Pharma Marketletter articles from June 2008

Pharma Marketletter archives from June 2008

Roche to lift stake in Chugai to 59.9%.
June 2, 2008... Chugai Pharmaceutical says that it has decided to accept Switzerland-based Roche's offer to raise its stake in the Japanese drugmaker to 59.9%, from its current holding of 50.1%, saying this would allow it to raise profitability and corporate...

GSK shareholders protest at AGM.
June 2, 2008... Shareholders of the UK's leading drugmaker, GlaxoSmithKline, protested on two fronts at the firm's annual general meeting, which also saw Jean-Pierre Garnier pass the chief executive's baton to Andrew Witty. Around 20% of GSK stockholders,...

German biotech buy: start of a new tend?
June 2, 2008... The acquisition of Munich-based biotechnology company U3 Pharma AG by Japan's Daiichi-Sankyo (Marketletter May 26) is being seen by some pharmaceutical sector observers as a significant move both for small-scale German biotechnology firms and...

Vietnam to resist drug price hike calls.
June 2, 2008... The Drug Administration of Vietnam has decided not to accede to requests from representatives of international pharmaceutical and import companies to increase drug prices until June 30 to stabilize medicine costs, according Truong Quoc Cuong,...

Vietnam pharma ind viability possible.
June 2, 2008... The Vietnamese pharmaceutical industry could experience a new era of development if national strengths are used more effectively to boost its auxiliary sectors, according to Deputy Prime Minister Nguyen Thien Nhan. He said that, as a country...

Tanzania FDA plan.
June 2, 2008... The Tanzania Food and Drugs Authority will inaugurate a new laboratory to analyze the chemical composition of medicines coming into the country, with a view to enhancing the safety of drugs and other medical products that the country imports,...

IFPMA launches pediatric CT database.
June 2, 2008... The International Federation of Pharmaceutical Manufacturers and Associations has added a special pediatric trials search facility to its well-established clinical trials portal (Marketletters passim), to help people locate information about...

New fake drug definition could hit generics.
June 2, 2008... The government of India does not consider there is a need for a new, broad definition of counterfeit medicines, according to a report by Livemint.com, which is owned by the Wall Street Journal. The proposal by the International Medical Products...

PhRMA defends DTC advertising.
June 2, 2008... The Pharmaceutical Research and Manufacturers of America (PhRMA) has issued a robust defense of direct-to-consumer advertising, following a US congressional hearing into alleged malpractices in the promotion of some drugs. The American Medical...

Aflibercept: strong Ph II data in ovarian cancer.(Clinical report)
June 2, 2008... French drug major Sanofi-Aventis and the USA's Regeneron Pharmacuticals have reported encouraging results from a trial of single-agent aflibercept in advanced ovarian cancer patients, a population for whom few therapeutic options are available....

Elocalcitol yields strong Ph IIb BPH findings.
June 2, 2008... BioXell SpA says that Phase IIb trial data on elocalcitol in benign prostatic hyperplasia presented at the American Urological Association annual meeting, held in Orlando, Florida, show that the agent is effective in improving maximum urinary...

Greater lung exposure for inhaler than IV.(Brief article)
June 2, 2008... At the American Thoracic Society annual meeting, held in Toroton, Canada, Amikacin Inhale, currently being studied for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients, achieved over 1,000...

Multaq reduces severe CV complications 24%.
June 2, 2008... Data presented at the Heart Rhythm Society's 29th annual sessions, held in San Francisco, USA, show that French drug major Sanofi-Aventis' anti-arrhythmic Multaq (dronedarone) met the primary endpoint, significantly decreasing the risk of...

Canadian Health Food Association presses for Bill C-51 amendments.
June 2, 2008... The Canadian Health Food Association has launched a postcard lobby campaign to build on the group's recent advocacy efforts aimed at addressing members' concerns about a piece of legislation proposed in April by the federal government of Prime...

MRA for Canada and EU on NHPs.(Natural Health Products)(Good Manufacturing Practice)(Brief article)
June 2, 2008... Health Canada is pursuing a mutual recognition agreement with the European Union with both sides willing to consider Good Manufacturing Practice requirements of the EU as being equivalent to the GMP requirements outlined in the 2004 Canadian...

Illegal California pharmacy faces charges.
June 2, 2008... A grand jury in Philadelphia, USA, has indicted the alleged operator of an illegal pharmacy for the distribution of prescription drugs via the Internet. The defendant, Jorge Alan Rodriguez Sanchez, has been charged with conspiracy to distribute...

California Senate urged to protect patient data.
June 2, 2008... The California Senate has provisionally rejected a bill sponsored by a drug marketing firm after privacy concerns were raised. The bill, SB 1096, which has a second chance to pass the Senate and is due to be voted on again before the end of...

US clinical trial patient matching service launched.
June 2, 2008... Two pioneers of customer-driven on-line health care have teamed up in an effort to address the long-standing problem in the USA of patient recruitment in cancer drug clinical trials (Marketletter July 31, 2006). Revolution Health and...

Court approves Shire scheme of arrangement.(Shire Pharmaceuticals Group PLC)(Brief article)
June 2, 2008... UK drugmaker Shire plc says that the High Court approved the scheme of arrangement between the company and its ordinary shareholders at a hearing on May 22. The scheme, which became effective on May 23, results in the UK-listed, Jersey...

NeoPharm in deal with SIRO for Ph III cintredekin besudotox study.
June 2, 2008... Illinois, USA-based NeoPharm has signed a letter of intent with SIRO ClinPharm USA for the latter to oversee a planned confirmatory Phase III trial for its drug product candidate Cintredekin Besudotox (IL13-PE38QQR; "IL-13"), for the treatment...

Amarin completes first tranche of $60M placement.(appointments)(Brief article)
June 2, 2008... Amarin Corp says that it has closed the $30.0 million first tranche of its previously announced $60.0 million private placement. The net proceeds, after deducting the placement agents' fees and estimated offering expenses, will be around $27.0...

Allergan gets Canadian right to Sanctura.
June 2, 2008... Indevus Pharmaceuticals has signed a license agreement with the Canadian affiliate of USA-based Allergan, granting the firm the right to market Sanctura XR (trospium chloride extended release preparation) throughout Canada. Indevus jointly...

Good results for Novartis' Exforge.(Clinical report)
June 2, 2008... Swiss drug giant Novartis presented positive results of a study on Exforge (amlodipine and valsartan) for the treatment of high blood pressure in black patients, at the 23rd annual scientific meeting and exposition of the American Society of...

Orphan status for Alimentary's Pediatric UC treatment.
June 2, 2008... Cork, Ireland-based biotechnology company Alimentary Health says that the US Food and Drug Administration has granted orphan status to its bifidobacterium infantis 35624 for the treatment of pediatric ulcerative colitis. The drug has...

Ergonex' Terguride granted Orphan Status for PAH.
June 2, 2008... Swiss pharmaceutical company Ergonex' Terguride (transdihydrolisuride) has been granted orphan drug status by the US Food and Drug Administration. The agent is an anti-serotoniergic and a potent antagonist against the 5-HT2B and 5-HT2A...

New JPMA chief blames Japan's NHI drug pricing system for sector decline.
June 2, 2008... In his first press conference since being appointed president of the Japan Pharmaceutical Manufacturers Association, the research-based drugmakers' organization in Japan, Takashi Shoda stressed the need for a National Health Insurance drug...

Foreign generics firms on offensive in Japan.
June 2, 2008... With the Japanese government actively encouraging the prescribing of lower cost generic medicines (Marketletters passim), foreign drugmakers are expanding their operations in this country, where the copy sector is expected to grow rapidly. ...

Latest RNAi mega-deal sees Takeda team up with Alnylam for up to $1.0 billion.
June 2, 2008... Alnylam Pharmaceuticals has entered a deal with Japan's largest drugmaker, Takeda, that could see the US RNA interference specialist earn over $1.0 billion. The strategic platform alliance, which will focus on oncology and metabolic...

US joint initiative by FDA and CMS to improve medical product safety.
June 2, 2008... US Health and Human Services Secretary Mike Leavitt has announced efforts underway at the Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the...

Restrictions on Pfizer's Chantix as reports of neuropsych AEs prompt fresh concerns.
June 2, 2008... New safety concerns on Pfizer's Chantix (varenicline) could slow the sales expansion of the smoking-cessation drug and land the world drug giant into legal difficulties, observers suggest. Chantix is facing greater scrutiny after a US...

S-P to initiate Ph III boceprevir program.
June 2, 2008... US drug major Schering-Plough has announced plans to initiate two large-scale Phase III studies of its investigational oral hepatitis C protease inhibitor boceprevir in chronically-infected genotype-1 HCV. One trial will be in...

Strong long-term CD data on Humira.(Clinical report)
June 2, 2008... New data show that adult moderate-to-severe Crohn's disease patients treated with Abbott Laboratories' Humira (adalimumab) achieved long-term clinical remission and clinical response. Results from the two open-label extension studies, CHARM and...

61st World Health Assembly fails to achieve most anti-pharma activist goals.
June 2, 2008... The 61st World Health Assembly in Geneva, Switzerland, has approved watered down versions of policies requested by opponents of the research-based pharmaceutical industry model. The much vaunted public health, innovation and intellectual...

ProStrakan's early-2008 sales exceed projections.(Brief article)
June 2, 2008... Scottish drugmaker ProStrakan says that trading in the first four months of 2008 has been at the upper end of management expectations, with total product revenues increasing 38% over the like period in 2007, with the stronger euro accounting...

BioAlliance's 1st qtr boosted by Loramyc.
June 2, 2008... BioAlliance Pharma SA saw a marked rise in first-quarter 2008 revenues thanks to the launch of its first marketed product, the antifungal Loramyc (miconazole). The French drugmaker's sales during the period totaled 3.8 million euros ($5.9...

Vectura fiscal 2007 revenues jump 80%.(revenue report)(Financial report)(Brief article)
June 2, 2008... Vectura says that, for the 12 months ended March 31, 2008, it became cash generative for the first year in its history. The UK-based inhaled drug specialist saw net cash inflow of L3.6 million ($7.0 million) versus net cash burn of L6.3 million...

Speedel earned $2.4M in 1st-qtr 2008.
June 2, 2008... Swiss biotechnology firm Speedel earned a total of 2.6 million Swiss francs ($2.4 million) in the first quarter of 2008, which compares well with the 2.2 million francs estimate that management had previously forecast ahead of the release of...

Approval for Novartis' generic Betaferon in EU.
June 2, 2008... Swiss drug major Novartis has received approval from the European Commission for Extavia (interferon beta-1b), its generic version of Bayer Schering's Betaferon, for the treatment of early and relapsing forms of multiple sclerosis. The...

JapanBridge to market Sancuso in SE Asia.
June 2, 2008... Galashiels, Scotland-based specialty pharmaceutical company ProStrakan has granted the Tokyo-based firm JapanBridge an exclusive license to develop and market the Sancuso patch (transdermal granisetron) in specified Southeast Asian countries....

Almirall reports Ph II data for COPD drug.(Clinical report)
June 2, 2008... Spanish drugmaker Almirall reported strong results for its aclidinium bromide in Phase II studies on patients suffering from chronic obstructive pulmonary disease at the 2008 international conference of the American Thoracic Society held in...

DOR withdraws EMEA application for orBec.(DOR BIOPHARMA UK Ltd)(European Marketing Authorization Application)(Brief article)
June 2, 2008... The UK subsidiary of US biopharmaceutical firm DOR BioPharma has had to withdraw its European Marketing Authorization Application for orBec (beclomethasone dipropionate). In the official notice letter, the firm advised the European...

42% of US pharma settlements with FTC involved payments to generics firms.
June 2, 2008... The US Federal Trade Commission's Bureau of Competition has issued a summary of agreements filed with the agency in fiscal year 2007 (ending September 30, 2007) by both generic and branded manufacturers of pharmaceutical products. The US...

Research overturns medical theory on blood vessel growth; drug discovery implications.
June 2, 2008... New research conducted by a group of European Union-funded researchers is shedding new light on the way blood vessels grow, overturning many years of medical thought. The findings have important implications for the development of novel drugs...

Japan stock market week to May 26, 2008.
June 2, 2008... Tokyo retreated in the week to May 26. The Nikkei 225 declined 4.1%, to close below the 14,000 mark, while the Topix index was off 4.3%. The market opened the review week lower due to profit-taking by some investors in stocks which performed...

Somaxon secures $65M financing.
June 2, 2008... Somaxon Pharmaceuticals, a US specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, has entered into...

CuraGen to sell $12M worth of TopoTarget shares.
June 2, 2008... USA-based CuraGen has completed a series of privately-negotiated transactions in which the company sold the five million shares of Danish firm TopoTarget common stock issued to the company as partial payment for the sale of its ownership in...

China Sky One cleared for AMEX.
June 2, 2008... China Sky One Medical, a manufacturer, marketer and distributor of pharmaceutical, medicinal and diagnostic products in China, says that its common shares have been approved for listing on the American Stock Exchange. The company expects to...

Bracco-Eisai's Iomeron products cleared for more uses.(Brief article)
June 2, 2008... Bracco-Eisai, a Tokyo-based associate of Japanese drugmaker Eisai, says that its non-ionic contrast agents, Iomeron 350 and Iomeron (350 syringe (iomeprol) have received additional approval for usage in dynamic computed tomography of the liver...

EFPIA opposes EU plan to raise sales tax on pharmaceutical products.
June 2, 2008... The European Federation of Pharmaceutical Industries and Associations has published its strong opposition to "any recommendation aimed at deleting pharmaceutical products from the list of categories of goods and services eligible for a reduced...

Wyeth's bazedoxifene receives third "appro" letter, as Relistor misses Ph III endpoint.
June 2, 2008... US drug major Wyeth's osteoporosis drug candidate bazedoxifene received a third "approavable" letter in the same week that a second drug candidate, Relistor (methylnaltrexone bromide) injection, missed its primary endpoint in a late-stage...

Dementia patients on antipsychotics face three times greater risk serious events.
June 2, 2008... Dementia patients on antipsychotics face three times greater risk of hospitalization/death Dementia patients living in the community more than tripled their risk of a serious event leading to death or hospitalization within a month of...

Lundbeck buys drug rights for up to $350M.
June 2, 2008... Danish drugmaker Lundbeck has acquired European commercialization rights to USA-based Myriad Genetics' Flurizan (tarenflurbil), a drug candidate which might have the potential to delay disability in patients suffering from Alzheimer's disease,...

Bayer seeks Polish acquisitions.
June 2, 2008... The Berlin-headquartered Bayer-Schering drugs business of Bayer is looking to acquire operations in the biogenerics sector in Poland, Burghard Bruch, the firm's representative for central and eastern Europe, has said. He expects the Polish...

Emergent BioSol gets PSC assets for $78M.
June 2, 2008... Emergent BioSolutions and fellow USA-based Protein Sciences Corp have entered into an asset purchase agreement under which the former will acquire PSC's ongoing operations, including FluBlok (trivalent recombinant hemagglutinin vaccine) and...

Astellas' fiscal 2007 sales increase 5.6%.(Astellas Pharma Inc.)(Financial report)(Brief article)
June 2, 2008... In the 12 months ended March 31, 2008, Japanese drug major Astellas' consolidated net sales rose 5.6% year-on-year to 972.59 billion yen ($9.43 billion) thanks to the strong performance of its immunosupressant Prograf (tacrolimus) and Vesicare...

Eisai's fiscal 2007 hit by MGI Pharma buy.
June 2, 2008... Japanese drugmaker Eisai's sales reached a record high of 734.3 billion yen ($7.19 billion) in the 12 months ended March 31, 2008, a 9% year-on-year increase, thanks to the strong performance of its mainstay products: Aricept (donepezil) for...

Taisho's sales jump 4.7% in fiscal 2007.(Financial report)
June 2, 2008... Taisho's fiscal 2007 sales rose 4.7% on the previous year to 96.98 billion yen ($950.4 million) thanks to strong turnover of both its prescription and self-medication range, and lower selling, general and administrative expenses. During...

Shionogi's Crestor boosts fiscal 2007.
June 2, 2008... In the 12 months ended March 31, 2008, sales of the cholesterol-lowerer Crestor (rosuvastatin) drove Shionogi's strong performance. The Japanese drugmaker's sales grew 2.1% year-on-year to 155.1 billion yen ($1.52 billion), while royalty income...

Studies find genetic susceptibility to COPD.
June 2, 2008... Studies by Anglo-Swedish drug major AstraZeneca and the Swedish Karolinska Institutet has discovered that genetic factors may be of almost as great a contribution to the development of chronic obstructive pulmonary disease as the environment....

Asthma uncontrolled in 40% of US patients.(Survey)
June 2, 2008... A US study by UK-based drug major GlaxoSmithKline shows that over 40% of American adults with asthma do not have sufficient control over the symptoms of the disease, it was reported at the international conference of the American Thorasic...

New survey reinforces link between asthma and hay fever.
June 2, 2008... The latest Ipsos MORI Asthma UK survey, this year part funded by Merck Sharp & Dohme, the local subsidiary of US drug major Merck & Co, found that over two thirds (67%) of the 1,235 respondents diagnosed with asthma also suffered from symptoms...

Japan contributes a further $560M to Global Fund.(The Global Fund to Fight AIDS, Tuberculosis and Malaria)(Brief article)
June 2, 2008... Japan's Prime Minister, Yasuo Fukuda, has announced a new contribution worth $560.0 million for the coming years from 2009 onwards to the Global Fund to Fight AIDS, Tuberculosis and Malaria. This pushes Japan's total offering to the Global Fund...

Bayer Vital settles law suit.(German Bundeskartellamt)(Brief article)
June 2, 2008... The German Bundeskartellamt (BKartA) has ended its law suit against Bayer Vital GmbH, a unit of German drug major Bayer, and imposed a fine. The BKartA believes that it has evidence to show that employees of the company influenced the retail...

FDA OKs Osmoteca's venlafaxine ER.
June 2, 2008... US drugmaker Osmotica Pharmaceutical has received notice of final approval of its New Drug Application for its venlafaxine HCl extended-release 37.5mg, 75mg, 150mg and 225mg tablets from the Food and Drug Administration for major depressive...

BioMS reports progress on MS drug.
June 2, 2008... Canada's BioMS Medical, a developer in the treatment of multiple sclerosis, says that the independent Data Safety Monitoring Board for its Phase II MINDSET-01 trial of MBP8298 (dirucotide) in patients with relapsing-remitting MS has completed a...

AMAG and 3SBio link on ferumoxytol for China.
June 2, 2008... The USA's AMAG Pharmaceuticals and 3SBio Inc, a Chinese biotechnology company, have signed a development and commercialization agreement for ferumoxytol, an intravenous iron replacement therapeutic agent being developed to treat iron deficiency...

Akorn-Strides' rifampin cleared by FDA.(Food and Drug Administration)(Brief article)
June 2, 2008... Akorn-Strides has announced the approval of an Abbreviated New Drug Application for rifampin for injection USP, 600mg/vial. This is the first lyophilized Injectable product approval for the Joint Venture. The company is a joint venture that...

Santaris begins trials on the world's first microRNA treatment.
June 2, 2008... Danish biopharmaceutical company Santaris Pharma has commenced a Phase I study on the world's first microRNA targeted medicine, for the treatment of hepatitis C. The placebo-controlled, double-blind, randomized, single dose,...

GVK partners with Wyeth.
June 2, 2008... US drug major Wyeth Pharmaceuticals has entered into a research agreement with Indian drug discovery firm GVK Biosciences. Under the terms of the deal, GVK will identify potential drug candidates for Wyeth to advance to clinical studies....

Bavarian Nordic begins early trials on HIV vaccine.
June 2, 2008... Danish biopharmaceutical firm Bavarian Nordic has initiated a Phase I/II trial of its MVA-BN(R) HIV mutiantigen candidate. The study on the safety and immunogenicity of the agent in 15 HIV-infected patients has begun enrollment in the USA....

NicOx completes enrollment for final trial of naproxcinod.
June 2, 2008... French drug developer NicOx has completed patient enrollment for the final late-stage trial on its osteoarthritis of the hip treatment, naproxcinod, before its New Drug Application can be filed. The trial, known as 303, is a 13-week,...

Positive results for Allergy Thera once-a-year hay fever drug.(Brief article)
June 2, 2008... UK-based company Allergy Therapeutics has announced positive results for a trial of its Pollinex Quattro, a once-a-year course of injections to treat allergic rhinitis. The treatment is administered in four weekly injections, after which...

UK's NICE issues updated guidance on CVD, diabetes and other treatment issues.
June 2, 2008... UK health authority the National Institute for Health and Clinical Excellence (NICE) has issued new guidance for the National Health Services in England and Wales on how to manage people at risk from cardiovascular disease, including the...

ABPI collaborates with NHS PCT on COPD care.
June 2, 2008... A pilot project which aims to enhance the treatment of National Health Service patients in Nottingham, UK, with chronic obstructive pulmonary disease has been announced by the Association of the British Pharmaceutical Industry and the...

922M-euro R&D spend by Spanish pharma.
June 2, 2008... Spain's pharmaceutical industry invested 922.0 million euros ($1.45 billion) on R&D in 2007, according to an annual study by the country's drug industry representative group, Farmaindustria. The figure was 15.1% compared with the previous year...

EU researchers find potential new link between AD and amyloid plaques.
June 2, 2008... A team of European Union researchers has found a molecular link between Alzheimer's disease and the development of amyloid plaques, one of the defining hallmarks of the disease. Partly funded by the EU's Marie Curie program, the findings were...

COMP recommends OD status for five new drugs.
June 2, 2008... At a meeting in May, the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) adopted five positive opinions recommending the following medicines for designation as orphan medicinal products to the European...

Stock Commentary - New York week to May 26, 2008.
June 2, 2008... NEW YORK: equities, having just reclaimed the important 13,000 level on May 19, moved sharply lower for nearly all of the holiday-shortened week to May 26, leaving the Dow Jones with a 4.2% decline. Blamed for the lack of investor confidence,...

Stock Commentary - Europe - week to May 26, 2008.
June 2, 2008... EUROPEAN: bourses, after a strong showing the previous week, went into retreat in the reporting period to May 26, as worries about supply versus demand pushed oil prices ever higher. All the major markets were down substantially. With most of...

Kenya's secret services hunt for drug counterfeiters.
June 2, 2008... Kenya's National Security and Intelligence Services have been assigned to a crack down on counterfeit drug imports to the country, according to a report by the Agence France Presse. Anyang Nyongo, Kenya's Medical Services Minister, told the AFP...

NanoViricides views options for EKC drug.
June 2, 2008... US firm NanoViricides says that it has signed or has in attorney-review non-disclosure agreements with major pharmaceutical companies to enable further discussions regarding its nanoviricide drug candidate against epidemic kerato-conjunctivitis...

China Pharma Holdings raises $10M.
June 2, 2008... Hainan-based China Pharma Holdings, which develops, manufactures, and markets generic and branded bio-pharmaceutical products in China, has entered into a securities purchase agreement and a registration rights accord with institutional and...

Santarus developing new Zegerid formulation.
June 2, 2008... San Diego, USA-based Santarus, a specialtydrug company, says that it is developing a new tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. The new formulation is a tablet that combines...

Barr confirms Entocort patent challenge.
June 2, 2008... US generics firm Barr Laboratories has initiated a challenge of the patents listed by Anglo-Swedish drug major AstraZeneca in connection with its Entocort (budesonide) enteric coated capsules, 3mg. The US company believes that it is the first...