Products

Partnered proprietary products and technologies In the asthma and COPD market, we offer licensing opportunities for our products and also offer technologies to other pharmaceutical companies, where our expertise enables a more effective delivery of products.

NVA237 and QVA149 for COPD

NVA237 and QVA149 for chronic obstructive pulmonary disease (COPD) NVA237 is a dry powder formulation for inhalation of glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA) with a rapid onset of activity.

NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development partner, Sosei Group Corporation (Sosei). Novartis intends to launch NVA237 as a once-daily monotherapy for COPD in 2012 and as a combination (QVA149) with its once-daily LABA, indacaterol (Onbrez® Breezhaler®) in 2013.

In April 2011, Novartis announced positive Phase III data showing NVA237 significantly improved lung function while demonstrating a good safety profile in patients with moderate-to-severe COPD. The data from this pivotal GLOW1 study show once-daily NVA237 met its primary endpoint, demonstrating superior bronchodilation (trough FEV1) relative to placebo (p<0.001) at 12 weeks and Novartis expects to present detailed results at the European Respiratory Society meeting in Amsterdam in September 2011.

We believe that QVA149 could be the first once-daily LABA/LAMA combination therapy on the market for COPD. The dual activity of a beta-adrenergic agonist (beta2-agonist) and a muscarinic antagonist could result in a potent bronchodilator with convenient once-daily dosing. This could address a large and unmet need for COPD sufferers where patient compliance is a key consideration.

Novartis received European regulatory approval for indacaterol in November 2009 and it is now approved in more than 50 countries and available in more than 20 under the brand-name Onbrez® Breezhaler®, with US approval dependent on an FDA decision expected in July 2011.

Novartis commenced Phase III studies with QVA149 in May 2010, triggering a $7.5m milestone payment to Vectura. These studies are ongoing and Novartis expects the first product launches in 2013.

To date, Vectura has received $30m from Novartis and, under the terms of the licence, could receive up to an additional $157.5m for achievement of regulatory and commercialisation targets for both the monotherapy and combination product. In addition, royalties will be received on future product sales in the event of successful launches.

GlaxoSmithKline (GSK)

Formulation technologies licensed to GlaxoSmithKline (GSK) for asthma/COPD In August 2010, Vectura signed a worldwide, non-exclusive licence agreement with GSK that enables them to use some of our dry powder drug formulation patents for two late-stage development compounds in their respiratory product pipeline.

Under the agreement, Vectura received an up-front payment of £10m in August 2010, with a further £10m to be received up to the time the compounds are launched. We will also earn royalties on sales of these products, generating up to £13m per year. We believe this agreement underlines the value of our technology platform and we continue to seek other deals.
 
Generic/branded generic products Branded, combination dry powder inhaler (DPI) therapy makes up the biggest sector of the respiratory market, with annual sales of over $10bn. With an ever-growing need for effective and affordable medicines, these products have excellent potential to generate value as generics or branded generics. With extensive formulation and device expertise, both of which are needed to create DPI products, we are ideally placed to take advantage of this opportunity.

VR315 for asthma/COPD

VR315 for asthma/COPD VR315 is an inhaled combination therapy for asthma and COPD, delivered with Vectura’s GyroHaler® DPI device in Europe, where it is licensed to Sandoz AG for development and commercialisation. The deal is worth up to €22.5m in milestones and development funding, plus royalties on all products sold. Vectura has received all development funding with €7.5m in milestones to be received.

In December 2006, we signed a cost/profit-sharing agreement with Sandoz for the development of VR315 in the US. In March 2010, we received full development and commercialisation rights back from Sandoz. This revised agreement provided a $9.5m payment from Sandoz in May 2010, which follows a $6m milestone in August 2009 and $2m in 2006. As a result, we now own rights to VR315 for the US market as well as the RoW market and we are currently discussing licensing options with potential partners.

VR632 for asthma/COPD

VR632 for asthma/COPD VR632 is our second inhaled combination therapy for asthma and COPD, which also uses our GyroHaler® technology. Vectura licensed the European rights for VR632 to Sandoz in December 2007 in a deal worth up to €15.5m in milestones and development funding plus royalties on all products sold. We retain the rights for the US and other territories. In October 2010, we received the penultimate development milestone payment of €0.6m from Sandoz for progress made with VR632.

VR506 for asthma

VR506 for asthma VR506 is an inhaled corticosteroid (ICS) for the treatment of asthma that entered clinical development in early 2011. Steroids are the mainstay of prophylactic therapy for asthma. As the recommended "preventer" drugs for adults and children, they are often prescribed alongside beta2-agonist bronchodilators.

Duohaler® combination products for asthma/COPD

Duohaler® combination products for asthma/COPD The Duohaler® dry powder inhaler provides advantages over a number of other multidose DPIs. Two separate drug reservoirs feed two individual drug formulations into two separate metering chambers, and the drugs are then delivered to the user in the same inhalation. This process obviates the need to co-formulate combination drugs and provides a means of delivering simultaneously a combination formulation from one reservoir and an individual drug from the second. This technology is available for licensing.
 
Licensing opportunities In addition to the large asthma/COPD market, we also have a portfolio of specialty products addressing smaller indications. Our current strategy is to take these products to Phase II clinical development and then look for licensing partners.

VR496 for cystic fibrosis (CF)

VR496 for cystic fibrosis (CF) VR496 is a multi-modal treatment for respiratory symptoms associated with airway disorders such as cystic fibrosis. The active component is heparin, a drug that has been approved worldwide as an injected or infused treatment for other indications.

In March 2011, we announced data from a proof-of-concept study that showed VR496 was safe and well-tolerated, with evidence of anti-inflammatory and mucolytic activity.

The European Medicines Agency (EMA) and US FDA have designated VR496 an orphan drug. The multi-modal profile differentiates VR496 from current treatment options. VR496 therefore has the potential to address unmet treatment requirements in CF and other inflammatory airway disorders. We are in discussions with potential licensing partners for the use of VR496 for CF and for other indications in the larger markets such as COPD.

VR040 for Parkinson’s disease (PD)

VR040 for Parkinson’s disease (PD) VR040 is an inhaled, systematically acting, rapid-onset treatment for "off" episodes associated with Parkinson’s disease. The active ingredient is apomorphine hydrochloride, which is marketed for this indication as a solution for injection in Europe and the US. VR040 is our formulation of apomorphine, delivered by inhalation using our proprietary technology.

The EMA has designated VR040 an orphan drug and we are using the EMA scientific advice procedure to drive product development. Results from a Phase II study announced in November 2010 showed that VR040 produced a clinically relevant and statistically significant improvement of a patient’s ability to control movement. In addition, VR040 reduced the time patients were in an "off" state by over two hours, also considered by the investigators to be clinically relevant. These results are consistent with previous Phase II study findings.

We are currently talking to companies interested in licensing VR040.

VR461 for fungal-related lung disease

VR461 for fungal-related lung disease VR461 is an inhaled anti-fungal that is in a pre-clinical stage of development for the treatment of lung diseases in patients with fungal sensitisation.

VR909 following lung transplant

VR909 for the prevention of chronic rejection following lung transplant VR909 is an inhaled, adjunctive, chronic immunosuppression therapy in pre-clinical development as a treatment to delay the onset of chronic rejection and increase survival.
 
Marketed products Six products are currently being marketed by partners and generating revenue for Vectura, ADVATE® being the main value driver.

ADVATE® for haemophilia A

ADVATE® for haemophilia A In 2000, we granted worldwide rights to Baxter to use our stabilisation patents in its serum-free recombinant Factor VIII, ADVATE®. This is indicated for the treatment of haemophilia A and is marketed worldwide by Baxter and from which Vectura earns royalties from sales.

Extraneal® for peritoneal dialysis

Extraneal® for peritoneal dialysis Extraneal® is a peritoneal dialysis solution containing icodextrin, licensed to Baxter in 1996 and marketed by Baxter worldwide. Vectura receives royalties on sales in the US and certain other territories.

Adept® for prevention of surgical adhesions

Adept® for prevention of surgical adhesions Adept® is a 4% icodextrin solution used during surgery to reduce post-surgical adhesions, a frequent and major complication after gynaecological and other abdominal surgery. It has been used in Europe since 2000, and since 2006 in the US. In December 2005, we signed a licence deal with Baxter for the manufacture and distribution of Adept®.

Products delivered in Clickhaler® for asthma

Products delivered in Clickhaler® for asthma Five products have gained regulatory approvals for the treatment of asthma that are delivered using Clickhaler®, our proprietary reservoir DPI device.

Five products have gained regulatory approvals for the treatment of asthma that are delivered using Clickhaler®, our proprietary reservoir DPI device.

Asmasal® and Asmabec® are marketed by Recipharm in the UK, France and Ireland. Asmasal® contains salbutamol, a shortacting beta2-agonist for the rapid relief of asthma symptoms. Asmabec® contains beclometasone, an inhaled steroid used as standard preventative therapy for asthma. Meptin® (procaterol) is a short-acting beta2-agonist for the rapid relief of mild, intermittent asthma symptoms, marketed by Otsuka Pharmaceutical in Japan.

Regulatory approvals have also been received for Clickhaler® budesonide in Germany, the Netherlands and New Zealand, with approvals for Clickhaler® formoterol received in Denmark, the Netherlands, South Africa and New Zealand. Neither of these products is marketed at present; we are actively exploring new territories for marketing them as well as other Clickhaler® products. One of the countries we are considering is China, where an estimated 5% of the population suffers from asthma or COPD.