CoreRx, Inc. Announces Commercial Supply Agreement for Aimmune Therapeutics’ Investigational Peanut Allergy Treatment

CLEARWATER, FL, USA, May 14, 2019 /EINPresswire.com/ -- CoreRx, Inc. Announces Commercial Supply Agreement for Aimmune Therapeutics’ Investigational Peanut Allergy Treatment

Clearwater, Florida, May 14, 2019 — CoreRx, Inc. today announced that it has executed a commercial supply agreement with Aimmune Therapeutics, Inc., for the commercial manufacture of AR101, an investigational treatment for peanut allergy currently under review for potential approval by the U.S. Food and Drug Administration. CoreRx has been the development manufacturer of AR101 through multiple successful phase 2 and phase 3 clinical trials of the drug. 

Todd R. Daviau, President and CEO of CoreRx stated: “Aimmune has long been an important client-partner of CoreRx, and we're pleased to build on that relationship with this agreement as the company prepares for the potential commercial launch of AR101. We’re proud to be part of the team working to make the potential first treatment for peanut allergy available to the millions of children at risk of having allergic reactions to peanut. This agreement positions CoreRx to meet the anticipated strong demand for AR101, both in the United States and globally, for the next several years. This agreement is also a significant milestone for CoreRx, providing the opportunity to showcase the capabilities of our world-class organization in a major emerging therapeutic space, and we expect to follow it with additional strategic manufacturing arrangements with other CoreRx clients.”

AR101 is being developed as a treatment to reduce the risk of anaphylaxis following accidental exposures to peanut. Aimmune began phase 2 clinical trials of AR101 in early 2014, followed by phase 3 clinical trials in early 2016. The AR101 commercial manufacturing facility, located on the CoreRx campus, includes state-of-the-art air-handling systems and equipment to prevent cross contamination of allergens, along with controls and management systems to ensure safety and compliance with U.S. and European pharmaceutical manufacturing regulations. It can manufacture approximately 189 million dosage units of AR101 per year. 

“CoreRx shares Aimmune’s commitment to improving the lives of people with food allergies and has been a great partner through the complex operation of supplying multiple different doses of AR101 for our clinical trials on a timely basis,” said William Turner, Aimmune’s Senior Vice President, Technical Operations and Regulatory Science. “We’re pleased to have their experience and expertise on board as we prepare for commercial launch of what could be the first treatment for peanut allergy, as we have seen them become a key contributor to the rapidly growing life science and biotechnology industry in the central Florida area.”

About CoreRx, Inc.
CoreRx is a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical – niche commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing, and testing of solid, liquid and semi-solid dosage forms.

Keep on top of new developments at CoreRx and throughout the drug development industry by following www.linkedin.com/company/corerx-inc. To get more detailed information about the company, visit www.corerxpharma.com.

Mark DaFonseca, Chief Business Officer
CoreRx, Inc.
+1 727-259-6950

Vigene Biosciences Secures Institutional Investment in New Round of Growth Capital Financing

ROCKVILLE, Md., April 29, 2019 /PRNewswire/ -- Vigene Biosciences, Inc ("Vigene") a leading provider of viral vector products and services used in gene therapy, has completed a substantial growth capital financing transaction.  The investment was made by Signet Healthcare Partners ("Signet"), a New York based growth equity firm specializing in healthcare investments.

The growth capital will be used to support Vigene's expansion into a new facility to support the growing demand for viral vector and plasmid production in the rapidly expanding fields of cell and gene therapy.  Construction of the new facility, located in Rockville, Maryland, is set to be completed mid-2019 and will increase Vigene's office, laboratory and cGMP production space by 51,000 sq. ft. The most notable additions from the expansion are 5 state-of-the-art cGMP viral manufacturing suites, which will increase Vigene's cGMP production facilities to 10 suites with over 30,000 sq. ft. of cGMP space.   

Vigene CEO Dr. Zairen Sun said, "We are very excited to receive this investment, which will allow us to accelerate the growth of our business. Signet Healthcare Partners is an ideal partner in further developing Vigene as a leader in the Contract Development and Manufacturing Organization (CDMO) space for viral vector cGMP production. The new facility and equipment will allow us to innovate and meet production demands as the fields of gene and cell therapy continue to advance."

Concurrently with the financing, Ashley Friedman, Managing Director at Signet Healthcare Partners, will join the board of directors at Vigene. "I believe the company is well positioned to capitalize on the rapidly evolving field of gene therapy. Signet looks forward to a close collaboration with Dr. Sun and the leadership team at Vigene," said Ashley Friedman.  Additionally, Jeffrey M Ostrove, Ph.D. will be joining Vigene as an Independent member of the board of directors.  Dr. Ostrove is a biotechnology executive with extensive experience in gene therapy, both on the drug development and CDMO side of the business.  Dr. Ostrove is currently the CEO of Locana Inc. "There is a great need for additional contract manufacturing and support services in the fields of cell and gene therapy as the FDA predicts there will be over 200 Investigational New Drug applications filed over the next 2 years which represents a substantial expansion of the field and Vigene is poised to support that effort," stated Dr. Ostrove.

Shulman Rogers Gandal Pordy & Ecker, P.A., acted as legal counsel for Vigene and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Signet Healthcare Partners.

About Vigene Biosciences

Founded in 2012, Vigene Biosciences is an award-winning leader in viral vector-based gene delivery for both life science research and gene therapy applications with the mission to make gene therapy affordable. Vigene offers cGMP as well as research-grade production of plasmid, AAV, lentivirus, adenovirus, and other viruses with proven technologies that comply with FDA and EMA guidelines. In 2018, Vigene ranked 81st on the Inc. 5000 list and was named the ACG Emerging Company of the Year. For more information, visit https://vigenebio.com/.

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

For more information please contact:

Vigene Biosciences
Jeffrey Hung, Ph.D.
Chief Commercial Officer
Vigene Biosciences
301-251-6638
jhung@vigenebio.com

Signet Healthcare Partners
Jerry Liao
212-893-1179
jerry.liao@signethp.com

SOURCE Vigene Biosciences

Goodwin Biotechnology Secures Significant Institutional Investment in New Round of Growth Capital Financing

FORT LAUDERDALE, Fla., April 22, 2019 /PRNewswire/ -- Goodwin Biotechnology, Inc. ("Goodwin") announced that it has completed its largest ever round of financing with growth capital which will help fund its next stage of expansion.  Goodwin is a full GMP, FDA-registered biopharmaceuticals Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from Cell Line Development, Process Development including Bioconjugation, Scale-Up, cGMP Contract Manufacturing and Aseptic Fill/Finish of mammalian cell-culture derived life-saving monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs). The investment was made by Signet Healthcare Partners ("Signet"), a New York based growth equity firm specializing in healthcare investments.

Concurrently, Nikhil Puri and Jerry Liao, investors at Signet, will join the board of directors of Goodwin Biotechnology. The growth capital will be used to support Goodwin's investments in doubling its space available for cGMP capacity as it readies for further expansion of its biopharmaceutical manufacturing, including support for commercial product manufacturing and developing various capabilities to better serve its growing customer base. 

Goodwin's Chief Executive Officer Karl Pinto said, "Since the early 1990s, Goodwin has served its clients in bringing their products through the clinic with our unmatched service, flexibility and quality. We are now at a point where the opportunity to grow and support our clients transcends the clinic and takes them into commercial manufacturing. Our efficient size, experience and breadth of capabilities position us very strongly to serve in particular, cutting edge 'new biologics' products requiring small-to-mid volumes, to progress from the clinic and into the market, often within today's shortened and abbreviated clinical pathways. We thank our loyal clients, employees, advisors and investors for helping us get here, and we welcome the Signet team to the Goodwin family. My management team and I look forward to working with them to scale our business as our clients and the market demand us to, and ultimately help patients with some of the newest medical technologies being developed." 

Signet Healthcare Partners Managing Director Nikhil Puri said "Goodwin has established leading vertically integrated capabilities in process development and clinical manufacturing of complex large molecules, evidenced by projects consummated with more than 100 clients.  A substantial portion of new drug development pipeline are biologically derived, and I believe Goodwin is well positioned to serve biotech and pharma companies developing such products.  Signet is very pleased to be partnering with the Company at this important inflection point, and we look forward to close collaboration with Karl and his leadership team at Goodwin."

Fairmount Partners LP served as financial advisor for Goodwin. Pepper Hamilton LLP acted as legal counsel for Goodwin and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Signet Healthcare Partners.

About Goodwin Biotechnology, Inc.

Goodwin Biotechnology is a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution™ for our clients from cell line development, exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for early- and late-stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has been awarded Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing!  In addition, Goodwin Biotechnology was awarded "Best in Sector: Biopharmaceutical Contract Development & Manufacturing" at Acquisition International magazine's 2015 Sector Performance Awards. Last year, Goodwin Biotechnology received Global Health & Pharma's 2017 award for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing. In 2018, Goodwin Biotechnology was named Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News.  Click here to view the press releases!  Additional information may be found at http://www.GoodwinBio.com.

About Signet Healthcare Partners

Signet Healthcare Partners ("Signet") is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

For more information please contact:

Goodwin Biotechnology 
SooYoung Lee, Ph.D.
Chief Operating Officer
954-327-9603
slee@GoodwinBio.com 
Or 
Info@GoodwinBio.com

Signet Healthcare Partners 
Jerry Liao
Senior Associate 
212-893-1179 
jerry.liao@signethp.com

SOURCE Goodwin Biotechnology, Inc.

TELA Bio® Announces 510(k) Clearance for Restella™ Reconstructive BioScaffolds for Reconstructive Surgery

Innovative product portfolio based on TELA Bio's proven technology platform advances the design of biologic-based materials for reconstructive surgery.

MALVERN, Pa., April 18, 2019 /PRNewswire/ -- TELA Bio®, Inc., a regenerative medicine company leading the development of advanced medical devices for soft tissue reconstruction, announced today that the company's Restella™ Reconstructive BioScaffolds have been awarded 510(k) clearance from the U.S. Food and Drug Administration for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive procedures. 

"We are excited to bring Restella Reconstructive BioScaffolds to U.S. surgeons and patients. These products were purposefully engineered to allow for rapid tissue integration and revascularization and biomechanical control," said Antony Koblish, president and chief executive officer of TELA Bio. "Specifically designed for use in reconstructive surgery, Restella products leverage the strong clinical experience of our OviTex® Reinforced BioScaffolds that have now been implanted in more than 4,500 patients."

The TELA Bio technology platform is based on interwoven polymer through layers of biologic tissue in a patented "lockstitch" pattern that creates a unique embroidered construction. The biologic material, derived from ovine rumen, is optimized to reduce foreign body response, minimize inflammation, and enable functional tissue remodeling. The interwoven polymer helps provide support along with improved handling and load-sharing capability.   

While biologic materials are often used for soft tissue reinforcement in reconstructive surgery, many surgeons report that currently available materials are costly and may stretch over time leading to patient dissatisfaction. Restella Reconstructive BioScaffolds are tailored to be highly permeable with controlled stretch to support a variety of surgical techniques and procedures. TELA Bio plans to offer resorbable and permanent polymer versions in the Restella Reconstructive BioScaffolds portfolio that will include a range of sizes and shapes.       

"Our success in applying the advantages of our technology platform to develop Restella Reconstructive BioScaffolds is another example of TELA Bio's unique ability to bring innovation and cost savings to address a wide range of needs in surgery," said Mr. Koblish, adding, "By expanding our platform to more surgeons and patients, we are bringing the same level of innovation and cost savings to the reconstructive surgery market that we have delivered with OviTex Reinforced BioScaffolds in hernia repair procedures."

About Restella Reconstructive BioScaffolds

Restella Reconstructive BioScaffolds are intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Bench and animal testing may not be indicative of clinical performance.

Caution: Federal (US) law restricts this device to sale by or on order of a physician.

About TELA Bio, Inc.

TELA Bio, Inc. is a disruptive regenerative medicine company focused on making advanced medical devices accessible to patients requiring soft tissue reconstruction. The company's products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA Bio's portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over commercially available products. The company's OviTex Reinforced BioScaffolds for hernia repairs and abdominal wall reconstructions are commercially available in the U.S. and in Europe, and Restella Reconstructive BioScaffolds for reconstructive surgery are commercially available in the U.S. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in soft tissue reconstruction. To learn more about TELA Bio visit http://www.telabio.com.

Investor relations contact
Stuart Henderson
TELA Bio, Inc
484-320-2933
shenderson@telabio.com

Media contact
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

SOURCE TELA Bio, Inc.

RoundTable Healthcare Partners and Signet Healthcare Partners Establish New Platform in the Global Consumer Healthcare Market

Advantice Health Becomes a Global Consumer Healthcare Company with Category Leading Brands

LAKE FOREST, Ill., April 1, 2019 /PRNewswire/ -- RoundTable Healthcare Partners ("RoundTable"), an operating-oriented private equity firm focused exclusively on the healthcare industry, and Signet Healthcare Partners ("Signet"), an established provider of growth capital to innovative healthcare companies, announced today that they have established a new global consumer healthcare platform focused on over-the-counter ("OTC") pharmaceuticals.  The new platform company, Advantice Health, consists of the category-leading brands recently acquired from Moberg Pharma AB ("Moberg").  The brands Kerasal®, Kerasal Nail®, New Skin®, Dermoplast®, Domeboro®, Emtrix®, and Zanmira® fall into the footcare and first-aid OTC categories.

Advantice Health is the eighth company in RoundTable's current portfolio, joining three other companies participating in the consumer healthcare marketplace.  "RoundTable's fourth platform investment in the consumer healthcare market represents a highly strategic opportunity for us," said Thomas P. Kapfer, Senior Operating Partner and Chairman of the Board of Advantice Health.  "OTC pharmaceuticals are poised for considerable growth as consumers take more responsibility and make decisions for their own healthcare."

Mr. Kapfer continued, "Our newly-acquired brands provide an excellent foundation for us to build upon. We see a clear opportunity to build the Advantice product portfolio in OTC therapeutic skin care.  Our work in prescription-based dermatology products and high-end cosmetic skin care provides us with the experience and expertise needed to add value to this business.  This value creation orientation has been a long-standing strategic requirement for us."

RoundTable also announced the appointment of Timothy J. Connors to the position of Chief Executive Officer of Advantice Health.  Tim has over 30 years of experience in consumer healthcare and has held senior leadership positions in sales, marketing, new product development, and strategic planning.

"We are pleased to welcome Tim to Advantice Health and to RoundTable," said Mr. Kapfer.  "Tim is an outstanding leader who has a wealth of experience, expertise, and insight with a consistent track record of success. His appointment is a key element of our ongoing strategy to complement the management teams of our portfolio companies with world-class talent to accelerate their prospects for growth."

"I am excited to join the RoundTable family of companies and lead the Advantice Health team," said Mr. Connors.  "Our newly acquired group of brands, with leading category positions, is a solid foundation for future growth.  The company has a strong team of people and strategic partners that have created a successful business upon which we will build.  We plan to invest in growing the category and our market share through innovative marketing, exciting new products, and acquisitions.  RoundTable's unique operating orientation, transaction expertise, and commitment to the business will allow us to focus relentlessly on providing consumers with what they need, want, and value."

Advantice Health is the sixth investment from RoundTable's Equity Fund IV.  Signet joined RoundTable as an investor in Advantice Health.  As part of the transaction and to finance further growth opportunities for the company, RoundTable facilitated the completion of new senior credit facilities and a private placement of senior subordinated notes.  The senior credit facilities were led by Capital One, National Association and included CIBC Bank USA and Madison Capital  Funding LLC while the senior subordinated notes were provided by RoundTable Healthcare Capital Partners III, RoundTable's third captive subordinated debt fund.  Sidley Austin LLP acted as legal advisor to RoundTable in this transaction.

ABOUT ROUNDTABLE HEALTHCARE PARTNERS
RoundTable Healthcare Partners, based in Lake Forest, IL, is an operating-oriented private equity firm focused exclusively on the healthcare industry. RoundTable partners with companies that can benefit from its extensive industry relationships and proven operating and transaction expertise. RoundTable has established a successful track record of working with owner/founders, family companies, management teams, entrepreneurs and corporate partners who share a vision and believe in the value creation potential of its partnership model. RoundTable has raised $2.75 billion in committed capital, including four equity funds totaling $2.15 billion and three subordinated debt funds totaling $600 million. More information about RoundTable Healthcare Partners can be found at www.roundtablehp.com.

ABOUT SIGNET HEALTHCARE PARTNERS
Signet Healthcare Partners is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over USD 400 million and has invested in more than 45 companies. More information about Signet Healthcare Partners can be found at www.signethealthcarepartners.com

Moberg Pharma Completes the Divestment of the OTC-business for USD 155 million

STOCKHOLM, March 29, 2019 /PRNewswire/ -- Moberg Pharma AB (publ) ("Moberg Pharma" or the "Company") has today completed the divestment of its OTC-business (over-the-counter) to RoundTable Healthcare Partners and Signet Healthcare Partners (the "Purchaser") for USD 155 million. After the divestment, Moberg Pharma's remaining business consists of the development and commercialisation of new pharmaceutical products. The transaction enables Moberg Pharma to further focus resources on the pipeline program (MOB-015 in particular) and distribute significant value to its shareholders. The Company intends to use the cash consideration to redeem its outstanding bonds and to distribute approximately SEK 43–45 per ordinary share to its shareholders. In addition, the Purchaser has provided financing to the Company's remaining business amounting to USD 5 million. The combined value of the transaction equals approximately SEK 78–80 per share, based upon the expected distribution and the Purchaser's subscription in the Company.

"We are excited about this opportunity – being able to offer our shareholders a significant distribution while retaining the considerable upside of the fully funded MOB-015 program. The transaction enables us to increase the focus on making MOB-015 the future market leader in onychomycosis. I would also like to thank the OTC team for their exceptional contributions to Moberg Pharma over the past years and wish them continued success", says Peter Wolpert, Moberg Pharma's CEO.

The transaction, announced on February 12th 2019, was carried out as a sale of all shares in MPJ OTC AB and all units in Moberg Pharma North America LLC – which together held Moberg Pharma's entire Global Consumer Health Business comprising both direct and distributor sales under the OTC brands Kerasal®, Kerasal Nail®, New Skin®, Dermoplast®, Domeboro®, Emtrix® and Zanmira®, including all assets and liabilities related to such business (the "OTC-business").

The completion of the transaction was conditional upon inter alia the approval at a general meeting in Moberg Pharma and the waiting period under the HSR Act being terminated or having expired. All conditions for finalising the transaction have now been fulfilled and the transaction has today been completed.

The OTC-business was divested for a cash consideration of USD 155 million (equivalent of SEK 1.43 billion [1]) adjusted for working capital, resulting in a capital gain of approximately SEK 500 million and multiples of 3.3x sales, as well as 14.1x EBITDA and 11.6x EBITDA for commercial operations. The Company intends to use the cash consideration inter alia to redeem its outstanding bonds and to distribute approximately SEK 43–45 per ordinary share to its shareholders (the "OTC-dividend"). The MOB-015 phase 3 program is fully funded through retained cash and licensing revenues.

As part of the transaction, the Purchaser has subscribed and paid for 660,843 series B shares in the Company at a price of SEK 35.16 per share (without any right to the OTC-dividend), entailing an increase of the total number of shares in the Company from 17,703,762 to 18,364,605 shares in total after the issue has been completed. The Company has also issued 659,421 warrants without consideration, each of which gives the Purchaser a right to subscribe for one ordinary share in the Company at a subscription price of SEK 35.16 per share. Neither the newly issued series B shares nor the warrants or any shares subscribed for by exercising the warrants will entitle to the OTC-dividend and the warrants will not be exercisable until the OTC-dividend has been paid. After payment of the OTC-dividend, the series B shares will be converted into ordinary shares in the Company. Moreover, the Purchaser has provided a loan to the Company amounting to USD 2.5 million (equivalent of approximately SEK 23 million), for the purpose of financing the Company's remaining business.

The Extraordinary General Meeting, held on March 15th, 2019, elected Andrew B. Hochman as ordinary member of the Board of Directors until the end of the next Annual General Meeting, conditional on and with effect from closing of the transaction. As a result of the completed transaction, the election has entered into effect.

After the divestment of the OTC-business, the Company's remaining business consists of the development and commercialisation of new pharmaceutical products, including its late-stage clinical developments MOB-015 (onychomycosis) and BUPI (pain management in oral mucositis). As a consequence of the completed divestment of the OTC-business, Jeff Vernimb and Gunilla Wengström are as of today no longer members of the management team of Moberg Pharma.

References:

[1] Based on a USD/SEK exchange rate of 9.23, being the exchange rate applicable to the Company as a result of a hedging arrangement entered into by the Company at signing of the transaction. 

For additional information, please contact: 
Peter Wolpert, CEO, phone: Sweden: +46 707 35 7135, US: +1 908 432 2203, e-mail: peter.wolpert@mobergpharma.se 
Anna Ljung, CFO, phone: +46 707 66 6030, e-mail: anna.ljung@mobergpharma.se

About this information               
This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact persons set out above, at 22.00 CET on March 29th, 2019.

Moberg Pharma Divests Its OTC-business for USD 155 Million and Secures New Funding for MOB-015 in Transformational Transaction

STOCKHOLM, Feb. 11, 2019 /PRNewswire/ -- Moberg Pharma AB (publ) ("Moberg Pharma" or the "Company") (OMX: MOB) today announces that it has entered into agreement with a holding company owned by RoundTable Healthcare Partners and Signet Healthcare Partners (the "Purchaser") to divest MPJ OTC AB and Moberg Pharma North America LLC, which at closing will hold Moberg Pharma's entire OTC-business, for a cash consideration of USD 155 million(equivalent of SEK 1,431 million[1]) adjusted for working capital, resulting in a capital gain of approximately SEK 500 million and multiples of 3.3x sales, as well as 14.1x EBITDA and 11.6x EBITDA for commercial operations. The Company intends to use the cash consideration to redeem its outstanding bonds and to distribute approximately SEK 43–45 per share to its shareholders. In addition, the Purchaser has undertaken to provide financing to the Company with a total amount USD 5 million (equivalent of SEK 46 million), of which half is subscription for newly issued series B shares in the Company, at a price of SEK 35.16 per share, and the remaining half is a loan to the Company with pertaining warrants. The combined value to Moberg Pharma's shareholders of the transaction equals approximately SEK 78–80 per share, based upon the expected payment to shareholders and Purchaser's subscription in the Company. The transaction enables Moberg Pharma to further focus resources on the MOB-015 pipeline program and distribute significant value to its shareholders. The transaction is among other things conditional upon shareholder approval at a general meeting in Moberg Pharma.

[1] All equivalent amounts based on a preliminary USD/SEK exchange rate of 9.23. However, the Company will enter into a forward contract or a similar hedging arrangement, securing the exchange rate applicable to the Company per Closing to approximately 9.23.

Summary of the transaction and its overall effects

  •  The Company has entered into the following agreements regarding the divestment of the OTC-business and the funding of the MOB-015 pipeline program:

    • a share purchase agreement, whereby all shares in MPJ OTC AB and all units in the Company's American subsidiary, Moberg Pharma North America LLC – which together at closing will hold Moberg Pharma's entire Global Consumer Health Business comprising both direct and distributor sales under the over-the-counter brands Kerasal®, Kerasal Nail®, New Skin®, Dermoplast®, Domeboro®, Emtrix® and Zanmira®, including all assets and liabilities related to such business (the "OTC-business") – will be transferred from the Company to the Purchaser for a cash consideration of USD 155 million (equivalent of SEK 1,431 million), to include a customary working capital adjustment to be determined upon closing (the "Cash Consideration"). The transaction is expected to result in a capital gain of approximately SEK 500 million. Since the transaction involves the divestiture of subsidiaries it is not expected to be subject to taxation. The Cash Consideration will be used by the Company to redeem its outstanding SEK 600 million bonds and make a payment to its shareholders of approximately SEK 43­­–45 per share;

    • an investment and subscription agreement, whereby the Purchaser undertakes to subscribe for newly issued series B shares, which will constitute a new class of shares, in the Company for an aggregate subscription amount of USD 2.5 million (equivalent of SEK 23 million) at a subscription price of SEK 35.16 per share, valuing MOB-015 at approximately SEK 630 million (equivalent of USD 70 million) (the "New Shares"); and

    • an investment and warrant instrument undertaking, whereby the Purchaser undertakes to (i) subscribe for 659,421 newly issued warrants in the Company, each of which gives the holder a right to subscribe for one ordinary share in the Company at a subscription price of SEK 35.16 per share, (the "Warrants") and (ii) provide a loan to the Company with a principal amount of USD 2.5 million (equivalent of SEK 23 million) (the "MOB-015 Loan").

    •  In addition, the Company will prior to or upon closing of the transaction enter into:

      • an asset transfer agreement, whereby the OTC-business of Moberg Pharma will be separated and transferred to the special purpose vehicle MPJ OTC AB; and

      • a transitional services agreement, whereby Moberg Pharma will provide certain services to MPJ OTC AB with respect to the OTC-business.

      •  Completion of the divestment of the OTC-business ("Closing"), including the steps described above, is expected by the end of March 2019, but conditional upon:

        • the passing at a general meeting in Moberg Pharma of a resolution to approve the contemplated transaction and any other steps related thereto, passed with the relevant required majority;

        • the waiting period (and any extension thereof) applicable to the share purchase agreement and the transaction under the HSR Act (Hart-Scott-Rodino Antitrust Improvements Act) shall have been terminated or shall have expired;

        • certain fundamental warranties under the share purchase agreement being true, accurate and not misleading on Closing; and

        • the Purchaser having received debt financing on certain specified terms.

        •  The parties have agreed on a termination fee and reimbursement of expenses on a mutual basis, entailing that Moberg Pharma is entitled to a termination fee of USD 6 million (equivalent of SEK 55 million) if Closing does not take place solely due to the Purchaser's failure to receive the relevant debt financing according to the abovementioned closing condition, whereas the Purchaser is entitled to reimbursement from the Company of any direct external expenses incurred in connection with the transaction if the transaction is not approved by the general meeting in Moberg Pharma.

        •  The Company intends to announce a notice for an extraordinary general meeting in Moberg Pharma to approve the proposed transaction and any other steps related thereto. Such general meeting is expected to be held on or about March 15th, 2019 (the "Extraordinary General Meeting"). In due time before the Extraordinary General Meeting, the Company intends to make public an information document containing information regarding the transaction and its effects for Moberg Pharma.

        •  Shareholders representing approximately 39% of the voting rights in the Company have entered into voting undertakings in which they commit to, at the Extraordinary General Meeting, vote in favour of the transaction as well as of electing a person suggested and nominated by the Purchaser as an ordinary board member of the Company for the period from Closing up to and including the next annual general meeting in Moberg Pharma.

        •  The Company intends to use part of the Cash Consideration to redeem its outstanding SEK 600 million bonds due 2021 with ISIN SE0007953989 (the "Bonds") in full in accordance with the terms and conditions for the Bonds.

        •  The Company further intends to use the remaining part of the Cash Consideration net of the Company's transaction expenses and cash retained for the MOB-015 development program to make a payment to its shareholders, which may include a formal dividend distribution, share split and redemption of split shares, reduction of the share capital or similar events (the "OTC-dividend").

        •  The combined value to shareholders of the transaction equals approximately SEK 78–80 per share and can be calculated as follows:

          • The OTC-dividend which is expected to be approximately SEK 43–45 per share to be distributed to shareholders.

          • Subscription in the Company for USD 2.5 million at a subscription price of SEK 35.16 per share.

          •  Post-Closing, the Company will be well funded by the USD 5 million from the New Shares and the MOB-015 Loan as well as a portion of the proceeds.

Rationale for the transaction

  • Realizes compelling value for the OTC-business: The Cash Consideration of USD 155 million (equivalent of SEK 1,431 million) allows shareholders to recognize the value the Company has created in developing its OTC-business over the last years. The OTC-business generated sales of SEK 434 million. The transaction implies a multiple for the entire Moberg Pharma group of 3.3x sales and 11.6x EBITDA for commercial operations (14.1x EBITDA for total Moberg Pharma).

  • Provides continued funding for MOB-015 at an attractive implied value: The Company will receive USD 5 million (equivalent of SEK 46 million) to support on-going development of MOB-015. This will include USD 2.5 million(equivalent of SEK 23 million) received from newly issued series B shares at a subscription price of SEK 35.16 per share, implying a value for MOB-015 of approximately SEK 630 million (equivalent of USD 70 million).

  • Offers shareholders meaningful near-term liquidity and preserves future upside: The transaction will allow the Company to both redeem the Bonds and distribute substantial proceeds to shareholders. In addition, the Company and Management will be focused on development and commercialization of the pipeline, with a focus on MOB-015. Shareholders will continue to benefit from future value creation associated with the MOB-015 program.

Peter Wolpert, CEO Moberg Pharma, says:

"We are excited to announce this transformational transaction. The transaction delivers exceptional value for the OTC-business and further validates the significant potential in MOB-015. The proceeds from this transaction offer near-term liquidity to our shareholders while preserving future upside. I would like to commend and thank our team for all of their hard work. Over the last few years we have acquired, built and generated superior performance for the company, and those efforts are reflected in this transaction."

Recommendation
The transaction is, inter alia, conditional upon shareholder approval at a general meeting in the Company. Against the background provided in this press release, the Board of Directors of the Company consider the terms of the transaction to be fair and reasonable and in the best interests of the Company and its shareholders. Accordingly, the Board of Directors unanimously recommend that the Extraordinary General Meeting approves the transaction by voting in favour of proposed resolutions to be included in the notice for the Extraordinary General Meeting. The recommendation by the Board of Directors is supported by a diligent auction process conducted by the Company's financial advisor Sawaya Partners LLC aimed at providing the Company and the shareholders with the best possible transaction outcome in terms of value and deal certainty, where multiple third party transaction proposals and offers were evaluated, and where this transaction was compared with similar transactions, of which this transaction was determined by the Board of Directors to offer the shareholders the best value and highest level of deal certainty. The Board of Directors, accordingly, based on this process, found the current transaction to be fair and reasonable and in the best interests of the Company and its shareholders.

Thomas Eklund, Chairman of the board at Moberg Pharma, added:

"After a thorough process, the board is convinced that the proposed transaction is the most attractive and brings significant value to the shareholders. The combination of a premium consideration for the OTC-business, specialized U.S. Healthcare investors entering at a premium valuation, while repaying outstanding debt, is highly attractive. Shareholders benefit from receiving a significant dividend while retaining the considerable upside of the MOB-015 program."

Use of Cash Consideration for Bond redemption and OTC-dividend
The Company intends to use the increased liquidity following Closing and the receipt of the Cash Consideration to redeem the Bonds in full and pay the OTC-dividend to its shareholders. Information regarding the contemplated redemption of the Bonds is expected to be announced through a press release and sent by mail to the bondholders on or about the date of Closing. 

Payment of the OTC-dividend will require that the Company has adopted an annual report for the current financial year in order to demonstrate sufficient distributable earnings. In order to carry out the OTC-dividend in 2019, the Company plans to shorten the current financial year to the period January 1st – June 30th, 2019. The resolution to change the Company's financial year is expected to be passed at the Extraordinary General Meeting. Furthermore, the payment of OTC-dividend will be subject to shareholder approval at the annual general meeting for the shortened financial year January 1st – June 30th, 2019. For these reasons, and according to the Company's current time plan, completion of the OTC-dividend is expected by the end of October 2019. It is the Company's current estimate that the OTC-dividend is expected to amount to approximately SEK 43–45 per ordinary share in the Company. However, the actual and final amount of the OTC-dividend is subject to change and dependent on several different factors, such as transaction costs, expected milestone payments received, expected research and development investments, business development and administrative expenses for completing the MOB-015 development program, changes in exchange rates as well as other factors affecting the Company's financial position at the actual time of the payment of the OTC-dividend. The final amount of the OTC-dividend will be announced at the latest when the notice for the annual general meeting for the shortened financial year is announced.

In accordance with the parties' agreement, the Purchaser will be excluded from the OTC-dividend. As a result, the New Shares will be issued as a new class of shares (class B shares) in the Company that will not be entitled to receive the OTC-dividend. The New Shares may be converted to ordinary shares in the Company after the payment of the OTC-dividend.

Funding obtained for the MOB-015 pipeline program 
Subject to Closing taking place, the Purchaser shall subscribe and pay for the New Shares and subscribe for the Warrants in the Company and issue the MOB-015 Loan to the Company.

The total subscription amount for the New Shares will amount to USD 2.5 million (equivalent of SEK 23 million), corresponding to approximately 3.6% of all shares in the Company and entailing a valuation of the Company's MOB-015 business at SEK 35.16 per share and a total value of the MOB-015 business of approximately SEK 630 million (equivalent of USD 70 million).

The MOB-015 Loan, with a principal amount of USD 2.5 million (equivalent of SEK 23 million), will be advanced to the Company promptly following Closing. The proceeds from the MOB-015 Loan will be used to fund the MOB-015 pipeline program. The MOB-015 Loan will accrue PIK interest at a rate of 3 months LIBOR + 5.50% and the loan will mature on 31 March 2023. If, prior to 31 March 2023, the Company receives milestone payments, royalties and any other similar payments from partners in excess of USD 10 million (equivalent of SEK 92 million) plus any amounts actually received from partner agreements signed to date (for the avoidance of doubt, not including payments received to cover fees, expenses and other costs), the Company will use such excess funds to repay any amount outstanding under the MOB-015 Loan in full or in part.

The principal amount outstanding under the MOB-015 Loan may be reduced by way of set off against the exercise price in connection with the exercising of the Warrants to subscribe for ordinary shares in the Company. The Warrants will not be issued against payment, i.e. no subscription price will be paid in connection with the issuance and allocation of the Warrants. Each Warrant will entitle the holder to subscribe for one ordinary share in the Company at a price of SEK 35.16per share. However, no Warrant may be exercised prior to the payment of the OTC-dividend.

The Purchaser shall subscribe for such number of New Shares, at a subscription price of SEK 35.16 per share, to be issued for an aggregate subscription amount of USD 2.5 million by applying the exchange rate reported by Bloomberg one business day prior to Closing. With an application of the exchange rate reported as of February 8th, 2019 (9.27), the number of shares and votes in the Company would accordingly upon Closing increase by 656,286 from 17,440,762 to 18,097,048 shares and votes[1]. This would imply a dilution of approximately 3.6 percent of the shares and votes in the Company. In case all 659,421 Warrants are exercised, an additional 659,421 shares may be issued, corresponding to an additional dilution of approximately 3.5 percent, implying a total dilution of 7.0 percent of the shares and votes in the Company.

Overall financial effects of the transaction for Moberg Pharma
The transaction will yield gross proceeds of USD 155 million (equivalent of SEK 1,431 million) for the OTC-business and a capital gain[2] of approximately SEK 500 million. The Purchaser's undertaking to subscribe for newly issued series B shares in the Company will generate USD 2.5 million (equivalent of SEK 23 million) and MOB-015 Loan will generate USD 2.5 million (equivalent of SEK 23 million). These funds will be used for MOB-015.

The Company intends to use part of the Cash Consideration to redeem its outstanding SEK 600 million Bonds. The Company intends to use remaining part of the Cash Consideration net of the Company's transaction expenses and cash retained for the MOB-015 development program to make a payment to its shareholders.[3]

Following the transaction, Moberg Pharma's operations will change from selling products to focusing on MOB-015. The business will be operated with an organization dedicated to research and development, regulatory matters and business development. The Company's assets following the transaction will primarily consist of balanced research and development assets, while the classes of assets data systems, goodwill, acquired product rights and stock are divested in connection with the transaction. Accounts receivable and other receivables will decrease substantially while the Company's leverage will be significantly reduced when the Bonds are repaid. In addition, the Company's assets will comprise cash retained from the divestment of the OTC-business, the share issue to the Purchaser and the MOB-015 Loan.

As regards the Company's revenue streams following the transaction, the revenue from the current product sales will stop, and the revenue will initially comprise milestone payments, royalties and similar payments from existing and new license partners. The Company's costs following the transaction will be primarily comprised of research and development, business development and administrative expenses.

Detailed information on the financial effects of the transaction, including certain financial information for 2018 prepared on a pro forma basis, will be included in the information document that the Company intends to make public in due time before the Extraordinary General Meeting.

Indicative high-level timetable for the transaction

February 12th, 2019

Announcement of transaction 

February 15th, 2019

Notice of Extraordinary General Meeting(Notice is announced on February 13th, 2019) 

March 15th, 2019

Extraordinary General Meeting 

End of March 2019

Closing, including that the Purchaser (i) pays the Cash Consideration, (ii) extends the MOB-015 Loan and (iii) subscribes for the New Shares and the Warrants  


Notice of redemption of Bonds 

End of April 2019

Redemption of Bonds 

June 30th, 2019

Last day of shortened financial year 

End of September 2019

Annual general meeting for shortened financial year resolving on among other things payment of the OTC-dividend to shareholders 

End of October 2019

Payment of OTC-dividend to shareholders 

On February 12th, 2019 at 9:00 am (CET), investors, analysts and journalists are hereby invited to participate in an information meeting with the Management of the Company at the offices of Gernandt & Danielsson to receive additional detail about the transaction. Participants may also dial in to the meeting.

To participate in the meeting, please visit the following address before the start of the meeting:

Gernandt & Danielsson Advokatbyrå KB
Hamngatan 2
111 47 Stockholm

To participate in the conference, please dial in on any number below before the start of the call:

SE: +46 8 566 427 03
US: +1 646 722 49 57

On February 12th, 2019, at 3:00 pm (CET), Moberg Pharmas's CEO Peter Wolpert will present the Year-end report 2018 and the transaction in a teleconference. The presentation will be held in English.

To participate in the conference, please dial in on any number below before the start of the call:

SE: +46 8 505 583 53
US: +1 646 722 49 57

Advisors to Moberg Pharma
Sawaya Partners has been engaged as financial advisor regarding the transaction. Hansen Law has been engaged as legal advisor regarding the transfer and sale of the OTC-business and Gernandt & Danielsson has been engaged as legal advisor regarding the MOB-015 funding, public and corporate law aspects of the transaction and the redemption of the Bonds.

Advisors to Purchaser
Sidley Austin LLP and Roschier have been engaged as legal advisors to the Purchaser in respect of the acquisition of the OTC-business and the investment in Moberg Pharma and the MOB-015 funding.

About this information               
This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact persons set out above, at 01.00 am (CET) on February 12th, 2019.

About RoundTable Healthcare Partners            
RoundTable Healthcare Partners, based in Lake Forest, IL, is an operating-oriented private equity firm focused exclusively on the healthcare industry. RoundTable partners with companies that can benefit from its extensive industry relationships and proven operating and transaction expertise. RoundTable has established a successful track record of working with owner/founders, family companies, management teams, entrepreneurs and corporate partners who share a vision and believe in the value creation potential of its partnership model. RoundTable has raised USD 2.75 billion in committed capital, including four equity funds totalling USD 2.15 billion and three subordinated debt funds totalling USD 600 million. More information about RoundTable Healthcare Partners can be found at www.roundtablehp.com.

About Signet Healthcare Partners 
Signet Healthcare Partners is an established provider of growth capital to innovative healthcare companies. Signet invests in commercial-stage healthcare companies that are revenue generating or preparing for commercial launch. The firm's focus has primarily been on the pharmaceutical sector and medical technology companies. Signet maintains a disciplined, yet flexible investment approach. As an active investor, Signet partners closely with its companies to build their value including facilitating activities between portfolio companies. During Signet's 18-year history, it has developed a strong reputation and track record of successful investments. Signet has raised four funds with total capital commitments of over USD 400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

About MOB-015 and Onychomycosis 
Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. Moberg Pharma estimates the annual world-wide peak sales potential for MOB-015 to be in the range of USD 250-500 million.

MOB-015 is an internally developed topical formulation of terbinafine based on Moberg Pharma's experience from its leading OTC product Kerasal Nail®/Emtrix®. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. For many years, developing a topical terbinafine treatment without the safety issues of oral terbinafine has been highly desirable, but unsuccessful due to insufficient delivery of the active substance through the nail.

In a previous phase 2 study, MOB-015 demonstrated delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the phase 2 study. The results are remarkable, particularly when taking into account the severity of the nails included in the study – on average approximately 60% of the nail plate was affected by the infection. Plasma levels of terbinafine with MOB-015 were substantially lower than after oral administration, reducing the risk of liver toxicities observed with oral terbinafine.

MOB-015 is currently being evaluated over 52 weeks in two randomized, multicenter, controlled Phase 3 studies, including in total approximately 800 patients in North America and Europe. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. Topline results from the North American study are expected in the fourth quarter of 2019, followed by results in Europe in 2020.

About BUPI and oral mucositis
BUPI is intended for pain relief for patients suffering from oral mucositis (OM), a serious complication of cancer treatment. OM affects approximately 400,000 patients annually in the US and may hinder completion of cancer treatment and result in expensive hospital care. BUPI is an innovative, patented formulation of the proven substance bupivacaine, in the form of a lozenge, for the treatment of pain in the oral cavity. In January 2016, Moberg Pharma reported positive results from a Phase 2 study in which BUPI was evaluated for cancer patients with oral mucositis. Based on external analysis, Moberg Pharma estimates the annual sales potential for BUPI to USD 100-200 million, assuming successful commercialization in oral mucositis and at least one further indication. Planning of regulatory development programs as well as partner discussions are ongoing.

[1] Excluding treasury shares held by the Company.

[2] The capital gain is not expected to be subject to taxation.

[3] The payment may be effected through formal dividend distribution, share split and redemption of split shares, reduction of the share capital or similar events.

CONTACT:

For additional information, please contact: 
Peter Wolpert, CEO, phone: Sweden: +46 707 35 7135, US: +1 908 432 2203, e-mail: peter.wolpert@mobergpharma.se 
Anna Ljung, CFO, phone: +46 707 66 6030, e-mail: anna.ljung@mobergpharma.se

This information was brought to you by Cision http://news.cision.com

http://news.cision.com/moberg-pharma/r/moberg-pharma-divests-its-otc-business-for-usd-155-million-and-secures-new-funding-for-mob-015-in-tr,c2738703

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Moberg Pharma divests its OTC-business for USD 155 million and secures new funding for MOB-015 in transformational transaction

SOURCE Moberg Pharma

Pharmaceutical Industry Veteran Dr. Kurt R. Nielsen to lead Pharmaceutics International, Inc.

HUNT VALLEY, Md., Jan. 15, 2019 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the appointment of Kurt R. Nielsen, Ph.D., to the position of President and CEO, effective immediately.  Dr. Nielsen is a seasoned pharmaceutical executive with over 20 years of diverse experience, most recently as the President of Lupin Somerset, responsible for all their generic and branded products.  Prior to Lupin, he held the post of Vice President, U.S. Development, Portfolio and Launch Management at Sandoz Inc., where he was accountable for the U.S. development of generic, OTC and specialty brand products.  Dr. Nielsen has also held positions at Catalent, where he was Senior Vice President of R&D and Chief Technology Officer, and URL Pharma where he was the Executive Vice President, Pharmaceuticals.  With the appointment of Dr. Nielsen to President and CEO, Pii further announces that Dr. Abidi, Founder and former CEO of Pii, will transition into an advisory role and as the Executive Chairman.

Dr. Kurt R. Nielsen, President and CEO, Pharmaceutics International, Inc.

Dr. Nielsen commented, "As we enter the 25th year of service to our valued partners, Pii is well-positioned to outpace the growth of the CDMO market with our depth and breadth of expertise in development and reliable supply of Branded, Specialty Generic and OTC products."

"The appointment of Dr. Nielsen to the position of President and CEO reflects a further commitment to growth, building upon Pii's legacy of success, his diverse experiences, proven leadership and industry insights will be instrumental in achieving our strategic objectives," said Dr. Abidi, Pii's Founder and Executive Chairman of the Board of Directors.     

About Pharmaceutics International, Inc. 
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances.  For more information, please visit www.pharm-int.com.

Contact: 
Syed E. Abidi, Ph.D., Executive Chairman 
Pharmaceutics International, Inc. 
10819 Gilroy Road 
Hunt Valley, MD 21031 
Phone: (410) 584-0001 
Email:  seabidi@pharm-int.com 

Pii Announces Positive Inspection News from FDA and MHRA

Posted on Jun 11, 2018, 09:00 ET

HUNT VALLEY, Md., June 11, 2018 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development Manufacturing Organization (CDMO) based in Hunt Valley, Maryland, received notification on June 4, 2018 from the Medicines and Health Care products Regulatory Agency ("MHRA") that the previously restricted GMP Certificate would be withdrawn based on the Mutual Recognition Agreement (MRA) and recent inspections conducted by the FDA. The notification stated that "following confirmation from the USFDA, Pii sites at Hunt Valley (Pii1) and Cockeysville (Pii3) and associated laboratories and storage facilities are now considered to operate in general compliance with GMP."  The FDA conducted inspections of Pii in the fall of 2017 and recently issued Establishment Inspection Reports ("EIR") associated with these inspections.  The FDA also confirmed that Pii's parenteral facility is now approved for product profile codes for both terminally sterilized products (SVT) and aseptically filled products (SVS). 

The lifting of the restricted license means that any existing and future EU Marketing Authorization applications will now be supported by a Certificate of Pharmaceutical Product required from USFDA and any EU clinical trial applications will be supported by QP declaration for Import.  Pii will be able to continue to support ongoing as well as new clinical studies in the US and EU for oral solid, liquid, topicals and injectable drug products. 

Dr. Syed Abidi, Chairman and CEO, states "The withdrawal of the restricted license based on mutual recognition between MHRA and FDA demonstrates Pii's commitment to regulatory compliance, with a focus on continuous quality improvements and strengthening of overall quality systems within the organization. Along with our partners, we've received FDA market approval for seven products and commercially launched six products in 2017.  We anticipate approval of a minimum of three products by the end of the year."   

About Pharmaceutics International, Inc.

Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances.  For more information, please visit https://www.pharm-int.com.

 

Contact: 

Syed E. Abidi, Ph.D., Chairman and CEO
Pharmaceutics International, Inc. 
10819 Gilroy Road
Hunt Valley, MD 21031
Phone: (410) 584-0001
Email:  seabidi@pharm-int.com

pSivida Corp. Announces Transformative Acquisition of Icon Bioscience Inc. and Growth Capital Financing with Essex Woodlands Healthcare Partners

Acquisition and additional funding significantly accelerate the company's
transformation to a specialty biopharmaceutical company with the potential to
commercialize two ophthalmic products in 1H 2019

Icon Bioscience's DEXYCU (dexamethasone intraocular suspension) 9% was
approved by the FDA on February 9, 2018, and is the first long acting intraocular
product approved for the treatment of postoperative inflammation
         

Essex Woodlands (EW) Healthcare Partners, an established growth equity firm, and a
third party investor will make an equity investment in pSivida for a total of up to
approximately $60.5 million
       

SWK Holdings will provide up to $20 million in debt financing

pSivida Corp. will rebrand and change its name to EyePoint Pharmaceuticals Inc. 
(NASDAQ:EYPT) effective April 2, 2018

Conference Call and Webcast Tomorrow, March 29, 2018, at 8:00 a.m. ET

WATERTOWN, Mass., March 28, 2018 (GLOBE NEWSWIRE) -- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced the acquisition of Icon Bioscience Inc. (Icon). Icon is a specialty biopharmaceutical company whose lead product DEXYCU (dexamethasone intraocular suspension) 9% is FDA approved for postoperative inflammation and is administered as a single dose at the end of ocular surgery. DEXYCU is the first long-acting intraocular product approved by the FDA for the treatment of postoperative inflammation. DEXYCU utilizes Icon's proprietary Verisome® drug-delivery platform which allows for a single injection that releases over time.

The Company has entered into a financial agreement with EW Healthcare Partners. EW Healthcare Partners and a third party investor will make equity investments in pSivida for a total of up to approximately $60.5 million. In addition, SWK Holdings Corporation (SWK) has agreed to provide pSivida with up to $20 million in a debt facility. The Company will use these resources to finance the Icon acquisition and prepare for the commercial launches of DEXYCU and, if approved by FDA, Durasert™ micro-insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

Two Potential Near-Term Launches

  • On February 9, 2018, the FDA approved Icon Bioscience's New Drug Application (NDA) for DEXYCU, a dropless, long-acting therapeutic for the treatment of postoperative inflammation. There are over four million cataract surgeries performed annually in the U.S. pSivida plans to launch DEXYCU in the U.S. in the first half of 2019 following the successful scale up of commercial supplies.
     
  • On March 19, 2018, the FDA accepted pSivida's NDA for Durasert micro-insert for treatment of non-infectious posterior segment uveitis, which will be subject to a standard review and has a Prescription Drug User Fee Act (PDUFA) action date of November 5, 2018.  Posterior segment uveitis is a high unmet need area with limited treatment options and the third leading cause of blindness in the U.S. If approved, pSivida expects to launch Durasert in the U.S. in the first half of 2019.

Strategic Rationale for Transactions

This transformative acquisition and financing are driven by the shared vision held by pSivida and its new partners, EW Healthcare Partners and SWK.

  • Ophthalmology represents a large and growing therapeutic category with a sizable market, favorable demographics due to an aging population, and significant unmet clinical needs.
  • DEXYCU offers a unique value creation opportunity, especially with the experience of pSivida's CEO, Nancy Lurker, who has built multiple sales and marketing organizations that have successfully commercialized numerous products. The Company is well positioned to capitalize on DEXYCU and the potential Durasert opportunity.
  • pSivida and its strategic partners will remain opportunistic in evaluating additional ophthalmology assets.             

MTS Health Partners, L.P. served as pSivida's financial advisor in connection with the transaction and its affiliate, MTS Securities LLC, provided the pSivida board of directors with a fairness opinion. Torreya Partners served as the advisor to pSivida on the debt financing. Hogan Lovells US LLP acted as pSivida's legal advisor and Danforth Advisors, LLC acted as pSivida's corporate finance advisor.

EW Healthcare Investment

EW Healthcare Partners and a third party investor will provide pSivida with funding in two tranches totaling $35 million, approximately $25.5 million of which is subject to the approval of the Company's stockholders.  EW Healthcare Partners and a third party investor also have an option, subject to the approval of the Company's stockholders, to make an additional investment of approximately $25.5 million for a total of up to $60.5 million.

  • In the first tranche, which closed concurrently with the Icon acquisition, EW Healthcare Partners purchased 8,606,324 shares of pSivida  common stock.
     
  • In the second tranche, which is subject to stockholder approval, EW Healthcare Partners and a third party investor will purchase approximately $25.5 million of the Company's common stock and receive a warrant to purchase an additional approximately $25.5 million of the Company's common stock.  The warrant will be cash-exercise only and exercisable no later than 15 business days after the issuance of a pass-through reimbursement code for DEXYCU.

Ron Eastman, a Managing Director with EW Healthcare Partners, who will immediately join pSivida's Board of Directors, said, "EW Healthcare Partners is pleased to have the opportunity to invest in Nancy Lurker and her team as they drive the growth and transformation of EyePoint Pharmaceuticals into a fully integrated specialty biopharmaceutical company. Nancy has a strong track record of building successful commercial organizations, and we look forward to continuing to support the Company as it capitalizes on DEXYCU, Durasert and other potential ophthalmology opportunities."

SWK Investment

pSivida also entered into a $20 million senior secured, non-dilutive term loan agreement with SWK Funding LLCand its partners. SWK Funding LLC is a subsidiary of SWK.

"We are pleased to partner with pSivida and are fully committed to working with the team to build a leading business in ophthalmology," said Winston Black, CEO, SWK. "Nancy has a proven track record of successfully commercializing products and we believe pSivida has a very attractive future."

EyePoint Pharmaceuticals Marks the Transformation of pSivida

"Today's announcements significantly accelerate the transformation of pSivida into a specialty biopharmaceutical company with the potential to launch two ophthalmic products in the first half of 2019 with the FDA approval of DEXYCU, and active regulatory review of Durasert micro-insert for posterior segment non-infectious uveitis. Our goal is to leverage the commercial infrastructure we are building and become a sustainable growth company," said Nancy Lurker President and CEO. "Our rebranding and name change reflect the tremendous progress we've made and embody the momentum at EyePoint Pharmaceuticals. Our goal is to establish EyePoint Pharmaceuticals as a leader in developing and launching innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders. We are pleased to partner with EW and SWK to assure that we have not only the funding to achieve our goals, but also the deep strategic and healthcare domain expertise to ensure our ability to execute on our strategy."

DEXYCU is the first long-acting intraocular product approved by the FDA for the treatment of postoperative inflammation. Cataract surgery is the most frequent surgical procedure in the U.S., with over four million performed annually. The primary endpoint of the DEXYCU placebo-controlled Phase 3 program was to assess the percent of patients achieving total anterior chamber cell (ACC) clearance at post-surgical Day 8. The percentage of patients with ACC clearance at post-surgical Day 8 was 60% in the DEXYCU treated group versus 20% in the placebo group. The most commonly reported adverse reactions occurring in 5-15% of subjects included an increase in intraocular pressure, corneal edema, and iritis.

"DEXYCU offers surgeons a new option to treat post-surgical inflammation with a single injection following surgery, thereby potentially eliminating the need for patients to administer a complex regimen of steroid drops for up to 4 weeks post-surgery which many patients have difficultly adhering to," said Dr. Cynthia Matossian, MD, FACS, who is the founder and Chief Executive Officer of Matossian Eye Associates.

EyePoint Pharmaceuticals will trade under the new NASDAQ ticker symbol "EYPT" effective April 2, 2018. The former ticker symbol "PSDV" will remain effective through the market close on March 29, 2018. The new website for EyePoint Pharmaceuticals is www.eyepointpharma.com.

ASX Delist

pSivida has requested that its shares be delisted from trading on the Australian Securities Exchange.  Due to a significant decrease in the proportion of the Company's common stock held by Australian shareholders, low trading activity and the costs of maintaining the listing, the Board of Directors of pSivida after careful consideration has determined that there are minimal benefits to maintaining its listing on the ASX and that it would be in the best interests of the Company and its shareholders to delist.

Conference Call

pSivida Corp. will host a live webcast and conference call tomorrow, March 29, 2018, at 8:00 a.m. ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 6188674. A live webcast will be available on the Investor Relations section of the corporate website at http://www.psivida.com.

A replay of the call will be available beginning March 29, 2018, at approximately 10:30 a.m. ET and ending on April 30, 2018, at 11:59 a.m. ET. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number: 6188674. A replay of the webcast will also be available on the corporate website during that time.

About Icon Bioscience and Verisome®

Icon Bioscience Inc. was previously a privately held specialty biopharmaceutical company focused on the development and commercialization of unique ophthalmic pharmaceuticals based on its patented and proprietary Verisome® extended-release drug delivery technology. On February 9, 2018, the United States Food and Drug Administration (FDA) approved Icon Bioscience's New Drug Application (NDA) for DEXYCU™ (dexamethasone intraocular suspension) 9%, a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. DEXYCU is the first long-acting intraocular product approved by the FDA to treat post-surgical inflammation. Cataract surgery is the most frequent surgical procedure performed in the U.S., with over four million procedures annually. Under current standard of care for inflammation associated with this surgery, patients assume the post-surgical responsibility of self-administering medicated eye drops, several times daily for up to 4 weeks. DEXYCU breaks new ground in the post-surgical treatment of inflammation because it is applied as a single injection at the conclusion of surgery. For additional information visit the Icon website at www.iconbioscience.com.

About EW Healthcare Partners

With over $3.0 billion under management, EW Healthcare Partners is one of the largest and oldest growth equity firms pursuing investments in pharmaceuticals, medical devices, healthcare services, and healthcare information technology. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been involved in the founding, investing, and/or management of over 150 healthcare companies, ranging across sectors, stages, and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, London, Palo Alto and Houston.

About SWK Holdings Corporation

SWK Holdings Corporation is a publicly traded, specialized finance company with a focus on the global healthcare sector. SWK partners with ethical product marketers and royalty holders to provide flexible financing solutions at an attractive cost of capital to create long-term value for both SWK's business partners and its investors.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (formerly pSivida Corp.) (www.eyepointpharma.com), headquartered in Watertown, MA, is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company has developed three of only four FDA-approved sustained-release treatments for back-of-the-eye diseases.  In addition, DEXYCU™ was approved by U.S. Food and Drug Administration (FDA) on February 9, 2018.  DEXYCU is administered as a single intraocular dose at the end of ocular surgery for postoperative inflammation and it is the first and only FDA approved intraocular product with this indication.  ILUVIEN®(fluocinolone acetonide intravitreal implant), a micro-insert for diabetic macular edema, licensed to Alimera Sciences, is currently sold directly in the U.S. and several EU countries. Retisert ® (fluocinolone acetonide intravitreal implant), for posterior uveitis, is licensed to and sold by Bausch & Lomb. The New Drug Application (NDA) for our lead product candidate, Durasert™ micro-insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye, has been accepted for filing by the FDA and is currently under standard review with a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018. The Company's pre-clinical development program is focused on using its core Durasert platform technology to deliver drugs to treat wet age-related macular degeneration, glaucoma, osteoarthritis and other diseases. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter, LinkedIn, Facebook and Google+.

INDICATION: DEXYCU (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation.  IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONS - None. WARNINGS AND PRECAUTIONS - Increase in Intraocular Pressure - Prolonged use of corticosteroids, including DEXYCU, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Delayed Healing - The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of corticosteroids. Exacerbation of Infection - The use of DEXYCU, as with other ophthalmic corticosteroids, is not recommended in the presence of most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Use of a corticosteroid in the treatment of patients with a history of herpes simplex requires caution and may prolong the course and may exacerbate the severity of many viral infections. Fungal infections of the cornea are particularly prone to coincidentally develop with long-term local steroid application and must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. Cataract Progression - The use of corticosteroids in phakic individuals may promote the development of posterior subcapsular cataracts. ADVERSE REACTIONS - The most commonly reported adverse reactions occurred in 5-15% of subjects and included increases in intraocular pressure, corneal edema and iritis. Please see full Prescribing Information.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; successful commercialization of, and receipt of revenues from, ILUVIEN® for diabetic macular edema ("DME"), which depends on Alimera's ability to continue as a going concern; Alimera's ability to obtain marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN; the number of clinical trials and data required for the Durasert technology for the treatment of non-infectious uveitis affecting the posterior segment of the eye, uveitis marketing application approval in the U.S.; our ability to use data in promotion for Durasert micro insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye, U.S. NDA approval which includes clinical trials outside the U.S. U.S. NDA including clinical trials outside the U.S.; our ability to successfully commercialize DEXYCU in the U.S.; our ability to obtain stockholder approval for portions of the EW and SWK investments; our ability to successfully commercialize Durasert three-year uveitis, if approved, in the U.S.; potential off-label sales of ILUVIEN for uveitis; consequences of fluocinolone acetonide side effects; the development of our next-generation Durasert shorter-duration treatment for posterior segment uveitis; potential declines in Retisert® royalties; efficacy and the future development of an implant to treat severe osteoarthritis; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements, including our agreement with Alimera; termination or breach of current license agreements, including our agreement with Alimera; our dependence on contract research organizations, vendors and investigators; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of the potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

Contact:

Barbara Ryan - Investor
Barbara@barbararyanadvisors.co
203-274-2825

Thomas Gibson - Media
tom@tomgibsoncommunications.com
201-476-0322