Mr. Keith Berman MPH, MBA

GLG News^SM Analyses by Keith Berman(?)

Talecris Biotherapeutics Proposes IPO; Hits Favorable Timing Window

September 23, 2009

Analysis of:Talecris Joins Crowd of Stock Offerings | www.newsobserver.com

Talecris Biotherapeutics and its two private equity owners -- Cerberus Capital Management and Ampersand Ventures -- are counting on the third time being the charm with their new IPO slated to sell 44.7 million shares at a target price of $18 to $20 each. About $515 million of these funds are earmarked to pay off loans, with the balance available to bolster commercialization activities, advance the company's ambitious R & D pipeline and help fund capacity expansion.

FDA Approves CSL's RiaSTAP Human Fibrinogen Product

January 22, 2009

Analysis of:CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatmetn of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency | www.cslbehring.com

Rabies Surveillance in the United States during 2007CSL Behring's human fibrinogen concentrate, sold for years in Europe as Haemocomplettan P, will be welcomed as a treatment for bleeding problems in U.S. patients with a rare genetic absence or deficiency of this critical clotting protein.  RiaSTAP will eliminate the need for infusions of large quantities of "cryoprecipitate" that can cause dangerous clots or potentially transmit blood-borne infections.  Most of these RiaSTAP revenues will go directly to CSL's bottom line, as fibrinogen is already present in same donor plasma from which CSL currently extracts immune globulins, albumin, factor VIII and other therapeutic proteins.  RiaSTAP addresses a small market, but each new niche product like this (and there will be others) is like found money:  the cost of purifying it is generally modest in relation to the value and pricing it can command.

CSL Gets FDA Approval for Its RiaSTAP Fibrinogen Product

January 20, 2009

Analysis of:CSL Behring Receives FDA Approval of RiaSTAP, First and Only Approved Treatmetn of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency | www.cslbehring.com

CSL Behring's human fibrinogen concentrate RiaSTAP, sold for years in Europe as Haemocomplettan P, will be welcomed for management of bleeding problems in U.S. patients with a rare genetic absence or deficiency of this critical clotting protein.  RiaSTAP will eliminate the need for infusions of large amounts of "cryoprecipitate" that can cause dangerous clots or potentially transmit blood-borne infections.  Most incremental RiaSTAP revenues will go directly to CSL's bottom line, as fibrinogen is already present in same donor plasma from which CSL currently extracts immune globulins, albumin, factor VIII and other therapeutic proteins.  RiaSTAP addresses a small market, but each new niche product like this (and there will be others) is like found money:  the cost of purifying it is generally modest in relation to the value and pricing it can command.

Highly Promising Phase III Trial of Baxter's IVIg for Alzheimer's Disease Begins

September 29, 2008

Analysis of:Baxter Initiates Phase III Trial for the Treatment of Alzheimer's Disease | www.baxter.com

Not surprisingly, everything tried thus far to slow the relentless progression of Alzheimer's disease has failed.  But if strong efficacy signals from two pilot studies and a recently completed Phase II trial of human immunoglobulin (IVIg) are confirmed in a Phase III trial scheduled to start next month, that string of failures will be coming to an abrupt end.  The two NIH-supported pivotal trials will answer two questions:  (1) is an age-related failure of natural antibody-mediated immunity important in the development of Alzheimer's disease, and (2) can this disease process be slowed by restoring therapeutic levels of antibodies that some older people no longer make enough of?  With what we know about the role of beta-amyloid protein in Alzheimer's, and have learned from studies testing anti-beta amyloid monoclonal antibodies, and have seen in those three small IVIg trials , I wouldn't bet on another failure this time around.

Talecris IVIg Product Gets FDA Approval for Serious Neurological Disorder

September 17, 2008

Analysis of:FDA Grants Approval to Talecris Biotherapeutics for Gamunex as a Treatment for Neurolgoical Disorder CIDP in the US | www.talecris.com

The efficacy of intravenous immunoglobulin (IVIg) for treatment of CIDP was documented many years ago.  Neurologists have ordered IVIg for years to treat this debilitating disorder, particularly for patients who fail therapy with corticosteroids or other immunosuppressive drugs. Talecris Biotherapeutics' elaborate Phase III crossover study (published earlier this year in The Lancet) proved unequivocally that chronic treatment with Talecris' Gamunex IVIg yields better long-term patient disability scores than placebo treatment.

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