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Pfizer and Protalix BioTherapeutics announce approval of Type 1 Gaucher disease treatment

BY Michael Johnsen

NEW YORK — Pfizer and Protalix BioTherapeutics last week announced that the Food and Drug Administration approved Elelyso (taliglucerase alfa) for injection for pediatric patients.  Elelyso is therefore now indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
 
"The approval of Elelyso to treat pediatric patients with Type 1 Gaucher disease provides physicians another treatment option for this rare and potentially debilitating disease,” stated Rory O’Connor, SVP global medical affairs, Global Innovative Pharma Business at Pfizer. “This pediatric indication, along with the recent announcement that Elelyso received kosher certification by the Orthodox Union, reinforces the ongoing commitment of Pfizer to addressing the needs of the Gaucher community.”
 
The safety and efficacy of Elelyso were assessed in 14 pediatric patients with Type 1 Gaucher disease in two clinical trials. The recommended dosage of Elelyso for treatment of pediatric patients four years of age and older is 60 units/kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. 
 
Patients previously treated on a stable dosage of imiglucerase are recommended to begin treatment with Elelyso at that same dosage when they switch from imiglucerase to Elelyso. Dosage adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.
 
Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with Elelyso. The most common adverse reactions for Elelyso in clinical trials were itching, flushing, headache, joint pain, pain in extremity, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea and rash. Vomiting occurred more often in pediatric patients than adults. 
 
“While Type 1 Gaucher disease can manifest in childhood or adulthood, the disease more often presents during childhood,” noted Paige Kaplan, of the Section of Biochemical Genetics (Metabolic Diseases) at Children's Hospital of Philadelphia. “It is important that children with this disease have access to a range of FDA-approved treatment options that are effective.”  
 
As part of its ongoing commitment to helping address the unmet medical needs of people with rare diseases, Pfizer also offers a specialized support program — called Gaucher Personal Support — for people living with Gaucher disease. Pfizer GPS is a one-stop resource for personalized patient support and specialty pharmacy services for patients and healthcare professionals. Pfizer GPS employs a dedicated team of healthcare specialists who are available to help patients with Gaucher disease and their caregivers with reimbursement assistance, coordinating and locating infusion services and ongoing pharmacy support.  
 
Elelyso for injection is supplied as 200 units/vial and is available by prescription only. 
 
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Following disappointing quarter, Fred’s to shut 60 stores and focus on pharmacy

BY Michael Johnsen

MEMPHIS, Tenn. — In the wake of a disappointing second quarter, Fred's Super Dollar last week announced a series of initiatives, including the shuttering of 60 non-pharmacy stores and a stepped up focus on pharmacy.
 
"Our second-quarter results reflected the strategic decision the company has made to build our business model for the future as a convenience/pharmacy-centric store, driven by data-based inventory management," reported Bruce Efird, Fred's CEO. "The dynamic challenges we face surfaced in fourth quarter 2013 throughout our general merchandise and pharmacy departments. Customer trips came under pressure from internet intrusion, while generic drug price inflation ramped up faster than our payer increases were occurring," he said. 
 
"As a result, in January we undertook a deep analysis into all processes with a recognition that retail will not continue with business as usual and changes will have to take place," Efird added. "From this thinking came key changes that will drive the transformation of the stores to a convenience/pharmacy-centric store, which began the in the second quarter."
 
Those changes included:
 
  • An acceleration of pharmacy acquisitions that will help Fred's achieve a target of reaching a 65% to 70% penetration rate of stores with a pharmacy. Fred's derived 40.4% of its sales from pharmaceuticals in the second quarter, compared with 36.4% for the same period a year ago;
  • The initiation of a new marketing plan, directed at driving customer traffic through multiple avenues, including expanded ad circulars and in-store programs;
  • The utilization of data-driven inventory and category-management tools and metrics;
  • Process changes to distribution and store procedures to get inventory directly from the truck to the store floor in the same day;
  • Expanded leadership throughout the organization, particularly in merchandising sourcing, store operations and information technology; and
  • The decision to close a greater number of stores that do not fit the thresholds of the convenience/pharmacy-centric store model, allowing a reallocation of capital.
 
That expanded leadership included naming Jerry Colley as Fred's EVP store operations; Ken Donahue as SVP and chief information officer; Craig Barnes assumed the role of SVP global sourcing and hardlines merchandising responsibility; and Kelly Ma joined Fred's as VP international and domestic sourcing.
 
"Although we were disappointed in second quarter financial results, there were several key wins in the quarter," Efird noted. "We saw improvement in general merchandise sales and customer traffic from our new marketing program, which indicates positive traction for the future, [and] in pharmacy, we completed the prime vendor agreement that has substantial benefits to all aspects of our pharmacy operations and our specialty division, with components needed to support our accelerated investment in pharmacy acquisitions."
 
Following the second quarter results, the dollar store/pharmacy hybrid announced several forward-looking operational changes, including:
 
  • Addressing low-productive inventory that does not fit Fred's go-forward store model;
  • The closing of 60 stores that have no pharamcies and do not meet operational performance targets;
  • Supply chain and operational improvements at stores to improve productivity and remove costs associated with excessive inventory;
  • Expanded general merchandise product sourcing capabilities; and
  • The transition to a new pharmacy prime vendor agreement with Cardinal Health.
 
And Fred's pharmacy business going forward is looking up. "We anticipate the improved script comp performance we’re seeing each month during the first half of year to continue and even accelerate in the second half as many of our growth initiatives matures," Efird told analysts last week. "For example, we’re ahead of schedule on our Time My Meds program, which is an appointment-based model to drive improved patient compliance and adherence. We’ve already exceeded our patient enrollment goal by over 40%, and we’re beginning to see benefits, [such as] improved script comp."
 
Fred's total sales for the second quarter of fiscal 2014 increased 2% to $491.2 million. On a comparable-store basis, second-quarter sales decreased 0.1%. Fred's total sales for the first six months of fiscal 2014 increased 1% to $989.4 million. Six month same-store sales decreased 1%. 
 
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Carma Labs taps actress Shay Mitchell to represent Carmex line

BY Michael Johnsen

MILWAUKEE — Carma Laboratories last week announced its partnership with actress Shay Mitchell, who is best known for her role as Emily Fields on the ABC Family series "Pretty Little Liars."
 
"We're excited to partner with someone who loves this product as much as we do," stated Paul Woelbing, president of Carma Laboratories, the maker of Carmex products. "Shay's love of fashion and beauty products makes her the perfect fit for our Moisture Plus lip balm line. Her style exemplifies the trendy, chic user that we envisioned when we designed and created this line, and we look forward to working together."   
 
Mitchell first appeared in the Canadian teen drama series "Degrassi: The Next Generation," and was later a guest on the global series "Rookie Blue," before being cast in her role on "Pretty Little Liars." In addition to building and maintaining a successful career, Mitchell is also a passionate philanthropist, actively supporting multiple nonprofits, such as Free the Children, which is dedicated to helping children in developing countries.
 
"I have grown up using Carmex, so I'm very excited about all of the fashionable new design options that are now available with the Moisture Plus fall line," Mitchell said. "Having fun is an important aspect of my beauty routine, and lip care is essential. Using a cute product with designs to complement my daily style makes it even better."
 
Carmex Moisture Plus lip balm packs a moisturizing satiny shine, SPF 15 and a soft vanilla flavor. The fashion-inspired exteriors appeal to a variety of unique styles with personalities to match, including Fab in a brightly colored pattern, Chic in classic black & white, Whimsical in a teal dandelion design and Adventurous in a multi-colored bird print. "We introduce limited-edition designs four times a year, so consumers can expect to see fun new sets of fashionable sticks regularly at their favorite retailer," said Jona Mancuso, senior marketing manager at Carma Laboratories.
 
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