News (Updated May 22, 2011)

[Home]  [
Previous news]


Bionor Pharma strengthens its IP-platform in the US

* Reuters is not responsible for the content in this press release.

Fri May 20, 2011 9:29am EDT

This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

( Oslo , May 20th 2011)

Bionor Pharma ASA has today received confirmation of submission of patent applications in the US for its platform technologies. This entails establishment of two arms of Intellectual Property Rights which will provide general coverage for future peptide vaccines that induce cellular immunity and humoral immunity, respectively.  

The US submissions are follow-ups of the international patent applications of the two platform technologies that were made on December 2nd 2010 and January 6th 2011, respectively.

Bionor Pharma's technology relates to identification of peptide regions on proteins important for viral replication, followed by modifications of these regions to enhance immune responses. The properties to be protected in the platform patents involve general means to enhance these immune responses. These common properties will be the basis for the development of current and future specific vaccines, which also will be protected by individual product patents.

 "Building IP around our vaccine technology will contribute to protect our leading position within modified peptide vaccines and support our freedom to operate, says CEO Henrik Lund. "These patent submissions are among the measures necessary to be well positioned for future out-licensing and commercialization of our vaccine candidates in USA , the most important vaccine market."

 

U.S. FDA approves J&J HIV drug for combination use

Fri, May 20 2011

* Edurant approved for previously untreated patients

* Must be used as part of antiretroviral regimen

NEW YORK, May 20 (Reuters) - A Johnson & Johnson HIV drug won U.S. approval for use in combination with other drugs in patients who have not received prior treatment for the virus that causes AIDS, the Food and Drug Administration said on Friday.

The drug, a once-a-day pill to be sold under the brand name Edurant, works by blocking viral replication and was approved to be taken as part of an antiretroviral therapy regimen designed to suppress the amount of HIV in the blood.

Edurant, known chemically as rilpivirine, is likely to be used in combination with HIV drugs sold by Gilead Sciences Inc

"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement.

Edurant was approved based on clinical trials in which it was shown to be as effective in lowering viral load as Bristol-Myers Squibb's HIV drug Sustiva, the agency said.

The most commonly reported side effects seen with Edurant in clinical trials included depression, insomnia, headache and rash. (Reporting by Bill Berkrot. Editing by Robert MacMillan)

 

US study finds easier way to prevent tuberculosis

By Bill Berkrot

NEW YORK , May 16, 2011 (Reuters) - U.S. health officials say they have found a far simpler therapy for people at risk of developing tuberculosis, addressing a key barrier to preventing the spread of the disease.

Patients who took a combination of two drugs just 12 times over three months fared as well as those who received the standard treatment that requires 270 daily doses, according to a landmark U.S. government study released on Monday.

"New, simpler ways to prevent TB disease are urgently needed, and this breakthrough represents one of the biggest developments in TB treatment in decades," Thomas Frieden, director of the U.S. Centers for Disease Control and Prevention, said in a statement.

The far less onerous regimen involves taking rifapentine, an antibiotic sold by French drugmaker Sanofi <SASY.PA> under the brand name Priftin, along with isoniazid, an effective tuberculosis drug in use since the 1950s.

The study results, presented at a medical meeting on Monday, could mark a major advance in preventing TB in countries with low-to-medium incidence of the highly infectious disease, according to the CDC, which sponsored the study.

While many people believe TB to be a largely conquered disease of the past, there were more than 11,000 cases reported in the United States last year, and it remains one of the world's leading infectious killers, according to the CDC.

The 10-year study included more than 8,000 patients with latent TB infection, meaning they have the tuberculosis bacteria in their bodies but no symptoms and are not contagious. More than 11 million Americans are positive for latent TB, the CDC said, with Asians, other minorities and foreign-born individuals disproportionately affected.

Between 5 percent and 10 percent of people with latent TB develop the disease. Those with a weakened immune system are particularly susceptible.

BETTER COMPLIANCE

While the results mark a significant finding for fighting TB in countries like the United States , researchers stressed the need for additional studies before the new regimen can be recommended in countries with a high incidence of the disease, especially those with high HIV prevalence, due to a known drug interaction between some anti-HIV drugs and rifapentine.

Worldwide, TB kills an estimated 1.7 million people each year, and the number of new cases -- around 9.4 million -- is higher than at any other time in history, according to the World Health Organization.

In the U.S. study, patients with latent TB received either 900 milligrams each of rifapentine and isoniazid once a week for 12 weeks under a doctor's supervision, or the current self-administered standard of 900 mg isoniazid every day for nine months for a total of 270 doses.

The combination therapy was found to be safe and as effective as the standard regimen in preventing new cases of TB disease, according to researchers who presented the data at the American Thoracic Society International Conference in Denver .

Seven cases of TB occurred among those receiving the new treatment regimen, compared with 15 cases among those on the lengthy standard treatment, researchers said.

While the old one-drug method works, patient compliance has traditionally been a problem.

"Ensuring that those who need treatment both begin and complete the lengthy, cumbersome isoniazid regimen is challenging," Frieden said.

In the CDC study, 82 percent completed the new, shorter regimen, compared with a 69 percent completion rate for the standard nine-month regimen.

"By effectively treating latent TB infection, not only can we reduce the potentially deadly consequences among those individuals, but we can also prevent many others from ever becoming infected," Kevin Fenton, director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, said in a statement.

Given the promising results and potential for far higher patient compliance under the new regimen, CDC said it had begun working on new guidelines for its use in the United States . (Reporting by Bill Berkrot; Editing by Michele Gershberg and Lisa Von Ahn)

 

Indian drug firms use S.Africa to access continent

By Joshua Howat Berger (AFP) – 22 May, 2011

JOHANNESBURG — A white South African woman runs the local operations of India's largest drug company, Ranbaxy, and the second largest, Cipla, is listed on the Johannesburg Stock Exchange.

India 's pharmaceutical industry has rolled out a strong local presence in South Africa , cornering a large share of the market and using the country as a base to gush a flood of cheap generic drugs into Africa .

Unlike most multinational companies, India's "big three" pharmaceuticals -- Ranbaxy, Cipla and Dr Reddy's -- have carefully cultivated their local credentials by bringing South Africans into the top corporate echelons.

Ranbaxy and Cipla have also won fans by slashing the price of anti-AIDS drugs, saving countless lives in the country with the world's largest HIV epidemic.

"They've been very strategic in terms of how they've positioned themselves in South Africa and using South Africa as a launch pad into Africa ," said Abdullah Verachia, an analyst at consulting firm Frontier Advisory who has followed the Indian companies' ascent.

"That reflects one, their understanding of the market and two, their commitment to South Africa . You seldom get a foreign multinational company appointing a local CEO," he told AFP.

India 's pharmaceutical industry has transformed itself over the past three decades from almost non-existent to the second-largest in the world by volume, with revenues of $3 billion (two billion euros).

Cheap generic drugs have been the catalysts of that growth, and Africa has been a key market, buying 14 percent of India 's $8-billion pharmaceutical exports in 2009.

The relationship was cemented in 2001 when Cipla announced it would supply anti-AIDS drugs to Africa at a massive discount, slashing the per-patient price of the "AIDS cocktail" from more than $10,000 a year to less than $400.

"Indian pharmaceutical companies have been absolutely critical in bringing down the cost of treatment," Francois Venter, head of the South African HIV Clinicians Society, told AFP.

"If the cost of treatment hadn't come down, there would be very many fewer people on the drugs."

Sub-Saharan Africa , which has an estimated 22.5 million HIV positive people -- 68 percent of all infections globally -- is chronically short of funds to fight the disease.

Thanks to cheap Indian drugs, it has been able to increase the proportion of AIDS patients on treatment from two percent in 2003 to 37 percent in 2009.

But the Indian firms have gained more than just goodwill in the bargain. Providing discount generics has been big business and helped the Indian industry displace its Western rivals.

South Africa , which has 5.6 million people living with HIV, in 2008 launched a tender worth $526 million to provide its health department's anti-AIDS drugs for two years, giving preference to companies with local operations.

South African firm Aspen Pharmacare took the lion's share of the contract, but Ranbaxy's local joint venture Sonke won 4.5 percent of the deal and Cipla Medpro, Cipla's local subsidiary, won 1.9 percent.

Ranbaxy, today South Africa 's fifth-largest pharmaceutical company, last year opened a $30-million manufacturing facility west of Johannesburg -- its second.

Cipla, the country's sixth-largest pharmaceutical, has announced a $36-million upgrade to its plant in the eastern city of Durban .

Verachia said the thriving pharmaceutical partnerships are part of a larger vision of south-south cooperation that South Africa and India share.

"We share a very close diplomatic and political relationship in that both countries are advancing the interests of the south," he said.

"That close and burgeoning political relationship has translated into quite a strong commercial relationship."

Copyright © 2011 AFP.


[Home]  [Previous news]