Pharma Marketletter articles from May 2003

Pharma Marketletter archives from May 2003

Spanish consumer drug prices.
May 5, 2003... The consumer price of pharmaceuticals in Spain in March was unchanged as compared with February and 1.1% lower than in the same month of last year, reports the National Statistics Institute. In comparison, the monthly and annual increases in...

French drug spending up 5.4% in March.
May 5, 2003... Despite widespread economies, French health care spending has continued to rise this year. Provisional figures published by the health fund organization CNAM for March 2003 show year-on-year growth of 7.5% to 24.9 billion euros ($27.04...

Greek health care prices in March.
May 5, 2003... The National Statistical Service of Greece reports that the consumer price of health care in the country was 0.3% higher than in February and 5.1% higher than in March 2002. In comparison, the monthly and annual increases in the consumer price...

Merck drops Celltech-partnered asthma drug.
May 5, 2003... Merck & Co has decided to discontinue development of its lead phosphodiesterase-4 inhibitor compound, licensed from Celltech of the UK, at the Phase II trial stage. The latter company said that one patient in the trial had deveoped ischemic...

Medarex, UMass in SARS collaboration.
May 5, 2003... Medarex has formed a collaboration with the University of Massachusetts in the USA to develop an antibody-based treatment for severe acute respiratory syndrome, currently causing concern around the globe. The parties plan to use Medarex'...

Sanofi-Synthelabo 1st qtr below consensus.
May 5, 2003... Although French drugmaker Sanofi-Synthelabo posted a 13.4% increase on a comparable basis (5.6% reported) to 1.96 billion euros ($2.13 billion) in sales for the first quarter of 2003, the figure was slightly below consensus forecasts of...

Serono's 1st-qtr net falls 13.4%.
May 5, 2003... Switzerland-based Serono SA, Europe's largest biotechnology group, posted disappointing first-quarter profits, largely as a result of milestone charges associated with its upcoming psoriasis drug Raptiva (efalizumab). Net profit for the quarter...

Genzyme gets US go-ahead for Fabry drug Fabrazyme.
May 5, 2003... The US Food and Drug Administration has granted marketing approval to Genzyme for its Fabrazyme (agalsidase beta) enzyme replacement therapy for Fabry disease. Fabrazyme is the first treatment approved in the USA for people suffering from this...

Japanese companies face harsh reality as power shifts in domestic market.
May 5, 2003... Japan's pharmaceutical companies must face up to the harsh fact that they are rapidly losing competitive power and no longer dominate the domestic market. Moreover, those who had believed that the Japanese market was closed to foreign...

Western drugmakers grow Japanese share on R&D and field force strength.
May 5, 2003... Leading western drugmakers are increasing their marketing efforts in Japan by showcasing their diverse product line-ups and boosting sales forces at a much greater pace that their Japanese rivals, reports the Nikkei Weekly. At last count,...

India pharma shows recovery in March.
May 5, 2003... Indian drug industry sales rose 1% in March to 13.90 billion rupees ($293.4 million) against a fall of 1.4% to 13.67 billion rupees in February, reports AC Neilsen-ORG-Marg.

India sets guidelines for foreign drugmakers.
May 5, 2003... India has introduced, with immediate effect, guidelines for registration of manufacturing premises of foreign drugmakers, prior to the import of their products. Firms wanting to set up manufacturing plants in India will have to apply for...

GSK cuts HIV/AIDS Rx prices to LDCs again.
May 5, 2003... Ahead of a roundtable meeting organized by the European Commission to discuss access to medicines (see page 10), GlaxoSmithKline has announced a further reduction in the not-for-profit prices of its HIV/AIDS drugs to the world's least-developed...

India reduces VAT on medicines to 4%.
May 5, 2003... India's Empowered Committee of State Finance Ministers has reduced value-added tax on medicines to 4%, instead of 12.5% as had been proposed, and may make further cuts in the case of certain life-saving drugs. The pharmaceutical industry had...

Burkina Faso buys HIV/AIDS drugs from India.
May 5, 2003... The government of Burkina Faso has announced that it is to purchase generic HIV/AIDS drug treatments from Cipla Labs of India, in a move which it says will enable it to treat patients at a cost of $37-$70 per month. Health Minister Alain...

UK guide on disease awareness campaigns.
May 5, 2003... Disease awareness campaigns must not promote medicinal products to the public, the UK Medicines Control Agency says in new guidelines for industry, noting that a key provision of European Directive 2001/83/EC, which regulates the advertising of...

French protests at Rx de-reimbursements.
May 5, 2003... French Health Minister Jean-Francois Mattei's decision to cut reimbursement on 617 drugs, many of them mainstream products to treat major illnesses (Marketletter April 28), has been widely attacked. The mutual funds' federation, the FNMF,...

Bayer forecasts good growth, sales up 4%.
May 5, 2003... Germany's Bayer AG has reported a solid set of preliminary results for the first quarter of 2003, buoyed by the inclusion of the recently-acquired Aventis Crop Science unit into its balance sheet (Marketletters passim). The firm also said...

Biotie in antibody deal with Japan's Seikagaku.
May 5, 2003... Finnish drug development company Biotie Therapies has signed a $16.7 million licensing deal with Seikagaku of Japan covering the use of the former's VAP-1 antibody technology. Under the terms of the agreement, Seikagaku will have exclusive...

Losses widen at PPL in 2002 as firm refocuses.
May 5, 2003... UK-based PPL Therapeutics, the firm responsible for cloning Dolly the sheep, has reported widening losses for 2002 as it finalized its exit from the regenerative medicines business (Marketletter April 21) and completed a boardroom clear-out...

Roche to launch SARS diagnostic in July?
May 5, 2003... Roche of Switzerland is in the process of developing a diagnostic test for severe acute respiratory syndrome which could be on the market as early as July, according to a Reuters report. The World Health Organization welcomed the announcement...

US biotech firms soar on SARS treatment announcements.
May 5, 2003... The impact of the public paranoia surrounding the epidemic of severe acute respiratory syndrome became clear on April 25, when three US biotechnology firms saw their share prices score big gains after announcing very early-stage R&D programs...

AVI Biopharma joins SARS treatment testers.
May 5, 2003... AVI Biopharma of the USA on April 28 became the latest company to announce plans to develop a new drug treatment for severe acute respiratory syndrome, the infection, caused by a coronavirus, currently causing consternation across the globe....

Rapid assay for bladder cancer cleared by US FDA.
May 5, 2003... The US Food and Drug Administration has approved the first rapid assay screening test that physicians can use in their offices to help diagnose patients with bladder cancer. Matritech's NMP22 BladderChek test detects a bladder cancer nuclear...

Orphan status granted for photodynamic therapy for CML.
May 5, 2003... Celmed BioSciences, a subsidiary of Theratechnologies, has been granted orphan drug designation in the USA for Theralux, a photodynamic therapy technology, in the treatment of patients with chronic myeloid leukemia. The technology is being...

US FDA "has authority for Rx-OTC switches".
May 5, 2003... The US Food and Drug Administration believes it has the legal authority to decide whether a drug should have prescription or over-the-counter status, John Jenkins, director of new drugs at the FDA Center for Drug Evaluation and Research, has...

On-line pharmacies' "very limited" threat.
May 5, 2003... While US consumers spent a sizeable $700 million on-line to purchase prescription drugs from foreign Internet pharmacies in 2002, this represents under 0.4% of the total US pharmaceutical market, according to a new report published by Jupiter...

Iran's low levels of health care spending.
May 5, 2003... Iran's deputy Health Minister, Mohammad Ismail Akbari, says that state health spending in Iran currently stands at 5.7% of Gross Domestic Product, which is well below the figure found in most developed countries, reports the IRNA news agency....

Norway: first-quarter pharma imports.
May 5, 2003... Norway imported pharmaceuticals worth 1.96 billion kroner ($277 million) in the first quarter of this year, compared with 1.64 billion kroner in the same period of 2002, Statistics Norway has reported.

German health fund chief rejects govt claim.
May 5, 2003... The German industrial health funds federation, the BKK, has said that the average rate of patient contribution is already almost 15% of basic wage rates. However, federation president Wolfgang Schmeinck rejected health Minister Ulla...

Duty-free pharma trade between EURASEC states.
May 5, 2003... Trade in pharmaceuticals and other products between the EURASEC countries - Belarus, Kazakhstan, Russia and Tajikistan - may be conducted duty-free from 2006 onwards, reports the RIA novosti news agency. This was agreed at a meeting of the...

Gene therapy may bring relief to erectile dysfunction sufferers.
May 5, 2003... Researchers from the University of Pittsburgh Medical Center in the USA have found that gene therapy may not only be feasible, but also may be an ideal treatment for men with neuropathic erectile dysfunction, according to the results of a...

West Pharma and Chiron to develop nasal DT vaccine.
May 5, 2003... West Pharmaceutical Services has signed a development and worldwide licensing agreement with Chiron's vaccine division for the development and commercialization of a diphtheria and tetanus nasal vaccine. The new product would be based on using...

Pierre Fabre licenses TCM-based cancer drug from Pharmagenesis.
May 5, 2003... France's Pierre Fabre Medicament has licensed PG490-88Na, a patented derivative of a compound from a plant widely used in traditional Chinese medicine, from US/ Chinese company Pharmagenesis. Preclinical studies have shown that using...

4SC, ProQinase in cancer collaboration.
May 5, 2003... 4SC AG and fellow Germany company ProQinase GmbH have forged a research collaboration to identify a new generation of protein kinase inhibitors as the basis for the development of new anticancer drugs. Under the terms of the deal,...

J&J files Risperdal Consta new data with FDA.
May 5, 2003... Johnson & Johnson has submitted additional data and analyses to the US Food and Drug Administration in response to the not-approvable notice issued by the agency regarding the firm's Risperdal Consta (risperidone; Marketletter July 8, 2002)....

Life Medical makes progress with adhesion barrier.
May 5, 2003... Life Medical Sciences has successfully completed a feasibility trial of its REPEL-CV bioresorbable adhesion barrier, designed to reduce post-operative adhesion formation in cardiac surgical procedures. The trial involved 13 newborns who...

Alizyme's renzapride promising in IBS.
May 5, 2003... The UK's Alizyme has reported positive preliminary results from a Phase IIb clinical trial of renzapride in patients with constipation-predominant irritable bowel syndrome. The firm's chief executive, Richard Palmer, said that the results...

Vicuron files NDA for anidulafungin in USA.
May 5, 2003... Vicuron Pharmaceuticals of the USA, born out of the merger of Versicor with Biosearch Italia (Marketletters passim) has submitted the first marketing application for its antifungal anidulafungin in the USA. Approval is being sought for use of...

Noven tanks as ADHD patch is rejected by US FDA; partner Shire also impacted.
May 5, 2003... Noven Pharmaceuticals' transdermal patch product for individuals with attention-deficit hyperactivity disorder, Methypatch (methylphenidate), has been turned down by the US Food and Drug Administration. The news wiped 38% off the value of...

US HHS compliance guide tells firms: "stick to PhRMA Code in dealings with doctors".
May 5, 2003... The Office of Inspector General at the US Department of Health and Human Services has issued its voluntary guidance for pharmaceutical manufacturers which outlines the actions they can take to promote compliance with the rules and regulations...

EU Commission urges USA and slams pharma over LDC drug access stalemate.
May 5, 2003... There is now broad agreement that the way forward to increasing the availability of and access to medicines for developing countries is through tiered drug pricing, not as a substitute for other actions but interrelated with them, European...

PowderJect receives bid from unnamed party.
May 5, 2003... UK-based vaccine manufacturer PowderJect saw its shares move 7% higher on April 28 on news that the company had received an approach "which may or may not lead to a formal offer for the company." PowderJect, Europe's largest vaccine...

Kyowa Hakko profits slump in fiscal 2002.
May 5, 2003... Japan's Kyowa Hakko has reported pretax profit of 11.5 billion yen ($95.5 million) for the fiscal year ended March 2003, a slump of 39% on the prior fiscal year and below the forecast of 14 billion yen. Reductions in drug prices and...

Primagen alliance with Pharmasset.
May 5, 2003... Primagen BV of the Netherlands has entered into an exclusive worldwide licensing agreement to commercialize a novel mitochondrial DNA detection and toxicity technology developed by the USA's Pharmasset. Damage to mitochondrial DNA can cause...

Novartis, Cytos extend Immunodrug alliance.
May 5, 2003... Cytos Biotechnology AG and Novartis have extended their collaboration on the development of therapeutic vaccines for allergy, rheumatoid arthritis and central nervous system disorders, first announced in 2001 and based on Cytos' Immunodrug...

Targeted Genetics and CFFT link up for cystic fibrosis trial.
May 5, 2003... Targeted Genetics and Cystic Fibrosis Foundation Therapeutics are to collaborate on the conduct of a Phase IIb trial of tgAAVCF, the former's gene-based product candidate. The trial will evaluate the efficacy of tgAAVCF in patients with...

Pain Therapeutics' IBS study enrolled.
May 5, 2003... Pain Therapeutics says it has completed patient enrollment in a pilot clinical study of PTI-901, a novel opioid anagonist being developed for patients who suffer from irritable bowel syndrome.

Focus Inhalation: new deal with Perlos.
May 5, 2003... Focus Inhalation Oy of Finland has signed a development and manufacturing agreement with Perlos Oyj, a Finnish specialist in component manufacture, in what it describes as "a major step towards full industrialization and commercialization" of...

Speedel signs new renin inhibitor collaboration.
May 5, 2003... Speedel, a Swiss pharmaceutical company focused on cardiovascular and metabolic drug development, has formed a research collaboration with Locus Pharmaceuticals of the USA focusing on the design of novel renin inhibitors, a new class of...

Wyeth's Zosyn dosing cut.
May 5, 2003... Wyeth has been granted approval in the USA to cut the daily dose of its antibiotic Zosyn (piperacillin/tazobactam) from six to four times daily for patients with hospital-acquired pneumonia. The firm said that cutting the doses means that less...

Ortho cleared to launch Axert in USA.
May 5, 2003... Ortho-McNeil Pharmaceuticals has been given the go-ahead to re-launch the antimigraine drug Axert (almotriptan malate), licensed from Spain's Almirall, in the USA. The move follows an early termination of the Federal Trade Commission's review...

King gets Orange Book patent for Levoxyl.
May 5, 2003... King Pharmaceuticals has received a US patent covering the thyroid replacement drug Levoxyl (levothyroxine) in a development which could block generic competition for its second-largest product. The company says the listing of the patent in the...

Tokyo stocks to April 28.
May 5, 2003... Tokyo saw a pullback due to a dearth of buying incentives and market players' restrained activities waiting for a long holiday break. The Nikkei 225 dropped 4.5% to 7607.88, renewing a new 20-year low. The Topix index fell 3.6%. Selling...

Update: Genzyme gets US go-ahead for Fabrazyme.
May 5, 2003... The US Food and Drug Administration has granted marketing approval to Genzyme for its Fabrazyme (agalsidase beta) enzyme replacement therapy for Fabry disease. Fabrazyme is the first treatment approved in the USA for people suffering from this...

J&J's drug-eluting stent Cypher approved for CAD patients in USA.
May 5, 2003... Johnson & Johnson's medical device subsidiary, Cordis, has been granted marketing approval for its Cypher drug-eluting stent in the USA. The clearance by the US Food and Drug Administration follows the registration and launch of the device in...

Pharma calls for drug access initiatives ahead of G8 Summit.
May 5, 2003... Most progress in improving poor countries' access to health care has been made on the supply side and more needs to be done on the demand side, by increasing the capacity of developing countries and the resources available to them, according to...

Eight EU treaties ban parallel imports.
May 5, 2003... The European Union accession treaties for eight Central and Eastern European states signed this month in Athens, Greece, include a special mechanism which allows drugmakers to block these nations' trade in parallel imports. The derogation...

German health spend: pharma share falls.
May 5, 2003... While German health care spending rose 38.5% during 1992-2001, pharmaceuticals' share of the total grew just under 35%, reports the Federal Statistics Office. Public and private health care spending reached 225.9 billion euros ($248.06...

Profits down at AstraZeneca as Prilosec sales plummet, but Nexium turnover soars.
May 5, 2003... Anglo-Swedish drugmaker AstraZeneca has posted a 3% decline in pretax profits for the first quarter of 2003 as the company began to feel the full effect of generic competition to its blockbuster antiulcerant Prilosec/Losec (omeprazole)....

GSK overcomes Augmentin woes, posts strong sales and earnings in 1st quarter.
May 5, 2003... Europe's leading drugmaker, GlaxoSmithKline, has reported results ahead of expectations for the first quarter of 2003, as the firm benefited from cost-cutting measures and managed to absorb much of the impact of generic competition for its...

US stents market "near-$1 billion in first year".
May 5, 2003... In their first full year on the market, drug-eluting stents for the treatment of coronary artery disease (see page 18) will have US revenues of nearly $1 billion, says a new study by Kalorama Information. However, issues surrounding pricing and...

Colorado Medicaid sets eight-drug limit.
May 5, 2003... Medicaid beneficiaries in the US state of Michigan can now receive only eight prescription drugs at any one time, with prescribers required to obtain prior authorization before providing them with any further medications. Six categories of...

Frist hopes Rx bill will pass by end-June.
May 5, 2003... US Senate Majority leader Bill Frist has said that, while Congress has only an eight-week narrow window of opportunity in which to approve a Medicare prescription drug benefit, he is hopeful that final legislation can be passed by the end of...

Massachusetts seeks to end seniors' Rx plan.
May 5, 2003... Legislation before the House of Representatives in the US state of Massachusetts which seeks to break the state's $3 billion budget deficit would abolish the state Prescription Advantage drug benefit program, which covers 80,000 seniors and...

Executive changes t Takeda.
May 5, 2003... Takeda Chemical Industries board director Yasuchika Hasegawa has been named president of the company (and will double as chief operating officer), replacing Kunio Takeda who becomes chairman of the board.

Hybrigenics acquires Semaia.
May 5, 2003... French pathway-based drug discovery firm Hybrigenics SA has acquired 100% of the shares of Dutch company Semaia BV, which specializes in the exploration of new drug targets in oncology, in an all-share transaction, the financial details of...

Nihon Schering names Gunter Stock as chairman.
May 5, 2003... Schering AG of Germany's Japanese subsidiary, Nihon Schering, has appointed Gunter Stock, currently a director of the unit, as chairman, replacing Klaus Pohle.

Mexico's Gasa Saba sees net profit fall.
May 5, 2003... Grupo Casa Saba of Mexico has reported a 14.3% decline in net profit for the first quarter of 2003 to 147.5 million pesos ($14.0 million) on sales of 4.83 billion pesos, an increase of 5.0%. The group's Government Pharma division saw turnover...

Research collaboration for Olympus and Panacea Pharma.
May 5, 2003... Japan's Olympus Optical has signed an agreement with US biotechnology start-up Panacea Pharmaceuticals to conduct joint research on disease-related proteins. Under the terms of the deal, Olympus' state-of-the art analysis equipment will be...

DSM names new pharma business director.
May 5, 2003... Dutch chemicals and pharmaceuticals group DSM has named Bernard van Schaik as business group director of DSM Pharmaceutical Products, replacing Henk Numan who becomes corporate director strategic projects, where he will continue to focus on the...

Inpharmatica in genomics link with Galapagos.
May 5, 2003... UK-based drug discovery firm Inpharmatica has entered into a collaboration with Belgian functional genomics company Galapagos Genomics NV. Under the terms of the deal, Inpharmatica will use its chemogenomics technology platform, PharmaCarta, to...

Promotions at Meiji Seika.
May 5, 2003... At Japan's Meiji Seika Kaisha, current president Ichiro Kitasata and Naotada Satoh (now executive vice president) have been promoted to chairman and president, respectively, effective June 26.

Hakan Mogren goes non-exec at AstraZeneca.
May 5, 2003... Hakan Mogren, executive deputy chairman of Anglo-Swedish firm AstraZeneca, will become non-executive deputy chairman effective August 31. Dr Mogren was chief executive of Astra prior to its merger with Zeneca in 1999.

Eurand names Henry Kwan VP of R&D in USA.
May 5, 2003... Italy-headquartered specialty pharmaceutical company Eurand has appointed Henry Kwan as vice president of R&D for its North American operations, responsible for R&D and regulatory affairs. Prior to joining Eurand, Dr Kwan, who has held numerous...

lAntisoma promotes Nigel Courtenay-Luck.
May 5, 2003... UK-based Antisoma has promoted Nigel Courtenay-Luck to chief scientific officer, an ambassadorial role, presenting the company's science at conferences.

Serono slams CPMP decision on Serostim.
May 5, 2003... Switzerland's Serono has taken issue with the decision by the European Union's Committee on Proprietary Medicinal Products not to recommend granting marketing authorization for Serostim (somatropin), the firm's growth hormone-based treatment...

Indevus files for OAB drug trospium in USA.
May 5, 2003... Indevus Pharmaceuticals has filed for approval of its overactive bladder treatment, trospium, in the USA. The company also unveiled new Phase III data, reported at the American Urological Association's annual meeting in Chicago, showing that...

GSK unveils SARS vaccine plans.
May 5, 2003... GlaxoSmithKline says it has joined the ranks of companies pursuing treatment and prevention options for severe acute respiratory syndrome (see also page 21). The company's chief executive, Jean-Pierre Garnier, told a conference call on its...

Mixed results for India's pharma sector in 1st quarter; market growth flat.
May 5, 2003... Pharmaceutical companies based in India reported a mixed set of financial results for the first quarter of 2003, with their performances influenced by market forces and other, broader, factors, reports the Marketletter's local correspondent....

Palatin makes progress with nasal ED drug.
May 5, 2003... US company Palatin Technologies has reported the results of two Phase IIa trials which indicate that its intranasal therapy for erectile dysfunction, PT-141, has a promising safety and efficacy profile. The drug has a different mechanism of...

Levitra effect seen in 16 minutes.
May 5, 2003... Bayer and GlaxoSmithKline's new erectile dysfunction drug Levitra (vardenafil HCl) is associated with a high level of satisfaction among users and can achieve a response as early as 16 minutes after dosing, according to the results of two new...

Data back Zometa's role in prostate cancer.
May 5, 2003... 24-month data from a Phase III trial of Novartis' bisphosphonate Zometa (zoledronic acid) in patients with prostate cancer that has metastasized to bone reveal that the drug can slow pain progression and reduce bone complications. The study...

Four-year Avodart data reinforce role in BPH.
May 5, 2003... GlaxoSmithKline's 5-alpha reductase inhibitor Avodart (dutasteride) has shown long-term safety and efficacy out to four years in men suffering from benign prostatic hyperplasia. The new data come from two-year, open-label extensions of the...