December 21 -- Pfizer gets approvable letter for new antibiotic, again
Pfizer’s dalbavancin, or Zeven, a once-weekly antibiotic for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), was given an approvable letter by the FDA.
Analysts anticipate sales of $419m by 2012, according to consensus data from EvaluatePharma.
This is a further setback for a product originally filed with the FDA over three years ago, with the FDA raising concerns over proof of non-inferiority versus currently marketed products, manufacturing issues and storage length times.
Pfizer sourced dalbavancin, along with an anti-fungal agent, Eraxis, through its September 2005 acquisition of Vicuron Pharmaceuticals. According to EvaluatePharma's NPV Analyzer, the sum NPV for these two products amounts to $1.96bn, only just matching the $1.9bn in cash the group stumped up for Vicuron, which hardly represents a value enhancing deal.
December 21 -- Lundbeck expands deal with Paion over desmoteplase
Lundbeck announced plans to broaden its license agreement with Paion over desmoteplase, a genetically engineered drug based on a protein found in bat saliva. The Danish company plans to obtain rights in the US, on top of European rights already owned, and said it will conduct a new phase III trial in acute ischaemic stroke.
Shares in Paion jumped on the news, and by midday on January 2, had gained a total of 10%. The new deal is conditional on due diligence, which should be completed this month. Under the terms, Paion will be eligible for up to €71m in milestone payments, with €8m upfront.
The news is a significant boost for the German biotech, which saw its stock lose three-quarters of its value last year, after desmoteplase failed a previous phase III trial, and US partner Forest Laboratories handed back its rights.
December 21 –- Pharmacyclics’ Xcytrin gets rebuffed by FDA
Pharmacyclics received a non-approvable letter from the FDA for Xcytrin, as a treatment for non-small cell lung cancer brain metastases, the second time the drug has been turned down.
Questions about efficacy stymied the first attempt for approval, and remaining doubts have likely caused the second approval failure. With little else in the pipeline, shares in the US company have fallen 36% since the news.
Pharmacyclics said it will seek a partner to help support future development of the drug, which is being studied in other cancer types.
December 21 -- Jazz, Solvay’s Luvox gets approvable letter
Jazz Pharmaceuticals and Solvay Pharmaceuticals got an approvable letter from the FDA for once-a-day Luvox, for the treatment of social anxiety disorder.
The FDA approved the pill for obsessive compulsive disorder on December 20.
December 24 -- Wyeth dealt double blow
Wyeth was dealt a double blow by the decision by Teva Pharmaceuticals to launch an 'at risk' generic version of ulcer drug Protonix, and refusal by the FDA for a second time to grant approval of a treatment for post-menopausal osteoporosis.
The patent protecting Protonix does not expire until July 2010, and US sales of the drug booked by Wyeth were forecast to edge 1% higher this year, to $1.94bn, according to EvaluatePharma. Wyeth is suing Teva, although they have entered into 30-day settlement discussions, during which Teva will not sell any generic product. The US major pharma group said it would initiate cost cuts, and analysts lowered earnings forecasts for the year.
Meanwhile, the FDA has asked for further analysis of safety data for Viviant, or bazedoxifene, before granting approval.
December 27 -- Fresenius blood loss drug gets FDA nod
Germany’s Fresenius received marketing clearance from the FDA for blood loss drug Voluven, for use during and after surgery.
December 28 -- Glaxo’s Advair comes out top in COPD study
GlaxoSmithKline published results from a two-year study which it said showed Advair was superior to Boehringer Ingelheim and Pfizer’s Spiriva, in treating the lung disease COPD.
The trial found both drugs had a similar impact on the rate of exacerbations, but people treated with Glaxo’s drug had a significant improvement in health and a 52% reduced the risk of dying from any cause.
December 28 -- Mylan wins FDA approval for generic Zyrtec
Mylan said it will start shipping generic versions in the US of allergy pill Zyrtec, after receiving marketing approval from the FDA. The medicine is co-promoted in the US by Pfizer and UCB, which also markets the drug in Europe.
Nine companies have launched generic versions of Zyrtec in the US.
December 28 – Ireland’s Merrion defers dual listing
Merrion Pharmaceuticals cancelled a secondary listing on the Nasdaq, after floating in Ireland earlier in the month, blaming tough market conditions.
The company, which develops oral drugs, raised €5.6m on December 18, to fund clinical trials.
December 30 -- GlaxoSmithKline, AstraZeneca in Iraq bribery investigation
UK-based drugmakers GlaxoSmithKline and AstraZeneca have been asked to hand over confidential documents by the UK Serious Fraud Office, amid allegations bribes were paid to win contracts in Iraq, a Sunday newspaper reported.
The SFO is investigating possible breaches of the oil-for-food sanctions programme. Both drugmakers deny any wrongdoing.
US drug maker Eli Lilly has also has been asked to submit documents in connection with the inquiry.
December 31 -- Sanofi-Aventis hands back rights to skin cancer vaccine
Sanofi-Aventis handed back the rights to IDM Pharma’s therapeutic skin-cancer vaccine Uvidem, prompting shares in the US company to drop 12% to a record low.
The decision marked the end of a bad year for IDM, which also saw the FDA turned down approval of the company’s lead drug, a treatment a rare bone cancer in children, in August.
The loss of Sanofi-Aventis, which owns an 8% stake in IDM, could prompt the company to put itself up for sale. IDM will announce the outcome of a restructuring, which will include job reductions, in the first quarter of 2008.
January 2 -- Orion studying options to protect Stalevo
Finnish drugmaker Orion said it is studying its legal options to prevent the sale of generic forms of Parkinson's disease drug Stalevo in the US.
India's Sun Pharmaceutical Industries is challenging the patents of the drug, Orion’s most important growth driver, which is forecast to generate sales of $148m in 2012, according to EvaluatePharma.