The Big Red Biotech Blog

Please, Sir. May I have some more? Fabrazyme

According to WSJ just now, Genzyme expects to stop rationing its Fabrazyme during the 1st half of next year - which could still be up to 9 months from now by my calendar.

For the patients who are waiting on their meds to return to normal, I hope it is sooner rather than later.

The timing may be a little curious for this announcement since its not really effective until 2011 at the earliest.  Would this have anything to do with positive PR at a time when the company is under acquisition rumors?  Perhaps, a few kudos for current management?

Posted by Bruce Lehr September 15th 2010.  

Industry Strategy for Viral Inactivation in Liquid Media

With recent incidents of virus contamination in Biopharmaceutical manufactuirng sites, e.g. Mouse minute virus (MMV) or Vesivirus 2117, I believe virus risk mitigation strategies are accelerating in many organizations.  Two popular strategies for viral inactivation in liquid media used in biopharmaceutical manufacturing are High Temperature Short Time (HTST) and Ultra Violet Radiation subtype C (UVC) treatment.

Am I imagining this trend or do you see a generalized industry shift to these technologies for lowering risk of viral contamination in cell culture media to be used in bioprocessing?  If your organization is pursuing either of these technologies, are there specific support activities from your current media vendors that would assist your organization in implementing these technologies? 

Feel free to comment on your view of the current industry situation.

Posted by Bruce Lehr August 20th 2010.  

Pendulum Swinging Back to Virtual Biotech Model?

I saw this post Sunday by Seeking Alpha's Jason Chew and thought I would pass it on.  Unfortunately (for me), Maureen Martino of Fierce Biotech beat me out of the blocks this morning. However, I thought it was interesting to note that biotech's may be going back to more of a virtual model again in the wake of economic downturn, more limited venture funding, patent cliff pressure at Big Pharma, rising costs of new drug development, etc.  This is a model I think of from the late 90's and early part of 2000's -- but one that had drifted into more fully integrated biotechs in the last part of the decade.

Now with new economic and scientific pressures, both biotech's and even Big Pharma itself seems to be dusting the model off and putting it back into play. One example of the latter cited is Lilly's Chorus division founded in 2002. The virtual model relies on many fewer people (lower overhead) and places a premium on the expertise to manage external relationships - especially R&D in CROs.  The projects, after reaching proof of concept (POC) are usually sold off to Big Pharma.  Or in the case of Big Pharma, move from the "virtual development group" to process development et al when POC is established. The premium is placed on putting as many candidates as possible through the POC process as fast and cheaply as possible. 

Lilly's Chorus program claims it can now handle as many as 10 candidates at once with only 24 staff.  POC can be reached 1.5 years sooner and at as little as 10% of the cost (eye opening if true or remotely typical).  If this type of success is possible, and money remains tight with regard to venture capital or IPOs, it seems certain that the virtual model will again take root.  It remains to be seen if it will show sustainable success rates to justify it.

Posted by Bruce Lehr August 16th 2010.

 

DATELINE - Key dates in Genzyme's manufacturing crisis

From the PharmaTimes via the PharmaGossip blog, here we have a recap of the 'Genzyme manufacturing woes' saga by key dates.  The latest this month is the revelation that an additional $6.5 M inventory write off had to be taken and that the manufacturing fixes mandated by the FDA are likely going to take more than 4 years to complete.

PharmaGossip: TIMELINE - Key dates in Genzyme's manufacturing crisis - London South East.

How this might affect the Sanofi purchase offer is anyone's guess?  It is likely to make it more improbable that Sanofi would try anything hostile if negotiations don't go well as the ongoing manufacturing issues are a bit of a black box to an outside bidder. Read the comments section for more info from other sources.

Posted by Bruce Lehr August 16th 2010.

 

 

 

Genzyme Manufacturing Fixes Delayed - Effects on Sanofi Buy Try?

According to Bloomberg this morning, Genzyme expects that its fixes to the Allston manufacturing facility will now take longer than originally estimated - going from 2-3 years to more than 4 yrs in latest guess. This is not particularly good news for Genzyme shareholders or patients.

The Allston plant is the main source (though not sole) of Genzyme manufacturing problems and is the plant that supplies bulk of Genzyme's two top sellers -- Cerezyme and Fabrazyme. The plant was hit with a $175 M consent decree in May and may face additional fines up to $130 M if it fails to meet FDA deadlines under that decree.

Given this, and a conspicuous lack of competitive bidders for Sanofi in its attempt to acquire Genzyme, there is no obvious driver to allow Genzyme to lever its asking price up from the purported Sanofi offer of $67-70/share to Genzyme's desired greater than $80/share offer. Many analysts are predicting that Sanofi can hold out for the lower price with no bidder in sight, and the prospect if they walk that Genzyme stock will tumble back below $50/share.  Ouch!  It's been characterized as a game of chicken.  That's why top execs get the big bucks afterall.

Says Pictet Asset's investment manager Marc Booty, "No one wants to be the one holding Genzyme stock when it was down near $50, reaches near $70 and then goes down to $50 again, which would happen if Sanofi walked away."

Counterpoint from Sven Borho, a partner with OrbiMed Advisors -- with 2.5 million Genzyme shares, "Genzyme is not in a weakened state, where they have to sell and they have no choice.  It's just the other way around."  Whistling in the dark or prophetic?  Time will tell.

Posted by Bruce Lehr August 12th 2010.

SAFC's Verona CMO for HPAPI and ADC Manufacturing

 As evidenced by the Seattle Genetics and Genentech deal announced today, high potency active pharmaceutical ingredients (HPAPIs) and antibody drug conjugates (ADCs) are seen as important new technologies within the oncology fields.

The idea of targetting a cancer cell with a potent payload of toxin that hits the mark is a powerful new tool in the cancer fighting battle. It is also a means by which companies can take their naked antibody drugs and create a new drug with lengthened market life and improved effectiveness.

Recognizing the trends in this area for some time, SAFC has been a leader in manufacturing capability for high potent products.  We have had the Madison, WI site for a number of years and have just opened a new facility in Verona, WI that extends our capability for manufacturing HPAPIs or ADCs by using state of the art containment designs.

in-Pharma Technologist.com is hosting a video interview with Dave Bormett, the SAFC Director Operations for its new Verona site. Follow the link for an exclusive look inside the facility. 

Posted by Bruce Lehr August 3rd 2010.

 

 

 

 

 

 

Biotech on a Shoestring? There's a Better Way

Follow in the footsteps of other industries like automobiles or electronics.  Cut costs to reduce waste and to add value for the customers. Repeat over and over again with a customer focus in mind.

Biotech on a Shoestring? There's a Better Way.

Seems like simple advice that others have employed successfully.  Now it's well past time that Biotech follow suit. Waste not. Profit more.

Posted by Bruce Lehr July 27th 2010.

SAFC - New Cell Culture Raw Materials Centers of Excellence

SAFC is investing in the expansion of its manufacturing sites to support biopharmaceutical cell culture production in Lenexa, KS, St. Louis, MO, and Irvine Scotland - creating new Centers of Excellence. This is a $17.3 M program aimed at optimizing its global manufacturing footprint in the US and Europe.

The Lenexa site will be enhanced as the US Center of Excellence for dry powder medium manufacturing. This $6.25 M program, supported by a $250,000 grant from the Kansas Bioscience Authority, will include explanded pin milling and blending capability. The expansion will increase batch capacity by 30% and is slated to be complete by the end of 2010. It will also result in completely separate Animal Component Containing (ACC) and Animal Component Free (ACF) manufacturing spaces. Powder scale up will be seamless from 25 to 4000 Kg in pin milling technology.

Similarly, the St. Louis, MO and the Irvine, Scotland facilities will be augmented as the liquid media, feeds and reagents Centers of Excellence. The improvments will result in an additional ACF manufacturing space in Irvine, and both ACC and ACF dedicated spaces in the St. Louis Broadway facility. Batch capacities will range from 1L to 10,000L at both sites. These are also slated to have construction completed by the end of 2010 with qualification extending into the 1st Qtr of 2011.

"As the biopharm market continues to mature and place an increasing emphasis on efficiency, cost containment and increased regulatory compliance, SAFC will continue its strategy to invest in manufacturing capabilities and facilities that uniquely address these requirments," said SAFC President Gilles Cottier.

Posted by Bruce Lehr July 4th 2010.

Getting Provenge like Getting a New Kidney or Heart

As reported below in Bloomberg article via Pharmalot blog, now that Provenge is approved, Dendreon does not have enough current manufacturing capacity to serve more than 2% of the expected patient demand.  That's bad (even worse) news if you have advanced prostate cancer.   

Dendreon’s Provenge Vaccine Faces Rationing // Pharmalot.

The situation is not expected to improve much until well into 2011 and maybe a bit further out than that. We may need to see if a Big Pharma player comes in to scoop up the Company and then is in the position to speed an investment in manufacturing. 

In the meantime, the WSJ blog reports that treatment centers around the World are using techniques derived from transplant programs to prioritize patients who will receive the vaccine first. Some institutions, notably MD Anderson, are even considering a lottery system. Unfortunately, the ability to pay the expected $93,000 for a course of treatment may also be an important criterion on who gets the first treatments.

Posted by Bruce Lehr June 28th 2010.