Was looking into their other drug molecules mentioned by another poster. They licensed the patent for Zafirlukast almost 5 years ago from AstraZenica a drug that is already FDA approved, to create an inhaled form for the same indication.
It has been through phase 1/2 trials successfully and should be likely well into its final phases of trialling, likely very soon to be able to be commercialised.
Asthma/COPD is a huge industry and it seems like their inhaled form is quite superior to current oral medications and is also non-steroidal.
http://inviongroup.com/invion-enters-into-global-licence-agreement-for-inhaled-zafirlukast-inv104/
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Invion enters into global licence agreement for inhaled zafirlukast: INV104
Posted on
October 28, 2013 by
Company Secretary
- Invion announces it has licenced intellectual property to develop inhaled zafirlukast, to be known as INV104
- Zafirlukast is currently marketed by AstraZeneca as Accolate, an oral leukotriene receptor antagonist for the treatment of asthma
- INV104 to be developed as inhaled, non-steroidal, anti-inflammatory treatment for asthma
- Invion EVP R&D and CMO Dr Mitchell Glass led development of oral Accolate to FDA approval
Clinical-stage drug development company Invion Limited (ASX:IVX) today announced the execution of a licence agreement with Accolade Pharma LLC for intellectual property to develop inhaled formulations of zafirlukast for the treatment of asthma and other respiratory conditions.
The agreement provides Invion with an exclusive, worldwide licence to develop and commercialise all inhaled formulations and applications of zafirlukast. A licence fee of $500,000 is payable by Invion to Accolade Pharma LLC over a 12 month period commencing January 2014.
Zafirlukast is a leukotriene receptor antagonist (LTRA) or anti-leukotriene that blocks the action of the cysteinyl leukotriene receptors to reduce inflammation, constriction of the airways, and the build-up of mucus in the lungs.
The oral formulation of zafirlukast, currently marketed as a generic drug as well as by AstraZeneca as Accolate, has recently become available in the public domain due to the expiry of its original patents. Accolade Pharma LLC has created a patent strategy and strategic opportunities to develop non-oral formulations of the drug, aimed at reducing side effects and increasing effectiveness.
Invion aims to develop INV104 for novel inhaled indications using the FDA’s abbreviated 505(b)(2) regulatory pathway.
Invion’s CEO, Dr Greg Collier said, “Invion is delighted to announce this licence agreement. The introduction of zafirlukastinto our portfolio as INV104 complements Invion’s existing pipeline of inflammatory and respiratory disease treatments. INV104 represents a potential new inhaled, non-steroidal, anti-inflammatory treatment for asthma, which, similar to INV102 uses a drug with an existing safety profile.”
“The development of INV104 will utilise existing knowledge, skills and competencies in the Invion clinical team, while strengthening Invion’s development pipeline and asset commercialisation opportunities.
“Having been used in over four million people, there is a large safety database for this drug, and as we know, there continues to be a large unmet need for more effective and accessible asthma therapies. Having the INV102 (nadolol) and INV104 (zafirlukast) inhaled programs running in parallel means we can leverage IP and strategic efficiencies to the benefit of the Invion portfolio,” he said.
Dr Mitchell Glass, Invion’s Executive Vice President of R&D and Chief Medical Officer, led the development and submission of Accolate for Zeneca (now AstraZeneca) to its FDA approval letter in 1998, and is a substantial shareholder of Accolade Pharma LLC.
Key terms of the licence
Licensee Invion Limited
Licensor Accolade Pharma LLC, a Delaware USA private company (which is a related party of Invion by virtue of Dr Mitchell Glass’ relationship with the Licensor).
Term Until the last to expire of the Intellectual Property Rights in the Licensed IP.
Licensed IP All information including data, contacts, contracts and other arrangements in connection with zafirlukast, owned or controlled by Accolade Pharma LLC.
Fees The total Fee is AUD$500,000. The Fee will be paid by way of equal monthly payments, for a period of 12 months, commencing on 16 January 2014. In the event that the Licensee has net cash in excess of AUD$10 million during the 12 month period, then the Licensee may accelerate these payments.
Royalties 20% of the Net Sales received by the Licensee in connection with the development and commercialisation of zafirlukast. Net Sales include the gross amount invoiced by or on behalf of Invion less customary deductions.”
Is anyone able to comment on the terms of the licensing in the case it comes to commercialisation?
Their other drug Nadolol, indicated for smoking cessation seems to be in quite a sweet spot as the Aussie gov keeps slamming taxes on tobacco and currently NRT is one of the main therapies for smoking cessation, the other alternative is ‘Champix’, quite expensive and many side effects.
From what I’ve read, Nadolol is also quite advanced in its clinical trials and similar to zafirlukast was already FDA approved for hypertension/tremors and other conditions.
(20min delay)