Pharma Marketletter articles from April 2003

Pharma Marketletter archives from April 2003

Pliva closes deal to acquire Spain's Edigen.
April 7, 2003... Croatia's Pliva says that it has closed the all-paper purchase of Spanish drugmaker Edigen from Farmadis Alcala and Espariola de Desarrollo e Impulso Farmaceutico of Spain. The company was acquired for 9.3 million euros ($10.0 million) in a...

Synta closes $75M financing round.
April 7, 2003... USA-based Synta Pharmaceuticals has announced the closing of a $75.3 million series-B financing. The round was raised from a combination of institutional and experienced private investors, noted the company. The funds will be used to advance...

Zonagen terminates merger with Lavipharm.
April 7, 2003... Zonagen says that it has terminated the merger agreement initiated last year with Lavipharm and certain of the latter's stockholders, effective immediately. The merger agreement had provided that, if it had not been completed by February 28...

ACADIA completes $25M private placement.
April 7, 2003... ACADIA Pharmaceuticals, headquartered in the USA and with research facilities in Denmark, says that it has completed a $25 million private placement of its preferred stock. The financing round was led by Oxford Bioscience Partners and included...

Abbott completes bar code initiative.
April 7, 2003... Abbott Laboratories has completed its initiative to affix unit-of-use bar codes to 100% of its hospital injectable pharmaceuticals and IV solutions. The achievement, which encompasses more than 1,000 products, is part of Abbott's initiative to...

Savage discontinues Nitrol product line.
April 7, 2003... US firm Savage Laboratories says that it has discontinued its Nitrol (nitroglycerin) product line and will no longer produce or distribute any of the Nitrol product line. Nitroglycerin ointments are indicated for the prevention of attacks...

Genzyme fined L6.8M over market abuse regarding Cerezyme in the UK.
April 7, 2003... The UK subsidiary of US biotechnology major Genzyme has been fined L6.8 million ($10.7 million) by the Office of Fair Trading for breach of Chapter 11 of the Competition Act regarding the firm's selling practices for its Gaucher's disease drug...

Merck KGaA lifted by Erbitux trial review.
April 7, 2003... Merck KGaA of Germany has reported that an independent review of its European Phase III trial of Erbitux (cetuximab), a candidate treatment for colorectal cancer, puts the firm on track to file for approval in mid-2003. Merck's shares rose...

Threats to innovation could see drug R&D fall into a "death spiral," says Eli Lilly CEO.
April 7, 2003... According to Sidney Taurel, chief executive of Eli Lilly, the threat to pharmaceutical innovation is very real and is growing. Moreover, Mr Taurel told the American Enterprise Institute in Washington that continued pharmaceutical innovation...

Cytos beats forecasts with 2002 results.
April 7, 2003... Swiss firm Cytos Biotechnology AG has posted 2002 results which are ahead of estimates, says broker Sarasin. Net loss for the year reached 21.7 million Swiss francs ($15.7 million), compared with 10.5 million francs in the first nine months of...

Lonza invests 100M SwFr in new plant.
April 7, 2003... Switzerland-based life sciences group Lonza has started construction of a new biopharmaceutical manufacturing plant at its Visp site, which will involve an investment of 100 million Swiss francs ($72.2 million) and will create over 100 new...

English primary care spending on four Rx groups up 25% last year, says Audit Comm.
April 7, 2003... Drug prescribing costs in England rose L540 million ($850 million) last year and, of this, L240 million was due to just four drug groups, says a new report from the UK's independent Audit Commission. Last year's general drug inflation was...

Pharmacia gets US approval for acromegaly treatment Somavert.
April 7, 2003... Pharmacia's new drug for the treatment of acromegaly, Somavert (pegvisomant), has been approved in the USA a few months after its registration in Europe (Marketletter November 25, 2002). Acromegaly is a life-threatening disorder caused by...

Merck & Co's Emend cleared by FDA for nausea in cancer chemotherapy.
April 7, 2003... Merck & Co has been granted approval by the US Food and Drug Administration for Emend (aprepitant), its new drug for the treatment and prophylaxis of nausea and vomiting in patients undergoing chemotherapy for cancer. The product is indicated...

Abgenix links with Japan's Sosei on inflammation R&D.
April 7, 2003... Abgenix of the USA has entered into an agreement with Japan's Sosei to discover, develop and commercialize fully-human monoclonal antibody therapies against CRTH2 (chemoattractant receptor-homologue on Th2 cells), which is expressed on human...

Orphan status for BCY's dextran-1 in cystic fibrosis.
April 7, 2003... BCY LifeSciences has been granted orphan-drug status in the USA for dextran-1, the major constituent of BCY's lead compound, DCF 987, in the treatment of cystic fibrosis. The drug is currently in a Phase II study and is due to report...

New clinical data back promise of Guidant's everolimus stent.
April 7, 2003... Guidant Corp has reported positive six-month results from its FUTURE I clinical trial, which is comparing the safety of an everolimus-eluting coronary stent to a bare metal stent platform in previously-untreated lesions. After six months,...

Takeda forecasts solid growth for fiscal 2003; shares continue to slide.
April 7, 2003... Japan's leading drugmaker, Takeda Chemical Industries, is forecasting another record year of operating profits on the back of robust diabetes care product sales, both on the domestic market and overseas. The company, which holds a 19%...

B-MS grows Asian presence via new hub.
April 7, 2003... USA-based drugmaker Bristol-Myers Squibb has announced the opening of a new research facility in Singapore. The unit, which will focus on helping B-MS' scientists expedite the development of new medicines more rapidly, was established with the...

US Court OKs Michigan preferred drug lists.
April 7, 2003... In a decision which will have nationwide repercussions, a US federal court has upheld the state of Michigan's use of preferred drug lists in its Medicare and Medicaid programs. Judge John Bates in the US District Court for the District of...

US Congress urged over web pharmacy.
April 7, 2003... US state legislators and medical licensing boards have called for stronger Congressional action to protect consumers who buy prescription drugs over the Internet, including giving the Attorney General nationwide injunctive powers to shut down...

FDA backs state action on Canadian imports.
April 7, 2003... The US Food and Drug Administration has said it "strongly supports" the filing by the US state of Oklahoma's Board of Pharmacy and Attorney General's Office of a petition for injunction against the Rx Depot storefront pharmacy on the grounds...

California directs HMOs over switched drugs.
April 7, 2003... In the US state of California, the Department of Managed Health Care has told health maintenance organizations and other insurers that they cannot stop covering an entire class of prescription drugs when one product in the group switches to...

European pharmaceuticals industry is strong, says S&P.
April 7, 2003... The European pharmaceuticals industry is as strong as ever, backed by young product portfolios, and many players project growth levels well above national Gross Domestic Product for 2003, according to a report published by the USA-based...

Aventis Behring CEO urges joint effort to boost plasma protein ind.
April 7, 2003... The future of the plasma protein industry and the challenges facing companies seeking safe, high-quality protein therapies in a business environment hampered by conflicting international regulations was addressed in a key note speech by Ruedi...

Novo Nordisk chief sees pitfalls in EU takeover directive.
April 7, 2003... Speaking at his firm's annual general meeting about the European Directive on takeover bids now under discussion, Novo Nordisk chairman Mads Ovlisen said that, while its final content is not yet known, "unfortunately proposals are afoot to...

Regeneron dives as statement on Phase III obesity trial alarms investors.
April 7, 2003... Shares in US biotechnology company Regeneron took a nosedive on March 31, after the company reported Phase III trial results on Axokine (ciliary neurotrophic factor), its candidate treatment for obesity. Although the study achieved both its...

Losses up at TKT but Replagal sales recover.
April 7, 2003... The USA's Transkaryotic Therapeutics has reported a solid sales performance from its lead product, Replagal (agalsidase alfa), for the fourth quarter and full year ended December 31, 2002, while net losses widening on the back of exceptional...

Zonagen's losses widen on write-offs.
April 7, 2003... USA-based Zonagen has posted a more than three-fold increase in net loss to $1.4 million, or $0.12 per share, for the fourth quarter ended December 31, 2002, while losses for the full year widened to $3.9 million, or $0.34 per share, from...

Palatin raises $19M to advance product developments.
April 7, 2003... US biopharmaceutical firm Palatin Technologies has announced the conclusion of an offering which yielded gross proceeds of $19 million. The company sold approximately 13.4 million shares and, for every four purchased, the investors also...

Millennium starts cash offer for notes.
April 7, 2003... Millennium Pharmaceuticals has announced its required cash offers to the holders of its outstanding 4.5% Convertible Senior Notes due June 15, 2006 and 5.0% Convertible Subordinated Notes due March 1, 2007. Millennium assumed the...

Cephalon files patent suits over generic Provigil.
April 7, 2003... Cephalon of the USA has filed a lawsuit in the US District Court in New Jersey against four generic drug companies for infringement of its US patent no RE37516. The '516, which patent covers the pharmaceutical compositions of the form of...

GSK's Coreg gets post-MI mortality claim.
April 7, 2003... New labeling for GlaxoSmithKline's beta blocker Coreg (carvedilol), which covers the use of the drug to reduce mortality in patients with impaired cardiac function after a heart attack, has been approved in the USA. The company notes that...

J&J to pick up Kosan antibiotic.
April 7, 2003... Johnson & Johnson has agreed to take up an option to license a macrolide antibiotic discovered in a collaboration with Kosan Biosciences, a company specializing in the development of drug candidates from polyketides. The move sparks an...

Abbott and Karo Bio identify diabetes drug.
April 7, 2003... A collaboration between Abbott Laboratories and Karo Bio of Sweden has borne its first fruit with the identification of a novel, first-in-class compound, A-348441, for the treatment of type 2 diabetes. Currently in preclinical development,...

China tightens controls on drugs and biologicals, approves food/drug admin.
April 7, 2003... China's State Drug Administration has this year introduced the Biological Products Approval Administration Procedure, to ensure the safety and efficacy of a range of vaccines, blood products and in vitro diagnostic preparations. This...

ImClone to restate earnings for 2001/02.
April 7, 2003... Embattled US drugmaker ImClone says that it has been forced to delay its fourth-quarter and full-year 2002 results and will have to restate earnings for 2001 following news that it could be forced to take a $60 million charge relating to the...

Zonagen losses widen merger plans collapse.
April 7, 2003... USA-based Zonagen posted a more than three-fold increase in net loss to $1.4 million, or $0.12 per share, for the fourth quarter ended December 31, 2002, while losses for the full year widened to $3.9 million, or $0.34 per share, from...

Roche CEO reiterates 2003 forecasts.
April 7, 2003... Having reviewed the dismal performance for 2002, when Switzerland's Roche made a loss of 4.03 billion Swiss francs ($2.98 billion; Marketletter March 3), chief executive Franz Humer said that the New Year "is off to a good start." ...

Elan gains $89.5M from Xcel investment.
April 7, 2003... Irish drugmaker Elan, which is divesting all sorts of assets to raise funds to pay off debts due to mature by year-end (Marketletters passim), has received $89.5 million in cash from its investment in Xcel Pharmaceuticals. In 2001, Elan bought...

Celltech's stake in OGS now 14.4%.
April 7, 2003... As the battle for Oxford GlycoSciences rages on, fellow UK firm Celltech, which has made a cash offer of 182 pence a share, valuing the company at some L101.4 million ($160.3 million; Marketletters passim), says it had received acceptances for...

Merlin bids for ReNeuron.
April 7, 2003... Confirming earlier rumors, UK firm ReNeuron is the subject of an agreed takeover offer from the Merlin Consortium through the latter's St James' unit. The offer is at 10 pence cash for each share, a 129% premium, valuing ReNeuron at some L3.6...

Budget crisis threatens Massachusetts Rx plan.
April 7, 2003... On April 1, the second anniversary of the US state of Massachusetts' Prescription Advantage drug insurance program, over 80% of state residents aged over 40 said they oppose Governor Mitt Romney's closure of any further enrolment into the...

Firms overcharged $6.1M for 11 drugs: HHS.
April 7, 2003... Five unnamed pharmaceutical manufacturers overcharged medical institutions which treat America's poorest people an estimated $6.1 million for 11 prescription drugs during the year to September 30, 1999, says an audit report issued by the...

Montana plans "USA's widest" Rx program.
April 7, 2003... In the US state of Montana, the legislature is examining a proposal by Senate Majority Leader Fred Thomas to give significant prescription drug cost aid to around 30,000 state seniors on low incomes. SB 474 would set up the Montana Gold...

New Mexico law boosts drug access.
April 7, 2003... Some 20,000 low-income seniors and disabled people in the US state of New Mexico are expected to gain access to prescription drugs under a new law setting the eligibility level at 185% below the federal poverty threshold. The plan, which was...

Allergan launches national glaucoma education campaign.
April 7, 2003... US firm Allergan has launched Partnership for Sight, a voluntary group focused on glaucoma awareness, at a media conference in San Francisco. Glaucoma is a leading cause of blindness among African Americans, who represent half of the...

Immune Response gets $2M funding.
April 7, 2003... Immune Response has closed a $2 million investment from Cheshire Associates LLC which purchased from the company on March 28 a short-term convertible promissory note in the amount of $2 million and bearing interest at 8% per annum. The note is...

Sankyo establishes start-ups fund.
April 7, 2003... Japanese pharmaceuticals firm Sankyo has announced the establishment of a fund for start-ups in the USA with investment company Thomas Weisel Partners LLC, reports the Nihon Keizai Shimbun. The total investment amount is expected to reach...

Array BioPharma lowers forecasts.
April 7, 2003... Array BioPharma is lowering its revenue forecast due to general market softness and the ending of two significant drug discovery collaborations. Overall, Array estimates that these factors will result in reduced revenue of approximately $6.0...

Decontamination lotion cleared by US FDA.
April 7, 2003... The US Food and Drug Administration has approved a lotion, for neutralizing and destroying chemical warfare agents, developed by E-Z-EM. The filing of the product, called Reactive Skin Decontamination Lotion, came about as a result of a joint...

Pyrosequencing in IBD deal with US university.
April 7, 2003... Sweden's Pyrosequencing has formed a research collaboration with Thomas Jefferson University in the USA to analyze genes involved in inflammatory bowel disease. The University recently purchased Pyrosequencing's benchtop high-sensitivity...

Alkermes reports progress in Vivitrex trial.
April 7, 2003... Alkermes has completed enrollment in its Phase III trial of Vivitrex (naltrexone) as a once-monthly treatment for alcohol dependence. The product has been developed using Alkermes' proprietary Medisorb microsphere-encapsulation technology.

Exelixis nears trials of first product.
April 7, 2003... Exelixis has filed an Investigational New Drug application in the USA for a small-molecule anticancer compound, XL784, which targets a cell surface protease thought to be involved in the cleavage of growth factors that promote cell growth and...

Symbicort launched for COPD in UK.
April 7, 2003... AstraZeneca's Symbicort 200/ 6 Turbohaler and Symbicort 400/ 12 Turbohaler (budesonide/eformoterol) have both been granted a licence in the UK for use in the symptomatic treatment of patients with severe chronic obstructive pulmonary disease....

Cyclacel in RNAi collaboration.
April 7, 2003... Cyclacel of the UK has forged a four-way collaboration with an undisclosed pharmaceutical company, Cancer Research Technology and the University of Cambridge aimed at developing and improving RNA-mediated interference as a technology for...

Amylin files New Symlin data in Switzerland.
April 7, 2003... Amylin Pharmaceuticals has submitted a response to inquiries from the Swiss regulatory authorities in connection with its review of the marketing application for its diabetes drug candidate Symlin (pramlintide acetate). The response includes...

Allergan's Zymar cleared in USA.
April 7, 2003... Allergan's ophthalmic solution formulation of the fluoroquinolone antibiotic gatifloxacin, Zymar, has been approved in the USA for the treatment of bacterial conjunctivitis. The company expects to launch the ophthalmic formulation of the...

New HCV drug target unveiled by Progenics.
April 7, 2003... Progenics Pharmaceuticals says it has discovered the first liver-specific receptor for the hepatitis C virus, called L-SIGN, raising the prospect of a new class of drugs to treat the infection. The company also reported the identification of...

Ranbaxy gets OK for generic Tambocor.
April 7, 2003... Ranbaxy Laboratories has received US Food and Drug Administration approval to market a generic version of 3M Pharmaceuticals' Tambocor (flecainide acetate tablets) in 50mg, 100mg and 150mg strengths. The brand-name version had sales of $105.6...

Update: Regeneron dives on Phase III obesity trial.
April 7, 2003... Shares in US biotechnology company Regeneron took a nosedive on March 31, after the company reported Phase III trial results on Axokine (ciliary neurotrophic factor), its candidate treatment for obesity. Although the study achieved both its...

Losses up at deCODE on charges, R&D spend.
April 7, 2003... Iceland-based deCODE genetics has reported widening losses for 2002 on the back of increased R&D expenditure and several one-time charges. The company also said that, following the termination of an agreement to develop and market genotypic...

Cyprotex' losses soar after 1st trading period.
April 7, 2003... UK-based drug discovery firm Cyprotex, which began trading as a publicly-listed company on the Alternative Investment Market last February (Marketletter February 18, 2002), has reported a lackluster set of results for the 14-month period ended...

Italian doctors failing to report ADRs.
April 7, 2003... Only a third of doctors in Italy say they regularly report adverse drug reactions and, of the reports which are made, around half are not filed correctly, with this particularly true of hospital doctors, according to a new survey conducted by...

UK NICE to view statins, antipsychotics, etc.
April 7, 2003... The National Institute for Clinical Excellence, which provides guidance on treatments to be made available on the National Health Service in England and Wales, has published preliminary details of additional topics for its forward work...

Norwegian wholesale drug trade in 2002.
April 7, 2003... The wholesale turnover of pharmaceuticals in Norway in 2002 reached a value of 25.5 billion kroner ($3.45 billion), according to data from Statistics Norway, which notes that the trade reached a value of 5.07 billion kroner during the...

Forthcoming meetings and conferences.
April 7, 2003... - Protection of biotechnological inventions, April 28-29, Copenhagen, Denmark; - Global generic strategy: the changing face of the market, May 12-15, Barcelona, Spain; - Pharmaceutical Marketing Congress, Amsterdam, the Netherlands, May 19-21....

Promotions at Serono.
April 7, 2003... Switzerland-based Serono SA has promoted Fereydoun Firouz, currently executive vice president reproductive health, to president of its US operation, Serono Inc, while Timothy Wells moves to senior executive VP, research, from head of...

France and Iran plan pharma JV.
April 7, 2003... France and Iran are creating a joint venture to set up pharmaceutical plants in various parts of the latter country, according to the Islamic Republic News Agency, which quoted the deputy head of budget planning at the Tolidaru Pharmaceutical...

IVAX names two VPs.
April 7, 2003... IVAX Corp of the USA has appointed Dan Weiner (now consulting for the firm) as senior vice president, global clinical development, and Stephen Marcus as senior VP, proprietary pharmaceutical business development. The latter has been VP,...

J&J completes 3-D Pharma acquisition.
April 7, 2003... Johnson & Johnson has completed its previously-announced acquisition of 3-Dimensional Pharmaceuticals (Marketletter January 27). Under the terms of the transaction, 3-D shareholders will receive $5.74 for each outstanding share held, valuing...

Akzo pulls out of buying GSK Scottish plant.
April 7, 2003... Netherlands-based Akzo Nobel has decided to withdraw from negotiations to acquire GlaxoSmithKline's active pharmaceutical manufacturing facility at Montrose, Scotland (Marketletter December 16, 200), citing "changed economic circumstances in...

SangStat names Richard Murdock CEO.
April 7, 2003... US biotechnology firm SangStat has named acting chief executive Richard Murdock as chairman, president and CEO.

Pharmaco growing in south eastern Europe; most valued Icelandic firm.
April 7, 2003... Icelandic drugmaker Pharmaco now has three subsidiaries in south eastern Europe - BalkanPharma in Bulgaria, Serbia's Zdravle and its affiliate in Macedonia - and sees the region as likely to be more dynamic for the drug sector than established...

Jim Bull joins Genetix as head of North American sales.
April 7, 2003... Jim Bull, most recently director of sales at GeneMachines, has joined UK proteomics technology firm Genetix as vice president of North American Sales.

Rick McCLue joins The Medicines Co as VP, endovascular medicine.
April 7, 2003... USA-based The Medicines Company has appointed Rick McLure to the newly-created position of vice president, endovascular medicine. Dr McLure was previously president of the Kentucky Cardiovascular Group.

Korean research-based Pdrug industry body elects BI's Richter as president.
April 7, 2003... The Korean (research-based) Pharmaceutical Industry Association has elected Michael Richter, head of Boehringer Ingelheim Korea, as its chairman.

Atrix takes on Cheri Jones as VP regulatory affairs.
April 7, 2003... Cheri Jones joins USA-based Atrix Laboratories as vice president, regulatory affairs. Most recently, Ms Jones was director of global regulatory affairs at ICN Pharmaceuticals.

Hemisphere Bio names James Knill VP clinical development, HIV/AIDS.
April 7, 2003... Former vice president, medical affairs, at Interferon Sciences, James Knill has been named VP of clinical development for the HIV/AIDS division at US company Hemisphere Biopharma.

PowderJect set to win new L50M contract.
April 7, 2003... UK-based vaccine maker PowderJect, which has long been the center of allegations relating to the involvement of its chief executive Paul Drayson with the ruling Labour Party (Marketletters passim), looks poised to win a fresh contract from the...

SkyePharma swings to profit in 2002; forecasts increased growth this year.
April 7, 2003... The UK's SkyePharma has reported a swing to profit for 2002 on the back of increased royalty payments, particularly from its agreement with GlaxoSmithKline relating to the the antidepressant Paxil CR (paroxetine extended-release), and says...

As FDA moves to efficient risk management, pharma "must make similar reforms".
April 7, 2003... The current slowdown in US drug approvals is likely to be only temporary, Food and Drug Administration Commissioner Mark McClellan has said, with the National Institutes of Health's doubling of its budget over the past five years and...

AstraZeneca says Lipitor users benefit from switch to Crestor.
April 7, 2003... AstraZeneca has presented the results of a clinical trial in its GALAXY program of Crestor (rosuvastatin) at the the American College of Cardiology meeting, as it continues its marketing offensive to set the stage for the international...

Saudi Arabia: higher drugs, food authority.
April 7, 2003... Saudi Arabia's Council of Ministers has established a new, higher authority to regulate the production and licensing of pharmaceuticals, medical devices, chemicals, foods and cosmetics. The new authority will develop its role in two...