Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

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.

 

The European Commission (EC) has authorised DuoCort Pharma’s Plenadren (hydrocortisone) to be marketed in the EU for the treatment of adrenal insufficiency.

The dual release hormone replacement therapy is the first pharmaceutical innovation in over 50 years for adults suffering from adrenal insufficiency, or cortisol deficiency.

Professor Gudmundur Johannsson, Chief Medical Officer at DuoCort Pharma, said: “Plenadren offers a welcome new treatment option to help patients suffering from adrenal insufficiency. It can improve therapy for many of the almost 200,000 patients in Europe who suffer from this disease and who need lifelong cortisol replacement therapy for their survival.”

The once-daily tablet is designed to imitate the normal physiological cortisol profile, with an outer layer that releases hydrocortisone immediately into the bloodstream and an inner core releasing the rest of the medicine gradually throughout the day.

Although glucocorticoid replacement therapy for adrenal insufficiency has been available for decades, complications have been linked to the medication, including premature death, impaired quality of life, increased risk of cardiovascular diseases, and decreased bone mineral density.

Adrenal insufficiency (cortisol deficiency) is a rare, life-threatening disease that affects patients in their active years. Patients require lifelong replacement therapy with hydrocortisone, the synthetic form of cortisol, replacing or substituting the hormones that the patient's adrenal glands are not producing.

DuoCort Pharma provides drug development with a focus on improving glucocorticoid therapy. The company is currently being absorbed by ViroPharma, who acquired the pharmaceutical company for an upfront payment of $33 million dollars in October.

Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.

The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.

Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.

Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.

More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.

Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.

Novartis’ ACZ885 (canakinumab) has met both of its primary endpoints in Phase III studies for the treatment of active systemic juvenile idiopathic arthritis (SJIA) treatment, the company has said.

Data showed that ACZ885 allowed nearly half (45%) of children with SJIA to reduce their use of steroids within 28 weeks and that patients were nearly three times less likely to suffer a new flare.

David Epstein, Head of the Pharmaceuticals Division of Novartis, says the data demonstrates “the significant benefits that ACZ885 may provide”.

The results of the trial, along with data from a second pivotal study, are planned to form the basis for worldwide regulatory submissions next year.

A total of 177 patients between the ages of 1 and 19 years with active SJIA were enrolled in the study. The primary endpoints were to assess if ACZ885 allows tapering of steroids in at least 25% of SJIA patients and demonstrates that time to flare is extended with ACZ885 versus placebo.

Only 27% of ACZ885-treated patients experienced a new flare, compared to three-quarters of patients on placebo.

"These data are very welcome because nearly half of ACZ885-treated patients were able to reduce their steroid use during the study, potentially helping decrease the impact that these drugs can have on this young population," said Dr Nico Wulffraat, one of the study investigators and pediatric immunologist at Wilhelmina Children's Hospital, University Medical Center in Utrecht, The Netherlands.

SJIA is the most serious form of childhood arthritis affecting less than one child per 100,000. Traditional therapies used to treat the condition only partially mitigate symptoms but do not usually prevent long-term damage. Long-term steroid use can also contribute to slowed growth, delayed puberty and reduced bone density.

Under the brand name Ilaris, ACZ885 is already approved in more than 50 countries, including the EU, US, Switzerland and Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). It is also being studies for use in other diseases which cause inflammation.

Baxter International has recalled 300,000 doses of its flu vaccine Preflucel after a considerably high number of side effects were reported.

Most of the vaccines were distributed in Ireland and Scotland, where reports of side effects included tiredness, muscle pain and headache, which are typically associated with flu jabs.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on its website saying: “The vaccine should no longer be used and any remaining stock should be returned to the original supplier for credit. No further Preflucel of any batch should be administered at this time.”

Baxter commented that the recall was precautionary and that those who have received the jab do not need to be re-vaccinated.

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

Eli Lilly has withdrawn Xigris (drotrecogin alfa) from all markets due to it showing no gain in 28-day survival of septic shock patients in the PROWESS-SHOCK study.

New results showed that the drug failed to meet its primary endpoint and question the overall benefit-risk balance of Xigris for patients with severe sepsis.

Timothy Garnett, Senior Vice President and Chief Medical Officer of Lilly, said that the results were unexpected to the company. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”

Xigris was approved in the US by the FDA in November 2001, and in the EU in 2002 under exceptional circumstances for septic shock patients with multiple organ failure, in addition to best standard care.

As a condition for continued market authorisation in Europe, Eli Lilly established the placebo-controlled PROWESS-SHOCK study in March 2008, to assess the benefit-risk profile of the product.

Aside from failing its primary aim, the study also failed its secondary endpoint of reducing mortality in patients with severe protein C deficiency. The small difference in the 28-day mortality of the overall population (26.4% in the Xigris arm versus 24.2% in the placebo arm) was not statistically significant.

Xigris is administered as a continuous intravenous infusion, in one dose for a total duration of 96 hours.

The CHMP will assess the issue during its plenary meeting in November 2011.

VistaMed’s investment of €7.2 million in R&D and product expansion will create 79 jobs, nearly doubling its workforce.

The Irish company designs, develops and manufactures catheters and complementary medical devices, exporting to the UK, Europe, US, South America and India.

Paddy Mulholland, Managing Director of VistaMed, said that the company “has continued to develop its capabilities and today we offer a comprehensive design development and manufacturing of innovative catheter solutions”.

The company’s investment is supported by the government through Enterprise Ireland.

Currently, 93 people are employed by VistaMed at its facility in Leitrim.

A new childcare product designed to improve posture and assist spinal development has been launched by a UK company.

The PosturePadJunior wedge cushion (pictured) from Derby-based Jolly Back Enterprises was developed with support from the Healthcare and Bioscience iNet, which is part-financed by the European Regional Development Fund (ERDF).

Designed by physiotherapist Lorna Taylor, the product was launched during National Back Care Awareness Week.

Taylor received an iNet Innovation, Advice and Guidance grant, which enabled her to design and test the wedge cushion prior to commercialisation. She is working on a DVD to train teachers and nursery managers in manual handling and back care.

The same company launched the Jolly Back chair earlier this year, using the same wedge-shaped cushion technology to prevent or reduce back pain. The product has 23 UK distributors and has sold worldwide.

“As a children’s physio, I am concerned at how child development is being adversely affected by current lifestyles,” said Taylor, who noted that correct positioning of babies can “allow core strengthening of the back and neck”.

Taylor described the PosturePadJunior wedge cushion as “a simple means of naturally supporting the spine for comfort and physical development”.

iNet advisor Dr Ros Graves commented: “Lorna has shown incredible resourcefulness by coming up with simple but effective products and bringing them to market so efficiently. The potential impact of all her ideas is enormous so we are delighted to have been able to help.”

The Healthcare and Bioscience iNet is an initiative delivered by Medilink East Midlands that assists companies and inventors in the healthcare sector to develop new technologies, products and services. It brings together firms, academics and public service representatives.