Product profiles

NVA237 is a dry powder inhaled formulation 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.

Mechanism of action
NVA237 is a rapid-onset, long-acting anti-muscarinic bronchodilator that is designed to treat the symptoms of COPD by increasing the diameter of the airways in the lungs, allowing the patient to breathe more effectively. It is a so-called anti-muscarinic, since it works by blocking muscarinic receptors in the lungs to provide a dose dependent and prolonged bronchodilator effect.

More than 12 million people in the US are affected by COPD, while another estimated 12 million people are believed to have the disease but remain undiagnosed. COPD ranks as the third leading cause of death in the US, and is a major cause of serious long-term disability. Worldwide, COPD is estimated to affect a total of 210 million people.

Competition
Vectura believes that NVA237 will be the second once-a-day anti-muscarinic treatment to be approved for marketing for COPD in a marketplace where the first LAMA product achieved 2010 annual sales of more than US$4 billion. Novartis filed NVA237 in Europe in September 2011 and intends to launch the product in 2012 as a differentiated LAMA for treating COPD, with improved benefits for patients compared to existing therapies.  In November 2011 Novartis filed NVA237 in Japan.

NVA237 is being developed by Novartis both as an inhaled “monotherapy” and as an inhaled combination therapy with its once-daily, long-acting beta-agonist (LABA) indacaterol (QAB149). The combination product is known as QVA149.

Mechanism of action
Indacaterol works by stimulating beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. Indacaterol is on the market in Europe and has recently received approval in the US and Japan.  It has been shown to have a similar rapid onset to NVA237 and to benefit lung function for a 24-hour period. The dual activity of a muscarinic antagonist (NVA237) and an adrenergic beta-agonist (QAB149) has the potential to be a potent bronchodilator and would have the potential to address a large unmet need for COPD patients. 

Market opportunity
More than 12 million people in the US are affected by COPD, while another estimated 12 million people are believed to have the disease but remain undiagnosed. COPD ranks as the third leading cause of death in the US, and is a major cause of serious long-term disability. Worldwide, COPD is estimated to affect a total of 210 million people.

Competition
Vectura believes that QVA149 is the most advanced once-daily LAMA/LABA combinations in development and could be the first such combination to come to market for COPD. 

VR315 is an inhaled combination therapy for asthma and COPD that is being developed as a generic product using the GyroHaler^® dry powder inhaler (DPI) delivery device.

Vectura licensed the European rights for VR315 to Sandoz in March 2006 and the RoW rights to the same company in August 2011.  Also in August 2011, Vectura licensed the US rights for VR315 to an undisclosed leading International Pharmaceutical company.  

Market opportunity
There are over 24 million people suffering from asthma in the US alone and prevalence continues to rise. However, the disease remains under-treated due to a combination of under-diagnosis, inappropriate therapy, and patient non-compliance.

Inhaled fixed dose combination therapy is the use of two or more drugs in combination in an inhaler to gain optimal clinical benefits by improving patient compliance and efficacy. Combination therapy for asthma is the biggest and fastest growing sector of the asthma market.

Competition
In addition to the current branded combination products, VR315 will be competing with new asthma therapies and other generic products. Vectura believes that the unique performance of GyroHaler^® gives VR315 a good competitive position against other generics.

VR632 is an inhaled combination therapy for asthma and COPD that is being developed as a generic product using the GyroHaler^® dry powder inhaler (DPI) delivery device.

Vectura licensed the European rights for VR632 to Sandoz in December 2007.

Market opportunity
There are over 24 million people suffering from asthma in the US alone and prevalence continues to rise. However, the disease remains under-treated due to a combination of under-diagnosis, inappropriate therapy, and patient non-compliance.

Inhaled fixed dose combination therapy is the use of two or more drugs in combination in an inhaler to gain optimal clinical benefits by improving patient compliance and efficacy. Combination therapy for asthma is the biggest and fastest growing sector of the asthma market.

Competition
In addition to the current branded combination products, VR632 will be competing with new asthma therapies and other generic products. Vectura believes that the unique performance of GyroHaler^® gives VR632 a good competitive position against other generics. 

VR506 is an inhaled corticosteriod for asthma that is being developed as a generic product using one of Vectura's dry powder inhaler (DPI) delivery devices.
 
Market opportunity
There are over 24 million people suffering from asthma in the US alone and prevalence continues to rise. However, the disease remains under-treated due to a combination of under-diagnosis, inappropriate therapy, and patient non-compliance.
Inhaled fixed dose combination therapy is the use of two or more drugs in combination in an inhaler to gain optimal clinical benefits by improving patient compliance and efficacy. Combination therapy for asthma is the biggest and fastest growing sector of the asthma market.
 
Competition
In addition to the current branded combination products, VR506 will be competing with new asthma therapies and other generic products. Vectura believes that the unique performance of its device gives VR506 a good competitive position against other generics.

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.

Market opportunity
There are over 24 million people suffering from asthma in the US alone and prevalence continues to rise. However, the disease remains under-treated due to a combination of under-diagnosis, inappropriate therapy, and patient non-compliance.

Inhaled fixed dose combination therapy is the use of two or more drugs in combination in an inhaler to gain optimal clinical benefits by improving patient compliance and efficacy. Combination therapy for asthma is the biggest and fastest growing sector of the asthma market.

Competition
In addition to the current branded combination products, both Duohaler^® projects will be competing with new asthma therapies and other generic products.Vectura believes that the unique performance features of Duohaler^® will provide a good competitive position against other products. 

VR496 is being developed by Vectura as an inhaled, locally acting treatment for cystic fibrosis (CF). The active component of VR496 is heparin, a drug that has been approved worldwide as an injected or infused treatment for other indications.  The EMEA and the FDA have designated VR496 an Orphan Drug.

Market opportunity 
Up to 100,000 patients worldwide suffer from CF. It is anticipated that the multiple activity properties of VR496 will have a beneficial effect upon the key underlying pathologies of CF. In addition, the efficient, targeted and controlled attributes of Vectura’s proprietary delivery technology present significant benefits compared to current nebulised treatment options that are associated with a time-consuming and inefficient delivery system.

Competitive position
The two key products that are currently approved for the treatment of CF are Pulmozyme® (inhaled dornase alpha) and Tobi^® (inhaled tobramycin). Tobi^®, an inhaled antibiotic, is used to control acute and chronic bacterial infections with the mucolytic properties of Pulmozyme^® facilitating the clearance of the thick, sticky mucus secretions. Both products are delivered by nebulisation. Nebulisers are relatively inefficient and variable with respect to lung deposition and also time-consuming for the patient. Vectura believes that the multi-modal and complementary properties of VR496 may offer an alternative safe, effective and patient-friendly inhaled therapy for the treatment of CF and COPD and one that may be used concomitantly with current treatment options.

An undisclosed Japanese pharmaceutical company that had an exclusive licence to the Clickhaler^® for use with budesonide in Japan has decided to no longer sell products in the respiratory market.  The company has therefore returned all rights to Vectura, including access to the Phase III data generated to date.  This product is now available for licensing to other third parties.

Market opportunity
The global asthma market is dominated by inhaled bronchodilators and corticosteroids. However, the disease remains under-treated due to a combination of under-diagnosis, inappropriate therapy, and patient non-compliance.

Competition
In addition to the current asthma products, Budesonide Clickhaler^® will be competing with new asthma therapies and other generic products. Vectura believes that the unique performance features of GyroHaler^® will provide a good competitive position against other products. 

VR040 is an inhaled, systemically acting product being developed by Vectura for treating “off” episodes associated with advanced Parkinson's disease (PD). The active ingredient in VR040, apomorphine hydrochloride, has previously been approved as an injectable formulation in Europe, and more recently in the US, for treating “off” episodes.  The EMEA has designated VR040 an orphan drug.

Mechanism of action
PD is a disease with major motor function abnormalities caused by dopamine deficiency. Consequently, treatment approaches are primarily based on levodopa (which is metabolised to dopamine) and dopamine agonists. Apomorphine is a potent, short-acting dopamine agonist that stimulates dopamine receptors in the corpus striatum leading to anti-Parkinsonian activity.

Market opportunity
It is estimated that approximately 1 million people in Europe and 1.5 million people in the US have PD. Approximately 10% of these experience severe on/off motor fluctuations which require apomorphine treatment.

Competition
Vectura believes that VR040 will provide significant benefit to patients compared with subcutaneous apomorphine as it employs a non-invasive route of administration and potentially has a quicker onset of action, more predictable therapeutic response and, by virtue of increased systemic bioavailability, a superior safety profile.

VR147 is an orally inhaled DPI formulation of a triptan that offers the potential to provide a rapid onset of action, and so provide early symptomatic relief for migraine sufferers.  Vectura is not developing VR147 any further and the product is available for out-licensing.

Market opportunity
Migraine is a frustrating, chronic illness that is widespread; approximately 10% of a given population is diagnosed as suffering from migraine and 5% undiagnosed, with seriousness varying from a rare annoyance to a severe debilitation.

Competition
There is significant market potential for an inhaled migraine treatment that provides both a rapid onset of action and greater bioavailability, reducing the amount of medication required compared to conventional therapies taken by the oral route.