Data from Clinical Study of Pharmalink's Nefecon® to be Presented at American Society of Nephrology's Kidney Week 2014

STOCKHOLM, November 3, 2014 /PRNewswire/ —

Pharmalink AB, a specialty pharma company focused on orphan and niche products, announces that clinical results from the initial run-in phase of its Phase IIb clinical study with Nefecon® will be presented in a poster during Kidney Week 2014, the annual meeting of the American Society of Nephrology (ASN). The abstract of the presentation is published on the ASN website (click here), and details are below. ASN Kidney Week, the world’s largest nephrology meeting, will take place 11- 16 November in Philadelphia, PA.

Nefecon is a new oral modified-release capsule formulation of the corticosteroid, budesonide, in development by Pharmalink for the treatment of patients with IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD) despite optimized RAS blockade.

The safety and efficacy of Nefecon is currently under evaluation in a prospective, randomized, placebo-controlled study (NEFIGAN Trial). Patients entering the study undertake a six-month Run-in Phase during which standard-of-care therapy [angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB)] is optimized according to KDIGO guidelines*. Run-in phase data from patients completing the Run-in Phase will be presented.

Alex Mercer, Clinical Development Director of Pharmalink, said: “The data from the Run-in Phase of the NEFIGAN Trial show that IgAN patients remain at risk of progression to ESRD despite optimized standard-of-care therapy, and highlight the need for new treatment options. This need is recognized in the renal disease community and we have been delighted with the positive and enthusiastic engagement from key opinion leaders in the area around the NEFIGAN Trial. This support has enabled Pharmalink to complete enrolment into the study and remain on track to report headline results in Q3 2015 as planned.”

Poster title: The NEFIGAN Trial: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NEFECON® in IgA Nephropathy Patients at Risk of Developing ESRD: Preliminary data from the Run-in Phase

Poster board #: TH-PO442

Session Title: Glomerular and Tubulointerstitial Disease: Clinical Trials and Outcomes                      

Session Date, Time: Thursday, 11/13/2014, 10:00 AM – 12:00 PM

*KDIGO  Kidney Disease Improving Global Outcomeskdigo.org/home/ 

About Nefecon 

Nefecon is a potential disease-modifying treatment for patients with primary IgA nephropathy (IgAN) at risk of developing end-stage renal disease (ESRD). Nefecon has shown positive results in an open-labelled Phase II trial evaluating safety and efficacy and is now being tested in a placebo-controlled randomized Phase IIb study (http://www.nefigan.net/). The study has been designed to enable an optimal dose of Nefecon to be selected for a Phase III registration trial. Headline data is anticipated in Q3 2015.

Nefecon is an oral formulation of a locally-acting and potent corticosteroid, budesonide, that down-regulates the disease process in the kidney through suppression of the gastrointestinal immune system thus exploiting the pivotal role the gastrointestinal tract plays in the overall immune response. Early treatment with Nefecon of IgAN patients at risk of developing ESRD may slow or halt disease progression and further loss of renal function, and provide an alternative to dialysis and transplantation. Nefecon has received orphan drug designation by the US Food and Drug Administration (FDA).

About IgA Nephropathy 

IgA nephropathy (IgAN) is the most common form of glomerulonephritis (inflammation of the kidney glomeruli). The disease is characterized by deposits, predominantly containing polymeric IgA antibody, in the kidney that cause inflammation and renal damage.

IgAN can occur at any age, but the clinical onset is commonly during the second or third decades of life. It has been estimated that 20-40% of patients with IgAN progress to renal failure, often referred to as end-stage renal disease within 5-30 years following diagnosis. This patient population is estimated to at least 200,000 in major markets.

Patients suffering renal failure require dialysis or kidney transplantation. IgAN accounts for 10% of renal transplants among patients with primary glomerulonephritis in the US and between 7-20% of patients in Europe and Australia in long-term dialysis and renal transplantation programs.

About the Nefigan trial 

The Nefigan trial is a multicenter, randomized, double-blind, placebo-controlled study conducted at more than 60 centers in ten European countries. The objective of the study is to evaluate efficacy and safety of two different doses of Nefecon in the treatment of IgAN patients at risk of developing ESRD, under standardized rigorous blood pressure control with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin II receptor I blocker (ARB).

Read more at http://clinicaltrials.gov/ct2/show/NCT01738035

About Pharmalink 

Pharmalink is a specialty pharma company developing high value products for niche and orphan indications. Pharmalink draws on its extensive experience of pharmaceutical development and marketing to identify and progress products that address significant unmet medical needs. With a successful history in pharmaceutical sales and marketing, and highly experienced, dynamic management team, Pharmalink is focused on the development and commercialization of valuable, de-risked projects. It has two late-stage clinical phase products under development, Nefecon® and Busulipo™. Pharmalink is actively seeking opportunities to acquire or in-licence product opportunities in niche and hospital care indications. Visit http://www.pharmalink.se for further information.

For further information, please contact:
Pharmalink AB:
Johan Häggblad, Managing Director, +46-(0)70-668-0644
Email: [email protected]

Marek Poszepczynski, Business Development Director, +46-(0)70-377-22-73
Email: [email protected]
http://www.pharmalink.se

Citigate Dewe Rogerson(for Pharmalink):
Mark Swallow/Chris Gardner, +44-207-638-9571
Email: [email protected]

SM to carve niche with Alfamart

Couples tying the knot at Paco Park think the place is a garden with its towering old trees and walled coziness of a park. One of Paco Park’s oldest residents is one Dorotea Mateo, who died on August 14, 1882. All of the grave markers or lapidas are in Spanish, a testament to a time when Spanish was once the Philippines’ official language until American colonial rule brought in English. …

Columbariums: Finding one’s final niche

Cubic compartments called columbarium have been changing the face of some cemeteries in Newfoundland and Labrador. 

A columbarium is a vertical, above-ground granite or marble structure normally found in cemeteries.

Each structure contains a number of columbaria, often referred to as niches, that hold urns containing cremated remains.

However, the idea is not a new one. In fact, the preservation practice dates back to Roman times. 

Anne Walsh, director of Adult Faith Formation for the Roman Catholic Archdiocese in St. John’s, said use of a columbarium has been used for centuries.

“Colum [or columba] is the Latin word for a dove, and a dove is the traditional symbol of peace, and that’s what we want for our beloved dead,” Walsh told CBC.

“So, a columbarium in the Roman tradition, and again all through history, was a place where the doves were housed. It’s quite a beautiful image really.”

Breathing new life into an old cemetery

There is now at least one columbarium in most of the older cemeteries in St. John’s. 

The first was installed in 2000 at the Anglican Cemetery on Forest Road, which dates back to 1849. 

‘Once those niches are locked, there is no other maintenance required by our families, our remaining families — and that’s the way we wanted it to be. Very simple and no trouble for our family.’– Dorothy Noel

Arthur King, chairman of the cemetery committee, said 14 years ago, there was little or no room left for burials. He estimates there are close to 21,000 people buried there.

A space-saving columbarium could breathe new life into an old, crowded cemetery, he said. 
 
The cemetery is about to install its seventh structure.

Columbarium at Anglican Cemetery

Columbariums might represent a significant change in the way we document our history. (Jane Adey/CBC)

?King said people are choosing to spend less on their ultimate farewell. Cremation and columbarium committal is less expensive than traditional in-ground burials — sometimes as little as half the cost.?

“We have often heard it said, that by doing this, we can pass on $10,000 to our grandchildren. And the neat thing about this too though, the cemetery will maintain these over a period of time,” said King.

“It’s perpetual care, that’s also factored into the price. So all the care and the maintenance … we have plants, decorative plants all around here … we have chairs where people can sit down and meditate, and be quiet,” he said.

“That’s one of the reasons why I think the sale of these is so high — people just like the setting, and the fact that somebody else then will look after it, and for an indefinite period of time.”

Fewer words, in a smaller space

When Dorothy Noel and her husband Fred first heard of the above-ground cremation structure in 1999, they decided to reserve their spots at the Anglican Cemetery. 

“Once those niches are locked, there is no other maintenance required by our families, our remaining families — and that’s the way we wanted it to be. Very simple and no trouble for our family,” said Noel.

“Compared to the ground, I watched my father and my mother being buried … and it stays with you. It’s cold and it’s bleak, although we know that it’s only the body, the soul isn’t there, but I think when you’re making this decision you base it on experience.”

Noel said she understands that some people might view a columbaria as a loss of individual expression, but said she’s not worried about not having a headstone.

“They’re lovely to visit, and I know a lot of our visitors come on the island, a lot of them visit the graveyards … and they do have stories to tell. I’d like to tell our stories before we die, and I feel that the columbarium is the right place for us. I feel we’ll be very happy there,” Noel said.

New Columbarium at Holy Sepulchre Cemetery

This columbarium was recently installed in Holy Sepulchre Roman Catholic Cemetery in St. John’s.
(Jane Adey/CBC)

?This past summer, Holy Sepulchre Roman Catholic Cemetery erected its first columbarium.

Gordon Holden, operations supervisor at the cemetery, said when he first heard the word two years ago, he was at a loss.

“I barely knew how to spell the word, much less knew what they were,” he said.

“Up to around 10 years ago, cremation wasn’t an option that was chosen by very many Roman Catholics, but in the last 10, 12 or 15 years, it has risen from about 10 per cent to around 65 or 70 per cent.”

‘So, a columbarium in the Roman tradition, and again all through history, was a place where the doves were housed. It’s quite a beautiful image, really.’ – Anne Walsh, Roman Catholic Archdiocese of St. John’s

Holy Sepulchre currently has four grey stone columbarium with multiple mailbox-like storage compartments. 

?“So there’s 24 niches in this unit here, there’s 24 niches in that unit over there, there’s 15 in the corner unit and another 15 over here,” said Holden.

“The ones in the middle here, they’re 15-inch cubes, they’re a little larger … so if people choose a larger urn or they want to put in three urns, they should be able to fit them in there. And then these are 12 inches, these are smaller units for people who may only want one urn,” said Holden.

Japan 'anime' king Anno haunted by fears of apocalypse

Once regarded as a geek-only niche market, Japanese animation movies have shot to worldwide success thanks in large part to Oscar-winner Hayao Miyazaki’s whimsical tales of fantasy.

With Miyazaki having retired, Japan has a new king of ‘anime’: Hideaki Anno.

Famous for the hit sci-fi franchise “Evangelion”, Anno draws inspiration from the darker recesses of the human soul, haunted by the threat of nuclear holocaust growing up as a child in Japan during the Cold War era and in the shadow of the US atomic bombings of Hiroshima and Nagasaki in 1945.

“The fear of the Cold War was in essence the fear of nuclear war,” Anno told AFP in an interview during the Tokyo International Film festival, where 53 of his films were being showcased.

“There was a real sense that if atomic war broke out, the world would be destroyed. If someone pushed the nuclear button it would lead to the destruction of the world — that was the reality at the time, that fear of Armageddon.”

Miyazaki, whose 2001 box-office smash “Spirited Away” became the first anime to win an Academy Award, passed the torch to Anno after saying that last year’s “The Wind Rises” would be his last feature-length film.

The “Evangelion” series, about gigantic bio-machines piloted by teenagers battling monstrous giants that are terrorising human survivors of a global catastrophe, has produced five feature movies and spawned manga comics, games, character merchandise, and even a theme park attraction since it was first broadcast in 1995.

“I sincerely thought that the world would end in the 20th century,” said Anno.

“It was a big influence on “Evangelion”, which is about what happens after the world has been destroyed. At that time a lot of Japanese anime dealt with what happens after a nuclear holocaust.”

A tsunami also wreaks deadly havoc in “Evangelion”, which is permeated by religious references.

“Japan is a country where a lot of typhoons and earthquakes strike,” said Anno, who was given his break by Miyazaki as an animator in 1984.

“It’s a country where merciless destruction happens naturally. It gives you a strong sense that God exists out there.”

Anno, who has collaborated with Miyazaki on various projects, speaks in hushed tones about his mentor, describing the master storyteller as a one-off.

– Chillingly dark –

“Miyazaki-san’s animation can be enjoyed by children and adults, a very broad demographic,” he said.

“Miyazaki-san’s works have had a major influence on Japanese film. They can never be replicated, and nobody will make movies like that again.

“Watching his approach to film-making — he sacrificed himself for his work. His principle was that his art was everything, the movie was more important than anything. That was special.”

Miyazaki has been compared with Walt Disney, but Anno insisted that the depth of the themes tackled by Japanese anime, often chillingly dark, were a major factor in their enduring appeal, not just their enchanting nostalgia and humour.

“Japanese animation is not just for kids,” said the 54-year-old.

“If it were just for children you would stop watching when you get older and it would be like watching American cartoons.”

Anno, who bristles at comparisons to “Star Wars” creator George Lucas, believes his work would not make the transition to “Pacific Rim”-style live action movies.

“I don’t think it would work,” he said.

“The concept of “Evangelion” was that of an animation and it would be very difficult to express in live action. You would have to remake it totally and then it would be something different, so I don’t see it ever happening.”

Anno shrugged off the weight of expectation after the co-founder of Miyazaki’s celebrated Ghibli animation studio, producer Toshio Suzuki, proclaimed that Anno would “lead the anime world for the next 10 years” following Miyazaki’s retirement.

“There is no pressure,” he smiled.

“It’s what other people say, not me. I just want to continue making stimulating movies and I’d like to give something back to the industry.

“Hopefully I can help the culture and art of anime become even bigger and contribute to society in some way, leave something that will last.”