GLG News by Generic Pharmaceuticals Economic Experts (Germany)

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

It’s official: the rise of blockbusters is at an end

August 18, 2011

Top 200 medicine highlights | pharmalive.com

The much heralded decline in the number of blockbusters has now come to pass. There were 118 products in 2010: down from 126 in 2009. Patent expiries account for most of this decline. But of particular concern is the number of new blockbusters – only 4 in 2010. It took longer than many expected for a lack of new products to undermine blockbuster numbers. Likewise, I expect it to take six years at least to reverse the current downward trend, even with a quick upturn in new product productivity.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Almirall deal with Nycomed says more about Daxas prospects than meets the eye

May 6, 2011

Nycomed and Almirall announce commercialization agreement for roflumilast in Spain | www.nycomed.com

Almirall and Nycomed have announced a one-off deal giving the former co-marketing rights to its new COPD product roflumilast . This strongly suggests that the product's sales progress since last autumn across Europe has been good - sufficient for Almirall to think it worth belatedly entering the fray in Spain. Daxas should soon have the credibility to attract partners - including Almirall - for developing fixed combinations, a potentially much bigger prize.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Actelion undermined by loss of its crown jewel project

January 28, 2011

GSK and Actelion discontinue clinical development of almorexant | www.gsk.com

Actelion and GSK have announced that clinical development of their Phase III compound for insomnia, almorexant, has been discontinued. This has severe implications for the future of Actelion in particular.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Merck shifts away from CNS whilst bolstering respiratory

October 26, 2010

Lundbeck and Merck Sign Exclusive Commercialization Agreement for SYCREST | www.merck.com

A shift of emphasis by Merck & Co away from the CNS area could also indicate a further licensing opportunity. This contrasts with further recent concentration by the company on the respiratory area.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Pfizer's licensing judgment in question

July 7, 2010

Committee for Medicinal Products for Human Use (CHMP) Issues Opinion on European Regulatory Filing for Merck's Atypical Antipsychotic Medication SYCREST® (asenapine) | www.merck.com

Two recently approved new products, Saphris/Sycrest (asenapine) and Daxas (roflumilast), were both once in-licensed projects which belonged half a dozen years ago to Pfizer's R&D pipeline. Pfizer not long afterwards returned rights to both compounds to the licensor companies. Its US rival Merck & Co now holds rights to both of these new products. We explore how this could have come to pass.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

A Key Landmark Achieved for Nycomed's Daxas

July 7, 2010

Nycomed’s Novel Anti-inflammatory Therapy Daxas® (roflumilast) Receives Marketing Authorisation in the European Union for Patients with COPD | www.nycomed.com

Whilst approval of Daxas in the US is a bigger goal, approval in Europe is an important landmark that at last provides a solid platform for the product.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

Building on Advair

March 25, 2010

GSK starts Relovair phase-III asthma programme | www.pharmabiz.com

Revolair addresses a vulnerability of GSK in the asthma and COPD market with its current product, Advair - frequency of dosage. It also prioiritizes the indication with greater unmet need: COPD.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

GSK's newly acquired Traficet-EN could fill a clear gap in the IBD market

January 13, 2010

GSK obtains license to develop ChemoCentryx’s Traficet-EN to treat inflammatory bowel diseases | www.pharmabiz.com

Traficet-EN is an interesting and different approach to inflammatory bowel disease. Whilst it is outside the core therapeutic areas GlaxoSmithKline is currently concentrating upon, the product could fill a significant gap in this market.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

A triple combination for H1N1: good in principle

October 30, 2009

Triple-combo Drug Shows Promise Against Antiviral Resistant H1N1 | www.medicalnewstoday.com

The principle behind Adamas’s triple combination development for influenza is a good one. There is clearly a need for improved treatments, as the latest wave of swine flu is now showing. Oseltamivir (Tamiflu) and ribavirin are reasonable drugs to select but the third component, amantadine, may prove the weak link.

John Ansell, Director

John AnsellDirectorJohn Ansell Consultancy What is a GLG Leader?|The Gerson Lehrman Group&reg; (GLG) Leader Program<sup>SM</sup> is our premium Member Program<sup>SM</sup>. Those identified as GLG Leaders are in the top 5% of GLG CouncilRank and have an exclusivity agreement with GLG.

GSK's new venture into Duchenne's makes sense

October 14, 2009

GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular Dystrophy | www.pipelinereview.com

GSK's latest deal on Duchenne's muscular dystrophy with the Dutch company Prosena is a further indication of the former's interest in diversifying out of the more obvious, major areas of medicine.This can make sense: such "esoteric" indications areas are less well understood, there is less competition and commercial rewards can turn out to be greater than superficially apparent.

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