Product profiles

Please select the links below for a description of each of Vectura’s products in development.

Respiratory products


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Budesonide Clickhaler®

Vectura has an exclusive agreement with an undisclosed Japanese pharmaceutical company for the marketing rights to the Clickhaler® for use with budesonide in Japan . Under the agreement, Vectura supplies devices on commercial terms and could receive milestone payments based on its successful clinical and regulatory development and royalty payments on future sales.

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.

NVA237 for COPD

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.

Market opportunity
Twenty million people suffer from this condition in the US alone. Anti-muscarinics currently represent an important part of this global market; 30-50% of COPD patients in the US are treated with anti-muscarinics. The American Thoracic Society recommends their use as first-line treatment for COPD.

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 is forecast to achieve annual sales of more than US$3 billion. Novartis intends to launch NVA237 as a differentiated LAMA for treating COPD, with improved benefits for patients compared to existing therapies.

QVA149 for COPD

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 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
There are 20 million sufferers from COPD in the US alone. Anti-muscarinics currently represent an important part of this global market; 30-50% of COPD patients in the US are treated with anti-muscarinics. The American Thoracic Society recommends their use as first-line treatment for COPD.

Competition

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

VR315 for asthma/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 a leading international company in March 2006, and the US rights to the same company in December 2006.

Market opportunity
There are over 17 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 for asthma/COPD

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.

In December 2007, Vectura licensed VR632 to the same partner as VR315, another combination therapy for asthma and COPD.

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.

Duohaler® for asthma/COPD

Vectura has two exclusive agreements with a global pharmaceutical company for the marketing and distribution in Europe and other specified countries (excluding the US and Japan) of two Duohaler^® products, each of which delivers two separately formulated respiratory drugs using a single inspiratory breath.

Market opportunity
About 300 million people worldwide suffer from asthma and the Global Initiative for Asthma predicts that this number will increase to 400 million by 2025.

About 600 million people worldwide suffer from COPD and it is the fourth leading cause of death. Due to mis- and under-diagnosis in 50-85% of patients, there is a substantial growth opportunity in the market.

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.

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.

Boehringer Ingelheim collaboration

In April 2006, Vectura signed a worldwide collaboration and licence agreement with Boehringer Ingelheim to develop a dry powder inhaler as a tailored device to deliver a range of Boehringer Ingelheim proprietary respiratory products, primarily for treating asthma and COPD.

Market opportunity
About 300 million people worldwide suffer from asthma and the Global Initiative for Asthma predicts that this number will increase to 400 million by 2025. The market is dominated by drugs combining inhaled corticosteroids and long-acting beta agonists (LABAs) in a fixed dose.

About 600 million people worldwide suffer from COPD and it is the fourth leading cause of death. Due to mis and under-diagnosis in 50-85% of patients, there is a substantial growth opportunity in the market. As in the asthma market, fixed-dose corticosteroid/LABA combination products dominate the market.

VR496 for cystic fibrosis and COPD

VR496 is being developed by Vectura as an inhaled, locally acting treatment for cystic fibrosis (CF), and has the potential to be developed as a therapy for COPD. VR496 has been formulated using PowderHale® and is expected to be delivered with the GyroHaler® dry powder inhaler. The EMEA and the FDA have designated VR496 an Orphan Drug.

Market opportunity
Approximately 70,000 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.

Neurology products


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VR040 for Parkinson’s disease

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. Vectura has formulated VR040 for inhalation using the Aspirair® dry powder inhaler.

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 for migraine

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 exploring out-licensing opportunities for VR147.

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.

Other products


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VR004 for erectile dysfunction

VR004 is inhaled, ultra-low dose, apomorphine that has the potential to provide rapid benefit to patients with mild, moderate and severe erectile dysfunction ED. Apomorphine has been approved previously in Europe for ED as a sublingual tablet. VR004 is formulated in a proprietary Vectura formulation, delivered using Vectura’s Aspirair^® device. Vectura is exploring out-licensing opportunities for VR004.

Market opportunity

Around one in ten men will experience recurring impotence problems at some point in their lives, resulting in a considerable potential market for a rapid-onset treatment with few or no side effects.

Competition

There are a number of treatments available; via the oral route, such as sildenafil, injections prior to intercourse, vacuum pumps, hormone treatment or, more rarely, surgery, all of which take time to take action, are invasive or inconvenient. VR004 using the inhalation route may offer an effective and convenient alternative.

VR776 for premature ejaculation

VR776 is a proprietary, inhaled, systemic treatment for premature ejaculation (PE0 in which the active ingredient is an off-patent neuro-active drug approved worldwide for the treatment of other indications. VR776 is formulated using PowderHale^® and is delivered with Aspirair^®. Vectura is exploring out-licensing opportunities for VR776.

Mechanism of action
The active constituent of VR776 is thought to act via 5-HT and noradrenergic-mediated pathways in the brain. These neurotransmitters are involved in the central control of ejaculation by activating and inhibiting 5-HT receptor subtypes.

Market opportunity

Around 50 million males over the age of 40 are estimated to be affected by PE in the US and Europe. Vectura believes that the lack of a licensed drug that specifically addresses PE, the high incidence of PE and the increasing willingness of patients to present with this problem will mean that this is an important future market for effective pharmaceutical products.

Competition

The active component has been approved worldwide for treatment of other indications but has never been licensed for PE. Currently no product is marketed in the United States or Europe specifically for the treatment of premature ejaculation.

QDose insulin

Vectura is developing an inhaled insulin product in a joint venture with MicroDose Technologies Inc, called QDose Limited. Inhaled insulin is being developed as rapid-acting inhaled insulin for the treatment of diabetes. After successful completion of a glucose clamp study a licensing partner is being sought prior to the programme entering later stage clinical trials.

Market opportunity

There are approximately 200 million diabetics globally, forecast to reach 333 million by 2025.

Competition

Although the diabetes market appears crowded, with a number of oral glycaemic control agents and insulin treatments available, there is still a clear unmet need. Diabetes is a progressive disease associated with major life threatening complications. Numbers of diabetics are expected to double within a decade, allowing significant opportunity for both existing products and novel therapies.