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Pharma Marketletter articles from October 2006

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<a href="http://www.highbeam.com/Pharma+Marketletter/publications.aspx?date=200610" title="Articles and back issues from Pharma Marketletter">Pharma Marketletter articles</a>

Pharma Marketletter back issues from October 2006:

Altana's shares rise 3% on news of the sale of its drugs unit to Nycomed for $5.7B.(Altana Industrie-Aktien und Anlagen AG acquired with Nycomed A/S)

Oct 02, 2006 ... Shares in Germany's Altana AG reached a six-month high after the firm agreed to sell its pharmaceuticals unit to privately-held Danish drugmaker Nycomed for 4.5 billion euros ($5.7 billion). The price is short of the 6.0 billion euros it had initially asked for, but the firm was ...

Hospira buys Mayne Pharma for $2.0 B.

Oct 02, 2006 ... Australian drugmaker Mayne Pharma has agreed to a A$2.6 billion ($2.0 billion) takeover by Hospira, a USA-based maker of hospital products spun out from Abbott Laboratories. Shareholders will receive A$4.10 per outstanding ordinary share of Mayne, which represents a 32% premium over its ...

Amgen's Denosumab MAb effective in trial.(product development)(Brief article)

Oct 02, 2006 ... USA-based biotechnology firm Amgen says that data from a Phase II study of its therapeutic antibody denosumab shows that it has potential as a treatment for bone diseases. The results, which were presented at the American Society for Bone and Mineral Research's annual meeting in ...

Methylnaltrexone enters trials for POI.

Oct 02, 2006 ... USA-based firms Progenics Pharmaceuticals and Wyeth Pharmaceuticals, a division of Wyeth, say they have begun the first of two global Phase III trials designed to evaluate the safety and efficacy of intravenous methylnaltrexone for the treatment of post-operative ileus. The condition, for ...

Teva and Procognia sign exclusive R&D deal.(Teva Pharmaceutical Industries contracts with Procognia)(Brief article)

Oct 02, 2006 ... Teva Pharmaceutical Industries and fellow Israel-based Procognia, a wholly-owned subsidiary of the UK's Procognia, say they have entered into a deal covering the development of two new biopharmaceutical compounds. Under the terms of the deal, Procognia will supply Teva with ...

Early Trexima use cuts migraine symptoms.(trials of Trexima )(Brief article)

Oct 02, 2006 ... UK-based drug major GlaxoSmithKline has reported that new data from trials of Trexima (sumatriptan succinate/naproxen sodium) demonstrates that it successfully reduces the pain symptoms associated with migraine. Specifically, the results showed that patients who began treatment within one ...

Novartis' Sebivo gains domestic approval.(treatment for patients with chronic hepatitis B)(Brief article)

Oct 02, 2006 ... Swiss drug major Novartis' Sebivo (telbivudine), a new treatment for patients with chronic hepatitis B, has been cleared in Switzerland. According to the firm, the approval of the drug, which has been shown to deliver more rapid and profound viral suppression than the potent reverse ...

Navamedic's Glucomed gets nod from CHMP.(ommittee for Medicinal Products for Human Use )(Brief article)

Oct 02, 2006 ... Lysaker, Norway-based Navamedic says that its osteoarthritis treatment Glucomed/Flexove (glucosamine HCl) has been recommended for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA), dispelling doubts about the product which surfaced ...

Rotarix nominated for prestigious Prix Galien.(GlaxoSmithKline's Rotavirus vaccine's Prix Galien Award)(Brief article)

Oct 02, 2006 ... UK drug major GlaxoSmithKline's Rotavirus vaccine, Rotarix, has been nominated for the prestigious UK Prix Galien Award, which recognizes pharmaceutical innovation and is one of the highest accolades in the development of new medicines. Rotavirus is the most common cause of ...

Strong Ph III data for Bioenvision's Evoltra.(product development of Evoltra (clofarabine) )(Brief article)

Oct 02, 2006 ... New York, USA-based Bioenvision says that the latest results from an ongoing European study of Evoltra (clofarabine) in pediatric acute lymphoblastic leukemia (BIOV-111) supports its recent European approval (Marketletter June 12), showing that the purine nucleoside analog delivers a ...

CHH buys $3.1M China manufactuing plant.(Shaanxi MeiChen Pharmaceuticals Company acquired with China Health Holding)(Brief article)

Oct 02, 2006 ... China Health Holding, a developer, marketer and manufacturer of natural herbal supplement products based on traditional Chinese medicine, has executed a definitive acquisition agreement with Shaanxi MeiChen Pharmaceuticals Co and all of its shareholders to acquire 100% of the issued and ...

Inovio establishes Asian unit with $5.4M offering.

Oct 02, 2006 ... Inovio Biomedical Corp, a USA-based late-stage developer of therapies for cancer and other applications, has established Inovio Asia Pte Ltd, a majority-owned subsidiary in the Republic of Singapore, with the goal of pursuing business and scientific development opportunities in the east ...

Kowa Soyaku vows to enter top 20 Jap firms.(Kowa's prescription pharmaceuticals business acquired with Nikken Chemicals Company Ltd.)(Brief article)

Oct 02, 2006 ... With the integration of Kowa's prescription pharmaceuticals business into Japanese medium-sized drugmaker Nikken Chemical, the new entity will restart as Kowa Soyaku, focusing on therapeutics in the field of lifestyle diseases (cardiovascular, diabetes and renal disorders), sensory organs ...

AAIPharma to aquire France's CAC.(aaiPharma Inc. acquired with Cvitkovic and Associes Consultants SA)(Brief article)

Oct 02, 2006 ... AAIPharma has entered a definitive agreement to acquire Cvitkovic and Associes Consultants SA, a French contract research organization specializing in oncology drug development and medical consulting. According to the USA-based provider of product development and support services, the ...

CHMP positive about exenatide in diabetes.

Oct 02, 2006 ... USA-based firms Eli Lilly & Co and Amylin Pharmaceuticals say that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use has issued a positive opinion regarding the use of their co-developed drug exenatide as a treatment for type 2 diabetes. The compound is ...

Trasylol endorsed by FDA in CABG surgery.(Food and Drug Administration)(Brief article)

Oct 02, 2006 ... German drugmaker Bayer AG says that Trasylol (aprotinin injection), its product for the prevention of blood loss during surgery, has been strongly endorsed by the Cardiovascular and Renal Drugs Division of the US Food and Drug Administration. The announcement followed the ...

Positive results for icatibant in HAE trials.

Oct 02, 2006 ... German drugmaker Jerini AG says that the results of two pivotal Phase III trials (FAST-1 and -2) of its drug icatibant, a bradykinin B2 receptor antagonist, show that it may have efficacy in relieving the symptoms of hereditary angiodema (HAE). The FAST-1 study, which compared ...

ThromboGenics' microplasmin in stroke trial.(ThromboGenics NV clinical trial)(Brief article)

Oct 02, 2006 ... Belgian biotechnology company ThromboGenics NV, a specialist in the area of vascular disease, says that it has initiated a Phase IIa trial, designed to evaluate its anticlotting agent, microplasmin, in the intra-arterial treatment of stroke. The drug, which is a truncated form of the human ...

Alcon's Travatan OKed by FDA for glaucoma and OH.(open-angle glaucoma)(Food and Drug Administration)(Brief article)

Oct 02, 2006 ... Texas, USA-based Alcon says that the Food and Drug Administration has approved Travatan Z (travoprost ophthalmic solution) 0.004% for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, who are intolerant of or insufficiently ...

Pozen gets $40M upfront payment from AstraZeneca.(AstraZeneca PLC partnership with POZEN Inc)

Oct 02, 2006 ... North Carolina, USA-based Pozen has received a $40.0 million initial upfront payment from Anglo-Swedish drug major AstraZeneca in connection with the exclusive global collaboration agreement between the two companies. The previously-announced accord has cleared the waiting period required ...

UCB makes further stride into pharma with proposed buy of Schwarz Pharma.(Celltech Group PLC acquired with UCB S.A.)

Oct 02, 2006 ... Belgium group UCB, which said it would focus all its attention on pharmaceuticals and biotechnology rather than chemicals when it acquired the UK's Celltech in 2004, has announced another major move with the proposed purchase of Germany's Schwarz Pharma. Under the terms of the ...

Sanofi Pasteur MSD's Gardasil becomes first HPV vaccine approved in Europe.(Gardasil (human papilloma virus vaccine) has been granted a European license )

Oct 02, 2006 ... French vaccines developer Sanofi Pasteur, part of the Sanofi-Aventis group, says that its product Gardasil (human papilloma virus vaccine) has been granted a European license for the prevention of cervical cancer and other HPV diseases before and beyond cervical cancer. The vaccine targets ...

GPC shares rise 40% on strong satraplatin data.(GPC Biotech AG partnership with Pharmion Corp)(Brief article)

Oct 02, 2006 ... German drugmaker GPC Biotech AG and the USA's Pharmion Corp have reported positive top-line results from their double-blinded, randomized Phase III registrational trial for their co-developed anticancer drug satraplatin. Shares in GPC Biotech soared 40% to 15.05 euros, on the day after the ...

FDA-commissioned report becomes vehicle for pharmaceutical companies' critics.

Oct 02, 2006 ... A report commissioned by the US Food and Drug Administration has produced scathing criticism of the agency and the pharmaceutical industry, recommending 25 measures designed to improve consumer confidence. Many of the proposals are welcomed by industry observers, insofar as they aim to ...

Nigeria's war on fake drugs shows progress.(rules for drugs)(Brief article)

Oct 02, 2006 ... Nigeria's National Agency for Food and Drug Administration and Control has issued its first report on the level of counterfeit and substandard drugs in the country, following earlier efforts by the Nigerian Ministry of Health and the World Health Organization, from 1989 to 2005. ...

Pfizer commits $15M to malaria treatment.

Oct 02, 2006 ... Global number one drugmaker , Pfizer, has announced a $15.0 million commitment to address critical treatment gaps for malaria in the African nations of Ghana, Kenya and Senegal. The firm describes the move as a "collaborative effort" with the Clinton Global Initiative and will involve ...

SA Health Minister's ARV program backed.(antiretroviral drugs)(Brief article)

Oct 02, 2006 ... South African Health Minister Manto Tshabalala-Msimang, who has been the target of foreign-led calls for her resignation (Marketletter September 4), received an endorsement from the Washington DC, USA-based think-tank, the Hudson Institute. Jeremiah Norris, the Institute's ...

Kenya's ARV drug use overtakes Uganda's.(antiretroviral drug treatments)(Brief article)

Oct 02, 2006 ... Figures showing the numbers of HIV positive patients in African countries who are receiving antiretroviral drug treatments reveal that Kenya's patient numbers receiving treatment could soon overtake Uganda's totals. Last December, more than 70,000 people in Kenya were on ARV ...

German health reform row splits coalition; government could fall.

Oct 02, 2006 ... There is widespread agreement among German political commentators that the continuing and intensifying controversy over coalition health reform plans could bring down the government under Chancellor Angela Merkel. The Christian Democrats (CDU) appear to have lost their ...

Austrian pharmacy liberalization call.(pharmacy drug sales)(Brief article)

Oct 02, 2006 ... The liberalization of the Austrian pharmacy sector with the legal possibility of setting up chains could lead to a reduction in drug prices of up to 20% in the medium term, according to a study from the market research organization Kreutzer Fischer & Partner. Its report suggests that ...

Novartis' Exjade approved in the UK.(approval of Exjade (deferasirox))(Brief article)

Oct 02, 2006 ... Switzerland-based drug major Novartis says that Exjade (deferasirox) has been approved in the UK for the treatment of transfusional iron overload in patients who suffer from diseases such as thalassemia, sickle cell disease, myelodysplastic syndromes and other rare anemias. The ...

Gilead signs eight generic Viread licenses.(Gilead Sciences Inc license agreements with generic companies)(Brief article)

Oct 02, 2006 ... USA-based drugmaker Gilead Sciences has signed eight new non-exclusive license agreements with generic companies in India for its anti-HIV medicine Viread (tenofovir). The deals grant the licensees, Alkem Laboratories, Aurobindo Pharma, FDC, JB Chemicals & Pharmaceuticals, ...

Apotex' denied motion to restart Plavix sales.(product development of Apotex)(Brief article)

Oct 02, 2006 ... The US Court of Appeals for the Federal Circuit has denied the motion by Apotex to stay the August 31, 2006, preliminary injunction issued by the US District Court for the Southern District of New York, which ordered the Canadian generic drugmaker to halt sales of its copy-cat version of ...

Good pediatric study data for Atopiclair.(study of atopic dermatitis product)(Brief article)

Oct 02, 2006 ... Godalming, UK-based Sinclair Pharma has reported positive results from a new US pediatric study of its atopic dermatitis product, Atopiclair. The multicenter, double-blind, randomized, 142-patient trial demonstrated significant improvement of ...

Phosphagenics' cancer drug: strong early data.(product development of Phosphagenics )(Brief article)

Oct 02, 2006 ... Victoria, Australia-based drugmaker Phosphagenics reported strong preclinical trial data on its patented anticancer agent GTP-0805. Oral GTP-0805 in combination with tamoxifen inhibited the rate of tumor growth by more than three times the rate achieved by the established breast cancer ...

CPH predicts $20M sales by end-2006.(China Pharmaceutical Holdings)(Brief article)

Oct 02, 2006 ... China Pharmaceutical Holdings says it expects to achieve revenues of $20.0 million and net income of $8.0 million for the year ending December 31, 2006. The firm said that it had based its predictions on a 30% income increase for the years 2006 and 2007, and added that its pipeline ...

VPPJS is sole producer of Alsem in Vietnam.(Vinh Phuc Pharmaceutical Joint Stock)(Brief article)

Oct 02, 2006 ... The Vinh Phuc Pharmaceutical Joint Stock company has become the county's sole producer and distributor of the anticancer agent Aslem, the Vietnamese News Agency reports. The agent is designed as an immunostimulatory adjuvant to cancer therapy. The drug, which was originally ...

Synairgen's turnover falls 60% in 2006.(financial report)(Financial report)(Brief article)

Oct 02, 2006 ... UK-based drug discovery firm Synairgen says that its revenue for the year ended June 30, 2006, was L82,000 ($155,984), down 60% on the L202,000 it earned in the previous financial year. The firm explained that the decline follows its decision to cease undertaking purely "fee-for-service ...

ValiRx to obtain AIM listing through Azure.(Alternative Investments Market)(Brief article)

Oct 02, 2006 ... ValiRx, a biopharmaceutical company developing a range of anticancer product candidates, plans to join the London, UK, Alternative Investments Market via the reverse take over of Azure Holdings. It is expected that trading in the enlarged group's shares will begin on October 3, reports the ...

After 40 years waiting, glimmer of light at the end of the tunnel for SLE patients.(systemic lupus erythematosus)

Oct 02, 2006 ... Imagine your body's immune system turning against you and actually attacking your bodies own healthy cells. Far from this being restricted to the realms of science fiction, this is the incurable reality for sufferers of systemic lupus erythematosus (SLE) and other autoimmune diseases. ...

Advaxis' Listeria-based cancer vacc starts preclincial tests.(treatment of vaccines)(Brief article)

Oct 02, 2006 ... Researchers at New Jersey-based biotechnology company Advaxis have say they are working on a suite of new vaccines to treat women with different types of cancers, including breast cancer. A team led by Yvonne Paterson, the company founder and professor of microbiology at the ...

Immutep's lead candidate enters Ph I trial.(Product development Immutep SA)(Brief article)

Oct 02, 2006 ... French drugmaker Immutep SA's lead product candidate, ImmuFact IMP321, has entered a Phase I clinical trial in disease-free melanoma. The natural human T cell immunostimulatory factor is designed to amplify the T cell immune response and can be used as an immunopotentiator in therapeutic ...

Fampridine-SR improves walking in MS patients.(Acorda Therapeutics Inc clinical trial of Fampridine-SR on people with multiple sclerosis)(Brief article)

Oct 02, 2006 ... USA-based Acorda Therapeutics has reported positive results from a Phase III clinical trial of its drug candidate Fampridine-SR (4-aminopyridine) on walking in people with multiple sclerosis. Statistical significance was achieved on all three efficacy criteria defined in the US Food and ...

Epilepsy drug star of R&D day as UCB unveils 10 candidates in clinical testing.

Oct 02, 2006 ... At its first R&D day, Belgian drugmaker UCB updated the media on its development pipeline. The firm's next-generation anti-epilspy drug brivaracetam was the star of the London, UK, meeting on the strength of positive data which could position it as a sucessor to UCB's mainstay drug Keppra ...

World's largest retailer offers generics at $4.(generic drugs to customers with or without medical insurance)(Brief article)

Oct 02, 2006 ... Wal-Mart, the world's largest retailer, has launched a pilot program in the US State of Florida to provide nearly 300 generic drugs to customers with or without medical insurance for $4 per month. For many customers who are insured, these prices will actually be lower than their ...

75% of cancer drugs "available on Medicare".(cancer drugs)(Brief article)

Oct 02, 2006 ... A study conducted by the Avalere Health, a leading strategic advisory firm specializing in the health care industry, has found that Medicare prescription drug plans provide coverage for 75% of cancer drugs. The figures are based on research carried out in the first two months ...

US Congress authorises some Canadian imports.

Oct 02, 2006 ... The US Congress has reached a tentative agreement on amendments to the $33.7 billion 2007 fiscal year Homeland Security appropriations Bill, that would allow US citizens to import 90-day supplies of prescription drugs from Canada, provided these have not been purchased over the Internet ...

Singapore biomedical output down in Aug.(Economic Development Board)(Brief article)

Oct 02, 2006 ... Results from the pharmaceutical sector impacted on Singapore's August 2006 manufacturing output, which increased just 5.5% overall, having risen 19.8% in July and 22.5% in June, according to data from the island state's Economic Development Board. The biomedical manufacturing ...

Pharma assurances on drug affordability.(Free Trade Agreement )

Oct 02, 2006 ... The multinational pharmaceutical industry has given some measure of assurance to parties concerned with the impact of a Free Trade Agreement with the USA on access to affordable medicines, reports the Malaysian newspaper Sun2Surf. Among the main concerns over the current FTA negotiations ...

Singapore to close Johns Hopkins unit.(government of Singapore is to close the Johns Hopkins University)(Brief article)

Oct 02, 2006 ... The government of Singapore is to close the Johns Hopkins University's biomedical center stating that its program has failed to yield results, according to Andre Wan, director of the state Biomedical Research Council, who added that although the government had spent more than $50.0 million ...

Australian state acts on OTC drug dealers.(quantity of pseudoephedrine from 20g to 10g)(Brief article)

Oct 02, 2006 ... To crackdown on drug dealers, new laws passed by the Victorian state parliament in Australia lowered the threshold for possessing a quantity of pseudoephedrine from 20g to 10g. Pseudoephedrine is extracted from the tablets to make methamphetamine or speed. Possession of 14 packets or more ...

Plethora's losses cut after Timm Medical buy.(Food and Drug Administration)(Brief article)

Oct 02, 2006 ... UK specialty drugmaker Plethora Solutions reports that its losses for the six months ended June 30 were L2.0 million ($3.8 million), down 38% on the comparable period in 2005. The firm explained that the loss reduction was driven by the introduction of revenues, L2.4 million in the period, ...

Asterand sees first-half 2006 losses decline.(financial report)(Financial report)(Brief article)

Oct 02, 2006 ... Detroit, USA-based Asterand, a supplier of human tissue samples and drug discovery services to the pharmaceutical industry, says that its merger with UK drugmaker Pharmagene in January this year has had a positive impact on its financial standing. The company added that the combined ...

Protagen sets up US subsidiary.(Protagen AG establishes new US subsidiary)(Brief article)

Oct 02, 2006 ... German biotechnology firm Protagen AG, a specialist in the fields of nanobiotechnology and proteins, says it has established a wholly-owned US subsidiary in Chester, New Jersey. The firm added that the business, which will be known as Protagen Incorporated, is the ...

US HHS response IOM report on FDA.(offered his own two-part action plan)(Brief article)

Oct 02, 2006 ... Mike Leavitt, the Secretary of the US Department of Health and Human Services, has offered his own two-part action plan in response to the recent report into the Food and Drug Adminstration's effectiveness by the Institute of Medicine (Marketletter Oct 2). He recognised that ...

USAID's $100M award for neglected tropical diseases.(specific treatment programs to care for millions of the world's poorest people)(United States agency for International Development)(Brief article)

Oct 02, 2006 ... The US Agency for International Development has announced a $100.0 million award to the nonprofit research organization RTI International to reduce the impact of neglected tropical diseases in developing nations. The project, which will treat more than 40 million people over ...

Merck KGaA mandates banks to finance Serono buy.

Oct 02, 2006 ... Germany's Merck KGaA says that it has mandated Bear Stearns, Dresdner Kleinwort - the investment banking division of Dresdner Bank AG - and Societe Generale Corporate and Investment Banking as mandated lead arrangers for the 11.5 billion-euro ($14.6 billion) syndicated multi-currency ...

Takeda gets attorney's fees in Actos patent case.(popular oral antidiabetic agent)(Angell Palmer and Dodge)(Brief article)

Oct 02, 2006 ... US law firm of Edwards Angell Palmer & Dodge says that its clients, Takeda Pharmaceutical Co and Takeda Pharmaceuticals North America, have prevailed in a fees motion involving the patent infringement action against generic drug manufacturers challenging the Japanese firm's patent on Actos ...

Actavis launches generic trimipramine in USA.(trimipramine maleate capsules gets approval from United States. Food and Drug Administration)(Brief article)

Oct 02, 2006 ... Actavis US, a manufacturing and marketing division of Iceland-based generic drugmaker Actavis Group, says that it has received approval from the Food and Drug Administration to market trimipramine maleate capsules. Distribution of the product will commence immediately. The ...

Stiefel debuts Duac in Italy.

Oct 02, 2006 ... Stiefel Laboratories, the world's largest independent pharmaceutical company specializing in dermatology, says that its product Duac (clindamycin, 1% - benzoyl peroxide, 5%) is now available in Italy. Duac is the first dual-action, topical acne medication containing clindamycin and benzoyl ...

ALK-Abello's Grazax approved in Europe.(approval for Grazax the vaccine against grass pollen allergy )(Brief article)

Oct 02, 2006 ... Authorities in 27 European countries have now approved ALK-Abello's tablet-based vaccine against grass pollen allergy, Grazax - the first allergy tablet to address the underlying cause of the disease. The Denmark-based company expects to launch this on the first European markets by the end ...

Perrigo's generic famotidine cleared in USA.(product development of Perrigo)(Brief article)

Oct 02, 2006 ... Michigan, USA-based Perrigo has received approval from the Food and Drug Administration to manufacture and market over-the-counter famotidine tablets, USP, 20mg. The FDA has determined that Perrigo's product is bioequivalent to Maximum Strength Pepcid AC tablets, 20mg, ...

Avera completes Ph II Neurokinin-1 study enrollment.(neurokinin-1 clinical trails)(Brief article)

Oct 02, 2006 ... Avera Pharmaceuticals has completed enrollment in its ongoing Phase II study of the neurokinin-1 (NK-1) antagonist AV608 in subjects with social anxiety disorder (also called social phobia). This double-blind, placebo-controlled, 12-week, multicenter trial in the USA, ...

EntreMed's MKC-1 in Ph I study in leukemia patients.

Oct 02, 2006 ... USA-based pharmaceutical company EntreMed says that it has initiated a Phase I study of its drug candidate MKC-1, a novel, orally-active inhibitor of mitotic spindle formation during cell division, in patients with hematological malignancies. EntreMed said that its decision to ...

MorphoSys to develop Abs for USAMRIID.(Army Research and Materiel Command)(MorphoSys AG contracts)(Brief article)

Oct 02, 2006 ... German antibody specialist MorphoSys AG says that its AbD Serotec business unit has been awarded a contract by the US Army Research and Materiel Command to produce five fully-human recombinant antibodies against bacterial toxins, for use in the US Biological Defense Program. AbD Serotec ...