Wound-care dressing built on water

“Part of Alliqua’s story is our hydrogel,” explains Dave Johnson. “Part of the story is using that as a platform to expand even further.”

Johnson is a businessman. He’s been in the medical industry for 32 years, working for companies such as American Hospital Supply, Exeter, Zimmer, and others. Before joining Alliqua he was CEO at ConvaTec, where he helped the wound-care company grow into a $1.7 billion franchise. He stepped down in 2012, calling his time there, “a nice run.”

After he resigned, offers poured in for Johnson’s services in the wound-care field. He turned them all down, until Alliqua called.

Alliqua specializes in manufacturing and distributing hydrogels, which are gel-like substances made of water and solids. They can be created chemically or by mixing polymers and water. Alliqua creates them using the latter strategy. The company uses an electron beam accelerator to cross-link the gel, which reduces the number of ingredients needed to build the product.

At the time the company sought Johnson, it had two products. One was Hydress, a hydrogel patch that moisturizes a wound and debrides it. The other was the SilverSeal, which incorporates silver ions to fight against bacteria and infection.

“Here’s what I saw,” Johnson says. “First of all, this great innovative technology that allowed electron beam cross-linking of hydrogels to really eliminate some of the problems that these things have had in the past. Second, I saw two wound care products that were both FDA-cleared and fully reimbursed, so it took all of the risk out of the regulatory and reimbursement side of the business.”

The third thing he saw was an opportunity to leverage the hydrogel platform to establish Alliqua as a “preeminent company in the wound-care space.” Johnson determined to focus on developing wound-care technologies, relocating offices, and striking partnerships – all on the strength of its two hydrogel products.
 

Electron beam accelerator

Speed is one of Alliqua’s greatest advantages in manufacturing hydrogels. Greg Robb, head of manufacturing, credits Alliqua’s electron beam accelerator for the swiftness. It has what Robb describes as “extreme repeatability.” Once Robb’s team sets a specific formulation, the electron beam can cross-link a stock of product based on the specific parameters.

“You basically take the same formulation, and you process it under the same conditions with the accelerator, and you’ll get the same results at the back of the line,” Robb elaborates.

In addition to the machine’s repeatability, Robb says tinkering with parameters is easy, so working with different companies with different requirements is not a problem.

“It’s specific from run to run and batch to batch,” Robb says.
 

Importance of water

Perhaps even more important – at least to patients receiving the end product – is the accelerator’s ability to impregnate hydrogels with a high concentration of water. Some companies offer hydrogels containing about 65% water. Alliqua’s hydrogels hold approximately 94% water. The hyper-hydrated hydrogel soothes a patient’s injury more effectively and reduces the risk of skin irritation. If the company cross-linked with ultraviolet light instead of an electron beam, it would have to use additional catalysts and chemicals, which would decrease water levels.

“We don’t need anything else,” Robb says. “Just [water and polymer] and we can make a hydrogel. So, it’s as pure as it’s going to get.

“If you use a UV, the UV’s acting as an activator,” Robb adds. “For us, literally, polymer and water is all we need. That’s really the crux where the electron beam kind of starts. It’s a very clean product if you look at it that way. Simple and clean.”
 

SilverSeal

Alliqua has used the hydrogel platform for a number of applications, including transdermal drug delivery and wound-care products – such as SilverSeal – for burns, blisters, and abrasions. One of the company’s newest releases, SilverSeal, includes the antimicrobial properties of silver and is a standout among the company’s offerings because of its special reliance on water. Silver, according to Robb, has a unique property. It creates an ion that, when combined with water, prevents the reproduction of microbes in a wound.

“Silver alone doesn’t have any effect like that,” Robb says. “Water has to be present. So by taking the silver and putting it into a hydrogel…the ions are already available to fight bacteria.”

Johnson and Robb say SilverSeal is less coarse than similar products, provides a cooling effect, and becomes active immediately after being placed on the wound. The sheets, available in different sizes, can hold themselves in place without bonding to the skin, so removing them is painless.
 

Building business

The wound-care market is a big, burgeoning industry. The market is expected to reach $21 billion by 2015, due to an aging population and rising cases of people suffering from chronic wounds, according to The Wall Street Journal.

Johnson is familiar with the field’s territory. Only a handful of companies make up half the global market share, he says. The limited choices have put a squeeze on wound-care physicians’ options for treating patients. Johnson says practitioners are looking for a variety of treatments to deal with the spectrum of wounds they see, from acute wounds to chronic wounds from diseases such as diabetes.

Johnson’s plan is to build a suite of solutions that addresses those needs. “Wound-care physicians do not like people who come in with one technology and push it,” he explains. “They really want to deal with a company that has a variety of options.

“That’s what we’re building here, a unique solution-driven program for wound care practitioners. Something that isn’t available today in the marketplace.”

In September 2013, Alliqua took a major step in building that suite. The company signed a long-term agreement with a German company, sorbion GmbH & Co, giving Alliqua its second technology platform. Alliqua distributes the sorbion sachet S, sorbion sana, and other products that feature hydrokinetic fibers as primary dressing. The German dressings are for moderately- to highly-exudating wounds, such as surgical wounds, leg ulcers, or diabetic ulcers.

Then in November, Alliqua took another step by entering into a licensing agreement with Celgene Cellular Therapeutics, a subsidiary of Celgene Corp., whereby Alliqua received the right to develop and market the advanced wound care products Biovance and Extracellular Matrix (ECM). Biovance is a collagen-based, decellularized, and dehydrated topical-wound covering produced from human amniotic membrane that is indicated for the management of non-infected partial- and full-thickness wounds; ECM is a suite of advanced wound management products made from extracellular matrix derived from the human placenta.

The company also partnered with Martin Enterprises, a distributor organization that works with the Department of Veteran Affairs community. Alliqua currently is having tentative discussions about sending products to Afghanistan or Iraq, “because our sorbion technology is just so incredibly well-suited for battlefield applications,” Johnson notes. None of his company’s products have been used in battle so far.

A consolidation effort is also underway where Robb works at Alliqua’s manufacturing headquarters in Langhorne, Pa. Located approximately 30 miles northeast of Philadelphia, Langhorne offers a vastly different landscape than New York, where the company’s administrative offices are now. Soon, all of Alliqua’s operations will move to Langhorne, saving the company time and money.

“What we’re looking for, because we’re a small company, is the synergistic effect that you can have by everybody being within five steps of each other,” Robb explains. “It should lend itself to making things happen quicker.”

For Johnson, the consolidation lends itself to both parts of Alliqua’s story: the hydrogel and, ironically, the expansion effort.

“What a great place to be [in Langhorne],” he says. “We’ll be able to bring customers and investors and potential employees to a facility that has our offices, where we can get them talking to sales and marketing people, our manufacturing people, our development people, and do a tour of the plant. As a marketing tool, it remains a very positive thing to do.”

Alliqua
www.alliqua.com

About the author: Danny English is an associate editor with TMD and may be contacted at denglish@gie.net or 330.523.5354.