Breaking News Coverage for Alliqua, Inc. (OTCQB:ALQA) - October 21,  2013

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Company Snapshot
Alliqua, Inc.

850 Third Avenue
Suite 1801
New York, NY 10022

http://alliqua.com/

Officers:
David Johnson, CEO
Steven Berger, CFO
Tel: (646)218-1450
Email: info@alliqua.com

Sector: Biomedical/Healthcare
Ticker Symbol: ALQA
Exchange: OTCQB
Shares Outstanding:
273,924,657
 

52 Week Low: $0.03
52 Week High: $0.104

 



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Alliqua Signs Distribution Agreement for SilverSeal® and Hydress® Wound Dressings
 

U.S. Health Care Services Company to Distribute SilverSeal and Hydress Dressings to Alternate Site Market in All 50 States

 

LANGHORNE, PA – October 21, 2013 – Alliqua, Inc. (OTCQB: ALQA) (“Alliqua” or “the Company”), has signed a distribution agreement with McKesson Medical-Surgical, by which their U.S. distribution network will stock and offer for sale Alliqua’s SilverSeal® and Hydress® wound dressings to healthcare customers nationwide. 


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David Johnson, Chief Executive Officer of Alliqua, said, “This encompasses expanding our distribution network within the U.S. for our SilverSeal® and Hydress® wound dressings. McKesson Medical-Surgical is one of the most well-known and respected health care distributors in the U.S. market. The expansion in distribution made possible by this agreement will assist customers with easy access to these products across the continuum of alternate site health care. ”

Brad C. Barton, Chief Operating Officer of Alliqua, stated, “Signing an agreement with McKesson Medical-Surgical is very exciting to our customer base. Whether in home care, long term care or elsewhere in the alternate site market, customers can access our products from a source widely familiar to those in the position of purchasing health care supplies.

Alliqua’s SilverSeal is a flexible, sterile hydrogel dressing that incorporates the antimicrobial properties of silver. It is designed for use on partial and full-thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

Alliqua’s Hydress is a cross-linked polymer-based gel that is able to provide and maintain a moist wound environment. There are several benefits associated with increased moisture content, including the cleansing and autolytic debriding of necrotic tissue.

Other terms of the agreement were not disclosed.

About McKesson

McKesson Medical-Surgical’s parent, McKesson Corporation, currently ranked 14th on the FORTUNE 500 list, is a healthcare services and information technology company dedicated to making the business of healthcare run better. McKesson Medical-Surgical works with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson Medical-Surgical helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit www.mckesson.com..

About Alliqua, Inc.

Alliqua, Inc. (ALQA) ("Alliqua") is a biopharmaceutical company focused on the development, manufacturing, and distribution of proprietary transdermal wound care and drug delivery technologies. Alliqua's technology platform produces hydrogels, a 3-dimensional cross-linked network of water soluble polymers capable of numerous chemical configurations.

Alliqua currently markets its new line of 510(k) FDA-approved hydrogel products for wound care under the SilverSeal® brand. Alliqua's electron beam production process, located at its 16,000 square foot GMP manufacturing facility in Langhorne, PA, allows Alliqua to develop and custom manufacture a wide variety of hydrogels. Alliqua's hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. Additionally, Alliqua's drug delivery platform, in combination with certain active pharmaceutical ingredients, can provide pharmaceutical companies with a transdermal technology to enhance patient compliance and potentially extend the patent life of valuable drug franchises.

For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.

Any statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.

Legal Notice Regarding Forward-Looking Statements
This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the our control that can make such statements untrue, including, but not limited to, inadequate capital, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, termination of contracts or agreements, technological obsolescence of our products, technical problems with our research and products, price increases for supplies and components, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and/or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that we will be able to develop new products on the basis of our technologies. In addition, other factors that could cause actual results to differ materially are discussed in our Annual Report on Form 10-K/A filed with the SEC on May 16, 2013, and our most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.

SOURCE: ALLIQUA, INC

Recent News Events for  Alliqua, Inc. - OTCQB: ALQA

Preclinical Results Show Alliqua's Investigational Lidocaine Transdermal Patch Compares Favorably to Lidoderm Patch  

Pharmacokinetic Study Encourages Additional Testing

LANGHORNE, Pennsylvania, October 16, 2013 /PRNewswire via COMTEX/ -- A preclinical study commissioned by Alliqua, Inc. (OTCQB: ALQA) ("Alliqua" or "the Company") concluded that the Company's investigational lidocaine transdermal patch compares favorably to the Lidoderm(r) (Lidocaine patch 5%) patch that is currently on the market. The overall study results indicate that Alliqua's patch is able to deliver in the pig a slightly higher amount of lidocaine than Lidoderm and to reach maximum delivery within a comparable period. No skin irritation occurred with either the Alliqua transdermal patch or Lidoderm patch. The study concludes that further development could result in Alliqua creating a commercial lidocaine patch that could be a generic version of the Lidoderm patch or provide better drug delivery resulting in a 505 (b)(2) approval.

David Johnson, Chief Executive Officer of Alliqua, said, "As we continue to expand our suite of wound care products, building the value proposition of our hydrogel technology for topical and transdermal drug delivery remains one of our major goals. The results of this preclinical study serve as a significant motivation for us to continue our efforts to develop a core transdermal delivery technology platform to deliver lidocaine and other beneficial ingredients through the skin."

James Sapirstein, Chief Executive Officer of Alliqua Biomedical, said, "The strong showing of our transdermal patch compared to Lidoderm, the leading product currently on the market, illustrates the potential of our technology. We are evaluating our strategic options to maximize these findings."

The primary objective of the study was to conduct a comparative pharmacokinetic (PK) analysis of lidocaine in Alliqua's transdermal patch compared to Lidoderm in the pig. The non-GLP in vivo crossover study was designed to evaluate the delivery of lidocaine over 24 hours in Alliqua's patch and Lidoderm with regard to feasible length of application.

The study found that Alliqua's patch offers a higher peak plasma concentration (Cmax) of lidocaine than Lidoderm (4.961.16 ng/mL versus 3.031.92 ng/mL) and higher mean total area under the curve (AUCtotal) than the competing product 66.5 ng/mL-h versus 48.9 ng/mL-h)). The mean period of peak concentration (Tmax) was 8.7 hours for Alliqua's patch versus 10.7 hours for Lidoderm.

In addition, Alliqua's patch was easier and cleaner to remove from the skin after application, with minimal or no patch impression (outline) remaining. The presence of adhesive in Lidoderm seemed to have a "peel-off effect" on the skin (similar to a band-aid); in contrast, Alliqua patch hydrogel has self-adhering characteristics and is easily removed from the skin at the end of a patch application without residual skin markings.
 

 

Alliqua Provides Update on Media Coverage of its Advanced Wound Care Portfolio and Corporate Developments  

LANGHORNE, Pennsylvania, October 7, 2013 /PRNewswire via COMTEX/ -- Alliqua, Inc. provided an update on a series of independent news stories highlighting the Company's wound care portfolio and corporate developments. The links below provide direct access to each complete article.

Reports on Alliqua's corporate developments, including its transformation into a wound care products and technology company from a wound care contract manufacturer, its growth strategy, and recent strengthening of its management team, were carried in the Philadelphia Business Journal and Medical Device Daily. Separate reports of Alliqua's SilverSeal� hydrogel wound care dressing and its unique characteristics were featured in Manufacturing Chemist Pharma, WOUNDS and Qmed.com.

Links to the articles follow:

"Reinventing the Bandage with Hydrogels," on Qmed.com: http://www.qmed.com/mpmn/medtechpulse/reinventing-bandage-hydrogels

"Biopharm company gets new home, new focus," in Philadelphia Business Journal:


http://www.bizjournals.com/philadelphia/blog/health-care/2013/09/biopharm-company-gets-new-home-new.html?page=all

"Lidocaine hydrogel patches will be developed to treat localised acute pain," in the September issue of Manufacturing Chemist: http://www.manufacturingchemist.com/news/article_page/Lidocaine_hydrogel_patches_will_be_developed_to_treat_localised_acute_pain/91318

"Alliqua's SilverSeal Dressing Shown to Improve Surgical Wound Outcomes in Clinical Study," on the WOUNDS magazine website: http://www.woundsresearch.com/news/alliquas-silverseal-dressing-shown-improve-surgical-wound-outcomes-clinical-study

David Johnson, CEO of Alliqua, said, "As our company continues to meets its strategic growth objectives, we are pleased to receive recognition in the media for our achievements, both in terms of our portfolio of wound care products and our corporate developments, including Alliqua's strong management team."
 

Alliqua Signs Long-Term Distribution Agreement with sorbion for Hydroactive Wound Product Line with Hydration Response Technology 

LANGHORNE, Pennsylvania, September 23, 2013 /PRNewswire via COMTEX/ -- Partnership to Be Officially Launched at SAWC in Las Vegas in September
Adds to Alliqua's Suite of Advanced Wound Care Solutions

Alliqua, Inc. (OTCQB: ALQA) ("Alliqua" or "the Company"), a biomedical company offering a suite of wound care solutions and drug delivery technologies, has signed a long-term agreement with sorbion GmbH & Co. KG ("sorbion") to distribute the sorbion sachet S, sorbion sana and new products with hydrokinetic fibers as primary dressings. sorbion hydroactive wound care products will be distributed by Alliqua throughout all of the Americas. The new partnership will be officially launched at the Fall 2013 Symposium on Advanced Wound Care ("SAWC"), to be held September 26-29 in Las Vegas.

The sorbion sachet S and sorbion sana brands have been market leaders in the MMP (matrix metalloproteinase) modulator wound dressing category in Germany and the U.K. for the past several years and were initially introduced into the U.S. marketplace three years ago. These dressings are FDA-cleared and are reimbursable.

Intended for wound bed preparation, sorbion sachet S is indicated as a primary dressing for moderately to highly exudating wounds such as surgical wounds, venous leg ulcers and diabetic ulcers. It offers enhanced performance for the removal of slough, and toxins, locking in bacteria and reducing odor. sorbion sachet S's hydration response technology combines mechanically modified cellulose fibers with gelling agents; the close interaction of the two components allows for active regulation of the wound climate.

Another form of wound treatment is possible with sorbion sana, which is indicated as a primary dressing. It maintains a wound climate which supports healing and thus supports granulation by protecting tissue and offers a reduction of pain during dressing changes. sorbion sana consists of an absorbent core with hydration response technology and a three-dimensional outer cover made of polyethylene. Selected materials and an optimized manufacturing process allow the avoidance of glues and adhesives, making the sorbion dressings less likely to cause an allergic reaction.

Olaf Ohm, Sales & Marketing Director, Global Operations of sorbion, said, "We are confident that Alliqua is the ideal partner to expand the distribution of the sorbion family of wound care products across the Americas. Alliqua's team has extensive wound care experience. sorbion's products, when taken together with Alliqua's SilverSeal� and Hydress� products, comprise an ideal portfolio of wound care dressings from which healthcare providers can choose to meet the best needs of the patient."

Michael Stonner, Managing Director of sorbion, said, "Alliqua's success in conveying the specific benefits of its own wound care products will serve us well as our international partner. As Alliqua begins its distribution of sorbion sachet S, sorbion sana, and new products with hydrokinetic fibers in the Americas, we expect the products' sales and reputation to grow at an impressive rate."

David Johnson, Chief Executive Officer of Alliqua, said, "This agreement is one example of how Alliqua is fulfulling its vision to build a suite of technological solutions that will allow wound care practitioners to solve the challenges that are presented to them in both chronic and acute wounds. sorbion's products expand our suite of wound dressings and together, these products offer a broad range of solutions for practitioners tasked with treating various wound types and conditions providing a favorable wound environment for healing. Overall, we expect the clinical effectiveness of these products will contribute to their role as very cost-effective solutions for wound care specialists around the globe."

About sorbion GmbH & Co. KG

sorbion GmbH & Co. KG is an owner-operated company based in Senden (M�nsterland region, Westphalia, Germany) which specializes in the development, production and sale of products for modern wound treatment. Since its foundation in 2001 by the Riesinger family, sorbion has established itself as an internationally acknowledged provider of modern treatment solutions. Research and development has always been one of the company group's main focuses and, with new products and technologies, it is central to the company's growth. Today, sorbion is represented by sales and partner companies in 14 countries. For more information, please visit http://www.sorbion.com.

 

Alliqua Initiates Proof-of-Principle Study of Transdermal Lidocaine Hydrogel Patch for Pain Relief

LANGHORNE, Pennsylvania, July 23, 2013 /PRNewswire via COMTEX/ -- Alliqua, Inc. (OTCQB: ALQA) ("Alliqua" or the "Company") today announced the initiation of a preclinical proof-of-principle study of an experimental hydrogel patch containing lidocaine. Safety and tolerability of Alliqua's lidocaine hydrogel patches will be explored in an animal model. Further, the pharmacokinetic profile will be analyzed to determine the amount of systemic absorption and local lidocaine concentration in the skin immediately beneath the patch.

"The ease of use, stability and compatibility with active ingredients make our hydrogels well suited for the transdermal delivery of a variety of compounds, including pain medications like lidocaine," commented James Sapirstein, chief executive officer of Alliqua Biomedical. "Our lidocaine patch development program is just the first in our effort to build a portfolio of products that leverage our hydrogel platform. We believe success in this proof-of-principle study for our lidocaine patch would increase the likelihood of success with other compounds and greatly enhances our efforts in this area. Beyond lidocaine, the Alliqua Biomedical division plans to explore transdermal delivery of dermatological, oncology, antibiotic and neurology products."

The Company plans to develop lidocaine hydrogel patches for the treatment of localized acute pain, including post-operative pain, back pain, as well as pain associated with sports injuries and arthritis. Alliqua expects results from this preclinical proof-of-principle study later in the third quarter.

"Lidocaine is an important therapeutic agent with a strong potential market opportunity," Mr. Sapirstein added. "Following successful completion of this proof-of-principle study, Alliqua intends to develop a clinical and development path forward based on discussions with the U.S. Food and Drug Administration as well as scientific advisers and potential partners."

 

Alliqua's SilverSeal Dressing Shown to Improve Surgical Wound Outcomes in Clinical Study

Study Results to be Presented at the Annual Meeting of the American Orthopaedic Foot & Ankle Society

LANGHORNE, Pennsylvania, July 18, 2013 /PRNewswire via COMTEX/ -- Alliqua, Inc. (OTCQB: ALQA) ("Alliqua" or the "Company") today announced the results from a post-marketing study to assess surgical wound outcomes in patients who have undergone foot and ankle surgery. In this study, Alliqua's SilverSeal® dressing was shown to have a lower incidence of incision complications, including infection, and a greater reduction in scar length compared to standard petroleum-based dressing. Study results are being presented at the annual meeting of the American Orthopaedic Foot & Ankle Society, which is being held in Hollywood, Florida July 17-20.

Stephen A. Brigido, DPM, director of the foot and ankle fellowship at the Coordinated Health Foot and Ankle Center and a primary investigator in the study, stated, "The results from this study are consistent with our preliminary findings reported earlier this year and indicate SilverSeal has potential to not only improve post-surgical incision healing but to reduce healthcare expenditures related to incision complications."

"The reduction in post-surgical incision complications and scarring shown in this study is a meaningful benefit for patients as well as for surgical centers and hospitals. We believe this study demonstrates that SilverSeal can be an effective tool in reducing complications such as infection, and will be useful in driving further adoption," added Philip Forman, Alliqua's EVP of clinical affairs.

In this study, patients who had undergone ankle and foot (including forefoot, midfoot or hindfoot) surgery were randomized to receive either SilverSeal or a standard petroleum-based dressing. Patients were monitored for three months following surgery to assess degree of scarring and the incidence of incision complications such as superficial or deep infections or wound rupture, along the surgical suture. Of the nine incision complications observed, eight occurred in patients using the petroleum-based dressing and only one in those using SilverSeal (p=0.03). Length of post-surgical scarring was also reduced to a greater extent in patients using SilverSeal compared to those with a standard petroleum-based dressing.

These results are summarized in a poster titled "Utilization of Silver Hydrogel Sheet Dressing on Post-Surgical Incisions: A Pilot Study in Foot & Ankle Surgery" that is currently being presented at the American Orthopaedic Foot & Ankle Society annual meeting.

 

Alliqua Raises $3 Million in 2nd Quarter of 2013, Led by Members of Management and its Board of Directors

Equity Financings will Support Product and Business Development Initiatives

NEW YORK, July 8, 2013 /PRNewswire via COMTEX/ -- Alliqua, Inc. (OTCQB:ALQA) ("Alliqua" or the "Company") today announced that it has successfully met its financing goals, raising $3 million through the sale of common stock and warrants over the past 3 months. A group of accredited investors purchased the equity at $0.081 per share, coupled with a warrant to purchase an additional share of common stock at $0.097 per share.

The first $1 million investment, as previously disclosed by the Company, took place between April and May of 2013. The remaining $2 million was raised on June 28, 2013 and was led by group of Alliqua's management and board of directors, including Jerome Zeldis, Dave Johnson, David Stefansky, Joseph Leone and Kenneth Pearsen. Dr. Zeldis, who serves as the Chairman of the Board of Alliqua, is the current chief medical officer of Celgene Corporation. Mr. Johnson, who serves as Alliqua's CEO, was previously the CEO of Convatec. Mr. Johnson assumed the role of CEO of Alliqua in February 2013. Mr. Stefansky, who serves as a board member, is a co-founder and principal of Harborview Advisors, LLC. Summer Street Research Partners acted as lead investment banker to raise funds outside of insider participation.

Proceeds from the capital raises will provide additional working capital to support the Company's ongoing expansion of its wound dressing portfolio, which includes marketed products SilverSeal® and Hydress® dressings. It will also be used to further the development of Alliqua's transdermal drug delivery platform, as well as other potential business expansion opportunities. "We are excited to have completed this important financing to help us support our continued sales growth, as well as the advancement of key wound care products," commented David Johnson, Alliqua's CEO. "Moreover, I believe that the substantial financial commitment on the part of the executives and board members who contributed to this financing round is indicative of our commitment to the success of Alliqua as well as our belief in the vast commercial potential we all believe exists in our technology. Together, we will continue to work diligently to drive sales growth, improve design and functionality of our dressings, expand our product lines and further our transdermal drug delivery platform."

 

About Alliqua, Inc. - OTCQB: ALQA

Alliqua, Inc. (OTCBB: ALQA) is a wound management and drug delivery company that creates superior outcomes for patients, providers, and partners through its platform technology and proprietary products.

Its core businesses include advanced wound care, transdermal drug delivery, and contract manufacturing. ALQA leverages its proprietary hydrogel technology platform to add value to its own products and also those of our partners.

Moving Alliqua Forward in 2013: Increasing Revenues and Expanding the Product Portfolio

Alliqua's hydrogel technology – the same technology that gave the company its marketed surgical dressings, SilverSeal® and HyDress® – is the backbone of the company and represents an enormous opportunity for growth in many ways. In 2013 ALQA intends to roll out a strategy to leverage this technology platform.

First, ALQA is in the process of hiring a select group of senior, proven, sales and marketing managers who, together with its existing talent, will strive to increase revenues from the company's marketed products: Together, it intends to:
•open up new distribution channels
•drive demand in our current channels including the VA
•leverage the strong clinical data

Through these and the existing educational and marketing efforts that are already underway, Alliqua expects to see SilverSeal® and HyDress® revenues start to increase in the Q2-Q4 timeframe.

Second, the company plans to utilize business development opportunities to expand its product offerings. Namely, ALQA intends to:
•focus on in-licensing marketed transdermal products to fulfill its vision around leveraging the hydrogel in transdermal drug delivery use. Initially, the company intends to focus on wound healing associated with pain, dermatology, infection and cancer
•expand ALQA's portfolio beyond products with potential hydrogel application by endeavoring to in-license or acquire additional wound-care products

This 2013 direction is intended to provide some early wins, while building for sustained growth in the future.

Wound Management

In the area of advanced wound care, ALQA manufactures and market a line of proprietary advanced wound dressings that include:

  • SilverSeal®: A flexible, sterile, non-adherent hydrogel dressing that incorporates the antimicrobial properties of metallic silver coated fiber.
  • Hydress®: A flexible, sterile, non-adherent hydrogel dressing that can absorb two-times its weight in exudate.

ALQA is in the process of expanding its advanced wound care portfolio to better meet the needs of clinicians and the patients they serve. This suite of differentiated advanced wound care products will enhance their ability to effectively and efficiently manage a variety of wound indications and wound conditions throughout the healthcare continuum.

Transdermal Drug Delivery

In the area of transdermal drug delivery, ALQA's hydrogel technology can be used to deliver therapeutic compounds through the skin. Key advantages of our delivery platform include stability of form and composition, purity, reproducibility, and compatibility with various active ingredients. Within certain patient populations, transdermal drug delivery has multiple advantages over oral drug delivery or injections. Alliqua hydrogels provide a welcome texture and flexibility for the patients; their ease of administration is an added bonus. ALQA intends to commercialize its drug delivery platform in multiple therapeutic areas.

Contract Manufacturing

Alliqua contract manufacturing business unit provides custom hydrogels to the OEM market. The company develops and manufactures electron-beam cross-linked sheet gels for customers that include manufacturers of medical devices, cosmeceuticals, and other commercial product applications. ALQA's ability to meet the varying specifications of its customers, while maintaining tight tolerances and ensuring delivery on-time and within budget, has made us a leader in the electron beam cross-linked hydrogel market.
 

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