Tuesday, April 24, 2012

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.

Saturday, April 14, 2012

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.