GLG News by Mr. John Ansell MBA, Director
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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.
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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.
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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.
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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.
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Pfizer's licensing judgment in question
July 7, 2010
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.
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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.
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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.
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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.
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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.
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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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What does Solvay offer to a bidder ?
September 25, 2009
Sources: Abbott sparks Solvay bidding war, UCB may follow | www.fiercebiotech.com
In considering the outcome of the current bidding war, what can Solvay Pharmaceuticals offer to an acquirer ? It can’t be the R & D pipeline. In 2004 Solvay was described by one industry observer as having a great pipeline. But except for one modest short-term success in the market, all of the projects then at Phase III or beyond fell down.
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Dainippon Sumitomo acquires a bridgehead and settles Sepracor's uncertain future
September 4, 2009
Dainippon Sumitomo Pharma to Acquire Sepracor for U.S. $23.00 Per Share in an All-Cash Tender Offer Valued at Approximately U.S. $2.6 Billion | www.pipelinereview.com
In acquiring Sepracor, Dainippon Sumitomo is gaining a modest-sized commercial bridgehead for marketing its products in North America, but one which by itself had an uncertain future. Dainippon Sumitomo will need to take action to stabilize a company which has been facing issues concerning its future sustainability.
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An important landmark for Nycomed's Daxas
September 1, 2009
Four studies published in The Lancet show roflumilast (Daxas®), a new oral approach to COPD, improves lung function and reduces exacerbations | www.nycomed.com
The level of unmet need in COPD, a very common respiratory disease, is high. Consequently, provided a new drug is registrable it does not have to have outstanding qualities to become a substantial success. Nycomed’s Daxas has recently been submitted for registration for COPD in the US and Europe. If registered, this novel drug will be the first member of its class to reach the market.
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Nycomed’s Daxas takes an important step forward
May 12, 2009
Nycomed files European marketing authorisation application for Daxas® in COPD | www.pipelinereview.com
With the recent setbacks to Almirall’s clidinium bromide – it is not now scheduled to re-enter the regulatory fray until late 2011/early 2012 - the way has opened up for the PDE4 inhibitor Daxas (roflumilast) to be the next big thing in COPD. If it can only overcome the final, regulatory hurdles, it stands a good chance of becoming a substantial blockbuster. Daxas may not turn out to be the greatest thing since sliced bread for this indication – but then it doesn’t need to be. COPD is a common respiratory disease with a much greater level of unmet need than exists in the more familiar asthma indication. Only one dedicated drug, Spiriva (tiotropium) from Boehringer Ingelheim/Pfizer, has really made it in COPD so far, with recently announced sales of $2.7 billion in 2008.
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Solvay Strategy - the company appends a note
April 27, 2009
Sanofi moves on Solvay's pharma division | www.ft.com
On April 22nd Solvay appended a note to its initial April 1st press release which we commented upon at the time (Solvay confirms it is proceeding with an analysis of various options for its pharmaceutical activities) on its web site: http://www.solvay.com/services/newsfrompo/0,,73459-2-0,00.htm This confirms that Solvay is proceeding with an analysis of various options for its pharmaceutical activities - not just M&A - which rumors have concentrated upon.
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Glaxo Stiefel deals with the dermatology question
April 21, 2009
Glaxo agrees $3.6bn Stiefel deal | www.ft.com
Dermatology, formerly a heritage area for GSK, currently accounts for less than 3% of the company's total pharmaceutical turnover. Incorporation of Stiefel's business will only bring this up to around 6%. Neither company has succeeded since the 1980s in developing genuinely novel dermatologicals - it's some years since dermatology has been a therapeutic area GSK has actively pursued.
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Solvay Pharmaceuticals – prospects for a sale
April 6, 2009
Sanofi moves on Solvay's pharma division | www.ft.com
How attractive is Solvay’s Pharmaceuticals sector ? Sanofi clearly believes Solvay is worth a bid. But in terms of its current product range, in 2008 Solvay only had one product, Fenofibrate, selling over €0.5 billion (€511 million in 2008), and one other, Androgel, over €200 million. Its products would scarcely be large enough to make an impact when subsumed within a major pharmaceutical company of the size of Sanofi Aventis. What about Solvay's R & D pipeline ? There may be 10 projects in the Phase III pipeline but the proportion accounted for by NCEs capable of being developed into major new products is limited.
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Pfizer-Wyeth: Increased Scale Could be The Achilles Heel
January 26, 2009
Pfizer To Acquire Wyeth, Creating the World's Premier Biopharmaceutical Company | www.premierbiopharma.com
Let’s look at one particular aspect of this merger, which, for quite some time now has appeared to me to be the Achilles heel of megamergers: increased scale. Pfizer is already the largest pharmaceutical company, with 2008 global sales announced today of $44 billion. I consider that some of the problems the company has been encountering are related to its already unprecedented size. As I shall show below, these problems of scale will be exacerbated again with the incorporation of Wyeth. Wyeth’s pharmaceutical sales announced today for 2008 were $19 billion. Aggregating these with Pfizer’s current sales, this will increase the scale of Pfizer by 43%.
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Pfizer focuses down - but at the same time takes on more risk
October 8, 2008
Pfizer shifts focus to cancer and biotech drugs | ap.google.com
As the biggest pharmaceutical company, Pfizer's R & D needs to be more productive than any other company's if it is to survive and prosper. But Pfizer must have new products that are big if they are to make an impact on its bottom line. The conundrum is that disease is a diffuse market, with few very big pharmaceutical products to treat it, and far more smaller ones. Thus in 2007 there were only 52 products whose global sales exceeded $2 billion. A product with $2 billion turnover product would contribute 4% to Pfizer's total turnover - just about big enough to make a significant impact on its performance. But those 52 products are for all therapeutic areas. Therefore Pfizer in focusing down is aiming at a rather limited-size target. And rights to the majority of products becoming blockbusters will not be on offer to Pfizer as they will be retained by its competitors.
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Chinese generics is nothing new
May 21, 2008
China Muscles In On The Generics Industry | www.pharmalot.com
In 1976, sitting in my office in International Marketing at Fisons, Loughborough, UK, I used to watch the drums of bulk paracetamol arriving at the factory from China - easily recognizable from the Chinese script decorating them. I'm sure the UK wasn't the only country importing raw materials from China then.
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