Q: My nails crack and split in winter. Are there any treatments that really work?

A: Funny you should ask. Well, actually, not funny. I have the same problem and I’ve never found myself laughing about it. Since dryness is the culprit, wash only with nonsoap cleanser or a moisturizing soap, moisturize your hands and nails after every washing, rub vitamin E or cuticle oil or shea butter cream into your nails as many times a day as you can stand, and wear gloves outside. I do all that—pretty religiously—and my nails still occasionally split in the winter. But now there’s something else to try.

Boni E. Elewski, MD, professor of dermatology at the University of Alabama School of Medicine, recommends Nuvail, a prescription product recently FDA approved for “nail dystrophy”, which (sorry to say) is what we with the stressed nails probably have. The formula works, the company says, by protecting nails from drying out while allowing oxygen—important to nail health—in. It’s applied as needed like a polish and wears off naturally.

Keep in mind: It might seem obvious, but I’ve found that very short nails are less vulnerable to problems—and they look great in dark polish.

Innocutis is pleased to announce the FDA approval of Nuvail™ (poly-ureaurethane, 16%) nail solution, a novel prescription product to help manage fragile, damaged or brittle nails with cracking or splitting, a condition medically referred to as “nail dystrophy”.

Among the most common forms of nail dystrophy is Brittle Nail Syndrome (BNS), which often is referred to simply as “brittle nails”.   Studies show that, on average, 20% of the population is affected by BNS and women are affected twice as often as men.¹ BNS may have various origins and is characterized by increased fragility of the nail plate.  Patients who experience BNS, or other types of nail dystrophy, report their nails are painful and impair daily activities, which often negatively impacts their occupational abilities.²

Nuvail is formulated to mechanically support the damaged nail plate using a proprietary polymer blend that creates a strong adhesion to the nail surface, forming a breathable barrier while protecting and strengthening the nail.   This breathable barrier allows for oxygen transfer to the nail plate while blocking water absorption therefore preventing the wet-dry cycle that leads to damaged nails.  Daily application of Nuvail also protects the nail from harm caused by work activity such as direct abrasion and friction. The clinical benefits of Nuvail have recently been documented in a peer reviewed clinical study published by the Journal of Drugs in Dermatology®.

“Innocutis is proud and excited to introduce Nuvail as a unique and innovative breakthrough in the treatment and protection of damaged and dystrophic nails.  For the first time, patients will have a nail treatment that allows the nail to breathe but is still non water-soluble and is able to protect the nail from the impact of moisture and friction.” said Jonathan Alba, Innocutis Chief Operating Officer.

Nuvail is available at all major retail pharmacies and can be purchased by prescription only in a 15ml bottle. For more information about Nuvail or to help locate a physician near you please see our physician finder.

About Innocutis:

Innocutis is a pharmaceutical and medical device company specializing in the development and commercialization of therapies focused on medical treatments of dermatological conditions.  We believe our focus on dermatologic conditions sets us apart as a company that understands the growing needs of the dermatology specialty.  Our commitment is to be best-in-class in skin-related therapies, providing clinicians with improved solutions for the management of daily challenges experienced in their practice.

References:

1. Lubach D, Cohrs W, Wurzinger R. Incidence of brittle nails. Dermatologica 1986; 172:144-7.

2. Scher RK. Brittle nails. Int J Dermatol 1989;28:515-6

3  Nasir A, Goldstein B, van CleeffM, Swick L. Clinical evaluation of safety and efficacy of a new topical treatment for onycomycosis. J Drugs Dermatol. 2011; 10(10): 1186-91.

Innocutis is pleased to announce the introduction of three new prescribing options of Bionect® (hyaluronic acid sodium salt 0.2%): an aqueous base 20ml spray, and aqueous base 100g cream and gel formulations.

Available by prescription only, Bionect is formulated using a patented low molecular weight hyaluronic acid (LMWHA) and is indicated for irritations of the skin and managing redness associated with chronic conditions.

Market research has shown that patients and physicians are looking for value options when treating chronic conditions. The new Bionect 100g aqueous gel and cream formulations double the current treatment size options and are preferred by patients treating large skin areas affected by irritation and redness.

While creams and gels are commonly prescribed for topical use, they are not ideal for all areas of the body. Bionect spray 20ml is ideal for patients to use for symptoms occurring near the hairline or hair bearing areas.

For more information or help locating a physician near you to prescribe Bionect, please see our physician finder.

About Innocutis:

Innocutis is a pharmaceutical and medical device company specializing in the development and commercialization of therapies focused on medical treatments of dermatological conditions. We believe our focus on dermatologic conditions sets us apart as a company that understands the growing needs of the dermatology specialty. Our commitment is to be best-in-class in skin-related therapies, providing clinicians with improved solutions for the management of daily challenges experienced in their practice.

For more details about Nuvail™, please click on this image to visit the official Nuvail site.

A New Approach for Damaged Nails

Nuvail™ is a new, unique, patented polymer that leaves a breathable, elegant, invisible film when applied to nails. Nuvail is FDA approved for managing signs and symptoms of nail dystrophy. Easy-to-use Nuvail helps prevent nail brittleness and fragility. Because Nuvail quickly dries with a clear matte finish, Nuvail looks great on women and men alike.

Nuvail is best applied once a day at bedtime. Nuvail is easy and convenient to use. Nail polish may be worn on top of Nuvail. Do not apply polish until Nuvail is completely dry. Polish must be removed before the next application of Nuvail.

Nuvail is available by prescription only.

Nuvail Improves Overall Nail Appearance¹

• Penetrates intercellular spaces and nail surface ridges
• Creates a stable, yet flexible molecular structure
• Provides mechanical support

Plus, Nuvail Has Staying Power

• Not water soluble, yet breathable
• Hydrophobic molecule – does not wash off
• Continues to work after the first application
• Protects the nail from environmental factors

Nuvail Full Prescribing Information (pdf) – download

Ideal for Managing Redness, Inflammation & Discomfort Associated with Irritations of the Skin

• Low molecular weight hyaluronic acid (LMW-HA) stimulates healing at the source of inflammation
• NON-STEROIDAL safely manages skin irritations
• WATER BASED VEHICLE prevents dessication
• NON-SENSITIZING minimizes irritation potential

• Bionect can help delay and manage the signs and symptoms of irritation while creating an optimal environment for the skin healing process.
• Bionect is available in cream, gel and aqueous-base spray. Available by prescription only.
• Now announcing Bionect Spray, designed for hair bearing and hard to reach areas. Available in a 20 ml spray bottle.
• Bionect Cream and Gel are now available in an economical 100g tube.

For more details about Bionect, please visit the Bionect website.

Bionect Full Prescribing Information (pdf) – download

Bionect(R) Strengthens DARA’s Growing Portfolio of In-Licensed Oncology and Oncology Supportive Care Products

RALEIGH, N.C., March 26, 2012 (GLOBE NEWSWIRE) — DARA BioSciences, Inc. (Nasdaq:DARA) announced today that it entered into an exclusive agreement with Innocutis Holdings, LLC (“Innocutis”) for U.S. commercial rights to Bionect® (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology marketplace. Bionect® is an FDA-approved product indicated for the management of irritation of the skin as well as first and second degree burns. Bionect® is currently being promoted and sold by Innocutis in the dermatology market.

Bionect® is the third oncology-based agent DARA has licensed to date as part of its strategy to build a focused portfolio of niche opportunity products for the oncology and oncology supportive care markets. DARA expects to launch Bionect® in the second quarter of 2012.

David J. Drutz, MD, DARA’s President and Chief Executive Officer, stated, “The exclusive agreement with Innocutis for rights to commercialize Bionect® in both radiation oncology and medical oncology is an important step that provides DARA with an additional commercial opportunity and shows DARA’s ability to execute on its strategic plan for adding cancer and cancer-support products through ongoing licensing efforts. We believe there is considerable upside potential in the oncology supportive care market.”

The principal component of Bionect® is a patented low molecular weight hyaluronic acid, a biological polysaccharide which is a major component of the extracellular matrix of connective tissues. Bionect® is FDA approved for the treatment of skin irritation– a well-documented side effect of radiation and chemotherapy treatment.

Clinical studies have shown that as many as 90 percent of breast cancer patients treated with radiotherapy will develop some degree of radiation dermatitis. Researchers have also reported that therapeutic doses of radiation can cause persistent skin erythema, desquamation, rash, pain, itching and ulceration that increases the risk of infection. Chemotherapy has also been shown to significantly increase the severity of acute radioepithelitis. Thus, DARA believes that there is a significant need for Bionect in the oncology and radiation oncology markets.

Earlier this year, DARA obtained U.S. rights to Soltamox® and gemcitabine. Soltamox®, the only FDA approved oral liquid form of tamoxifen, is for breast cancer patients who have difficulty swallowing tablets or simply prefer a liquid form of this widely prescribed hormone blocking therapy. DARA intends to launch Soltamox® later this year. Gemcitabine posted $780 million in sales under the Lilly brand Gemzar® in 2010 and is still widely prescribed as a ‘gold standard’ chemotherapeutic for breast, ovarian, lung and pancreatic cancers. An ANDA filing for gemcitabine is planned for later this calendar year.

About Innocutis Holdings, LLC

INNOCUTIS is a pharmaceutical and medical device company specializing in the development and commercialization of therapies and devices focused on medical treatment of dermatological conditions. INNOCUTIS’ current products consist of an established portfolio of branded prescriptions as well as a novel surgical device for skin closure.

Contact at Innocutis:
Innocutis Holdings LLC
171 Church St., Suite 140
Charleston, SC 29401

About DARA BioSciences, Inc.

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA sharpened its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®. Soltamox® is a novel oral liquid formulation of tamoxifen, a product used widely in the treatment and prevention of breast cancer. Soltamox® is the only FDA approved oral liquid version of tamoxifen and fulfills a vital clinical need for patients who cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox® in the U.S. in the third quarter of 2012.

Prior to acquiring Oncogenerix, DARA was focused on the development of a cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic pain in patients with cancer. This product is an excellent fit with DARA’s strategic oncology focus and has successfully completed a Phase IIa study and has been designated as a Fast Track Drug by the United States Food and Drug Administration. We are working with the National Cancer Institute (NCI) to design an additional clinical trial under joint DARA-NCI auspices while considering further internal Phase 2 development.

In addition to its oncology products, DARA’s pipeline includes DB959, a novel, non-TZD dual delta/gamma, PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase I testing of DB959 and is presently pursuing opportunities to out-license this product. DARA also has rights to other PPAR and DPPIV-inhibitor compounds for which it intends to seek out-licensing or partnering opportunities.

For more information please visit the DARA BioSciences web site.

Safe Harbor Statement

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA’s ability to timely commercialize and generate revenues or profits from Bionect®, Soltamox® or other products given DARA’s lack of a current sales force and lack of history as a revenue-generating company, FDA and other regulatory risks relating to DARA’s ability to market Bionect®, Soltamox® or other products in the US or elsewhere, DARA’s ability to develop and bring new products to market as anticipated, DARA’s current cash position and its need to raise additional capital in order to be able to continue to fund its operations, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA’s intellectual property and the intellectual property of others, the potential delisting of DARA’s common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA’s ability to successfully integrate Oncogenerix and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission (“SEC”). Copies of DARA’s filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

Contact at DARA:
DARA Desk
Redington, Inc.
212 926-1733
203 222-7399

Charleston-based dermatology drug and device firm Innocutis Holdings LLC announced Monday that it has received a $6.5 million investment from a Florida venture capital fund.

Innocutis, which specializes in late-stage marketing, received the cash infusion from Ballast Point Ventures almost five months ago, around the same time the company changed its name from JSJ Pharmaceuticals Inc. Innocutis didn’t want to publicize it then for competitive reasons, according to Chief Operating Officer Jonathan Alba.

“We wanted to get the jump on some things, and it’s working well so far,” Alba said.

For instance, the money has enabled the company to hire about a half-dozen new sales representatives since the beginning of May, bringing its total staffing to about 35, Alba said. He said the company, roughly half of whose current employees are in Charleston, hopes to reach 45 or 50 employees by sometime next year “and take a breath there.”

The rest of the investment proceeds will be used to develop Innocutis’ products, which include a skin-stapling device and three main prescription drugs. Alba said Innocutis — “innovation of cutis, which in Latin is skin” — has “recommercialized” its skin cream Bionect within the past month and plans to release its second complementary surgical device in March.

“We’re really going to be changing the dynamics of the way that physicians practice medicine in the areas of skin cancer treatment and repair,” he said.

Alba and Innocutis CEO Joe Pecora, both medical sales veterans, were the two “J’s” in JSJ Pharmaceuticals when they founded the company in 2005 in Philadelphia. The pair moved to Charleston in 2007, and in the most recent fiscal year, revenues were $10 million.

Between the name change, the recent investment and the creation of the charitable Innocutis Foundation, “I guess you could say we’re growing up a little bit,” Alba said.

Ernest Andrade, director of the Charleston Digital Corridor, praised Ballast’s investment, which he called “real money” in a time of economic uncertainty. Andrade said it “opens up the doors” for other tech companies in the area to attract such investment, a sentiment Alba echoed.

“They said to me, ‘Look we’re coming to Charleston for board meetings, we’re invested and vested in Innocutis, and we want another reason to be there,” Alba said of Ballast, which is a joint venture between Raymond James Financial and the principals of South Atlantic Venture Funds. “They’re on the hunt.”