Oriel Therapeutics is all about removing the mysteries, challenges and “delivery inconsistencies” of today’s current inhalers that are use to treat such ailments as asthma.

The company has patented a means of delivering drugs in a consistent manner as a dry powder. And should the company win approval from the FDA, it believes the financial awards — as well as patient benefits — would be quite attractive.

Projected income statements disclosed by Oriel as part of its presentation at Venture 2003 show the company achieving profitability as soon as next year with net income of $37 million as early as 2008.

In responding to Local Tech Wire’s request for company information, Oriel chose to respond in a somewhat different format. (Previous profiles can be found under the Executive Q&A menu.)

Here is the chief executive’s view of Oriel, as provided by Dr. Paul Atkins, founder and chief executive officer.

Why should investors be interested in your company?

Oriel Therapeutics Inc. is an emerging inhalation drug delivery company focused on addressing drug delivery inconsistencies of current inhalers. Based on a patented universal approach to powder drug delivery we have developed a unique aerosolization system that provides highly consistent dose delivery. Our initial strategy is to partner with one or more pharmaceutical companies with molecules to treat asthma and Chronic Obstructive Pulmonary Disease (COPD). Subsequent focus, based on the very consistent dose delivery achievable with this technology, will be in the peptide and protein therapeutic area.

What makes your company and its technology unique?

To date the USA Food and Drug administration has only approved two “passive” multi-dose powder devices and for only a handful of drugs. This is because many passive devices available today do not meet the FDA standards in terms of consistent drug delivery. Oriel plans to develop a DPI technology that will be “active” (i.e. requires minimal energy input from the patient) but simple in that the energy source is part of the drug packaging. Oriel plans to compete in the DPI sector and will hold a superior technological position compared to current and future DPIs with regard to consistency in dose delivery.

Oriel’s technology is driven by a fundamentally different approach to DPI development. A novel method of aerosol powder dispersion for pulmonary delivery has been developed that requires mathematical characterization of powder flow properties as a precursor to delivering vibratory energy at a frequency and amplitude tuned to the nature of the powder.

This is based on sound science conducted over the past 12 years at the University of North Carolina, Chapel Hill, under the guidance of Professor A.J. Hickey, a recognized expert in aerosol drug delivery. This mechanism has been shown to maximize emitted dose in a highly reproducible fashion and to achieve very efficient control of the proportion of small particles (the pharmacologically important size range) within the aerosol cloud.

This is very different from conventional “passive” inhalers. A piezo-electric polymer, polyvinyldiene fluoride (PVDF), within the drug packaging is employed as a vibratory surface with which powder derived signals are applied in a complimentary fashion to the inspiratory airflow rate provided by a patient upon inhalation.

Current DPI technology is limited by the nature of “passive” devices and the need for patients to generate the energy to deliver the drug. This leads to inconsistent dosing and in many cases has limited approval of devices by regulatory agencies (e.g. SymbicortTM TurbuhalerTM in the United States). Control is applied by the development of complex drug formulations and by tolerances on critical orifice dimensions within the device. These often have to be constructed to very tight tolerances.

The novelty of the Oriel approach is that the active part of the device is effectively disposed of after each dose is delivered. The signal is also tailored to the pharmaceutical powder of interest. Hence distinct and unique proprietary “software” is used for each pharmaceutical agent. Thus formulation requirements will be minimal and development times significantly shortened. It is these two features that Oriel believes will lead to highly consistent product performance, simplified product development, and potentially rapid regulatory approval.

Oriel’s proprietary DPI (or devices that contain this novel platform technology) will have a number of technical advantages over current devices:

  • The DPI will be independent of patient effort (suitable for young children; seniors)
  • The DPI will not be limited to a specific range of formulations
  • The DPI will be capable of delivering two drugs independently
  • The DPI will be inexpensive

What is the target market?

The worldwide pulmonary drug delivery market is expected to double in the next five years to $15.2 billion (Front Line Strategic Marketing). Subsequent growth through the next decade is expected to be moderate (double digit) fuelled by the introduction of new powder inhalers replacing CFC MDIs and injectable therapies. Leading pharmaceutical brands include SereventTM, FloventTM, AdvairTM (SeretideTM) (GlaxoSmithKline); AtroventTM and CombiventTM (Boehringer Ingelheim); and SymicortTM and PulmicortTM (AstraZeneca). Sales of these brands accounted for over $8.2 billion in 2001. Today the inhaled drug delivery market is dominated by treatments for asthma and Chronic Obstructive Pulmonary Diseases (COPD).

For these diseases there is a need for chronic administration of drugs, which typically are given via either a metered dose inhaler (MDI) or a dry powder inhaler (DPI). However, new combination asthma therapies are rapidly gaining adoption and contributing to strong growth. Currently bronchodilators and anti-inflammatory agents represent the largest segments commanding a 48 percent and 42 percent market share respectively.

It is estimated that globally there are currently (2001) over 500 million units used annually to delivery of medicine to the lung. These drugs have traditionally been given by MDIs but with advent of newer viable methods of delivery it is anticipated that the use of metered dose inhalers (MDIs) will decline over the coming decade. The propellants they have used traditionally (CFCs) are being phased out (under the Montreal Protocol) and the propellants that have replaced those (HFAs) are coming under increasing focus as environmentally harmful agents as greenhouse gases (Kyoto Protocol). In Japan emissions of HFAs have already been capped and in certain European countries legislation is pending to limit HFA use.

Historically, global use of DPIs accounted for less than 10 percent of all inhaled drug delivery units (ca less than 50M units per year) but in the past several years the picture has altered dramatically. In Europe the percentage of DPI use has now grown to almost 35 percent and this has also been seen in Japan. In the United States with the recent successful launch of GSK’s AdvairTM DiskusTM the use (on a unit basis) of DPIs is estimated at 14 percent (June 2002) and is growing rapidly. Over the coming decade continued strong growth in the DPI market is expected.

The current limitations of existing DPIs is that, unlike the MDIs that use propellants to expel the drug and drive it into the lungs of patients, the DPIs require the patient to provide the energy to do this. These devices are thus called “passive”. A consequence of the patient providing the energy to suck the drug from the device is that this can lead to variability in delivery of the drug to individual patients. Regulatory agencies are striving to provide a minimum standard for products to achieve and this has resulted in some products not gaining regulatory approval or only in a limited number of countries because the device could not meet the required standards.

Thus in order to achieve a “blockbuster” product in the pulmonary drug delivery business there is a need to achieve a sound pharmacological agent and a good device that will meet global regulatory specifications. We believe the Oriel technology will provide this advantageous, approvable device thus providing a very attractive partnering opportunity.

Why should investors be impressed with your management team?

An experienced management team and key advisors are now in place at Oriel. This team has extensive experience within the pharmaceutical and related industries. The key members of the team in addition to (Atkins):

  • Timothy M. Crowder, PhD – Chief Technology Officer and Founder (Developed the aerosolization technology (PhD at UNC in Biomedical Engineering; experience in technology transfer to industry – semiconductors)
  • Anthony J. Hickey, PhD – Chief Scientific Officer and Founder (Over 20 years experience advising top tier pharma and biotechnology companies; founder, president and CEO of Cirrus Pharmaceuticals, a pharmaceutical CRO)
  • Tom Sekel, Chief Financial Officer (25 years experience across a wide variety of industries ; previous role as Vice President Finance, Bespak Inc.)
  • Keith J. Johnson, Consultant Pharmaceutical Development (Vast experience in inhaled product development and scale up; GSK and Inhale Therapeutics)
  • Dean McKinney, Consultant Business Development (Extensive pharma experience and broad industry network; 18 years of commercial development at Bespak Inc. including negotiations on GSK DiskusTM and Elan (Dura) SpirosTM )

In addition a Scientific Advisory Board has recently been established under the leadership of Professor Hickey. This Board contains recognized global experts in their fields including a past President of the American Thoracic Society; the past Chair of the FDA Pulmonary Drugs Advisory Committee; a physicist with extensive experience and a globally recognized Respiratory Physician.

How will company generate revenue?

Oriel intends to develop revenue streams from two main sources;

1. License the Oriel technology in return for royalties for applications for particular drugs, or in selected therapeutic categories. This will allow current pharmaceutical companies opportunities to realize patent extensions (for their molecules) and enhance lifecycle management

2. As the technology becomes validated and accepted Oriel intend to retain a therapeutically defined area to allow it to develop its own product(s) by combining the new delivery device with selected off patent molecules that can provide therapeutic and commercial advantages.

Just the facts: Oriel Therapeutics Inc.

Address: 630 Davis Drive Suite 120, Durham, NC 27713, USA
Mailing address: P.O. Box 14087 Research Triangle Park, NC 27709
Phone: (919) 313-1290
Fax: (919) 313-1295