-blind, placebo-controlled study exploring the...

JapanBridge and Kyowa Hakko in oncology cooperation.
October 1, 2007... Tokyo-based JapanBridge, a specialty pharmaceutical company founded in 2006 by MPM Capital and Itochu Corp, has entered into a strategic alliance with Japanese drugmaker Kyowa Hakko Kogyo to collaborate on the commercialization of oncology and...

LEEM response to new French health resources.
October 1, 2007... Expected new resources for the French sickness insurance program will necessitate an improved sense of responsibility in their proper utilization on the part of all stakeholders, France's pharmaceutical industry association (LEEM) has declared....

US flu pandemic database launched.
October 1, 2007... Public health planners in the USA have a new tool to help them prepare for an influenza pandemic. PandemicPractices.org, launched by the Center for Infectious Disease Research & Policy at the University of Minnesota and the Pew Center on the...

German generics firms and pharmacies clash.
October 1, 2007... The German generics sector organization Pro Generika reports that the combined effect of legislation which was designed to ensure cost-effective drug prescribing and distribution, as well as to increase competition in the public-sector health...

Integrity Pact against fake drugs launched by trio of EU trade groups.
October 1, 2007... The European Association of Pharmaceutical Full-line Wholesalers (GIRP) has announced the creation, with the European Generic Medicines Association (EGA) and the Pharmaceutical Group of the European Union, of the Integrity Pact, officially...

EMEA clears GSK's Cervarix vaccine.
October 1, 2007... The European Medicines Agency (EMEA) has granted UK drug major GlaxoSmithKline marketing approval for its cervical cancer vaccine Cervarix. The product, which utilizes the company's AS04 adjuvant system, is indicated for the prevention of...

Exelon gets EC OK for Alzheimer's disease.
October 1, 2007... Swiss drug major Novartis says that its Alzhiemer's disease product Exelon (rivastigmine transdermal patch) has been approved by the European Commission. The drug has been cleared for the treatment of patients suffering from mild-to-moderate...

CHMP recommends S-P's HCV drug regimen.
October 1, 2007... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding US drug major Schering Plough's combination hepatitis C virus therapy. Specifically, the CHMP recommended...

Researchers buy out Pfizer Japan laboratory.
October 1, 2007... Global pharmaceutical giant Pfizer's Nagoya Research Laboratories in Japan, which will formally close at the end of March 2008, will be survived as a new independent organization operated by about 80 researchers working in the unit, Hiromitsu...

India's Wockhardt to contract manufacture.
October 1, 2007... Indian drugmaker Wockhardt is to expand into the contract manufacturing sector from the next fiscal year. The company's chairman, Habil Khorakiwala, said the move would allow optimum use of manufacturing capacity. Wockhardt's European...

AstraZeneca buys Verus asthma program.
October 1, 2007... Verus Pharmaceuticals, a San Diego, USA-based pediatric-oriented specialty pharmaceutical company, says that Anglo-Swedish drug major AstraZeneca has acquired its pediatric asthma development programs. Included in the transaction, it notes,...

Speculation on UK drug major execs.
October 1, 2007... With UK pharmaceutical majors GlaxoSmithKline and AstraZeneca both looking to replace senior executives, the press has started to speculate about outcomes, and the involvement of outsiders. GSK has previously made clear that it is expecting...

Japan's generic drug market grows 14%.
October 1, 2007... Sales of the 39 member companies at the Japan Generic Pharmaceutical Manufacturers Association have increased 13.8% to 390.8 billion yen ($3.40 billion) in fiscal 2006 compared to a year ago, due to the growing use of generic drugs, according...

Japan's Chuikyo begins NHI price system debate.
October 1, 2007... A fully-fledged discussion on the reform of Japan's National Health Insurance drug pricing system has opened at the Expert Subcommittee on NHI drug pricing within the Central Social Insurance Medical Council (Chuikyo). Responses made at the...

More compulsory drug licenses for Thailand.
October 1, 2007... The military-supported government of Thailand has announced that up to four more drugs will be subject to compulsory licensing, according to local reports. Reuters' Bangkok correspondent stated that, four oncology drugs will be affected, which...

US SBA rule change welcomed by BIO.
October 1, 2007... The US Biotechnology Industry Organization has expressed its strong support for the Small Business Investment Expansion Act (HR 3567) which has been cleared by the House of Representatives' Committee on Small Business. Jim Greenwood, the...

First pediatric HIV/AIDS center in West Africa under construction.
October 1, 2007... Construction has begun on the first pediatric HIV/AIDS medical center in West Africa. Located in Burkina Faso, one of the world's most resource constrained countries, the center will provide treatment and support to HIV-positive children and...

2007 Pharmaceutical R&D Factbook from CMR now available.
October 1, 2007... The Center for Medicines Research International (CMR), a Thomson business, has published the CMR 2007 International Pharmaceutical R&D Factbook, a reference and business planning tool for decision makers in pharmaceutical R&D, corporate...

Patent expiries will reduce bipolar drug market $400M.
October 1, 2007... The use of the antipsychotics AstraZeneca's Seroquel (quetiapine) XR and Solvay/Lundbeck/Wyeth's bifeprunox will help offset a decrease in the overall bipolar disorder drug market over the next decade, says a new report from Decision Resources,...

Headlines 25 years ago this week....
October 1, 2007... The French government is looking at the possibility of reducing the prices of top-selling drugs between 5% and 20%, in line with its previously-announced intention of saving some $72.0 million on its annual pharmaceuticals bill. Roche's...

GATC to develop sepsis-inducing pathogen test.
October 1, 2007... Germany's GATC Biotech, a specialist DNA sequencing services provider, has entered into a collaboration that aims to develop a DNA-microarray based diagnostic test capable of detecting sepsis-triggering pathogens. The company's partners in the...

Zebrafish-screening technology presented at drug safety conf.
October 1, 2007... UK-based biotechnology company Summit says that pharmacology data generated by its zebrafish technology platform can be used to assess the safety of potential drug candidates. Example results, which were presented at the 7th annual meeting of...

FDA accepts Nitec's Lodotra IND.
October 1, 2007... Switzerland-based Nitec Pharma AG says that the US Food and Drug Administration has accepted an Investigational New Drug application that seeks approval for the initiation of clinical trials of Lodotra, a developmental circadian cytokine...

CHMP gives Merck Serono's Cyanokit thumbs up.
October 1, 2007... Merck Serono, a division of German drug and chemical firm Merck KGaA, says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding its Cyanokit (hydroxocobalamin)...

Velcura meets with FDA to discuss development plans.
October 1, 2007... Michigan, USA-based biotechnology company Velcura Therapeutics says it has met with the Food and Drug Administration to clarify details for the early clinical development of VEL0230, a candidate bone disease treatment. The pre-Investigational...

EU Directive could put cancer management back 30 years, ECCO hears.
October 1, 2007... A lack of joined up thinking between European politicians and the medical profession has led to the formulation of policies that could radically threaten cancer management and research throughout Europe, cancer leaders warned at the European...

US HHS issues report on personalized health care.
October 1, 2007... A study by the US Department of Health and Human Services has been touted as its first department-wide report on the goal of personalized health care. Michael Leavitt, the HHS Secretary, said the publication, titled: Personalized Health Care:...

New survey finds strong American public interest in prescription drug safety issues.
October 1, 2007... The American University's Center for Congressional and Presidential Studies announced the results from a national survey assessing public views on safety of prescription medicines, the Food and Drug Administration, and overall satisfaction with...

Acambis' six month loss down 16% as R&D costs fall; awaits warmbase deal.
October 1, 2007... UK vaccines developer Acambis loss for the six-month period ended June 30 was L19.3 million ($38.9 million), down 15.7% from the deficit it recorded in the comparable period last year. The firm said that the improvement was due to lower...

Alcon's Retaane gets FDA approvable letter.
October 1, 2007... Swiss eye care specialist Alcon has received an approvable letter from the US Food and Drug Administration regarding its wet age-related macular degeneration drug Retaane (anecortave acetate depot suspension). The agency said that an additional...

Neurontin ruling overturned by US court.
October 1, 2007... The US Court of Appeals has overturned a 2005 ruling, which granted a summary judgement that several generic drugmakers had not infringed upon a patent covering US drug giant Pfizer's epilepsy treatment Neurontin (gabapentin). The appeals court...

Lymphoma drug gets EU Orphan Status.
October 1, 2007... USA-based oncology firm Pharmion and Canada's MethylGene say that their co-developed Hodgkin's lymphoma drug candidate, MGCD0103, has been designated as an Orphan Medicinal Product by the European Medicines Agency (EMEA). Preliminary data...

Mixed news for PI-88 in cancer trials.
October 1, 2007... Australian drugmaker Progen Pharmaceuticals says that its developmental anticancer agent PI-88 failed to meet it primary efficacy goal in a trial examining it as a treatment for non-small cell lung cancer. The firm explained that the drug, in...

UPDATE: China's fake Rx drug factories exposed, imitation Viagra "would give overdose".
October 1, 2007... An undercover report by the UK's Sunday Times newspaper has revealed that a Chinese factory is allegedly producing counterfeit Viagra (sildenafil citrate) tablets with three times the permitted dose. Undercover reporters posing as...

UPDATE: Bristol-Myers Squibb looks to oncology come-back with $430M bid for Adnexus.
October 1, 2007... Bristol-Myers Squibb, the US drug major that once dominated the oncology market with products such as Taxol (paclitaxel) is making a come-back bid with an agreed takeover of US biotechnology firm Adnexus Therapeutics, developer of a new class...

Europe leads surge in Pharma M&A deal values.
October 1, 2007... A surge in mergers and acquisitions deal values in the global pharmaceutical and health care sectors in 2006 has continued into the first half of 2007, says a new report from PricewaterhouseCoopers Corporate Finance. Deal values in the...

Europeans more interested in medical/ health research than economic/social news.
October 1, 2007... People in the European Union are more interested in the results of medical and health research than in international, economic and social news, according to a new Eurobarometer report. A survey conducted for the European Commission by...

Targeted therapies promise new hope for brain cancer patients; Datamonitor.
October 1, 2007... Despite the many millions of dollars being invested into brain cancer research, primary brain cancer remains one of the most deadly diseases in the developed world. While primary brain tumors are relatively rare, the chances of survival...

Japan stock market week to September 24, 2007.
October 1, 2007... Tokyo continued advancing in the week ended September 24 (four trading days only because the last was a national holiday in Japan). The Nikkei 225 rose 1.1%, to close at the 16,300 level, while the Topix index edged up 0.5%. The Nikkei recorded...

Ablynx gets 1.9M-euro award for nanobodies research.(Institute for the Promotion of Innovation by Science and Technology)(Brief article)
October 1, 2007... Ghent, Belgium-based Ablynx the biopharmaceutical company focused on the discovery and development of nanobodies, has been awarded a grant worth nearly 1.9 million euros ($2.6 million) by the Institute for the Promotion of Innovation by Science...

Savient to sell up to $200M stock.
October 1, 2007... Savient Pharmaceuticals has filed a universal shelf registration statement with the US Securities and Exchange Commission that, if declared effective by the SEC, will allow the firm to sell, from time to time, up to $200.0 million of its common...