Just (g)OUT

AstraZeneca have announced their purchase of Ardea Biosciences for around $1 bn. Definitely not comparable to the ~15 bn dollar acquistion of MedImmune in 2007. Not surprising is the move of AstraZeneca to any follower of Pharma industry. With such a weak late stage pipeline, AstraZeneca have been trumpeting their desire to strike deals, either licensing or acquisition. The recent collaboration with Amgen on the Immunoinflammatory area added some life to the pipeline of AZ. The collaboration with Amgen included a Phase III ready candidate, brodalumab (for psoriasis) and the rest were early stage assets. This time, the purchase of Ardea will bring another late stage asset, lesinurad (RDEA594) for gout. 

Interestingly, Takeda recently announced a similar deal (pretty close in the $ too) of buying URL Pharma for around 800 mn$. URL Pharma already markets Colcrys (colchicine) for treatment of gout. Takeda already had a drug for the treatment of gout, Uloric (febuxostat) through their partners Teijin Pharma.

Overall, good news for AZ this April. first with the EMA's CHMP recommending the approval of dapagliflozin for type 2 diabetes. Dapagliflozin team at AZ might have felt a bit of relief of heat under their collars by this recommendation since earlier in Jan 2012, the US FDA issued a Complete Response Letter asking AstraZeneca for additional clinical data to allow a better assessment of the benefit-risk profile for dapagliflozin. (FDA had pushed back the PDUFA data from October 28th, 2011, to January 28th, 2012). Secondly, the purchase of Ardea.

There is light at the end of the tunnel for AstraZeneca.

Director General (DG) of Pharmaceutical Export Promotion Council of India (Pharmexcil)

The Pharmaceutical Export Promotion Council of India (Pharmexcil) has created a new post of Director General (DG) and appointed Dr P V Appaji as the new DG of the Council. Prior to this appointment, Dr Appaji had served as Executive Director (ED) of the Council for the past 8 years since 2004.

Raghuveer Kini has been appointed as the next Executive Director of the council. Earlier, Kini had served the council in the capacity of additional executive director since its inception. He is regarded as a well experienced and dynamic personality who is fully aware of all the activities of the Council.

Earlier, the Council did not have the Director General post, but as part of its internal review, the administration had decided to create the new post to forgo the growing work pressure on the ED. At the same time, it had also decided to honour the exemplary services of Dr Appaji and promote him to the next higher level as the DG.

The new DG will now focus his concentration on the policy matters of the council. Apart from devising policies for pharmaceutical export promotion, the DG will also supervise the over all functioning of the council. “Now, my job will be to focus more on policy matters. In the next one to two months we will organize a meeting and come out with a new frame work for our export activities,” said Dr Appaji.

On the upcoming activities of the council, Dr Appaji said, “As of now we are concentrating on organizing India Pavilion at 15th South East Asia Healthcare & Pharma Show in Malaysia. The event will be held from April 17-19, 2012. Apart from this, we are also attending the interactive meeting with duty drawback committee which is going to be held on April 12. We will put forth our views and suggestions to the committee,” said the new DG.

Since inception in 2003 the Council had been striving hard to promote the Indian pharmaceutical sector to the world markets. In its endeavour it had organized many national and international events, seminars and exhibitions. It had facilitated networking with world’s leading players to the Indian manufactures and had played a catalytic role in framing viable export policies and helped the government to understand industry point of view in resolving various issues pertaining to export regulations.

H1N1 toll rises to five in Karnataka

With two more persons succumbing to H1N1 influenza in the last three days, the swine flu toll has risen to five in the State since February, health officials said.

The latest victims were a 32-year-old woman from Kolar and a 45-year-old man from Chikballapura, the officials told PTI.

Since January, 531 samples were tested for H1N1, out of which 82 tested positive. “Out of these 82 patients, five have succumbed to the disease,” they said. 

Resistance to malaria drug rings alarm bells

 Resistance to anti-malarial drug artemisinin in western Thailand is sending alarm bells ringing among global experts involved in controlling and eliminating the scrouge worldwide, a new study says.

Another study, also by Texas Biomedical Research Institute and their Thai collaborators has indentified a major region of the malaria parasite genome tied to artemisinin resistance, raising hope that there may soon be effective molecular markers for monitoring the spread of resistance.

Malaria killed 655,000 people or over one per minute in 2010. Malaria deaths have declined by 30 per cent over the past decade, because of effective control using treatment with combination therapies containing artemisinin, a plant-derived antimalarial drug developed in China, the journal Lancet reported.

Patients infected with malaria parasites who respond poorly to treatment have been observed in Cambodia, bringing forth a coordinated World Health Organization effort to eliminate the disease in this region, said a university statement.

From 2001 until 2010, the Texas Biomed team and collaborators studied 3,202 patients in clinics in Northwestern Thailand, 500 miles from the Cambodian focus, according to the journal Lancet.

Researchers observed a dramatic decline in the drug potency over that period. Further, by measuring drug potency in patients infected with genetically identical malaria parasites, they were able to show that the decline in potency results from the spread of resistance genes.

“Spread of drug resistant malaria parasites within Southeast Asia and overspill into sub-Saharan Africa, where most malaria deaths occur, would be a public health disaster resulting in millions of deaths,” said Texas Biomed’s Standwell Nkhoma, who led the study.

“The problem we have is that treatment with artemisinin-based drugs will promote spread of resistance, but there are no viable alternative treatment options in Southeast Asia,” said Nkhoma.

“Our group wanted to understand what genetic changes have occurred in these parasites,” said Texas Biomed’s Ian Cheeseman, who led the companion study, the journal Science reported.

“This study narrows the search to a region of the parasite genome containing around 10 genes. We haven’t yet found the precise changes involved, but we are getting close,” said Cheeseman.

Source: The Hindu