Dr. Andrew Dahl MD

GLG News^SM Analyses by Andrew Dahl(?)

Lumigan X EU Committee Recomendation

October 27, 2009

Analysis of:EU committee backs marketing approval of Lumigan | www.pharmabiz.com

The Committee for Medicinal Products for Human Use (CHMP) of the European Union has recommended granting a Marketing Authorization for a new version of Allergan's Lumigan (bimatoprost ophthalmic solution). This new version will be marketed as Lumigan-X after approval. Lumigan X offers Allergan a new formulation to compete against generic versions of its glaucoma drug Lumigan after patent protection for Lumigan expires shortly.There will be very limited demand for Lumigan-X.

U.S. Ophthalmologists Still Waiting for Prostaglandin/Timolol Combo

November 8, 2007

Analysis of:Allergan, Inc. Receives FDA Approval For COMBIGAN™ (Brimonidine Tartrate/timolol Maleate Ophthalmic Solution) 0.2%/0.5% | www.medicalnewstoday.com

The market for eye drops for the treatment of open angle glaucoma is huge. Profit potential for pharmaceutical companies, however, is limited by the time period that they are afforded patent protection. Combigan, the just approved brimonidine/timolol combination therapy, affords Allergan new patent rights on the combination whose two components individually have multiple generic competitors.                          

Interesting Approach to the Lucrative Dry Eye Market

October 16, 2007

Analysis of:Alacrity Biosciences Announces Positive Results from a Phase 2 Study of Its Dry Eye Treatment ALTY-0501 | www.pipelinereview.com

Alacrity Biosciences has completed a Phase 2 clinical trial of ALTY-1501, an eye drop for the treatment of dry eye. Dry eye (or keratoconjunctivitis sicca (KCS) affects more than 10% of the US population and its incidence is increasing as baby boomers become senior citizens. Although the small clinical trial produced promising results, the FDA will require both subjective (patients feeling better) and objective (decreased conjunctival and corneal staining) statistical advantage over placebo in two phase III trials prior to approval of the eye drop drug.

Restriction on Avastin distribution will add to Genenetech's bottom line.

October 15, 2007

Analysis of:Maker Seeks to Restrict Cancer Drug Used on Eye | www.nytimes.com

       Genentech has had first year revenues of $800 million from its drug Lucentis, which is used intravitreaaly to treat macular degeneration on label and some other conditions off label.   Although this amount of sales places Lucentis well within the blockbuster category, Genenetech realizes that, were it not for the off-label use of its own drug Avastin for treatment of the same conditions, revenues would have been $1.2 billion for that same period.        Vials of Avastin containing either 100 mg. or 400 mg. are currently being split into 1 mg doses by compounding pharmacies, dropping the price per dose to the $50 range as opposed to the $2000 per dose price for Lucentis.   

FDA "Bifocal LASIK approval" not truly for bifocal vision.

July 16, 2007

Analysis of:FDA Approves Bifocal LASIK Surgery | www.medpagetoday.com

The FDA has just approved a "bifocal LASIK" technique from Advanced Medical Optics using their CustomVue Excimer laser platform.   It has been approved as " a new device". In actuality, it is neither a new device nor does it provide bifocal vision.

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