Pharma Marketletter articles from October 2008

Pharma Marketletter archives from October 2008

Teva in generics JV with Japan's Kowa.
October 6, 2008... Israeli drugs giant Teva Pharmaceutical Industries and Japanese mid-sized drugmaker Kowa Co have signed a definitive agreement to establish a generic pharmaceutical company in Japan. This is a further expansionary move for Teva, which is in the...

Nuvelo agrees to an Arca bio takeover.
October 6, 2008... California, USA-based Nuvelo, which has no products on the market and suffered a major blow in March when its lead drug candidate alfimeprase, an anticoagulant, disappointed in clinical testing, has agreed to merge into Arca biopharma, a...

DioGenix spins out into Nerveda.
October 6, 2008... Maryland, USA-based molecular diagnostics enterprise DioGenix has announced its sale to Nerveda, a privately-held, US specialty pharmaceutical and diagnostic company. As consideration for acquiring all of the outstanding stock of DioGenix, Ore...

Spain's Farmaindustria stresses importance of biotechnology.
October 6, 2008... Antoni Esteve, the president of Farmaindustria, Spain's research-based drug industry group, has outlined the importance of the biotechnology sector to the future of the pharmaceutical sector as a whole. Speaking at Biospain 2008, an...

Italy's Farmindustria rewards university researchers.
October 6, 2008... Italy's drug industry association, Farmindustria, has awarded two prizes to the best young academic researchers for contributions to pharmaceutical-related science. Maria Letizia Barreca of the University of Messina, Sicily, and Gianluca...

Belgium launches pharma R&D campaign.
October 6, 2008... A joint campaign involving Belgium's Ministry for Enterprise and Simplification and the federation of chemical life sciences industries, essenscia, has been launched under the English language slogan, "Belgium, the place to be for...

Belgium's drug bill analysis from pharma.be.(Brief article)
October 6, 2008... The pharma.be, Belgium's research-based drugmakers' association, has published its half-yearly analysis of the country's drug reimbursement budget, which is produced in partnership with the National Institute for Sickness -Disability (INAMI)...

Merck & Co drug gets first nod under PIP.
October 6, 2008... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has made US drug major Merck & Co's Cancidas (caspofungin) its first recommendation based on a pediatric investigation plan (Marketletter February 12,...

UCB withdraws Vimpat application to EMEA.(European Medicines Agency)(Brief article)
October 6, 2008... Belgian drugmaker UCB is withdrawing its Marketing Authorization Application to the European Medicines Agency (EMEA) for Vimpat (lacosamide) in the treatment of diabetic neuropathic pain. UCB has taken this decision based on the EMEA's...

List of new CHMP drug recommendations.
October 6, 2008... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for the following new medicines: - Azarga (brinzolamid/timolol), from UK-based firm Alcon Laboratories, to decrease...

Takeda withdraws application for ramelteon.(Takeda Pharmaceutical Company Ltd.)(Brief article)
October 6, 2008... Japan's Takeda has withdrawn its centralized Marketing Authorization application to the European Medicines Agency (EMEA) for ramelteon 4mg and 8mg tablets. In its official letter, the company stated that the decision was based on its...

CHMP wants stronger Tysabri warning label.(Committee for Medicinal Products for Human Use)(Brief article)
October 6, 2008... The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Elan and Biogen Idec'sTysabri (natalizumab) be updated to warn about the risk of progressive...

US industry experts discuss New Jersey's bioscience future.(Brief article)
October 6, 2008... A group of national and New Jersey, USA-based partners on September 26 hosted the New Jersey Biz/Bio event - New Jersey's Bioscience Community: Strengthening the Foundation - discussing the state's bioscience industry, which represents a major...

Top-20 cancer therapy brands market report from C&M.
October 6, 2008... Companies and Markets has announced the addition of Commercial Insight - Top 20 Therapy Cancer Brands market research report to its portfolio. The report shows that cancer therapy brand sales totalled over $30.0 billion in the seven major...

Eularis' first study of ROI of pre-launch named-patient programs.
October 6, 2008... Jointly headquartered in the UK and USA, Eularis has released what it says is a first-ever study on the return-on-investment of named-patient programs, also known as compassionate use programs. The paper, Implementing a pre-launch...

50 new BIA members in first part of 2008.(BioIndustry Association)(Brief article)
October 6, 2008... A total of 50 companies have joined the UK's BioIndustry Association during the year ended August 31, the BIA reported at its annual general meeting. These include corporate members developing new medicines and technologies as well as...

FEP promotes generic Rxs; no co-pay for first four mail orders.
October 6, 2008... The USA's Blue Cross and Blue Shield government-wide Service Benefit Plan (Federal Employee Program) will waive Standard Option members' first four mail order generic drug co-pays as part of their 2009 benefits package, says the Blue Cross and...

Law firm investigates Pharmacopeia/Ligand merger.
October 6, 2008... New York, USA, law firm Levi & Korsinsky is investigating possible breaches of fiduciary duty and other violations of state law by the board of directors of Pharmacopeia arising out of their attempt to sell the company to Ligand Pharmaceuticals...

Isolagen settles class action and law suits.
October 6, 2008... US biopharmaceutical firm Isolagen says that it has reached an agreement in principle to settle its securities class action law suit and its two derivative actions against the company and certain of its current and former officers and directors...

Crucell licenses PERMEXIS to Lonza.
October 6, 2008... Switzerland-based custom peptide manufacturer Lonza and Dutch biotechnology company Crucell have entered into a co-exclusive manufacturing, sales and distribution agreement related to the PERMEXCIS cell culture medium developed by Crucell for...

Santhera publishes results of DMD trial.(Clinical report)
October 6, 2008... Santhera Pharmaceuticals, a Swiss specialty drug company focused on neuromuscular diseases, has published study results that support the potential efficacy of its lead compound SNT-MC17 (idebenone) in Duchenne Muscular Dystrophy in the European...

Orient gets Summit PD drooling drug rights.
October 6, 2008... UK biotechnology company Summit has entered into a co-development agreement with Orient Pharma for its Phase II candidate SMT D001, a treatment for excessive drooling as a non-motor symptom of Parkinson's disease and other neurological...

Sanofi launches drug screening consortium.
October 6, 2008... French drug major Sanofi-Aventis has launched the dScreen Consortium, a research initiative to develop the next generation of high-throughput screening for drug discovery applications. Based in Strasbourg, France, the consortium includes:...

Roche completes acquisition of ARIUS.
October 6, 2008... Swiss drug major Roche has completed the acquisition of 100% of the issued and outstanding shares and warrants of Canadian biotechnology firm ARIUS (Marketletter July 28). ARIUS is the developer of a proprietary antibody platform called...

FPMAJ's prescription drug pricing plan continues to be discussed.
October 6, 2008... Although a new proposal of Japan's National Health Insurance drug pricing, which the Federation of Pharmaceutical Manufacturers Associations of Japan had submitted at a hearing of the NHI Drug Pricing Expert Subcommittee within the Chuikyo (the...

Japan's Ab market set to grow three-fold.
October 6, 2008... The Japanese market for antibody pharmaceuticals such as rheumatoid arthritis drugs and anticancer agents will expand about three-fold to 340.0 billion yen ($3.2 billion) in 2017 from 113.0 billion yen in 2007, according to a recent survey by...

FDA again delays NDA for Eli Lilly/Daiichi Sankyo's potential blockbuster prasugrel.
October 6, 2008... The US Food and Drug Administration has further delayed the approval of the New Drug Application for US drug major Eli Lilly and Japanese pharmaceutical firm Daiichi Sankyo's antiplatelet agent prasugrel beyond the most recent goal date of...

FDA warns over deaths in German epoetin alfa stroke trial; further woes for J&J.
October 6, 2008... The US Food and Drug Administration has issued an early warning regarding data under review from an investigational trial by health care major Johnson & Johnson on Eprex (epoetin alfa) in the unapproved indication of improving cognitive...

ImClone's mystery bidder has a "Cinderella" deadline.
October 6, 2008... In what brings to mind thoughts of the Cinderella fairy story, US biotechnology firm ImClone System says that the "large Pharma" company that had made the $70 a share counter offer to Bristol-Myers Squibb $60 bid, now upped to $62...

Nomad Bioscience in licensing deal with Bayer/Icon.
October 6, 2008... Munich-headquartered Nomad Bioscience GmbH hast entered into a broad licensing agreement with fellow Germany-based Bayer Innovation GmbH and its subsidiary Icon Genetics. This provides Nomad access to Icon's proprietary technology platforms,...

$25M private placing by Clinical Data.
October 6, 2008... Massachusetts, USA-based biotechnology firm Clinical Data has entered into a definitive agreement with certain affiliates of Randal Kirk, chairman of its board of directors, with respect to the private placement of 1,514,922 shares of...

MedImmune licenses IP to Japan's BIKEN.
October 6, 2008... MedImmune, a US subsidiary of Anglo-Swedish drug major AstraZeneca, has licensed its proprietary reverse genetics intellectual property to BIKEN, the Research Foundation for Microbial Diseases of Osaka University in Japan, to support the...

Alpharma board rejects King's offer.(King Pharmaceuticals)
October 6, 2008... New Jersey, USA-based Alpharma's board of directors has filed with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 and sent a letter to shareholders in which the members unanimously rejected King...

Shionogi extends deal with MorphoSys.
October 6, 2008... Germany's MorphoSys AG says that Japan's Shionogi has elected to extend its current license agreement covering the use of the former's HuCAL technology in drug discovery, for three additional years. Under the terms of the deal, Shionogi will...

Nitec secures 24M SwFr funding.
October 6, 2008... Nitec Pharma AG, a Switzerland-based specialty drug company focused on the development and commercialization of innovative medicines and effective treatment solutions for chronic inflammation and pain-related diseases, says that it has closed a...

Repros Thera enters $15.6M financing deal.(Repros Therapeutics)(Brief article)
October 6, 2008... Texas, USA-based Repros Therapeutics has entered into definitive agreements to sell an aggregate of 2.4 million shares of its common stock at a purchase price of $6.50 each, for an aggregate $15.6 million financing under its...

TorreyPines repositions as development firm focusing on three lead compounds.
October 6, 2008... California, USA-based TorreyPines Therapeutics says that it will transition from a discovery and development company to a development-only enterprise, focusing on its three clinical development programs. As a result, the firm will streamline...

$84M for PharmAthene.(Brief article)
October 6, 2008... PharmAthene, a US biodefense company developing medical countermeasures against biological and chemical threats, says that the National Institute of Allergy and Infectious Diseases, has awarded it a multi-year contract for up to $83.9 million...

Silence loss worsens on "lumpy" milestones.(Silence Therapeutics revenue report)(Financial report)(Brief article)
October 6, 2008... UK RNA interference specialist Silence Therapeutics fell deeper into loss in the six months ending June 30, 2008, on increasing R&D spending and milestone payments from licensing partners that new chief executive Iain Ross described as "lumpy,"...

Durect licenses Eldur patch to Alpharma.
October 6, 2008... Specialty pharmaceutical firm Durect has entered into an up to $263.0-million license agreement with fellow-US drugmaker Alpharma granting exclusive worldwide rights to develop and commercialize Eladur (bupivacaine) patch, which is under...

CytRx completes acquisition of Innovive.(Brief article)
October 6, 2008... US drugdeveloper CytRx has completed its acquisition of New York-based biopharmaceutical firm Innovive for a total consideration of around 2.6 million shares of CytRx common stock, $18.3 million of performance-based milestones, and the...

Bioniche falls further into loss on rising R&D.(revenue report)(research and development)(Financial report)(Brief article)
October 6, 2008... Canadian drug developer Bioniche's net loss worsened to C$16.3 million ($15.7 million) in the full fiscal-year 2008, versus a net loss of C$14.8 million year-on-year, as rising R&D costs outweighed a marginal gain in revenues. Sales rose...

Invitrogen ready for Applied Bio buy.(Applied Biosystems)(Brief article)
October 6, 2008... Invitrogen says the syndication of the $2.65-billion financing for its acquisition of Applied Biosystems has been completed. The term loan A, in the amount of $1.4 billion, and the revolving credit facility, in the amount of $250.0 million,...

Key decision-makers will shape the biosimilars market, says Datamonitor.
October 6, 2008... With many biologic drugs treating diseases of old age like cancer and arthritis, whose incidence is on the rise in Europe and the USA, the use of biologics is set to increase - to the extent that this sector is projected to be responsible for...

OECD report explores pharmaceutical pricing policies around major markets.
October 6, 2008... A new study from the Organization for Economic Cooperation and Development - Pharmaceutical Pricing Policies in a Global Market - details national differences in the consumption and cost of medicines and outlines how prices are established,...

Northern Ireland to scrap Rx charges by 2010.
October 6, 2008... England is likely to be the only part of the UK where National Health Service patients are charged for prescription drugs, despite having the same levies to pay for government-provided health care. Since April 2007, people in Wales have been...

Ireland's drug firms and pharmacists team up.
October 6, 2008... The Irish Pharmaceutical Healthcare Association and the Irish Pharmacy Union have teamed up with Age Action Ireland to launch an educational campaign to help older people to use their drugs more safely. The move follows the release of survey...

NHS physicians "under pressure" to switch Rxs.
October 6, 2008... A survey of 131 National Health Service Primary Care Trusts by Pulse, a UK newspaper for general practitioners, has found that more of them are adopting campaigns to encourage switching from branded to copy drugs. There is growing pressure...

Costly specialty/biotech drugs get ever more expensive in USA, AARP study finds.(Report)
October 6, 2008... Since the US Medicare drug benefit took effect in 2006, drug manufacturers have substantially raised the prices of the expensive specialty drugs most widely used by Medicare beneficiaries, according to an AARP Rx Watchdog Report. Specialty...

Sun Pharma says 2008 US growth will be 25%.
October 6, 2008... India's Sun Pharmaceuticals is focusing ever more on the difficult US market, even as its contemporaries spread their risk away from the troubled area, according to a report by the US Business Standard. Sun's US sales rocketed to reach 41%...

Pfizer quits cholesterol sector seeking profit.
October 6, 2008... Global drug giant Pfizer is to cease development of drugs in its traditional focus areas, such as high-cholesterol and hypertension, in order to concentrate on more lucrative fields like oncology. According to an internal memo by R&D head...

Takeda establishes two Singaporean subsids.
October 6, 2008... Japanese drug major Takeda has established two Singaporean wholly-owned subsidiaries, called Takeda Clinical Research Singapore and Takeda Pharmaceuticals Asia, to serve as its centers in the Asian region. TPAsia will supervise the overall...

Australia PBAC move on transparency.(Pharmaceutical Benefits Advisory Committee)(Brief article)
October 6, 2008... Australia's Pharmaceutical Benefits Advisory Committee, the independent body which recommends to the Minister of Health and Aging medicines that should be subsidized by the government on the Pharmaceutical Benefits Scheme, has said that it...

Australian Pharma's code compliance.
October 6, 2008... The Australian research-based pharmaceutical industry is demonstrating a high level of compliance with the Medicines Australia Code of Conduct with regard to educational events sponsored by drugmakers. The trade group revised its code governing...

Nigeria bid to cut 150B naira malaria cost.
October 6, 2008... Nigeria's federal government spends about 150.0 billion naira ($1.27 billion) on the treatment of malaria among over 30% of the nation's population annually. This has triggered the decision by the Gombe State government to establish a malaria...

Lilly gets third appro for Alimta.
October 6, 2008... US drug major Eli Lilly has received a third approval from the Food and Drug Administration for the use of Alimta (pemetrexed for injection), in combination with cisplatin, for the first-line treatment of locally-advanced and metastatic...

Obesity drugs could fight viral infection.
October 6, 2008... Existing anti-obesity drugs may represent a new way to block the increased cellular metabolism caused by viruses and inhibit viral infection, according to a study published in the journal Nature Biotechnology. Many viruses, including...

New firm PolyMedix presents TB pipeline.
October 6, 2008... The USA's PolyMedix, an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders based on biomimetics, presented data on its pipeline tuberculosis treatments at the New Directions...

Regeneron and Bayer present wet AMD data.
October 6, 2008... USA-based Regeneron Pharmaceuticals and Germany's Bayer HealthCare presented data on the former's VEGF Trap-Eye at the annual meeting of the Retina Society in Arizona, USA. In a double-masked Phase II trial, patients with age-related...

Thailand's new Health Minister will keep CLs.(compulsory licensing policy)(Brief article)
October 6, 2008... Thailand's new Public Health Minister, Chalerm Yubamrung, has pledged to maintain the government's policy of compulsory patent licensing, despite facing pressure to adopt a position that is more helpful for relations with the USA and European...

Austria's Pharmig greets VAT cut.
October 6, 2008... Austria's research-based pharmaceutical industry association, Pharmig, has welcomed proposals from the coalition Social Democrat-Christian Democrat government to reduce the rate of value-added tax on drugs. The group's secretary general, Jan...

Dutch pharma group reviews training body.
October 6, 2008... Nefarma, the research-based pharmaceutical industry association in the Netherlands, has reorganized its relationship with the Farmeduca, which regulates the training of drugmakers' marketing representatives both to physicians and dentists. The...

$3 billion for global malaria campaign.
October 6, 2008... A group of international organizations, public and private, has pledged nearly $3.0 billion as part of a new scheme, the Global Malaria Action Plan, which aims to "eradicate malaria" by 2015. The Global Fund to Fight Aids, Tuberculosis and...

South Africa's Health Minister replaced.(Brief article)
October 6, 2008... South Africa's Health Minister, Manto Tshabalala-Msimang, who was a hate figure for HIV/AIDS activist groups over her suggestion that sufferers should eat a healthier diet as a substitute for antiretrovirals (Marketletters passim), has been...

Merck & Co joins Lilly in transparency move.
October 6, 2008... New Jersey, USA-based drug major Merck & Co has followed swiftly the move by Indianapolis-headquartered Eli Lilly to make public all payments to physicians for consulting or speaking services, saying it is committed to industry-leading...

Japan stock market week to Sept 29, 2008.
October 6, 2008... Tokyo continued its losing streak in the week to September 29 (four trading days because September 23 was a national holiday in Japan), influenced by further turmoil on the US financial sector with the bankruptcy of the largest savings and loan...

FDA clears Oncophage export to Russia.
October 6, 2008... USA-based biotechnology firm Antigenics says that the Food and Drug Administration has granted the necessary permission to allow for the export of its Oncophage (vitespen) to Russia. The Russian Ministry of Public Health approved the...

Telormedic raises 21M SwFr in financing.
October 6, 2008... Switzerland-based Telormedix, which focuses on novel immunotherapeutic molecules, has closed its first series A equity investment round, raising 21.0 million Swiss francs ($19.0 million), which it says is one of the largest such financings by a...

New alliance for emerging biotechs.
October 6, 2008... The New York Biotechnology Association and the New York Academy of Sciences have announced an alliance designed to give emerging biotechnology companies reduced price access to NYAS corporate membership. The new "Growth Partners" program...

Ipsen updates on Dysport progress at FDA.
October 6, 2008... The US Food and Drug Administration has provided notification that the Prescription Drug User Fee Act action date for French drug firm Ipsen's Dysport (botulinum toxin of type A) Biologics License Application for the treatment of patients with...

EU Competition Council tackles fake products.
October 6, 2008... The European Commission has welcomed a resolution from the European Union's Competitiveness Council for more effective ways of combating counterfeiting and copyright piracy. The Internal Market Commissioner, Charlie McCreevy, said: "we have to...

Cephalon agrees to pay $425M to resolve off-label marketing allegations.
October 6, 2008... The US Justice Department has announced that biopharmaceuticals firm Cephalon will enter a criminal plea and pay $425.0 million to resolve claims that it marketed three drugs for uses that have not been not approved by the Food and Drug...

Qiagen buys Biotage biosysems unit.(Brief article)
October 6, 2008... Netherlands-based Qiagen has acquired all assets related to the biosystems business from Biotage AB, a publicly-listed Swedish developer, manufacturer and distributor of products for genetic analysis and medicinal chemistry. The transaction is...

GlaxoSmithKline to axe 850 R&D staff.
October 6, 2008... UK-headquartered GlaxoSmithKline, the world's second largest drugmaker by sales, has announced plans to dramatically reduce its R&D head count, revealing that a total of about 850 jobs in the sector would go. GSK, which has around15,000...

Up to $448M US govt BioThrax contract.
October 6, 2008... Emergent BioSolutions that it has signed a new, multi-year, firm fixed price contract with the US Department of Health and Human Services to supply an additional 14.5 million doses of BioThrax (anthrax vaccine adsorbed), its Food and Drug...

Bayer to make bios in tobacco plants.
October 6, 2008... Germany's Bayer Innovation GmbH and the USA's Kentucky Bioprocessing are collaborating to develop a facility at the latter's Owensboro plant for the production service of biopharmaceuticals. Based on Bayer's proprietary magnICON technology,...

FDA and Indevus agree over Nebido NDA.(Food and Drug Administration)(new drug application)(Brief article)
October 6, 2008... The USA's Indevus Pharmaceuticals has reached an agreement with the Food and Drug Administration over the additional data and risk management strategy that will lead to re-submission of its New Drug Application for Bayer Schering's Nebido,...

More indications for Merck & Co's Gardasil.
October 6, 2008... US drug major Merck & Co's cervical cancer vaccine Gardasil has received further approvals from the Food and Drug Administration for the prevention of vulvar and vaginal cancers caused by human papillomavirus types 16 and 18. The approval,...

AP Pharma's APF530 ready for submission.
October 6, 2008... California, USA-based specialty pharmaceutical company AP Pharma has reported positive results from a pivotal Phase III study comparing APF530 (sustained-release granisetron) with fellow US drug major Eli Lilly's Aloxi (palonosetron HCl) for...

Savient fails to update investors on Puricase.(Savient Pharmaceuticals Inc.)(Brief article)
October 6, 2008... New Jersey, USA-based Savient, a biopharmaceutical firm that develops and distributes products targeted to unmet medical needs in specialty and broader markets, says it will not provide to investors the promised update on the strategic business...

AEterna enrolls Ph III cetrorelix proram.(Clinical report)
October 6, 2008... Canada's AEterna Zentaris has completed patient recruitment for the company's second efficacy trial of its Phase III program in benign prostatic hyperplasia with its flagship product candidate, cetrorelix, a luteinizing hormone-releasing...

Pharmaxis files first MA for Bronchitol.(marketing application)(Brief article)
October 6, 2008... Australian drugmaker Pharmaxis says it has submitted a marketing application for its mucus clearing agent, Bronchitol, a dry-powder formulation of mannitol for inhalation, has been submitted to the Therapeutic Goods Administration division of...

Wyeth/ALS deal for antibiotic in Asia/Pac.
October 6, 2008... Advanced Life Sciences and fellow USA-based Wyeth Pharmaceuticals have signed a development and commercialization agreement for cethromycin in the Asia Pacific region, excluding Japan. Cethromycin is a novel, once-a-day, oral antibiotic for...

ALS files cethromycin NDA for use in CAP.
October 6, 2008... Chicago, USA-based Advanced Life Sciences has submitted a New Drug Application for cethromycin in mild-to-moderate community acquired pneumonia. The company also entered into debt and equity financing agreements to strengthen its balance sheet...