Pharma Marketletter articles from January 2004

Pharma Marketletter archives from January 2004

Appeals court rules for Pfizer.(Brief Article)
January 5, 2004... Federal courts in the USA have ruled in Pfizer's favor in two challenges to its patents for the antibiotic Vantin (cefpodoxime) and its antidepressant Zoloft (sertraline), the company said. A December 23, 2003, decision by the Court of Appeals...

Eisai's pravastatin generic sluggish.
January 5, 2004... Elmed Eisai, the generics subsidiary of Japanese drugmaker Eisai, has revised its fiscal 2003/4 sales forecast downward from 4 billion yen ($37.2 million) to 3 billion yen as a result of sluggish turnover of its copy version of Bristol-Myers...

Fujisawa's Funguard sales up on forecast.(Brief Article)
January 5, 2004... Japanese firm Fujisawa Pharmaceuticals' candin antifungal agent Funguard for Drip Infusion (micafungin sodium) is showing stronger than expected sales thus far this fiscal year. The company forecast turnover of 6.7 billion yen ($62.3...

Xechem completes Ceptor acquisition.(Brief Article)
January 5, 2004... US firm Xechem International has completed the acquisition of Ceptor, a privately-held biotechnology company, significantly increasing the former's drug pipeline. Xechem will issue $6 million of convertible preferred stock to Ceptor's...

Barr introduces generic Tri-Cyclen.(Brief Article)
January 5, 2004... US company Barr Laboratories has begun shipping its generic version of Ortho-McNeil Pharmaceutical's Ortho Tri-Cyclen (norgestimate and ethinyl estradiol) oral contraceptive. The company is marketing its product under the Tri-Sprintec...

Shire files suit against IMPAX.(Brief Article)
January 5, 2004... UK-based Shire Pharmaceuticals says that its US subsidiary, Shire Laboratories, has filed a lawsuit in the District Court for the District of Delaware against IMPAX Laboratories, for infringement of its patent number 6,322,819 and 6,605,300....

Watson launches TriNessa oral contraceptive.(Brief Article)
January 5, 2004... Watson Pharmaceuticals of the USA says it has initiated shipments of TriNessa (norgestimate and ethinyl estradiol tablets), the authorized brand equivalent of the oral contraceptive Ortho Tri-Cyclen marketed by Ortho-McNeil Pharmaceutical....

Fabre takes full control of Dolisos.(Brief Article)
January 5, 2004... French independent drug group Pierre Fabre, which already owns 86.6% of the homeopathic drug company Dolisos, has acquired a further 13.2% stake from Lehning to take full control of the enterprise with a holding of 99.79%. Fabre has paid...

Cell Therapeutics and Novuspharma complete merger.(Brief Article)
January 5, 2004... Cell Therapeutics Inc of the USA and Italy's Novuspharma SpA have completed their $236 million merger (Marketletter June 23, 2003), which was approved by the shareholders of both companies in October. All closing conditions have now been...

Merck & Co re-submits NDA for Arcoxia.(Brief Article)
January 5, 2004... US drug major Merck & Co has re-submitted a New Drug Application for Arcoxia (etoricoxib) to the Food and Drug Administration, nearly two years after withdrawing the application in March 2002. Merck's NDA seeks indications for Arcoxia for the...

Sweden's Capio sells PolyClinique.(Brief Article)
January 5, 2004... Swedish health care group Capio has sold its loss-making French unit PolyClinique Marzet to a local enterprise, SAS Harpin. Shortly after Capio took over the Marzet clinic it had to close for a month on the orders of the Health Ministry over...

Lilly drug cleared for depressive bipolar disease.(Brief Article)
January 5, 2004... Eli Lilly has received US Food and Drug Administration regulatory clearance to sell a combination drug to treat the depressive phase of bipolar disorder. The drug, Symbyax, combines two widely-used Lilly medicines, Prozac (fluoxetine) for...

Aventis submits NDA for once-daily Alegra.(Brief Article)
January 5, 2004... Franco-German drug major Aventis has announced the submission of a New Drug Application to the US Food and Drug Administration for Allegra-D 24-hour tablets (fexofenadine HCl 180mg/pseudophedrine HCl 240mg). The company is seeking marketing...

Fujisawa launches Precol as OTC rhinitis drug.(Brief Article)
January 5, 2004... Japanese drugmaker Fujisawa Pharmaceutical has launched an over-the-counter product, Precol, for the treatment of rhinitis. Precol is formulated with pseudoephedrine hydrochloride to relieve nasal congestion, d-chlorpheniramine maleate as...

Spanish pharma gears for new prices regime.(Brief Article)
January 5, 2004... The Spanish drug industry was relatively buoyant through 2003, with prescription drug sales rising 12% to 6.78 billion euros ($8.53 billion) in the 11 months to November. However, due to high growth in the levels of national drug spending, the...

Seventh govt report on UK PPRS.(Pharmaceutical Price Regulation Scheme)(Brief Article)
January 5, 2004... With negotiations between the UK Department of Health and the Association of the British Pharmaceutical Industry on the future of the Pharmaceutical Price Regulation Scheme due to start this month, the government's Seventh Report to Parliament...

German doctors' pact with OTC makers.(Brief Article)
January 5, 2004... German doctors have agreed to provide specialist advice to patients in collaboration with the drug industry and pharmacists in the choice of non-prescription medicines. This "green prescription" scheme will mainly affect medicines which...

Hungary: 10-month pharma trade data.(Brief Article)
January 5, 2004... Hungarian pharmaceuticals and drug raw materials production was up 11.7% in the first 10 months of 2003 over the like period of 2002, reports the Central Statistical Office. Total sales of these products rose 15.4% year-on-year, with domestic...

Scotland moves to scrap Rx charges.(Brief Article)
January 5, 2004... Plans to scrap prescription charges have won cross-party support in the Scottish Parliament, and a finalized document is to go out for consultation shortly. Its sponsor, Socialist Colin Fox, says the Scottish Executive's current review of the...

French health reform proposal attacked.(Brief Article)
January 5, 2004... A 13-point plan to reform the French health funds, drawn up by Daniel Bouton, the president of insurer Societe Generale, has been attacked by politicians and unions. His plan includes the imposition of a patient charge fixed on a per...

Study queries COX-2s' cost-effectiveness.
January 5, 2004... A study by pharmacy benefit manager Express Scripts has called into question the cost-effectiveness of the COX-2 inhibitor class of anti-inflammatory drugs. COX-2 inhibitors offer greater protection from adverse gastrointestinal events...

US FDA to halt ephedra dietary supp sales.
January 5, 2004... The US Food and Drug Administration has issued a consumer alert on the safety of dietary supplements containing ephedra and has sent 62 letters to firms marketing such supplements containing ephedra and ephedrine alkaloid, notifying the...

Abbott Labs' Humira marks first successful year.
January 5, 2004... US health care major Abbott Laboratories' Humira (adalimumab), a biologic and the first fully-human monoclonal antibody for the treatment of rheumatoid arthritis, was prescribed to more than 40,000 patients suffering from the potentially...

All Bayer's subgroups now separate legal entitites.(Brief Article)
January 5, 2004... The reorganization of Germany's Bayer Group into a holding structure, previously announced ahead of its fall 2003 press conference (Marketletters passim) has been completed. Bayer MaterialScience AG (formerly the Bayer Polymers business area),...

Institut Pasteur sets up South Korean R&D operation.(Brief Article)
January 5, 2004... French infectious disease enterprise Institut Pasteur has signed an agreement with the South Korean government to set up a joint research institute which will go into operation this year. The Seoul government will provide the entire budget of...

CAT and Amgen restructure deal.(Cambridge Antibody Technology)(Brief Article)
January 5, 2004... Cambridge Antibody Technology of the UK has announced the restructuring of an existing antibody development and marketing collaboration agreement with US firm Immunex, subsequently acquired by biotechnology company Amgen, in which the latter...

GSK moves to stop AIDS drug smugglers.(Brief Article)
January 5, 2004... GlaxoSmithKline, a leading manufacturer of AIDS/HIV drugs, is changing the color of its best-selling HIV treatment, Combivir (lamivudine and zidovudine), in order to combat smuggling of such products which are being sold to developing...

Baxter sells its 20% stake in Acambis.(Brief Article)
January 5, 2004... Cambridge, UK-based Acambis says that Baxter International has filed a Schedule 13D with the US Securities and Exchange Commission, announcing the sale of all of its equity shareholding, around 20%, in the firm. This had a positive impact on...

PPL sells off assets and technology.(Brief Article)
January 5, 2004... PPL Therapeutics, the firm behind the now dead cloned Dolly the sheep, has said that, on December 9, 2003, it held a public auction to sell certain items of fixtures, fittings, plant, manufacturing and laboratory equipment from its pilot...

Amgen signs accord with ViaCell.(Brief Article)
January 5, 2004... Global biotechnology leader Amgen has entered into a collaborative agreement with ViaCell, under which the latter will have licenses to certain cellular growth factors and Amgen will have the right to collaborate with ViaCell in the development...

Aphton submits first filing for G17DT.(Brief Article)
January 5, 2004... The USA's Aphton Corp has filed for approval of its anti-gastrin immunogen G17DT with the Australian Therapeutic Goods Administration. The product is indicated as a monotherapy in patients with advanced pancreatic cancer who are either unable...

Nascobal Nasal spray NDA submitted to FDA.(Brief Article)
January 5, 2004... Questcor Pharmaceuticals and Nastech Pharmaceutical have submitted a New Drug Application with the US Food and Drug Administration for use of Nascobal (cyanocobalamin) Nasal Spray as a treatment for vitamin B12 deficiency. Nascobal Nasal...

Aventis files for US approval of Alvesco.(Brief Article)
January 5, 2004... Franco-German drug major Aventis and Germany's Altana AG have submitted a New Drug Application with the US Food and Drug Administration for the use of Alvesco (ciclesonide) in the treatment of persistent asthma in adults, adolescents and...

Pharmion submits US NDA for Vidaza.(Brief Article)
January 5, 2004... Pharmion Corp of the USA has filed a New Drug Application with the Food and Drug Administration for Vidaza (azacitidine for injectable suspension). The product, which has been granted fast-track status by the FDA, is indicated for the treatment...

China moves to speed pharma imports.(Brief Article)
January 5, 2004... On January 1, China introduced new regulations aimed at getting imported medicines to market an average one month quicker than has been the case. Pharmaceuticals are the only imports which must, by law, be channelled through dedicated...

China bans sales of OTC antibiotics.(Brief Article)
January 5, 2004... China's State Food and Drug Administration has said that, from July 1, sales of antibiotics not in the official catalog of over-the-counter products will be prohibited without a doctor's prescription. The move is part of China's campaign...

Canada's US envoy slams House Speaker Hastert over drug patent "threat" claims.
January 5, 2004... Canada's Ambassador to the USA, Michael Kergin, has denied that his country uses "threats to steal the patents of American drug companies in order to negotiate lower prices," as has been claimed by Dennis Hastert, Speaker of the US House of...

UK govt seeks L30M for Rx "overcharging".
January 5, 2004... The UK government and the 28 English Strategic Health Authorities have issued further proceedings in the High Court against seven drugmakers, claiming that they agreed anti-competitive deals which led to the National Health Service being...

Bayer defeats EU in parallel imports case.
January 5, 2004... The European Court of Justice in Luxembourg has thrown out allegations by the European Commission that Bayer, the German pharmaceutical firm, had established a cartel agreement with its wholesalers to restrict the trade flow of its...

Finland sees major savings from generics.(Brief Article)
January 5, 2004... In the eight months since April 2003, when Finland introduced generic substitution, total savings from the move reached 55.1 million euros ($69.8 million) and they could exceed 70 million euros for the first full year. This is far more...

Highlights of pharmaceutical mergers and acquisitions during 2003.
January 5, 2004... 2003 was a year marked by significant consolidation in the pharmaceutical sector, particularly in biotechnology, worldwide. Overshadowing events in the mainstream drug sector came the well-documented, $57 billion, mega-merger of Pfizer and...

Lilly provides 2004 guidance, says acquisitions will weigh on 1st-qtr.
January 5, 2004... US drug major Eli Lilly has issued guidance on its first-quarter and full-year 2004 results, which foresees a 10% increase in sales, but with earnings likely to be impacted by acquisition costs and increased R&D spending. The forecast was below...

Revenues warnings from SkyePharma.(Brief Article)
January 5, 2004... UK-based drug delivery specialist SkyePharma has said that, as a result of delays in concluding a number of key deals in 2003, revenues for the year will come in substantially below the L85-L100 million ($153.6-$180.8 million) range indicated...

Zavesca capsules available in the USA.(Brief Article)
January 5, 2004... Celltech and its partner Actelion have launched Zavesca (miglustat) in the USA, the first oral treatment option for type I Gaucher disease, a rare genetic lysosomal storage disorder affecting around 10,000 people worldwide. The product was...

Array surges on news of Genentech deal.(Brief Article)
January 5, 2004... Shares of USA-based Array BioPharma surged on the news that the firm had signed a licensing and collaboration agreement with US biotechnology major Genentech to advance two of its proprietary oncology programs into clinical development. ...

Barr receives approval for generic Larium.(Brief Article)
January 5, 2004... The US Food and Drug Administration has approved Barr Laboratories' mefloquine hydrochloride tablets, 250mg, the generic equivalent of Roche's Larium tablets. The product is indicated for the prophylaxis and treatment of mild-to-moderate acute...

US state Rx fee plan halted, after one day.(Brief Article)
January 5, 2004... Just one day after introducing a scheme under which pharmacists were to decide whether Medicaid enrollees and the medically needy should be charged a co-payment for their prescription medicines, the US state of Florida has ordered a temporary...

US NIH director pledges action over staff pharma consulting concerns.(United States. National Institutes of Health)
January 5, 2004... The US National Institutes of Health might seek to expand public disclosure of paid consulting arrangements between drug development companies and agency staff, according to NIH director Elias Zerhouni. In a letter to Billy Tauzin, chairman...

UPDATE: AstraZeneca's Exanta gets first approval in France for preventing VTE in surgery.
January 5, 2004... Anglo-Swedish drug major AstraZeneca has received the first regulatory approval for its oral anticoagulant Exanta (ximelagatran) in France for the prevention of venous thromboembolic events in major orthopedic (hip or knee replacement) surgery....

Celltech begins Ph III trials for CDP870.(Brief Article)
January 5, 2004... The UK's largest biotechnology firm, Celltech, has commenced dosing of patients in the first of two pivotal Phase III trials (PRECISE-1) to evaluate its CDP870 for the treatment of Crohn's disease. The second study (PRECISE-2) is scheduled to...

PI traders tell EC: "fight on" after Bayer ruling.(Pharmaceutical industry)(European Court)
January 5, 2004... The research-based pharmaceutical industry has welcomed the European Court of Justice's backing for earlier European court rulings that Bayer had entered into no concerted agreement with its wholesalers to limit parallel imports of its...

EU to probe Turkish pharma trade; local industry fears over data concession.(European Union)
January 5, 2004... The European Commission has announced that it is to initiate a formal examination procedure concerning the measures imposed and practices followed by the Republic of Turkey which affect trade in pharmaceutical products. The Commission's...

Warning to Canadian doctors over e-Rx sales.(Brief Article)
January 5, 2004... The Canadian Medical Protective Association has warned Canadian doctors that it is likely to decide not to provide malpractice insurance cover for lawsuits involving Internet drug sales which are brought in Canadian courts. The Association...

Indian firms urge govt over life-saving drugs.(Brief Article)
January 5, 2004... The Indian Bulk Drug Manufacturers Association and the Indian Drug Manufacturers Association are among those lobbying their government for inclusion of some protective measures in the Patent Act under consideration as part of the World Trade...

India: 0% duty on life-saving drugs unlikely.(Brief Article)
January 5, 2004... India's Finance Ministry is unlikely to agree to calls for imports of life-saving drugs to be exempted from customs duty, even though such a change has been recommended by the Ministry of Chemicals and Fertilizers, as well as industry groups....

Vietnamese drug prices rise 21%, other news.(Brief Article)
January 5, 2004... Vietnam's consumer price of pharmaceuticals in December 2003 was up 20.9% on December 2002, compared to a 3% annual rise in the consumer price index, say General Statistics Office data reported by the Vietnamese News Agency. It also...

Japan plans bar codes for Rx drugs.(Brief Article)
January 5, 2004... The Japanese Ministry of Health, Labor and Welfare has revealed plans for all prescription drugs to eventually carry bar codes. It will shortly set up a committee of medical experts and drugmakers to advise on the plan, which is aimed at...

Uganda: free HIV/AIDS drugs from February.(Brief Article)
January 5, 2004... In February, the Ugandan government will start supplying free antiretroviral drugs to people infected with HIV, the government has said. The program will be rolled-out in stages, and the first recipients will include health workers and people...

Iranian drug imports.(Brief Article)
January 5, 2004... Pharmaceuticals were Iran's eighth most valuable imported commodity in the first nine months of the current Iranian year (March 21-December 20, 2003), when they reached a value of $364 million, reports the IRNA news agency.

Roche and Trimeris halt trials of HIV drug.(Brief Article)
January 5, 2004... Swiss drug major Roche and US partner Trimeris have halted clinical trials of an investigational HIV drug called T-1249. The companies said they had stopped the studies because of problems with its formulation. Shares in Trimeris were down 16%...

Colorectal cancer trial for Velcade stopped.(Brief Article)
January 5, 2004... Millennium Pharmaceuticals of the USA has stopped further accrual to a Phase II trial examining the use of Velcade (bortezomib) either alone or in combination with Camptosar (irinotecan) for the treatment of metastatic colorectal cancer. Shares...

Ranbaxy 5th largest generics firm in France.
January 5, 2004... India's largest pharmaceutical company, Ranbaxy Laboratories, says that all the necessary formalities and consents required for the conclusion of the acquisition of RPG (Aventis) SA have been obtained and that the deal has now been completed...

GSK: $2.7B tax claim?(Brief Article)
January 5, 2004... GlaxoSmithKline says that, as part of its long-running dispute with the US Internal Revenue Service, it has now received a claim for additional taxes. The demand is for a $2.7 billion deficiency that, with interest, is about $5 billion, which...

Temasek and Newbridge to take stake in Matrix.(Brief Article)
January 5, 2004... Temasek Holdings (a wholly-owned investment arm of Singapore's Ministry of Finance) and Newbridge Capital of the USA plan to acquire a 13.91% stake each in active pharmaceutical ingredients maker Matrix Laboratories of Hyderabad, India. ...

PT Darya Varya's sales slump 35%.(Brief Article)
January 5, 2004... Indonesian drugmaker PT Darya Varia Laboratoria Tbk has said that sales for the first nine months of 2003 reached 320.9 billion rupiah ($38.3 million), a fall of 35% on the like, year-earlier period, according to a report by the Asia Pulse news...

Corixa awarded $11.6 million from NIH Biodefense Partnership.(Brief Article)
January 5, 2004... USA-based immunotherapeutics developer Corixa Corp has been granted a five-year contract worth $11.6 million by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to develop its proprietary...

Barr completes reincorporation from New York to Delaware.(Brief Article)
January 5, 2004... USA-based generics maker Barr Pharmaceuticals has announced the completion of reincorporation from a New York to a Delaware corporation, as approved by its shareholders at its annual meeting in October 2003. Effective December 31, 2003, the...

Merck KGaA launches OTCs in China; sells BioMer stake.(Brief Article)
January 5, 2004... German drugmaker Merck KGaA has entered the over-the-counter market in China, with the launch of four products from the established Dr Freeman brand range for fever, cough, pain relief and asthma, reports the Chinese Medical News. Merck plans...

Xenova sells Farnham research facility to Bioventix for $1.4M.(Brief Article)
January 5, 2004... Xenova Group of the UK has sold certain premises at its Farnham, Surrey, research facility together with related assets to Bioventix. The sale assets constitute part of the business bought by the company on the acquisition of KS Biomedix...

Pfizer remains pharma market leader in Spain.(Brief Article)
January 5, 2004... The world's largest drugmaker, Pfizer, has remained at the head of the Spanish market with a share of 9.8% in the first 11 months of 2003, 3.5% ahead of its main competitor, the local firm Almirall Prodesfarma. Pfizer's sales rose 12.4% in...

Noven earns $500,000 milestone from P&G Pharma.(Brief Article)
January 5, 2004... Noven Pharmaceuticals says it has earned a $500,000 cash payment from fellow US firm P&G Pharmaceuticals (a subsidiary of Procter & Gamble) for attaining a milestone under their product development agreement. Noven expects to report the payment...

Tokyo pharma stocks - week to Jan 5.
January 5, 2004... Tokyo saw an extended rise in the three weeks to January 5, the first trading day in Japan for 2004. The Nikkei 225 advanced 3.2% to close at 10,825.17, recording a high since early November 2003, while the Topix index went up 3.5%. The Tokyo...

Ferring expands infertility portfolio by acquiring Novartis' Norprolac.
January 5, 2004... Denmark's Ferring Pharmaceuticals has concluded a deal with Swiss health care major Novartis for the acquisition of the worldwide manufacturing, marketing and distribution rights to Norprolac (quinagolide). No financial terms of the accord were...

SPECTRUM.(Brief Article)
January 5, 2004... ------------------------------------------------ Stock Close %Change On Week Vivus $4.38 +23.4 Mitsubishi Pharma 882 yen +16.2 UCB ...

Stock Commentary - Europe.(Brief Article)
January 5, 2004... European: bourses, with the exception of MILAN, moved higher over the Christmas and New Year holidays, ending the reporting period to January 5 with three to five point gains. Italy's poor showing was due to the scandal surrounding dairy...

Stock Commentary - New York.
January 5, 2004... NEW YORK: equities edged steadily higher through most of the holiday-spattered three-week period to January 5, with the Dow Jones closing up 5.2% overall. Wall Street also managed to ignore the "high-alert" threat of terrorism over the holidays...

Repligen's RG1068 fails in autism trial.(Brief Article)
January 5, 2004... USA-based Repligen's RG1068, a synthetic human secretin, has failed to meet its primary goals in a Phase III trial for autism, with no significant improvements in social interaction, as measured by the Autism Diagnostic Observation Schedule and...

Millennium's MLN3897 begins Ph I trial.(Brief Article)
January 5, 2004... Millennium Pharmaceuticals' MLN3897 has entered Phase I evaluation, and becomes the first compound to enter clinical trials from the company's inflammation collaboration with Aventis. MLN3897 blocks the CCR1 chemokine receptor and has potential...

Wyeth legal promotions, appointment.(Brief Article)
January 5, 2004... US pharmaceutical major Wyeth has promoted William Ruane to the position of vice president and associate general counsel - litigation, and William Haskel to VP and associate general counsel - corporate. In addition, the company has recruited...

Xechem/Ceptor merger completed.(Brief Article)
January 5, 2004... USA-based Xechem International has completed the acquisition of Ceptor, a privately-held biotechnology firm, significantly increasing the former's drug pipeline. Xechem will issue $6 million of convertible preferred stock to Ceptor's...

Promotions at aaiPharma.(Brief Article)
January 5, 2004... aaiPharma of the USA has promoted David Hurley, previously president of its pharmaceutical division, to the role of chief operating officer for the group, and Vijay Aggarwal, now president of AAI development services, to president, R&D, which...

Avid Bio expands capacity.(Brief Article)
January 5, 2004... Avid BioServices, a wholly-owned subsidiary of Peregrine Pharmaceuticals, says it is expanding manufacturing capacity with a 1,000-liter working volume mammalian cell culture bioreactor to be operational by June this year. This increases Avid's...

Allergan wins Acular patent case.(Brief Article)
January 5, 2004... US firm Allergan says that the US District Court for the Northern District of California has ruled in favor of itself and Syntex in their patent suit against Apotex and Novex Pharma covering the non-steroidal anti-inflammatory drug Acular...

Approval of Remodulin in France delayed.(Brief Article)
January 5, 2004... US firm United Therapeutics has reported that the French regulatory agency, the AFSSAPS, has requested further information before it will approve the company's antihypertensive drug Remodulin (treprostinil sodium) injection. The firm was...