Pharma Marketletter articles from October 2003

Pharma Marketletter archives from October 2003

Illegal cross-border trade threat to Canada's Rx supply, may violate trade deals: study.
October 6, 2003... The supply of branded prescription drugs to Canadians is likely to dry up if the government does not act to stop illegal shipments to the USA, warns a new study by the Fraser Institute, a Canadian public policy organization which claims to...

Takeda to double marketing offices.
October 6, 2003... Japanese drugmaker Takeda has unveiled plans to almost double the number of marketing offices it has in the country to 156 from the current 86 during October, reports the Nihon Keizai Shimbun. The boost will allow each office to focus its...

Pharmaco secures 185M-euro loan.
October 6, 2003... Icelandic drugmaker Pharmaco has secured a 185 million-euro ($210.9 million) loan from a syndicate of 10 European banks. The company, which recently passed the $1 billion stock market valuation mark, says that it will use the funds to stimulate...

CryoCath raises C$29M from share sell-off.
October 6, 2003... Canadian cardiovascular disease specialist CryoCath says that it has reached an agreement with a syndicate of its underwriters to sell common stock worth C$29 million ($19.4 million). The funds will be used to support both research and...

Quintiles merges with Pharma Services.
October 6, 2003... Pharmaceutical contracting specialist Quintiles Transnational and Pharma Services Holding have completed a merger which sees the former's public shareholders receive $14.50 per share in cash, valuing the firm at some $1.7 million. Pharma...

Rich nations must pay more for drugs, says US FDA head; warns of global R&D crisis.
October 6, 2003... The main reason why US prescription drug prices are so high is because the country is paying most of the costs of developing new treatments. Not only has this got many Americans angry, it means there is now a global crisis over affordable, safe...

Massachusetts sues 13 generics makers.
October 6, 2003... The Attorney General of the US state of Massachusetts, Tom Reilly, has filed a lawsuit against 13 generic drug manufacturers, alleging that they improperly inflated the prices paid for their products by the state Medicaid program for a numbers...

Zeltia provides more data on Yondelis safety to sway EMEA approval.
October 6, 2003... Spanish pharmaceuticals group Zeltia has disclosed more information about the safety of its lead cancer compound Yondelis (ET-743) following the European Medicines Evaluation Agency's recent decision not to approve the drug for marketing...

Cannabis drug Sativex shows promise in MS.
October 6, 2003... Bayer says that Sativex, a pump-action oromucosal spray which delivers a formulated blend of two cannabis plant extracts (tetrahydrocannabinol and cannabidiol) in a 1:1 ratio, is effective in reducing both neuropathic pain and sleep disturbance...

UCB Pharma's strategy on allergy franchise could shift, says broker.
October 6, 2003... While Belgian drugmaker UCB Pharma's Zyrtec (cetirizine) may continue to perform well on the US market mid-term, the expiry of its patent there is still looming, and the firm's defense strategy for its allergy franchise in Europe could shift,...

Watson licenses novel product to UCB.
October 6, 2003... UCB Pharma of Belgium has entered into a licensing agreement with a unit of US firm Watson Pharmaceuticals to market the latter's novel oxybutynin transdermal patch for the treatment of urinary incontinence in Europe. Watson's product, which...

Forest's Namenda on track for US approval.
October 6, 2003... The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously recommended the approval of Forest Laboratories' Namenda (memantine HCL) for the treatment of moderate to severe Alzheimer's...

Alizyme's renzapride shows efficacy in m-IBS.
October 6, 2003... UK-based Alizyme has released positive preliminary results from a Phase IIb trial of its renzapride in patients with mixed-symptom irritable bowel syndrome. The European study was a randomized, double-blind, placebo-controlled, parallel...

Schering AG's Zevalin gets positive opinion.
October 6, 2003... The European Union's Committee for Proprietary Medicinal Products has issued a positive opinion for Germany-based Schering AG's radioimmunotherapy product Zevalin (ibritumomab tiuxetan). The product is indicated for the treatment of adult...

Enbrel recommended in EU for new use.
October 6, 2003... Wyeth and Amgen's Enbrel (etanercept) has been recommended for approval by the European Union's Committee for Proprietary Medicinal Products as a treatment for adults with severe active ankylosing spondylitis who have inadequate response to...

Pharmacy licenses issued in Spain.
October 6, 2003... A hundred pharmacy licenses are being offered, subject to competition, in the Spanish state of Valencia following an earlier decision by the authorities to reduce the ratio of inhabitants per pharmacy from 4,000 to 2,800. Some 20,000...

Judgement on Hep A vaccination.
October 6, 2003... An international consensus panel has concluded that the hepatitis A primary vaccination course provides long-term immunity against the virus into adulthood, with no need for a booster vaccine for healthy individuals, according to an article...

CORRECTION: ref placebo approval.
October 6, 2003... In all good faith, Marketletter published a news item based on what appeared to be a comprehensive report from a usually very reliable source, in the September 29 issue, that the US Food and Drug Administration had approved placebo for...

German health reform voted in; pharma industry plans legal action.
October 6, 2003... The German government's health reform has been voted in by the country's parliament with a strong majority of 517 votes in favor, 54 against and three abstentions. It now has to go through committee stages and then into the upper house, with...

EMEA, new EU states discuss priorities.
October 6, 2003... The European Medicines Evaluation Agency has held a meeting with the head of medicines agencies of the European Union accession countries, as part of the preparations ahead of EU enlargement on May 1, 2004. The heads of the accession...

Swiss drug sales data.
October 6, 2003... Swiss retail sales of pharmaceutical and medical products increased 23.5% in July over the previous month, the Federal Statistical Office has reported.

World Rx sales up 6% in year to July 2003.
October 6, 2003... Drug sales made through retail pharmacies in 13 leading world markets grew 6% overall to total $296 billion in the 12 months to July 2003, IMS Health has reported. The US market grew 9% to $154.91 billion, while Canadian sales reached...

Indian firms win US approvals, other news.
October 6, 2003... Recent news of Indian drugmakers' US marketing approvals, plus patent and joint venture developments, have boosted the firms' share prices, despite a sluggish market, writes Ajoy Sen, the Marketletter's New Delhi correspondent. The US Food...

Indian exemptions for export-only pharma.
October 6, 2003... The Drug Controller General of India has exempted 100%-export-oriented domestic drugmakers from having to obtain registration and import licenses to buy raw materials and goods from abroad, the Directorate General of Health Services has...

Jordan moves to boost pharma exports.
October 6, 2003... Jordanian-made drugs have a good reputation but face strong competition, Jordan Investment Board director general Reem Badran has told the Jordan Times. Lowering costs and improving their quality is essential, he added. Reporting on moves...

Egypt to register Jordanian drugs.
October 6, 2003... Egypt has finally approved the registration of Jordanian drugs, with a formal memorandum from the Health and Population Ministry saying that five types of medicines from six Jordanian firms will be registered for sale in Egypt.

Growth factor market "set to surpass $30B by 2007".
October 6, 2003... The global market for growth factor-based therapeutics, currently valued at $20 billion, is set for a period of growth and change over the next five years, according to a new study published by Kalorama Information. In addition to revenue...

Abbott, Boehringer Ingelheim donate to beat MTCT of HIV.
October 6, 2003... Abbott Laboratories and Boehringer Ingelheim have announced a cooperative arrangement under which eligible groups with comprehensive programs for prevention of mother-to-child transmission of HIV can receive, free, Abbott's Determine HIV1/2...

British Pharmacopoeia 2003 published.
October 6, 2003... The 2003 edition of the British Pharmacopoeia, which was published at the end of September, contains the new standards which will be legally enforceable in the UK and European markets from December 1. It is supplied in three formats - a boxed...

FDA panel gives partial backing for Cephalon's Provigil, but not sleepiness.
October 6, 2003... The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has backed approval of two new indications for Cephalon's narcolepsy drug Provigil (modafinil), but split down the middle, four-four, on...

UPDATE: US FDA advisers back Forest's memantine in moderate-to-severe Alzheimer's.
October 6, 2003... Forest Laboratories moved its Alzheimer's therapy Namenda (memantine) one step closer to the US market when the Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that the drug is...

Satraplatin in Ph III.
October 6, 2003... GPC Biotech AG has said that the first patient has been dosed in the satraplatin Phase III registrational trial. The multicenter, global, randomized study has been named SPARC (Satraplatin and Prednisone Against Refractory Cancer) and is...

Abbott to buy Integrated Vascular for $65M.
October 6, 2003... US health care major Abbott Laboratories has announced the acquisition of Integrated Vascular Systems, based in Sunnyvale, California, a developer of a novel vessel closure technology. Under the terms of the agreement, Abbott has acquired all...

Change in US policy adds cancer option, says Chiron.
October 6, 2003... Chiron Corp of the USA has commended the US federal Centers for Medicare and Medicaid Services for implementing a reimbursement change due October 1 that will increase access to high-dose interleukin-2 therapy for certain patients with...

Progenics gains $28.6M HIV vaccine contrat.
October 6, 2003... Progenics Pharmaceuticals has been awarded a contract by the US National Institutes of Health to develop a novel vaccine against HIV. The contract, from the NIH's National Institute of Allergy and Infectious Diseases, provides the company with...

$252M offering by Angiotech.
October 6, 2003... Canada's Angiotech Pharmaceuticals says that it has executed an underwriting agreement with respect to the previously-announced public offering for the sale of 5 million common shares at a price of $43.75 per share (C$59.01 per share). Gross...

Lilly's Gemzar-based therapies show promise for metastatic breast cancer.
October 6, 2003... An Eli Lilly-sponsored satellite symposium at the 12th European Cancer Conference in Copenhagen, Denmark, has highlighted the importance of combination therapy in the fight against metastatic breast cancer and reviewed the clinical data...

Aventis says human vaccines business will maintain double-digit growth.
October 6, 2003... Franco-German pharmaceutical major Aventis highlighted its human vaccines business at a meeting of investment analysts late-September, at which it said this unit has achieved double-digit sales growth over the last decade and is expected to...

Tokyo pharma stocks - week to Sept 29.
October 6, 2003... Tokyo saw an extended consolidation in the week ended September 29 amid increasing caution about the recent fast pace of the stock market's rally. The market was discouraged by a series of unfavorable external factors, such as the yen's ascent,...

French dereimbursement: 1st phase cuts 82 prods.
October 6, 2003... 82 products will be removed from France's list of reimbursable drug specialties on October 25, in a first phase of de-reimbursement due to "inadequate medical service." The products are listed in the Official Journal.

New NICE guidances for England and Wales.
October 6, 2003... New guidances published by the National Institute for Clinical Excellence related to National Health Service treatment in England and Wales say that: - Eli Lilly's Zyprexa (olanzapine) and Sanofi Synthelabo's Depakote (valproate...

Spain cuts patient co-pays in three areas.
October 6, 2003... As part of moves to adapt the health care system to new demographic and other priorities, Spain is cutting patient contributions for some drugs. A new law reduces co-payments for hypercholesterolemia drugs from 40% to 10% and provides up to 90%...

Scottish NHS drugs bill up 10% in 2002.
October 6, 2003... Scotland's National Health Service drugs bill rose 10% to L773 million ($896.3 million) last year. The number of prescriptions increased 5% to 69.5 million and 77% of these were filled by generics, it is reported.

Actelion acquires Axovan AG as biotechnology consolidation continues.
October 6, 2003... Switzerland's Actelion, one of only a handful of European biotechnology concerns currently making a profit, has acquired fellow Swiss firm Axovan AG in a deal worth nearly $190 million. The move is intended to bolster both its late-stage...

CeNeS turns to profit on disposals.
October 6, 2003... UK-based drug discovery concern CeNeS has reported a profit for the first half of 2003 thanks to the disposal of a number of its products earlier this year (Marketletters passim). The company, which recently completed a thorough cost-cutting...

GSK's Paxil losing ground fast, says IMS.
October 6, 2003... Sales of GlaxoSmithKline's blockbuster antidepressant Paxil/Seroxat (paroxetine) are rapidly being eroded by generic versions which have recently entered the market, according to data from IMS Health. The drug rang up sales of around $2.2...

US FDA/Customs import blitz finds 88% contained unapproved drugs.
October 6, 2003... Recent spot examinations of mail shipments of foreign drugs into the USA conducted by the Food and Drug Administration and US Customs and Border Protection have found they often contain dangerous unapproved or counterfeit drugs. The...

Oct 17 deadline for US Medicare Rx bill.
October 6, 2003... Republican leaders in the US Congress have set October 17 as the deadline for the House-Senate negotiators to reach agreement on a Medicare prescription drug benefit. If they fail, House Speaker Dennis Hastert and Senate Majority Leader Bill...

Herceptin combi helps breast cancer survival.
October 6, 2003... Data presented at the 12th European Cancer Conference in Copenhagen, Denmark, showed that Roche/Genentech's Herceptin (trastuzumab) in combination with Aventis' Taxotere (docetaxel) nearly doubles median survival time in women with advanced...

Genentech files BLA with FDA for Avastin.
October 6, 2003... Genentech has revealed that it has completed the filing of a Biologics License Application with the US Food and Drug Administration for use of its Avastin (bevacizumab) as a first-line treatment for metastatic colorectal cancer in combination...

S-P to compare hep C therapies.
October 6, 2003... Schering-Plough Corp is to conduct the first direct study to compare two approved forms of pegylated interferon therapy for chronic hepatitis C virus infection. The trial will examine Schering's Peg-Intron (peginterferon alfa-2b) versus Roche's...

Sales improve at Tissue Science Labs.
October 6, 2003... UK-based Tissue Science Laboratories, a medical devices concern specializing in tissue repair and associated products, has reported a widening of its losses for the first half of 2003, although sales improved in line with the firm's forecasts....

Baxter/Aventis receive $18M SARS funding.
October 6, 2003... US health care major Baxter International and Franco-German drugmaker Aventis have been granted a total of $18 million in research grants from the US National Institute for Allergy and Infectious Diseases. The funds are intended for the...

Profits down at Integrated Biopharma.
October 6, 2003... The USA's Integrated Biopharma, which manufactures both pharmaceuticals and nutraceuticals, has reported a dip in profits for the first half of 2003 as revenues edged down and the company increased spending on its Paxis Pharmaceuticals...

Protein Design Labs buys Zenapax for $80M.
October 6, 2003... The USA's Protein Design Laboratories says that it has obtained exclusive worldwide rights to Roche's transplant drug Zenaplax (daclizumab), in all indications, for a reported $80 million. Roche will retain the rights to market the product in...

Bayer units gain legal freedom from parent.
October 6, 2003... German chemicals and pharmaceuticals major Bayer AG says that Bayer HealthCare AG, Bayer Chemicals AG and Bayer Technology Services GmbH achieved legal independence when the carve-outs of their respective businesses from the parent company were...

Sanofi responds to research note claims.
October 6, 2003... Sanofi-Synthelabo of France says that it has contacted the French stock market regulator in the wake of a recent analyst's report from Dresdner Kleinworth Wasserstein. The firm refutes a claim made by the DKW analyst that one of its product...

US approvable letter for Forest's Lexapro in GAD.
October 6, 2003... Forest Laboratories has received an approvable letter from the US Food and Drug Administration to expand the use of Lexapro (escitalopram oxalate) to include the treatment of generalized anxiety disorder. The company says that Lexapro "is...

Irish Deputy Premier to attend CORDIA.
October 6, 2003... Mary Harney, Ireland's Deputy Prime Minister and the incoming president of the European Union Competitiveness Council from next January, has agreed to speak at the opening plenary session of CORDIA - EuropaBio Convention 2003, December 2, in...

Arqule initiates first human study with CO-501 in cancer.
October 6, 2003... US firm ArQule has initiated the first human clinical trial with CO-501, a novel investigational small-molecule anticancer drug. CO-501 is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular...

Aventis/Teva's Copaxone fully available in France.
October 6, 2003... Aventis and Teva Pharmaceutical Industries have announced that their Copaxone (glatiramer acetate), used for the treatment of relapsing-remitting multiple sclerosis, is now widely available (in both hospitals and private pharmacies) throughout...

New data for Taxotere in the MBC setting.
October 6, 2003... Results presented at the 12th European Cancer Conference in Copenhagen, Denmark, demonstrated that women with metastatic breast cancer who were given Aventis' Taxotere (docetaxel) had a statistically-significant improvement in overall survival...

Philadelphia files fraud suit against Medco.
October 6, 2003... A federal lawsuit has been filed by the Associate US Attorney for the Eastern District of the US state of Philadelphia against Medco Health Solutions, the USA's largest pharmacy benefit manager, alleging violations of the federal False Claims...

Parallel trade: is the US industry at risk?
October 6, 2003... While the parallel trade in pharmaceuticals can be looked at from moral, economic and legal angles, the most influential factor on its development will be political, according to a new report from Urch Publishing. Parallel importing of...

UK govt "not putting money aside for next-generation drugs".
October 6, 2003... The UK government is failing make financial provision for the next generation of medicines, yet new cancer drugs alone could cost the National Health Service L2.5 billion ($2.90 billion) a year, warns a leading private health insurer. Last...

Mitsubishi forecasts 17% dip in profits.
October 6, 2003... Japanese drugmaker Mitsubishi Pharma says that it expects consolidated operating profit for the first half of fiscal 2004, ended September 30, 2003, to be down 16% on the like, year-earlier period at 16 billion yen ($144.5 million). This...

Australia's Cottee going to the wall?
October 6, 2003... Australian drugmaker Cottee Health PharmAction has filed for voluntary administration, having lost a major contract and owing A$10 million ($6.7 million). The company did not have sufficient funds to upgrade quality control and struggled to...

Sankyo targeting 50% share of statins market.
October 6, 2003... Leading Japanese drugmaker Sankyo is targeting peak annual domestic sales of some 18 billion yen ($162 million) and a 6% market share of the statins sector for its recently-launched lipid-lowerer Livalo Tab (pitavastatin; co-marketed with...

Oz biotech firms team up for diabetes R&D.
October 6, 2003... In Australia, two biotechnology firms, StarPharma and AGT Biosciences, have joined forces in a bid to bring a type 2 diabetes drug to market. StarPharma will develop the drug and AGT will conduct the evaluation, employing its...

Losses widen at Proteome in first half.
October 6, 2003... UK biotechnology concern Proteome Sciences has reported widening losses for the first half of 2003, although the firm said that positive newsflow on commercialization deals could be expected in the coming months. The company, which has...

British Biotech strips pipeline, targets commercial success.
October 6, 2003... British Biotech has dumped half of its drug pipeline as it focuses on those products which it considers most likely to have commercial success. The company, which was renamed Vernalis October 1 following its merger with the latter...

Altana Pharma US names Roberto Cetrullo VP business development.
October 6, 2003... Altana of Germany's subsidiary Altana Pharma US has recruited Roberto Cetrullo, formerly with Human Genome Sciences, as vice president, business development, responsible for executing in-licensing, acquisitions and out-partnering opportunities....

Probitas Pharma delays listing.
October 6, 2003... Spanish blood derivative products group Probitas Pharma is to postpone its application for a stock market listing until June 2004. The company had hoped to make the move this year (Marketletter June 2) but has said that market turbulence had...

Appointments at Ariad Pharma.
October 6, 2003... USA-based Ariad Pharmaceuticals has named former Novartis executive Paul Sekhri as its president and chief business officer. Chief executive Harvey Berger will relinquish his title as president to make room for Mr Sekhri. In addition, Ariad has...

Stallergenes forecasts strong 2003 rise in profits.
October 6, 2003... French specialist immunotherapy drugs producer Stallergenes has posted a rise of 113% in first-half 2003 profits to 3.2 million euros (3.4 million) and is forecasting strong results for the full year, despite seasonal rebalancing of sales in...

Pharmos' dexanabinol on FDA fast-track.
October 6, 2003... The US Food and Drug Administration has granted fast-track designation for Pharmos Corp's dexanabinol in the treatment of severe traumatic brain injury. The neuroprotective agent is currently undergoing a pivotal Phase III trial which aims to...

VaxGen awarded $80.3 million NIAID contract.
October 6, 2003... US firm VaxGen has been awarded a three-year contract worth $80.3 million from the National Institute of Allergy and Infectious Diseases to assist in the development of its anthrax vaccine candidate, rPA102. The product, composed of an alum...

Xoma's topical acne treatment enters Ph I.
October 6, 2003... A Phase I trial has been initiated by Xoma for its XMP.629 compound, which has potential utility as a topical treatment for acne. The study will evaluate the safety of the agent in healthy volunteers when administered three times per week over...

Ranbaxy launches cholesterol-lowerer Rosuvas.
October 6, 2003... Indian drugmaker Ranbaxy has launched Rosuvas (rosuvastatin) for lowering low-density lipoprotein cholesterol and triglyceride levels, while raising high-density lipoprotein cholesterol levels. The company's regional director, Malvinder Mohan...

Promising data for Fujisawa's FK778.
October 6, 2003... Japan-based Fujisawa's immunosuppressant, FK778, demonstrates efficacy and is well tolerated in kidney transplant patients, according to data presented at the 11th Congress of the European Society for Organ Transplantation in Venice, Italy....

New large-scale breast cancer prevention trial starts.
October 6, 2003... Cancer Research UK has announced the launch of a major new study on preventing breast cancer called IBIS-II. This international multicenter study will evaluate AstraZeneca's Arimidex (anastrozole) versus placebo in postmenopausal women at...

CORRECTION: Placebo not cleared by FDA.
October 6, 2003... CORRECTION: In all good faith, the Marketletter published a news item based on what appeared to be a comprehensive report from a usually very reliable source, in the September 29 issue, that the US Food and Drug Administration had approved...

Nastech names Paul Johnson senior VP, R&D.
October 6, 2003... Nastech Pharmaceuticals of the USA has recruited Paul Johnson as senior vice president, R&D, and chief scientific officer. Prior to this, Mr Johnson held a similar post with EpiGenX Pharmaceuticals.

Appointments at Axonyx.
October 6, 2003... US firm Axonyx has promoted Gosse Bruinsma (now president of Axonyx Europe) to the post of president, and has named Gerrard Viak as vice chairman of its board.