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Aeris LogoAcquisition Opportunity:

Intellectual Property Assets - Aeris Therapeutics

This memo is in regards to an acquisition opportunity for an intellectual property portfolio relating to an innovative solution for emphysema treatment developed by aeris therapeutics.

MARKET OPPORTUNITY AND BACKGROUND

Emphysema is a common lung disease characterized by irreversible tissue destruction. It affects 20 million people worldwide. 500,000 have advanced disease that cannot be effectively managed with medications because they do not correct the problem of lung destruction that is responsible for hyperinflation and dysfunction. A significant fraction of these present potential candidates for aeriSeal System therapy.

For patients with advanced emphysema, surgical alternatives have been considered. One such procedure known as Lung Volume reduction Surgery (LVrS) can be performed. LVrS involves removing diseased portions of the lung to enable the remaining, healthier portions to function better. another alternative for some patients is lung transplantation. While effective for some emphysema patients, LVrS and lung transplantation are very invasive and associated with frequent, serious post-operative and long term complications.

AeriSeal System therapy represents a non-surgical alternative to these invasive procedures. It can produce the benefits of LVrS without the accompanying risks. In some patients, it has served as a successful bridge to transplantation.

company Background and clinical information:

Assets are being sold pursuant to an Assignment for the Benefit of creditors. craig Jalbert, of Verdolino & lowey, is the Assignee.

The AeriSeal System was developed through a robust clinical development program that enrolled approximately 250 patients across 5 clinical studies. The clinical development program culminated in the conduct of a multi-national pivotal trial, the ASPIrE trial, designed to obtain FDA commercial approval. This randomized and controlled pivotal study was designed to enroll 300 patients at approximately 45 leading clinical centers including Brigham and Women’s hospital, the Cleveland Clinic, Washington University, and University of Alabama, among others. The study was terminated due to lack of financing after a total of 90 patients were enrolled. Clinical data from these studies demonstrated that the AeriSeal System was effective at improving lung function, quality of life and symptoms of patients with advanced emphysema.

The AeriSeal System has reimbursement approval in germany under the nUB reimbursement process. The AeriSeal System also has a designated OPS code in germany, similar to an ICD9 code in the United States.

AVAILABLE ASSETS

Aeris Therapeutics has developed the Aeriseal™ system. it is a simple bronchoscopic solution for lung volume reduction using a proprietary polymer sealant delivered to diseased lung areas. This solution is clearly differentiated from competing minimally invasive approaches.

ASSETS

The portfolio includes:

  1. Patent related iP including:
    • 10 issued US patents (8361484, 8198365, 8445589, 6610043, 6682520, 7654998, 765499, 7300428, 7819908, 7861710)
    • 2 pending US applications
    • 23 international issued patents
    • 7 pending international patent applications
  2. IDE file documents
  3. Technical file documents
  4. Aeris SOPs and QC documents
  5. Product Manufacturing Controls
  6. Distributor Lists
  7. Databases of clinical trial data

AERISEAL™ EMPHYSEMATOUS LUNG SEALANT SYSTEM

The AeriSeal Emphysematous Lung Sealant System is a novel treatment for patients with severe emphysema that no longer responds to conventional medical therapy. It represents a minimally invasive alternative to surgical options, such as lung volume reduction surgery and lung transplantation. AeriSeal System therapy was designed to eliminate damaged regions of non-functional lung by sealing and collapsing pre-selected target areas. By reducing gas trapping and hyperinflation, treatment improves breathing function and quality of life in patients with advanced emphysema.

The aeriSeal Foam Sealant is a single use device that functions as a mucosal surface tissue glue. the foam sealant is created at the bedside by mixing and foaming the device components. it is delivered into the lung periphery using a catheter positioned through
a bronchoscope, a small flexible tube that can be positioned under direct visual guidance in the airways when patients are mildly sedated. The Foam Sealant is administered as a liquid but polymerizes in situ, physically blocking small airways and collateral air channels leading to collapse via absorption atelectasis.

The AeriSeal™ System achieves lung volume reduction without the risks of traditional surgery. It seals and shrinks the damaged areas, thereby reducing lung volume. As disease progresses, treatment can be administered again to achieve additional benefit. During the AeriSeal™ System procedure, four different areas of damaged lung are treated, two on each side. The procedure is usually completed within 15-30 minutes. Following the procedure, patients need to stay at least one night in the hospital.

Unique features of Aeriseal system endoscopic lung Volume reduction:

  1. Procedural simplicity requiring very short anesthesia and bronchoscopy times
  2. Easy to learn and perform
  3. Treatment shown to be effective independent of collateral ventilation, a condition that limits the effectiveness of other endoscopic  approaches
  4. Can be repeated in patients at the same treatment sites as disease progresses over time
  5. Can be performed in combination with other endoscopic treatments in complex or difficult patients
  6. responses equivalent to surgery in published studies (Kramer Mr et al, Chest, nov 2012)
  7. Durability of responses out to 2 years in published studies (Kramer Mr et al, Chest, Oct 2013).

SALE PROCESS

Hilco Streambank is actively soliciting offers for the available assets. Further information is available upon request. Data room entry will be granted upon execution of non-disclosure agreement.

Assets are being sold pursuant to an Assignment for the Benefit of creditors. craig Jalbert, of Verdolino & lowey, is the Assignee.

Bid Deadline: 5 PM ET, February 28, 2014

Bid Qualification: Qualified Bids must execute a form of Asset Purchase Agreement acceptable to the Assignee (Seller), and substantially of the form provided by the Assignee. Additionally, Qualified Bids must be accompanied by a deposit of 10% of the amount of the bid into the Assignee’s Escrow Account, and Bidders may be asked to provide evidence of financial wherewithal from a Chief Financial officer or banker if the Bidder is a private company.

  • Only Qualified Bids submitted by the Bid Deadline will be considered.
  • The winning bid will be awarded by the Assignee.
  • The Winning bidder is expected to close within 10 business days of notification by the Assignee that they are the winning bidder and execution by the assignee of the asset Purchase agreement.

Bidders who submitted deposits but did not win will have deposits returned to them within 2 business days of the Bid Deadline, except for the second place bidder who will be notified that they are the second place bidder and whose deposit may be held until the purchase closes with the winning bidder.

All bids are binding until deposits have been returned.