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Medicines and Health Care products Regulatory Agency ("MHRA") that the previously restricted GMP Certificate would be withdrawn based on the Mutual Recognition Agreement (MRA) and recent inspections conducted by the FDA.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

Smart Medical Systems Secures $8M in Series B Financing

RA'ANANA, Israel, February 15, 2018 /PRNewswire/ --

SMART Medical Systems Ltd., a manufacturer of innovative gastro-intestinal endoscopy products, announced today that it secured US$8 million in series B financing. The financing round was led by Signet Healthcare Partners, a NY-based healthcare investment firm. As part of the investment, Todd Sone and Ashley Friedman from Signet will join SMART's Board of Directors.

SMART's present financing will be used primarily to commercialize its G-EYE® product, which is clinically evidenced to enhance polyp detection during cancer-prevention colonoscopy procedures. The G-EYE® product is a novel add-on balloon device that works with standard endoscopes to assist visualization of the colon when screening for adenomas (pre-cancerous polyps). Adenomas are often missed during colonoscopy, which may lead to interval cancers - colon cancers that develop in the intervals between routine screening colonoscopies. Quality guidelines issued by the leading medical societies are citing adenoma detection rate as the key quality criterion for screening colonoscopy. As demonstrated in clinical studies, the use of the G-EYE® balloon in routine colonoscopy results in substantial increases in adenoma detection rates and corresponding meaningful reductions in colonoscopy miss-rates.  

Gadi Terliuc, SMART's CEO, stated, "We are truly excited with the newly-formed partnership with Signet, which provides us with the resources for executing the company's commercial plan, and making the G-EYE® a widely available, standard colonoscopy solution. We believe the G-EYE® is perfectly suited to support physicians in their clinical efforts of diminishing interval colon cancers."

SMART plans on investing resources to expand commercial activity with its partners in both existing markets and by expanding into other selected geographies, where the G-EYE® is approved for marketing. Investment proceeds will also be directed to obtaining FDA clearance for the G-EYE® product and building U.S. commercial operations to support future U.S. product launch.

About SMART Medical Systems: 

SMART Medical Systems is a pioneer in the development and manufacture of innovative gastro-intestinal endoscopy devices. Its proprietary technology enhances the performance and capabilities of existing endoscopy equipment, intuitively and cost-effectively. SMART's CE Marked and FDA cleared NaviAid™ products are commercially distributed in key global markets. Its G-EYE® product is currently distributed in selected regions. SMART is headquartered in Israel. For more information, visit http://www.smartmedsys.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 and medical technology sectors. 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 http://www.signethealthcarepartners.com .

Contact info:

Signet Healthcare Partners: 
Louise Hamilton
+1-646-840-4990  
louise.hamilton@signethp.com

Smart Medical Systems: 
Yaelit Rosen
+972-9-7444321
info@smartmedsys.com

Pii and Its Partners Received FDA Market Approval for Seven Products and Commercially Launched 6 Products in 2017

Posted on February 8, 2018 at 10:59 ET

HUNT VALLEY, MARYLAND (February 8, 2018) - Pharmaceutics International, Inc. (Pii), a Contract Development Manufacturing Organization (CDMO) based in Hunt Valley, Maryland, together with their partners, received FDA market approval for seven new products and commercially launched six products in 2017.

In early 2017, Pii conducted a cGMP baseline risk assessment and implemented remediation initiatives to enhance its cGMP systems.  These initiatives yielded great results including successful MHRA and FDA inspections early in that year, and the approval and launch of numerous products, one of which was the Company’s first oral solution product.

During 2017, the FDA approved seven products for the Company and its partners, including two oral tablets, one oral capsule, one oral solution, one oral suspension, and two sterile injectable products. Pii currently has multiple additional approvals pending, including a fast-tracked, aseptically pre-filled syringe product. Pii and its partners also launched four new products and relaunched two sterile injectable products to the market during the year. 

These successful approvals and launches give Pii great momentum as it moves into 2018.

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.  

Leading Pharma, LLC Receives $40 Million in Growth Capital

FAIRFIELD, N.J., Jan. 5, 2018 /PRNewswire/ -- Leading Pharma, LLC, a privately-owned generic pharmaceutical company that manufactures, markets, and distributes products to drug chains, wholesalers, and other channels, announced today that on December 28, 2017 it completed a financing transaction for $40 million of growth capital. The transaction was led by Signet Healthcare Partners in addition to Crestline Investors with other investors comprised of Cane Investment Partners and existing Leading Pharma members. Concurrently, Nikhil Puri, Managing Director at Signet Healthcare Partners, and Chris Semple, Managing Director at Crestline Investors, will join the board of directors of Leading Pharma's parent company. The growth capital will be used to support Leading Pharma's research and development (R&D) investments in expanding the company's diverse pipeline of generic products and to repay existing indebtedness.

Ronald Gold, Co-Founder and Chief Executive Officer of Leading Pharma, stated, "This investment allows us to accelerate the development of our robust pipeline to build a more comprehensive product portfolio. We are excited to partner with prudent investors who have experience in the pharmaceutical industry and believe in our business model as well as our ability to develop and market new generic drugs."

Since the acquisition of Excellium Pharmaceutical, Inc. in 2014, Leading Pharma has evolved from exclusively outsourcing product development work into a vertically-integrated generic pharmaceutical company with internal R&D capabilities. The company operates a 53,000 square foot manufacturing plant dedicated to oral solid pharmaceuticals.

"I believe Leading Pharma has the necessary building blocks in place, and is well positioned to capitalize on the vast opportunity that the generic pharma sector presents," said Nikhil Puri, Managing Director at Signet Healthcare Partners. "Signet is very pleased to be partnering with the company at this important juncture, and we look forward to close collaboration with the leadership team at Leading Pharma."

"Under the leadership of industry veterans Ron Gold and Rasik Gondalia, Leading Pharma is well-positioned to capitalize on its development strategy as the company has built an attractive pipeline of diverse, difficult-to-formulate products," said Chris Semple, Managing Director at Crestline Investors. "We look forward to continued growth at the company under Ron and Rasik, who have both successfully founded and exited generic pharmaceutical companies in prior ventures."

Kramer Levin Naftalis & Frankel LLP acted as legal counsel for Leading Pharma and Sheppard, Mullin, Richter & Hampton LLP acted as legal counsel for Crestline and Signet. 

About Leading Pharma, LLC
Leading Pharma, LLC is a privately-owned generic pharmaceutical company that purchases, licenses, develops, manufactures, and distributes high-quality, safe and effective products to drugstore chains, distributors, wholesalers, mass merchandisers, government agencies and managed care accounts in the U.S. Leading Pharma's products are available in various dosage forms across many therapeutic areas under the Leading Pharma label. For more information, visit www.leadingpharma.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 $400 million and has invested in more than 45 companies. For more information, visit www.signethealthcarepartners.com.

About Crestline Investors
Crestline Investors, Inc., founded in 1997 and based in Fort Worth, Texas, is an institutional alternative investment management firm with approximately $9.4 billion of assets under management. Crestline specializes in credit and opportunistic investments, including financing and restructuring solutions for mature private equity funds. In addition, the firm manages a multi-PM equity market-neutral hedge fund, and provides Beta and Hedging Solutions for Institutional clients. The company maintains affiliate offices in New York City, Chicago, London, Toronto and Tokyo. For more information, visit www.crestlineinvestors.com.

For more information, please contact:

Leading Pharma Business Development:
Brian Shapiro
201-746-9166
bshapiro@leadingpharma.com

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

Crestline Credit & Opportunistic Investment Opportunities:
Jonathan Ben-Horin
817-339-7169
jbenhorin@crestlineinc.com

Media Contact:
Dmitriy Ioselevich
212-279-3115 ext. 243
dioselevich@prosek.com

 

AltemiaTM Achieves Successful Clinical Results in Pediatric Patients with Sickle Cell Disease (SCD)

  • Statistically significant results confirm the mechanism of action of AltemiaTM for the treatment of SCD
  • Primary and secondary endpoints were met
  • A clinically meaningful reduction of vaso-occlusive crises (VOCs) was observed in the top line results
  • No treatment related serious adverse events (SAEs) were observed
  • Majority of patients elected to continue treatment in the open label extension (OLE)

November 01, 2017 07:55 AM Eastern Daylight Time

RIVIERA BEACH, Fla.--(BUSINESS WIRE)--Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced positive top line results from a clinical study evaluating the efficacy and safety of AltemiaTM, an oral soft gelatin dosage form, in pediatric sickle cell patients aged 5-17 years (https://clinicaltrials.gov/ct2/show/NCT02973360).

Sickle cell disease is characterized by an imbalance of certain fatty acids in blood cell membranes resulting in an increase in blood cell adhesion, chronic inflammation, increased coagulation activity and red blood cell hemolysis, all factors that lead to pain episodes, VOCs, and organ damage. Based on research, SPCI developed Altemia™, a combination of specific lipids formulated with the Company’s proprietary Advanced Lipid Technologies®platform (ALT®), to restore the appropriate balance to blood cell membranes affected by the disease.

The primary endpoint was the measurement of the change from baseline compared to placebo in blood cell membranes’ fatty acids concentration. Statistical significance was achieved within 4 weeks in patients treated with AltemiaTM.

Statistically significant improvements in markers of coagulation (D-Dimer), inflammation (C-Reactive Protein) and adhesion (E-selectin), key elements associated with the clinical manifestations of SCD, were seen after 8 weeks of treatment. A clinically meaningful reduction of VOC was also observed. No treatment related SAEs were reported.

Ninety-four percent (94%) of subjects completed the study and the majority have chosen to participate in the open label extension phase that will continue monitoring the safety and effectiveness of the drug.

“An effective and safe treatment of Sickle Cell Disease has been elusive for decades. The findings from this successful double blinded randomized controlled multi-center clinical study may lead to a new treatment which is safe and effective for patients wordlwide with this devastating disease,” said Dr. Frederick D. Sancilio, President and Chief Executive Officer of SPCI.

“A safe and well tolerated treatment, presented as a small soft gelatin capsule, administered once a day, will be a major and novel breakthrough in the treatment of Sickle Cell Disease. The clinical efficacy and safety profile of AltemiaTM clearly warrants further advancement of the program,” said Adrian L. Rabinowicz, MD, Chief Medical Officer of SPCI.

Additional analysis of the data is ongoing, and SPCI plans to present detailed data from this study in peer reviewed journals and upcoming scientific conferences. The Company plans to meet with the U.S. Food and Drug Administration (FDA) as well as European Medicines Agency (EMA) to address next steps for AltemiaTM.

About Sickle Cell Disease (SCD)

Sickle Cell Disease (SCD) is a group of genetic disorders that results in dysfunctional hemoglobin (HbS) and a depletion of certain lipids in the walls of blood cells. These abnormalities create an inflammatory state and an increase in the red and white blood cells’ tendency to adhere to each other, resulting in episodic occlusions of blood vessels, reperfusion damage and excruciating pain. Ultimately, many children develop organ damage and strokes. There are approximately 100,000 cases of SCD in the United States and treatment options are limited. The cost of care for this group may exceed $5 billion.

About Altemia™

Altemia™ is our proprietary product candidate that is being developed for the treatment of SCD. Altemia™ consists of a complex mixture of lipids formulated using Advanced Lipid Technologies® (ALT®) specifically to address the treatment of the disease. The drug is encapsulated in a small soft gelatin capsule and intended to be taken once daily to reduce VOC episodes, anemia, organ damage and other disease complications in sickle cell patients.

HbS destroys specific lipids, creating a cascade that culminates in VOC episodes. Altemia™ is designed to replenish those lipids in order to prevent the cascade effect from initiating.

Based on research performed by Sancilio Pharmaceuticals Company, Inc. (SPCI) and others, the specific lipids contained in Altemia™, may restore balance and fluidity to red blood cells and other cells impacted by the disease. We believe that Altemia™ will treat sickle cell disease by decreasing blood cell adhesion, chronic inflammation and red blood cell hemolysis, the factors that lead to reduction in pain episodes, VOCs and organ damage. Based on its formulation and mechanism of action, we believe that Altemia™ is well-positioned to deliver a narrow, therapeutic dose of certain lipids directly to the membrane of red blood cells of sickle cell patients. The combination of ALT®drug delivery technology and highly purified lipids may reduce VOCs significantly. We also believe that Altemia™ has the potential to address the inflammatory symptoms of SCD and to assist in reducing sickle cell events in general. By minimizing damage, Altemia™ may be able to reduce sickle cell crisis events and related mortality.

About Sancilio Pharmaceuticals Company, Inc.

Sancilio Pharmaceuticals Company, Inc. (SPCI) is a fully integrated, specialty pharmaceutical company focused on developing, manufacturing and commercializing pharmaceutical products, including those based on our proprietary Advanced Lipid Technologies® (ALT®) platform. SPCI is pursuing treatments for sickle cell disease, short bowel syndrome and severe hypertriglyceridemia. We utilize our cGMP compliant facility to develop and manufacture our products. Our ALT® platform is designed to enhance the bioavailability, reduce the food effect and improve the efficacy of lipids and lipophilic active pharmaceutical ingredients (APIs). Lipids are hydrophobic or amphipathic molecules, including fatty acids, steroids (including hormones) and fat-soluble vitamins (such as vitamins A, D, E and K). Our business model is to apply our ALT® platform to lipids or lipophilic APIs to create unique product candidates that address the disorders and diseases resulting from imbalances of lipids in the body. In addition to our primary focus of developing our proprietary products using the ALT® platform, we make use of, and license rights to, our proprietary ALT® platform and other technologies to third parties, providing both development and subsequent soft gelatin encapsulation services. More information is available at: www.sancilio.com.

 

Contacts

Sancilio Pharmaceuticals Company, Inc.
Marc Wolff, 561-847-2302
Executive Vice President & Chief Financial Officer

Pacira Pharmaceuticals and TELA Bio Announce Equity Agreement

Pacira to invest up to $25 million in TELA Bio to enhance commercial and clinical initiatives for distinct class of novel surgical implants for soft tissue repair

PARSIPPANY, N.J. and MALVERN, Pa., Oct. 25, 2017 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced that it has committed to invest up to $25 million in TELA Bio, a privately-held surgical reconstruction company that markets its proprietary OviTex™ portfolio of products for ventral hernia repair and abdominal wall reconstruction.

TELA Bio’s OviTex Reinforced BioScaffold (RBS) products are a distinct class of surgical implants that integrate biologic and synthetic materials in a unique embroidered construction that allows free movement of fluid and cells through the construct. OviTex RBS products have been used in over 1,000 implantations across a wide range of hernia patients using a variety of surgical techniques. Surgeons report ease of placement, permeability and handling properties, such as suppleness and conformity to the surgical site, as key benefits.  TELA Bio has exclusive commercial rights to OviTex for hernia repair and abdominal wall and breast reconstruction procedures in the U.S. and European markets.

“We are thrilled with this Pacira investment given its complementary commercial experience and success in driving innovation within the surgical community,” said Antony Koblish, president and chief executive officer of TELA Bio. “This investment will provide us with additional resources to scale-up our clinical and commercial efforts for hernia repair and abdominal wall reconstruction. We also look forward to developing new OviTex products purposely designed for additional soft tissue procedures such as breast reconstruction.”

“We believe the OviTex platform is a highly innovative and differentiated solution that is positioned to emerge as a leading surgical mesh that synergistically blends the strength of a synthetic with the regenerative properties of a biologic,” said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. “Given the strong commercial overlap in soft tissue procedures between our two organizations, we look forward to identifying ways to further collaborate with TELA Bio over time.” 

Under the terms of the agreement, Pacira will make an initial investment of $15 million with the potential for an additional investment of up to $10 million under certain performance scenarios. Pacira is entitled to one seat on the TELA Bio Board of Directors. The agreement also includes a standstill provision precluding a change of control in TELA Bio for at least 12 months. RBC Capital Markets LLC acted as financial advisor to Pacira in connection with the transaction.

About Pacira 
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL®(bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

About TELA Bio
TELA Bio, Inc. is a privately-owned company focused on bringing innovative, cost-effective, surgical reconstruction solutions to surgeons, hospitals and patients. The company's OviTex Reinforced BioScaffolds (RBSs) products, designed for hernia repair and abdominal wall reconstruction procedures, integrate polymer and biologic materials in a uniquely embroidered construction using novel engineering design principles. The OviTex portfolio is supported by high-quality, data-driven science and extensive pre-clinical research that has consistently demonstrated the advantages of an RBS over commercially available products. OviTex RBSs are commercially available in the U.S., and TELA Bio plans to launch OviTex RBSs in the European Union. The company is collaborating with leading surgeons to drive rapid product development and establish TELA Bio as a leader in surgical reconstruction. To learn more about TELA Bio visit http://www.telabio.com.

About OviTex Reinforced BioScaffolds
OviTex Reinforced BioScaffolds (RBSs) are intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Do not use OviTex RBSs in patients known to be sensitive to materials of ovine (sheep) origin. For additional important safety information, please see the OviTex RBSs Instructions for Use.

Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook andprospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and our other products; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical trials in support of an existing or potential DepoFoam-based product; our commercialization and marketing capabilities; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Contact:
Pacira Pharmaceuticals, Inc.
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com

Media Contacts:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com  

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

Baxter Completes Acquisition of Claris Injectables

Baxter Completes Acquisition of Claris Injectables, Expanding Generic Injectable Medicines Portfolio

  • Increases Patient Access to Medicines
  • Provides Platform for Accelerated Growth
  • Expected to be Modestly Accretive to Adjusted Earnings for 2017

DEERFIELD, Ill., July 27, 2017 – Baxter International Inc. (NYSE: BAX), a global medical products company, today announced the completion of the acquisition of Claris Injectables Limited, a global generic injectables pharmaceutical company. The transaction broadens Baxter’s presence in the generic pharmaceuticals space and will help boost the supply of essential medicines to Baxter customers.

“This acquisition reinforces our commitment to establishing Baxter as a global leader in generic injectable medicines,” said José (Joe) E. Almeida, chairman and chief executive officer, Baxter. “The combination of Baxter and Claris Injectables will allow us to increase access to lower-cost generic injectables and strengthen our ability to meet the needs of healthcare providers and patients around the world.”

With this acquisition, Baxter gains access to the complete Claris Injectables product portfolio and pipeline as well as three manufacturing plants. These facilities feature state-of-the-art technology and are registered with global regulatory agencies, including one plant registered with the U.S. Food and Drug Administration. Baxter plans to invest in further increasing Claris Injectables’ capacity and capabilities, including adding new aseptic manufacturing and lyophilization; new technology platforms in areas like cytotoxics, aseptic development and complex formulations; and an expanded research and development footprint to accelerate and increase pipeline output and portfolio breadth.

The expanded capabilities and facilities gained in the acquisition will provide a foundational growth platform for Baxter to help accelerate the number of products it launches in both the near- and long-term. The acquisition is anticipated to add more than 50 products to Baxter’s portfolio in 2017, almost 20 new products in the aggregate in 2018 and 2019, and 10-15 products per year beginning in 2020.

The total consideration for the transaction was approximately $625 million. The transaction was financed through a combination of cash on hand and debt. Annual sales for Claris Injectables were approximately $112 million in 2016, and Baxter expects the growth of this business to be modestly accretive to adjusted earnings for 2017 and increasingly accretive thereafter. Baxter updated its full-year 2017 guidance in conjunction with its second-quarter 2017 earnings results (issued 7/26/17) to account for the anticipated completion of the Claris Injectables acquisition.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Source:  Baxter International Inc. (NYSE: BAX)

 

Signet Healthcare Partners Closes $137.2 Million Life Science Fund

NEW YORK, Jan. 11, 2017 (GLOBE NEWSWIRE) -- Signet Healthcare Partners (“Signet”), a private equity fund that provides growth capital to commercial Life Sciences companies, is pleased to announce the closing of Signet Healthcare Partners IV L.P. with $137.2 million of capital commitments.  The firm intends to invest in 10-12 companies and will typically invest $10-15 million per company (with co-investment from its limited partners).  "We are very grateful for the continued support of our loyal investor base during this fundraising, and welcome our new investors," said James Gale, Founding Partner and Managing Director of Signet.

Two new general partners have joined the firm in connection with this fund.  Nikhil Puri has joined Signet from Pfizer, where he was Vice President and Head of Business Development for the Global Established Pharmaceuticals business.  Prior to that, Mr. Puri had spent 15 years as an investment banker, most notably at Bear Stearns and Lehman Brothers.  Ashley Friedman has also become a general partner.  He previously had been a venture partner since 2014 when he joined Signet from Investor Growth Capital (the private equity and venture arm of Investor AB).  While at Investor, Mr. Friedman participated in and led a number of life science private equity financings.  He started his career at Lehman Brothers.

"The commercial Life Sciences segment continues to offer significant growth avenues for companies with differentiated product offerings, and we believe that strategic growth capital will play an integral role in harnessing these opportunities," said Nikhil Puri.

"We are excited and committed to build on Signet’s successful and focused approach to growth-stage healthcare investing and partnering with exceptional management teams to drive value and healthcare innovation," said Ashley Friedman.

About 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.

leon Appoints Pharma Expert Michael Mehler as Chief Executive Officer

leon nanodrugs GmbH appoints pharma expert Michael Mehler, Sc.D. as new CEO of the Munich based company and its U.S. subsidiary leon-nanodrugs Inc, effective today.  He succeeds Dr. Theron (Ted) Odlaug who will continue to serve the company in the Supervisory Board, as was agreed at the beginning of 2016.

Dr. Michael Mehler brings to leon-nanodrugs over 25 years of experience holding significant leadership roles in the international pharma and biotechnology industries. In his previous tenure he was the CEO of SpePharm AG, Lucerne, a pan-European specialty pharma company focused on high-value specialty hospital products. Prior to that he led Riemser Arzneimittel AG, today Riemser Pharma GmbH, Greifswald, as CEO from 2009 to 2014and guided the company through the sale to AXA Private Equity, today Ardian, in 2012. From 2003 to 2009 he served Actelion Pharmaceuticals, (Allschwil) in several senior executive roles, Michael started his long-time international career at Merck/MSD and Novartis. Michael graduated in Chemical Engineering from the Technical University in Darmstadt and holds a Doctor’s degree (Dr. rer. nat; Sc.D.) in Biochemistry from the University of Mainz.

Dr. Hubert Birner, Chairman of the leon Board and Managing Partner at TVM Capital Life Science commented “We welcome Michael to lead leon nanodrugs on our joint journey to continued growth and internationalization. We know Michael as a very experienced executive and look forward to working with him. We would also like to express our sincere appreciation to Ted who did a tremendously impressing job – he will obviously bring his valuable expertise to the Board in his new role and continue to complement our management team.”

Michael Mehler added:  “I am delighted to join the leon team and I am grateful for the faith of the Board and shareholders in me. I am convinced that our proprietary nano technology has an enormous potential to not only successfully reformulate established and new active molecules but by doing so to bring relevant advantages to patients, enabling us to take leadership in this re-formulation market.”

About leon-nanodrugs

leon-nanodrugs GmbH, headquartered in Munich, is a nanotechnology-based drug development company focused on reformulations and reinventions of drugs on a contract or co-development basis. The core business is the reformulationsto develop novel oral and parenteral formulations and innovative drug combinations, which have not been possible in the past due to low bioavailability caused by low solubility of APIs. The 2014 CPhI Pharma Awards for Best Innovation in Formulation was won by MJR PharmJet GmbH, leon nanodrugs’ reformulation service partner for its patented nanotechnology. The company also has partnership with CoreRX in Clearwater, Florida. For more information, please visit www.leon-nanodrugs.com.

Contact

Dr. Michael Mehler

CEO

m.mehler@leon-nanodrugs.com

0049 89 41 42 488 995