Recent Developments

Allergan-Pfizer Deal Terminated

Allergan and Pfizer have mutually agreed to end their merger agreement, according to a statement from Allergan. Pfizer has agreed to pay Allergan $150 million in reimbursement for expenses associated with the transaction. The announcement came shortly after the US Treasury Department’s new anti-inversion regulations were announced.

Dublin-based Allergan reiterates in the statement its growth opportunities, highlighting over 70 mid-to-late stage projects in development. The company says it is positioned to drive strong, sustainable growth through leading franchises, new potential product launches, and its pipeline.

“While we are disappointed that the Pfizer transaction will no longer move forward, Allergan is poised to deliver strong, sustainable growth built on a set of powerful attributes. Leading therapeutic franchises with strong brands across seven therapeutic areas provide the foundation for continued strong growth in 2016 and beyond. Our pipeline is one of the strongest in the industry, loaded with 70 mid-to-late stage programs including 14 expected approvals and 16 regulatory submissions in 2016 alone,” said Brent Saunders, CEO and President. “Allergan is focused on delivering growth from an efficient operating structure while also being committed to investing in R&D through our Open Science model. The Company is also poised to deliver additional growth opportunities from its attractive financial profile and balance sheet, propelled by approximately $40.5 billion pre-tax from the sale of our Actavis Generics business to Teva, expected to close in June 2016.”

Based on a preliminary review of the proposed regulations outlined in the US Treasury Notice, Allergan believes that the regulations will have no material impact on the Company’s standalone tax rate. Allergan plans to report its first quarter earnings in its normal timelines by May 10, where it will also provide an update on its plans to simplify the company’s operations post the close of the Teva transaction.

FDA Greenlights Taltz for Psoriasis

The FDA approved IL-17A blocker Taltz (ixekizumab) for adults with moderate-to-severe plaque psoriasis. Taltz is marketed by Eli Lilly and Company. Given via 80 mg/mL injection, Taltz’s active ingredient is an antibody (ixekizumab) that binds to a protein (interleukin (IL)-17A) that causes inflammation. It is intended for patients who are candidates for systemic therapy, phototherapy, or a combination of both.

Taltz’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature, and severity of psoriatic changes of the skin.

Taltz is being approved with a Medication Guide to inform patients about risk of infection or allergic or autoimmune condition. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with use. The most common side effects include upper respiratory infections, injection site reactions, and tinea infections.

FDA Approves Inflectra, a Biosimilar to Remicade

The FDA approved the biosimilar Inflectra (infliximab-dyyb) for multiple indications. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. This is the second biosimilar approved by the FDA.

Inflectra is administered by intravenous infusion. The biosimilar is manufactured by Celltrion, Inc.

Inflectra can be prescribed by a healthcare professional to treat:

• patients with active psoriatic arthritis;
• adult patients with chronic severe plaque psoriasis;
• adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
• adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;
• patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
• patients with active ankylosing spondylitis (arthritis of the spine)

The FDA’s approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade. Inflectra has been approved as biosimilar, not as an interchangeable product.

The most common expected side effects of Inflectra include respiratory infections and stomach pain. Infusion reactions can happen up to two hours after an infusion. Symptoms of infusion reactions may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash and itching.

Inflectra contains a Boxed Warning to alert healthcare professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and others. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products such as Inflectra.

Other serious side effects may include liver injury, blood problems, lupus-like syndrome, psoriasis, and in rare cases nervous system disorders.

Dupilumab Improves Symptoms in Moderate-to-Severe AD

Dupilumab helps improve the signs and symptoms of moderate-to-severe atopic dermatitis (AD) in adults, according to two late stage clinical trials. The FDA granted dupilumab Breakthrough Therapy designation in AD in November 2014. US regulatory submission for dupilumab is planned for Q3 2016.

Regeneron and Sanofi’s dupilumab is an investigational fully human monoclonal antibody that blocks interleukin-4 receptor alpha subunit (IL-4Ra). Through this effect, it also blocks IL-4 and IL-17, which are known to drive the type 2 helper T-cell–mediated inflammation that is responsible for the hallmark symptoms of AD.

In the studies, known as LIBERTY AD SOLO 1 and SOLO 2, treatment with dupilumab monotherapy significantly improved measures of overall disease severity, skin clearing, itching, quality of life, and mental health.

A total of 1,379 adult patients with moderate-to-severe AD were enrolled in the identically designed SOLO 1 and SOLO 2 trials. Patients were enrolled if they were not adequately controlled with topical medications, or if topical treatment was not medically advisable. All patients were assessed via the 5-point Investigator’s Global Assessment (IGA) scale, ranging from 0 (clear) to 4 (severe); entry criteria required a baseline score of 3 or 4. Patients were also assessed using the Eczema Area and Severity Index (EASI) and other measures. Patients were randomized into one of three treatment groups: dupilumab 300mg subcutaneously once per week, dupilumab 300mg subcutaneously every two weeks, or placebo for 16 weeks following an initial dupilumab loading dose of 600 mg subcutaneously, or placebo.

For SOLO 1 and SOLO 2, respectively, 37 and 36 percent of patients who received dupilumab 300 mg weekly, and 38 and 36 percent of patients who received dupilumab 300mg every two weeks, achieved clearing or near-clearing of skin lesions (IGA 0 or 1), compared to 10 and 8.5 percent with placebo (p less than 0.0001). This was the primary endpoint of the study in the US.

For SOLO 1 and SOLO 2, respectively, the percent improvement in EASI from baseline was 72 and 69 percent in patients who received the 300 mg weekly dose, and 72 and 67 percent for patients who received dupilumab 300mg every two weeks, compared to 38 and 31 percent for placebo (p less than 0.0001).

For SOLO 1 and SOLO 2, respectively, 52.5 and 48 percent of patients who received dupilumab 300mg weekly, and 51 and 44 percent of patients who received dupilumab 300mg every two weeks, achieved EASI-75 compared to 15 and 12 percent with placebo (p less than 0.0001). This was the key secondary endpoint in the US and one of the primary endpoints in the EU.

For the 16-week treatment period, the overall rate of adverse events (65-73 percent dupilumab and 65-72 percent placebo) was comparable between the dupilumab groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for dupilumab and 80.5-82 percent for placebo. The rate of serious adverse events was one to three percent for dupilumab and five to six percent for placebo. Serious and severe infections were also numerically higher in the placebo groups in both studies (0.5-one percent dupilumab and two to three percent placebo). Adverse events that were noted to have a higher rate with dupilumab treatment across both studies included injection site reactions (10-20 percent dupilumab; seven to eight percent placebo) and conjunctivitis (seven-12 percent dupilumab; two percent placebo); approximately 26 percent of patients in both studies reported a history of allergic conjunctivitis at study entry. No patient discontinued therapy due to injection site reactions and only one patient discontinued therapy due to conjunctivitis.

FDA Clears Venus Versa for 20-Plus Common Clinical Indications

The FDA cleared Venus Concept’s Venus Versa system for skin rejuvenation, hair removal, facial wrinkles and rhytides, skin resurfacing, pigmented and vascular lesions, and acne vulgaris. Venus Versa combines Intense Pulsed Light, SmartPulse technology, Multi-Polar Radio Frequency, Pulsed Electro Magnetic Fields, and Nano-Fractional Radio Frequency via SmartScan technology to address more than 20 common skin concerns.

More Than 1,000 Patients Join Corrona Psoriasis Registry

The Corrona Psoriasis Registry, a joint collaboration between the National Psoriasis Foundation (NPF) and Corrona, LLC, now includes more than 1,000 patients from 100 sites.

Dermatologists assess registry patients every six months during routine visits and fill out a comprehensive questionnaire. Patients participating in the registry are tracked for at least eight years, and the information collected will be used by researchers to compare the safety and effectiveness of psoriasis treatments, study diseases associated with psoriasis, and better understand the natural history of the disease.

“The achievement of these milestones demonstrates the potential impact of this unique resource for the psoriasis community, providing us with real world data on novel psoriasis treatments,” says Mark Lebwohl, MD, scientific co-director of the Corrona Psoriasis Registry, and chairman emeritus of the NPF Medical Board, in a news release.

Going forward, Corrona expects to add more than 200 dermatology sites to the network of sites. Interested dermatologists can email psoriasis@corrona.org for more information.

Galderma, Mentor Worldwide, LLC Set to Collaborate

Galderma and Mentor Worldwide LLC, are joining forces to increase awareness and provide a broader range of offerings to healthcare providers and patients seeking aesthetic injectable treatments and breast enhancement.

Data show up to 33 percent of women who had injectable treatments also had breast augmentation, according to 2014 research by Bain & Company.

The new collaboration will include Galderma’s aesthetic brands, including the Restylane family of fillers, Dysport (abobotulinumtoxinA) 300 units for Injection and Sculptra Aesthetic, along with the MENTOR MemoryShape and MENTOR MemoryGel Breast Implants portfolio, for the US aesthetics (non-reimbursed) market.

The two companies will look for opportunities to leverage market growth strategies to benefit both healthcare providers and consumers. For Galderma, this will include ASPIRE Galderma Rewards loyalty program. n

Take 5

With Diane Goostree, President & CEO, Alastin Skincare

Buzz about the relative newbie Alastin Skincare was palpable at the recent American Academy of Dermatology (AAD) meeting in Washington, DC. This skincare line came out of the gate fast with the July 2015 launch of their initial Procedure Enhancement System, and has been steadily generating headlines ever since. In the days leading up to the AAD, the company announced their new eight-member scientific council and tapped Allergan vet Lynn Salo for the board of directors, leaving industry watchers wondering what’s next. President and CEO Diane Goostree comments.

1. A-list Advisors

“We are very excited to be working with key opinion leaders in the aesthetic dermatology and plastic surgery areas. Our group includes Vivian Bucay, MD, Doris Day, MD, Sabrina Fabi, MD, Jeannette Graf, MD, Alexander Rivkin, MD, Amy Forman Taub, MD, Randy Waldman, MD, and Heidi Waldorf, MD. The Scientific Advisory Council will work with Alastin Skincare on both the currently marketed Alastin Procedure Enhancement System, as well as new products in development. We will be consulting with them as we seek ways for our products to be introduced and incorporated with various procedures.”

2. The Alastin Niche

“We have seen a continuing evolution of patients who are moving toward less invasive procedures, and there is a need for synergistic products that boost results. This is our sweet spot with our current product line. There are so many ‘anti-aging’ products, but there hasn’t been anything in the pre-, peri- and post-procedure realm that works well. There is a growing need for products that can be used in combination with procedures, in between procedures and even before procedures to prepare the skin to maximize results and speed healing. Our concept of ‘recycling the extracellular matrix’ focuses on skin bed preparation prior to a rejuvenating procedure. For example, our Skin Nectar can be applied prior to a procedure to prepare it to receive a treatment, and then immediately post-procedure for faster recovery and healthier looking skin. Our product is also designed to trigger the body’s own natural production of elastin as well as collagen to improve the overall appearance of the skin.”

3. An “Exciting Time”

“It’s a very exciting time at Alastin Skincare. We are receiving positive feedback on the results of the Alastin Procedure Enhancement System, and we are just starting to get samples of our new anti-aging Restore and Renew line to our advisory council. The Alastin Restore and Renew line is slated to be introduced in Q2 2016.”

4. Robust Pipeline

“We plan to grow our sales force and continue to expand in key markets of the country in the coming months. Our pipeline grows every week as far as concepts. We expect to have a number of new products over the next two years. Our strategy is to continue to evolve our science to differentiate us and develop new products to address patients’ major skin concerns, whether aged skin, aging eye appearance, excess pigmentation, effective sun protection, or the desire for products that enhance rejuvenating procedure outcomes.”

5. Sound Science

“We are receiving a significant level of interest related to our science. Our technology is very new and different. Not only are we stimulating collagen deposition, we are the first product line that has demonstrated additional elastin deposition, and improvement in the extracellular matrix. The key to this is our patent-pending formulation with Alastin TriHex Technology, which is focused on clearing the Extracellular Matrix (ECM) and stimulating both collagen and elastin production.

“We have incorporated selected peptides along with other complementary ingredients, and have conducted biopsy studies to demonstrate the formulation does penetrate the skin and begins to quickly generate positive effects. We are starting to see a recycling of the extracellular matrix, and enhanced deposition of collagen and elastin in just two to three weeks with regular use.” n