Biotie Therapeutics has terminated its planned $63 million acquisition of Newron Pharmaceuticals because it says Merck Serono’s decision to return full global rights for safinamide, Newron’s lead asset, in April 2012 constitutes a material adverse effect not in its best interest. As a result, Newron is obligated to pay Biotie a $2.12 million break-up fee. Newron will continue development of safinamide, in late stage development for Parkinson’s disease. Newron’s shares slid 10 percent on the Swiss stock exchange on the news.
Illumina said it will cut 200 jobs, or eight percent of its workforce in regulatory documents filed one day after reporting that its third-quarter revenues missed expectations. The company expects to complete the layoffs by the end of this year and also plans to record a restructuring charge of $15 million to $17 million for the fourth quarter. The layoffs are part of a strategy to better align the company’s cost structure in consideration of uncertainties with academic and government research funding. In a conference call, CEO Jay Flatley cited the reduced NIH budget, global academic funding concerns, and the launch of the company’s V3 sequencing kits, which resulted in a decrease in consumables revenues per instrument, as the main factors that led to the disappointing third quarter results. Despite the news, Illumina’s shared jumped 7 percent on Tuesday, to $30.80.
Just two months after taking over as the new CEO at Celesio, Markus Pinger has announced a radical cost-cutting shakeup that includes potentially selling its Manufacturer Solutions division to focus on distribution, slashing costs to improve earnings, and expanding outside its European home market to tap into faster-growing and less regulated markets, Reuters reported. Celesio has cut its profit outlook for the full year due to regulatory constraints in Britain and increased competition in large markets such as France and Germany. It expects to post full-year earnings of $800 million, down from its initial outlook of $850 million. To combat the more difficult environment and improve earnings for 2012, Pinger plans to bundle Celesio’s purchasing, halt projects with high-start up costs, and cut administrative costs.
Amsterdam Molecular Therapeutics said it has suspended development of its lipoprotein lipase deficiency drug, Glybera, and plans to cut 50 percent of its jobs after receiving a negative opinion by the European Medicines Agency’s Committee for Medicinal Products (CHMP). Although CHMP didn’t approve Glybera, it didn’t identify any safety risks with AMT’s virus vector technology allowing the company to leverage its technology to build other portfolio products. After completing a careful review of operations and resources needed for development of its remaining pipeline products, AMT’s management and board of directors believe that for AMT to remain a viable business it will have to reduce its workforce by 50 percent, to only 45 full-time employees.
Amgen has set aside $780 million to resolve a civil and criminal investigation into whether it had engaged in improper sales of drugs. Federal and state investigators are probing 10 whistle-blower lawsuits against the company, reported Bloomberg. Among them is a suit filed by former sales representative Kassie Westmoreland, who alleges Amgen officials provided overfilled vials of Aranesp, for the treatment of anemia, to doctors and then encouraged them to overbill insurance companies for the extra amounts. Though a federal judge in Boston had initially dismissed the claims Westmoreland had brought on behalf of 15 U.S. states, an appellate court reinstated the claims in July. Amgen has asked the U.S. Supreme Court to the review the ruling.
Antitrust regulators in South Korea have fined GlaxoSmithKline $2.6 million for striking an agreement with generic drug-maker Dong-A Pharmaceutical to prevent a generic drug from entering the market. The Korean FTC also fined Dong-A $1.85 million for its role in the agreement making it the first time it has applied the country’s Fair Trade Act to a generic drug deal. The fines stem from a lawsuit settled in 2002 in which GSK had sued Dong-A for launching a knockoff version of its anti-nausea drug Zofran. According to the South Korean government, GSK then offered exclusive rights to Dong-A to market Zofran and its antiviral drug Valtrex, provided that Dong-A promised not sell its generic version of Zofran or sell any product that would be a direct competitor to either Zofran or Valtrex. The Korean FTC stated that the “reverse payment” delivered up to $14 million worth of unfair profits to GSK and blocked the development and sale of a generic drug even after its patent rights had expired. GSK has denied the allegations and the company has hinted that it plans to appeal.
Novartis announced in its third quarter report that the U.S. Food and Drug Administration has requested to see more information on dosing before it can approve indacaterol, a COPD drug considered to be one of Novartis’ biggest potential blockbusters. Novartis will need to come up with a fresh set of clinical data for NVA237, one half of the late-stage QVA149 program, which will now require new clinical studies and delay its schedule for the combo therapy. The delay has the potential to push the program back nearly two years. The news severely hurt Novartis’ development partner, Vectura, as its stock plummeted 30 percent on the news.
Around 300,000 doses of Baxter Healthcare’s flu vaccine, Preflucel, have been recalled across Europe amid reports of adverse side-effects. The Medicines and Healthcare products Regulatory Agency issued the warning and notified pharmacies that the drug is to be immediately withdrawn. A spokesman stated that “because there has been a slightly higher number of mild adverse advents…the manufacturer of the vaccine has withdrawn the batch.” Preflucel is the UK’s only egg-free vaccine for allergic patients but alternative products have been made available to prevent any shortages. The spokesman also stated that individuals who have already been vaccinated with Preflucel should not be concerned.
October 28, 2011
http://www.burrillreport.com/article-biotie_therapeutics_breaks_off_plans_to_buy_newron_pharmaceuticals.html