Genzyme Partly Rights Past, As Competition Coming (GENZ, PFE, PLX)

December 1, 2009 · Filed Under Financial, M&A, R&D, fda · Comments Off 

Genzyme Corporation (NASDAQ: GENZ) would normally be taken as though the company has some good news out after it announced that it has begun shipping vials of newly produced Cerezyme® from its Allston Landing plant.  The problem is that Pfizer Inc (NYSE: PFE) is acquiring the worldwide marketing rights to Protalix BioTherapeutics Inc. (AMEX: PLX) experimental drug for Gaucher’s disease for an upfront payment of $60 million.  This will compete head to head against Genzyme if and when it is approved, and if Pfizer is buying it it seems likely that an approval is expected.

Genzyme also gave an update on its progress to restore supplies of Cerezyme and Fabrazyme® (agalsidase beta) for patients worldwide.  The initial Cerezyme shipments will provide uninterrupted treatment for the most vulnerable patients under the current supply conservation guidelines. Genzyme will expand shipments of Cerezyme by the end of this month to patients worldwide who have experienced interruptions in their treatment this year.

Genzyme has also noted that it expects meet anticipated worldwide demand and allow all patients to return to their normal infusion and dosing regimen during the first quarter of next year.  Genzyme is also preparing to ship vials of newly produced Fabrazyme from the Allston plant.  The company is currently producing Fabrazyme at a rate of approximately 70% of what is believed to be the anticipated demand for 2010 and is working to improve the productivity of Fabrazyme manufacturing.

Genzyme noted that it will continue to ship 30% of Fabrazyme demand during Q1-2010 and to build inventory to begin shipping 70% to 100% of demand in Q2-2010 and it will communicate further details about Fabrazyme supply in February 2010.

As far as the competition from Protalix, that company is also eligible to receive additional milestone payments of up to $55 million from Pfizer and will retain the marketing rights to the drug, Uplyso in Israel.  Pfizer and Protalix will share future revenues and expenses for the development and marketing of the drug, with 60% Pfizer and 40% Protalix.  Protalix was granted an orphan drug designation, as well as a fast track status, by the FDA and will compete with Genzyme’s Cerezyme when and if approved.

JON C. OGG

Tags: , ,

Market Hates Protalix (PLX) 10-Q

November 10, 2009 · Filed Under Financial · Comments Off 

Protalix Biotherapeutics (AMEX:PLX) has had a good run.

A little over a month ago, the ompany said preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company’s proprietary ProCellEx technology, pr-antiTNF is a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel.

In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model including joint inflammation, swelling and tissue degradation.

Shortly after that Canaccord Adams upped its rating on the company.

Today, Protalix released its 10-Q and the stock took a nose dive. It is going to be a contest to see what the market didn”t like.

Douglas A. McIntyre

Tags:

Protalix BioTherapeutics (PLX) Up On FDA Action

August 17, 2009 · Filed Under fda · Comments Off 

Protalix BioTherapeutics (PLX) is up 10% on news that that the U.S. Food and Drug Administration (FDA) has approved the Company’s treatment protocol for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The treatment protocol allows physicians and other care-providers to treat patients of Gaucher disease with prGCD in the United States and additional countries world-wide while studies of prGCD continue as part of the Company’s ongoing pivotal Phase III clinical trial. Prior to accepting the protocol, the FDA reviewed available data from the Company’s on-going Phase III clinical development programs.

Douglas A. McIntyre

Tags:

    Subscribe to BioHealth Investor BioHealth Investor RSS Feed