Innovata enters second Duohaler deal and revise BMS deal
development of a combination asthma therapy could generate in
excess of £25 million (€37 million) in milestones and development
funding.
The deal marks one of the biggest deals, in which combination therapy for asthma has become one of the biggest and fastest growing sectors of the asthma market. Global annual sales currently exceeding $6 billion and European annual sales estimated at approximately $1.5 billion.
Under the terms of the agreement, Innovata will develop a combination therapy based on two generic asthma treatments in collaboration with its pharmaceutical company partner.
In return, Innovata will receive development funding and milestone payments in excess of £25 million in addition to rising royalties on product sales.
The agreement covers Europe and certain other countries, with Innovata retaining rights for the combination product in the US and Japan.
"The agreement announced today represents the second deal for our Duohaler technology. It demonstrates Innovata's innovation in pulmonary delivery," said Kieran Murphy, Chief Executive Officer of Innovata.
Innovata's Duohaler technology, formerly known as the C200 inhaler, is designed to deliver two drugs together, in the same breath, from separate reservoirs.
This concept allows for flexibility in the formulation of each active ingredient and enables Innovata to further expand its portfolio of formulations, which can be tailored, to fit with new chemical entities from its partners' research and development programmes.
Innovata has also reported an update to its agreement with Qdose, MicroDose Technologies (MicroDose), and Bristol-Myers Squibb Company relating to fast acting inhaled insulin.
Under the revised details of the agreement, Bristol-Myers Squibb has transferred all rights to the product to Qdose, a move that is suprising considering the investment the pharma company has made in this insulin programme.
Since signing the agreement in September 2003, Bristol-Myers Squibb has been involved in all aspects, in particular, the design and development of a best-in-class inhaler device, development of blister form, fill and seal equipment, and the preparation for clinical studies, including scale-up of the manufacturing processes relating to the formulation.
"When it became clear that the project may not be in line with Bristol-Myers Squibb's long-term strategic goals, it made sense for this current arrangement to be brought to a conclusion," said Murphy.
"We remain fully convinced of the product's potential and are confident that it will attract significant interest from prospective partners with strategic interests in the treatment of diabetes," he added.
As part of the revised agreement, Innovata, MicroDose and QDose will receive undisclosed payments from Bristol-Myers Squibb, which will share in certain future revenues generated by the QDose inhaled insulin product.
In addition, all intellectual property rights, data, materials and know-how generated during the course of the collaboration will become the property of QDose.
The company will continue to build on the progress achieved to date by completing preparations for an IND submission to the US Food and Drug Administration (FDA).
