The Big Red Biotech Blog

Roche acquires Marcadia Biotech

Roche beat the end of year holiday rush yesterday by acquring Marcadia Biotech - probably the last pharma deal of 2010.  Marcadia is located in Carmel, IN and was founded by former Lilly executives.

Roche acquires Marcadia Biotech | Indianapolis Business Journal | IBJ.com.

The financial terms of the deal have no yet been disclosed. Roche indicated they would be forthcoming in their February financial report. Marcadia is a relatively small company but has been successful in raising venture funds for its obesity and diabetes drug programs.  The company has partnered with Lilly and Merck in the past in these therapeutic areas. Roche has strong programs in both the diabetes and obesity areas thus fueling its interest in Marcadia.

 

 

Posted by Bruce Lehr December 31st 2010.

New Drugs 2010 - Fewest FDA Approvals since 2007

Here's a piece republished in its entirety from Bloomberg. 

Twenty-one new drugs were approved in the U.S. this year, the fewest since 2007, as the Food and Drug Administration showed more willingness to delay or reject medicines with potential safety risks.

The tally, compiled by Bloomberg from an FDA database, compares with 25 approvals last year and 24 in 2008, according to the FDA’s website. Nineteen new drugs were cleared in 2007, the fewest in 24 years.

Today marks the last regular work day of 2010 for the U.S. government. This year, the FDA also restricted the use of London-based GlaxoSmithKline Plc’s diabetes pill Avandia and withdrew from the market the weight-loss drug Meridia made by Abbott Park, Illinois-based Abbott Laboratories. The agency citied heart complications in both actions.

“There’s a sense that the FDA is being more cautious,” said Les Funtleyder, a fund manager at Miller Tabak & Co. in New York, in a telephone interview. “If the rules get too onerous, it could potentially keep innovative drugs out of U.S. hands.”

My comments is that the drug makers and agency still need to work harder at collaboration during the drug development process and in defining data needed from clinical trials and designs needed to generate same.  The industry is struggling enough with a withering R&D pipeline. It really cannot afford to have drugs go down as frequently as has been the case in the past few years in phase III.  Also, there needs to be a reality check by industry to NOT put drugs into late stage clinicals that do not have a chance to better the results of products that are already out there.  In many cases, we simply need to be testing better drugs that are designed to deliver better benefits. 

 

 

 

Posted by Bruce Lehr December 31st 2010.

 

Acquisition Deals in 2010 that Topped $1B

This article in GEN recounts the deals in pharma and biotech that topped $1 B in 2010.  Unlike last year, where three deals topped $40 B, there was only one such deal like that in 2010 - that being Novartis' acquisition of Alcon.  The next highest deal in the queque remains Sanofi's likley $18.5 B plus soon to be acquisition of Genzyme.  After that, nothing topped $10 B this past year.

Acquisition Deals in 2010 that Topped $1B.

This may be another indication that mega-merger mania is really dead in the industry - partly I suspect from the mixed results being seen with Pfizer/Wyeth and Merck/Schering-Plough.  This big merger/consolidations are just hard to pull off financially and operationally.  Many CEO's have effectively said they will not pursue so-called mega-mergers.  These include CEOs of Roche, GSK, Lilly, AZ, and Sanofi among others.  All these executives purport to be looking for smaller focused purrchases in specific technology niche areas that they are trying to build for their companies.

That philosophy is more than likely the one that will prevail in the coming years - plus the fact is that there are very few, if any, mega-targets out there that are even realistic to go after - even by the Big Boys.  

 

 

Posted by Bruce Lehr December 31st 2010.

Cancer Drugs in Combination - A New Testing Trend?

This piece comes from Xconomy and notes that Merck and Sanofi are joining forces to test new cancer drugs in combination - a trend that appears to be gaining traction with other players in the oncology field as well.  Combination therapies are often used in cancer.  However, historically the combinations weren't tested together until each drug separately reached a fairly late stage (or was already approved).  Now we have companies developing philosophies to test drugs in combination at an early stage of clinical trials.  This is particularly popular in the treatment of cancer as frequently several signalling pathways that could affect the disease may be simultaneously attacked.

Previously, Merck and AZ have teamed up with their respective AKT  and MET inhibitors.  Now Merck and Sanofi plan to test their SAR245408 and SAR245409 inhibitors of the PI3K/mTOR pathway. Both partners will test each other's drug in combination with their own in Phase I trials.

The FDA issued draft guidelines designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses. In addressing the new guidelines, FDA commissioner Margaret Hamburg said they are the result of a growing understanding that experimental therapies may need to be used together in order to be more effective or to prevent drug resistance.

Despite the excitement, efforts to study investigational drugs in combination are still in their infancy. Phase I is the first stage of clinical testing, so these new drug “cocktails” are still several years from reaching the market. Scientific, clinical, regulatory and intellectual property hurdles all must all be overcome if these novel combinations are to provide breakthrough cancer therapies for the patients who desperately need them.

 

 

Posted by Bruce Lehr December 30th 2010.

Seattle Genetics Gets Glowing Review of Prospects

Seeking Alpha's Michael Bryant waxes positively about Seattle Genetics prospects for the next few years and recommends it as an investment candidate.  This is largely based on the Company's success with SGN-35 and its promising collaboration with Millenium (Takeda) with the phase III drug for the treatment of relapsing Hodgkin's lymphoma. 

SGN appears to be in good cash position, has a late stage candidate which looks like it will gain approval, is managing its burn rate -- and has promising "empowered antibody" technology for oncology -- a hot area.  It may also be an attractive acquisition candidate given its promise and the faltering pipelines of many in Big Pharma -- who have the cash but no pipeline candidates and a dire revenue need in the short term.

 

Posted by Bruce Lehr December 30th 2010.

Pfizer to Diversify into Animal Diagnostics with Synbiotics Purchase

A Reuter's report has Pfizer purchasing Synbiotics Corp for 30.6 cents per share to its shareholders.  Pfizer is known to be looking to diversify its business portfolio as is faces one of the steeper patent cliffs in the ethical pharma industry and lacks the pipeline to replace the revenues from drugs like Lipitor as patents expire. 

Pfizer reportedly had been interested in acquiring assets in the animal health industry earlier this year from Merck and Sanofi - specifically in the companion animal segment.  The Synbiotic deal would presumably provide synergies with diagnostic products for companion animals. The diagnostics segment is reportedly growing at about 8% annually or twice that of the overall animal health market.

So now Pfizer will have companion diagnostics for companion animals.

 

 

 

 

 

Posted by Bruce Lehr December 29th 2010.

Vaccines: One Man's Choice as Top 2010 Healthcare Innovations

According to an article in Xconomy, Larry Corey, president and director of the Fred Hutchinson Cancer and Research Center in Seattle, chooses vaccines as providing some of the top innovations in healthcare in 2010.

Specifically, Corey tabs Dendreon's innovative Provenge vaccine for the treatment of prostate cancer.  This is the first product of its type to make it through the FDA gauntlet.  It provides the proof that immunotherapy is a viable approach to cancer treatment and likely will open the door to other such treatments in the near future.

Corey also singles out GSK's human papillomavirus (HPV) vaccine for recognition. It established the link between infectious disease and some cancers and highlights the success of a vaccine in preventing the disease from ever developing. GSK's vaccine also includes the first novel adjuvant (immune response booster) to be used in the USA in more than 30 years.  This can also be expected to usher in a new wave of more effective adjuvants to be applied to other cancer vaccines in particular. 

The resurgence of vaccines is a welcomed story.  Vaccines of course are designed to prevent disease and not treat it after the fact.  It is further welcomed by me to see vaccines singled out in a very positive light given the sordid history of the anti-vaccine movement in associating these life saving treatments with a host of side effects and diseases that are based solely on innuendo and pseudo science (autism).  Let's see the clinical trial results and then results on follow up in the field to base our conclusions on efficacy on.

 

 

 

 

Posted by Bruce Lehr December 29th 2010.

Recipe of Month - Bonus - December 2010

I ask readers all the time what they want to see in new recipes.  As predicted, I'm just overwhelmed with requests for a good catfish recipe!  So here's one to try during the holidays.

Sweet-and-Sour Catfish

• 2 to 3 lbs catfish fillets
• 1 tablespoon light soy sauce
• 1/2 cup white wine
• 2 teaspoons hot sauce
• 2 teaspoons minced fresh ginger
• 1 (8-oz) can pineapple chunks packed in juice
• 1/2 cup water
• 1 table spoon plus 1 cup cornstarch, divided
• 1/2 cup cornmeal
• 1 teaspoon seasoned salt
• 1 teaspoon onion powder
• 1 teaspoon garlic powder
• 1/4 teaspoon ground red (cayenne) pepper
• 2 1/2 cups of peanut oil, divided
• 6 to 8 carrots, cut diagonally into bite-sized pieces
• 1 rib celery, cut diagonally into bite size pieces
• 1 medium onion cut into 8 wedges
• 1 medium red bell pepper, cut into bite size pieces
• 1 cup purchased sweet-and-sour sauce
• Hot cooked white rice
• 4 green onions, green portion chopped for garnish


Preparation

1. Cut catfish on the diagonal into 1-inch pieces. Place in self-sealing plastic bag
2. For marinade, stir together soy sauce, wine, hot sauce and ginger.  Drain pineapple reserving juice.  Cover and refrigerate pineapple chunks.  Add 1/2 cup pineapple juice to marinade.  Stir together water and 1 tablespoon cornstarch; add to marinade.  Pour over the catfish.  Refrigerate for 1 hour.
3. Make the coating in paper bag.  Add 1 cup cornstarch, cornmeal, seasoned salt, onion powder, garlic powder and cayenne pepper.
4. Remove fish from marinade, let liquid drip off.  Put about half the fish into the bag and shake to coat.  Shake off excess coating.  Repeat with other half of fish. Discard marinade and residual coating.
5. Heat 2 cups of peanut oil in a wok or large skillet to 360 degrees or until oil begins to ripple slightly (i.e. it is hot).  Fry fish in small batches until golden brown. Drain on paper towels.
6. When all fish is cooked, drain wok and wipe it out with paper towels.  Return wok to heat.
7. Add 3 tablespoons of peanut oil.  Add stir-fry vegetables - carrots first, then celery, then bell pepper and lastly the onion.  Cook until tender (7-8 min) and remove vegetables to plate.
8. Pour 1 tablespoon peanut oil into the wok.  Stir in sweet-and-sour sauce.  Return fish and vegetables to wok and coat in sauce.  Finally, add reserved pineapple chunks.
9. Serve with white rice, garnished with green onions. 

Yield: 6-8 servings

Posted by Bruce Lehr December 29th 2010.

 

 

 

Recipe of the Month - December 2010

Today. we have a recipe for good luck in the New Year -- black-eyed peas.  This one comes from Lucy Buffet's (yes, Jimmy's sister) restaurant called Lulu's in Homeport Marina in Gulf Shores, Alabama. It is rather whimsically called - LA (lower Alabama) Caviar.

LA Caviar

• 3/4 cup balsamic vinegar
• 1/2 cup extra-virgin olive oil
• 1/4 cup granulated sugar
• 2 teaspoons salt
• 1 teaspoon ground black pepper
• 4 (15-ounce) cans black-eyed peas, rinsed and drained
• 1 1/2 cups cherry tomatoes, quartered
• 1 cup each - chopped green bell pepper, yellow bell pepper and red bell pepper
• 1 cup chopped red onion
• 1 cup finely chopped fresh parsley
• Saltine crackers or tortila chips, optional

Instructions

1. Make dressing by combining vinegar, oil, sugar, salt and pepper in a jar.  Close and shake vigorously to dissolve sugar.
2. Place balck-eyed peas in a large glass bowl.  Add tomatoes, bell peppers, onion and parsley.
3. Pour dressing over pea mixture; toss well to combine.  Cover and refrigerate 2 hours to overnight.
4. Serve as side dish or with crackers or tortilla chips as an appetizer

Yield: 20 to 25 appetizer or 8 side-dish servings.  Cut down recipe if you want less. 

Happy New Year - remember eating this will bring you luck!

 

Posted by Bruce Lehr December 29th 2010.

 

Drug Profits Down? Repurpose

It is getting tougher out there to bring novel pharmaceuticals to market -- especially when you aren't working on bringing novel compounds to market to meet unmet medical needs.  As this article in FT.com makes clear, it is now fashionable to repurpose drugs to extend their patent life or apply to a new area in an attempt to extend their revenue generating capacity. 

Famous examples cited in the article include products like Viagra or Avastin.  Viagra was repurposed from its original purpose as a "high blood pressure" treatment when it went on to fame and fortune with the brand new "erectile dysfunction" category. It has since also been introduced (different shape & color) as Revatio for pulmonary arterial hypertension.  Avastin of course has been aimed at a whole spectrum of cancers with varying success - especially with the regulators.

The appeal of such drugs of course is there solid IP portfolio which can allow their holders to fund new clinical trials and establish new applications before the patents run out. But not everyone in the market (i.e physicians and consumers) is happy about this strategy in all instances.  Biomarin, for example, recently launched a high-priced version of amifampridine phosphate to treat a rare autoimmune disease and received "orphan drug" status in the process. But Britsh physician groups have complaned the drug was formerly available in the pharmacy for a fraction of the cost.  A Biomarin spokesman explains the company upgraded quality and spent $30 M bringing it to market.

None of this obviates the fact that pursuing this path as a important strategy gets us further away from discovering and developng novel therapeutics for unmet need - and to that end I think it is a bad trend to continue without concommitant efforts on the side of innovation.

It might do us well to to remember these words in the pharma field:

"I am here for a purpose and that purpose is to grow into a mountain, not to shrink to a grain of sand. Henceforth will I apply ALL my efforts to become the highest mountain of all and I will strain my potential until it cries for mercy."

- - Og Mandino

Posted by Bruce December 25th 2010.

 

Ho! Ho! Ho-Hum! Sanofi and Genzyme drone on............

Sanofi and Genzyme continue to drone on about making a deal.  Henri Termeer was quoted in the WSJ today saying "Clearly, we will have conversations at the right moment...It can't go on forever."

Get on with it already.  Apparently, Genzyme has been unable to entice either J&J, Merck or Pfizer to put in a competitive bid and no other bidders are apparent.  The $69 price per share Sanofi offered is inadequae to the shareholder or otherwise more than 0.9% would have tendered their shares prior to the last deadline! 

The two still can't agree on the value of Genzyme's MS drug, alemtuzumab, now to be branded Lemtrada for the MS market.  Genzyme is sticking with their $3.5 B peak sales figure while Sanofi says it will be lucky to get to $700 M.  The two companies are said to be haggling over putting CVR in the final agreement related to the drug.  Genzyme shareholders would then receive more cash in the future if Lemtrada hits its sales milestones. 

All this sounds like so much - blah, blah, blah.  In the meantime, Genzyme's share price is holding steady at $69.65 per share for a market cap of about $18.1 B -- i.e. very close to the $18.5 B Sanofi hostile offer - the deadline of which has been extended to Jan 21st.

Ho! Ho! Ho! Merry Christmas!

Posted by Bruce Lehr December 21st 2010.  

 

Novartis strikes deal to build Russian drug manufacturing plant

Novartis announced it has signed a Memorandum of Understanding with St. Petersburg, Russia to build a new $500 M pharmaceutical manufacturing plant.  It is part of the company's plan to invest more heavily in the important Russian emerging market. The MOU addresses a 5-yr partnership fo local manufacturing, R&D partnerships and public health development.

Novartis strikes Russian allegiance; builds manufacturing plant.

Construction is expected to be completed in 2011. The plant will make both branded drugs and generics to serve initially the Russian domestic market but ultimately other markets outside of Russia. Novartis further plans to partner on R&D projects with Russian companies and Universities - as well as in-license and out-license products.

Said a Novartis spokesman, "With its increasing commitment to and demand for better healthcare, the Russian government is well suited to partner with Novartis to address their healthcare priorities and improve healthcare outcomes."

 

 

 

Posted by Bruce Lehr December 21st 2010.

AstraZeneca drops drug, takes $445 mln charge

AstraZeneca axed its RSV drug motavizumab and with it took a $445 M write off.  What's more?  This kills its chance to bring to market a successor to its blockbuster Syngaxis. Woe is me!

PharmaGossip: AstraZeneca drops drug, takes $445 mln charge | Reuters.

Ultimately, the new therapy failed to show improvement over Syngaxis and also exhibited significant side effects. So far as a result, AZ's acquisition of MedImmune for $15.6 B has been a complete bust in terms of delivering new licensed biotherapeutics to market - and the old ones are losing patent protection.

This is a GIANT lump of coal this Christmas.

 
 
Posted by Bruce Lehr December 21st 2010.

Biogen Idec Buys Drug Rights from Neurimmune for $32.5M

Biogen Idec bought thre CNS programsfrom Neurimmune for $32.5 M upfront plus future payments up to $395 M in future milestones.  In acquiring the 3 candidate drugs targeted to the neurotoxic proteins alpha-synuclein, tau, and TDP-43, Biogen acquires potential therapeutics aimed at Alzheimer's, ALS (Lou Gehrig's disease) and Parkinson's.

Biogen Idec Buys Drug Rights from Neurimmune for $32.5M.

"Biogen Idec is committed to becoming the global leader in the development of innovative therapies for neurodegenerative diseases," said Alfred Sandrock, senior vice president, neurology research and development, Biogen. See Fierce Biotech.

 

 

Posted by Bruce Lehr December 21st 2010.

New SAFC paper on MicroRNA profiling in CHO cells

An team from SAFC's Cell Sciences and Development department, led by Dr. Nan Lin, recently published a paper in Biotechnology Progress profiling microRNAs in parental CHO DG44 and CHO K1 cell lines as well as 4 recombinant DG-44 derived CHO lines producing a recombinant IgG.

MicroRNAs play an important role in global gene regulation and it has been theorized that miRNAs could be useful biomarkers and cell engineering targets for recombinant protein production. More work needs to be done with miRNAs in CHO cells though.

This paper describes miRNAs that were found to be up- or down- regulated in IgG expressing CHO clones as compared to the parental, as well as differences in miRNA expression between the two parental CHO cell types.  It is a first step toward potentially using miRNAs in cell engineering.

 

Posted by Bruce Lehr December 21st 2010.

SAFC adds off-the-shelf ZFNs for CHO cell engineering

SAFC recently added two new CompoZr^R Zinc Finger Nucleases (ZFN) as off-the-shelf catalog items to modify CHO cells for biopharmaceutical production.  The two new ZFNs will knock out dhfr and GS genes - both of which are useful in selection of recombinant clones of interest. This catalog offer is in addition to services to create custom ZFN products for other genes of interest or custom cell engineering services (CCES) to create modified cell lines.

The offer is intended to enable biopharmaceutical customers to create robust, efficient cell lines, thus allowing them to focus their R&D efforts on developing new therapeutics.  The ability to make targeted, heritable changes to genes has already lead to quicker development of knock-out cell lines for biopharm production. 

This is an evolving offer at SAFC.  The company plans to add new ZFNs targetted to different genes on a regular basis affecting properties like cell production, cell growth, culture longevity, recombinant protein quality (glycosylation), elimination of HCPs or viral elments, etc. Modified CHO K1 clones will also be offered as catalog items soon.  The first cell lines will be biallelic knockouts of dhfr and GS with others soon to follow. It is SAFC's intention to offer a CHO cell line platform with optimized chemically-defined medium and feed sets, process instructions and complete validation and application package to support the production of therapeutics.  We believe that this wil be interesting to biopharmaceutical, vaccine and biosimilar producers.

For more information on SAFC's ZFN offer visit. For more information on SAFC's Custom Cell Engineering Services (CCES) offer visit.

 

Posted by Bruce Lehr December 21st 2010.

 

EMA Head Rips Pharma R&D Waste vs. Big Pharma Fears Increasing Regulatory Hurdles

Last week, departing EMA chief Thomas Lonngren took the opportunity to question Big Pharma's R&D spending - saying, in effect, that $60 B of $85 B spent annually was being wasted.  He reasoned that only 7-9 drugs were making it to market that were worth maybe $20 B and where did the rest of the $85 B in value go?  He also took Big Pharma to task in relation to which therapeutic areas it chose to pursue - sopecifically he criticized cutbacks in CNS therapies and in antibiotic research. He finished his mini-rant with conviction that drug regulators around the world would unite to cooperate more in the coming years, saying "The evolutionary momentum of this is unstoppable." See Fierce Biotech report.

Yesterday, I read this article in the WSJ regarding Big Pharma's (and its investors) fears of how regulatory scrutiny is rising in unpredictable ways -- from Big Pharma's viewpoint.  The poster child in this particular case was AstraZeneca's Brilinta receiving a delay in regulatory approval from the FDA - despite having already been approved by EMA earlier this month. AstraZeneca feels it can negotiate the regulatory hurdle but at what cost?  Investors reacted by causing a significant drop in AZ's share price - reflecting a possible worst case scenario that the drug will never be approved in the US.  Are drug developers and regulators working at odds here?

The fact is that success rates for new chemical compounds have fallen from about 12% a decade ago to less than 8% today and the trend is still going down. Clinical trials must be up to twice as large and costs of development are rising.  Is this anyway to run an industry? It is high time that both developers and regulators work on changing the model to better optimize use of precious R&D and regulatory resources to get more successful launches of needed drugs to the market. This would seem to be more productive than hand wringing by either side.

 

 

 

Posted by Bruce Lehr December 21st 2010.

 

Novazyme and SAFC Risk Management Strategy for Long R3 IGF-I

 

For nearly 20 years, SAFC in partnership with [now] Novazymes has provided Long R3 IGF-I as a key raw material to biopharmaceutical manufacturers for the production of their marketed recombinant protein drugs via cell culture.  Everyone is aware that requirments for quality standards, supply chain management and transparency, and risk management strategies have increased steadily over that period -- and will continue to do so to protect patient safety and enhance regulatory desired consistency in manufacturing.

SAFC and Novazyme have issued a short document outlining and updating our current risk management strategy with Long R3 IGF-I.  It addresses risk management of inventory/safety stock, offsite storage, second-stie manufacture, quality standards and external audit program, manufacturing capacity, product safety and risk assessment and management.  See below for the plan.

Download LONGR3_SupplyChainRM_Dec2010

 

 

Posted by Bruce Lehr December 20th 2010.

 

Pay-for-Delay Seeks Its Day Before Supreme Court

 

 

According to Pharmalot blog, three pharmacy chains and a wholesaler have petitioned the Supreme Court to review legality of so called "pay-for-delay" arrangements between brand manufacturers and generic drug companies.

Supreme Court Asked To Review Pay-To-Delay Deals // Pharmalot.

Pay-for-delay deals have been controversial for years.  Various circuit courts around the US have issued conflicting rulings on the topic.  The US Federal Trade Commission has been an outspoken opponent of these deals as "anti-competitive" for the consumer. The plaintiffs have asked the Supreme Court to review a deal between Bayer and Barr Pharmaceuticals (now owned by Teva) for the antibiotic ciprofloxacin.

Plaintiff's brief states that:

“The question of the proper standard for determining whether an exclusion payment is anti-compeitive has been percolating in the courts, and thoroughly debated in academica, for over a decade….This case presents the best opportunity for the court to resolve the circuit split, require compliance with the court’s patent and anti-trust precedents, and restore the Hatch-Waxman Act balance between extending pharmaceutical patent terms and preserving judicial review of those patents to ensure that the results monopolies are are warranted”

After more than a decade, it seems well past time for the High Court to set an appropriate National standard to judge these cases. Let's hope the court decides to hear the case.

 

 

 

Posted by Bruce Lehr December 20th 2010.

The Pharma Rogues Gallery

As follow up to the previous post, more than half of the fradulent behavior from Big Pharma falls on the shoulders of the Big Four Offenders as reported in the Pharma Times via a Public Citizen analysis of the statistics.

The four companies - GlaxoSmithKline, Pfizer, Eli Lilly and Schering -Plough - and they accounted for more than half of all financial penalties over the past two decades, paying $10.50 billion in fines collectively. The two largest fines ever assessed by the US government against any companies were against Lilly ($515 million) and Pfizer ($1.2 billion), both in 2009.

Can anyone say Patent Cliff (and poor following pipeline) as a motivator of criminal or ethically challenged behavior?

 

 Posted by Bruce Lehr December 20th 2010.

 

 

Say "It Ain't So, Big Pharma, Say It Ain't So"

I've written several posts this year about the ethical challenges that Big Pharma seems to be facing and failing!  The Industry as a whole certainly doesn't appear to be striving for the ethical high ground at the moment and 2010 may represent a real nadir in criminal and ethical failures.  Take a look at the link below to an article in the Pharma Times.

Article Pharma industry tops government fraud table in USA.

It seem that Big Pharma has now displaced the Defense Industry as the number one defrauder of the US government.  Who woulda thunk that could ever happen?  Didn't this used to be called the Ethical Pharmaceutical industry?  Wow!

 

Posted by Bruce Lehr December 20th 2010.

Merry Christmas! Big Pharma Naughty Not Nice

Increasingly Big Pharma has been caught with its hand in the regulatory cookie jar resulting in a rapidly increasing set of criminal and civil penalties as chronicled below in this post from PharmaGossip.

http://pharmagossip.blogspot.com/2010/12/merry-christmas-big-pharma-naughty-not.html.

 

 
Posted by Bruce Lehr December 19th 2010.

 

SAFC and SartoriusStedim Biotech New Mixing Application Guides

 

As part of the collaboration between SAFC and SartoriusStedim Biotech (SSB), the companies have worked to produce application guides showing rapid and scalable preparation of powdered media and buffers with single-use magnetic mixing systems and the LevMixer^R technology.

For media, batch sizes ranged from 50 L to 1000 L and utilized SAFC's Ex-Cell^TM CHO Fusion and Ex-Cell^TM EBx^R GRO-I formulations. For buffers, sodium citrate, PBS and Tris were used in tests in batch sizes from 50 L to 1000L at various transient concentrations of powders (16 g/L, 73 g/L, 224 g/L) before final dilution. The purpose of the study is to assess the performance of the Flexel^R for Magnetic Mixer technology or the LevMixer^R to dissolve the test powders.

In this study mixing time to achieve complete product dissolution was determined both by visual inspection and by conductivity measurements.  In the case of the media, conductivity measures to determine when the product was completely dissolved is a novel application. Complete study details and results are contained in the reports below.

The study concluded that large volumes of media and buffer solutions were easy to prepare using the combination of SAFC product and the high efficiency mixing provided by the Flexel with Magnetic Mixer technology or LevMixer technology.

Download SAFC SSB Media prep with Magnetic Mixer

Download SAFC SSB buffer preparation single use magnetic mixer

Download SAFC SSB buffer preparation with LevMixer

  

 

 

Posted by Bruce Lehr December 19th 2010.

 

India and China to Team Up on Global Pharma Tenders

As reported in LiveMint and India Today, the Indian Drug Manufacturers' Association (IDMA) and the China Pharmaceutical Industry Association (CPIA) plan to sign a memorandum of understanding (MOU) in January to collaborate in joint tendering for global pharma export orders. Such a partnership, they believe, could expand the global pharma market to $1.1 trillion by 2014.

China has ability to produce low cost APIs and India can add formulation expertise and expertise in preparing documentation for tenders.  IDMA secretary general Daara Patel said, "The collaboration between the two will give an edge over the developed countries. Together we can meet the generic drugs' requirements of the world."  China and India manufacturers believe they can make product at less than 60% of western costs.

China officials say their drug makers are open to Indian regulators inspecting their manufacturing plants.  The drug controller general in India has expressed a desire to make such inspections as China is a major bulk drug supplier to India - in the past there has been a problem with counterfeit drugs from China. China's government acknowledges that the two nations have to work jointly to tackle the counterfeit drug problem.

 Just an observation.  This type of agreement definitely should create a formidable presence in the generics markets - especially for tenders aimed at developing nations in competition with western suppliers.  But it also opens the door for more potential counterfeiting activity and therefore the regulatory diligence in both countries (and elsewhere) needs to keep increasing to make sure the qulaity standards are being adhered to and in the long-term leveling the quality playing field accross the globe.  

Posted by Bruce Lehr December 17th 2010.

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.