Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Healthcare corporation 3M has lost its dispute with representatives of the British Government over the company’s failure to market a diagnostic for MRSA developed within the Ministry of Defence.

The complainants have won $1.3 million in damages, whereas they were seeking $40 million – an outcome claimed by both sides as a success.

The BacLite medical device, which uses photoluminescence to detect MRSA bacteria, was purchased by 3M in 2007 and then abandoned as having failed the necessary clinical trials to support its marketing in the EU and the US.

The MoD, its spin-out company Ploughshare Innovations and private equity firm the Porton Group together claimed that 3M had deliberately mismanaged the BacLite trials in order to protect its rival (and more expensive) Fastman device.

The High Court in London found that 3M was in material breach of its obligation “actively to market” BacLite in the EU, the US, Canada and Australia, including its obligation to seek regulatory approval in the US.

However, it did not find that 3M had “intended” a breach of contract and thereby conducted the clinical trials dishonestly.

3M has announced its intention to pursue charges in the US against the Porton Group for alleged attempts to “extort” an out-of-court settlement by threatening to use political influence.

While the arguments rage on, the question of whether BacLite has the potential to improve worldwide treatment of MRSA remains unresolved.

Bristol-Myers Squibb has entered into a strategic partnership with Singapore-based ASLAN Pharmaceuticals for the licensing and development of one of its investigational oncology compounds.

Under the agreement, ASLAN has the rights to develop and commercialise BMS-777607, a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumours, in China, Australia, Korea, Taiwan and other selected Asian countries. BMS will retain rights for the rest of the world.

ASLAN will also complete and fund the development of the compound under a pre-agreed programme that will initially target gastric and lung cancers.

Francis Cuss, Senior Vice President, Research, BMS, says the agreement is part of the company’s “Oyster strategy” which aims to produce “high-quality data that may be used to further develop and commercialise the medicine worldwide”.

“As part of our biopharma strategy, Bristol-Myers Squibb seeks to seed companies in key markets with promising investigational medicines of continued interest to Bristol-Myers Squibb,” he said.

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

Merck Serono has launched its easypod Connect, which monitors injection data collected by the easypod auto-injector in patients receiving growth hormones, in Europe.

The medical software is designed to display patients’ injection history from the easypod electronic auto-injector on a secured online database.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “easypod Connect is a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient.”

easypod Connect provides healthcare professionals with reports and data from the patient’s injection history, which both monitors and analyses patients treatment adherence.

The easypod Connect Observational Study (ECOS) has already been in use since its launch at the end of 2010, offering the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data.

Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono, said: “By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes.”

easypod Connect has already been launched in Canada and Australia. The medical device has not been submitted for use in the US.

A neurostimulation device that offers sufferers from obstructive sleep apnoea (OSA) an alternative to continuous positive airway pressure (CPAP) therapy has gained CE Mark approval.

The Hypoglossal Nerve Stimulation (HGNS) system from US company Apnex Medical has been approved for sale in Europe based on the results of clinical studies in the US and Australia that showed the device to reduce the symptoms of OSA.

OSA – an inability to breathe during sleep – is estimated to affect 100 million people worldwide. It causes excessive daytime fatigue and increases the risk of stroke, heart disease and death.

CPAP therapy is the current standard for OSA, but many patients cannot tolerate it or comply poorly with it. The HGNS system offers a radically different approach: an implantable therapy that activates the muscles in the upper airway.

Implanted in the shoulder, the HGNS system measures the patient’s breathing during sleep and delivers mild electrical pulses to the hypoglossal nerve (which controls the tongue) to keep the airway open.

The system can be programmed to operate only when the patient is asleep, or be turned on and off with a hand-held switch.

The Apnex Clinical Study, a randomised clinical trial, is ongoing in the USA, Europe and Australia. It is designed to test the safety and effectiveness of the HGNS therapy in patients with OSA in whom CPAP therapy has not been effective.

“CE Mark approval is an important confirmation of the substantial benefits that patients receive from our HGNS therapy for obstructive sleep apnoea and is a key milestone for our company,” said Chas McKhann, President and CEO of Apnex Medical. “We are excited to bring this innovative new therapy to Europe.”

Based in Minnesota, USA, Apnex Medical specialises in innovative therapies for sleep-disordered breathing.

Pharmaxis has received a positive opinion from the CHMP for Bronchitol to treat adults with cystic fibrosis (CF) in Europe.

The drug’s indication is to help clear mucus, improve lung function and reduce exacerbations in CF patients over the age of 18, which represents approximately two thirds of those who could benefit from the therapy.

Dr Alan Robertson, CEO of Pharmaxis, said that the positive opinion “is good news for the CF community, which has supported us throughout the development of Bronchitol”.

The treatment consists of mannitol administered as a dry powder in a hand-held inhaler and is to be used as an add-on therapy to standard medications already in use.

Professor Stuart Elborn, President of the European Cystic Fibrosis Society, said that the medication will be the first approved therapy in Europe to improve both lung function and reduce exacerbations when added to standard medications in use today.

“Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies,” he added.

Bronchitol’s approvals in Australia and Europe are based on two Phase III clinical trials involving more than 600 CF patients.

Bronchitol was developed in Australia and will be commercialised through the EU in collaboration with the company’s marketing partner, Quintiles.

Pharmaxis plans to undertake a clinical trial in children aged 6-17, with a view to extend the drug’s licence.

Pharmaceutical company Pharmaxis researches, develops and commercialises therapeutic products for chronic respiratory disorders.

Scottish medtech company Aircraft Medical has signed an exclusive INTERNATIONAL distribution agreement with global healthcare supplier Covidien.

Covidien will market and distribute Aircraft’s McGRATH MAC video laryngoscope (pictured) in the UK, the US, Japan, Latin America, Australia and New Zealand.

The new agreement complements Aircraft Medical’s existing distribution agreements in 35 countries, and will see the number of specialist sales and marketing professionals selling the McGRATH laryngoscope worldwide rise above 500.

Launched in October 2010, the portable McGRATH MAC – a development of the award-winning McGRATH design – is the first low-cost video laryngoscope designed to assist both routine and difficult airway intubation in hospitals.

In the US, the majority of the estimated 17 million intubations carried out each year are performed with Covidien products – opening a major market opportunity for the McGRATH MAC.

About 50 million intubation procedures take place globally each year, and that figure is predicted to rise by 5% per year.

“This agreement with Covidien is a significant step forward in the global rollout of the McGRATH MAC video laryngoscope,” said Matt McGrath, CEO of Aircraft Medical. “We expect to now further strengthen our position in the growing video laryngoscope market.”

James E. Willett, General Manager, Respiratory and Monitoring Solutions at Covidien, commented: “Our partnership with Aircraft Medical demonstrates our commitment to deliver clinical value and improve patient outcomes in fast-growing critical-care markets throughout the world.

“By integrating the McGRATH MAC video laryngoscope into our respiratory product portfolio, Covidien can provide critical-care practitioners with a complete intubation solution to meet the needs of the continuum of patients.”

Aircraft Medical, based in Edinburgh, specialises in video laryngoscopes.

Covidien, based in Dublin, is a leading global provider of healthcare products whose 2010 revenue was $10.4 billion.

MedX Health’s skin imaging diagnostic systems, MoleMate and SIMSYS, have been granted FDA approval for sale in the US.

These non-invasive medical technologies use light to look beneath suspicious moles, creating accurate images to help physicians evaluate lesions, often eliminating the need for painful and expensive skin biopsies.

Steve Guillen, President and CEO of MedX Health, said: “The US market alone is estimated to be a $1 billion opportunity, and MoleMate and SIMSYS are the only FDA approved and patent protected siascopy products in this important health segment.”

MoleMate features a hand-held scanner designed for office use, providing images of the pigment, blood, and collagen below the mole or lesion.

SIMSYS allows image capture and storage as well as special features that can be used to compare moles. It will support ‘mole mapping’ in 2012, where the entire surface of the patient's skin is photographed to observe changes over time, so that suspicious moles can be monitored more closely.

Dr. R. H. Falcon, a dermatologist in New York, said: “I chose this technology because it gives me extra information about my patients’ suspicious moles and lesions through the additional views of the skin and helps me and the patients to come to a more informed decision about removal.”

Almost 13 million people in the US have a history of non-melanoma skin cancer, usually diagnosed as basal cell carcinoma or squamous cell carcinoma. The survival rate for patients whose melanoma is detected early is about 99%. This statistic falls to 15% for patients with advanced disease.

The MoleMate and SIMSYS medical technologies are already available in Australia, Europe and the UK.

A new campaign for the introduction of rapid drug testing after road accidents is being supported by a leading UK supplier of devices for rapid testing.

Concateno, formed by the merger of seven UK drug and alcohol testing specialists, is assisting the campaign for a law that would allow roadside drug testing of motorists involved in accidents.

A similar programme introduced in Australia has halved the incidence of driving under the influence of illegal drugs.

The company’s hand-held drug testing device, the DDS, can analyse a sample of oral fluids for six illegal drugs in five minutes. It won a Queen’s Award for Innovation in 2010.

The legislation demanded by the campaign has been named ‘Lillian’s Law’ after teenager Lillian Groves, who was killed by a car whose driver had been smoking cannabis. The driver escaped a conviction for driving under the influence of drugs because he was tested nine hours later.

Roadside drug testing, using rapid diagnostic tests of saliva, has been applied in several countries including Australia, Spain, Germany and Italy. In Victoria, Australia, it has seen the number of people driving under the influence of illegal drugs fall in five years from one in 44 to one in 94.

“In Australia, the use of roadside drug testing technology has proved extremely successful and has certainly helped to make our roads safer,” said Victoria’s Police Inspector, Martin Boorman.

Concateno spokesperson Iain Forcer commented: “Police in the UK are not allowed to use these devices that can quickly test drivers for drug use. Instead, they are required to carry out a lengthy Field Impairment Test which can take up to 30 minutes to complete, and few police officers are qualified to carry out these FIT assessments.”

This autumn, Concateno will attend two major UK conferences on transport security and traffic policing, as well the European DRUID conference on industry and innovation.

Concateno is a subsidiary of US company Alere, a specialist in rapid diagnostics.