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Major Announcement: Positive Bronchitol opinion for Europe

Pharmaxis has announced the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a Marketing Authorisation for Bronchitol, clearing the way for the product to be used in Europe “for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care.”

Pharmaxis expects the European Commission to confirm this opinion and grant the Marketing Authorisation for Bronchitol in January 2012.

Pharmaxis CEO Dr Alan Robertson welcomed the decision saying, “This outcome from the CHMP meeting is an important milestone for the company.  It is good news for the cystic fibrosis (CF) community which has supported us throughout the development of Bronchitol.  As the life expectancy of CF patients has lengthened, the size of the adult population in Europe has increased.  Bronchitol will be used for CF patients aged 18 and above, which represents about two thirds of all patients who could potentially benefit from the drug. Pharmaxis will undertake a short term clinical trial in children (age 6-17) with a view to extending the license to this age group.

“Bronchitol is a drug which was discovered and developed in Australia.  It is approved for marketing in Australia and is now set to become available throughout the 27 countries of the European Union.  This outcome represents the culmination of a great deal of work by many people.

“Pharmaxis will move quickly to commercialise Bronchitol in Europe.  We have established our supply and logistics arrangements and advanced launch preparations and pricing applications with our marketing partner, Quintiles.  The awareness of Bronchitol’s clinical data amongst CF clinicians has increased through publications and presentations at scientific conferences.  European clinicians provided valuable support to the CHMP decision and are looking forward to Pharmaxis bringing this new therapeutic treatment option to their patients in the near future.” Dr Robertson said.

Professor Stuart Elborn, President of the European Cystic Fibrosis Society, stated; “Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies which can improve lung function and reduce exacerbations.  Bronchitol increases mucociliary clearance and will be the first approved therapy in Europe with this mechanism of action and has been shown to improve both lung function and reduce exacerbations when added to standard medications in use today.  I welcome this decision by the CHMP.”

Robert J. Beall, Ph.D, President and CEO of the American Cystic Fibrosis Foundation said; “The Cystic Fibrosis Foundation is delighted to see an important new CF medicine being made available to patients in Europe.  It takes a lot of dedication from industry and the CF community to develop a drug to this point.  We are proud to have played a part in this process through our clinical trial group and look forward to Bronchitol being submitted to the FDA early next year.”

Bronchitol’s approval for the treatment of cystic fibrosis patients in Australia and the European Marketing Application are based on the results of two Phase 3 clinical trials involving more than 600 people and conducted in 95 centres throughout the world.

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Bronchitol receives TGA approval for Australians with CF

Pharmaxis has announced that the Australian Therapeutic Goods Administration (TGA) has approved Bronchitol (inhaled dry powder mannitol) for marketing in Australia for the treatment of cystic fibrosis and it is now to be included in the Australian Register of Therapeutic Goods (ARTG).

Bronchitol has been approved for the treatment of cystic fibrosis (CF) in both adult and paediatric patients aged over six years as either an add-on therapy to dornase alfa or in patients intolerant of, or inadequately responsive to, dornase alfa.

Mr Terry Stewart, CEO of CF Australia, said: “We welcome the approval of Bronchitol and congratulate Pharmaxis on its commitment to helping patients and in getting a long awaited new treatment to this point. There is a great need for new medicines for people with CF. We must not forget that this is a genetic condition; people have cystic fibrosis from their first breath, so anything new that can improve patients' way of living, their quality of life and potentially their length of life is a wonderful step forward."

Dr Alan Robertson, Pharmaxis Chief Executive Officer, said: “The TGA's decision is the first approval for Bronchitol anywhere in the world and is an historic milestone for the company. It is fitting for a product that has been discovered and developed in Australia to be made available first to Australian patients. We are extremely pleased to have concluded the regulatory review process for Bronchitol with the TGA, one of the world's leading regulatory bodies. This approval is a testament to the hard work of many people in Pharmaxis and those in the CF community worldwide who have assisted in the clinical development of Bronchitol."

Bronchitol has been the subject of two pivotal clinical trials in cystic fibrosis in over 600 people involving 93 hospitals around the world. In April 2009 Bronchitol was awarded Orphan Drug designation in Australia for the treatment of patients with cystic fibrosis to improve lung function and reduce exacerbations.

Bronchitol has received Orphan Drug Designation and fast track status from the US Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency.

 

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Results of entitlement offer

On 16 November 2011, Pharmaxis Ltd (ASX: PXS) announced a pro-rata accelerated non-renounceable entitlement offer (Entitlement Offer) to raise approximately $80 million, comprising an institutional component (Institutional Entitlement Offer) and a retail component (Retail Entitlement Offer).  Merrill Lynch International (Australia) Ltd and Wilson HTM Corporate Finance Ltd are Joint Lead Managers and Underwriters to the Entitlement Offer.  The Entitlement Offer is fully underwritten. 

The Institutional Entitlement Offer was completed on 18 November 2011 and raised a total of approximately $49 million with approximately $42 million settled on the first settlement date of 28 November 2011 through the issue of 40,127,238 new ordinary shares and a further approximately $7 million through the issue of 6,940,876 new ordinary shares to be settled on the second settlement date of 15 December 2011. 

Pharmaxis today announces that the Retail Entitlement offer closed at 5.00pm (Sydney time) on 8 December 2011 and will raise approximately $31 million. Eligible retail shareholders subscribed for 13,815,725 new shares (approximately $14.5 million) under the Retail Entitlement Offer representing a subscription rate of approximately 47%. All eligible retail shareholders who subscribed for new shares in excess of their pro-rata entitlement will be allocated the full amount of their application.  Settlement of these new shares under the Retail Entitlement Offer will occur on the second settlement date of 15 December 2011.

The balance of 15,490,841 new shares (approximately $16.3 million) comprising of shares not subscribed for by eligible retail shareholders and the entitlements of ineligible retail shareholders will be issued to the sub-underwriters of the Retail Entitlement Offer, which have sub-underwriting agreements in place with the Underwriters and include a number of existing shareholders of Pharmaxis.

The allotment of new shares under the second settlement will be completed on 16 December 2011 and those shares are expected to commence trading on the Australian Securities Exchange on 19 December 2011.

Pharmaxis Chief Executive Officer, Dr Alan Robertson, said “I am very pleased with the support shown in the Entitlement Offer from both our institutional and retail shareholders. The capital raising will enable Pharmaxis to continue its transformation into a profitable, international, pharmaceutical business.”

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Phase II allergic asthma trial completes enrolment

Pharmaxishas completed enrolment of all subjects into its Phase II clinical trial evaluating ASM8, a potential new treatment for patients with moderate to severe asthma.

Dr Alan Robertson, Pharmaxis' Chief Executive Officer, commented: “ASM8 is a new approach to asthma and operates early in the cascade of events that lead to inflammation and hyper-responsiveness in the lungs of asthmatics. We have completed enrolment into this trial smoothly and ahead of schedule. Previous studies of shorter duration have shown ASM8 to be effective in reducing the signs and symptoms of allergic asthma and this trial will give us a better understanding of the performance of the product when administered for 2 weeks."

 

This trial is a cross over design and its purpose is to evaluate the efficacy and safety of two doses of inhaled ASM8 compared to placebo when administered over 14 days. The Phase II trial is being conducted in four hospitals in Canada and recruited 16 asthmatic adults. The data from the trial will be available during Q2 2012 and a successful outcome will allow a dose to be selected for a longer trial in patients with uncontrolled, persistent, asthma.

 

ASM8 is a combination product of two RNA-silencing oligonucleotides targeted at a number of mediators of inflammation in asthma and has been developed for those patients who continue to experience moderate to severe, persistent, uncontrolled asthma despite existing medications. This market represents a significant commercial opportunity as there are few treatment options and serious consequences for the patient if disease progression is not halted.

 

The prevalence of asthma is estimated at 60 million in the US, Europe and Japan of which approximately, three million are classified as having severe, persistent asthma.

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