Pharma Marketletter articles from November 2003

Pharma Marketletter archives from November 2003

S African competition ruling "inconsistent".
November 3, 2003... Boehringer Ingelheim has expressed surprise at the South African Competition Commission ruling that it abused its position in its antiretroviral market (Marketletter October 27), saying the panel ruled in the firm's favor in a similar complaint...

Remicade, Avandia, Actos, EpiPen join Australia's PBS; Gleevec's listing widened.
November 3, 2003... Starting November 1, Australia's Pharmaceutical Benefits Scheme includes the following new listings: - Centocor's Remicade (infliximab) for rheumatoid arthritis. The cost will be about A$20,000 ($14,014) per patient per year and some 1,700...

French pharma and the rise of "temporary" scientists.
November 3, 2003... In France, the pharmaceutical industry is increasingly using "temporary" scientists and technicians as recruitment processes become lengthier, more expensive and more difficult. The idea that highly-qualified pharmaceutical industry...

As R&D and marketing unite, NME numbers rise: study.
November 3, 2003... By September 30, the US Food and Drug Administration's New Molecular Entity approvals in 2003 totaled 15, suggesting the full-year total will be nearly 20% higher than in 2002. This is the result of a growing trend in the industry to break down...

AstraZeneca beats expectations as strong sales drive third-quarter growth.
November 3, 2003... Anglo-Swedish drug major AstraZeneca has reported a better-than-expected set of results for third-quarter 2003 as the company overcame revenues lost to generic competition and posted a 21% leap in pretax profits to $1.12 billion. The figures...

EU approval for GSK's Avandamet.
November 3, 2003... The European Commission has granted marketing approval for GlaxoSmithKline's Avandamet, a combination of its globally-established Avandia (rosiglitazone) and metformin, for the treatment of type 2 diabetes. The new formulation is particularly...

Xenova initiates Ph IIb trial of TA-CD.
November 3, 2003... UK biopharmaceutical company Xenova has initiated the first randomized, placebo-controlled Phase IIb clinical trial of TA-CD, its therapeutic vaccine under development for the treatment of cocaine addiction. Up to 132 subjects, all of whom...

Roche's Fuzeon more cost-effective in HIV.
November 3, 2003... A new evaluation presented at the European AIDS Clinical Society Congress in Warsaw, Poland, at end-October shows that Fuzeon (enfuvirtide) was found to be cost-effective in pre-treated HIV-positive patients studied in a Phase III trials...

DepoMed prices placing at $5.50.
November 3, 2003... DepoMed of the USA has announced that it has priced a public offering of 6.5 million shares of its common stock at $5.50 per share. The company, which specializes in oral drug delivery technology, has also granted the underwriters an option to...

Gene Logic sees losses widen in 3rd qtr.
November 3, 2003... Nasdaq-listed contract pharmaceutical services provider Gene Logic has reported widening losses for the third quarter of 2003 as the firm included the results of the recently-acquired Therlmmune Research business for the first time. The figures...

Schering AG/IBC deal on cancer therapy.
November 3, 2003... USA-based Immunomedics' majority-owned subsidiary IBC Pharmaceuticals has entered into a research collaboration with Germany's Schering AG involving bispecific antibody, pre-targeting technologies under development by IBC for cancer therapy....

OSI-7904L in Ph II for gastric cancer.
November 3, 2003... USA-based OSI Pharmaceuticals has initiated a Phase II clinical study of OSI-7904L, an investigational anticancer drug, in patients with previously untreated advanced gastric cancer. OSI-7904L is a novel member of a well-established class of...

Added use for S-P's Remicade OKed by EU.
November 3, 2003... Schering-Plough says that the European Commission has granted approval for Remicade (infliximab), an anti-tumor necrosis factor agent, in maintenance dosing for sustaining clinical response in patients with fistulizing Crohn's disease who have...

EU clears Orion/Novartis' Stalevo.
November 3, 2003... A European Union-wide Marketing Authorization has been received by Finland's Orion for its Parkinson's disease treatment Stalevo (a combination of carbidopa, levodopa and entacapone) which, the company claims, is the first new PD therapy in...

German biotech sector development 2000-2.
November 3, 2003... The biotechnology sector in Germany developed positively in terms of turnover and employees during 2000-2, the Federal Statistical Office has reported. However, it adds, only 11 core biotechnology businesses commenced operations last year....

New NICE guidance on NHS use of Gleevec and CAD stents in England/Wales.
November 3, 2003... The National Institute for Clinical Excellence has issued guidance on the use of Novartis' Gleevec (imatinib) for chronic myeloid leukaemia on the National Health Service in England and Wales. Its key recommendations are that: - Gleevec...

Oregon sues doctors over illegal and Internet drug sales, after joint FDA probe.
November 3, 2003... The US state of Oregon's Attorney General, Hardy Myers, has filed a lawsuit in Washington County Circuit Court against two Oregon doctors alleging violations of state consumer protection laws in the unlawful sale and advertising of prescription...

US Medicare Rx bills: cancer care fears.
November 3, 2003... Up to $16 billion in cancer care cuts, as contained in the US House and Senate Medicare prescription drug bills, would exacerbate the already-unacceptable cancer mortality rates among African Americans and other minority groups, Otis Brawley,...

Minnesota to move Rx buying plan forward.
November 3, 2003... Reports that William Hubbard, associate commissioner for policy and planning at the US Food and Drug Administration, has said the FDA will not pursue legal action against US cities and states that initiate plans to re-import cheaper...

Pharma reimports: "a perversion of free trade".
November 3, 2003... Banning parallel imports of prescription drugs into the USA will not supply any remedy "to the persistent problem of foreign free-riding on American innovation, when foreign governments use their sovereign power to limit price freedom in their...

Pennsylvania Rx boost for people with HIV/AIDS.
November 3, 2003... The US state of Pennsylvania's Special Pharmaceutical Benefits Program for people with HIV/AIDS is adding hundreds of new drugs, including vaccines, analgesics, antidepressants, migraine agents, antiemetics and antidiarrheals, in the program's...

Indonesian legislators view generic price rises.
November 3, 2003... A Commission of Indonesia's House of Representatives plans to require domestic generic drugmakers to explain the recent increases in prices of their products, according to Commission member Surya Chandra Surapty. It will seek detailed...

India "can win 25% of 2005 generic sales".
November 3, 2003... With drugs worth $100 billion due to go off patent in 2005, India's pharmaceutical industry has the potential to corner some 25% of the global generics market which, at a value of $3.75 billion, is now worth the same as India's total...

India's Supreme Court to view Rx policy Nov 7.
November 3, 2003... On November 7, India's Supreme Court is set to examine the central government's appeal against a High Court order given in Bangalore in the southern state of Karnataka one year ago (Marketletter November 25, 2002). This sought to halt the...

New wave of drugs offer hope in treatment of colon cancer.
November 3, 2003... Colorectal cancer is the second-most deadly cancer in the USA, behind lung cancer. According to the American Cancer Society, around 147,500 people will be diagnosed with the condition this year and about 57,100 people will die from it. Recently...

Serono beats expectations with 3rd-qtr 2003 net income up 48%.
November 3, 2003... Swiss biotechnology firm Serono SA beat analysts' forecasts with its third-quarter 2003 results, although sales of its leading multiple sclerosis drug Rebif (interferon beta 1a) in the USA, where it is co-marketed with Pfizer, the world's...

Avant losses widened in third quarter.
November 3, 2003... Avant Immunotherapeutics of the USA has reported a widening of losses for the third quarter of 2003 as the company's revenues slumped to $2.6 million from $3.3 million during the like, year-earlier period. Net loss totaled $2.2 million, or...

Provalis underperforms as devices business fails to deliver.
November 3, 2003... UK drugs and diagnostics concern Provalis, which reported an encouraging set of results for the fiscal year ended June 30 (Marketletter September 8), has reported a lackluster sales performance for the three-month period ended September 30,...

European Parliament first reading of pharma review rejects DTC ads.
November 3, 2003... In its first reading of the European Union pharmaceutical review proposals package, the European Parliament has given its support to the proposal for all new medicines to be approved through the European Medicines Evaluation Agency's central...

UK study finds high Rx non-compliance levels.
November 3, 2003... Over one-fifth of the UK population admits to not always finishing a course of prescribed medication, and more than one in five people have suffered an adverse reaction as a result of taking a medication incorrectly at home, research...

Canadian drugs could save Illinois $90.7M a year, FDA safety fears unfounded: study.
November 3, 2003... The results of a study commissioned by the Governor of the US state of Illinois, Rod Blagojevich, on the potential cost-savings and feasibility of reimbursing state employees and retirees for prescription drugs purchased from Canada...

PBMs are "the best last hope" to beat Rx costs.
November 3, 2003... The US Pharmaceutical Care Management Association, which represents pharmacy benefit managers, has urged retail pharmacies, trial lawyers and others to put aside their "narrow, special-interest agenda" and work with PBMs to improve consumers'...

Schering AG sees strong profit growth.
November 3, 2003... Berlin, Germany-headquartered Schering AG says that net sales were 3.55 billion euros ($4.17 billion) in the first nine months of 2003 (+5% currency adjusted), due largely to the positive development of the company's business in the third...

Schwarz hit by more omeprazole generics.
November 3, 2003... German mid-sized drugmaker Schwarz Pharma has reported a 111.2% rise to 1.25 million euros ($1.47 billion) in sales for the first nine months of 2003, driven by revenues from its US subsidiary KudCo's generic omeprazole, which saw turnover leap...

IsoTis and GenSci complete merger.
November 3, 2003... Swiss-Dutch biotechnology firm IsoTis SA and US orthobiology company GenSci have completed their merger. With this combination of the two firms' sales and marketing functions and the integration of R&D virtually complete, the new IsoTis...

New findings show long-term RA therapy with Abbott's Humira is effective.
November 3, 2003... New data have been released at the American College of Rheumatology annual meeting in Florida, USA, showing that Abbott Laboratories' Humira (adalimumab) was safe and effective in the treatment of rheumatoid arthritis over a five-year period,...

Kyowa Hakko licenses technology to Medarex.
November 3, 2003... Japanese drugmaker Kyowa Hakko Kogyo has licensed to US firm Medarex technology which enhances the ability of antibodies to attack specific targets in the body, reports the Nikkei Business Daily. Called Potelligent, the technology developed by...

Watson buys research unit from Amarin.
November 3, 2003... Watson Pharmaceuticals has acquired Amarin Development AB, a wholly-owned drug development subsidiary of Amarin Corp. Under the terms of the agreement, Watson made a cash payment of approximately $15 million to Amarin. On a reported earnings...

Schering-Plough settles Claritin-D patent litigation with Impax.
November 3, 2003... Schering-Plough has reached a settlement with Impax Laboratories resolving litigation related to the latter's generic version of S-P's Claritin D (loratadine) 24-hour extended-release tablets. Available as an over-the-counter product,...

Merck KGaA reports strong third quarter.
November 3, 2003... Merck KGaA of Germany has reported that its third-quarter operating result rose 23% to 176 million euros ($206.7 million). This was aided by "excellent results" from its liquid crystals and generics operations, payments from Bristol-Myers...

Tokyo pharma stocks - week to Sept 29.
November 3, 2003... Tokyo witnessed a steep retreat in the week ended October 27. The pullback was prompted by profit-taking by foreign hedge funds and domestic institutional and individual investors. The selling pressure was on a broad range of issues which went...

BAY 43-9006 enters Ph III kidney cancer trial.
November 3, 2003... Bayer and Onyx Pharmaceuticals have initiated a pivotal Phase III trial to evaluate BAY 43-9006 as a potential treatment for advanced renal cell carcinoma. The international, multicenter, randomized trial will involve 800 patients, with...

ILEX files US NDA for clofarabine.
November 3, 2003... ILEX Oncology has submitted the first part of a New Drug Application with the US Food and Drug Administration for use of clofarabine in the treatment of refractory or relapsed pediatric acute leukemia. The remainder of the NDA will be filed on...

UK govt vows action on cancer "post-code Rxing;" industry says problem is wider.
November 3, 2003... UK Secretary of State for Health John Reid has asked the National Cancer Director, Mike Richards, to look at the National Health Service in every region and ensure that the drugs and treatments which have been approved for use on the NHS in...

French govt plans for long-term ill slammed.
November 3, 2003... The French National Assembly's social affairs commission says it does not accept the section of the 2004 social security funding bill which covers the nation's estimated 5.7 million chronically-ill people, who account for half of all health...

Protein, DNA purification kits: maintaining customer base.
November 3, 2003... The market for protein and DNA purification kits is maturing and the pace of technological innovation has slowed, but dozens of companies continue to fight for market share, say two new reports from BioInformatics. The first study examines...

New Vietnamese pharma plant starts up.
November 3, 2003... A new pharmaceutical plant costing 35 billion dong ($2.3 million) went into operation in southern Vietnam's Phu Yen province in mid-October, reports the Vietnamese News Agency. The plant, which has the capacity to produce 300 million pills a...

Japan: opportunities for small Euro biotechs.
November 3, 2003... Japanese pharmaceutical companies are conducting more late-phase clinical trial work in Europe than ever before and, for biotechnology companies with the right type of strategies and a willingness to collaborate, "there are some very exciting...

Indonesian Bio Island planned for 2007.
November 3, 2003... By 2007, the government of Indonesia plans to create a special economic zone for biotechnology companies on the island of Rempang, close to Singapore. Construction will start next year on the 1,235-acre, 600 billion-rupiah ($69.8 million)...

Japanese MoH panel concerns at OTC drug safety.
November 3, 2003... Consumer representatives and pharmacologists serving on a committee set up by the Japanese Ministry of Health to select "comparatively safe" drugs which can be sold over- the-counter in convenience stores have expressed concern as to whether...

Chiron grants HCV license to Pfizer.
November 3, 2003... Pfizer has obtained a non-exclusive license from Chiron Corp for the research, development and commercialization of therapeutics targeting certain hepatitis C virus drug targets. No financial details of the agreement were disclosed. As part of...

Gilead's Emtriva wins EU approval.
November 3, 2003... The European Commission has awarded marketing authorization for a 200mg hard capsule and 10mg/mL oral solution of Gilead Sciences' Emtriva (emtricitabine) in all 15 member states of the European Union. The agent is indicated for the treatment...

MetXia to start trial for pancreatic cancer.
November 3, 2003... The UK's Gene Therapy Advisory Committee has granted approval for a two-stage Phase I/II trial of Oxford BioMedica's MetXia in patients with pancreatic cancer. The open-label study will initially enroll six patients to assess the safety of...

Anger as industry is not called to US Congressional re-importation hearing.
November 3, 2003... No pharmaceutical industry witnesses were included on the list testifying before a US Congressional Field Forum on the issue of prescription drug market access, held in Boston, Massachusetts, October 28. The meeting was the eighth of a...

FDA slams US states' Canadian Rx claims.
November 3, 2003... The credibility of claims made in a new report issued by the Governor of the US state of Illinois, Rod Blagojevich, asserting that importing prescription drugs from Canada would pose no safety issues (see page 13) have been brought into...

US Congress urged to scrap Rx drug benefit.
November 3, 2003... A coalition of 38 organizations in 23 US states, led by the National Taxpayers Union, has written to all members of Congress urging them to scrap the "politically inexcusable" Medicare prescription drug benefit proposals. "On top of large...

WHO-hosted LDC investment meeting to urge more for HIV/AIDS drug treatment.
November 3, 2003... Ministers of health, finance and planning from 40 developing countries are meeting with development partners at the World Health Organization headquarters in Geneva, Switzerland, October 29-30, to address the need to significantly increase...

Wyeth enters discovery deal with Neurome.
November 3, 2003... Neurome, a privately-held US biotechnology company focused on molecular and cellular neuropathology, announced today that it has entered into a research agreement with Wyeth in which it will employ its proprietary technologies and expertise in...

TKT boosted by record Replagel sales.
November 3, 2003... Transkaryotic Therapies of the USA reports that total revenues for the three and nine months ended September 30, 2003, were $16.7 million and $43.3 million, respectively. Sales of Replagal (agalsidase alfa) for the third quarter totaled $15.2...

CV Thera initiates Ph III of CVT-3146.
November 3, 2003... California, USA-based CV Therapeutics says that it has initiated a pivotal Phase III clinical trial of CVT-3146, a selective A2A-adenosine receptor agonist being jointly developed with Fujisawa Healthcare, for potential use as a pharmacologic...

Avera licenses depression compound from Novartis.
November 3, 2003... Avera Pharmaceuticals, a private, US development-stage drug company, has licensed a novel, late-phase compound that has shown promise in clinical studies conducted to date for the treatment of depression and anxiety from Swiss drug major...

Sales near flat at Merck KGaA in third qtr, generics grow as pipeline is restructured.
November 3, 2003... Germany's Merck KGaA has reported a sharp increase in profits for the third quarter of 2003, due largely to an absence of charges in comparison with the like, year-earlier period and a strong showing from both its generics and liquid crystals...

FDA clears Xoma/Genentech's Raptiva as plaque psoriasis therapy in adults.
November 3, 2003... The US Food and Drug Administration has approved the use of Xoma/Genentech's Raptiva (efalizumab) in the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 or older who are candidates for systemic therapy or...

Roche and Nippon Shinyaku sign deal.
November 3, 2003... Roche and Japan's Nippon Shinyaku have entered a collaboration to develop agents for the treatment of dyslipidemia. The condition results from abnormal levels of lipids and lipoproteins in the blood and thereby significantly increases the risk...

New data shows Roche's Pegasys may have use in a wider range of patients.
November 3, 2003... Results from a study designed to examine if Roche's Pegasys (peginterferon alfa-2a), in combination with Copegus (ribavirin), should be used in treating chronic hepatitis C patients with "normal" alanine aminotransferase levels were presented...

Biogen beats forecast as revenues soar.
November 3, 2003... The world's oldest biotechnology company, Biogen, has reported a strong earnings performance for the third quarter of 2003, due in the main to robust sales of its multiple-sclerosis treatment Avonex (interferon beta-1a). Overall, revenues...

B-MS ups forecast on strong 3rd quarter.
November 3, 2003... US drug major Bristol-Myers Squibb has raised its full-year 2003 profit forecast after reporting a strong set of results for the third quarter ended September 30. The New York-headquartered firm said net income totaled $884 million, or $0.45...

Actelion aiming high as profits grow.
November 3, 2003... Swiss biotechnology concern Actelion, seen to be the world's fastest-growing drugmaker, says that it is targeting long-term sustained growth to rival the current market leaders. Following its recent emergence as a highly-profitable business...

Pfizer announces restructuring.
November 3, 2003... Pfizer chief executive Hank McKinnell has announced the setting-up of a new organization for the company, Pfizer Human Healthcare, which will include the firm's worldwide R&D, pharmaceuticals and manufacturing operations. Within this unit,...

Bayer divests interest in Millennium.
November 3, 2003... German drugs and chemicals major Bayer AG has divested the 6.6% stake (some 19.8 million shares) in US biotechnology firm Millennium Pharmaceuticals that it acquired in 1998 (for $97 million) as part of a wide-ranging, $465 million, drug...

Merck KGaA names Peter Zuehlsdorff as new supervisory board chairman.
November 3, 2003... At Germany's Merck KGaA, Peter Zuehlsdorff, a member of the firm's supervisory board since 1995, will assume the duties of chairman, effective January 1, 2004, immediately after Heinrich Hornef steps down from this post.

Spain's Puleva posts nine-month profits rise of 49%.
November 3, 2003... Spain's Puleva Biotech has posted a 49% jump in first nine-month 2003 net profits to 1.3 million euros ($1.5 million) on sales up 35% to 3.5 million euros. The results met analysts' sales forecasts and exceeded broker Ibersecurities' net profit...

Medarex and Avalon sign antibody deal.
November 3, 2003... USA-based firms Medarex and Avalon Pharmaceuticals have entered a collaboration to develop antibody therapeutics. Medarex will utilize its UltiMAb Human Antibody Development System to generate antibodies against cancer targets identified by...

Abbott to market Dabur's anticancer drugs in the USA.
November 3, 2003... India's largest ayurvedic company, Dabur Pharmaceuticals, has entered into "an exclusive strategic alliance" with Abbott Laboratories to market Dabur's anticancer drugs in the USA. The drugs will be developed and manufactured by Dabur at its...

Yamanouchi's Vesicare on track for US approval in 2004.
November 3, 2003... The US Food and Drug Administration has issued an approvable letter for use of Japanese firm Yamanouchi Pharmaceutical's Vesicare (solifenacin succinate;YM905) in the treatment of overactive bladder. The FDA requested additional clinical data,...

Positive Ph II data for BioSante's LibiGel.
November 3, 2003... Interim Phase II results were released at the International Society for the Study of Women's Sexual Health in Amsterdam, the Netherlands, showing that BioSante Pharmaceuticals' LibiGel (topical testosterone gel) achieved its primary goals in a...

GenVec and NCI sign CRADA for TNFerade.
November 3, 2003... GenVec has signed a Cooperative Research and Development Agreement with the US National Cancer Institute regarding the former's lead oncology product, TNFerade (tumor necrosis factor alfa). Under the terms of the deal, GenVec will provide...

Tularik's T67 on FDA fast-track.
November 3, 2003... The US Food and Drug Administration has granted fast-track designation to Tularik's T67 for first-line therapy in patients with unresectable hepatocellular carcinoma. No systemic chemotherapeutic agents have been approved for this indication,...

New appointments at Morphochem AG.
November 3, 2003... Morphochem AG, a German drug discovery and development firm, is strengthening its board in preparation for advancing products into clinical trials. Max Link is taking over the role of chairman from Helmut Schuehsler, who will become vice...

Celltech promotes Ingelise Saunders to executive director.
November 3, 2003... Ingelise Saunders, chief executive of Celltech Pharmaceuticals since March 2002, has been promoted to executive director of the Celltech Group.

Keith Carter becomes CEO of Allergy Therapeutics.
November 3, 2003... Keith Carter, co-founder of UK-based Allergy Therapeutics in 1998, has been elected chief executive of the company, effective November 1, succeeding Ignace Goethals, who becomes non-executive chairman.

Div Pharma appoints Warren Stern as senor VP, drug development.
November 3, 2003... US firm DOV Pharmaceutical has recruited Warren Stern as senior vice president, drug development. Dr Stern, who has been acting as a consultant to DOV, was previously a senior VP at Parexel.

Berna Biotech to raise capital by 86.9 million SwFr.
November 3, 2003... Swiss vaccines and immunotherapy products group Berna Biotech has completed an operation to raise its capital by 86.9 million Swiss francs ($65.9 million), in a global offering of 284,615 shares via UBS Investment Bank. The new funding will be...

Cash-rich Serono on acquisition trail.
November 3, 2003... Swiss biotechnology firm Serono, which currently has a cash position of some $1.8 billion, is on the hunt for new product acquisitions, despite presenting an array of drug candidates at its recent press and analysts' results meeting in London,...