The Big Red Biotech Blog

Genzyme Holds Serve Ball Back in Sanofi's Court at $89 per Share

Genzyme returned Sanofi's offer of $69 per share with a little math of their own this past week.  Genzyme management cited a new estimate of their 2011 earnings picture  at a bullish $4.30 to $4.60 per share --that was about 20% higher than most analysts have figured.  

Genzyme then noted that that Sanofi had fixed its bid by using the algorithm 20x expected 2011 earnings to arrive at the $69 per share figure.  Now, with Genzyme's new earnings estimate, and sticking with the 20x assumption, Genzyme says it would be worth $89 per share or $4.2 B more than Sanofi's original $18.5 B offer.

Sanofi's turn to return. so far, the French drugmaker has indicated that Genzyme's prognositcations are optimistic.  More to come I'm sure.

 

 

Posted by Bruce Lehr October 25th 2010.

Welcome Back Sam the Sham and His Dineros

According to the WSJ, Sam Waksal is back with his partners at Kadmon Pharmaceuticals and their company is acquiring privately held Three Rivers Pharmaceutical LLC of Warrendale, PA for "more than $100 M."  Waksal is the defrocked former CEO at Imclone.

Kadmon focuses on high value drugs in the areas of oncology, infectious disease and immunology.  Kadmon has raised over $200 M in debt and equity and has big monied investors from Japan and China. Waksal is Kadmon's CEO. 

Three Rivers currently markets several products for hepatits C, including Infergen, Ribasphere, and RibaPak.  It also markets Amphotec for systemic fungal infections and can be used for certain cancers. Kadmon appears to want Three Rivers as a fully-integrated commercial company to serve as its launching pad. Three Rivers top executives will exit stage left in this acquisition.

Kadmon will keep Three Rivers' Warrendale headquarters and its manufacturing, distribution, commercial and admin operations.  Kadmon hopes to develop a new model for small biotech firms who may be leery of the venture capital markets.

Says Waksal, "I'm taking what we did at Imclone and bringing it to the next step to build a 21st century biotech company."  Of course when last seen at Imclone, Waksal was nailed for insider trading and exited stage right to a 5-year prison term. So I guess I can hardly wait to see what this looks like in a 21st century model.

Posted by Bruce Lehr October 26th 2010.

 

FDA Mulls Tighter Standards on Generics?

According to a Bloomberg story quoting Janet Woodcock, director of the FDA's CDER, the agency is considering tighter standards for generics.  Why this is the case is not exactly clear to me.  In the article, Woodcock refers somewhat cryptically to alleged comments purportedly from patients and unnamed employees of generic manufacturers that say some generics "don't work as well as the originals".

Hmmm.  The employees are unnamed.  The companies they work for are unnamed.  The drugs in question are unnamed.  The basis for "don't work as well" claim is unsupported with data or specifics.  There seemed to be some innuendo aimed at anti-seizure drugs though. 

Woodcock made her statements at a meeting of the Generic Pharmaceutical Association. I speculate she was delivering a message to someone - certainly Miles and Sandoz sat up and took notice. Maybe they are supposed to help police some of their members?  PhRMA of course also took notice and the opportunity to state the FDA must keep us safe by ensuring generics are safe.

David Rosen, an attorney at Foley & Lardner LLP in Washington who served as a top-level generic official at FDA between 1980 to 1989, said questions have long been raised about generic compounds’ effectiveness based on anecdotal evidence. He wondered what is different now.

Nothing.  Just more sabre rattling by FDA. 

Woodcock said she didn’t know when the agency would come to any conclusions about generic standards of equivalence. The standards assure the generic is absorbed at the same rate and extent as the brand-name version.

The absorption problems aren’t necessarily harmful, Woodcock said. FDA permits generic drugs to absorb at a 25 percent different rate and extent than the originals they copy.  Australia, Canada, the European Union, Japan and South Africa have stricter bioequivalence standards for critical dose drugs. Woodcock also urged generic-drug makers to put more emphasis on “product presentation.” 

“Manufacturers need to think beyond therapeutic equivalence,” Woodcock said.  Why, if that is what the regulations emphasize?  If you want different emphasis, add to or emend the regs - preferably in public forum with commentary. 

Sounds like a case for SuperRegulator. 

 

 

 

 

 

 

 

 

 

 

Truth, Justice and the American Way!

 Posted by Bruce Lehr October 24th 2010

New home for Pharma Strategy Blog!

As promised yesterday, Pharma Strategy Blog has successfully changed hosts, but the url will remain the same - you can find the new site here.

For those of you who have bookmarked, subscribed by RSS or Email, nothing changes and the service should continue as usual.

We hope you like the new site, it's cleaner, more modern and functional plus Disqus commenting has been installed for improved functionality and community.

The historical data for this old Typepad blog will revert to it's original url, which you can still search and bookmark using this link for a limited period of time.

In future, all Pharma Strategy Blog posts will continue at the new home, we look forward to seeing y'all over there!

Come and join us, we're just a click away :)

via oncochat.typepad.com

Another Day Another Milestone for Big Red

The Big Red Biotech Blog is happy to recognize its 25,000th page view this morning! It's a beautiful Sunday morning here in Saint Louis and nothing goes better with Sunday Brunch than popping open some champagne.

So here's to my readership! Celebrate with me.  Not only do we hit another pageview milestone but the Rangers and Giants pull upsets to reach World Series.  And Mizzou wallops OU for a change. It's a beautiful day in the neighborhood.

 
Posted by Bruce Lehr October 24th 2010.

More Raw Material Trouble in China

The PharmaTech Talk blog reports more trouble out of China with supplies of crospovidone. It seems the FDA is investigating one lot of Chinese supplied raw material for excessive amounts of peroxide - reportedly found to be 4 times theses maximum allowed level of 400 ppm as recommended in the monographs.

These peroxide levels are not inherently dangerous to human health directly - but as crospovidone is used ubiquitously in many drug formulas - there is fear that elevated peroxide levels could have adverse effects on shelf life of active ingredients resulting in loss of drug potency before expected.

If problems with this Chinese source material are confirmed, this will just be another black eye for raw material suppliers in this area of the world given previous problems with heparin and melamine. Go to the blog link above for further links to FDA site on this topic.

 

Also, you may be interested in searching this blog for addtional posts on the SAFC raw material characterization program. We have established enhanced analytical and biological testing regimes to better characterize all our raw materials going into cell culture medium - for example - that support biopharmaceutical manufacturing.  Examples are here, here and here - but there are more.  There are also links to a couple of interviews on supply chain integrity and supporting quality systems - one from me and one from our VP of Quality and Regulatory Affairs, Tom Beil.

 

 

Posted by Bruce Lehr October 23rd 2010.

PhRMA Tries to Stave Off India's Compulsory Licenses Idea

In August, India's DIPP , Indian Department of Industrial Policy and Promotion, announced it is considering greater compulsory licensing provisions for drug makers.  These provisions could be applied, if necessary, to 3rd party drug (MNC) companies that takeover local generic competitors.  Indian regulators fear the upsurge in this type of activity in the recent past could result in pricing local populations out of the market in key therapeutic areas -- like cancer, HIV/AIDs or Hepaitis C treatments.

Pharmalot reports today that PhRMA is going to meet with DIPP and key high level officials this week to discuss the proposal. Compulsory licensing is about the last thing PhRMA wants to see - especially if restrictions were to extend to limits or bans on foreign takeovers.  Most of the West is looking to pharmerging markets to boost their revenues and India is certainly seen as a ripe target - plus it is a good launching pad for manufacturing generics more cheaply to be exported to other emerging markets.

Patient advocates/activist groups on the other hand have written an open letter to the Health Ministry to keep pursuing plans to make drugs affordable and available.  The lobbying shall commence.

 

 

 

 

Posted by Bruce Lehr October 22nd 2010.

Pharma Strategy Blog is moving!

Recently, the limitations of the current blogging platform have become apparent when we started to consider the idea of adding some new features to the blog such as podcasts, video interviews, newsletters etc. A number of readers have also requested more extensive downloadable reports for purchase, so this is something we will be able to do in the near future through a more secure site.

via www.pharmastrategyblog.com

Lilly Cornered? Need to Buy Way Out?

Lilly reported this week 3% growth in revenue and 7% in earnings for Qtr 3 - slighlty better than expected.  Nevertheless, Lilly has experienced several setbacks in its pipeline this year.  First it lost Semagacestat in a Phase III Alzheimer's trial, yesterday it reported that teplizumab went down in a phase III type 1 diabetes trial, and the prior day was told Bydureon will need to wait at least until the end of 2011 before it can apply for approval for the treatment of type II diabetes.

It also faces the steepest patent cliff in the industry with products coming off patent by 2014 that constitute fully 50% of its current revenues. And, in legal battles this year, a Michigan court invalidated its method-of-use patents for Gemzar and a NJ court did the same to method-of-use patents for Straterra.  Both drugs will now face earlier generic competition that will eat their market share.

So what's a CEO like John Lechleiter to do?  John holds steadfastly that Lilly will stay the course and focus on its internal R&D capability while coupling that to a strong cost savings program.  Lilly has already announced a headcount reduction of 5500 over the next two years and says it has already eliminated about half of those positions, and will continue to prudently reduce headcount. Mr. Lechleiter also reports that Lilly's is growing by double digits in Japan, double digits in its Elanco animal health business and by double digits in its emerging pharma markets.  All will add needed revenue as Lilly approches the 2014 cliff.

But will Lilly consider buying a large competitor? Is that back on the table as a possibility?  Lechleiter says No. "We continue to believe that our innovation-based strategy while not without risk will provide the greatest value to our shareholders and to society."  The CEO further notes Lilly still has 68 assets in human trials, 28 in phases II and III.  These include Imclone's 1121B for breast and gastric cancer, another phase III treatment for heatocellular cancer, and a phase III trial for solanezumab. 

Smaller niche company buys are on the table.  One of those might be Amylin - its partner on Bydureon.  Amylin shares plummeted by more than 50% on the news of the FDA decision.  Some analysts believe the stock has not yet hit bottom (Seeking Alpha).  It would be a very cheap time for Lilly to buy to stabilize its partner and boost its diabetes portfolio. 

Analysts from Leerink Swann's and Capital Markets have also nominated: Cephalon, Endo Pharmaceuticals, United Therapeutics and Forest Labs as other possible acquisition candidates.  Lilly has more than $5 B on its balance sheet to finance deals.  As Lechleiter remains committed to continuing Lilly's annual $2 B dividend - he may also have to buy his way out of the anticipated 2014 corner.  (See Fierce Biotech and Seeking Alpha Lilly earnings call).

Posted by Bruce Lehr Ocotber 22nd 2010.  

Genzyme Continues to Pitch for Higher Price from Sanofi

  
Genzyme went on the PR offensive this week with anaysts and its shareholders in conjunction with its earnings announcements for Qtr 3.  In doing so, a primary message it delivered repeatedly was that Sanofi's tender of $69 per share is too low. See WSJ.

Genzyme made its case for a higher valuation thusly (See GZ earnings call in Seeking Alpha):

• Reported earnings in the 3rd quarter that beat estimates
• Raised projected earnings estimates in 2011 to $4.30-$4.60 per share vs the current Wall Street smart guys estimates of $3.56 per share
• Reported that Cerezyme and Fabrazyme manufacturing issues were nearly fixed.  Cerezyme shipments are back to normal.  Fabrazyme remains on line for mid-year 2011 to reach normal.
• Reminded everyone that it improved shareholder value by selling the genetics business to LabCorp for $925 M in cash
• Stated the divestiture of the diagnostics and pharmaceutical intermediate businesses remain on track for end of year 2010
• Executed on first half of the $2 B stock buy back plan
• Continue to see good clinical results on alemtuzumab (Campath) for MS
• Saw strong sales of new drug Lumizyme in Qtr 3 after Q2 launch
• Reported cash position of $1.2 B

Further, Genzyme reminded analysts that Sanofi justified its valuation of Genzyme based on 36 times analysts projected 2010 EPS and 20 times 2011 EPS.  Based on Genzyme management's new estimate of EPS in 2011, Sanofi's bid would need to increase to $89 per share using their methodology. Further, GZ said that an analysis of large pharma all-cash deals for biotechs revealed a median premium of 73% but Sanofi offered only 38% on an artificially depressed (GZ's view) stock price in July.

Therefore, Genzyme says the offer is undervalued, and that Sanofi is not adequately accounting for value in the existing business, success of recovery plans, and new pipeline drugs. So -- pay up if you want us Chris V.  Otherwise, we believe we'll deliver at least $69 per share as a standalone company.

 

 

 

 

Posted by Bruce Lehr October 22nd 2010.

GSK Also Attacks Rare Diseases

GSK amplified on its plans to focus on rare diseases as part of its strategic mission.  Their goal is to develop therapies for a list of around 200 rare diseases out of the estimated 6000-8000 known diseases. A GSK spokeman said  "We will target those diseases where we realistically believe we can make a significant contribution; ideally we will be creating new medicines, but importantly by adding to the weight of scientific knowledge into rare diseases to the benefit of all working in this area."  See also Bioreasearch Online.

As a first foray in the area, GSK announced a licensing agreement Monday with Fondazione Telethon and Fondazione San Raffaele for a novel gene therapy treatment for ADA Severe Combined Immune Deficiency (ADA-SCID) - a rare life-threatening immunodeficiency that affects 350 children worldwide.  Working with the same two partners, GSK will also develop six more ex vivo stem cell treatments for a range of disorders including - metachromatic leukodystrophy (MLD) and Wiskott-Aldrich Syndrome (WAS), beta-thalasemia, mucopolysaccharoides type I (MPS), globoid leukodystrophy (GLD) and chronic granulomatous disorder (CGD).  All of the disorders are caused by a single gene defect and have well understood molecular mechanisms.  Clinical trials for MLD and WAS are currently underway.

"This collaboration is a breakthrough for gene therapy in rare diseases," said Professor Luigi Naldini, Director of San Raffaele Telethon Insititute for Gene Therapy, "We have spent years researching these promising new technologiess, but without GSK's experience in developing medicines, we would not be able to take all the steps towards making a potential therapy available to patients."

I'm actually both stunned and impressed that GSK can pursue a strategy that is such a divers set of niche diseases and presumably do so profitably.  It would appear to be a Godsend to those patients with one of these very rare diseases that would certainly not otherwise be addressed in any large scale or systematic fashion.   

 

 

 

Posted by Bruce Lehr October 22nd 2010

Novartis Revenues Run via Biosimilar Success

Novartis reported great Qtr3 results.  Revenues were up 13% and profits 10% year on year. The Sandoz generics unit played a big part in the runup.  Fierce Biotech reported on a Reuters story that enoxaparin, Novartis' recently approved biosimilar version of Lovenox, saw its revenues reach $292 M in the Qtr putting it on pace to pass the magical $1 B blockbuster mark.

The Sandoz unit also has three other biosimilars that are doing well - so far these consist of biologics like HGH and EPO. New drugs in Novartis' pipeline contributed to 20% of group revenues - up from 15% in the prior year.  With Pfizers announcement of a push in the biosimilar area too - as evidenced by its licensing deal with Biocon for insulin and insulin analogs - look for the Big Guys to rush down this track.

"The train has left the terminal and it's travelling in one direction," Evolution Securities' Dominic Valder tells Reuters. See Fierce Biotech.

  

Posted by Bruce Lehr October 21st 2010.  

We Need a Refocused, Kinder, Gentler NICE

The UK's NICE is often the butt of criticism with regard to its measures of drug cost effectiveness and its ability to recommend a thumbs up or down for use of a given therapy. Recently, the Association of the British Pharmaceutical Industry (ABPI) has called for a change in NICE's remit as reported in MNT.

The Director General, Dr. Richard Barker of the APBI suggested a three point plan for NICE's future:

• Broaden NICE's definition of value to capture all elements of healthcare innovation
• Refocus attention on best practice and quality standards and how innovation can enhance both
• Stop National Health Service practices that 'second-guess' NICE

"If we want the NHS and the UK economy to benefit from a vigorous life sciences sector, the reshaping of NICE's remit is an urgent priority. A focus on the future value of innovation, rather than decisions made on narrow cost-effectiveness criteria, would mean that NICE could play an important pivotal role in an outcomes-driven NHS."

Broadly, I agree with ABPI's position. I think cost-effectiveness measures of healthcare, representative of NICE's current charter are here to stay.  We really need to look at outcomes along with costs to keep medicine affordable.  However, a cost effectiveness  system that stifles or prevents the prospect of innovation is highly undesirable.  So if an organization like NICE, can have its marching orders tweaked so that it can both look at cost effectiveness but in the context of best practice and quality standards and improve access for patients that will be the best outcome.

As Frank Burns might say, "It's nice to be nice to the NICE".

 

 

 

 

Posted by Bruce Lehr October 21st 2010.

 

 

Lilly Shocked by 2nd Diabetes Setback in 2 Days!

Wasn't the FDA's complete response letter on Bydureon enough bad news for one week?  Nooooooooooo! Today Lilly announced that its late stage Type 1 diabetes drug, teplizumab, failed in a Phase III study.  Lilly will now suspend two other planned trials on this result.  The drug missed its primary efficacy endpoint.

Lilly acquired teplizumab from MacroGenics in 2007 for an upfront payment of $41 M plus potential milestones that could have totalled more than $1 B - well at least they saved that cash. However, they also missed out on the desperately needed revenues to help flatten out their industry leading patent cliff. So much, for best laid plans.

Lilly will now try to recover from the shock of a 20 month delay with its type 2 drug Bydureon and the collapse of its type 1 drug teplizumab.  Anybody have a another use for an anti-CD3 antibody?  Any use. 

 

Posted by Bruce Lehr October 21st 2010.

 

BI Anticlotting Drug Superior to Warfarin

Boehringer Ingelheim received good news from the FDA today when its anticlotting drug, Pradaxa was approved to prevent strokes and irregular heartbeat.  Thus BI beats its competitors to market with a drug to serve the $12 B anticlotting market.

Warfarin has been the standard in this segment for a very long time, but Norman Stockbridge, director of FDA's cardiovascular and renal products, notes that Pradaxa did better in clinical trials. Pradaxa could be a $4 B per year drug - a megablockbuster - and by reaching market first has a leg up on Bayer/J&J's rivaroxaban, BMS/Pfizer's pixaban and Merck/Portola's betrixaban.  See Fierce Biotech.

First to market = CASH and share.

 

 

Posted by Bruce Lehr October 20th 2010.

 

 

Fallout from FDA Bydureon Decision - Winners and Losers

By now, you know that the FDA issued a complete respnse letter to Amylin, Lilly and Alkermes late yesterday that refused to approve their application for Bydureon and asked for a full tQT study.  The impact is the the firms will not only NOT get their approval now, but will need to collect more data that will delay its next filing until at least the end of 2011 - with approval at least 6 months later in mid-2012.  Let's examine the fallout.

The biggest loser is Amylin.  The company was depending on the approval of Bydureon to bolster its revenues.  As a result of the FDA decision, its stock plummeted nearly 50% today reducing its market capitalization by half - or approximately $1.5 B if you are counting. This could make Amylin a takeover target by Lilly.

 

Alkermes also stood to earn significant royalties on sales post approval of Bydureon. Its deal calls for it to get 8% royalties on the first 40 million units soldand then slides down to 5.5%  It gets 0% on $0 in sales -- at least for now. Alkermes stock dropped 29% today on the FDA news.

By comparison, the third partner in crime, Eli Lilly's shares fell only 4.8% today.  However, the failure was the second late stage disappointment in the past couple of months - coming close on the heels of its failed Alzheimers drug this summer. Lilly's CEO, John Lechleiter has been touting the strength of Lilly's pipeline all year as a justification for the company not becoming involved in large merger activity and also depending on its in-house R&D prowess to create new products.  Now, he is facing the largest patent cliff in the industry and the cupboard is starting to look bare.  One would expect more scrutiny and questions coming his way on the Lilly development strategy. All he has to do is come up with answers.

According to the Pharmalot blog, analysts are saying that Lilly will need to look at cutting more costs, will face increasing pressure to "do a deal", or will need to partner some of its pipeline products. The pressure on Lilly will only continue to mount.  Lilly may need to look at acquiring Amylin, Alkermes or both to shore up its investment.

The Winner?  Well, it looks like Novo Nordisk benefits from the Bydureon turn down. Just yesterday, Novo's stock took a nearly 5% hit on the news Pfizer was teaming up with Biocon to enter the diabetes market with insulin and insulin analogs.  What a difference a day makes?  Today, Novo's stock leapt by more than 8% on the Bydureon news - its biggest gain in more than 2 years. Novo's competitive product, Victoza is now seen to have clear sailing in terms of competition for an extended period while the Amylin, Lilly, Alkermes triumverate comes up with recovery plan.

 

 Posted by Bruce Lehr October 20th 2010.

 

Genzyme Q3 Earnings May Aid Sanofi Takeover Bid

As reported in the WSJ, Genzyme's profits in Q3 quadrupled to 26 cents per share ($69 M) up from 6 cents per share ($16 M) a year ago.  Up to now, Genzyme has insisted that Sanofi's bid at $69 per share to purchase the company is too low and that the bid should be closer to $80 per share - this earnings report may help bolster their case.

Paradoxically, the earning report may also get them closer to being purchased as the increased earnings may well aid Sanofi in trying to convince its largest shareholders that a bid for Genzyme in the area of $75 per share is reasonable.  Then Sanofi will also be able to take such an offer to Genzyme's big shareholders too to pressure for a sale. 

Fierce Biotech reports this morning that Sanofi had no trouble raising $15 B in loans to serve as a war chest to provide flexibility in deal making for a Genzyme deal.  Additionally, Sanofi told Reuters the Hart-Scott Rodino antitrust waiting period had expired and a Genzyme purchase is in the clear from a regulator's point of view.  Genzyme's report that it may soon be fully back on line with Cerezyme and Fabrazyme - its two biggest revenue products - also will help Sanofi's confidence.  And, Genzyme's promising phase II results for Campath in the treatment of MS, where it might generate $1-2 B in annual sales doesn't hurt the cause either. 

On balance, the good Genzyme earnings report, if viewed as a case of turning the corner, just makes it all the more attractive as an acquisition candidate for Sanofi and should bolster Sanofi's confidence in upping the bid to get the deal done.

 

 

Posted by Bruce Lehr October 20th 2010.

FDA Throws Amylin/Alkermes Nasty Curve Ball

It's playoff season in baseball and as every fan knows good pitching stops good hitting. In keeping with the theme, the FDA threw Amylin, Alkermes and Lilly a nasty curveball in turning down their application for the once-weekly diabetes drug, Bydureon. 

In the agency's complete response letter, they've asked for a new study on QT Rhythm that would assess whether the drug is responsible for irregular heartbeat in trial patients. The three companies, clearly caught by surprise, indicated the issues were not "garden variety".  Unlike the previous FDA letter, which focused on manufacturing risk mitigation, this letter raises questions about safety and effectiveness.  Who says there's no predictability and consistency with the FDA?  The setback may be inspired by events that occurred with Avandia's approval and subsequent removal/restriction due to increased heart risks in patients receiving the drug.

All three companies were counting on the revenue from Bydureon to augment their flagging sales column. Now, with the latest FDA request, they don't believe they will be able to file their data for re-submission until the end of 2011.  Both Amylin and Alkermes are expected to suffer from the delay.  Amylin in particular was depending heavily on the Bydureon revenue and its stock can be expected to dive when the markets open.  Even since the March decision, they've restructured and cut staff - now there may need to be another round. See Xconomy.

 

 

Posted by Bruce Lehr October 19th 2010.

 

Genmab Seeks Money Partner to Fund Phase III Trials in US

Genmab's head and neck cancer drug zalutumumab performed well enough in a Phase III trial versus the standard platinum-based therapy that they will go for approval in the EU.  However, it looks like the FDA will require new studies costing hundreds of millions.

Now, Genmab is out looking for an appropriate "big bucks" partner to fund these US directed clinical trials.  Based on EU regulatory feedback, Genmab feels the new partner will be able to file in the EU now while chasing the needed data for the US.  Fierce Biotech notes in their coverage of this story that GSK may be one company interested in Genmab and as they have been rumored to be a takeover suitor in the recent past and currently have a co-development project with them on ofatumumab.   

 

 

Posted by Bruce Lehr October 19th 2010.

 

 

 

Want to buy results from a Medical Study or the Brooklyn Bridge?

Last week, I made a post based on a Pharma Times story regarding the scientific/medical literature being distorted by publication bias - i.e negative findings weren't published as often as positive - which is problematic when you are describing the effects and side effect of a drug that you're seeking approval on. Both sets of results are pretty germane to the conclusion of whether it's a safe and effective treatment or not.

Today, In the Pipeline, published another reminder of this publication bias and a link to a classic paper on the subject from John Ioannides.  Derek Low notes in his post that as publication bias goes - at least large Phase III studies are difficult to fake.  You usually get a fairly accurate depiction in a large controlled trial.

Still it is good to remember the caveats offered by Ioannides (outlined in the In the Pipeline post) regarding the liklihood a study's results are believable or not.  Take my word for it, or maybe you'd like to buy a nice bridge?

 

 Posted by Bruce Lehr October 19th 2010.

What's in Placebos: Who knows? Analysis of randomized, controlled trials

via www.annals.org

via www.pharmastrategyblog.com

Pfizer Taps BioCon to Go After Biologics in Pharmerging Markets

As reported in BioJobBlog and Fierce Biotech, Pfizer has struck a licensing deal, worth as much as $350 M, with Biocon for access to its rec human insulin and rec insulin analog products (Glargine, Aspart, and Lispro).  Pfizer says the deal will help it implement its strategy to get more heavily into the biosimilar market.  Pfizer will have co-exclusive rights to market these products in Germany, India and Malaysia - the latter two being important to the strategy of expanding in pharmerging markets.

Pfiser will pay Biocon $200 M upfront for access to the products and the Indian producer can earn up to another $150 M in milestones.  BioCon already has similar deals (for other products) with several members of the Big Pharma club, inlcuding Eli Lilly, Novo Nordisk and GSK.

According to livemint.com, the India Mubai exchange dropped 0.9% this morning, but BioCon stock hit records highs - soaring 15.4% - on the Pfizer news. And from Pharmainfonet, Novo Nordisk,world's largest insulin maker, shares dropped 4.4% on Copenhagen market based on fears of more competition from Pfizer.

Posted by Bruce Lehr October 19th 2010.

 

Ex FDA Generic BigWig Joins Biggest Generic DrugMaker

From Pharmalot blog, the former head of the FDA's Office of Generic Drugs, Gary Buehler, will be taking his services private in joining the world's biggest generic producer, Teva Pharmaceuticals.  Appropriately, he will assume the role of VP for Regulatory Strategic Operations.

Buehler should be well suited to helping Teva navigate the FDA as it devises policies on user fees for review of Generics.  He can also help Teva and the industry lobby for policies that will ultimately govern the review of biosimilars.  Teva, of course, is on record as wanting to be the world's leading biosimilar producer. Buehler is non-committal at this point, but did tell the WSJ that he is "curious about how the other side operates." 

He'll get his chance in this role and should be able to add value for Teva.

 

Posted by Bruce Lehr October 19th 2010.

Sanofi Goes to Harvard Hunting Goodwill (and Blockbusters)

According to a Fierce Biotech report, Sanofi has inked a deal with Harvard to collaborate on translational biomedical research focused in the therapeutic areas of cancer, inflammation and diabetes. Sanofi continues to explore new research models and collaborations in an effort to boost revenues due to expected shortfalls due approaching patent expirations on key drugs.

The funded projects will be selected by a Joint Scientific Steering Committee made up of members from Harvand and Sanofi. The awards will help Harvard researcher gain quick financial support for the development of innovative solutions in areas of high patient need. Sanofi will have the opportunity to develop diagnostic, therapeutic and prognostic applications from these discoveries.

"Our relationship with Harvard underscores sanofi-aventis' approach of leveraging our innovative internal resources while actively engaging a range of external partners to develop healthcare solutions," said Marc Cluzel, M.D., PhD, Executive Vice-President, Research & Development, Sanofi.

Ok, so it was MIT not Harvard in movie - poetic license.

Posted by Bruce Lehr October 18th 2010.

 

The Lilly Giveth and the Lilly Taketh Away in Singapore R&D Center

Foxbusiness reports this morning that Eli Lilly will close its Singapore Center for Drug Discovery in December as the revenue challenged company looks to shave costs.  The center is a collaboration between Lilly and Singapore Economic Development Board and has been in operation since 2002.

Lilly has decided to close the site, move all projects there that will be retained in their pipeline back to the main R&D center in Indianapolis. About 130 staff will lose their jobs with the site closing and that will save costs for Lilly who faces revenue challenges with both an impending patent cliff and recent failures in its late stage pipeline.  Lilly has been active at outsourcing R&D in and out of the US for several years now - a trend it is apparently reversing in this case at least with regard to doing work outside the US.  Presumably the retained projects will move to its partner Covance in IN as both companies inked a deal for early stage work back in 2008.

"We regret Lilly's decision to close the Lilly Singapore Center for Drug Discovery, and are working closely with the company to place affected staff," says EDB Director of Biomedical Sciences Beh Kian Teik.

More from Fierce Biotech.

 

Posted by Bruce Lehr October 18th 2010.