Novartis withdraws application for Exelon/Prometax extended indications

The Medical Technology Blog

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The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for  Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.

In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.

The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.

Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.


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Alexza Pharmaceuticals Issue Job Warning

The Medical Technology Blog

Alexza employees face the chop in company bid to prop up Adasuve development

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In an effort to save cash in the current economic downturn, Alexza Pharmaceuticals has made the difficult decision to appoint a financial advisor to assist in exploring strategic options for the company. These options could include a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. In order to conserve cash needed to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. The company expects to significantly reduce its workforce as it continues the actions necessary to pursue FDA approval of Adasuve (Staccato loxapine) and continues its MAA work with the EMA.

Recently, the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that Adasuve be approved for use as a single dose in 24 hours in conjunction with the FDA recommended REMS, for the treatment of agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain). The PDAC also concluded that the product had been shown to be effective (vote of 17/1/0; yes/no/abstain), and that the product would be acceptably safe for use as a single dose in 24 hours, when used in conjunction with the REMS proposed by the FDA (vote of 11/5/2; yes/no/abstain). The Adasuve NDA has a PDUFA goal date of 4th February 2012.

Adasuve is an anti-agitation product candidate that combines Alexza’s Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable with intravenous administration. In clinical studies, Adasuve has shown an onset of effect in ten minutes of dosing, which is the first time point measured in Phase III studies.

Article source; Kindly provided by Sophie Bracken, editor of Espicom’s business publication Drug Delivery Insight

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Gilead submits sNDA for Truvada for reducing the risk of acquiring HIV

The Medical Technology Blog

Gilead Sciences Truvada

Gilead Sciences has submitted an sNDA application for the approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults. Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the US.

If the sNDA is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex, a prevention approach called PrEP. The application is based on the results of two large placebo-controlled trials of Truvada as PrEP, sponsored by the National Institutes of Health (NIH) and the University of Washington.

The first trial providing data to support the Truvada sNDA is a Phase III, randomised, double-blind, placebo-controlled trial known as the Pre-Exposure Prophylaxis Initiative (iPrEx), which was sponsored by the NIH and conducted among 2,499 high-risk HIV-negative adult homosexuals in the US and countries in Africa, Asia and South America. Results from the trial, published in the New England Journal of Medicine in November 2010, showed that once-daily use of Truvada for PrEP reduced the risk of acquiring HIV overall by 44 per cent compared with placebo and by up to 73 per cent among men who reported taking the drug consistently (defined as at least 90 per cent of days). Among men who took the drug consistently enough to have detectable drug in their body, the risk was reduced by more than 90 per cent.

The Truvada sNDA submission is also supported by data from Partners PrEP, a Phase III, randomised, double-blind, placebo-controlled trial conducted among 4,758 heterosexual couples in Kenya and Uganda, in which one partner was infected with HIV and the other was not. The trial, sponsored by the University of Washington, showed that once-daily use of oral Truvada by the HIV-negative participants reduced their risk of acquiring HIV by 73 per cent compared with placebo.

Additional supportive data come from two studies sponsored by the Centers for Disease Control (CDC). The first trial, known as TDF2, was a Phase III, randomised, double-blind, placebo-controlled trial conducted in Botswana among 1,200 HIV-negative heterosexual men and women. Participants taking once-daily oral Truvada for PrEP had 63 per cent fewer HIV infections compared with those receiving placebo. The second trial, known as CDC 4323, was a Phase II, randomised, placebo-controlled, double-blind study of homosexual men in the US primarily designed to assess the safety, adherence and acceptability of PrEP.

Although full details are not yet available, another separate Phase III study of Truvada for PrEP known as FEM-PrEP was stopped in April 2011 based on a recommendation by the study’s Independent Data Monitoring Committee that the trial would not be able to establish the efficacy of Truvada among HIV-negative women in sub-Saharan Africa. The reason for this outcome is not yet understood and a complete detailed analysis of the data is currently under way.

In all studies, side-effects included nausea, weight loss and serum creatinine elevations. The incidence of side effects was consistent with Truvada’s safety and tolerability profile when used as HIV treatment, which is supported by more than 1.8 million years of patient use. Overall, there have been more than 4.4 million patient years of experience with tenofovir-containing regimens. Three cases of resistance to emtricitabine were reported in the iPrEx trial among participants who tested negative for HIV infection by serology at enrollment, but were later found to have been infected with HIV prior to enrolment using a different assay. Two of these cases occurred in the active drug arm, and one case occurred in the placebo arm.

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The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s post is taken for Espicom’s business publication Drug Delivery Insight, which is edited by Sophie Braacken, please read on…

Prosonix has presented new research showing that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix’ Dipesh Parikh at the Drug Delivery to the Lungs 2011 (DDL2011) conference in Edinburgh, UK.

In the presentation, Prosonix describes how its Umax technology has enabled the development of one such example of MCP, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with “exquisite” control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca’s multi-billion dollar respiratory drug product Symbicort. Combining multiple active drug components into a single particle using Umax® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.

The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance. Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation. Compared with these combination products, the improved co-localisation of MCPs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.

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FDA steps up bid to drive innovation in healthcare

The Medical Technology Blog

The FDA has handed over an award of US$2 million…

…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.

In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.

Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.

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Medical Futures & Cipher Pharmaceuticals in Tramadol Deal

The Medical Technology Blog

Medical Futures to gain a slice of Canadian tramadol market through deal with Cipher

Medical Futures, a Canada-based pharma company, has signed a pact for Cipher Pharmaceuticals to distribute Durela in Canada. Patent-protected Durela is a once-a-day formulation of tramadol for the treatment of moderate- to moderately-severe chronic pain in adults. It was approved by Health Canada in August and has immediate- and extended-release properties.

As for the particulars of the distribution deal, Cipher will receive an upfront payment from Medical Futures of C$300,000, and could also be eligible for future payments, dependant on net sales milestones. Also, Cipher will get its hands on a double-digit royalty on new sales. Cipher has further responsibily for product supply and manufacturing, which will be taken care of by its supplier, Galephar Pharmaceutical Research.

Medical Futures’ CEO, Colin Campbell, says he is excited to offer Durela in Canada, believing that the product “strengthens and demonstrates [Cipher’s] commitment to providing top tier solutions to the Canadian market”. It appears Cipher is equally delighted with the deal, as it provides valuable royalty revenue to the company. Cipher also recently shook hands on a US$5.5 million US distribution deal for Durela with Vertical Pharmaceuticals, with the former set to receive a payment of US$1 million on the first commercial sale of the product.

With sales of over US$60 million in 2010, the seemingly robust Canadian tramadol market looks like a sure thing for both parties. Medical Futures plans to launch Durela in the first quarter of 2012.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s business publication Drug Delivery Insight.

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Tekmira/Alnylam partnership hits the rocks!

The Medical Technology Blog

Tekmira Pharmaceuticals is taking its collaborative partner Alnylam Pharmaceuticals to court claiming, amongst other things, misappropriation of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising. The lawsuit was filed in the Business Litigation Session of the Massachusetts Superior Court, and accuses Alnylam of exploiting its relationship with Tekmira to engage in inappropriate and harmful conduct related to the latter’s lipid nanoparticle (LNP) siRNA delivery technology.

In summary, Tekmira says that Alnylam has harmed the company and its shareholders by: misappropriating confidential information, including trade secrets and other commercially valuable information from Tekmira; disclosing Tekmira’s step-by-step LNP formulation manufacturing instructions to at least one third-party collaborator; incorporating Tekmira’s confidential information into Alnylam’s patent filings and claiming ownership in direct violation of a licensing agreement between the two companies; wilfully and knowingly misusing Tekmira’s confidential information for Alnylam’s own enrichment; and engaging in other unfairly competitive, deceptive and misleading actions in their public disclosures such as claiming Tekmira’s technology as its own.

Tekmira wants substantial damages, and believes it has rights to Alnylam’s pipeline products. The damages, which include future milestones and royalties associated with these products could total over US$1 billion alone. Tekmira also wants to get its hands on any profits it thinks Alnylam has unfairly received based on “wrongful” use of Tekmira’s technology.  All this will be based on what emerges during Tekmira’s prosecution, but even now the company says it is entitled to a big payout.

Not surprisingly, Alnylam has moved swiftly to respond to the lawsuit, stating that Tekmira’s case is without merit or foundation.

The Drug Delivery Insight Perspective: Ultimately, the legal fall out is unlikely to help either company and will divert much needed investment funds into the pockets of the lawyers. One hopes that the lawsuit will force the two companies to the negotiation table and bring a swift end to the dispute.

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Roche To Lose Almost 5000 Jobs in Economy Drive

The Medical Technology Blog

“Operational Excellence” programme affects 6,000 jobs at Roche

Welcome back to the Medical Technology Blog, posts have been thin on the ground as i’ve been on holiday. Today’s post concerns the sad news that some major changes are happening at Roche, which will directly affect the workforce, please read on…

In response to mounting cost pressures in healthcare – particularly in the US and Europe – and to bigger hurdles for the approval and pricing of new medicines, Roche has started the “Operational Excellence” programme to change the way it spends its cash. A company focused on research-based healthcare in pharmaceuticals and diagnostics, Roche is hoping to generate savings of around SFr 1.8 billion in 2011, with forecast savings of SFr 2.4 billion in 2012 and beyond.

The Operational Excellence programme plans unfortunately include the reduction of Roche’s workforce, by about 4,800 employees worldwide – 6 per cent of the group’s employees – over the next two years. Another 800 jobs will be transferred to other Roche sites and 700 positions will be outsourced to other parties, making for a total combination of 6,300 affected employees. Roche has put aside SFr 2.7 billion to cover the cost of this restructuring for 2010 to 2012.

The most affected division for job losses will be Pharmaceuticals – mainly in the division’s worldwide sales and marketing organisation and manufacturing. Total Roche redundancies worldwide are expected to total 2,600 in these positions. Roche puts these job cuts mainly down to the setback of the company’s diabetes drug, taspoglutide, and structural adjustments the primary care sales organisations – mainly in the US and Europe. Also affected will be some Technical Operations activities, which will be reorganised in California, US; Mannheim, Germany; and other sites in the network, meaning the loss of 750 positions across this area. Roche is also looking for buyers for its Florence, SC and Boulder, CO sites, which would mean the loss of a further 600 jobs.

In line with the Operational Excellence ethic, Roche has also decided to pull the plug on some development activities – most from the US. Some, however, will be transferred to other Roche sites or third parties. Roughly 800 positions will be affected by this plan. Roche is further cutting certain activities in research and early development, including RNA interference research in Kulmbach, Germany; and in Nutley, NJ and Madison, WI. Plans include reorganising some internal functions, in order to free up resources for pipeline Phase II studies of new molecular entities; around 600 positions will be affected.

Roche’s Diagnostics division aims to consolidate three of its sites – a move that the company believes will “optimise seamless collaboration and cost structures in development and manufacturing”. This plan calls for the closure of the Graz, Austria site and transfer of developmental and manufacturing of blood gas diagnostics to Rotkreuz, Switzerland – home of Roche’s Professional Diagnostics division’s HQ.

In the Diabetes Care division, most activities will be based in Mannheim, Germany. The plan is to out-source manufacturing and close its Bugdorf, Switzerland site. Diagnostic chemical manufacturing and analytical services will be discontinued in Mannheim and transferred to Penzburg, Germany.

Redundancies are always an unfortunate side-effect of any company undertaking a restructuring plan, but Roche hopes to carry out its reduction in a “socially responsible” way, including informing the affected employees as soon as possible, and offering them assistance and support. Despite the changing healthcare market, Roche believes it is approaching this project from a position of strength. The company’s exposure to patent expiries over the next few years is comparatively low, and the group has 14 product groups that each generate over SFr 1 billion per year. The company’s late-stage development portfolio includes six drug candidates that are effective in specific patient populations, which could help advance personalised healthcare. Roche also has other important drug candidates in late-stage development for cancer, central nervous system diseases and metabolic disorders.

Thanks to Sophie Bracken for this article, Sophie is the editor of Espicom’s excellent business news service Drug Delivery Insight which tracks the important commercial and technology developments that are shaping the drug delivery industry.

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Drug Delivery Company Cuts Workforce

The Medical Technology Blog

SurModics renews its business focus but employees set to pay the price

Whilst conducting its annual strategic planning review, SurModics, a surface modification and drug-delivery company, has come to the conclusion that the businesses in which it competes would be best served by a more focused approach. As a result, the company has honed its energy onto three units – Medical Device, Pharmaceuticals and In Vitro Diagnostics – in the hope of improving its sales and business development activities.

In order to achieve this, Eden Prairie, MN-based SurModics has taken the difficult decision to cut its workforce by around 13 per cent, in order to reduce its cost structure. It is hoped the “difficult but necessary” move will bring the company’s operating expenses more in line with its revenue. As a consequent of the redundancies, SurModics will take a one-time restructuring charge of US$1.3 to US$1.7 million in the first quarter of 2011, but expects to save around US3.0 to US$3.5 million annually.

SurModics believes that in the long-run its customers will benefit from the organisational changes, which it hopes will enhance accountability, improve efficiency and allow the company to use its resources more effectively.

In Medical Devices, SurModics’ surface modification technologies are designed to improve access, deliverability and predictable deployment of medical devices, as well as drug-delivery coasting technologies to provide site-specific drug-delivery from the surface of a medical device. End markets include coronary, peripheral, neurovascular and urology, among others.

The company’s Birmingham, AL-based Pharmaceuticals business incorporates a range of drug-delivery for injectable therapeutics, including microparticles, nanoparticles and implants. Customers of this division include pharma and biotech companies addressing a range of applications including ophthalmology, oncology, dermatology and neurology, among others.

The In Vitro Diagnostics consists of component products and technologies for diagnostic test kits and biomedical research applications. Products include microarray slide technologies, protein stabilisation reagents, substrates and antigens.

This article was kindly provided by Sophie Bracken who is the editor of Espicom’s excellent publication Drug Delivery Insight

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