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Zika Virus Update

A Q&A with an expert virologist

The Zika virus has been all over the news of late, but what do we really know about this mosquito-born illness and how it is transmitted?

Here, Zika expert Leslie Lobel M.D., Ph.D., a virologist in the Department of Microbiology, Immunology and Genetics at Ben Gurion University of the Negev in Beer Sheva, Israel, helps us separate the facts from our fears.

Q.: Just how concerned should we be about Zika in the US?

A.: “You do not need to be to concerned at the present time as the virus has not entered the ecosystem. Regarding Zika in general, too little is known at present regarding cause and effect of viral infection. Zika virus infection is fairly mild and is not of great concern. However, caution is advised for pregnant women due to the compelling association between viral infection and microcephaly. For now, the most at risk are pregnant women and those contemplating pregnancy who live in or will be traveling to affected geographic regions. The hysteria surrounding Zika is simply far ahead of the research and facts.

Q. Have we ever seen Zika in the US before?

A. Although we haven’t seen it in the US before, it was not routinely tested for and has, until now, only produced a mild illness. 

Q. There was a recent reports that the virus was transmitted sexually in Dallas, Texas. Is sexual transmission common?

A. “This is not known. In epidemic regions, it will be hard to tell as transmission by mosquito is probably more likely. We don’t know how frequent this mode of transmission might be. Precautions are advised for couples in affected regions or who travelled to affected regions. “

Q. What do we need to get ahead of a potential epidemic?

A. “There is an urgent need for much research and vaccine development so that we are prepared for a changing virulence and global footprint of the virus. “


• The most common symptoms of Zika virus disease are fever, rash, joint pain, and conjunctivitis.

• A total of 35 travel-associated Zika virus disease cases have been reported to federal Centers for Disease Control and Prevention (CDC) as of Feb 3, 2016.

• There are no commercially available diagnostic tests for Zika virus disease.

• Report suspected Zika cases to your state or local health department to facilitate diagnosis and lower the risk of local transmission.


Pfizer Outlines Post-Allergan Deal Leadership Team Changes

Brent Saunders will become President and COO of the combined Pfizer and Allergan following the close of the merger deal. He will over see the company’s combined commercial businesses, manufacturing and strategy functions.

The combined company will create a new operating segment, Global Specialty and Consumer Brands, that will include Pfizer’s Consumer Healthcare unit and Allergan’s ophthalmology and aesthetics businesses and Botox Therapeutic. Bill Meury, currently Executive Vice President and President Branded Pharma at Allergan, will become Group President, Global Specialty and Consumer Brands, Pfizer.

After the close of the proposed transaction, Pfizer will continue to manage the combined company’s commercial operations through an Innovative Products business and an Established Products business. The Innovative Products business will be composed of the Global Innovative Pharmaceutical and the Global Specialty and Consumer Brands segment. The Established Products business will continue to be led by John Young, and consist of the Global Established Pharmaceutical segment, including all legacy Hospira commercial operations.


Novan Announces Robert A. Ingram as Chairman. Novan, Inc. named Robert A. Ingram as Chairman of the Board of Directors of Novan. In addition, Robert Keegan has been appointed to the Board of Directors. The company also announced that it received $32.8 million of net proceeds in a private Mezzanine B financing in December 2015 from its private investor network originating throughout the Research Triangle area of North Carolina. Following the financing, Neal Hunter, Novan’s founding investor, and Mark Schoenfisch, the Company’s co-founder, have resigned from the Board after eight and 10 years of service, respectively.

SENTÉ Raises $5 million, Appoints New CEO. Fresh off the announcement SENTÉ closed on a $5 million financing round, the company appointed Laurent Combredet as President and Chief Executive Officer. SENTÉ plans to use the new financing to increase their domestic sales force, support the launch of new products, pursue international expansion and invest in new technologies.

Alastin SkinCare Appoints Lynn Salo to Board of Directors. Lynn Salo is now a member of ALASTIN™ Skincare, Inc.’s board of directors. Ms. Salo has 27 years of experience with Allergan in the U.S., Canada, and Europe, including her role as Vice President, Sales and Marketing for the Facial Aesthetics Division.

Rosacea, Glioma Linked: Are MMPs the Common Denominator?

Rosacea may increase risk for glioma, according to a nationwide cohort study in Denmark. Findings, published online in JAMA Dermatology, suggest that an increased focus on neurologic symptoms in patients with rosacea may be warranted.

Exactly how the two conditions are linked is not fully undersood. “This association may be mediated, in part, by mechanisms dependent on matrix metalloproteinases,” study authors write. Rosacea has a poorly understood pathogenesis in which increased matrix metalloproteinase (MMP) activity might play an important role. Glioma accounts for 80 percent of all primary malignant tumors in the central nervous system, and these tumors also show upregulation of certain MMPs, they note.

A total of 5,484,910 individuals were eligible for analysis in this cohort study; of these, 68,372 had rosacea and 5,416,538 constituted the reference population. Of the 5,484,910 individuals in the study population, 21,118 individuals developed glioma during the study period, including 20,934 of the 5,416,538 individuals in the reference population and 184 of the 68,372 patients with rosacea. The incidence rate (95% CI) of glioma was 3.34 (3.30-3.39) in the reference population and 4.99 (4.32-5.76) in patients with rosacea. The adjusted incidence rate ratio (95% CI) of glioma in patients with rosacea was 1.36 (1.18-1.58) in the primary analysis. The adjusted incidence rate ratio was 1.82 (1.16-2.86) when analyses were limited to patients with a primary diagnosis of rosacea by a hospital dermatologist (n = 5,964).

Otsuka Licenses Investigational AD Treatment to Medimetriks

Otsuka Pharmaceutical Co., Ltd. and Medimetriks Pharmaceuticals, Inc. have entered into a licensing agreement granting Medimetriks exclusive development, manufacturing and commercialization rights for OPA-15406 in the US and Puerto Rico. OPA-15406 is a topical, non-steroidal phosphodiesterase IV (PDE-4) inhibitor for atopic dermatitis that demonstrated clinically significant results versus placebo and appeared to be safe and well tolerated in Phase 2 studies.

Under the terms of the new agreement, Otsuka will receive an upfront payment of $22 million from Medimetriks and additional milestones through NDA approval. In addition, Otsuka will receive sales royalties. Medimetriks will fund and be responsible for Phase III US studies.

Valeant: FDA Accepts BLA for Brodalumab

The FDA has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.

The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted that brodalumab has an effective mechanism of action that could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210 mg dose, brodalumab was shown to be effective in total skin clearance of psoriasis compared to placebo and superior to ustekinumab, a leading approved psoriasis treatment, at week 12 in two replicate comparator trials involving over 3,500 patients.

Promius Receives FDA Approval for Sernivo Spray for Psoriasis

Dr. Reddy’s US subsidiary Promius Pharma received FDA approval for Sernivo (betamethasone dipropionate) Spray 0.05%. Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

Promius has conducted two successful multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10-20 percent, and an Investigator Global Assessment (IGA) score of 3 (moderate). Treatment success was achieved in significantly more subjects using Sernivo than Vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo achieved treatment success of 42.7 percent and 34.5 percent compared to vehicle success rates of 11.7 percent and 13.6 percent, respectively.

FDA Approves Two New indications for Cosentyx

The FDA has approved Cosentyx® (secukinumab, Novartis) for two new indications—the treatment of adult patients with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

The approvals are based on the efficacy and safety outcomes from two AS and two PsA placebo-controlled Phase III studies which included more than 1,500 adult patients with either AS or PsA. In the studies, Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of AS and PsA, as measured by at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively. ASAS20 and ACR20 are standard tools used to assess clinical improvement in AS and PsA. The safety profile is consistent across the three approved indications.

FDA Awards Tentative Approval for Zenavod to Treat Rosacea

The FDA awarded Dr. Reddy’s Laboratories’ tentative approval for Zenavod™ (doxycycline) Capsules, 40mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.Promius will be responsible for commercializing Zenavod in the US market.

Study Shows Novel Effects of Eucerin Active Ingredient Complex on AD

Beiersdorf researchers in collaboration with the Dermatological Clinic of the University of Lübeck have shown in a double-blind clinical study that the AtopiControl ingredient complex including licochalcone, a from the licorice root and omega-6 fatty acids from evening primrose oil and grape seed oil is much more than just a common basic care product.

Over the course of up to 84 days, adult volunteers with a history of mild to moderate AD, who were symptom free at baseline, applied either AtopiControl lotion or lotion base without active ingredients in a blinded way. “Compared to the lotion base, the AtopiControl lotion led to a significantly longer symptom-free interval until the next acute flare. We were able to prove, for the first time, that the symptom-free interval in cases of atopic dermatitis can be extended by medical skin care actives,” says Beiersdorf researcher and physician Dr. Frank Rippke.

The study results were presented in October 2015 at EADV in Copenhagen and will be published in a journal.

Antiperspirant, Deodorant Use Disrupts Microbiome

Wearing antiperspirant or deodorant may influence the type and quantity of bacterial life found in the armpit’s microbiome, new research published in the journal PeerJ suggests.

Researchers recruited 17 study participants: three men and four women who used antiperspirant products; three men and two women who used deodorant; and three men and two women who used neither product.

On day one, participants followed their normal hygiene routine in regard to deodorant or antiperspirant use. On days two through six, participants did not use any deodorant or antiperspirant. On days seven and eight, all participants used antiperspirant.

Researchers cultured samples taken daily from the subjects to determine the abundance of microbial organisms growing on each participant and how that differed day to day.

Once all participants began using antiperspirant on days seven and eight, there were very few microbes on any of the participants, verifying that these products dramatically reduce microbial growth.

Using genetic sequencing on all of the samples from days three and six, researchers found that, among study participants who hadn’t worn deodorant or antiperspirant, 62 percent of the microbes they found were Corynebacteria, followed by various Staphylococcaceae bacteria (21 percent), with a random assortment of other bacteria accounting for less than 10 percent. Corynebacteria are partially responsible for producing the bad smells we associate with body odor, but they are also thought to help us defend against pathogens. Staphylococcaceae are a diverse group of bacteria that are among the most common microbes found on human skin and, while some can pose a risk to human health, most are considered beneficial.

Of participants who had been regular antiperspirant users coming into the study, 60 percent of their microbes were Staphylococcaceae, 14 percent were Corynebacteria, and more than 20 percent were filed under “other.” n

Take 5

with Bill Humphries, President and CEO, Merz North America, Inc.

It was rough getting out of the gates for Merz back in 2012. The company was hit with a 10-month injunction by Allergan just as they were set to launch Xeomin (incobotulinumtoxinA), their Botox competitor, at a major medical meeting, but that was then. Things are looking up for Merz these days. By all counts, 2015 was a banner year with opening of their North America headquarters in Raleigh, NC, US Food and Drug Administration (FDA) approval for Radiesse for hand augmentation to correct volume loss in the dorsum of the hands and 501-k clearance of Cellfina for the long-term improvement in the appearance of cellulite on the buttocks and thighs.

1. Much More to Come from Merz in 2016 and Beyond

“The plan is for all the flavors of Belotero® to come to the US, much like we have in Canada and Europe. This was the plan when Merz acquired Anteis 2013. One of the advantages of Belotero is that it can be injected without Tyndalling. We are excited to extend this benefit with the addition of new site-specific fillers. Belotero® Hydro, Belotero® Soft , Belotero® Intense and Belotero® Volume will join Belotero® Balance in the US . Most of the line is also available with lidocaine. There will also be more Neocutis SKUs coming soon. The most recent addition to this family of anti-aging products is Neocutis’ Micro-Firm Neck and Décolleté Rejuvenating Complex, and it will be available in March 2016. We plan to keep the dispensing market fresh with new products and new technology.“

2. More Activity on the Device Front, Too

“For Ultherapy, expect an advance that significantly reduces treatment time in the coming months. We will also be releasing three-year data on Cellfina and it looks really good. I think we will also be seeing more combinations of existing non- or minimally invasive procedures such as Ultherapy for skin tightening and Coolsculpting CoolMini for submental fat reduction, or CoolSculpting for fat reduction in the thighs, followed by Cellfina to treat cellulite.”

3. Xeomin Continues to Steal Market Share

“When patients come in to the doctor’s office today, they come in asking for Botox. Having a discussion about the differences and similarities between Botox and alternatives like Xeomin can be overly time-consuming for physicians. Our new rebate program will encourage patients to try Xeomin. Through the Xperience Program, we offer patients a $100 Visa rebate to be used toward their next Xeomin treatment. We are promoting this through social media and an influencer campaign. We are also boosting the impact of our physician loyalty program -My Merz Select. We successfully added Neocutis, Cellfina and transducers for Ulthera to the program. Our doctors are now universally rewarded. The rewards are based on breadth and depth. The more products, the better the discounts. We are looking for broad and deep partners.”

4. Searching for The Next Big Thing in Aesthetics

“In the past, hair and nails were in the budget, and toxins and fillers were a splurge, but today, toxins and fillers are in the budget and anything off of the face is the splurge such as non-invasive fat reduction or Radiesse for hands.

There are plenty of acquisitions we would like to make. We are seeking outstanding ideas and promising technologies in aesthetics that are capable of generating a high level of consumer interest, with a specific focus in anti-aging, skin rejuvenation and body-shaping or sculpting technology. The Merz Corporate Venture Capital Initiative allows us to offer up initial funding to such technologies. in the early stages of development. This could be alone, or in conjunction with other venture capital and investment funds. We also provide extensive experience and a global network that allows our partners to work closely with management teams and fellow investors to create significant value.”

5. The Secret to Merz’ Success

“Merz is a privately owned pharmaceutical company headquartered in Germany, and Germany gives us a fair amount of autonomy so we can operate and be nimble. We also have really good people working together now. The collegial and collaborative feel sets us apart. We pulled two leadership teams together to create one Merz with one leadership, and from there, we started to build and attract talent. I thrive on catching people doing things right and empowering people. We don’t fix the blame, we fix the problem. We are just getting started.” n

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