PHARMACY

GSK’s Shingrix proven effective in immune-compromised patient populations

BY Michael Johnsen

GlaxoSmithKline on Wednesday announced that new data from a Phase III clinical study supports the safety and efficacy of Shingrix ((Zoster Vaccine Recombinant, Adjuvanted) in preventing shingles (herpes zoster) when given to adults 18 years and above shortly after undergoing autologous haematopoietic stem cell transplant (auHSCT).

“The immune systems of these stem cell transplant recipients is substantially weakened compared to the general older adult populations studied in other Shingrix efficacy trials,” Emmanuel Hanon, senior vice president and head of vaccines R&D for GSK said. “This puts them at much higher risk for viral diseases like shingles and, at the same time, makes developing an effective vaccine to help protect them more challenging. Today’s results, demonstrating the vaccine’s ability to help prevent shingles and its complications with just two doses, may provide a much-needed benefit to these patients considering the high incidence and burden of disease they face.”

GSK is evaluating these results together with those of other Phase III studies in immune-compromised patient populations. All these data will be shared and discussed with regulatory as well as public health agencies with the objective of best informing health care providers on the use of Shingrix in those patients with greatest medical need.

Shingrix is a non-live, recombinant adjuvanted subunit vaccine given intramuscularly in two doses and is the first shingles vaccine to combine a non-live antigen, to trigger a targeted immune response, with a specifically designed adjuvant to generate a strong and sustained immune response.

Shingrix is now approved in Canada and U.S. for the prevention of herpes zoster in adults aged 50 years and above. Regulatory reviews are currently underway in the European Union, Australia and Japan.

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Fred’s mulls putting specialty business on auction block amid Q3, YTD losses

BY David Salazar

In its third quarter, Fred’s reported a $51.8 million loss — an increase over the $38.4 million loss it reported in Q3 2016. As it works to pay off its debt, the company canceled its quarterly dividend and said it is exploring strategic alternatives for non-core businesses, including its specialty pharmacy business and real estate. It’s also updating its share repurchase program.

The Memphis-based company noted that the Q3 loss reflected the $17.1 million impact of an unproductive inventory write-down, the $5.2 million impact of advisory fees associated with its turnaround strategy and $2.6 million from asset impairment for the sale of its corporate airplane, among other factors.

Fred’s CEO Mike Bloom noted that the company also was impacted by its aggressive inventory reduction, as well as the timing of shipments of high-margin seasonal merchandise — leading to inventory levels almost $50 million below its prior-year period. He said that the company’s board of directors was working to ensure the company’s profitability and growth.

“In the third quarter, we furthered our efforts to turn around the Company, and we are encouraged by our positive front store comp sales in both October and November,” he said. “We are aggressively executing our turnaround strategy to accomplish these goals, and we are seeing traction in both front store and pharmacy. We have witnessed a complete turnaround in our tobacco business, significantly enhanced cosmetics and successfully rolled out beer to approximately 150 stores and wine to approximately 50 stores. We have also kicked off a reduced price endcap test, which is showing promising results, and we intend to roll it out to all stores.”

Bloom noted that Fred’s is not yet in a place where it’s displaying positive quarterly comparable-store sales and improved store traffic. For the quarter, Fred’s posted $493.6 million in net sales, down 4.5% from last year’s third quarter. The company said this dip was driven by the closure of 39 underperforming stores being closed earlier in the year. Comps dipped 0.8%, compared with a 3.8% drop in the prior-year period. Comps saw the negative 36-basis-point impact of discontinuing low productive discontinued inventory, Fred’s said. Gross profit dropped to $94.6 million from $111.2 million in the year-ago period, also attributed to shuttered stores. Gross margin decreased 230 basis points to 19.2% from 21.5%.

For the first nine months of 2017, Fred’s reported a net loss of roughly $117.8 million, which included the $37.3 million impact of fees incurred in relation to its proposed acquisition of Rite Aid stores, as well as the implementation of its turnaround strategy, among other factors. Fred’s said the closure of 39 stores and planned closure of 13 stores and pharmacy departments as part of its asset management chainwide had a $16.3 million impact. The company’s net loss in the year-ago period was $44.1 million.

Fred’s also has canceled its quarterly cash dividend in an effort to retain cash flow for debt reductions and has amended its stock repurchase program to allow the repurchase of as much as 3.8 million shares of its common stock.

“We believe that we now are in a position to further enhance our strategic plan by exploring a variety of strategic initiatives and by investing in our common stock which we believe, given current share prices, represents an attractive use of funds and provides us an additional opportunity to build long-term value for our shareholders,” Bloom said.

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The Gates Foundation, NIH and J&J work together on HIV vaccine

BY Michael Johnsen

On the eve of World AIDS Day (Dec. 1), Johnson & Johnson announced that its Janssen Pharmaceutical Companies together with a consortium of global partners have initiated the first efficacy study for an investigational mosaic HIV-1 preventive vaccine.

The Bill & Melinda Gates Foundation and National Institutes of Health are joining forces with Johnson & Johnson to advance the potential prevention option, which is designed to be a “global vaccine” that could prevent a wide range of viral strains responsible for the HIV pandemic.

“Developing a vaccine against HIV is a top priority and our best hope for a world without AIDS. Finding an effective HIV vaccine to protect people at risk has been a major scientific challenge, but today there is new optimism that we can get there,” stated Paul Stoffels, chief scientific officer, Johnson & Johnson. “That’s why we’re joining forces with the world’s leading HIV researchers and global health advocates to help advance our experimental vaccine. Working together, our ultimate goal is to support efforts to make HIV history.”

The new, large-scale study, known as “Imbokodo,” will evaluate whether the investigational Janssen vaccine regimen is safe and able to reduce the incidence of HIV infection among 2,600 women in sub-Saharan Africa.

“The Imbokodo study is a result of an undeterred public-private partnership committed to responding to our formidable foe HIV,” said Glenda Gray, CEO and president of the South African Medical Research Council and chair of the Imbokodo study. “Africa’s leadership role in bringing an end to the epidemic is documented in its ground breaking scientific research and evident in the dedicated contribution of its people.”

The initiation of Imbokodo means that, for the first time in over a decade, two vaccine efficacy studies are taking place at the same time. Another study, HVTN 702, is currently underway in South Africa to evaluate a different vaccine candidate.

HIV/AIDS continues to be one of the world’s most pressing global health challenges. In 2016, an estimated 37 million people were living with HIV-1 globally, and 1.8 million people became newly infected with the virus. An estimated 790,000 new HIV infections occurred in eastern and southern Africa in 2016, where the new efficacy study is being conducted. In the United States, an estimated 1.1 million people were living with HIV at the end of 2014, and nearly 40,000 people were diagnosed with HIV in 2015.

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