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Female Health Company and Aspen Park Pharmaceuticals announce merger

BY Michael Johnsen
CHICAGO – The Female Health Company on Wednesday announced that it has entered into a definitive merger agreement with Aspen Park Pharmaceuticals, a privately held company focused on the development and commercialization of oncology and men’s and women’s health therapeutics and consumer health products. 
 
“For FHC, this is a transformational merger, creating a powerful company with solid cash flows and a deep product development portfolio that serves multi-billion dollar industry segments,” stated O.B. Parrish, chairman and CEO of The Female Health Company. “More specifically, APP brings numerous late and early stage product candidates focused in the areas of oncology and men’s and women’s health, as well as a first-class experienced management team. Importantly, the strategic benefits of the transaction deliver on our objective to add a diversified and complementary mix of products that has the potential to substantially expand our revenue base and grow our business. We believe merging with APP is in the best interests of our shareholders, providing exciting new opportunities, while substantially mitigating the risks associated with being a single product company.”
 
“FHC has a long and dedicated history of improving the health and well-being of women around the world,” said Mitchell Steiner, CEO Aspen Park Pharmaceuticals and president and CEO of the combined company, upon closing. “The merger strategically joins a market-leading consumer health product that has been solidly profitable since 2006 with multiple high profile drug product candidates. I am excited by the prospect of advancing the combined company’s promising product development program, while at the same time expanding the market for FC2 and leveraging a state-of-the-art, modular manufacturing facility and global distribution network.”
 
The plan is to establish both a Men’s Health Division and a Women’s Health Division offering pharmaceuticals as well as consumer health products.
 
The Men’s Health Division will include:
 
  • APP-111, a novel, new chemical entity, being developed as a first-in-class oral chemotherapeutic agent that targets tubulin in men with advanced prostate cancer. U.S. market is estimated to be $5 billion annually;
  • Tamsulosin DRS, a novel oral formulation for men with benign prostatic hyperplasia and swallowing difficulties. U.S. market for alpha blockers for BPH is estimated to be $4.5 billion annually per IMS. Plan to file FDA new drug application in 2017;
  • APP-112, NCE, oral drug being developed for treatment of acute gout flares that has the potential to have a better safety profile than the currently used colchicine. U.S. market is estimated to be $725 million annually;
  • MSS-722, being developed as the first oral agent for the treatment of idiopathic male infertility. Orphan drug status pending. U.S. market is estimated to be $700 million annually;
  • APP-944, an oral drug being developed for the treatment of hot flashes caused by prostate cancer hormone therapies. U.S. market is estimated to be $600 million annually;
  • Preboost, OTC medicated individual wipes for reducing the incidence of premature ejaculation. U.S. premature ejaculation market is estimated to be $500 million annually per IMS. FDA OTC drug monograph compliant. Plan to launch product in fourth quarter of fiscal 2016; and
  • Sexual health vitamin and mineral supplement. Already formulated but not yet launched.
 
The Women’s Health Division will include:
 
  • APP-111, a novel, NCE, being developed also as a first-in-class oral anti-tubulin targeting chemotherapy for women with advanced breast or ovarian cancer;
  • FC2 Female Condom, the only currently available female condom that is FDA approved and cleared by the World Health Organization and under a women’s control. FC2 provides dual protection against unintended pregnancy and sexually transmitted infections, including HIV/AIDS and the Zika virus. The product generated approximately $33 million of net revenues in fiscal 2015;
  • Female sexual health lubricating and warming gel with niacin to enhance sexual activity.  Already formulated but FDA 510(k) approval needed; and
  • Sexual health vitamin and mineral supplement. Already formulated but not yet launched.
The proposed merger, subject to certain closing conditions, including approval by a two-thirds vote of FHC stockholders, is expected to close in the third quarter of 2016 and has been approved by the boards of both companies.
 
             
 
 
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Weis Markets launches Nutri-Facts program to augment healthier eating habits

BY Michael Johnsen
SUNBURY, Pa. – Weis Markets on Tuesday announced its new shelf tag program, Nutri-Facts. As part of this program, customers will see brightly-colored icons on pricing tags to help them easily identify the foods that meet their unique health and lifestyle needs.
 
“Weis Markets is committed to helping our customers live well. We can accomplish this goal by providing tools and resources on healthy eating and simplifying the process of finding nutritious foods in our stores,” stated Beth Stark, manager of lifestyle initiatives for Weis Markets. “Our Nutri-Facts program is designed to provide a snapshot of food products so that at a glance, a customer can determine if its nutrition or lifestyle profile fits their individual needs and the needs of their family.”
 
Using U.S. Food and Drug Administration and the United States Department of Agriculture guidelines, the Weis Dietitians developed 13 Nutri-Facts icons that include popular dietary and health identifiers that are in demand by customers, including organic, gluten free, whole grain, carb conscious, heart healthy, vegan, no added sugar, low sodium and vegan. Customers will have to look no further than the product pricing tag on the shelf to see what health and lifestyle attributes are associated the products.
 
The Weis Dietitian team also recently launched its Fresh for You and Superfoods programs. Fresh for You foods are hand-selected by the dietitian team based on nutritional profiles and will be flagged with a sign that provides helpful information on ways to incorporate the food into recipes and meal ideas. The Superfoods program highlights nutrient-rich foods that naturally contain significant amounts of vitamins, minerals and antioxidants. Customers will see signs for colorful superfoods signs throughout the store that offer tips for use.
 
Since 2003, Weis Markets has employed dietitians to provide resources to customers to help them lead a healthy lifestyle. The current team consists of four registered dietitians, two of which are based in Weis stores, that are readily available to answer customers’ food, nutrition and wellness questions.
 
 
 
 
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Pfizer introduces first and only biosimilar monoclonal antibody therapy

BY Michael Johnsen
NEW YORK – The United States Food and Drug Administration on Tuesday approved Celltrion’s Inflectra (biosimilar infliximab) across all eligible indications of the reference product, Remicade (infliximab). Inflectra is now the first and only biosimilar monoclonal antibody (mAb) therapy, and only the second biosimilar, to be approved in the U.S.
 
“The introduction of high-quality, effective biosimilars provides an opportunity to expand access to important medicines,” stated Salomon Azoulay, SVP and chief medical officer, Pfizer Global Established Pharma Business. “As a leading global biologics company with several biosimilar products in our pipeline, we appreciate the significance of this milestone in developing a pathway for biosimilars to come to market in the U.S., and in helping advance their adoption in the healthcare system.”
 
Hospira, now a Pfizer company, entered into an agreement with Celltrion and Celltrion Healthcare in 2009 for several potential biosimilar products, including Inflectra. Pfizer holds exclusive commercialization rights to Inflectra in the U.S. and certain other jurisdictions.
 
Inflectra is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease.
 
The FDA approval was based on the comprehensive data package submitted by Celltrion demonstrating a high degree of similarity between Inflectra and the U.S. reference product, Remicade. The FDA’s decision follows the Feb. 9, 2016 FDA Arthritis Advisory Committee’s recommendation to approve proposed biosimilar infliximab across all eligible indications, by a vote of 21-3.
 
“Our experience in other markets across the globe demonstrates that biosimilars can be a welcome option for patients, physicians and others,” noted Jenny Alltoft, head of global biosimilars, Pfizer. “Pfizer is proud to play a leading role in preparing the U.S. market for biosimilars. We are committed to bringing these important medicines to patients in the U.S. as quickly as possible. While launch timing for Inflectra will ultimately depend on a number of factors such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016.”
 
 
 
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