Mr. Keith Berman MPH, MBA

GLG News by Mr. Keith Berman MPH, MBA, Consultant

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.

Cerberus Reportedly Shopping Talecris Biotherapeutics to Competitors

June 13, 2008

Analysis of:Owners Might Sell Talecris Instead of Pursuing an IPO | www.newsobserver.com

After abandoning a 2007 IPO, Talecris majority owner Cerberus Capital is now reported to be pursuing negotiations to sell the $1.2 billion plasma products firm. Talecris' valuation will necessarily involve projections of worldwide market demand for intravenous immunoglobulin (IVIg), the industry's most important product.

Cerberus May Be Looking to Sell Talecris Biotherapeutics

June 11, 2008

Analysis of:Cerberus eyes Talecris sale instead of IPO | www.ft.com

If a report in the Financial Times is credible, the already consolidating plasma products industry could render down to even fewer players in the near future with the sale of Talecris to a major competitor. The value of the company will be strongly influenced by the direction in demand for its industry's leading product:  intravenous immunoglobulin (IVIg).

FDA Explodes ZymoGenetics' Recothrom Safety Argument

May 9, 2008

Analysis of:FDA Asks ZymoGenetics to Revise New Product's Press Release | seattletimes.nwsource.com

The FDA -- likely with encouragement of King Pharmaceuticals -- has ordered ZymoGenetics to cease dissemination of materials that cite "a significantly lower incidence of antibody formation compared to the commercially available bovine thrombin product [Thrombin-JMI]." "This statement is false or misleading because it suggests that Recothrom is safer than the bovine thrombin product due to a lower incidence of antibody formation," while in fact "the incidences of pre-specified adverse events were similar between Recothrom and bovine thrombin" in a head-to-head clinical trial conducted by ZymoGenetics. Shortly after the U.S. approval of Recothrom was announced in January, I posted an analysis that concluded as follows:  "While ZymoGenetics deserves kudos for crossing the FDA finish line, its selling proposition is flawed." One of those flaws was the company's fast and loose promotion of this antibody safety claim.  The FDA's action comes as no surprise.

Startling New Evidence Suggests IVIg May Help Alzheimer's Patients

April 18, 2008

Analysis of:Study Suggests Gammagard Liquid May Target the Primary Pathway Involved in Alzheimer's Disease | biz.yahoo.com

Three presentations at this week's AAN meeting in Chicago are adding in a big way to accumulating evidence that intravenous immunoglobulin (IVIg) may slow, halt or even PREVENT accumulation of toxic beta-amyloid -- a prime culprit in the development of Alzheimer's disease (AD) in millions of aging individuals. Antibody-binding, serology and preclinical findings powerfully suggest that progression to AD has something to do with a failure to mount an adequate humoral (antibody) immune response to beta-amyloid oligomers, which then deposit in brain tissues.  New lab, PET scan imaging, clinical and lookback study results now offer important new evidence that frequent infusions with low doses of IVIg may restore the "missing link" in immunity and allow the patient's cellular immune function to more effectively kick in and clear the toxic beta-amyloid. Whether monoclonal antibody preparations now in development can mimic an array of natural human antibodies remains an open question.

ZymoGenetics' rDNA Thrombin Gets FDA Nod; The Battle vs King, J & J, Baxter Begins!

January 18, 2008

Analysis of:FDA Approves ZymoGenetics' RECOTHROM Thrombin, topical (Recombinant) | www.zymogenetics.com

ZymoGenetics exuberantly proclaimed yesterday in a conference call that "we expect RECOTHROM to become the leading thrombin product in the hemostasis field."  The company will test its premise that the U.S. hospital market will (1) abandon or snub three plasma-derived thrombin offerings, and (2) pay a price premium for theoretical safety advantages touted for its recombinant version.  We now have four strong competitors with diverse product forms and selling platforms vying for the $250 million U.S. thrombin market.  Simply put, there isn't enough room for four players to succeed in this atypical market.  As I said in my last update on 12/20, get ready for a bloodbath.  

As ZymoGenetics, Ethicon, King Gird for Thrombin Battle, Baxter Gets FDA Nod for Its Convenient Thrombin/GELFOAM Kit

December 20, 2007

Analysis of:Baxter Announces FDA Approval of GELFOAM Plus Hemostasis Kit | www.baxter.com

Without major fanfare, Baxter(NYS:BAX) Healthcare has secured FDA approval for a kit combining its proven-safe, pathogen-inactivated human thrombin in combination with Pfizer's(NYS:PFE) popular GELFOAM collagen pad.  The GELFOAM Plus kit will be launched early next year. But for years, Baxter's human plasma-based thrombin has been licensed as a component of its Tisseel VH fibrin sealant used primarily in cardiopulmonary bypass surgeries, and its vFloSeal collagen matrix product favored particularly for hemostasis involving anatomical defects. The long-expected 3-way battle over King Pharmaceutical's lucrative $250 million thrombin business just got more interesting -- and challenging -- for King Pharma (Thrombin-JMI), Johnson & Johnson's Ethicon unit (Evithrom) and ZymoGenetics, which still awaits approval of its touted low-immunogenicity recombinant thrombin product.

Bayer's Blood-Sparing Drug Trasylol Is Now in Critical Condition

November 1, 2007

Analysis of:FDA Issues Early Communication about an Ongoing Safety Review Of Aprotinin Injection | www.medicalnewstoday.com

Bad news for Bayer's Trasylol (bovine aprotinin) has come in waves.  In 2006, a large retrospective review identified a two-fold higher risk of kidney failure and heart failure, and much higher risks of heart attack and stroke in CABG surgery patients given Trasylol versus those not given the drug. Then a February 2007 observational study, involving more than 4,300 cardiac surgery patients in 69 hospitals, found that Trasylol (but not two other antifibrinolytic drug) was associated with a nearly 50% increased risk of death versus no treatment, after adjusting for other mortality risk factors. And on October 19, the FDA disclosed that it has been notified by study safety monitors of a higher death rate in cardiac surgery patients given Trasylol than two other antifibrinolytic drugs (aminocaproic acid and tranexamic acid).  From U.S. approval, it took some 15 years for these extraordinarily serious and diverse problems to be brought to light.

Northfield Labs to Push for "Priority Review" of its PolyHeme Blood Substitute

September 28, 2007

Analysis of:Northfield to Seek Quick Review for PolyHeme | www.chicagotribune.com

As billions of investment dollars over the last 20 years can attest, there is an important need for an effective temporary non-blood oxygen carrier, especially for severe bleeders facing an extended delay to reach the hospital.   Northfield's pivotal trial didn't manage to document "noninferiority" of its PolyHeme product in 714 intent-to-treat subjects, but the mortality gap narrowed substantially in the 586 subjects who met all enrollment criteria and got the right products. The company has asked independent reviewers to see if an imbalance in underlying risk factors could explain an 11:3 skew in heart attacks favoring the saline-and-blood control group. A plan to seek a "priority review" for its BLA reflects Northfield's confidence that the FDA will see the implied value of PolyHeme for the long transit population that can't be sustained with saline alone.

Baxter's IVIg in Alzheimer's Looks "Favorable;" Phase III Trial Announced

August 29, 2007

Analysis of:Baxter and the Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients with Alzheimer's Disease | www.baxter.com

For over 2 million Americans afflicted with mild and moderate Alzheimer's disease, there is nothing available to stop or meaningfully slow the progression of this brain-ravaging disease.  the sticky beta-amyloid peptide that is concentrated in plaques has been implicated for years.  Then a group at Cornell documented stabilization or improvement in most subjects in a small open-label study of IVIg.  This coincided with large elevations in beta-amyloid levels in the circulation. Yesterday Baxter announced "favorable" results after preliminary review of Phase II trial data involving 24 subjects infused with it's Gammagard IVIg products or a placebo solution.  Suddenly the wheels are in motion on a much larger Phase III study sponsored by Baxter and the U.S. National Institute on Aging.  That trial is set to begin in early 2008. A host of issues must be addressed if IVIg proves effective.  How effective? in whom?  And what about product supply?

Omrix' Thrombin Is Out of the Gate Ahead of ZymoGenetics

August 28, 2007

Analysis of:FDA Clears Omrix Blood-Clotting Drug | biz.yahoo.com

The expected near-simultaneous U.S. introduction of Omrix' ZymoGenetics' topical thrombin products has become a 4- to 5-month head start for Omrix with yesterday's FDA approval of "Evithrom" and last week's 3-month PDUFA postponement of rThrombin until January 17th. Aside from a delay in a $40 million approval milestone payment from marketing partner Bayer, the question is whether and to what extent this delay will hurt ZymoGenetics' commercial prospects for its much-touted recombinant human thrombin. 

China's albumin shortage creates a major shock

August 17, 2007

Analysis of:Hospitals face shortage of albumin | www.chinadaily.com.cn

Albumin is administered after major surgeries and in critically ill patients with a host of medical problems (shock, severe liver disease, severe burns, etc.).  Hospitals use a lot of it. Chinese health authorities moved recently to shut down the many blood centers that paid people for blood donations, but they didn't count on a serious side effect:  less blood plasma, the raw material manufacturers need to purify human albumin. The acute shortage has forced China to import albumin from US and European manufacturers -- just as domestic demand has picked up strongly.  And, 60 years after it was first used in WWII, potentially huge new demand drivers for albumin are looming in the near future. Things will get much more interesting for plasma fractionators and investors in this specialized sector.

CSL Behring's Liquid IVIg Ramps Up the Competition

July 31, 2007

Analysis of:CSL Behring Announces FDA Approval of Privigen -- First Proline-Stabilized 10 Percent Liquid IVIg | www.cslbehring.com

Two decades of two-tier U.S. IVIg pricing based on liquid vs. powder delivery form has effectively come to an end with last Friday's FDA approval of CSL Behring's Privigen 10% liquid IVIg. As long as IVIg supply just keeps up with demand, all five current competitors -- Baxter, Talecris, CSL Behring, Grifols and Octapharma -- should continue to enjoy strong pricing and robust sales. But a disruption in these market conditions could significantly change the competitive environment for this increasingly commodity-like liquid IVIg product class.

King Pharma's New Thrombin Delivery Kit Has a Good Nose

July 5, 2007

Analysis of:King Announces FDA Approval of Epistaxis Kit for THROMBIN-JMI | www.kingpharm.com

Even as ZymoGenetics argues that its recombinant thrombin is safer than King's popular THROMBIN-JMI topical bovine thrombin product, the FDA has just licensed yet another THROMBIN-JMI line extension.  This time it's an intranasal spray delivery device for THROMBIN-JMI, which is designed to aid in stopping nosebleeds (epistaxes).  King plans to launch its THROMBIN-JMI Epistaxis Kit in the U.S. by the fourth quarter of this year.  It will join the THROMBI-Pad thrombin-impregnated hemostatic pad for use in controlling moderate to severe bleeding in the emergency department setting.  Suggestions that nearing approvals of new recombinant (ZymoGenetics) and human (OMRIX) thrombin products could prompt the FDA to strip the THROMBIN-JMI marketing license look very much like a case of wishful thinking.

ZymoGenetics Signs Up Bayer to Drive Its U.S. and Foreign Thrombin Sales

June 21, 2007

Analysis of:ZymoGenetics Establishes Global Collaboration With Bayer HealthCare for Development and Commercialization of Recombinant Human Thrombin | www.zymogenetics.com

Betting on Napoleon's military principle of superior force at the site of engagement, ZymoGenetics has enlisted Bayer's underutilized 95-person hemostasis sales/MSL group to try to convince major hospital users of King's bovine thrombin product to convert to recombinant thrombin. In the radically different European and Pacific Rim markets, Bayer has agreed to take on the challenge of securing regulatory approvals and marketing rThrombin, with its attendant risks and potential rewards. ZymoGenetics' CEO argues that history is on the side of recombinant versions of plasma proteins, and suggested specific safety, convenience and supply advantages that will win the day against King's popular Thrombin-JMI and Omrix' forthcoming human thrombin product.

Northfield's "PolyHeme" Blood Substitute: Evidence of an MI Class Effect

May 24, 2007

Analysis of:Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study | phx.corporate-ir.net

Five months after disclosing "top-line" findings from its 720-subject urban trauma trial, Northfield has released disappointing final mortality results, which failed to reach a presumptive 7% upper confidence limit for "non-inferiority" of PolyHeme against the current standard of care (saline + red blood cells).  Most surprising to some is the disclosure of 11 heart attacks in the PolyHeme arm vs. 3 in the standard treatment arm, which is reminiscent of an excess of heart attacks in an earlier aborted trial of the product.  The likelihood of a "class effect" -- myocardial events triggered by free hemoglobin solutions -- now seems difficult to dismiss, given similar problems seen with products developed by Biopure, Hemosol and Baxter Healthcare. The question now is what development options remain for Northfield (with nearly $50 million in cash) and surviving competitors in this 20-year old "race" for one of the Holy Grails of medicine.

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