The Big Red Biotech Blog

AZ to Predict Drug Safety in Russian Center

AZ is planning to spend $1.2 billion to increase its presence in the fast emerging Russian market over the next 5 years.  Its latest project is an investment in advanced software to predict the safety and efficacy of drugs. It will open the Predictive Science Center in St. Petersburg and plans to employ Russians to develop biofinformatics, data analysis capabilities and new software tools. AZ will have 30 of its own employees at the center as well and is placing a bet that advanced computer systems will make its R&D more efficient.

Not surprisingly, the plan is backed by the Russian government no doubt eager for the investment and increased AZ presence. AZ is also building a $150 M drug manufacturing plant in the Kaluga region in Russia as part of its expansion.

"Russia is a dynamic economy where our growing investments will help us to offer to patients AstraZeneca's portfolio of innovative medicines," said AZ's CEO David Brennan. See Fierce Biotech.

 
Posted by Bruce Lehr June 16th 2011.

SAFC and Pfenex Partner on Protein Production

SAFC and Pfenex have agreed to a partnership to produce therapeutic proteins and vaccine components for their joint clients.  Pfenex will be responsible for engineering bacterial strains and developing production processes that can be transferred to SAFC's GMP fermentation facilities in Jerusalem ( Download Jerusalem-insert) for scale up and manufacturing.

The strategic partnership will focus on identifying customers seeking the total solution, from the design and engineering of a robust production strain, process development, scale up and GMP production. SAFC will subsidize a portion of upfront costs in return for the a commitment to use its GMP manufacturing services.  See Outsourcing Pharma.

 

Posted by Bruce Lehr June 8th 2011.

CMO Gallus buys Centocor bio facility

This one is of local interest for me.  The CMO Gallus has agreed to purchase the Centocor biologics manufacturing facility in St. Louis, Missouri through backing by Ridgemont Equity Partners. Gallus plans to invest $20 M in site expansion and to hire 160 staff.

CMO Gallus buys Centocor bio facility and plans investment.

This Centocor site previously had FDA approval to manufacture and distribute both Remicade and Stelara. Gallus plans to operate similarly by offering services for the contract manufacture of biologics. Gallus plans to add a clinical services suite and to expand the development labs. It also plans to complete a fill and finish suite by Qtr 4 2011. Gallus is a new CMO and this is its first manufacturing site.

"We see a tremendous market opportunity in the biologics contract manufacturing space and believe the facility we've acquired is well-positioned to mee the current and future market needs of our customers," said Jack Purcell, a principle at Ridgemont who will join Gallus' board.

Posted by Bruce Lehr May 19th 2011.  

Caliber opens world’s largest plant-based manufacturing facility

i don't know why exactly -- but thought this was an interesting development.  Probably as I have always been skeptical as to how quickly recombinant therapeutics in plants would take to make it to market -- i.e. be commercially and regulatorily viable. Even though, I've seen many projects at this pont that were technically possible.

Caliber opens world’s largest plant-based manufacturing facility.

The US-based vaccine specialist, Caliber Biotherapeutics, has opened the world’s largest modular pharmaceutical manufacturing facility utlizing plant technology at its headquarters in Bryan, Texas. The company claims the new facility is capable of producing 10-100 million low-cost vaccine doses per month, along with other protein therapeutics such as monoclonal antibodies.

“With plant-based systems we have an unprecedented level of flexibility and scalability,” said Barry Holtz, Caliber's CSO.

Biodefense expert and chief medical officer for Caliber, Brett Giroir, said the new facility provided the company with a flexible, scalable manufacturing capacity to meet changing demands in the global vaccines market.

In addition to the company’s new plant-based facility in Bryan, Caliber also announced its intention to develop a proprietary product pipeline for cancer and infectious diseases, which it claims will utilize cell and microbial-based production systems.

We shall see what impact this facility and technology actually has on the market. The low-cost production and flexibility  being described above would seem suited to production of biosimilars and vaccines for developing areas in the world to name two target segments.

 

Posted by Bruce Lehr April 26th 2011.

Organogenesis Facility Signals Regenerative Medicine Progress

Organogenesis broke ground on the construction of the world's largest automated living cell manufacturing plant in Canton, MA.  A facility that the company says will allow it to leverage its leadership in the regenerative medicine field and allow it to attract resources and jobs over the next decade.

Organogenesis breaks ground on state-of-the-art facility.

I was interested in this announcement as the facility to me represents tanglible evidence that regenerative medicine is moving toward commercialization and actually requires larger scale, automated manufacturing to make product.  Sometimes fields move faster than I give them credit.

Posted by Bruce Lehr April 19th 2011.  

Lonza invests in biomanufacturing

Lonza says it will further expand its biomanufacturing facility in Slough, UK at a cost of 16 million pounds. The expansion will add a new fermentation suite, new purifications suites, new process development labs, and a new GMP warehouse.

Lonza invests in biomanufacturing.

The Slough unit houses Lonza's Biopharmaceutical Center of Excellence offering mammalian cell line development, upstream and downstream process development and a broad range of analytical testing and characterization services. The site employs 650. 

The project is scheduled for completion by the end of 2012. The expansion is expected to allow Lonza to meet the immediate and future manufacturing needs of its clients - both established and emerging. The expansion will help meet the growing demands of new biologics coming on line.

Posted by Bruce Lehr March 29th 2011.  

Boehringer Ingelheim Completes Amgen Fremont, CA Facility Buy

Yesterday Boehringer Ingelheim (BI) formally acquired Amgen's biopharmaceutical development and manufacturing facility in Fremont, California (USA). The facility currently employs more than 300 and consists of more than 200,000 square feet for laboratories, manufacturing and process development.

"Presence in Fremont, CA aligns with our growth strategy," said Simon Sturge, Corporate Senior Vice President Biopharmaceuticals, Boehringer Ingelheim GmbH. "The state-of-the-art contract manufacturing facility in the U.S. Bay Area biotechnology cluster will give Boehringer Ingelheim a greater opportunity to serve current and future customers. In addition the technological expertise present at Fremont will complement our goal to further increase Boehringer Ingelheim's world leading position in the process development and manufacture of biopharmaceuticals."

Boehringer Ingelheim Finalizes Acquisition Of AMGEN's Fremont Facility In The USA.

The Fremont site complements the existing capabilities and technology found across the existing BI biopharma network located in Biberach/Germany and Vienna/Austria. BI has been a contract manufacturer for Amgen for ten years and will continue to support Amgen's delivery of safe and effective medicines to patients around the world.

The BI contract manufacturing portfolio includes sixteen licensed biopharmaceuticals manufactured in globally licensed multi-product facilities, a growing pipeline of New Biological Entities (NBEs), and a growth strategy in the Contract Manufacturing Business (CMB).  Boehringer Ingelheim's objective is to remain a leader in Contract Manufacturing as an industry benchmark for operational excellence.

 

 

Posted by Bruce Lehr March 27th 2011.

Dendreon NJ Factory a "Go" with FDA

As reported in Xconomy, Dendreon has received FDA approval for its new factory in NJ to produce Provenge, its prostate cancer treatment.  The new site will allow Dendreon to quadruple its current capacity.  With the new production levels, Dendreon has forecasted its sales for Provenge in 2011 in the range of $350-$400 million.

 

Posted by Bruce Lehr March 11th 2011.

Fujifilm acquires Merck Biomanufacturing Network

Fujifilm has purchased Merck's contract manufacturing sites for biologics in North Carolina and in Northeast England for $490 M. 

Fujifilm acquires Merck Biomanufacturing Network.

Fuji says the acquisition will enhance its pharma group profile - an area it is trying to build as it diversifies its holdings away from the shrinking photo paper business.  Fierce Biotech notes that it is ironic that Fuji views pharma as an atttractive diversification at a time when many Big Pharma companies are diversifiying into other industries like animal health, consumer products and the like.

Maybe the grass is greener looking through the eye of a digital camera?

 

Posted by Bruce Lehr March 2nd 2011.

Speaking of Outsourcing R&D and Cost Cuts - We Give You Pfizer

Pfizer announced several moves today pertaining to its R&D groups in multiple facilities as it looks to trim $1.5 B from its previous R&D budget.  The cuts will result in layoffs of 2400 R&D employees and the closing of its Sandwich, Kent facility.  Pfizer also announced that several operations will be shifted from its Groton, CT site to Cambridge, MA -- about 1125 employees will be affected by the move. Pfizer will also stop several disease programs - including allergy and respiratory in Sandwick, antibacterials in Groton, regenerative medicine in Massachuesetts,  The programs may be totally disbanded or in some cases outsourced. Programs in neuroscience, CVS and metabolic diseases will be shifted to Massachuesetts as well.

The cutbacks were announced with Pfizer's latest earnings statement as the company faces huge expected revenue losses in the $9-10 B range with the expiration of its patents protecting Lipitor - the World's best selling drug. Talk about a patent cliff - better be a rock climber if you are working in R&D there.  For more see Pharmalot and Fierce Biotech. 

 

 

 

 

 

Posted by Bruce Lehr Feb 1st 2011.

Big Pharma Putin in Some Russian Manufacturing

Russian PM Vladimir Putin has spoken.  Foreign drug manufacturers who want to operate in Russia will need to manufacture there and to transfer technology to the local economy or face restrictions to the market. Putin's Russia plans to raise the domestic pharmas share of the Russian drug market to more than 30%.

Big Pharma has heard the message and is responding. Teva will expand its Russian manufacturing operations in the country. It has pledged to invest $100 M to bolster its goal of tripling its sales in Russia by 2015. 

GSK will also pour cash into the emerging Russian market. It struck a deal earlier this year to invest in Russia's Binnopharm to produce cervical cancer, rotavirus and pneumococcal vaccines for the domestic market.

The drug makers Novo Nordisk, Sanofi-Aventis, AstraZeneca, Novartis, Pfizer and Nycomed also plan to place manufacturing in the Russian market through building or partnerships. See in-PharmaTechnologist

 

 

 

Posted by Bruce Lehr Jan 26th 2011.

Genzyme Builds new Myozyme/Lumizyme Plant in Belgium

Genzynme will spend Eu 250 M on a new manufacturing plant for its Pompe's disease drugs Myozyme and Lumizyme.  The plant will be located in Geel, Belgium and the company expects commercial regulatory approval of the site to be secured by 2014.

Genzyme to build New €250M Myozyme/Lumizyme Production Plant in Belgium.

The new Geel plant will have a maximum batch production capacity of 8000L and the existing Geel plant will add a thrid 12,000 L bioreactor. The expansion is meant to provide more capacity and better risk management for Genzyme. In recent years, the company has experienced well documented manufacturing failures (and is currently under a FDA consent  decree as a result) that have led to global drug shortages of its orphan products. 

Lumizyme and Myozyme are the only approved therapies for Pompe's disease at present.  Genzyme services more than 1400 of the estimated 10,000 patients with these afflctions. The commercial potential of these Pompe's disease drugs are expected to rival its best-selling Cerezyme for the treatment of Gaucher's disease. Genzyme is projects sales growth in excess of 30% with these products - especially if supplies are available for the full year in 2011. Sales wereup 39% ($128 M total) in the 4th quarter of 2010.

 

Posted by Bruce Lehr January 20th 2011.

Boehringer buys Amgen site to expand biologics CMO biz

Boehringer announced it will acquire Amgen's Fremont manufacturing site to further extend its global contract development and manufacturing capability for biologics.  The Fremont site came to Amgen via its acquisition of Abgenix for $2.2 B in 2006.  The Fremont site is 100,000 sq ft and houses 360 employees. It has previous experience producing panitumumab, Vectibix, commercially.

Boehringer buying Amgen site to expand biologics CMO biz.

The acquistion enhances Boehringer's global footprint.  It adds capability to its main manufacturing site in Biberach, Germany, and manufacturing and development partnerships that it has with Avid Bioservices and Kemwell in India. Financial terms of the Boehringer acquisition were not released but the company is supposed to take over the site formally in March.

 

 

Posted by Bruce Lehr January 20th 2011.

Dendreon Raises Its $500+ M

Xconomy reports on Dendreon's success in raising an additional $540 M in new capital to support its license application for Provenge in Europe as well as expansion of its European manufacturing footprint for Provenge in USA and Europe.

 

Posted by Bruce Lehr Jan 15th 2011.

 

 

 

Dendreon Seeks $500M Debt Deal

Dendreon will seek $500 M in convertible debt financing to fund its submission of Provenge for approval in Europe and to build a manufacturing plant in Germany for the same product.

Dendreon Seeks $500M Debt Deal.

It will also use the money to continue to complete the expansion of its manufacturing footprint in the US.  Any debt not retired by January 2016 would be convertible to stock by investors.

 

Posted by Bruce Lehr Jan 13th 2011.

Genzyme Lowers Guidance to Investors

Today, Genzyme lowered its EPS estimates for 2011 based on delays in returning to projected production levels for Fabrazyme in its Framingham, MA plant.  Genzyme had previously announced its expectation to be back in full production by June but has now pushed that back again.  Regulatory approval will not be forthcoming until the 3rd or 4th Qtr in 2011.

The results of the delay caused Genzyme management to lower its EPS guidance to $4.10-$4.35 down from the previous $4.30-$4.60 range.  It also adjusted its expected earnings down slightly from $5.1 B to $5.0 B for 2011.

Genzyme ability to meet all regulatory requirements to come back into full projection had been one of the issues that was under debate with Sanofi in setting an appropriate purchase price for the company.  The other main issue is the value of Genzyme's MS drug in phase III clinicals. Genzyme also lowered expectations for 4th Qtr EPS in 2010 - primarily due to lower Cerezyme revenues and margins - no doubt caused by Shire having entered the market with a competitive product while Genzyme experienced manufacturing problems.  See In Pharma.com.

It looks to me that the Sanofi deal will get done and at a lower price than the $80 per share that Genzyme has been flogging.

 

Posted by Bruce Lehr Jan 13th 2011.

 

Pharma Constructed How Many Facilities Last Year?

With more than 114,000 job cuts in the past two years, would you have predicted that  the pharma industry constructed more than 85 plants and R&D facilitieis in 2010?  This data comes from Industrial Info Resources.

Pharma Constructed How Many Facilities Last Year? // Pharmalot.

The number of facilities is up from 76 facilities in 2009 and represents an investment of $7.1 B in 2010 (vs. $5.7 B in 2009). The average project size is $82.5 M.  Notable projects include: Novartis' $1 B vaccine plant in Holly Springs, NC, Cannabis Sciences' $2.5 M to renovate R&D space, Dendreon's expansion of manufacturing capacity for Provenge in Atlanta, and Eli Lilly's animal health research center in Greenfield, IN. 

Posted by Bruce Lehr Jan 4th 2011.

Bayer injects €35m in biologics project expansion

in-Pharma Technologist.com reports that Bayer Healthcare has decided to invest in a new center for biotechnology production to support generation of "innovative" pharmaceuticals.  This would be a complement to Bayer's small molecule holdings.

Bayer injects €35m in biologics project expansion.

The new plant is to be built in Wuppertal, Germany at a projected cost of $47 M.  Bayer says its main focus lies with the manufacture of antibodies, as well as coagulation factors and other therapeutic proteins, and the firm hopes the new center will increase its chances of being able to offer new drugs in the fight against serious diseases such as cancer.  Operations at the 1000sq meter facility are expected to begin at the end of 2012.

 

Posted by Bruce Lehr December 16th 2010.

 

Takeda & Baxter aim to set up cell culture site in Japan

In response to future pandemic preparedness planning (say that 3x real fast), particulrarly for influenza outbreaks, the Japanesese goverment is encouraging Takeda and Baxter to collaborate on a new cell-culture based vacine manufacturing center of excellence in Japan.

Takeda & Baxter aim to set up cell culture site in Japan.

Takeda will be responsible for buidlign a Vero-based influenza production facility, and Baxter will support them with technology know-how to produce the flu vaccine. Takeda expects to be able to to produce a H5N1 vaccine at full scale by end of March 2014.

Takeda and Baxter will apply for 3.6 B yen ($42.9 M) from the Japanes government to invest in pandemic vaccines. Baxter will provide an exclusive license to its Vero-based technology toTakeda for the Japanese market.  Baxter claims the same technology shortened the response time in preparing H1N1 vaccines as it eliminated the time-consuming adaptation to allow growth of the virus in eggs - and Vero-based manufacturing is more consistent and predictable too.

 

Posted by Bruce Lehr December 8th 2010.

J&J Proceeds with Caution on Closing Crucell Deal

According to the WSJ, J&J will proceed with its $2.27 B acquisition of Crucell, but reserves the right to modify the deal should Crucell experience more difficulty with its manufacturing in South Korea. Crucell was forced to stop shipments of two vaccines due to sterility issues in late October.

The Dutch market regulator Autoriteit Financiele Markten (AFM) said that once it has approved the merger, the rules to amend an offer are very strict, making it difficult to adjust the bid. J&J expects to get final approval before the Crucell general shareholder meeting on December 10th.

 

 

Posted by Bruce Lehr December 3rd 2010.

GSK to invest £500m in UK R&D and manufacturing

GSK has announced plans to invest £500m in its UK R&D and production operations with a particular focus on boosting biomanufacturing capacity.  This is the first new manufacturing capacity that GSK has built in Britain in decades -- and perhaps not coincidentally the decision coincides closely with the UK government's announcement to introduce its "patent box" policy.  The new policy will decrease tax rates on patented products by 10%. 

GSK to invest £500m in UK R&D and manufacturing.

GSK says it will add capacity at its Ware, Hartfordshire facility, add a new dermatology-focused production center in Barnard Castle.  In addition to manufacturing, GSK will form a partnership with University of Nottingham for a "green chemistry" program, and will also establish a £50m venture capital fund to invest in "innovative, breakthorough science" most likely with small companies and universities. The overall GSK program is expected to add more than 1000 jobs over the next couple years - which I'm sure is welcomed by the UK government.

 

 

Posted by Bruce Lehr November 30th 2010.

Novo Nordisk Latest Big Pharma to Place R&D in China

Novo Nordisk announced it will spend $100 M in its Beijing R&D center, adding $40 M in 2011 for new labs and adding up to 200 new staff by 2015. It will be the largest Western owned R&D center in China.  It comes on the heels of Novo's $400 M investment in a China manufacturing facility for diabetes drugs in 2008.

Novo is just the latest Big Pharma to invest in R&D in China.  Both Sanofi and Lilly, earlier this year,  announced investments in new R&D centers in China covered in this blog here and here.  China is attractive as it is a large (No. 2) and fast growing drug market.  It has well educated scientists available.  And it is low compared to the West at this time -- although that is changing pretty rapidly with the growth of China's economic power and its burgeoning middle class.

Given all that it has going for it, don't be surprised to see most if not all major Pharma companies to open R&D centers in China - especially since its IP protections have improved as well. Quintiles CEO said earlier this week that he thought China had a chance to become the leader in biotech R&D. See Fierce Biotech.

  

 

Posted by Bruce Lehr November 13th 2010.

 

Dendreon Seeks OK to Grow NJ Factory

According to this article from Xconomy, Dendreon has applied to the FDA to quadruple the capacity of its New Jersey manufacturing site for Provenge.  The FDA is expected to make a determination over the next 4-6 months.

Dendreon Seeks OK to Grow NJ Factory.

 

In the meantime, Dendreon is also building similar manufacturing facilities in the Los Angeles and Atlanta regions - all in an effort to provide enough capacity to meet the demand for its newly approved prostate cancer vaccine. 

Posted by Bruce Lehr November 11th 2010.

Biogen Restructures with Layoffs and Plant Consolidations

 

Biogen Idec announced a major restructuring today that includes layoffs, plant closings and consolidation, killing clinical programs, and management/sales force reorganization.  The company will become more focused.

Biogen Restructures And Lays Off 650 Workers // Pharmalot.

Major elements of the restructuring include:

• Layoffs of 13% of its workforce or 650 workers
• Closure of the San Diego, Wellesley and Waltham facilities
• Shut down of 11 clinical programs - including cardiovascular and oncology in San Diego site
• Elimination of the Rituxan oncology and RA sales force
• Consolidation of business development, venture development and corporate strategy management/functions

The plan is expected to save $300 M annually.  It will result in a restructuring charge of $115 M.  Wellsley and Waltham will lose about 80 employees and operatins will be consolidated at the Cambridge and Weston sites.  San Diego will lose about 300-325 jobs and the oncology and CVS programs. About 25% of the San Diego workforce will be offered jobs in either the Cambridge or RTP, NC sites. The new company will have 4,275 employees after cuts.

Biogen will retain its Tysabri, Avonex and Rituxan franchises - though Rituxan will be sold by Genentech's sales force.  New development will concentrate on neurology products like a new oral MS drug called BG-12 and a longer lasting pegylated-IFN to replace Avonex.  See Xconomy here and here.

 “The company will leverage its immunobiology, process development and biologics manufacturing expertise to target high-potential treatments for select disorders where there is a significant unmet need and where the drug candidate has the potential to be highly differentiated,” the company said.

Even though the company has only launched 1 drug in the past six years, it says it will launch 5 new drugs in the next five years.  We shall see.

Posted by Bruce Lehr November 3rd 2010.  

Lilly R&D: Singapore's Loss looks to be China's Gain

In October Lilly announced it would be closing the Singapore R&D center, cutting about 130 jobs there, and moving the center's activity to the main office in Indianapolis.  See here.  Today, Lilly announced plans for a new R&D center in Shanghai, China employing 100 people initially that will focus on diabetes research.  Specifically, the center will look at treatments for diabetes and its sequelae obesity and cardiovascular disease.  The research will focus on differences in molecular mechanism for the disease in Chinese and other Asian populations.

The move is seen as supporting Lilly's strategic goal of increasing its footprint and market share in China - the largest emerging pharma market. Lilly, which faces the industry's steepest patent cliff in next coupel of years, will also benefit by cutting research costs through China's substantially reduced scientific labor rates.

 

 

Posted by Bruce Lehr November 2nd 2010.