The Bidding Process, Procedures for the Sale of certain Assets and Intellectual Property of Tarsa Therapeutics, Inc.
Further to Gerbsman Partners sales letters of December 12, 2017 and December 6, 2017 regarding the sale of certain assets of Tarsa Therapeutics, Inc. (“Tarsa”), I am attaching updated information regarding the Assets and Intellectual Property of Tarsa including an outline of potential “Tarsa Risk Mitigation Factors” for interested parties bidding on the assets and IP of Tarsa and performing due diligence, subject to the Tarsa CDA attached (TBRIA – Calcitonin–Salmon – Delayed Release Tablets; “the Only New Antirestorptive Drug for the Treatment of Osteoporosis)
Any and all the assets of Tarsa will be sold on an “as is, where is” basis and will be subject to “The Bidding Process for Interested Buyers”, outlined below.
Gerbsman Partners (http://www.gerbsmanpartners.com) has been retained by Tarsa (http://tarsatherapeutics.com) to solicit interest for the acquisition of part or substantially all of Tarsa’s assets, including its Intellectual Property (“IP”), in whole or in part (collectively, the “Tarsa Assets”).
Tarsa’s Potential Risk Mitigation Factors
Clinical Regulatory
1. The TBRIANDA has completed FDA review resolving the following issues
a. No need for a fracture study
b. No Ad Com meeting needed for NDA approval
c. No toxicology, safety, or cancer issues identifies
d. No API, biopharmaceutic or stability issues remain
e. No API related bridging issues for rsCT (TBRIA) = ssCT (Miacalcin) arose during NDA review
2. The sole outstanding clinical issue remaining from the CRL was the lack of Miacalcin Nasal Spray’s increase in Lumbar Spine Bone Mineral Density (LS BMD) being statistically superior to placebo
3. Negotiations with FDA (Office of New Drugs) resulted in agreement on a 2-arm 48 week non-inferiority study comparing TBRIAvs Nasal Spray Calcitonin study comparing changes in LS BMD (Tar: 01-1101)
4. Given TBRIA’s statistical superiority to Miacalcin in increasing LS BMD in the Phase III ORACAL Study there is a high likelihood of success
5. Tarsa’a new commercial tablet manufacturer, Quotient, will manufacture the Clinical Trial Material (TBRIA) for the agreed upon Tar: 01-1101 study thereby resolving the 483 related issue cited by FDA with Pii (original tablet manufacturer).
Commercial
- Since 2009 ~ 5 million women have stopped taking bisphosphonates (BPs) due to safety concerns
- FDA has also limited the duration of use for BPs to 3-5 years before taking a “drug holiday”
- Tarsa has performed 5 Waves of Physician Market Research (<1200 Physicians) supporting TBRIAgarnering ~20% of prescriptions for new and existing patients.
- Women who have stopped taking BPs either due to a physician recommended drug holiday or of their own volition are referred to collectively as “lapsed patients”
- The Physicians Market Research suggests that ~60% of lapsed patients will return to therapy within 2-3 years. Physicians will prescribe TBRIAto 1/3 of these lapsed patients.
- The anticipated product from Merck, Odanacatib, was terminated by Merck due to CV safety concerns. NO new antiresorptive drugs are on the horizon
- In concert these factors have contributed to TBRIA’ssales projections of ~$550 mm by year 5 with a sales force of 125-150 Reps.
- The market opportunity for TBRIA has been corroborated by outside interested third parties
IMPORTANT LEGAL NOTICE
The information in this memorandum does not constitute the whole or any part of an offer or a contract.
The information contained in this memorandum relating to Tarsa’s Assets has been supplied by Tarsa. It has not been independently investigated or verified by Gerbsman Partners or their respective agents.
Potential purchasers should not rely on any information contained in this memorandum or provided by Tarsa or Gerbsman Partners (or their respective staff, agents, and attorneys) in connection herewith, whether transmitted orally or in writing as a statement, opinion, or representation of fact. Interested parties should satisfy themselves through independent investigations as they or their legal and financial advisors see fit.Tarsa, Gerbsman Partners, and their respective staff, agents, and attorneys, (i) disclaim any and all implied warranties concerning the truth, accuracy, and completeness of any information provided in connection herewith and (ii) do not accept liability for the information, including that contained in this memorandum, whether that liability arises by reasons of Tarsa’s or Gerbsman Partners’ negligence or otherwise.
Any sale of the Tarsa Assets will be made on an “as-is,” “where-is,” and “with all faults” basis, without any warranties, representations, or guarantees, either express or implied, of any kind, nature, or type whatsoever from, or on behalf of Tarsa and Gerbsman Partners. Without limiting the generality of the foregoing, Tarsa and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Tarsa Assets and any portions thereof, including, but not limited to, environmental conditions, compliance with any government regulations or requirements, the implied warranties of habitability, merchantability, or fitness for a particular purpose.
This memorandum contains confidential information and is not to be supplied to any person without Gerbsman Partners’ prior consent. This memorandum and the information contained herein are subject to the non-disclosure agreement attached hereto as Exhibit A.
The Bidding Process for Interested Buyers
Interested and qualified parties will be expected to sign a Confidential Disclosure Agreement (attached hereto as Appendix A) to have access to key members of management and intellectual capital teams and the due diligence “war room” documentation (“Due Diligence Access”). Each interested party, as a consequence of the Due Diligence Access granted to it, shall be deemed to acknowledge and represent (i) that it is bound by the bidding procedures described herein; (ii) that it has had an opportunity to inspect and examine the Tarsa Assets and to review all pertinent documents and information with respect thereto; (iii) that it is not relying upon any written or oral statements, representations, or warranties of Tarsa, Gerbsman Partners, or their respective staff, agents, or attorneys; and (iv) all such documents and reports have been provided solely for the convenience of the interested party, and Gerbsman Partners (and their respective staff, agents, or attorneys) do not make any representations as to the accuracy or completeness of the same.
Following an initial round of due diligence, interested parties will be invited to participate with a sealed bid, for the acquisition of the Tarsa Assets. Each sealed bid must be submitted so that it is received by Gerbsman Partners no later than Tuesday – January 23, 2018 at 5:00pm Eastern Standard Time (the “Bid Deadline”) at Tarsa’s offices, located at 1628 JFK Blvd, # 1400, Philadelphia, PA 19103. Please also email steve@gerbsmanpartners.com with any bid.
Bids should identify those assets being tendered for in an identifiable way.
Any person or other entity making a bid must be prepared to provide independent confirmation that they possess the financial resources to complete the purchase. All bids must be accompanied by a refundable deposit in the amount of $200,000. The deposit should be wired to an escrow agent who will be outlined in a future update. The winning bidder will be notified within 3 business days of the Bid Deadline. Unsuccessful bidders will have their deposit returned to them within 3 business days of notification that they are an unsuccessful bidder.
Tarsa reserves the right to, in its sole discretion, accept or reject any bid, or withdraw any or all assets from sale. Interested parties should understand that it is expected that the highest and best bid submitted will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.
Tarsa will require the successful bidder to close within a 7 day period. Any or all of the assets of Tarsa will be sold on an “as is, where is” basis, with no representation or warranties whatsoever.
All sales, transfer, and recording taxes, stamp taxes, or similar taxes, if any, relating to the sale of the Tarsa Assets shall be the sole responsibility of the successful bidder and shall be paid to Bambeco at the closing of each transaction.
For additional information, please see below and/or contact:
Steven R. Gerbsman
Gerbsman Partners
Kenneth Hardesty
Gerbsman Partners
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