Pharma Marketletter articles from January 2003

Pharma Marketletter archives from January 2003

Hyseq and Variagenics advance merger.
January 6, 2003... Hyseq Pharmaceuticals and Variagenics have announced that they have set a date for their respective shareholder meetings of January 28, 2003, to approve the merger agreement announced on November 11. On December 16, the Securities and...

Bayer retains Canadian blood products supply deal.
January 6, 2003... Bayer Biological Products, a division of Bayer Corp, has been selected to continue as the primary supplier to the national blood system in Canada. Canadian Blood Services and Hema-Quebec, the two agencies that manage Canada's blood and blood...

IMI files injunction against Pfizer.
January 6, 2003... Inverness Medical Innovations, a US provider of women's health and nutritional products and a developer of advanced medical devices, has announced that the US District Court for the District of New Jersey has granted its motion for a...

DSM Biologics signs up with Crucell.
January 6, 2003... Dutch firms DSM Biologics and Crucell are to sign a collaboration agreement for the development and promotion of a unique technology platform, the objective of which will be the further development and production of biopharmaceutical products...

UK government to insure embattled HLS.
January 6, 2003... The UK's ruling Labour Party is to provide banking and insurance facilities to the controversial animal-testing company Huntingdon Life Sciences. Trade and Industry Secretary Patricia Hewitt said the steps had been taken to secure HLS "from...

India's Orchid to buy Mano Pharma.
January 6, 2003... India-based Orchid Chemicals & Pharmaceuticals says it will acquire Mano Pharmaceuticals and its sister company Sali Healthcare in an all-cash deal worth 260 million rupees ($5.4 million), reports India Infoline. Under the terms of the...

Eisai ups US capacity for core products.
January 6, 2003... Japan-based drugmaker Eisai says that it has undertaken work to increase the size of its North Carolina, USA, pharmaceutical manufacturing facility by around 70% in order to meet growing demand for its core products in the US market. The...

GSK in accord with Kaken on Zyloric.
January 6, 2003... Anglo-US drug major GlaxoSmithKline and Kaken Pharmaceutical of Japan have entered into an agreement to co-promote the former's hyperuricemia treatment Zyloric (allopurinol) from January 2003. Under the terms of the deal, GSK will utilize...

German court OKs drug price limits.
January 6, 2003... Germany's Federal Constitutional Court has ruled that the setting of upper limits for drug reimbursement under the government's fixed-level price support regime is compatible with Germany's Basic Law. The principle of setting upper...

Health care cost curbs introduced in Germany.
January 6, 2003... Just before Christmas, Germany's parliament completed the final processes of the controversial health cost-saving legislation which was approved by both chambers last November (Marketletter November 25, 2002), in order for the measures to take...

German KBV calls for tighter drug study regs.
January 6, 2003... 80% of all drug trials are nothing more than marketing instruments, according to Leonhard Hansen, deputy director of the German panel doctors' association, the KBV. Dr Hansen has urged the government to amend existing regulations in order...

Analysts see threat to Novartis' Lotrel.
January 6, 2003... Novartis may face a generic challenge to its fourth-largest drug in the wake of Dr Reddy's successful lawsuit with Pfizer over the calcium antagonist amlodipine (Marketletter December 23, 2002), according to analyst Denise Anderson at Julius...

Blow for ICOS as sepsis drug fails in Phase III.
January 6, 2003... ICOS Corp of the USA has joined the long list of companies which have had to concede defeat in their efforts to develop a drug to treat sepsis, a serious, life-threatening syndrome caused by the immune response of a patient to infection or...

Lilly's teriparatide backed for EU approval.
January 6, 2003... Hard on the heels of its approval in the USA (Marketletter December 2), Eli Lilly's osteoporosis treatment teriparatide has been granted a positive opinion from the European Union's Committee for Proprietary Medicinal Products. The European...

Cubist files NDA for lead drug Cidecin.
January 6, 2003... Cubist Pharmaceuticals of the USA has filed its first New Drug Application for Cidecin (daptomycin for injection), an investigational antibiotic for the treatment of complicated skin and skin structure infections caused by Gram-positive...

Drugs driving higher US health care costs: poll.
January 6, 2003... 52% of US adults polled recently have said that their out-of-pocket health care costs had risen during 2002, and that, in particular, their out-of-pocket spending on prescription drugs had gone up 37%. Moreover, 58% of those interviewed...

DTC, faster approvals are US FDA's priorities.
January 6, 2003... Speeding the approval of brand-name and generic drugs and medical devices and cracking down on deceptive advertising are top priorities for new US Food and Drug Administration Commissioner Mark McClellan. Review and approval times have...

Rx prices will rise 19% in 2003, say insurers.
January 6, 2003... US prescription drug prices will rise 19% in 2003, according to 60 major insurers polled by the Segal Co, which notes that, if these forecasts are correct, drug prices will double within five years. In contrast, the government is forecasting...

S Carolina patients slam Medicaid Rx plan.
January 6, 2003... The Medicaid preferred drug list and prior authorization requirements being considered for implementation by the US state of South Carolina have been attacked by patient groups. No public hearing has been held on the move and, in the run-up to...

Arab pharma seeks "cooperations" to stem reliance on multinationals.
January 6, 2003... Some Arab pharmaceutical companies are calling for increased cooperation to reduce the region's reliance on multinational firms, as well as R&D and technology transfers among themselves. These companies are also asking for firms operating...

10% of Rxs generate half industry returns.
January 6, 2003... Despite the increasing R&D costs associated with new pharmaceuticals, the top 10 newly-marketed drugs account for half of the financial returns on all new drug development, and only one-third of newly-introduced drugs generate earnings that...

UK's NHS acquires Life Resources for L49M.
January 6, 2003... Life Resources Inc, the largest independent supplier and collector of blood plasma in the USA, has become the first-ever private company purchased by the UK's National Health Service. The Department of Health bought the company for L48.8...

Schering AG in accord with USA's Valentis.
January 6, 2003... Germany's Schering AG has signed a multi-product license and option agreement with Nasdaq-listed Valentis to develop and commercialize gene-based therapeutic products, said the company. Under the terms of the deal, Schering obtains...

Bayer pays $257M in rebates probe.
January 6, 2003... Germany-based drugmaker Bayer AG says that it has reached "an agreement in principle" with the US Attorney's Office for the District of Massachusets in relation to the latter's investigation into rebates for pharmaceutical products. The...

Addex buys shelved CeNeS drug for $4.5M.
January 6, 2003... Cambridge, UK-based CeNeS Pharmaceuticals has sold its Phase II selective antagonist of dopamine D1 receptors, CEE 03-310, to Swiss drug addiction specialist Addex Pharmaceuticals. CeNeS will receive up to $4.5 million in upfront and milestone...

GSK CEO explains pay hike, criticizes press.
January 6, 2003... The chief executive of Anglo-US drug major GlaxoSmithKline, Jean-Pierre Garnier, has told shareholders that his much-publicized pay increase (Marketletters passim) merely reflected a broader increase in senior management renumeration at the...

Novartis inhaler filing boosts SkyePharma.
January 6, 2003... Novartis has filed for approval in the European Union of a new formulation of Foradil (formoterol fumarate), its long-acting beta agonist for maintenance therapy in patients with asthma. The new product, called Foradil Certihaler, makes use of...

Pharmacia, Yamanouchi file celecoxib in Japan.
January 6, 2003... Pharmacia and Yamanouchi Pharmaceutical have submitted their selective COX-2 inhibitor celecoxib to Japan's Ministry of Health, Labor and Welfare, seeking its marketing approval for treating patients with rheumatoid arthritis and...

Forest files revamped memantine NDA in USA.
January 6, 2003... Forest Laboratories has filed a New Drug Application for its Alzheimer's disease treatment memantine with the US Food and Drug Administration which it says "corrects minor structural and formatting deficiencies identified in a previous...

BioProgress signs new development deal.
January 6, 2003... UK-based drug delivery firm BioProgress says that it has entered into a development accord with an unnamed drug major relating to several products based on its XGel Film technology. The undisclosed company is among the top 10...

Genome Canada in Danish accord.
January 6, 2003... Canada's Federal Minister of Industry, Allan Rock, has announced the signing of a deal between Genome Canada and the Danish Ministry of Science, Technology and Innovation relating to a series of initiatives intended to increase scientific and...

Waxman-Hatch has boosted generics, but jury still out on effects on innovators.
January 6, 2003... With generics' share of the US drug market approaching 50%, Waxman-Hatch can been seen as a success, but the fact that this could rise to about 60% in the next decade could be symbolic of its failure, Robert Armitage, senior vice president and...

US biotech group urges a rethink of new CMS reimbursement rule.
January 6, 2003... Rate cuts by the US Centers for Medicare and Medicaid, due to take effect January 1, will reduce reimbursement rates well below cost for many new drugs and leave some Medicare patients with "yesterday's medicines," according to the...

CAT and Crucell settle patent dispute.
January 6, 2003... UK-based Cambridge Antibody Technology and Crucell NV of the Netherlands have agreed on terms whereby the latter receives from CAT a worldwide license with respect to all the UK firm's antibody phage display technology patents, both pending...

Array Bio adjusts growth expectations.
January 6, 2003... US firm Array BioPharma is revising its revenue forecast for the fiscal year ending June 30, 2003, and is now forecasting an annual revenue growth rate of 10%-15% versus 25%-30%. This mid-year adjustment, the firm notes, reflects...

Altana moves head office.
January 6, 2003... Germany's Altana announced that, as of January 1, 2003 it will move its head office to: Altana AG Herbert-Quandt-Haus Am Pilgerrain 15 61352 Bad Hophon, with contact numbers changing to phone: +49 (0) 6172 17 12 -0; and fax: +49 (0) 6172 17 12...

Schering Healthcare et al oral contraceptive judgement reviewed.
January 6, 2003... In the most significant product liability judgement of last year, according to law firm Davies Arnold Cooper, a leading UK product liability specialist, a group of 99 women lost their claim that third-generation combined oral contraceptive...

Contraception for UK teenagers: DTB advice.
January 6, 2003... Among countries of the developed world, the teenage pregnancy rate in the UK is second only to that in the USA, nearly five time that of the Netherlands and over threefold that in France, comments the UK Consumer Association's Drug and...

EFPIA complains to EU over Italian drug reg.
January 6, 2003... The European Federation of Pharmaceutical Industries and Associations has complained to the European Commission over Italy's new drug pricing and reimbursement regulations, introduced in third-quarter 2002 and aimed at saving the health care...

UK govt sues generics makers over price-fixing claims, more actions to come.
January 6, 2003... In an unprecedented move, the UK government has gone to court to seek damages from six generic drug manufacturers over claims that they colluded to keep prices to the National Health Service of the anticoagulant warfarin artificially high. ...

Crucell expects charges related to impairment of goodwill.
January 6, 2003... Dutch antibody and vaccine company Crucell NV says that it expects to record a goodwill impairment charge during the fourth quarter of 2002, as a consequence of changes made earlier this year to US accounting principles, under which Crucell...

Abbott gains FDA OK for once-daily Depakote.
January 6, 2003... Abbott Laboratories has announced that the US Food and Drug Administration has approved its Depakote ER (divalproex sodium extended-release) tablets for sole and adjunctive therapy to treat complex partial seizures and simple and complex...

Hisamitsu Pharma takes stake in packaging firm.
January 6, 2003... Japan's Maruto Sangyo has announced that its major client, Hisamitsu Pharmaceutical, will become the largest shareholder in the packing material company, with an 18.18% stake, according to the Nihon Keizai Shimbun. Maruto Sangyo will...

Whatman HemaSure sold to Pall.
January 6, 2003... UK firm Whatman plc says that it has agreed to sell substantially all of the assets of its Whatman HemaSure blood filtration business to Pall Corp for $5.95 million in cash. As part of the agreement, Whatman and Pall have also agreed to...

Novartis' Glivec gains FDA OK for first-line treatment.
January 6, 2003... Swiss drug major Novartis announces that the US Food and Drug Administration has approved Gleevec/Glivec (imatinib mesylate) for first-line treatment of patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid...

Isis re-aquires ISIS 113715 from Merck & Co.
January 6, 2003... Isis Pharmaceuticals has re-acquired full product rights to ISIS 113715, its preclinical type 2 diabetes antisense drug candidate, from Merck & Co and the firm now plans to initiate human clinical trials of the product rapidly in the first...

Pharmacia's Inspra meets EPHESUS primary endpoints.
January 6, 2003... Pharmacia Corp announced December 23 that a major clinical study evaluating Inspra (eplerenone) succeeded in meeting both of its primary endpoints, according to results of the Eplerenone Post-AMI Heart Failure Efficacy and Survival Study...

Baxter acquires ESI in $305M deal.
January 6, 2003... US health care firm Baxter International has been given approval by the US Federal Trade Commission to acquire Wyeth subsidiary ESI Lederle for $305 million, in a deal which was first announced during the summer of last year (Marketletter June...

Wyeth gets final OTC Claritin approval.
January 6, 2003... US drugmaker Wyeth says that the US Food and Drug Administration has granted final approval to the company's application for an over-the-counter version of Alavert (loratadine), a generic rival to Schering-Plough's Claritin brand.E The...

Ligand to receive $3.5M milestone.
January 6, 2003... San Diego, USA-headquartered Ligand Pharmaceuticals will receive a milestone payment of some $3.5 million during the fourth quarter of 2002 from Germany's Royalty Pharma AG, after the latter company formally notified Ligand of its intention to...

StemCell moves to Nasdaq SmallCap.
January 6, 2003... The USA's StemCells has received approval from the Nasdaq Stock Market to transfer the listing of its common stock from the National Market to the SmallCap Market, effective December 23, 2002. StemCells applied for the transfer as it no...

MorphoSys and CAT settle patent dispute.
January 6, 2003... Nasdaq-listed Cambridge Antibody Technology and Germany's MorphoSys have reached an agreement to settle all patent disputes between the two companies. Under the terms of the agreement, MorphoSys will now have the right to commercialize...

New deals at CAT to grow portfolio.
January 6, 2003... Nasdaq-listed Cambridge Antibody Technology and Germany's MorphoSys have reached an agreement to settle all patent disputes between the two companies. Under the terms of the agreement, MorphoSys will now have the right to commercialize...

Hassan seeks freedom assurances from S-P.
January 6, 2003... Pharmacia chief executive Fred Hassan says he wants the board of Schering-Plough to guarantee him the freedom he requires to revamp the US drug major before he takes the decision to accept the post of chief executive. Mr Hassan was chosen...

Belarus' Dialek to increase range.
January 6, 2003... Belarus-based drugmaker Dialek says that it will produce over 50 new products in 2003, according to the Belta news agency. The company currently has a portfolio containing 30 different products for the treatment of cardiovascular and...

Lithuania's Tamro to acquire Litfarma.
January 6, 2003... Lithaunian pharmaceutical manufacturer Tamro has been given the green light by the country's regulatory bodies to acquire a 100% stake in drugs wholesaler Litfarma Partneriai, reports the LETA news agency. The competition council said that the...

WTO fails to reach accord on drug access for LDCs.
January 6, 2003... The World Trade Organization's member states have failed to reach agreement by the year-end deadline on how the world's poorest countries without the capacity to manufacture life-saving drugs should be able to access them. Nor have they...

Frist election buoys hopes for US Medicare Rx benefit.
January 6, 2003... The unanimous election of Senator Bill Frist as US Senate Majority Leader, following the departure of Senator Trent Lott after making what were widely regarded as racially-insensitive remarks, has been welcomed by proponents of a prescription...

Pakistan cuts prices of life-saving drugs.
January 6, 2003... Pakistan's Ministry of Health has recently reduced the prices of 20 life-saving drugs, according to local reports, and Federal Health Minister Muhammad Nasir Khan has requested Ministry officials to monitor closely the prices and quality of...

Gilead cuts HIV/AIDS drug price for Africa.
January 6, 2003... Gilead Sciences has announced that it will sell its HIV/AIDS drug Viread (tenofovir disoproxil fumarate) at no profit throughout Africa and in another 15 least-developed countries. The firm will supply the drug, which costs $4,320 per patient...

Xoma earns $7.5M from Millennium deal.
January 6, 2003... In keeping with the terms of an existing collaboration between the two firms, USA-based biopharmaceutical company Xoma says that it has issued some 1.4 million shares to Millennium Pharmaceuticals in exchange for $7.5 million. Under the terms...

King buys Aventis drug rights for $200M.
January 6, 2003... The USA's King Pharmaceuticals says that it has purchased the rights to three branded prescription products from Franco-German drugmaker Aventis in a $199.5 million cash deal. The US firm now has the US, Puerto Rican and Canadian rights to...

Elan completes $82M Athena divestment.
January 6, 2003... Ireland-based Elan says that it has completed the previously-announced sale of its subsidiary Athena Diagnostics (Marketletter December 2, 2002) for the expected price of $82 million in cash to Behrman Capital. The transaction had been...

Tokyo pharma stocks - 2 weeks to Dec 30.
January 6, 2003... Tokyo saw a modest rally in the two weeks to December 30. The Nikkei 225 rebounded with a 1.5% gain, but registered the lowest year-end closing level in 20 years, while the Topix index rallied 1.9%. Due to the Christmas holidays, market...

Far East Research to offer drug trial services in China.
January 6, 2003... Japan-based clinical drug test outsourcing firm Far East Research plans to launch a service in February to perform clinical trials of drugs in China for Japanese, European and US pharmaceutical companies. Drugmakers in Japan and western...

Bayer reaches agreement with USA on drug rebates case.
January 6, 2003... Germany's Bayer has reached an agreement in principle on the terms of a settlement with the US Attorney's Office for the District of Massachusetts in the context of an investigation into rebates for pharmaceutical products (Marketletters...

Gilead and Triangle merger Hart-Scott-Rodino waiting period over.
January 6, 2003... US companies Gilead Sciences and Triangle Pharmaceuticals have said that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to Gilead's $464 million cash tender offer for Triangle...

Bob Hamm promoted at Biogen.
January 6, 2003... Biogen of the USA has promoted Bob Hamm, who joined the firm in 1994, to senior vice president of North American commercial operations.

Avenir sels portion of Abreva royalties to $24M.
January 6, 2003... US firm Avanir Pharmaceuticals has sold a portion of its future royalty stream on North American sales of Abreva (docosanol 10% cream) for the treatment of cold sores to Drug Royalty USA for $24.2 million, but retains rights to all current and...

Galderma KK names new general manager.
January 6, 2003... The Japanese subsidiary of Galderma, Galderma KK, has appointed Tatsuo Sawada as general manager, replacing Eiichi Kitano, who becomes senior advisor.

Mitsubishi to boost heparin output.
January 6, 2003... Japan's Mitsubishi Pharma has boosted by 160% the production capacity for its heparin-based anticoagulant drug, to meet growing demand, according to company sources reported by the Nihon Keizai Shimbun. Capacity at Mitsubishi's Ashikaga...

Adaltis and Picchio set up JV with CITIC Pacific.
January 6, 2003... Canadian firms Adaltis and Picchio Pharma have reached agreement with CITIC Pacific, a major Hong Kong conglomerate, for the creation of a joint venture that will manufacture and sell diagnostic tests in China. Adaltis and Picchio will own 50%...

GenVec names David Wright as COF.
January 6, 2003... David Wright (formerly chief business officer at Guilford Pharmaceuticals) joins US biotechnology firm GenVec as president and chief operating officer.

Abbott invests $50M in new Kansas facility.
January 6, 2003... Abbott Laboratories plans to invest more than $50 million to expand its biologics manufacturing facility in the US state of Kansas, while adding up to 150 permanent new jobs at the site.

Organogenesis names Gary Gillheeney COF.
January 6, 2003... USA-based Organogenesis has appointed Gary Gillheeney, currently the firm's chief financial officer, to the additional posts of executive vice president and chief operating officer.

Andrew Oakley succeeds Andre Mueller as CFO at Actelion.
January 6, 2003... Switzerland's Actelion has named Andrew Oakley to succeed Andre Mueller as chief financial officer, effective January 2. The latter will retain his role on Actelion's board, where he serves on the finance and audit committee.

Tom Mmartin moves to US post at Novo Nordisk.
January 6, 2003... Denmark's Novo Nordisk has promoted Tom Martin to the post of director of information technology at its US headquarters.

ABPI's Trevor Jones gets CBE.
January 6, 2003... Trevor Jones, director general of the Association of the British Pharmaceutical Industry, has received a CBE (Commander of the British Empire) award in the UK's New Year Honors list.

Managaement changes at Keryx.
January 6, 2003... At Israel-based Keryx Biopharmaceutical, Michael Weiss has been named as chairman and chief executive, replacing Benjamin Corn, who resigned with immediate effect on December 23, 2002. Mr Weiss will consolidate senior management in the USA and...

Update - USA offers patent moratorium for LDCs.
January 6, 2003... USA offers patent moratorium for LDCs, as WTO drug access talks collapse US Trade Representative Robert Zoellick has announced an interim plan to help the world's poorest countries import generic drugs to treat HIV/AIDS, tuberculosis, malaria...

Good 2002 for Indian Rx, but problems ahead.
January 6, 2003... India's pharmaceutical industry achieved relatively healthy growth of some 14% in 2002, helped to some extent by the government's new policy of exempting a growing number of drugs from price control. However, the policy, heralded as...

Fresh doubts raised over Iressa as Japan puts restrictions on use.
January 6, 2003... The news that Japan's Ministry of Health, Labor and Welfare has placed additional restrictions on the use of AstraZeneca's lung cancer drug Iressa (gefitinib) has renewed speculation that the product may experience difficulties in securing...

Biogen, Elan's Antegren effective in multiple sclerosis.
January 6, 2003... The results of a Phase II study of Biogen and Elan's Antegren (natalizumab), reported in the New England Journal of Medicine (January 2), provide further evidence of the potential of the humanized monoclonal antibody in the treatment of...

Partial victory for GlaxoSmithKline in Paxil patent dispute.
January 6, 2003... GlaxoSmithKline announced December 30, 2002, that a federal judge for the US District Court for the Eastern District of Pennsylvania had ruled on summary judgement motions filed by TorPharm Pharmaceuticals (a wholly-owned subsidiary of...