Pharma Marketletter articles from December 2002

Pharma Marketletter archives from December 2002

Levitra gets CPMP backing in Europe.
December 2, 2002... Bayer AG and GlaxoSmithKline have received a positive opinion recommending marketing approval from the European Union's Committee for Proprietary Medicinal Products for Levitra (vardenafil), their new oral drug for the treatment of erectile...

Allegra tops Zyrtec in drowsiness stakes.
December 2, 2002... Two studies reported at the American College of Allergy, Asthma and Immunology meeting in San Antonio have shown that, while Aventis' antihistamine Allegra (fexofenadine) 180mg once-daily formulation is equally effective as UCB's competing...

Hepsera backed for EU approval.
December 2, 2002... The European Union's Committee for Proprietary Medicinal Products has recommended approval of Gilead Sciences' Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B. The drug was cleared for marketing in the USA in September...

Mixed results at AHA for Aventis' enoxaparin.
December 2, 2002... The results of the TETAMI trial, presented at the American Heart Association meeting in Chicago, found that Aventis' low molecular weight heparin Clexane/Lovenox (enoxaparin) provided no benefit over unfractionated heparin or Merck & Co's...

New role for Glivec in cancer?
December 2, 2002... Animal data presented at an oncology conference in Frankfurt suggest that Novartis' chronic myeloid leukemia drug Glivec (imatinib) can boost the antitumor effects of the widely-used chemotherapy drugs 5-fluorouracil and paclitaxel, as well as...

GSK's Lotronex relaunched in USA.
December 2, 2002... GlaxoSmithKline's Lotrenox (alosetron hydrochloride) is available once again in the USA for female patients who suffer with severe diarrhea-predominant irritable bowel syndrome. The product is available under very restricted conditions of use...

Indian firms told: "raise quality, look abroad".
December 2, 2002... While efforts by the USA and UK governments to reduce health care spending present Indian drugmakers with a clear opportunity, they need to improve perceptions of the quality of their products, according to analysts at AT Kearney. India's...

Taiwan to cut hospital refunds on expired drugs.
December 2, 2002... The government of Taiwan has approved a plan to reduce the levels of refunds on medicines paid to hospitals by the Bureau of National Health Insurance. This move follows calls for the Bureau to be able to buy drugs directly from manufacturers,...

Vietnam's success in eliminating fake drugs.
December 2, 2002... Counterfeit drugs now comprise only 0.04% of all medicines sold in Vietnam, one of the lowest rates in the world, according to a Ministry of Health announcement reported by the Vietnamese News Agency. Almost the entire population can now...

India rejects price curbs on HIV/AIDS drugs.
December 2, 2002... India's National Pharmaceutical Pricing Authority has said that the prices of HIV/AIDS drugs marketed in the country are "reasonable" and that it would not be appropriate to place them under controls. This decision came after a...

China's nine-month drug exports.
December 2, 2002... China's General Administration of Customs has reported that the country exported medicines worth $1.67 billion in the first nine months of 2002, a year-on-year increase of 13.9%, according to the Xinhua news agency.

Daiichi's profits down, guidance lowered.
December 2, 2002... Japan's Daiichi has disappointed the markets with lower-than-expected first-half fiscal 2003 results and a substantial downward revision of its full-year forecast. Interim consolidated operating income plummeted 18.7% year-on-year to 27.8...

Sankyo profits up, US sales perform well.
December 2, 2002... Japan's Sankyo has reported encouraging fiscal 2003 interim results, driven by a strong performance in exports and robust US sales of its leading products. Consolidated operating income rose 11.4% to 46.3 billion yen ($377.2 million) compared...

Pharma information and knowledge management: P-D-R.
December 2, 2002... Opening the Pharma Documentation Ring's annual general meeting, its president, Sandy Mullen of Bayer AG, noted that the availability of biosequence information had increased dramatically in recent years. For example, he said, it took patent...

Kwizda buys Mayrhofer.
December 2, 2002... Austrian drug wholesaler Mayrhofer Pharmazeutika, based in Linz, has been acquired by the Vienna-based Kwizda group. No price has been disclosed. Kwizda now becomes the country's second-largest drug wholesale group behind Herba Chemosan, which...

Row over Biota bid from Bigshop.
December 2, 2002... Australia's Bigshop has intensified a row with the board of Biota Holdings by launching an off-market takeover bid for the cash-rich biotechnology firm. The all-paper deal, which offers 15 shares in the Perth-based corporate raider for every...

Japan pharma industry eschews in-house manufacturing - by P Reed Maurer.
December 2, 2002... Not long ago, the highest value-added function of a Japanese pharmaceutical firm was its manufacturing operation. These people held the power in every company, and the head of any plant facility was guaranteed a seat on the board. Every...

QLT streamlines workforce for continued profitability.
December 2, 2002... Canada's QLT Inc has announced a reduction of its workforce to reduce operating expenses and concentrate its resources on key product development programs and business initiatives. The company has reduced its overall headcount by 65 people, or...

Athelas raises 2M SwFr in first-round financing.
December 2, 2002... Switzerland-based biopharmaceutical firm Athelas says that it has secured 2 million Swiss francs ($1.4 million) in a first-round financing, which was led by Aravis and included Novartis Venture Fund Venture Incubator. Athelas, a spin-out...

Myriad Genetics raises $57.3 million.
December 2, 2002... USA-based Myriad Genetics has said that it will receive $57.3 million from an underwritten offering of 3 million shares of its common stock pursuant to its outstanding shelf registration statement. Morgan Stanley served as the sole underwriter...

Ligand prices $135 million offering.
December 2, 2002... Ligand Pharmaceuticals of the USA has announced the pricing of a private placement of $135 million of its 6% convertible subordinated notes due November 16, 2007. The offering is expected to close November 26, 2002. The notes are...

Nizhfarm targets $100M sales by 2005.
December 2, 2002... Russian drugmaker Nizhfarm says that it is aiming to grow its annual turnover to $100 million by 2005, reports the Interfax news agency. The company currently spends around 5% of its profits on advertising and hopes to increase sales,...

Belbiofarm of Belarus to grow exports.
December 2, 2002... Belarusian drugmaker Belbiofarm says that it is planning to increase exports to foreign markets, reports the Belta news agency. General manager Sergei Churakov is reported to have said that Belbiofarm has reached agreement with an unnamed...

Plurion buys stake in Australia's BresaGen.
December 2, 2002... Australian biotechnology concern BresaGen has received a boost after reaching an agreement with USA-based Plurion relating to intellectual property rights which will empower the former company to take its stem-cell technology through to the...

German biotech sector "future in question".
December 2, 2002... German biotechnology companies are facing an economic downturn so serious that questions are now being raised about the future of the sector. One typical firm is MorphoSys, whose quarterly spending is currently over 9 million euros ($9.1...

UK supplementary Rxing plans advance.
December 2, 2002... UK pharmacists and nurses will be able to prescribe drugs from early 2003, the government has announced. With the completion of consultations begun in the spring (Marketletter April 22), Health Ministers have said that training for pharmacists...

Fast rise in Spanish drug spending growth.
December 2, 2002... The Spanish national health service's drugs bill is growing rapidly, with the latest government figures showing an 11.7% increase, year-on-year, in October 2002. October's drugs bill reached 707 million euros ($7.1 million), while the...

Lundbeck acquires Synaptic for $121M.
December 2, 2002... Danish drugmaker H Lundbeck A/S has signed a definitive agreement to acquire US firm Synaptic Pharmaceutical, in a cash deal of $6.50 per share, or around $121 million. The offer price represents an 8% premium on Synaptic's closing price...

Stada heading for record 2002.
December 2, 2002... German generic drugmaker Stada has posted marked increases in sales and profits for the first nine months of 2002 and is forecasting a seventh record year in a row. Sales are set to put on double-digit growth, while pretax profits are expected...

Novartis completes Lek takeover.
December 2, 2002... After upping its offer for Slovenian generics firm Lek Pharmaceutical & Chemicals, Swiss drug major Novartis has finally succeeded in its bid to buy the company (Marketletter October 7). Novartis says that the offer was declared "successful"...

Novuspharma nine-month losses rise.
December 2, 2002... Italian biotechnology firm Novuspharma has reported revenues of 2.8 million euros ($2.8 million) for the first nine months of 2002, compared with 100,000 euros for the like, year-earlier period. The rise was mainly due to public grants...

PharmaKinetics and Bioanalytical amend merger deal.
December 2, 2002... US contract research organization PharmaKinetics Laboratories has entered a second amendment to its agreement of merger with Bioanalytical Systems (BASi) and PI Acquisition Corp dated June 20, as amended by a first amendment dated July 24. ...

Novartis returns Apligraf rights to Organogenesis.
December 2, 2002... Swiss drug major Novartis has reached an agreement to transfer the worldwide marketing and distribution rights to Apligraf, a "living skin" wound care product approved by the US Food and Drug Administration for venous leg and diabetic foot...

Solvay launches Omacor in UK.
December 2, 2002... Solvay Healthcare has launched Omacor, a new omega-3 fatty acid-based product licensed for reducing deaths after heart attack, in the UK, where it will be available on prescription. Thus far, Omacor has only been made available in Denmark,...

NeoTherapeutics completes equity offering.
December 2, 2002... NeoTherapeutics has announced that it has raised $938,000 through the sale to five investors, including Luigi Lenaz, president of the company's oncology division, of 469,000 shares of common stock, at a price of $2.00 per share. The investors...

Servier faces major legal case over Redux and Ponderal.
December 2, 2002... French drugmaker Laboratoires Servier is facing a major class action in Canada over alleged side effects of its two slimming drugs Redux (dexfenfluramine) and Pondimin (fenfluramine), which had been sold in France as Isomeride and Ponderal....

Japanese domestic drugmakers re-plan future R&D spending.
December 2, 2002... Major Japanese domestic drugmakers have begun to freeze or reduce their level of R&D spending, reports the Nikkei Weekly. The industry has experienced a long-term trend of increased R&D expenditure, the paper notes, but is now suffering from a...

Elan completes Athena deal and sells licensing rights to Abelcet.
December 2, 2002... Struggling Irish drugmaker Elan Corp has agreed to sell all of the outstanding stock of its subsidiary Athena Diagnostics, plus certain affiliated investment funds, to Behrman Capital for a gross consideration of about $122 million. Elan...

Cognet-X ranks Novartis no 1 in MCPs' Best Overall Needs.
December 2, 2002... USA-based pharmaceutical consultancy Cognet-X has rated Novartis Pharmaceuticals Corp as the pharmaceutical company that best meets the overall needs of managed care pharmacy directors. The Swiss firm was voted number one in the Overall...

Shionogi feels effects of price cuts, sales fall 13% in first-half fiscal 2003.
December 2, 2002... Japan-based Shionogi has reported a fall in consolidated first-half fiscal 2003 operating profit to 7.1 billion yen ($57.8 million), a decrease of 8.1% compared with the like, year-earlier period ended September 30, 2001. Total sales...

India's Swift in R&D accord with NIPER.
December 2, 2002... In India, Ind-Swift Laboratories has entered into a collaborative R&D agreement with the Ministry of Chemicals and Fertilizer's National Institute of Pharmaceutical Education and Research, reports India InfoLine. Under the terms of the...

Intercell moves HCV vaccine to Phase II.
December 2, 2002... Austria's Intercell AG has started a Phase II clinical trial of its therapeutic hepatitis C vaccine in Europe. The dose-escalation study will be conducted on hepatitis C virus-positive patients who exhibit no response to the current standard...

Zeltia's kahalalide of value in solid tumors.
December 2, 2002... Zeltia of Spain's pharmaceuticals subsidiary, PharmaMar, has reported promising early clinical data from a trial of its candidate cancer drug kahalalide F in patients with advanced solid tumors. The dose-ranging study, conducted in 38...

Acambis' Dengue fever vaccine clears Phase I.
December 2, 2002... UK company Acambis has completed a Phase I clinical trial of its candidate vaccine for dengue fever, which affects an estimated 50 million people every year. The 56-patient study found that one of the four components in the firm's...

EU Parliament OKs "very biotech-friendly" report on Commission Communication.
December 2, 2002... The resolution on the European Commission Communication: Life Sciences and Biotechnology - a Strategy for Europe (Marketletter October 21) which has now been adopted by the European Parliament, represents, according to the Parliament, a "very...

EU Commission health web site standards move.
December 2, 2002... The European Commission plans, in the week of December 2, to introduce recommendations for common quality standards for health care-related web sites. While no specific details were available ahead of the proposals' publication, observers...

Almirall Prodesfarma sets up Italian unit.
December 2, 2002... Spain's number one pharmaceutical company, Almirall Prodesfarma, says it is strengthening its international presence with the establishment of a subsidiary in Italy. In doing so, it says, the company is consolidating its presence and position...

Sinclair acquires Sweden's Biosurface.
December 2, 2002... UK-based Sinclair Pharmaceuticals has concluded an agreement to acquire the Swedish company Biosurface Pharma AB, following the approval, to date, of over 98% of the latter's shareholders. The consideration for the acquisition was new ordinary...

Bayer to boost Asian investment.
December 2, 2002... German drugmaker Bayer AG is to increase its Asian region investment spending despite a general streamlining of group expenditure under the new "capital discipline" strategy. Chief executive Werner Wenning said that Bayer would stick to its...

Iceland's Pharmaco moves into Serbia.
December 2, 2002... Icelandic pharmaceutical company Pharmaco has confirmed its agreement to acquire 60% of the shares of the Serbian drugmaker Zdravlje and has also negotiated to buy a further 15% stake within the next three years. The agreement has been signed...

Immune Response issues bankruptcy warning.
December 2, 2002... Nasdaq-listed Immune Response has issued a warning that it may have to file for bankruptcy as it reported third-quarter 2002 results which revealed limited cash resources and funds as the firm swung to a loss of $5.5 million, compared with a...

GenVec's BioBypass promising in CAD.
December 2, 2002... A Phase II proof-of-concept trial, REVASC, has shown that GenVec of the USA's vascular endothelial growth factor gene-based drug BioBypass (adVEGF121) can provide a benefit in terms of reducing ischemia in patients with severe coronary artery...

Biogen's Amevve plus light therapy.
December 2, 2002... A 21-patient, open-label study looking at the combination of Biogen's Amevive (alefacept) plus narrow-band ultraviolet B light has revealed promising results in patients with plaque psoriasis. 16 patients who received the treatment reported...

Photogen to buy MI assets from Alliance.
December 2, 2002... Photogen Technologies and fellow US firm Alliance Pharmaceutical have jointly announced that they have executed a term sheet for Photogen to acquire all of the assets of Alliance related to medical imaging, including all manufacturing and...

Bradley Pharma ups full-year 2002 guidance.
December 2, 2002... US firm Bradley Pharmaceuticals has released upward revisions of net sales and earnings per share for the year 2002. These new projections are based on continued significant net sales growth as well as a substantial expansion of new...

PRS opens subsids in Hong Kong, Malaysia, and Singapore.
December 2, 2002... Pharmaceutical Regulatory Services of the USA has recently opened fully-owned subsidiaries in Hong Kong (Pharmaceutical Regulatory Services Hong Kong), Malaysia (Pharmaceutical Regulatory Services Malaysia Sdn Bhd) and Singapore...

Two-for-one stock split for Teva.
December 2, 2002... Israel's Teva Pharmaceutical Industries says that its board of directors has approved a two-for-one stock split of the company's ordinary shares/American Depository Receipts, which will be effected in the form of a 100% stock dividend. Each...

Biotech demand drives Sigma-Aldrich.
December 2, 2002... Sigma-Aldrich, a $1.2 billion life science company headquartered in St Louis, USA, has reported strong third-quarter earnings driven by sales gains in its biotechnology division. Percentage growth in key life sciences areas was in the...

Immune Response verges on bankruptcy, Pfizer deal breakdown hits hard.
December 2, 2002... Nasdaq-listed Immune Response has issued a warning that it may have to file for bankruptcy. The company has reported third-quarter 2002 results which revealed limited cash resources and funds as the firm swung to a loss of $5.5 million,...

ICN Pharma settles in SEC legal dispute.
December 2, 2002... ICN Pharmaceuticals of the USA has reached an agreement with the US Securities and Exchange Commission which will see the drugmaker pay a $1 million fine and alter its disclosure practices. The settlement relates to a complaint filed by...

Allergan in $23M deal with Peplin Biotech.
December 2, 2002... USA-based Allergan has entered into an R&D collaboration and licensing agreement with Peplin Biotech relating to the latter's non-melanoma topical skin cancer treatment PEP005. The product candidate has already shown early promise in the...

PowderJect rebuffs unofficial offer.
December 2, 2002... UK-based vaccine manufacturer PowderJect says that, following more detailed discussions over a potential bid, it has turned down an unofficial offer for the business, believed to be from US drugmaker Chiron (Marketletters passim), on the basis...

Provalis encouraged by US partner uptake of Glycosal.
December 2, 2002... UK-based drugmaker Provalis says that its diabetes diagnostic Glycosal (generic name) is performing well in the USA, following a report from the firm's semi-exclusive marketing partner, Cholestech, that sales of the product have been...

AstraZeneca opens R&D center in China.
December 2, 2002... Anglo-Swedish drugmaker AstraZeneca opened its Clinical Research Unit-East Asia (ACRU-EA) in Shanghai, China, on November 26. With the unit's establishment, AstraZeneca says that it will become the first international pharmaceutical...

Tokyo pharma stocks - week to Nov 25.
December 2, 2002... Tokyo saw a rally in the week to November 25, assisted by strength of New York markets and certain new developments in Japan's policy measures. The Nikkei 225 advanced 7.2%, with a five-session winning streak, while the Topix index rose 5.9%....

Andrx and Novartis settlement approved.
December 2, 2002... Andrx Corp says that the US District Court for the Eastern District of Michigan has granted final approval of the previously-announced settlement entered into by Aventis with the direct purchaser class. The direct purchaser class is...

EC approves OGS' Gaucher drug Zavesca.
December 2, 2002... UK-based Oxford Glycosciences has received a Marketing Authorization from the European Commission for Zavesca (miglustat, previously known as Vevesca), which the company says is the first approved oral treatment for patients with...

NeuroSearch deal with GSK.
December 2, 2002... Danish biotechnology firm NeuroSearch A/S has entered into a three-year deal with UK-based GlaxoSmithKline to develop antidepressant drug candidates. Finn Eggert Sorensen, a senior executive with the Danish company, has told Reuters that,...

Rebif "more effective than Avonex".
December 2, 2002... Swiss drugmaker Serono has said that its multiple sclerosis drug Rebif (interferon beta-1a) has been shown to be more effective that Biogen's Avonex (also interferon beta-1a) in reducing relapses and active brain lesions in patients with...

Waxman-Hatch reform "must eliminate 30-day stay," says original sponsor.
December 2, 2002... While the US Congress has not yet been successful in passing legislation to reform the 1984 US Waxman-Hatch Act, original co-sponsor Representative Henry Waxman says he is confident that it will pass at some point. The recent spotlight on...

New US FDA chief backs CROs.
December 2, 2002... Clinical research organizations will play an important role in working with the US Food and Drug Administration in continuing to enhance the development of effective new medicines in the USA, the agency's new Commissioner, Mark McClellan, has...

UK govt launches anti-smoking campaign, NRT rebate.
December 2, 2002... All four major suppliers of nicotine replacement therapy in the UK - GlaxoSmithKline, GlaxoSmithKline Consumer Health, Novartis Consumer Healthcare and Pharmacia - have agreed to to offer the government a rebate on smoking cessation products...

Albania allocated $130M for health care 2003.
December 2, 2002... Albania's draft state budget for 2003 has allocated 18.3 billion leks ($130 million) for health care expenditure during the year, according to the Albanian Telegraphic Agency. The figure will be equivalent to 2.5% of Albania's Gross Domestic...

Lithuanian retail sales at dispensing chemists.
December 2, 2002... Lithuania's Statistics Department has reported that retail sales at dispensing chemists in the country for the first nine months of 2002 were 18.1% higher than in the same period last year. Sales in September were 9.6% higher than in August...

6B-euro French investment plan.
December 2, 2002... French Health Minister Jean-Francois Mattei has presented his 6 billion euro ($5.94 billion) investment plan for the public-sector hospitals in the period to 2007. The Minister has avoided the notion of "economies" and says there is no...

Lilly's non-stimulant ADHD drug, Strattera, is cleared in USA.
December 2, 2002... Eli Lilly has been granted marketing approval by the US Food and Drug Administration for Strattera (atomoxetine hydrochloride), its new drug for the treatment of attention-deficit hyperactivity disorder. This is the first approval worldwide...

PowderJect declines bid, US prospects rise.
December 2, 2002... UK-based vaccine manufacturer PowderJect says that, following more detailed consideration of a potential bid, it has turned down an unofficial offer for the business, believed to be from US drugmaker Chiron (Marketletters passim), on the...

GSK backs down on CEO's "fat cat" pay.
December 2, 2002... After receiving more press coverage in recent weeks for the sizeable incentive scheme offered to its chief executive, Jean-Pierre Garnier, than its entire product portfolio has attracted all year, drug major GlaxoSmithKline has finally given...

Vernalis buoyed by first EU product launch.
December 2, 2002... Vernalis, one of the few biotechnology firms in the UK which actually turns profit, has been boosted by the launch of its first product in Europe. The company said that its migraine drug Allegro (frovatriptan) has been launched in Germany by...

NeuroSearch reduces losses for interim.
December 2, 2002... Denmark-based NeuroSearch has posted a net loss of 6.8 million Danish kroner ($907,120) for the first nine months of 2002, compared with a loss of 105.6 million kroner during the like, year-earlier period. Revenue totaled 192.0 million kroner,...

BI's pramipexole assessed for restless legs.
December 2, 2002... Boehringer Ingelheim says it has started development of its dopamine antagonist pramipexole as a treatment for restless legs syndrome, following encouraging results in a pilot study. The drug was developed in partnership with Pharmacia and is...

Millennium starts prostate cancer trials.
December 2, 2002... Millennium Pharmaceuticals has initiated clinical trials of MLN2704 (formerly MLN591DM1) in patients with metastatic androgen-independent prostate cancer. The drug consists of a "payload" of the maytansanoid chemotherapeutic DM1, guided by...

IDM prostate cancer drug clears Phase I/II.
December 2, 2002... Immuno-Designed Molecules of France has completed a Phase I/II trial of its dendritic cell-based cancer vaccine, with "intriguing" results, according to the company. 24 patients with recrudescent prostate cancer after prostatectomy received...

Access Pharma progresses AP5280 to Ph II.
December 2, 2002... The USA's Access Pharmaceuticals has moved forward its platinum cancer drug candidate, AP5280, into Phase II development. Phase I results suggest that the compound has greater tolerability than current platinum-based drugs, such as cisplatin...