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Product pipeline
Respiratory development products
| Product | Indication | Description | Partner |
| NVA237 | COPD | Long-acting muscarinic antagonist | Novartis |
| QVA149 | COPD | Combination of NVA237 and a long-acting beta agonist (QAB149) | Novartis |
| VR315 | Asthma/COPD | Generic combination product | Sandoz US & Europe |
| VR632 | Asthma/COPD | Generic combination product | Sandoz Europe |
| Duohaler® | Asthma/COPD | Generic dual-drug product | – |
| BI collaboration | Various | DPI for respiratory products | Boehringer Ingelheim |
| VR496 | CF/COPD | Mucolytic/anti-inflammatory | – |
Marketed products
| Product | Indication | Description | Partner |
| ADVATE® | Haemophilia A | Serum-free recombinant factor VIII | Baxter Worldwide |
| Adept® | Prevention of surgical adhesions | 4% icodextrin solution | Baxter Worldwide |
| Extraneal® | Peritoneal dialysis | Solution containing icodextrin | Baxter Worldwide |
| Asmasal® | Asthma | Salbutamol delivered in Clickhaler® | UCB Europe |
| Asmabec® | Asthma | Beclometasone delivered in Clickhaler® | UCB Europe |
| Budesonide Clickhaler® | Asthma | Budesonide delivered in Clickhaler® | Merck Generics Europe |
| Formoterol Clickhaler® | Asthma | Formoterol delivered in Clickhaler® | Merck Generics Europe |
| Meptin Clickhaler® | Asthma | Procaterol delivered in Clickhaler® | Otsuka Japan |
Respiratory development products
NVA237 and QVA149 for chronic obstructive pulmonary disease (COPD)
NVA237 is a dry powder formulation for oral 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 and as a combination with Novartis’s once-daily, long-acting beta-agonist (LABA), indacaterol, which was filed for approval with the regulatory authorities as a monotherapy treatment for COPD at the end of 2008. The combination of NVA237 and indacaterol is known as QVA149.
COPD is a chronic obstruction of the airways that affects 210 million people worldwide and is projected to be the third leading cause of death by 2030. It is a progressive lung disease with symptoms including chronic bronchitis and/or emphysema, which slowly progresses and eventually leads to a largely irreversible loss of lung function. While there is no cure, bronchodilators such as LAMAs make breathing easier by enlarging the patient’s airways, and are recognised in international guidelines as an integral part of the treatment for COPD.
To date, Vectura has received $15m and, under the terms of the agreement with Novartis, could receive up to $172.5m for achieving clinical, regulatory and commercialisation targets for both the monotherapy and combination product. In addition, royalties on product sales will be received for both products. If additional combination products are developed by Novartis using NVA237, then further milestones and royalties will be receivable.
QVA149 is one of the most advanced once-daily LAMA/LABA combinations in development and Vectura believes that it could be the first such combination to come to market for COPD. The dual activity of a muscarinic antagonist and a betaadrenergic agonist promises to be a potent bronchodilator and, with convenient oncedaily dosing, has the potential to improve compliance and address a large and unmet need for COPD sufferers.
Novartis has made substantial progress in the development of NVA237 and QVA149, with both due to start Phase III clinical trials in 2009. We also expect Novartis to present the Phase II QVA149 data during 2009.
Data from the Phase II NVA237 trial were presented at the annual congress of the European Respiratory Society (ERS) in Berlin in October 2008. The data demonstrate that NVA237 provides sustained 24-hour bronchodilation in patients with moderate-to-severe COPD and showed similar efficacy and duration of action to Spiriva® with the potential for a more rapid onset of action. In addition, studies lasting up to 28 days showed that NVA237 was safe and well-tolerated, with no clinically relevant adverse events.
Another important outcome from the ERS meeting in October 2008 was the publication of the tiotropium (Spiriva®) safety database from approximately 20,000 patients. This meta-analysis, which included the prospectively designed UPLIFT study (Understanding Potential Long-term Impacts on Function with Tiotropium), demonstrated the cardiovascular safety of tiotropium and, in our view, allays any concerns over cardiovascular safety for this class of drug.
NDA submissions are expected to be filed for both NVA237 and QVA149 in 2011.
VR315 for asthma/COPD
Combination therapy for asthma is the biggest and fastest-growing sector of the asthma market, with annual sales of approximately $10bn.
VR315 is an inhaled combination therapy for asthma and COPD that is being jointly developed with Sandoz, the generics division of Novartis, using Vectura’s GyroHaler® Dry Powder Inhaler (“DPI”) device. Vectura licensed the European rights for VR315 to Sandoz in March 2006, in a deal worth up to €22.5m in milestones and development funding, together with royalties on all products sold. Rights in the US were licensed to Sandoz in December 2006 in a profit-sharing agreement, which includes the payment of up to $63m in milestones to Vectura. Sandoz has since invested over $50m in manufacturing facilities for VR315 and VR632.
With more key respiratory drugs coming off patent over the coming years and with increasing pressure on the regulatory authorities to approve lower cost drugs, both programmes have significant financial upside for Vectura. Vectura received a €2.5m (£2.2m) milestone payment from Sandoz in April 2009 and expects to receive a further €7.5m in milestones from its EU collaboration, and up to $30m from its US collaboration prior to the launch of VR315 in these regions. Revenues will also be earned on all product sales in the EU and from a profit share in the US. Vectura will also earn a margin on the commercial manufacture and supply of GyroHaler® and retains rights for un-licensed territories.
VR632 for asthma/COPD
VR632 is a second inhaled combination therapy for asthma and COPD that is being jointly developed with Sandoz, and is delivered using GyroHaler®. 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, together with royalties on all products sold. Vectura will also earn a margin on the commercial manufacture and supply of GyroHaler® devices. Vectura retains rights for the US and other un-licensed territories.
Respiratory disease affects an increasing number of people of all ages. Asthma and COPD (chronic obstructive pulmonary disease) markets are forecast to grow rapidly, achieving sales in 2011 of
$21bn and $11bn respectively
Boehringer Ingelheim collaboration on a DPI
Most treatments for asthma and COPD are delivered by inhalation. DPIs are increasingly the preferred choice for patients with these conditions and it is expected that DPIs will be used to deliver the majority of the drugs sold in these markets by 2011. Vectura believes that its device and formulation technologies are well placed to capture a significant market share.
In April 2006, Vectura agreed a nonexclusive, worldwide collaboration, development and licence agreement with Boehringer Ingelheim to develop a fully integrated, multi-dose DPI. The device will be available to Boehringer Ingelheim for the development and marketing of its proprietary respiratory medicines for the treatment of respiratory diseases such as asthma and COPD.
Boehringer Ingelheim is one of the world’s leading companies developing therapies to treat asthma and COPD. Its COPD therapy Spiriva® is the most prescribed COPD medicine worldwide, with sales in excess of $3bn in 2008.
Vectura has received a total of €37.5m (£31.2m) in equity investment and milestone payments from Boehringer Ingelheim to date, the latest receipt being €7.5m (£6.2m) in November 2008. Boehringer Ingelheim will be responsible for further development, manufacturing and clinical trial use of the DPI with its proprietary compounds, as well as the commercialisation of these products. Vectura will receive development milestones and royalties on sales of each product marketed in the device. Our collaboration with Boehringer Ingelheim has added significantly to our intellectual property portfolio and provided Vectura with an excellent DPI platform to deliver further value from its inhaled therapy technologies through other collaborations.
VR496 for cystic fibrosis (CF) (with potential for asthma and/or COPD)
VR496 is being developed as an inhaled, locally acting treatment for CF, and has the potential to be developed as a therapy for patients with other airway diseases such as asthma and COPD. The active component of VR496 is heparin, a drug that has been approved worldwide as an injected or infused treatment for other indications.
Vectura has initiated a Phase II clinical study with VR496 in CF patients. If the data prove to be positive in CF, Vectura intends to progress the product for this indication. A significant literature database describes the multi-modal and complementary pharmacological properties of inhaled heparin that are relevant to the treatment of CF, asthma and COPD, with mucolytic, anti-inflammatory, bronchodilatory and anti-infective activity being particularly relevant. Vectura will look to find a partner for the larger indications.
The European Medicines Evaluation Agency (EMEA) and US Food and Drug Administration (FDA) have granted VR496 orphan drug status.
Duohaler® for asthma/COPD
An undisclosed pharmaceutical company that had an exclusive agreement for the development, marketing and distribution in Europe of two Duohaler® products, has reviewed its portfolio of products following a recent acquisition. As a result of this review, the company is working to find a new partner for these projects and will continue to assist in the funding of the lead programme so that the development can proceed on schedule. The second Duohaler® project is currently on hold and will be reinitiated if interest is received from new partners.
£2.3m of milestone income generated from both of these projects, which was potentially repayable under certain circumstances, is no longer repayable and has been released from deferred income to revenue in the year.
The Duohaler® device provides advantages over some multi-dose DPIs. It has two separate drug reservoirs that feed two individual drug formulations to two separate metering chambers from which the drugs are delivered to the user in a single inhalation, avoiding co-formulation issues.
We believe that the Duohaler® lead product in development has the ability to capture an attractive share of the European and other generic markets and we look forward to the licensing discussions progressing.
Budesonide Clickhaler® for asthma in Japan
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.
Other development products
VR040 for Parkinson’s disease (PD)
VR040 is an inhaled, systemically acting product for the treatment of “off” episodes associated with advanced PD. The active ingredient in VR040, apomorphine hydrochloride, has been approved previously as an injectable formulation in Europe, and more recently in the US, for treating “off” episodes. VR040 is Vectura’s formulation of apomorphine, delivered by inhalation using Vectura’s proprietary DPI technology.
The EMEA has granted VR040 orphan drug status. Vectura is using the EMEA Scientific Advice procedure to progress the development of the product.
The successful results of a Phase IIa proof-of-concept clinical study for VR040 were reported in August 2006. In October 2007, Vectura announced successful completion of a second Phase II clinical study of VR040 in patients with PD. The study demonstrated that VR040 is safe and well tolerated. Following treatment with VR040, patients successfully and rapidly recover from an induced “off” episode; this effect was also durable. Vectura believes that delivery of apomorphine by inhalation will allow patients to experience benefits beyond those offered by current products.
Vectura initiated a Phase II “at-home” study at the end of 2008 and intends to out-license VR040 before the start of Phase III trials.
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. In April 2008, Vectura announced the successful completion of an early proof-of-concept study. The data demonstrated that VR147 is safe and well tolerated. Vectura is exploring out-licensing opportunities for VR147.
VR004 for erectile dysfunction (ED) and VR776 for premature ejaculation (PE)
Vectura is seeking licensing partners for these products. There is no expenditure in relation to these projects in the year to 31 March 2009 and no future expenditure will be incurred.
Marketed products
ADVATE® for haemophilia A
In 2000, Baxter was granted worldwide rights to use Vectura’s stabilisation patents and has utilised the technology in its serum-free recombinant Factor VIII, ADVATE®. ADVATE® is indicated for the treatment of haemophilia A and is marketed worldwide by Baxter. Vectura receives royalties on sales of ADVATE®, which have increased to over US$1.5bn in 2008, compared to US$1.2bn in 2007.
There is strong demand for ADVATE®, and Baxter continues to differentiate the product with various dosage forms, making it easier for patients to administer higher doses from fewer vials and to reduce the total infusion time. Growth of ADVATE® sales has continued to exceed our expectations as patients switch from plasma-based and other competing products in Europe and the US. Baxter recently announced that it has established the leadership position in Japan for recombinant Factor VIII. We expect to see further growth from increased compliance, establishing prophylaxis as the standard of care and the global penetration of the therapy.
Extraneal® for peritoneal dialysis
Extraneal® is a peritoneal dialysis solution containing icodextrin, licensed to Baxter in 1996 and marketed by Baxter worldwide. The product has been launched in over 45 countries including, in 2003, the US and Japanese markets. Vectura receives royalties on the sales of Extraneal® in the US, Japan and the rest of the world.
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 following gynaecological and other abdominal surgery. It has been used for this purpose in Europe since 2000 and in the US since October 2006. Vectura signed a global licence deal with Baxter in December 2005 for the manufacture and distribution of Adept®.
Asmasal® and Asmabec® for asthma
Asmasal® and Asmabec® are Clickhaler® based products. Asmasal® contains salbutamol, a short-acting beta-2 agonist for the quick relief of asthma symptoms. Asmabec® contains beclomethasone, an inhaled steroid used as standard preventative therapy for asthma. Asmasal® and Asmabec® are marketed by UCB SA in the UK, France and Ireland. Clickhaler® is Vectura’s proprietary reservoir DPI device.
Budesonide Clickhaler® and Formoterol Clickhaler® for asthma
These are Clickhaler® based products containing budesonide and formoterol respectively. Budesonide is a steroid used as standard preventative therapy for asthma. Formoterol is a long-acting beta-2 agonist with a fast onset of action and longer duration than salbutamol, benefiting sufferers with more severe symptoms. Mylan Inc, our licensing partner for these products, has received regulatory approvals for budesonide in Germany, The Netherlands and New Zealand; with regulatory approvals for formoterol received in Denmark, The Netherlands, South Africa and New Zealand. No further approvals are expected for these products in the near future. £0.9m of milestone revenue was released from deferred income in relation to these products during 2008/09.
Meptin Clickhaler® for asthma
Otsuka Pharmaceuticals, in Japan, has licensed the Clickhaler® technology from Vectura to deliver its short-acting beta-2 agonist Meptin® (procaterol) for the quick relief of mild, intermittent asthma symptoms.
Other Clickhaler® opportunities
Vectura continues to explore licensing opportunities for Clickhaler® products in other countries. Vectura supplies the Clickhaler® devices to licensees and earns a margin on these device sales.
©2009 Vectura Group plc Annual Report and Accounts 2008/09