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Archive for December 6th, 2017

SALE OF TARSA THERAPEUTICS, INC.

 

Gerbsman Partners (www.gerbsmanpartners.com) has been retained by Tarsa Therapeutics, Inc. (www.tarsatherapeutics.com) to solicit interest for the acquisition of all, or substantially all, the assets of Tarsa Inc.  (pls see attached Tarsa sales letter.pdf for additional detail information)

Tarsa Therapeutics, founded in 2009, is a privately held NDA-ready company focused on advancing its lead product, TBRIA to approval and commercialization.  TBRIA is a proprietary oral formulation containing recombinant salmon calcitonin (rsCT) for the treatment of postmenopausal osteoporosis.

Tarsa was funded ($78.4mm) by a syndicate of  four life sciences venture capital funds including: MVM Life Science Partners, Quaker Partners,  Novo A/S and Foresite Capital, in conjunction with Unigene Laboratories (now Enteris Biopharma), a leader in the design, delivery, manufacture and development of peptide-based therapeutics.  Tarsa Therapeutics is headquartered in Philadelphia, PA.

Tarsa has exclusive license rights from Enteris Biopharma to 12 issued US Patents covering Active Pharmaceutical Ingredient (API) manufacturing and oral peptide delivery technology supporting TBRIA.  Tarsa also has exclusive license to Global patents covering the same technologies. A patent application for a room temperature stable formulation of TBRIA if granted could extend the IP runway to August, 2037. The oral formulation patents qualify for Orange book listing preventing introduction of generic versions of TBRIA.  Tarsa also has an issued patent for a combination product consisting of oral calcitonin plus small molecules for the treatment of osteoarthritis.

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 Therapeutics Assets has been supplied by Tarsa Therapeutics.  It has not been independently investigated or verified by Gerbsman Partners or its agents. Potential purchasers should not rely on any information contained in this memorandum or provided by Tarsa Therapeutics, 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 Therapeutics, 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 Therapeutics or Gerbsman Partners’ negligence or otherwise.  

Any sale of the Tarsa Therapeutics 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 Therapeutics or Gerbsman Partners.  Without limiting the generality of the foregoing, Tarsa Therapeutics and Gerbsman Partners and their respective staff, agents, and attorneys, hereby expressly disclaim any and all implied warranties concerning the condition of the Tarsa Therapeutics 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.

Impact of Tarsa Therapeutics Products and Why Tarsa Therapeutics Assets are Attractive:TBRIA™ Tarsa’s Phase III Asset -Unique and Differentiated Therapy for Osteoporosis

 1.  TBRIA product profile highlights:

a.  Positive Phase III results demonstrated superiority to existing nasal calcitonin

b.  Product profile addresses significant unmet medical need in the market place

c. Year 5 peak US sales exceeding $550mm

2.  TBRIA will provide an antiresorptive product with a previously approved molecule and a distinct mechanism of action to address the unmet medical need arising from increasing safety issues with bisphosphonates (BPs) including:  atypical subtrochanteric fractures, risk of osteonecrosis of the jaw, & atrial fibrillation and for patients unable to tolerate BPs or SERMS

3. TBRIA™ will be the only new antiresorptive therapy on the market with no new antiresorptive therapies in development on the horizon, lack of competition lends to 50% of the OP market Rxs can be reached with only 150 reps

Significant Commercial Opportunity

Emergent AEs associated with the standard of care BPs has led > 5 million women to discontinue therapy for Osteoporosis (OP),  while initiation of therapy for newly diagnosed women has also dropped drastically

a. TBRIA has the potential to be a significant commercial product with peak US sales potential  in excess of  USD $550 million with a sales force of only 150 representatives

Majority of TBRIA sales will come from significant penetration of the “lapsed” patient population (5 million patients) that have discontinued bisphosphonate treatment

An immediate sales opportunity at market entry  in the US of ~ $100 mm exists for TBRIA to rapidly cannibalize nasal calcitonin prescriptions given TBRIA’s superior ease of administratio

b. Extensive market research (> 1200 high prescribing physicians) indicates that prescribers view TBRIA as a differentiated alternative with anticipated use in ~ 20% of new and existing treated osteoporotic patients and > 30% within the  discontinued patients population

3.  Tarsa Therapeutics Assets Intellectual Property (“IP) and Market Protectio

a.  Currently two distinct patent estates covering 12 US patents provide IP protection until 12/2029 for TBRI

b. These include global patent coverage for API manufacturing until June 2026 and  December, 2029 for the oral peptide formulation technology

c.  Patent pending for room temperature stable formulation of TBRIA may extend IP to August 2037

d.  Up to 4 formulation patents are Orange Book eligible to prevent generic entries to TBRIA

e.  The ANDA path is not viable option per FDA peptide/protein based therapeutic policy

4.  Regulatory Path Forward

a.  The TBRIA 505(b)(2) NDA received a CRL relating principally to the reference listed drug, Miacalcin Nasal Spray, demonstrating efficacy but failing to separate from placebo

b.  Tarsa has agreed with FDA that a single confirmatory de-risked, 2-arm, 48 week study comparing TBRIA with nasal spray calcitonin alone will satisfy the 505(b)(2) requirements. Initiation of the clinical study in late 2018 with positive results will result in an approved product in first half 2021.  Given the TBRIA versus Miacalcin nasal spray results from the completed Phase III ORACAL study there is a high likelihood of success.

5.  Chemistry, Manufacturing & Controls (“CMC”)

a.  API inventory valued at ~ $20 mm ($8 mm in house, $12 mm paid secured rights), sufficient to support  >$500mm in sales

b.  Larger commercial API requirements for follow on indications are addressed by rDNA process that affords greater scale and lower costs than traditional peptide chemical synthesis

c.  Tablet manufacture scaled to commercial size batch of 500,000 completed

6.  LIFE CYCLE MANAGEMENT

A higher strength version of TBRIA can provide significant upside revenue potential through expansion into other indications such as: Treatment of symptomatic osteoarthritis (>$1 billion) and pain associated with recent vertebral fracture (~$200 mm).

Key Personnel

Dave Brand President, CEO and Founder

Mr. Brand has more than three decades of pharmaceutical industry experience. Prior to Tarsa, he served as CEO and president of Cardiokine, where he led strategic and organizational development and negotiated a significant global agreement with Biogen Idec for late stage development and marketing of lixivaptan. Previously, Mr. Brand spent over 30 years at GlaxoSmithKline and its predecessor companies.  Mr. Brand held international senior management postions in marketing, acquisitions and country management.

James P. Gilligan, Ph.D. MSIB Founder & Chief Scientific Officer

Prior to joining Tarsa, Dr. Gilligan held positions of increasing responsibility for nearly 30 years at Unigene, where he led the development of the oral calcitonin product now licensed to Tarsa. He served as vice president of product development at Unigene, where he was project leader for the oral and nasal calcitonin programs, as well as the oral parathyroid hormone and site-directed bone growth programs. Dr. Gilligan was responsible for leading the clinical programs and successful U.S. and European regulatory registrations for the nasal calcitonin product Fortical® Nasal Spray and the injectable calcitonin product Forcaltonin® Injection.

Nicholas A. LaBella, Jr., MS, RPh Vice President, Global Regulatory Affairs

Mr. LaBella brings more than 30 years of hands-on experience managing biopharmaceutical R&D, clinical operations and regulatory affairs. Prior to joining Tarsa, Mr. LaBella was chief scientific officer at Insmed, where he drove a key acquisition. Previously, he was vice president, regulatory affairs and then vice president, development at Cardiokine, where he played a key role in designing and executing the development program for the company’s lead product.

George R. Maurer Vice President CMC and Supply

Mr. Maurer has more than 30 years experience in manufacturing and supply chain activities in the pharmaceutical industry. Prior to joining Tarsa, Mr. Maurer served as senior vice president of technical operations for Adolor Corporation, where he directed all manufacturing, supply and distribution activities for Adolor’s commercial product Entereg® capsules. Previously, Mr. Maurer was director of commercial manufacturing at ViroPharma, Earlier in his career

 

The Bidding Process for Interested Buyers

Interested and qualified parties will be expected to sign a nondisclosure agreement (attached hereto as Exhibit A) to have access to key members of the management and

intellectual capital teams and the due diligence “war room” documentation (the “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 an opportunity to inspect and examine the Tarsa Therapeutics 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 Therapeutics, Inc., 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 neither Tarsa Therapeutics nor Gerbsman Partners (or their respective, staff, agents, or attorneys) makes 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 Therapeutics Assets. Sealed bids must be submitted so that the bid is actually received by Gerbsman Partners no later than Tuesday, January 23, 2018 at 5:00 p.m. Eastern Time (the “Bid Deadline”) at Tarsa Therapeutics’s office, located at 1628 JFK BLVD. Suite 1400 Philadelphia, PA 19103. Please also email steve@gerbsmanpartners.comwith any bid.

Bids should identify those assets being tendered for in a specific and 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 where

applicable. All bids must be accompanied by a refundable deposit in the amount of $200,000 (wire transfer information will be supplied at a later date). The winning bidder will be notified within 3 business days after the Bid Deadline. Non-successful bidders will have their deposit returned to them.

Tarsa Therapeutics 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 bid will be chosen as the winning bidder and bidders may not have the opportunity to improve their bids after submission.

Tarsa Therapeutics will require the successful bidder to close within 7 business days. Any or all of the assets of Tarsa Therapeutics 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 Therapeutics Assets shall be the sole responsibility of the successful bidder and shall be paid to Tarsa Therapeutics at the closing of each transaction.

For additional information, please see below and/or contact:

 

Steven R. Gerbsman

steve@gerbsmanpartners.com

 

Kenneth Hardesty

ken@gerbsmanpartners.com

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