Pharma Marketletter articles from August 2003

Pharma Marketletter archives from August 2003

Spanish Health Minister says drug reference prices "benefit citizens".
August 4, 2003... Spanish Health Minister Ana Pastor believes that the new drug reference-price system for the national health system will "benefit all citizens," by making most common medicines cheaper to buy. Speaking at a gathering of doctors in the northern...

Nationwide attack on German health reform.
August 4, 2003... The "consensus" agreement between the German left- and right-wing parties over the government's health care reform is under heavy fire from all quarters of the nation. Health Minister Ulla Schmidt and CSU vice chairman Horst Seehofer announced...

AstraZeneca raises full-year earnings guidance on comforting 2nd-qtr results.
August 4, 2003... Anglo-Swedish drugmaker AstraZeneca says that it is raising its full-year 2003 earnings guidance to $1.65-$1.75 from the $1.50-$1.65 initially forecast after what it described as a "strong sales performance" in the first half of this year. ...

Roche acquires Igen for $1.4bn, ends dispute.
August 4, 2003... Swiss drugs and diagnostics major Roche has moved to settle its long-running legal dispute with USA-based Igen by acquiring the firm in a deal valued at around $1.4 billion. Roche made an offer of $47.25 per share, which has been approved by...

Concern at Australian NSAID sales proposal.
August 4, 2003... Serious concerns have been raised by a recent draft recommendation by Australia's National Drugs and Poisons Committee to allow the nonsteroidal anti-inflammatory drug ibuprofen to be sold at outlets other than pharmacies. Noting its fears...

Indonesia's fake drugs market hits President.
August 4, 2003... The recent claim by Indonesia's President, Megawati Soekarnoputri, that she was given counterfeit drugs by a presidential doctor has re-ignited the country's perennial problem of fake medicines. The major source for fakes is Pramuka in...

Singapore drug output in January-May.
August 4, 2003... Singapore's production of pharmaceuticals in the first five months of this year rose 11.3% on the same period of 2002, reports Statistics Singapore. In comparison, total manufacturing output was up 0.4%, year-on-year.

Vietnamese pharma output, other news.
August 4, 2003... Drug manufacturers operating under the Vietnam Pharmaceuticals Corp achieved export earnings worth $3.4 million in the first half of 2003, with some 50% of this figure coming from the sale of new products, reports the Vietnamese News Agency....

No surprises as EMEA shuns Yondelis.
August 4, 2003... The news was not unexpected but disappointing nonetheless, as Spain's Zeltia confirmed on July 24 that the European Medicines Evaluation Agency has deemed as unapprovable the firm's key cancer drug candidate Yondelis (ET-743; Marketletters...

Spain's Puleva Biotech 1st-half net up 36%.
August 4, 2003... Spanish biotechnology start up Puleva Biotech has recorded a 34% rise in first-half 2003 net profits to 932,000 euros ($1.1 million), helped by a buoyant third-party research business and other gains. The company, part of domestic food...

Pfizer Consumer UK considering move.
August 4, 2003... In the UK, Pfizer Consumer Healthcare is discussing a move from its Eastleigh, Hampshire, location to that of Pfizer Group Pharmaceuticals at Walton Oaks, Surrey. Explaining the desirability of such a relocation, Pfizer says that, with the UK...

Swiss OK for new use of Novartis' Diovan.
August 4, 2003... Novartis has announced that the Swiss Agency for Therapeutic Products has granted marketing authorization for a new use of its angiotensin II receptor antagonist Diovan (valsartan). The agent, which is already registered for the treatment of...

Cell Genesys and Novartis sign deal.
August 4, 2003... Cell Genesys and Novartis have entered into a collaboration for the development and commercialization of oncolytic virus therapies. Under the agreement, Cell Genesys has gained the exclusive worldwide rights to the oncolytic virus therapy...

Pfizer's Zyvox cleared for additional use.
August 4, 2003... The US Food and Drug Administration has approved the use of Pfizer's antibiotic Zyvox (intravenous and oral linezolid) for the treatment of diabetic foot infections without osteomyelitis, caused by Gram-positive bacteria, including resistant...

Positive news for H3 Pharma's Sanvar.
August 4, 2003... Canada-based H3 Pharma has revealed that the US Food and Drug Administration has sent it written confirmation stating that the dossier for Sanvar (vapreotide), which has already been granted Orphan Drug designation, is fileable for registration...

Sri Lanka govt to offer free filariasis medicines for one day.
August 4, 2003... In a massive effort to eliminate the disfiguring filariasis disease, the Sri Lanka Ministry of Health distributed free preventative medicines to nearly 10 million people in a single day. Filariasis Prevention Day, on July 27, was the latest...

US patent protection for Altana's pantoprazole extended to 2010.
August 4, 2003... Germany's Altana AG says that the US Patent and Trademark Office has extended the term of the patent on its proton pump inhibitor antiulcerant pantoprazole for a period of five years, to July 2010, under Waxman Hatch legislation. The news of...

Abu Dhabi's Neopharma starts drug production.
August 4, 2003... Manufacturing at Abu Dhabi's first pharmaceutical production plant, Neopharma, started July 28. Commercial operations with output of some 45 drugs and medicines will be launched after testing in three months. The $25 million project has...

Pfizer exploring options for its surgical ophthalmology business.
August 4, 2003... Pfizer has announced that it is exploring strategic options for its surgical ophthalmology business, including its possible sale, while confirming its commitment to focus on the development and marketing of medicines for eye diseases. The...

Tanabe to track Remicade users.
August 4, 2003... Japan's Tanabe Seiyaku says it will cooperate with medical facilities to track the progress of all patients taking its rheumatoid arthritis and Crohn's disease drug Remicade (infliximab), which was released onto the market July 17. The move is...

Probitas Pharma buys Alpha Therapeutic's assets in USA, Asia.
August 4, 2003... Probitas Pharma has bought a hemoderivatives production plant from Alpha Therapeutic, part of Mitsubishi Pharma, for 100 million euros ($113.5 million). As part of the deal, the Spanish company will also obtain the right to commercialize...

Biogen's profits soar on Avonex turnover.
August 4, 2003... US biotechnology major Biogen has posted a 33% hike in profits for the second quarter of 2002, on a 21% leap in revenues to $326 million. Underpinning the growth was a strong showing from the firm's leading drug, the multiple sclerosis...

B-MS beats forecasts in 2nd qtr.
August 4, 2003... USA-based drugmaker Bristol-Myers Squibb has posted a robust earnings performance for the second quarter of 2002 on the back of a solid showing from two of its leading products. Moreover, unlike last year's like period, the company did not have...

French Council halts 10 drugs' support cuts.
August 4, 2003... France's Council of State has moved to annul the reduction in reimbursement rates from 65% to 35% on 10 drugs marketed by seven companies. The products are: Lipha Sante's naftidrofuryl drugs Gevatran and Praxiline; Lafon's Fonzylane...

Euro Court rejects Commission drug ban.
August 4, 2003... The European Commission lacked the competence to impose a European Union-wide ban on slimming drugs, the European Court of Justice has decided, in a ruling which dismisses an appeal by the Commission in a case dating back to 1996 and upholds an...

Finnish cheap-drug tourism in Estonia.
August 4, 2003... Finnish tourists are flocking to Estonia to buy medicines because of their low prices, with some pharmacies in the capital, Tallinn, stating that 70%-80% of their customers are Finnish, reports the Baltic Business News. Many Finns...

UPDATE: B-MS beats forecasts in 2nd qtr.
August 4, 2003... USA-based drugmaker Bristol-Myers Squibb has posted a robust earnings performance for the second quarter of 2002 on the back of a solid showing from two of its leading products. Moreover, unlike last year's like period, the company did not have...

Zyprexa lifts Eli Lilly above estimates.
August 4, 2003... The USA's Eli Lilly has beaten market expectations and reported a 5% rise in profits for the second quarter of 2003, as sales of its top-selling antipsychotic drug Zyprexa (olanzapine) soared. The company was also boosted by the inclusion of...

Auriga awarded $10M contract by Delft.
August 4, 2003... Auriga Medical, the new name for the medical therapy business of QSA, a business owned by UK-based AEA Technology, has signed an agreement with Nucletron BV, a subsidiary of the Delft Instruments Group, to manufacture Iridium 192 sources which...

Dade Behring pledge to help lab labor crisis.
August 4, 2003... To help address the labor crisis in the clinical laboratory industry, Jim Reid-Anderson, chief executive of USA-based Dade Behring, announced the creation of a $150,000 scholarship fund to be distributed over a three-year period. 50 $1,000...

Novo Nordisk completes initial stake in Transition.
August 4, 2003... Canada's Transition Therapeutics has said that the closing of a private placement raising gross proceeds of approximately $500,000 has been completed. This private placement represents the initial investment of a potential $5.5 million...

Bradley Pharmna issues $12M notes.
August 4, 2003... US company Bradley Pharmaceuticals has issued an additional $12 million in aggregate principal amount of its 4% convertible senior subordinated notes due 2013. Bradley previously issued $25 million in aggregate principal amount of these notes...

Enbrel gets FDA OK for expanded use.
August 4, 2003... Amgen and Wyeth have announced that the US Food and Drug Administration has approved the use of 25mg twice-weeky Enbrel (etanercept) for the reduction of the signs and symptoms of active ankylosing spondylitis. The product becomes the first...

Gilead's Emtriva on track for EU approval.
August 4, 2003... Gilead Sciences has revealed that the European Union's Committee for Proprietary Medicinal Products has recommended granting a Marketing Authorization for a 200mg hard capsule and 10mg/mL oral solution of its Emtriva (emtricitabine). The...

MGI Pharma/Helsinn's Aloxi gets US approval.
August 4, 2003... The US Food and Drug Administration has approved the use of Aloxi (palonosetron hydrochloride) injection at a dose of 0.25mg for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly...

FDA clears Newron's IND for safinamide.
August 4, 2003... Italy's Newron Pharmaceuticals has received approval from the US Food and Drug Administration for an Investigational New Drug application to evaluate its safinamide as a therapy for Parkinson's disease. Under this IND, a safety study will be...

CPMP reviewing safety of paroxetine-containing medicines.
August 4, 2003... At a recent meeting, the European Union's Committee for Proprietary Medicinal Products focused on a Community-wide benefit-risk review of paroxetine-containing medicines. Paroxetine is GlaxoSmithKline's patented antidepressant Paxil/Seroxat,...

Japan's Waseda backs ventures into bioscience field.
August 4, 2003... Waseda University of Japan is taking measures to help nurture affiliated start-ups in the field of bioscience, according to the Nikkei Weekly. It has acted as an intermediary to help start-up GeneWorld Ltd raise 120 million yen ($1.0 million)...

Cost of insuring pharma execs against lawsuits up eight-fold.
August 4, 2003... According to a study by insurance brokerage and consulting firm Aon Group, the cost to European companies of insuring their executives against lawsuits has more than tripled in the past three years. However, the figure rises to an eight-fold...

Merck KGaA's 2nd qtr beats forecasts.
August 4, 2003... With profits up 36% at 84 million euros ($95.3 million), second-quarter 2003 results for German drugmaker Merck KGaA were ahead of market expectations and the forecasts of analysts at Julius Baer. Although total turnover was down 3.5% to 1.80...

Serono raises 2003 forecast; 2nd-qtr figs.
August 4, 2003... Switzerland-based Serono SA has posted a strong set of second-quarter 2003 results, with total revenues rising 33.8% to $508.4 million (plus 21.2% in local currencies) and product sales up 33.2% to 467.4 million. Given the solid performance...

UPDATE: Spain's Zeltia in disarray as EMEA shuns file on Yondelis.
August 4, 2003... The news was not unexpected but disappointing nonetheless, as Spain's Zeltia confirmed on July 24 that the European Medicines Evaluation Agency has deemed not approvable the firm's key cancer drug candidate Yondelis (ET-743; Marketletters...

Berlex selects Fast Track Systems for clinical trials.
August 4, 2003... Fast Track Systems, a US clinical development optimization company, has announced that Berlex, the US affiliate of Schering AG of Germany, has selected its TrialSpace Grants Manager to manage clinical trial costing and budgeting. Grants...

Cell Robotics sets out streamling plan.
August 4, 2003... USA-based Cell Robotics International says that, in an effort to reduce costs and optimize its workforce, it has implemented a comprehensive streamlining initiative that involves a reduction of the general workforce, a cut in management...

MGI Pharma offering 4 million shares.
August 4, 2003... MGI Pharma, an oncology-focused biopharmaceutical company, has said that it plans to publicly offer four million shares of its common stock. The offering would be made from a shelf registration statement that was declared effective by the...

AstraZeneca's Exanta sales to exceed $2.3B by 2012.
August 4, 2003... Decision Resources, a research and advisory firm focusing on pharmaceutical and health care issues, forecasts that AstraZeneca's Exanta (ximelagatran) will revolutionize the prevention of stroke in cases of atrial fibrillation and that sales of...

Iranian drugmakers "raising market share".
August 4, 2003... Iran currently imports 400-500 types of medicines but is increasing the share of domestically-made drugs in overall home consumption, the IRNA news agency quotes Health Minister Masoud Pezeshkian as saying. However, he added that the higher...

Indian call for generics-only prescribing.
August 4, 2003... Asking the National Human Rights Commission to order India's central and state governments to require all doctors to prescribe generic drugs only, the Punjab-based Forum for Common Cause says that, while branded drugs can be 500 times more...

India "must end taxes, duties on HIV drugs".
August 4, 2003... India's government cannot provide antiretroviral drugs free to the 4.6 million people in the nation estimated to be living with AIDS at end-2002, but it should abolish customs duties and sales taxes on ARVs and their ingredients, an Indian...

Brazil bans ads for impotence drugs.
August 4, 2003... Warning that "indiscriminate and unnecessary use" of sexual dysfunction treatments such as Pfizer's Viagra (sildenafil) may constitute a threat to public health, Brazil's health authority Anvisa has banned advertising of the drugs. The...

Tokyo pharma stocks - week to July 28.
August 4, 2003... Tokyo saw a rebound in the week to July 28 following seesaw movements. The Nikkei 225 advanced 3.3%, recovering the 9,800 mark at close, while the Topix index rose 2.8%. The market opened lower because investors sat on the sidelines with signs...

US pharma, Senate and FDA dismay as House OKs drug import bill.
August 4, 2003... Against the wishes of its majority leaders, the US House of Representatives has backed Representative Gil Gutknecht's Pharmaceutical Market Access Act of 2003 (HR 2427), which would allow the importation into the USA of prescription drugs from...

Divestments boost Wyeth as profits soar.
August 4, 2003... The USA's Wyeth has reported a leap in profits for the second quarter of 2003 as a number of gains were recorded in relation to the divestment of some of the firm's pharmaceutical and consumer health care products. Net income soared 44% to...

Botox injection fails to mask losses at Allergan.
August 4, 2003... The USA's Allergan has reported a net loss of $107.9 million for the second quarter of 2003 compared with a profit of $3.8 million during the like, year-earlier period. The result came despite a 27.5% increase to $143.1 million in sales of the...

Merger charge hits Pfizer in 2nd quarter, but deal boosts revenues to near $10bn.
August 4, 2003... Pfizer, the world's leading drugmaker, has reported a $3.59 billion loss, or $0.48 per share, for the second quarter of 2003 as the company counted the cost of completing its mega-merger with Pharmacia during the reporting period (Marketletter...

Disappointing results for Elan/Biogen's Antregen as a Crohn's disease therapy.
August 4, 2003... USA-based Biogen and its Irish partner Elan have reported that Antegren (natalizumab) did not meet the primary endpoint of a Phase III trial evaluating the potential of the agent as a treatment for Crohn's disease. The study, double-blind,...

Positive news for Roche's Bondronat.
August 4, 2003... Roche has announced that the European Union's Committee for Proprietary Medicinal Products has issued a positive opinion for the use of oral and intravenous Bondronat (ibandronate) in the prevention of skeletal events in patients with breast...

Schwarz still riding high on generic Prilosec.
August 4, 2003... Germany's Schwarz Pharma, which sprang to prominence last fall when it won an unexpected legal victory in the USA allowing it to market a generic version of AstraZenenca's blockbuster antiulcerant Prilosec/Losec (omeprazole; Marketletters...

Aventis on target as performance picks up.
August 4, 2003... Franco-German drugmaker Aventis has posted an 18.9% increase in profits from its core business for the second quarter of 2003, although the negative impact of a weak US dollar dragged turnover 6.2% lower to 4.17 billion euros ($4.79 billion)...

Australian govt info ad campaign for PBS.
August 4, 2003... The Australian government has begun an A$27 million ($18 million) national advertising campaign, starting with television ads, to inform consumers about the Pharmaceutical Benefits Scheme. Launching the campaign, the Federal Minister for...

Canadian view of US House Rx export vote.
August 4, 2003... The Canadian International Pharmacy Association, which represents on-line pharmacies, has welcomed the US House of Representatives' "wise" vote in support of Gil Gutknecht's Pharmaceutical Market Access Act of 2003 (HR 2427: see page 13). ...

Australian pharmacy deal "draining PBS".
August 4, 2003... Australian pharmacists earn over A$1.15 billion ($763.3 million) a year under the Third Community Pharmacy Agreement, which accounts for nearly 25% of the annual costs of the Pharmaceutical Benefits Scheme, according to a report in the Herald...

US Senate pediatric drug test bill passes.
August 4, 2003... The US Senate has unanimously passed legislation that would require pharmaceutical companies to test new drugs for safety, efficacy and dosing information in children. The Pediatric Research Equity Act, S 650, restores the 1998 Food and...

US FDA sued over experimental drugs.
August 4, 2003... The US Food and Drug Administration has been served a lawsuit by the Washington Legal Foundation and the Abigail Alliance for Better Access to Developmental Drugs, challenging the agency's restrictions which, it claims, are preventing...

Democrats urge US seniors over Rx benefit.
August 4, 2003... US seniors have been told by a leading Democrat that the Republican-led Medicare prescription drug benefit legislation passed by the House of Representatives (Marketletter July 7) would raise premiums, placing "an unfair burden on seniors who...

EMEA supports Abbott's Synagis for use in pediatric CHD cases of RSV.
August 4, 2003... The European Medicines Evaluation Agency has granted a positive opinion for the use of Abbott Laboratories' Synagis (palivizumab) in young children born with congenital heart disease to prevent respiratory tract infection caused by respiratory...

FDA approves Baxter hemophilia drug.
August 4, 2003... Baxter Healthcare has announced that the US Food and Drug Administration has approved its Advate (antihemophilic factor, recombinant), plasma/albumin-free method rAHF-PFM, for the prevention and control of bleeding episodes in people with...

Micrologix' MBO 226 diappoints in Ph III.
August 4, 2003... Canada's Micrologix Biotech reported disappointing preliminary top-line results from its Phase III trial on the anti-infective MBI 226, which showed no statistically-significant superiority in preventing central venous catheter-related...

Lilly gains positive opinion for new Zyprexa use.
August 4, 2003... US drug major Eli Lilly says that it has received a positive opinion from Europe's Committee for Proprietary Medicinal Products on a new indication for its antipsychotic drug Zyprexa (olanzapine) in bipolar disorder. The new claim states that,...

CPMP backs Shire's Xagrid in the treatment of essential thrombocythemia.
August 4, 2003... UK-based Shire Pharmaceuticals has gained a positive opinion from the Committee for Proprietary Medicinal Products, the scientific arm of the European Medicines Evaluation Agency, for Xagrid (anagrelide HCl) capsules in the treatment of...

S-P's Remicade gets CPMP recommendation for fistulizing Crohn's maintenance.
August 4, 2003... Schering-Plough says that Europe's Committee for Proprietary Medicinal Products has recommended approval of expanded labeling for its rheumatoid arthritis and Crohn's disease drug Remicade (infliximab) to include maintenance dosing for...

Tracleer continues to drive Actelion profits.
August 4, 2003... Switzerland's Actelion says that it remains on course to meet its full-year operating targets after reporting a strong performance for the first half of 2003, driven by the pulmonary arterial hypertension drug Tracleer (bosentan). Sales of...

Amersham profits hit by charges in 1st half.
August 4, 2003... UK-based health care concern Amersham says that the outlook for the second half of 2003 is encouraging, despite reporting a sharp decline in profits for the first six months of the year on the back of exceptional charges and goodwill...

Shire unit negotiates Canadian flu vacc deal.
August 4, 2003... Shire Biologics, the vaccine-making arm of the UK's third-largest drugmaker, Shire Pharmaceuticals, says that it has negotiated improved terms on its contract with the Canadian government. The unit, which last year invested around $20...

Elan secures waivers, allays debt run fears.
August 4, 2003... Embattled Irish drugmaker Elan has secured compliance waivers from noteholders of two of its off balance sheet investment vehicles, EPIL II and EPIL III, which seemingly quash fears that a potentially crushing run on the firm's debt could be...

Schering AG's Leukine may compensate for Yasmin generics, says Morgan Stanley.
August 4, 2003... Yasmin 30 (drospirenone and ethylestradiol), Schering AG's oral contraceptive, has provided significant revenue for the company since it was first approved in the USA May 2001; in 2002 the drug achieved sales of 152 million euros ($174 million)...

Seattle Genetics and Genencor extend collaboration.
August 4, 2003... US companies Seattle Genetics and Genencor International have agreed to extend and modify certain terms of their collaboration agreement established in January 2002. Under the amended agreement, Genencor will pay Seattle Genetics a fee to...

Labopharm finalizes Italian distribution for tramadol.
August 4, 2003... Canada's Labopharm says it has, through its Labopharm Europe subsidiary, signed a definitive distribution and licensing agreement for Italy with Gruppo Angelini for the company's lead in-house product, a once-daily version of the analgesic...

Bradley Pharma 4th in Fortune fastest-growing small co list.
August 4, 2003... Bradley Pharmaceuticals of the USA says that it has been named to the Fortune Small Business annual list of the 100 fastest-growing publicly-held small businesses in America, for the second consecutive year. In 2003, Bradley...

EU orphan status for Debiopharn/Dyax' DX-890.
August 4, 2003... Switzerland-based Debiopharm SA and Dyax Corp of the USA have received European Union Orphan Medicinal Product designation from the European Commission for the engineered protein inhibitor of human neutrophil elastase (EPI-hNE4), or DX-890, for...

Vertex/GlaxoSmithKline's 433908 does not achieve primary goal in Ph III study.
August 4, 2003... Vertex Pharmaceuticals and GlaxoSmithKline have released mixed preliminary findings from a Phase III trial of the HIV protease inhibitor, 433908. The CONTEXT study, involving 320 treatment-experienced patients with prior virologic failure, was...

New data for Xoma/Genentech's Raptiva.
August 4, 2003... Positive new data have been presented for Raptiva (efalizumab) at the American Academy of Dermatology meeting in Chicago, showing its potential as a long-term treatment for moderate-to-severe plaque psoriasis. The agent was developed by Xoma...

SPECTRUM.
August 4, 2003... --------------------------------------------------- Stock Close %Change On Week Dow Chemical $35.10 +13.2 Affymemtrix $24.50 +13.1 Altana 55.45...

Stock Commentary - Europe.
August 4, 2003... European: bourses, after a downbeat showing the previous week, ended the reporting period to July 28 with gains. Particularly strong was July 24, a day which also saw some hefty rises in drug stocks, with companies now reporting second-quarter...