Pharma Marketletter articles from July 2008

Pharma Marketletter archives from July 2008

CHMP gives go ahead to Tibotec's novel NNRTI.
July 7, 2008... Tibotec Pharmaceuticals says that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending conditional approval of its HIV drug Intelence (etravirine) in the European...

Cymbalta gets nod for GAD in European.(Committee for Medicinal Products for Human)(European Medicines Agency)(Brief article)
July 7, 2008... The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of German drug major Boehringer Ingelheim's Cymbalta (duloxetine HCl) for generalized...

CHMP gives nod to Krka's generic Sifrol.
July 7, 2008... The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of Krka's Oprymea (pramipexole) for the treatment of the signs and symptoms of idiopathic Parkinson's disease alone or...

EMEA recommends new warnings on epoetins.
July 7, 2008... The European Medicines Agency (EMEA) has recommended updating the product information for epoetin-containing medicines, with a new warning for their use in cancer patients stating that blood transfusion should be the preferred method of...

ProStrakan's Abstral gets nod from CHMP.(Committee for Medicinal Products for Human)(Brief article)
July 7, 2008... Scottish drugmaker ProStrakan says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Abstral (formerly branded as Rapinyl), the...

Expanded indication for Actelion's PAH drug.
July 7, 2008... The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended an expanded label for Swiss biotechnology firm Actelion's lead product, Tracleer (bosentan). The hypertension drug has been given...

Vimpat gets nod for epilepsy from CHMP.
July 7, 2008... Belgian UCB's Vimpat (lacosamide) has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The firm predicts that the epilepsy drug could generate peak annual...

Arcoxia to get CV European label warnings.
July 7, 2008... Finalizing a review of the benefits and risks of US drug major Merck & Co's Arcoxia (etoricoxib), the European Medicines Agency (EMEA) has concluded that it can be used to treat rheumatoid arthritis and ankylosing spondylitis, but recommended...

Biogenerics could save US $6.6B over 10 years.
July 7, 2008... The USA's Congressional Budget Office released a long-awaited cost analysis, which found that the creation of an abbreviated pathway for follow-on biologics - or biogenerics - would save the federal government $6.6 billion over 10 years and...

Generics now 63% of USA's MPD market.
July 7, 2008... A study that looks at key statistical outcomes of the USA's Medicare Part D (MPD) prescription drug program has found an increase in the uptake of generic drugs. After conducting a comprehensive comparative analysis of 2007 MPD prescription...

Bonuses to top FDA staffers slammed.
July 7, 2008... The release of information by the US House Committee on Energy and Commerce relating to compensation practices at the Food and Drug Administration reveals that the agency disbursed around $35.0 million in staff incentives during 2007. ...

Biopark signs up for France's LEEM.
July 7, 2008... The French drug industry association (LEEM) has welcomed Genopole, its 10th associate member, with a statement of intention to assemble "businesses which exercise an activity in the life sciences domain and which also contribute to the research...

Novartis and TB Alliance sign five-year deal.
July 7, 2008... The Novartis Institute for Tropical Diseases in Singapore and the Global Alliance for TB Drug Development have announced a five-year partnership to develop new drugs for the treatment of tuberculosis. The goal is to produce faster-acting...

US House considers on-line pharmacy regs.
July 7, 2008... The US House of Representatives' Judiciary Subcommittee on Crime, Terrorism and Homeland Security has examined proposals to restrict the sale of pharmaceuticals via the Internet. Although similar legislation cleared the Senate earlier this...

RFID concern for hospital equipment.
July 7, 2008... In a blow to the adoption of radio-frequency identification (RFID) as a security enhancement for the protection of drugs and medical devices, research carried out in the Netherlands has found that RFID tags can interfere with hospital equipment...

Isconova gets 30M SwKr growth financing.
July 7, 2008... Sweden-based vaccine adjuvant provider Isconova AB, says that it has secured financing of 30.0 million Swedish kronor ($4.9 million) from InnovationsKapital, a leading Nordic venture capital firm, and a group of private investors. Isconova is a...

Exelixis/GSK conclude six-year accord.
July 7, 2008... UK pharmaceutical major GlaxoSmithKline and US biotechnology firm Exelixis say they will bring their six-year collaboration to a successful conclusion on October 27, as scheduled. Under the terms of the collaboration, GSK has the right to...

S-P/Merck & Co pull loratadine/montelukast combo NDA.
July 7, 2008... US drug majors Schering-Plough and and Merck & Co have withdrawn their New Drug Application for the loratadine/montelukast combination tablet which had been intended for the treatment of allergies. The companies also terminated their...

Barr prevails in Boeh Ing patent challenge on Mirapex.
July 7, 2008... The US District Court for Delaware has ruled in favor of US generics major Barr Laboratories in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, in connection with the German drugmaker's Mirapex (pramipexole...

EC research funding for SMEs.
July 7, 2008... On June 23, the Council of Ministers agreed to provide 100.0 million ($154.8 million) from the European Union's Seventh Framework Program (FP7) budget to Eurostars, a R&D program jointly set up by 31 countries to boost research capacities of...

Bristol-Myers Squibb closes tender offer for Kosan.
July 7, 2008... US drug major Bristol-Myers Squibb says that stockholders of Kosan Biosciences, for which it made a $190.0 million takeover bid last month (Marketletter June 9, have tendered around 41,449,606 shares, including 1,682,151subject to guaranteed...

US experts urge expanding flu vacc season.
July 7, 2008... Health care professionals should increase influenza immunization rates by implementing key, practice-proven interventions and offering vaccine at every opportunity throughout the entire influenza season, conclude leading influenza experts in a...

Pinnacle Bio in stock purchase deal with MedImmune.
July 7, 2008... Pinnacle Biologics, a private, full-service US pharmaceutical and biotechnology solutions company, has entered into a preferred stock purchase transaction with MedImmune, which was acquired by Anglo-Swedish drug major AstraZeneca last summer...

Potential heart health role for cranberry juice.
July 7, 2008... New data presented at Experimental Biology suggest that a double serving of light cranberry juice cocktail can potentially increase artery dilation and blood flow immediately after consumption. Researchers from Tufts University and Boston...

Resveratrol mimics diet caloric restriction.
July 7, 2008... New data published in the June 3 edition of the Public Library of Science One suggests that low doses of resveratrol in the diet of middle-aged mice has a widespread influence on the genetic levers of aging and may confer special protection on...

Beta-carotene could boost skin UV resistance.
July 7, 2008... A paper sponsored by Dutch firm DSM Nutritional Products and published in a recent issue of Photochemistry and Photobiology analyzed data from seven clinical trials and found a possible link between the consumption of beta-carotene and skin...

Antioxidants could reduce chemo efficacy.
July 7, 2008... A new study published in the Journal of the National Cancer Institute has thrown into question the health benefits of taking antioxidants as an adjunct to chemotherapy. A team of US researchers reviewed findings from several trials and found...

Generic drugs accounted for 18.7% of Japan's Rx market in 2007, says MHLW.
July 7, 2008... Japan's generic drug market share increased from 16.8% on a volume basis and 5.9% by value of total prescription medicine sales, as at September 2005 to 18.7% and 6.4%, respectively, as of September 2007, according to the National Health...

Pakistan Pharma calls for drug price hikes.
July 7, 2008... The Pakistani government should allow drug producers to make upward revision in the prices of their products ranging from 15% to 20% to sustain the sector's existence, according to Pakistan Pharmaceutical Manufacturers Association chairman...

UK patients get mixed news on clinical trials, drug firms blame the NICE.
July 7, 2008... UK patients have been given mixed news about their future access to experimental drugs as part of clinical trials. Gordon Brown, the Prime Minister, has announced a package of measures designed to boost R&D investment and the faster uptake of...

NHS Constitution for faster UK drug access?(National Health Service)(Brief article)
July 7, 2008... The UK government has announced the drafting of a constitution to assert rights for patients under the 60-year-old National Health Service. According to the Secretary of State for Health, Alan Johnson, the core statement of intent is to...

Strong Ph III data for Merck & Co telcagepant.
July 7, 2008... US drug major Merck & Co says that, in a Phase III trial, telcagepant (formerly MK-0974) significantly improved relief of migraine pain and migraine-associated symptoms two hours after dosing compared to placebo, according to new data presented...

Vanda's insomnia drug improves LPS, Ph III trial.(Clinical report)
July 7, 2008... The USA's Vanda Pharmaceuticals has reported positive top-line results from a Phase III trial showing that its investigational drug candidate, tasimelteon (VEC-162), a novel melatonin agonist, met the primary endpoint and significantly improved...

Xarelto could set new gold standard in VTE.
July 7, 2008... The investigational anticoagulant Xarelto (rivaroxaban) was significantly more effective than enoxaparin at reducing the composite endpoint of symptomatic venous thromboembolism and all-cause mortality at day 12 of treatment after major...

Xeloda better than colon cancer gold-standard.
July 7, 2008... A pre-planned multivariate analysis of the five-year follow-up data from the X-ACT study shows that patients receiving chemotherapy after-surgery to treat colon cancer are more likely to live longer when taking Swiss drug major Roche's...

GW's 1st-half turnover climbs 85.9% to L5.7M.
July 7, 2008... UK drug developer GW Pharmaceuticals says that first-half 2008 turnover reached L5.7 million ($11.2 million) versus L800,000 in the comparable period the year before, reflecting income from its alliance with Japan's Otsuka and sales of Sativex,...

Gentium's 1st-qtr 2008 net loss widens 27%.(Financial report)(Brief article)
July 7, 2008... Italian drug developer Gentium SpA says that, in the first quarter of 2008, total revenues reached 2.7 million euros ($4.1 million), compared with 1.2 million euros in the like, year-ago period. Despite this, net loss amounted to 6.1 million...

Hovione's FY sales jump 11% to $103.7M.(Financial report)(Brief article)
July 7, 2008... Sales for Portugal's Hovione in the fiscal year ended March 31, 2008, amounted to $103.7 million, an 11% rise over the previous year, and the first time annual turnover rose above the $100.0 million level. The active pharmaceutical...

Sangui's nine-month sales reach $345K.(Sangui BioTech)(Financial report)(Brief article)
July 7, 2008... Germany's Sangui BioTech says that, in the first nine months ended March 31, 2007, it generated revenues of $345,000 versus $95,000 in the comparable period the year before, while operating expenses rose to $600,000 from $356,000 due to efforts...

Pharma becoming more aggressive outsourcing buyer.
July 7, 2008... The latest industry Perspective research paper from USA-headquartered EquaTerra depicts the pharmaceutical industry as reaching a critical inflection point - either change operating models or face long-term decline. In response, EquaTerra, a...

The truth about drug innovation; new report from Tufts.
July 7, 2008... A new report from the USA's Tufts Center for the Study of Drug Development, examines case histories for 35 important pharmaceutical innovations. Skeptics of the private industry assert that the development of new medicines is most attributable...

Canada DTC ban on trial over free speech.
July 7, 2008... A Canadian court case with potentially momentous consequences for the marketing of drugs in Canada is underway in Ontario. The plaintiff, Canwest MediaWorks, has brought the law suit against Health Canada, over the restrictions on...

Thailand "competitive" on pharmaceutical R&D.(Brief article)
July 7, 2008... The chief executive of Thailand's Pharmaceutical Research and Manufacturing Association (PReMA), Kitima Yuthavong, has described her country's prospects for drug R&D as quite competitive, according to an interview with the locally-published...

A record year for US pharma lobbyng in 2007, with spend reaching $168 million.
July 7, 2008... In the USA, Washington DC's largest lobby, the pharmaceutical industry, "racked up another banner year on Capitol Hill in 2007, backed by a record $168.0 million lobbying effort," according to a Center for Public Integrity analysis of federal...

Teva/Antisense see positive Ph IIa results for their MS drug.(Clinical report)
July 7, 2008... Israel's Teva Pharmaceutical Industries and Australian firm Antisense Therapeutics say that ATL/TV1102, their novel, anti-sense drug, significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis. A randomized,...

Abbott comments on NICE obesity drug guidance.
July 7, 2008... USA-headquartered health care major Abbott Laboratories has commented on the UK National Institute of Health and Clinical Excellence's (NICE) guidance on anti-obesity prescribing (Marketletter June 30), noting that it reinforces its own product...

New compound management deal for Galapagos.
July 7, 2008... Mechelen, Belgium-based Galapagos NV says that its service division BioFocus DPI will provide compound management and related services to Sepracor, a US firm focused on respiratory and central nervous system disorder medicines.Total contract...

Pharminox completes L2M funding.(Brief article)
July 7, 2008... Nottingham, UK-based Pharminox, a UK oncology R&D company, has successfully completed a new round of equity funding, raising just over L2.0 million ($3.9 million) from new and existing investors. The proceeds of the funding will be used to...

Strong Ph II data for Intercytex' Valveta.
July 7, 2008... Intercytex, a UK-based developer of regenerative medicinal products, has reported positive six-month follow-up data from two Phase II trials of Valveta, its cell therapy product for damaged skin, at the Facial Aesthetic Conference and...

NextGen and EP to offer combined service.(Expression Pathology)(Brief article)
July 7, 2008... NextGen Sciences, a provider of biomarker services, and fellow USA-based Expression Pathology, a specialist in tissue protein analysis, have signed a commercial agreement to provide protein biomarker services in formalin-fixed paraffin-embedded...

Progeria treatment validated in mice.
July 7, 2008... Five years after the identification of the gene responsible for progeria, a rare disease causing accelerated and premature aging, a team of Spanish and French researchers has successfully demonstrated a treatment for the disease, using mice....

FDA considers using clinical outcomes over surrogate markers in diabetes drug approval.
July 7, 2008... The US Food and Drug Administration is considering whether to raise the bar to approval of diabetes drugs by requiring them to show effiacy on cardiovascular safety and increased life expectancy, measures which are much harder and costly to...

Basilea/J&J's ceftobiprole approved in Canada.
July 7, 2008... Basilea Pharmaceutica's ceftobiprole (Zeftera) has been approved by Health Canada for the treatment of complicated skin and soft tissue infections including diabetic foot infections. The Swiss originator will co-promote the predicted...

217 drugs moved to OTC status in France.
July 7, 2008... A total of 217 non-prescription drugs are to be made available on an over-the-counter basis via French pharmacies, according to a decree published in the Journal Officiel, the government register. The medicines are mainly analgesics and cough...

New Russia subsidy for local drugmakers.
July 7, 2008... Russia's Prime Minister, former President Vladimir Putin, has announced a reform of the health care sector, effective in 2010, which is to begin with the introduction of a compulsory health insurance system to subsidize the cost of prescription...

France flips on drug reimbursement cut.(Brief article)
July 7, 2008... The ruling council of France's national sickness insurance mutual funds (CNAM) has forced the group's director, Frederic Van Roekeghem, to withdraw a plan to cut the reimbursement rate of treatments for some chronic conditions (Marketletter...

EU competition probe widens, EAEPC claims.
July 7, 2008... The European Commission's investigation into possible violations of competition rules by pharmaceutical firms has been widened from the original remit of looking into payments by research-based drugmakers to allegedly ensure that generic...

Execs pull out of buying Tongjitang.
July 7, 2008... Tongjitang Chinese Medicines Co, a specialty pharmaceutical firm focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, says that Xiaochun Wang, chairman and chief executive of the...

AMDL to buy China pharma distributor.
July 7, 2008... California, USA-based AMDL, a biopharmaceutical company with operations at home and in China, has signed a letter of intent, through its wholly-owned subsidiary Jade Pharmaceutical, to acquire China-based Sichuan ZhiTong Pharmaceutical, a...

Alizyme out-licenses Colal-Pred for $67M.(Alizyme PLC)(Norgine Europe B.V.)(Brief article)
July 7, 2008... UK-based biopharmaceutical firm Alizyme has entered into a deal that could earn it upfront and milestone payments of up to 42.7 million euros ($67.4 million) and sales royalties by out-licensing its ulcerative colitis drug candidate Colal-Pred...

Qiagen to pay up to $135M for Corbett Life Science.
July 7, 2008... Netherlands-based Qiagen NV has acquired Corbett Life Science, a privately-held developer, manufacturer and distributor of life sciences instrumentation headquartered in Sydney, Australia. The transaction is valued at around $66.0 million in...

Australian study finds child vaccine effect.(Clinical report)
July 7, 2008... Medicines Australia, the country's research-based drug industry group, has welcomed the broad findings of the Australian Institute of Health and Welfare's latest national report card on health. The biennial report, titled Australia's Health,...

Thrombogenics reports on vitrectomy study.(Brief article)(Clinical report)
July 7, 2008... Leuven, Belgium-based ThromboGenics announced positive results from the MIVI III trial of microplasmin in vitrectomy at the World Ophthalmology Congress in Hong Kong. The study was a Phase IIb, randomized, double-masked,...

Further delays for GSK's Cervarix vaccine.
July 7, 2008... UK drug major GlaxoSmithKline has submitted its reply to the US Food and Drug Administration's Complete Response Letter for its cervical cancer vaccine Cervarix that it received in December of last year. Given that final data from GSK's...

Bayer pools RECORD trial data for report.
July 7, 2008... Germany's Bayer HealthCare reported pooled data from three Phase III trials of Xarelto (rivaroxaban), jointly developed with Johnson & Johnson, at the International Congress on Thrombosis in Athens, Greece. The pre-specified pooled...

Sanofi presents new data on Rotavirus vacc.(Clinical report)
July 7, 2008... Sanofi Pasteur MSD, a joint venture of French drug major Sanofi-Aventis' vaccines division and USA-based Merck & CO, has presented new data on its RotaTeq oral rotavirus vaccine, at the International Congress for Infectious Diseases in Kuala...

[thorn]Virtual man[TM]may cut R&D time and costs two-thirds by 2020, says new research.
July 7, 2008... By 2020, the Pharma R&D process may be shortened by two-thirds, success rates may dramatically increase and clinical trial costs could be cut substantially, according to new research by PricewaterhouseCoopers. A report entitled Pharma...

FDA panel gives nod to Otsuka's tolvaptan.(Food and Drug Administration)(Brief article)
July 7, 2008... The US Food and Drug Administration Advisory Committee on Cardiovascular and Renal Drugs voted to recommend the approval of tolvaptan, Japanese drugmaker Otsuka's investigational treatment for hyponatremia. Characterized by low...

Myriad/Lundbeck drop Ph III AD drug Flurizan.
July 7, 2008... USA-based Myriad Genetics and Danish drugmaker H Lundbeck have discontinued the development of Flurizan (tarenflurbil), after the drug failed to improve cognition and activities of daily living - the primary endpoints - in an 18-month Phase III...

Weight-neutral antidiabetic could gain 25% market share.(Clinical report)
July 7, 2008... A weight-neutral oral antidiabetic drug would earn a 25% patient share in the treatment of type 2 diabetes, according to surveyed primary care physicians by health care advisory firm Decision Resources. Given the prices set for each of the...

Lev Pharma submits Cinryze to EMEA.
July 7, 2008... New York, USA-based Lev Pharmaceuticals has entered into a letter agreement with the Sanquin Blood Supply Foundation, authorizing the drugmaker to file for European marketing authorization of its lead product candidate, Cinryze (C1 inhibitor...

Japan stock market week to June 30, 2008.
July 7, 2008... Tokyo extended its previous week's retreat in the reporting period to June 30. The Nikkei 225 fell 2.7%, following a five-session losing streak to close at the 13,400 mark, while the Topix index was off 2.1%. Tokyo's pullback reflected a lack...

ZymoGenetics secures $100M funding.(Brief article)
July 7, 2008... Seattle, USA-based biotechnology firm ZymoGenetics says that it has received a $100.0 million funding commitment from Deerfield Management, a health care investment organization and a significant shareholder in the company. The funds can be...

Hana Bio gets US orphan status for Marquibo.
July 7, 2008... Hana Biosciences, a US company focused on strengthening the foundation of cancer care, says that the Food and Drug Administration has granted orphan drug designation for Marqibo (vincristine sulfate injection, OPTISOME) for the treatment of...

DOR and Numoda collaborate on orBEC Ph III trial.
July 7, 2008... DOR BioPharma, a US company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, has entered into a collaboration with Numoda Corp, experts in rapid information turnaround, for...

AstraZeneca seeks new dosages of Atacand Plus approval.
July 7, 2008... Anglo-Swedish drug major AstraZeneca has filed a European decentralized procedure submission seeking approval for two new dose strengths of Atacand Plus, for those hypertensive patients not optimally controlled by monotherapy. The reference...

Actelion's Tracleer shows benefit in FC II PAH.(Brief article)
July 7, 2008... Swiss drugmaker Actelion says that a pivotal pulmonary arterial hypertension study published in The Lancet concludes that Tracleer (bosentan) demonstrates benefits in mildly symptomatic WHO Functional Class II patients. According to the...

UCB's Cimzia under review for active RA.
July 7, 2008... Belgian drugmaker UCB says that a Marketing Authorization Application has been submitted to the European Medicines Agency (EMEA) requesting the approval of Cimzia (certolizumab pegol) as a subcutaneous treatment for adults with...

Raptiva label updated on long-term efficacy.
July 7, 2008... Merck Serono, a division of Germany's Merck KGaA, says that the European Commission has approved an update of the Summary of Product Characteristics for Raptiva (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis, a...

Eisai's Aciphex cleared for GERD by US FDA.
July 7, 2008... The US unit of Japanese drugmaker Eisai says that the Food and Drug Administration has approved Aciphex (rabeprazole sodium) 20mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease in adolescents aged 12 and...

Biotech industry is New Jersey, USA, sees growth and maturity; survey.
July 7, 2008... The US state of New Jersey's biotechnology industry continued to both grow and mature in 2007, according to the latest BioNJ industry survey. The industry expanded as measured by several important factors, with the number of public and private...

US court rules for AstraZeneca in Seroquel case.
July 7, 2008... US court rules for AZ in Seroquel case The US District Court of New Jersey has granted Anglo-Swedish drug major AstraZeneca's "motion for summary judgment of no inequitable conduct" with respect to its patent on the blockbuster bipolar...

Bayer buys Maxygen portfolio for $120M.(Brief article)
July 7, 2008... Germany-headquartered drug major Bayer HealthCare is planning to spend up to $120.0 million to acquire from California, USA-based Maxygen its hemophilia program assets, including a next-generation Factor VIIa protein known as MAXY-VII. This...

J&J unit gets offer for Wound Care business.
July 7, 2008... Johnson & Johnson subsidiary Ethicon says it has received an offer from One Equity Partners for its Professional Wound Care business. After a competitive bidding process, Ethicon has granted One Equity exclusivity on the purchase of the...