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 being developed by Novartis as a once-daily inhaled, rapid-onset, long-acting, muscarinic antagonist (LAMA) for the treatment of mild, moderate and severe COPD. It consists of glycopyrronium bromide, an existing off-patent compound that has been marketed for other indications but not for the treatment of COPD, in a novel formulation for delivery in a dry powder inhaler.

Vectura developed NVA237 originally in collaboration with Arakis Ltd (now part of Sosei Group Corporation) applying its proprietary formulation technology, PowderHale®, to improve delivery to the lungs. Vectura licensed NVA237 to Novartis in April 2005.

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

VR315 is being developed by Vectura as an inhaled combination asthma therapy using the GyroHaler® dry powder inhaler.

Vectura licensed the European rights for VR315 to an international pharmaceutical company in March 2006, and the US rights to an undisclosed international pharmaceutical 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

VR632 is being developed by Vectura as an inhaled combination asthma therapy using the GyroHaler® dry powder inhaler.

In December 2007, Vectura announced that its undisclosed European collaboration partner for VR315 had exercised an option to license VR632, a second combination asthma therapy.

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® Projects 1 and 2 for asthma/COPD

Vectura is developing two combination therapy products in the Duohaler® device, each using two different established respiratory drugs for the treatment of asthma/COPD. Each of these projects has been partnered with a leading European pharmaceutical company.

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 Boehringer Ingelheim device. It will potentially deliver a range of their proprietary respiratory products, mainly 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) with the potential to develop 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 for CF.

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 being developed by Vectura as a rapid-acting, inhaled apomorphine to treat ‘‘off’’ episodes associated with advanced Parkinson’s disease (PD) that do not respond to oral therapy and has been designated an Orphan Drug by the EMEA.

The active ingredient in VR040, apomorphine hydrochloride, has been approved in Europe and the United States for treating ‘‘off’’ episodes. Two products are available as solutions for subcutaneous injection and, in Europe , for subcutaneous infusion. Vectura has formulated VR040 for inhalation using the Aspirair® dry powder inhaler.

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 being developed by Vectura as a rapid-onset inhaled treatment for acute migraine attacks. As well as the speed of onset there is an additional advantage to VR147. During an attack some migraineures experience gastrointestinal disturbances that alter drug abosorption, and may also lead to nausea and vomiting. Oral drugs may therefore lack efficacy and the inhaled route by-passes this problem.

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 being developed by Vectura as a rapid-acting inhaled apomorphine to treat mild, moderate or severe erectile dysfunction (ED). VR004 has been formulated for inhalation using the Aspirair® dry powder inhaler. It uses the same active ingredient and dosage form as Vectura’s treatment for Parkinson’s disease, VR040, but at a lower dose range.

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 Vectura's proprietary, rapid-acting formulation of a centrally acting drug delivered by oral inhalation using its Aspirair® dry powder inhaler to treat premature ejaculation.

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.