GLG News by Generic Drug Economic Experts

John AnsellDirectorJohn Ansell Consultancy

Nycomed’s Daxas takes an important step forward

May 12, 2009

Analysis of: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.

Alan PattersonObstetrician and GynecologistALAN B PATTERSON MD, PA

Sequenom's delay

May 4, 2009

Analysis of:UPDATE 2-Sequenom delays Down Syndrome test; shares plunge | uk.reuters.com

This delay is not good for the company, especially since there are already tests in place that are effective to screen for Down's syndrome.  These tests now are the standard of care, so the longer it takes for Sequenon to launch it's test the worse, for the company.

John AnsellDirectorJohn Ansell Consultancy

Solvay Strategy - the company appends a note

April 27, 2009

Analysis of: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.

John AnsellDirectorJohn Ansell Consultancy

Glaxo Stiefel deals with the dermatology question

April 21, 2009

Analysis of: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.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Efalizumab Withdrawn Due to Serious Side Effect

April 16, 2009

Analysis of:Efalizumab withdrawn from US Market | www.medscape.com

I read with great interest that Genentech, the maker of Raptiva (Efalizumab) to treat psoriasis, has begun a voluntary, phased withdrawal of the drug from the U.S. market. The drug is not being withdrawn immediately to give physicians and patients taking Raptiva time to safely and appropriately discontinue treatment. Because it's possible that abruptly discontinuing Raptiva may cause a severe flare of psoriasis, As a pharmaceutical consultant and pharmacist, I think phase withdrawal is a good approach. Overall I do not think this withdrawal will have long term impact on other biologic products in US and world.Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.

Aemad AslamPresidentMindPharma

Thriving in a time of adversity - Sun Pharma pounces on shortage by getting approval on Oxycodone

April 13, 2009

Analysis of:Sun Pharma gets USFDA's nod to market painkillers | www.hindu.com

Sun Pharma can greatly benefit from the nationwide shortage of Oxycodone Immediate Release Tablet, by getting approval from the FDA on their own generic. With recent recalls from different manufacturers, and the shortage of a comparable product Morphine Sulphate, the FDA currently estimates that return to normal supply levels of Oxycodone may occur in approximately 2 months, during which time Sun Pharma can capitalize on the shortage by securing longer term contracts with wholesalers.

John AnsellDirectorJohn Ansell Consultancy

Solvay Pharmaceuticals – prospects for a sale

April 6, 2009

Analysis of: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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

Generic ADDERALL XR Launched By Teva (NasdaqGS:TEVA) - VYVANASE Sales Of Shire PLC (NasdaqGS:SHPGY) Might Decrease

April 2, 2009

Analysis of:Teva Introduces First Generic Adderall XR® Capsules in the United States | www.tevapharm.com

(1) As stated in the 02 Apr 2009 Press Release, Teva Pharmaceutical Industries Ltd. (NasdaqGS:TEVA) has launched its generic versions corresponding to the FDA-approved Orange Book Reference Listed Drug (RLD) medical products of ADDERALL XR Capsules (mixed salts of a single-entity amphetamine product; strengths/mg: 5 10 15 20 25 30) of Shire PLC (NasdaqGS:SHPGY).  This event, although unfavorable to Shire, was clearly a known possibility.  Its anticipated impact will likely be a decrease in Shire's American sales of ADDERALL XR Capsules.  (2) Spillover damage for American sales of VYVANSE Capsules (lisdexamfetamine dimesylate; strengths/mg: 20 30 40 50 60 70) might be possible.  The nexus between ADDERALL and VYVANASE follows. VYVANASE's Active Product Ingredient (API) is lisdexamfetamine dimesylate; a prodrug of dextroamphetamine.  ADDERALL's APIs are a mixture of 4 related amphetamines.  Thus, ADDERAL and VYVANASE are related medical products.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

OXYCONTIN Update: Ratiopharm And Sandoz Infringe 2 European Patents Controlled By Napp And Purdue

April 2, 2009

Analysis of:OXYCONTIN Update: England Patent Infringement Victory {Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH [2009] EWCA Civ 252 (01 April 2009)} | www.bailii.org

(1) In this article, the London 01 Apr 2009 html version of judgment of the England and Wales Court of Appeal (Civil Division), a recent appellate court decision provides Napp and Purdue, in protecting OXYCONTIN, with a definitive patent infringement victory over both Ratiopharm GmbH and Sandoz Ltd (winners at the prior lower court).  (2) Its conclusion at Paragraph No. 117 is clear and unambiguous.  "The patents are valid and infringed."  (3) This important decision reverses a prior 16 Dec 2008 decision.  From a financial point of view OXYCONTIN is vital - "Its importance is shown by its sales figures - of the order of £32 million per annum in the UK alone." (Paragraph No. 4)

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Various Generic Topiramate Tablets Approved by FDA

March 31, 2009

Analysis of:Ranbaxy, Aurobindo get US FDA nod for epilepsy drug | economictimes.indiatimes.com

As a Pharmaceutical consultant and pharmacist I read this article with great interest since prices Topiramate will further reduced due to additional generic company. Topamax® is very useful drug for the treatment of adult and pediatric Epilepsy. On September 2006, Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Tablets, 25mg, 100mg and 200mg On March 28, 2009, Various companies (Teva, Sun, Ranbaxy) will market its version of the Topiramate tablets, the medicine in Topamax, in dosages of 25, 50, 100, and 200 mg. Annual sales of Topamax(R) were approximately $2.4 billion in the United States for the twelve months that ended December 30, 2008, based on IMS sales data.

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