Merck KGaA, Oncothyreon hit as cancer vaccine fails

FRANKFURT, Dec 19  - An experimental lung cancer vaccine from Germany's Merck KGaA failed to improve survival in a pivotal study, dealing a blow to the company and the high-risk field of using vaccines to fight tumors.

Stimuvax, which Merck licensed from U.S. biotech firm Oncothyreon, failed to increase overall survival in the Phase III clinical trial, the German chemicals and pharmaceuticals group said on Wednesday.

The trial's coordinating investigator, Frances Shepherd of the University of Toronto, said the result was disappointing, although she said "notable treatment effects were observed in certain subgroups of patients".

While this could mean that Merck might conduct more studies to try and find particular groups of patients who would benefit from the treatment, industry analysts were skeptical that Stimuvax had any future.

"Despite potential positive effects in subgroups, we consider the drug dead," said Deutsche Bank analyst Holger Blum.

The trial was testing Stimuvax on more than 1,500 patients with stage III non-small cell lung cancer whose tumors could not be completely removed via surgery and whose disease had at least stabilized following chemoradiotherapy.

Merck said it would discuss the data with experts and regulatory authorities over the coming months.

Helvea analyst Odile Rundquist, who cut her price target on Merck by 2 euros to 97 euros a share, said the setback for Stimuvax was another blow for Merck's pharmaceutical division following recent disappointments with cancer drug Erbitux and the earlier failure of cladribine in multiple sclerosis.

Merck shares fell 3.3 percent to 98.22 euros by 1145 GMT, while Germany's blue-chip DAX index was up 0.2 percent. The market impact was limited by the fact that many Merck analysts had not included Stimuvax sales forecasts in their financial models, given the risky nature of the project.

The news is a much bigger setback for the German company's small U.S. partner Oncothyreon, whose shares fell 70 percent in premarket trading on Nasdaq.

Stimuvax is one of a number so-called therapeutic cancer vaccines being developed by drug companies to fight tumors by stimulating the body's immune system.

The first such vaccine was approved two years ago but Provenge for prostate cancer, made by Dendreon, has met with limited success, due to management missteps and doctors' reluctance to adopt the difficult-to-administer therapy.

A number of other cancer vaccines are in development that analysts believe may be more successful, including a product from GlaxoSmithKline against melanoma and lung cancer which is set to report clinical trial results next year.

Some investors had already been wary about prospects for Stimuvax after Merck said in March the trial would be continued and final data would be presented later than expected, raising doubts over its success.

"Given the history of the drug's development with postponements, discontinuations and break-ups we are not surprised about today's outcome," DZ Bank analyst Peter Spengler said.

Oncothyreon lung cancer drug fails in late-stage trial
Dec 19 - Biopharmaceutical company Oncothyreon Inc said a late-stage trial of its experimental lung cancer drug did not meet the main study goal of improving overall survival.
The drug, codenamed L-BLP25, is being tested in patients with unresectable, locally advanced stage IIIA or stage IIIB, non-small cell lung cancer (NSCLC).

The trial was conducted by Merck Serono, a division of Germany's Merck KGaA, under a license agreement with Oncothyreon.

Health info service for pregnant, new mothers

Dhaka, Dec 18 (bdnews24.com) – In its latest effort to cut maternal and child deaths further, the government has partnered with the private sector to offer vital health info to new and expectant mothers using mobile phones.

Styled 'Aponjon', the service can be used by free registration with a number, 16227, from Grameenphone, Banglalink, Robi and Airtel phones.

The registered numbers will get alter once a week with Tk 2 per text or voice message charge until the child completes one year of age.

Health Minister AFM Ruhal Haque inaugurated the initiative on Tuesday evening in Dhaka. He said it is a 'red-letter day' for the health sector.

"In the past it was unthinkable that just dialing a number, pregnant and new mothers would receive all the information related to risks during pregnancy period, procedures to get available healthcare services and food habits of both mother and children."

The minister extolled the service as he believed it would help more mothers to get in facilities during delivery and identify the would-be mothers at risk -- two challenges in the way of cutting maternal deaths further after a significant decline in the last decade.

The deaths reduced to 194 per 100,000 mothers in 2010 from 322 in 2001, an achievement that put Bangladesh on track to reach UN-set MDG-5 target of reducing deaths to 143 by 2015.

The phone call or message will remind pregnant women of their need on that particular week. Even after childbirth, they will get the message for the newborn care until completion of one year.

The service has been seen 'unique' as nearly two-third Bangladeshi use mobile phones.

But analysts say being informed about their need, many mothers at hard-to-reach areas might miss the vital healthcare during their pregnancies only due to unavailability of services.

Senior Secretary for Health Md Humayun Kabir at a 'meet the press' event after the launching said they would be able to intervene when they would learn that 'someone is in trouble.'

"Our priority is to change health-seeking behaviour as many mothers do not come to facilities during childbirths. We'll give them the info and ask them to go to the nearby facility. If they don't have (facilities nearby), we can intervene," he said.

He said the government's field staff including those from community clinics would help in the registration process of the mobile service that would be executed by D.Net, a private ICT firm.

The Ministry of Health and Family Welfare with its advisory body will oversee the service that gets $ 1 million for initial one-year implementation from USAID under its global public-private partnership Mobile Alliance for Maternal Action (MAMA).

USAID Mission Director Richard Greene said it is an evidence-based intervention. "We learnt it from the pilot project," he said referring to the piloting before the launching where 12,000 mothers registered themselves.

D.Net says they are taking private companies' support to make the public-private initiative a business model.

"We want to make it sustainable by increasing subscribers and reducing aids," its executive director Dr Ananya Raihan said.

He said a process was on to bring all mobile operators under the service, which will be made free for the poor 20 percent of the total subscribers.

UN recognises autism as mainstream disease
New York, Dec 13 –The United Nations on Thursday adopted Bangladesh's proposal to recognise autism as a mainstream disease paving way for autistic people to get proper treatment and respect.

"From now on, the UN and its member countries will collect details of people affected by autism. The path to bring them back to normal life will widen," Counsellor of the Permanent Mission of Bangladesh to the United Nations in New York Mohammad Tauhedul Islam told bdnews24.com.

"Training necessary for the treatment of the autistics will also be given," Islam said after a function on the occasion.

The US has already agreed to fund the data collection, he added.

Bangladesh's Permanent Representative to the UN, AK Abdul Momen, said, "Autism had not been recognised as a dangerous disease. There had been no allotment in the budgets of the international organisations, including the World Health Organisation, and the countries.

"Since the UN has adopted our proposal, autism will be recognised as a mainstream disease and every country will have to allocate money for the autistic people," he added.

The guests of the function thanked Prime Minister Sheikh Hasina's daughter Saima Hossain Putul for her contribution in the campaign on autism in Bangladesh. She is the Chairperson of National Advisory Committee of Global Autism Public Health Initiative in Bangladesh.

Later in the day, Foreign Minister Dipu Moni told a press conference in Dhaka that the proposal was accepted unanimously and 71 countries co-sponsored it.

About 0.8 percent of the total children in Bangladesh are autistic and the government is setting up specialized school for them, she added.

Putul had tabled the proposal titled "Socioeconomic help for autistic children and their family" in a special meeting of the 67th session of the UN General Assembly on Nov 20.

Autism is characterised by varying degrees of impairment in communication skills and social interactions and in restricted, repetitive behaviour.

Currently one in every 88 people in the US suffers from autism while 70 million people around the world are living with it. But international organisations, including WHO, do not offer any financial support to cope with it.