Recent Event Highlights: Demonstrating “healthcare value” is key to avoiding another Exubera, Small step for MannKind resurrects inhaled insulin, Exubera hangover hits West Tech group , West looks ahead to healthier 2008, Pfizer closes plant earmarked for Exubera, Pfizer to continue with manufacturing cuts, and 59 more...
Created by DNMPharma on 10/03/2009
Last updated: 11/03/10 at 02:57
MannKind is trying to buy a Pfizer insulin facility for $33m (€26m) as it continues to push Afresa towards commercialisation but, like many things in the saga, the deal might not be straightforward.
http://www.in-pharmatechnologist.com/Materials-Formulation/MannKind-picks-up-the-pieces-of-Pfizer-s-failure
MannKind, one of the inhaled-insulin market’s only remaining players, has posted higher than expected Q4 losses as costs for development of its lead product candidate Afresa increase ahead of its submission to the US FDA.
http://www.in-pharmatechnologist.com/Industry-Drivers/MannKind-s-loss-mounts-ahead-of-US-Afresa-submission
Pfizer’s Exubera failure need not be the final nail in the coffin for inhaled biopharmaceuticals as long as developers focus on proving “healthcare value” and addressing payer needs, according to Bruckner Group’s David Balekdjian.
http://www.in-pharmatechnologist.com/Industry-Drivers/Demonstrating-healthcare-value-is-key-to-avoiding-another-Exubera
MannKind’s inhaled insulin treatment, Technosphere, has met its study goal in the first of three Phase III trials, leading to Pfizer transferring its remaining Exubera patients to the treatment.
http://www.in-pharmatechnologist.com/Materials-Formulation/Small-step-for-MannKind-resurrects-inhaled-insulin
The discontinuation of Pfizer’s inhalable diabetes treatment Exubera (insulin human [rDNA origin) once again hurt West’s Tech services group. The division, which was responsible for the manufacture of the product’s delivery device, generated turnover of $70m, down $8m on those posted last year.
http://www.in-pharmatechnologist.com/Packaging/West-s-Q2-sales-and-profits-climb
Packaging component manufacturer West Pharmaceutical Services has shrugged off the after-effects of a difficult 2007 with an increase in revenues in the first quarter of 2008 that came ahead of analyst estimates.
http://www.in-pharmatechnologist.com/Packaging/West-looks-ahead-to-healthier-2008
Pfizer is planning to close its Terre Haute, Indiana manufacturing facility which had received $300m of investment to prepare it for Exubera production.
http://www.in-pharmatechnologist.com/Industry-Drivers/Pfizer-closes-plant-earmarked-for-Exubera
Pfizer's decision to drop the inhaled diabetes drug Exubera has left the firm with considerable overcapacity. Mr D'Amelio specified that two of the insulin production facilities that the firm had set up to support Exubera would be decommissioned as part of the cut-backs.
http://www.in-pharmatechnologist.com/Processing-QC/Pfizer-to-continue-with-manufacturing-cuts
MannKind has suspended its search for a potential partner for its inhaled insulin product Technosphere in the wake of the news of Exubera's possible cancer risk.
http://www.in-pharmatechnologist.com/Materials-Formulation/MannKind-stumbles-in-fallout-from-Exubera
Pfizer has updated the US product labeling of its inhaled insulin treatment Exubera to include a warning of increased risk of lung cancer among those using it.
http://www.in-pharmatechnologist.com/Processing-QC/Lung-cancer-warning-a-death-knell-for-inhaled-insulin
US-based drug delivery specialist Alkermes is cutting its losses following Eli Lilly's decision to scrap the companies' joint development programme for inhaled insulin.
http://www.in-pharmatechnologist.com/Packaging/Alkermes-takes-AIR-Insulin-blow-with-redundancies-facility-closure
The prospects for a viable market in inhaled insulin therapies were looking markedly thinner this week after Eli Lilly pulled the plug on its joint development programme with drug delivery specialist Alkermes for AIR Insulin.
http://www.in-pharmatechnologist.com/Materials-Formulation/Lilly-declines-to-inhale-with-AIR-Insulin-programme
The CEO of Californian company Nektar Therapeutics says that 2007 has been key in transforming the company into a fully integrated drug development organisation, despite the setback with Pfizer's inhaled insulin product Exubera.
http://www.in-pharmatechnologist.com/Materials-Formulation/Nektar-optimistic-despite-Exubera-fallout
Pfizer's announcement of plans to create a new €130m inhaled medicines unit at its facility in Amboise, France suggests that the firm is still intent on investing in inhalation technology, despite its disappointment with Exubera.
http://www.in-pharmatechnologist.com/Industry-Drivers/Pfizer-expands-in-inhaled-drugs-as-Nektar-cuts-back
660 Pfizer employees are the latest casualties of the drug giant's failed bid to capture the diabetes market with its once-touted blockbuster, Exubera.
http://www.in-pharmatechnologist.com/Packaging/Pfizer-reveals-latest-Exubera-casualties
Mere months after Pfizer's high profile exit from the inhaled insulin market in the wake of Exubera's much publicised market failure, Novo Nordisk announced late last night that it, too, has decided to halt development of its inhaled insulin product.
http://www.in-pharmatechnologist.com/Materials-Formulation/Novo-drops-inhaled-insulin-plans-in-post-Exubera-fallout
Pfizer yesterday announced a multi-million dollar pay-off to ex-partner Nektar Therapeutics, but the details of the deal reveal not only Nektar's concerns for its future, but also that Pfizer is still keeping its fingers in the Exubera pie.
http://www.in-pharmatechnologist.com/Packaging/Pfizer-Nektar-agreement-not-so-sweet-after-all
West Pharmaceutical Services, one of the two firms responsible for manufacturing Pfizer's failed Exubera device, recently turned in its third quarter financials, so far avoiding any major dent from the company's decision to drop the inhalable insulin product.
http://www.in-pharmatechnologist.com/Packaging/West-unscathed-by-Exubera-shot-for-now
Pfizer is already cutting jobs in relation to its failed Exubera with the announcement that some 200 jobs are to go at the drug giant's Portage and Kalamazoo sites, according to local media reports.
http://www.in-pharmatechnologist.com/Processing-QC/Pfizer-to-cut-another-200-jobs
MannKind Corporation needs an outside boost to get its inhaled insulin off the ground, but the likelihood of that partner being Pfizer is a 'very long shot', the president of the company says.
http://www.in-pharmatechnologist.com/Materials-Formulation/MannKind-all-but-shuts-the-door-on-Pfizer
Eli Lilly is remaining optimistic about its yet-to-be-approved inhaled insulin despite the dramatic downfall of Pfizer's Exubera. But is Exubera's fall from grace an indication of things to come for inhaled diabetes treatments?
http://www.in-pharmatechnologist.com/Materials-Formulation/Inhaled-insulin-make-or-break
We've all cringed at stories of people dumping their partners via text message but in the world of business, Pfizer seems to have taken things to a new level when its Exubera partners were allegedly left to find out the product was being scrapped through a press release.
http://www.in-pharmatechnologist.com/Industry-Drivers/Pfizer-partners-in-shock-after-surprise-Exubera-exit
With yesterday's perhaps unsurprising news that Pfizer has cut its losses and pulled out of the inhaled insulin market by dropping Exubera and giving up on second generation devices, the world's biggest pharma firm is in the process of scrabbling to get back on track and reaffirm its position at the top of the tree.
http://www.in-pharmatechnologist.com/Materials-Formulation/Pfizer-counts-the-cost-of-Exubera-Nektar-suffers
Pfizer revealed today that it is abandoning its once-touted blockbuster Exubera, ending months of speculation as to whether the fledging world-first inhalable insulin would sink or swim in the fierce waters of pharma.
http://www.in-pharmatechnologist.com/Materials-Formulation/Pfizer-abandons-ship-as-Exubera-sinks
Pfizer has started development on two next generation inhalers with the aim of replacing the underperforming Exubera inhaled insulin device.
http://www.in-pharmatechnologist.com/Materials-Formulation/Pfizer-looks-to-new-delivery-systems-to-boost-Exubera
An improved inhalable insulin product developed by collaborating UK and US firms has just completed a glucose clamp study in the US, with results suggesting that the product could pose a significant threat to Pfizer's Exubera franchise.
http://www.in-pharmatechnologist.com/Materials-Formulation/QDose-closes-in-on-Exubera
West Pharmaceutical Services have been informed to scale back production of Exubera devices following the dismal revenues the inhalable insulin product has generated so far this year.
http://www.in-pharmatechnologist.com/Packaging/West-to-cut-production-of-Exubera-devices
A young start-up company is gearing up to challenge the likes of Pfizer by developing a new insulin product, based on its novel nano-based intranasal delivery technology.
http://www.in-pharmatechnologist.com/Materials-Formulation/New-insulin-product-takes-the-nasal-route
West Pharmaceutical Services reported a 40 per cent increase in operating profit for the first quarter of 2007, despite profits diving 43 per cent in the Tech Group business that makes the delivery device for Pfizer's inhaled insulin Exubera.
http://www.in-pharmatechnologist.com/Industry-Drivers/West-Pharma-profit-lifts-40-per-cent-despite-Tech-Group-slump
While the market performance of Exubera may have fallen short of expectations, Pfizer's inhaled insulin has opened the door for a wider variety of macromolecules to take the pulmonary delivery route.
http://www.in-pharmatechnologist.com/Industry-Drivers/Exubera-has-opened-door-for-pulmonary-delivery-growth
West Pharmaceutical Services posted healthy financial results for 2006, with sales of the inhalable insulin device for Pfizer's Exubera significantly contributing to the results reported by the firm's Tech Group business segment.
http://www.in-pharmatechnologist.com/Processing-QC/Exubera-helps-boost-West-s-2006-results
French firm Valois Pharma will be providing Generex with a novel valve for its pressurised metered dose inhaler (pMDI), used for its innovative method of buccal delivery of insulin.
http://www.in-pharmatechnologist.com/Packaging/Valois-valve-in-insulin-device
Innovative, non-invasive new ways of delivering insulin are poised to transform diabetes management, despite concerns about their safety and efficacy, according to new research.
http://www.in-pharmatechnologist.com/Materials-Formulation/More-speculation-on-inhaled-insulin-market-potential
Novo Nordisk is planning to sue the head of the US Patent and Trademark Office after its inhaled insulin product has had its patent application knocked back for the second time.
http://www.in-pharmatechnologist.com/Industry-Drivers/Novo-Nordisk-to-sue-over-inhaled-insulin-patent-knock-back
Inhalable insulin is unlikely to achieve the blockbuster status the industry had hoped for, according to a new Datamonitor report.
http://www.in-pharmatechnologist.com/Materials-Formulation/Inhalable-insulin-may-be-a-flop-says-report
Injection molder and contract manufacturer Tech Group is relocating its Grand Rapids plant to a new molding facility in nearby Walker, Michigan, which will be expanded to cope with the high demand for medical devices and components.
http://www.in-pharmatechnologist.com/Packaging/Tech-Group-seeks-bigger-facility-as-demand-rockets
Bang & Olufsen Medicom has unveiled a new disposal breath-actuated inhaler which uses a reservoir technology that reduces the daily cost of pulmonary drug delivery.
http://www.in-pharmatechnologist.com/Materials-Formulation/New-inhaler-launched-with-a-bang
Eager to find a formulation that will give Pfizer's inhalation device Exubera (insulin rDNA) a run for its money, Nastech is initiating a Phase I study to compare Exubera to its insulin nasal spray and to an approved injectable product.
http://www.in-pharmatechnologist.com/Materials-Formulation/Nastech-pits-intranasal-formulation-against-Exubera
Generex has registered a new patent in the US that covers broad claims for the delivery of macromolecules via the buccal cavity of the mouth, further safeguarding its RapidMist drug delivery technology which it uses to spray insulin into the mouth.
http://www.in-pharmatechnologist.com/Materials-Formulation/New-patent-strengthens-Generex-oral-insulin-spray
The convenience of non-invasive insulin delivery methods is set to overcome their high cost and concerns about safety and efficacy, with the greatest beneficiary being the European inhaled insulin market which is predicted to swell from $49.3m (€38.5m) in 2006 to $611.7m in 2012, according to two new market reports from Frost & Sullivan.
http://www.in-pharmatechnologist.com/Industry-Drivers/European-inhaled-insulin-market-to-explode
West Pharmaceutical Services has reported a huge surge in both sales and profits for its second quarter, spurred on by the increasing demand for injectable drugs as well as the lucrative Exubera manufacturing contract, which helped double sales for the segment, although failed to stop a fall in profit margin.
http://www.in-pharmatechnologist.com/Packaging/West-profits-surge-Exubera-contract-gains-momentum
Partnerships in drug delivery need to fairly reflect the risk all parties take but there must also be a champion to drive the project forward, according to Pfizer's director of drug delivery.
http://www.in-pharmatechnologist.com/Industry-Drivers/Striking-the-right-drug-delivery-partnership
Innovata is moving forward with its dry powder pulmonary insulin inhaler, which it claims has a formulation superior to Exubera, gearing up for Phase II clinical trials and anticipating a new partnership deal by the end of the year.
http://www.in-pharmatechnologist.com/Processing-QC/Innovata-s-insulin-device-moves-forward
The boom in advanced drug delivery devices is creating demand for specialist manufacturers that can rise to the challenge of making these complicated devices, although such companies are currently thin on the ground.
http://www.in-pharmatechnologist.com/Packaging/Shortage-of-contractors-for-advanced-drug-delivery-manufacturing
The Tech Group has experienced a quarter of explosive growth as it ramps up production for the launch of Exubera - Pfizer's newly-approved and much-anticipated needle-free insulin.
http://www.in-pharmatechnologist.com/Packaging/Exubera-manufacturing-deal-sweetens-Tech-Group
The groundbreaking approval of Exubera signals that exciting times are ahead for the pulmonary route of drug delivery in many disease areas.
http://www.in-pharmatechnologist.com/Materials-Formulation/Pulmonary-drug-delivery-positioned-for-growth
Nektar Therapeutics is planning to buy fellow drug delivery specialist Aerogen for $32 million (€26m), boosting its position in respiratory technologies.
http://www.in-pharmatechnologist.com/Materials-Formulation/Nektar-buys-Aerogen-to-expand-into-inhaled-liquids
Its upcoming inhalable insulin drug may prove a blockbuster but Nektar's 2005 results brought the biopharmaceutical company further in the red, with a net loss of $108.2m (€91m) in Q4 more than five times higher than the $19.3m loss it posted in Q4 of 2004, as it struggles not just with one-time charges but also with higher expenditure.
http://www.in-pharmatechnologist.com/Industry-Drivers/Nektar-still-far-from-the-land-of-milk-and-honey
West Pharmaceutical Services reported a sales increase of 28 per cent to $700m (€590m) in 2005, boosted by $100m worth of new business.
http://www.in-pharmatechnologist.com/Packaging/West-looks-north-for-2006
The insulin delivery devices thriving in today's market will slowly be replaced as new and better technologies continue to rise from the R&D pipeline. For current market leader, Novo Nordisk, this threat is particularly dangerous.
http://www.in-pharmatechnologist.com/Industry-Drivers/Insulin-delivery-devices-an-industry-under-threat
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