The Big Red Biotech Blog

Sanofi Continues to Change R&D Model to Drive Innovation

Sanofi continues to morph its R&D footprint in an effort to become more focused, nimble and innovative.  As reported in Fierce Biotech, Sanofi will sell two R&D sites to CRO partner Covance in a 10 year, $2.2 B pact.  Covance will assume ownership of Sanofi's Porcheville, France and Alnwick, UK sites at a price of $25 M.  Sanofi will handle an important part of Sanofi's development pipeline.

"A key strategy for Sanofi-Aventis is to transform its R&D model and discover new medicines through the use of novel technologies and innovative partnerships," declared Sanofi R&D chief Marc Cluzel.  Covance also anounced the continuation and expansion of a similar deal with Eli Lilly today (see Outsourcing Pharma.com).

For Sanofi, this is a continuation of a flurry of activity that it has engaged in this year to reshape its R&D model. Other deals (in no particular order) announced this year include:

• A new R&D center is being built in China to support development of cures for diseases more  common to that area (here)
• Sanofi will join the Massachuesetts Life Science Center to expand its partnering and licensing activies (here)
• Sanofi and Aviesan - essentially a consortium of universities and private institutes in France - formed a research pact to develop therapies in focused disease areas (here)
• Last week the purchase of VaxDesign and its novel, rapid in vitro screening methodology to help select the best preclinical candidates to enter the pipeline (here)

It looks like they're serious and have really gotten busy in the past year and it's not over yet.  We still have a potential Genzyme acquisition looming on the horizon.  

Posted by Bruce Lehr September 30th 2010.

 

 

Biomarkers in cancer research - thoughts from AACR in Denver

via www.pharmastrategyblog.com

Sally Church, while adjusting to the high altitude of Denver at the American Association of Cancer Research (AACR) meeting on molecular diagnostics and cancer therapeutics, penned this item about new cutting edge ideas from the show.

She mentions the need for closer and more collaborative relationships between basic and clinical research in order to translate the knowledge and ideas into practice in the clinic more quickly. Essentially, better collaboration between academia, industry, between labs and between companies, even between what some may seem as competitors.  Sounds a lot like a cry for more open innovation.

A second theme she called out is the need to put more emphasis on systems biology - to look at "pathwayness" - that is trying to understand the complex pathways involved in cancer and devising strategies against the pathway versus attacking individual receptors that may only shut off portions of the pathway that can be bypassed by the cancer.

By taking the more open innovation route, and by picking up the tools we already have to more coherently apply to the pathways approach, we can potentially target more effective treatments for the individual patient -- and get there more rapidly. It again highlights a need for more work to identify biomarkers that can be used to assess successful outcomes in clinical trials within patient subpopulations - so we can apply the best treatments to the patient populations most likley to respond favorably.

Posted by Bruce Lehr September 30th 2010.

FDA on Teva Biologic, More Data Wanted, But No Trials Required

 As Ed Silverman explains in Pharmalot, the FDA sent back Teva's application for a generic (biosimilar) form of Amgen's Neupogen.  Teva had submitted their drug, called Neutroval, under a traditional approval pathway for a biologic.  The FDA declined it, however as stated in Teva's press release, the agency is requiring more data but is NOTrequiring more clincal trials to complete its review. (See WSJ article too)This, along with the agency's approval of the generic form of Lovenox earlier this year, suggests the FDA may be more amenable to licensing generic biologics and biosimilars than perhaps previously thought.

FDA Bounces A Biologic, But No Trials Required // Pharmalot.

Teva's Neutroval has already been approved in Europe since 2008 - but the FDA has yet to outline the pathway for submission and approval for biosimilars in the US.  The Healthcare reform bill in March however did lay the groundwork for biosimilars. 

The Patent Doc blog reminds us that the FDA will hold public hearings on Nov. 2nd and 3rd to obtain input from stakeholders on the agency's implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the portion of the Patient Protection and Affordable Care Act (PPACA) that creates an abbreviated approval pathway for biosimilars (like Neutroval) and interchangeable biological products (like M-Enoxaparin). See Patent Doc blog for more details on issues FDA is seeking comment on.   

Celebrate! Celebrate! Celebrate!

More self-congratulatory ecstasy, I've received my 20,000th page view today --  since I began this blog on January 1st.  My annualized run rate is now up to 55,000 page views - yeah! While I know for certain there are bloggers out there, who greatly exceed this rate of traffic -- allow me to pat myself on the back.  Ouch! I wrenched my arm again. 

Don't burst my bubble for now.  And for those of you who contributed views, thanks!

 
Posted by Bruce Lehr September 30th 2010

New FDA Site for Recall Data

The FDA Transparency blog reports that the FDA has created a new section of the FDA Web site for agency data sets. The new section includes all available downloadable data for major recalls from 2009 to present based on information provided by firms in press releases, including data on the recent Shell Egg recall.  The new gateway features data sets in XML format, which allows developers to easily create applications and mashups centered around FDA data. 

 

 

Posted by Bruce Lehr September 30th 2010.

    

Fierce Top 10 Pharma Companies Revenue/Employee

Fierce Biotech published its 2010 calculations of revenue per employee and ranked the Top 10 Big Pharma companies in a recent piece. Roche can out on top by this measure - one often used by industry analysts to quickly assess relative effficiency of competitors in an industry.  The range reported in the Fierce calculations went from number one Roche's $699,460 to number 10 Bayer's $205,720.

Though this metric varies widely from industry to industry and company to company it nonetheless provides an interesting view into how well a company is run. It can show for example how you’re doing against your competition while providing a simple tong-term tracking metric for both public and private companies. The best run companies (in general) have high revenue per employee figures. 

In looking at revenue per employee, industry leaders usually have higher values. What can cause such a wide variation within an industry? Operational efficiency and productivity are major factors. The number of outsourced business functions also has a big impact.

Investopedia notes that revenue per employee is best used within an industry comparing peers to peers, and that it is really important to look at this metric as it trends over time - more meaningful anyway than a single snapshot.  That means, for this post I should have looked up the Fierce figures for the past several years!

Briefing.com notes that  as a quick "litmus-test" for judging a company, it is hard to beat the revenue-per-employee metric. Labor intensive businesses generally have a lower revenue-per-employee metric. Businesses with a scalable business model generally have low revenue-per-employee ratios when they are small, but demonstrate ever-increasing ratios as they grow.

Revenue Per Employee	Median Operating Margin	Percentage of Stocks Unprofitable	Number of Companies
Less Than $100,000	-1.2%	56.9%	513
$100,000 to $200,000	4.2%	38.8%	953
$200,000 to $300,000	7.7%	26.9%	934
Higher than $300,000	9.8%	28.1%	2,016

Source: Reuters, for raw data, Briefing.com calculations

The above table summarizes how the revenue-per-employee metric can help you gauge, with a reasonable probability, whether a company is profitable or not. The data is calculated only from public companies trading on either the NYSE, the American Stock Exchange, or Nasdaq and includes more than 4,000 companies.

Posted by Bruce Lehr September 30th 2010.

AZ Forges Ahead with R788 - Earns Rigel $25 M Milestone

AZ is moving quick to advance R788, licensed from Rigel, into phase III trials for the treatment of rheumatoid arthritis via oral administration. Rigel, for its part, earns a $25 M milestone payment for the effort.

AZ is racing to get R788 (fostamatanib) to the finish line before Pfizer's new drugs hit the scene. Rigel says fostamatinib now will be the focus of one of the largest phase III studies in RA patients to date.    Rigel can earn up to $1.24 B with the drug in milestones and royalties. See Fierce Biotech.

Posted by Bruce Lehr September 29th 2010.

BMS Hits Early ZymoGenetics Jackpot

As reported earlier in Xconomy and Fierce Biotech, BMS may have hit the jackpot early with its acquisition of Zymogenetics.  Today, Zymogenetics is reporting startling results from a phase II (not III) trial of its IL-21 molecule for the treatment of metastatic melanoma.  Patients with this extremely intractable disease responded to IL-21 in this study by exhibiting  a mean survival rate of 12.4 months - with over 50% of trial subjects living more than 1 year. This result is eye-popping.

Earlier this year, BMS grabbed attention in the medical community at ASCO with its own drug for the treatment of metastatic melanoma when it established a mean survival time of 10 months - compared to 6.4 in the control group. The Zymogenetics result with IL-21 was characterized as "very encouraging" by Zymo's chief medical officer.

Now BMS may have it rich with IL-21 too in addition to the hepatitis C treatment that it primarily counted on in acquiring Zymo. Of course, with cancer therapies, phase III results are usual more telling - but so far so good with IL-21.

Posted by Bruce Lehr September 29th 2010.

 

 

"Stonewall" Termeer Ready to Sashay if Sanofi Price is Right

According to Financial Times via the NY Times, Henri Termeer in an interview indicate that he is prepared to leave Genzyme to facilitate the deal.  He further indicated that he may be on schedule to do so sometime next summer after the Genzyme Campath results are available from an MS trial.

Termeer, who has been accused of "stonewalling" negotiations in the recent past by Sanofi CEO Chris Viehbacher, says he is more open to a takeover than any time in past.  He also says he is in 'no hurry' to get deal done and that neither is Viehbacher.

"This process is a dance," said Termeer. "i have loads of things that I could spend more time on but I love Genzyme"

Posted by Bruce Lehr September 29th 2010.

hESC Research Gets Stay from Federal Appeals Court

According to the WSJ, a federal appeals court said Tuesday the Obama administration can continue to fund embryonic stem-cell research, reversing for the time being a trial judge's injunction barring the funding.

The one-page order by a three-judge panel of the U.S Court of Appeals for the District of Columbia Circuit said the administration met the legal standard for a stay of the injunction, but didn't discuss the case in detail.

So, hESC cell funding gets a reprieve while the case wends its way further through the court system

Posted by Bruce Lehr September 28th 2010.

Pfizer Goes On Pipeline Diet

Pfizer has reduced the number of drugs in its pipeline according to a report in InPharm.   The project is of course necessitated by its acquisition of Wyeth as the company takes a hard look at which drugs will provide the greatest return - and help to replace revenue soon to be lost via patent expirations.

Pfizer says it will cut 31 programs overall.  Of the 31 programs to be cut, 15 are in phase I. Pfizer will still have  26 programs in phase III and 9 in registration.  It also has 27 products that are biologics and another 4 vaccines in development.

As announced earlier this year, Pfizer will place more emphasis on rare, orphan and neglected diseases - including new drugs for onchocerciasis (river blindness) and the fungal infection aspergillosis - often seen in immuno-compromised patients.

 

Posted by Bruce Lehr September 28th 2010.

Sanofi Buys Innovative Drug Evaluation Platform

Sanofi announced today that it is acquiring Florida-based VaxDesign for $60 M dollars.  VaxDesign develops and manufactures in vitro models of the human immune system, known as Modular IMmune In-vitro Construct technology (say that fast 3x).

Sanofi says the technology will enable it to more rapidly and accurately screen new drug candidates prior to phase I to facilitate selection of "the best".  This should save big bucks in late stages by weeding out pretenders earlier in the process.

MIMIC (now say that fast 3x - better) "is the most advanced platform in the field", said Michel DeWilde, Sanofi's Senior VP of R&D. Reportedly, MIMIC reproduced Sanofi's own clinical data and will have particular application to the development of vaccines. See Fierce Biotech.

 

 

Posted by Bruce Lehr September 28th 2010.

Acceleron ACE's Fund Raising With Pharma Partners Shifts From VC $

As explained in Xconomy, Acceleron has been able to successfully shift its source of funding from venture capital firms to partnerships with pharma companies - particularly since 2008.  The firm has two major deals in particular providing pharm funding and continues to seek other strategic partners.

Acceleron earlier this month announced a deal with Shire that called for $45 M upfront plus royalties and milestones that could total up to $498 M. The deal for ACE-031 is for the treatment of Duchenne's Muscular Dystrophy (DMD). ACE-031 stimulates muscle growth and mass. Currenlty, there is no treatment for DMD. Acceleron retains marketing rights in the US and will receive royalties in the rest of the world.

Previously, Acceleron had struck a deal with Celgene for ACE-011 for the treatment of anemia in cancers.  ACE-011 blocks the cell signal that destroys RBCs and bone tissue - by giving ACE-011 to cancer patients it is hoped to reverse this effect and thereby block the development of anemia. The Celegen deal also required a $45 M upfront payment with milestone and royalties that could reach $510 M. 

Acceleron is also seeking strategic partners for its ACE-041 drug that controls tissue growth in blood vessels.  ACE-041 is envisioned to treat cancers by blocked blood vessel supply to tumors.  By following this strategy, Acceleron has gone from raising $100 M in VC funds to now adding another $140 M through its pharma partnerships.

Posted by Bruce Lehr September 28th 2010.

"Give Me More Drugs, More Revenue by 2014" says Lilly

With revenue gaps looming when Lilly's best selling antipsychotic, Zyprexa, loses market exclusivity in October 2011, and its one-time projected mega-blockbuster Alzheimer's drug, semagacestat, failed in phase III, the company is turning to licensing to fill the hole. See WSJ Health blog report.

Lilly's president of R&D, Jan Lundberg, stated the company is "particularly interested in late-stage opportunities that can be revenue-generating in 2014." No pressure or anything. Lilly has already been busy this year, acquiring Alnara Pharmaceuticals pancreatric-enzyme replacment therapy, and co-promoting Kowa Pharmaceuticals cholestrol drug, Livalo.

Lundberg says Lilly has already examined over 1000 deal opportunties in 2010 but only "a handful" resulted in anything.  That would equate to a 0.5% close rate.  Lilly is looking to bolster its holdings in cancer, diabetes, and neurological therapies.

Previously this year, Lilly CEO John Lechleiter had been particularly bullish on the Lilly pipeline and indicated they wouldn't be in any large scale buying mode to escape the patent cliff.  However, internal programs are still years from getting on the market in most cases and mega-failures like semagacestat (which actually made patients worse) has no doubt caused Plan B to kick in.

Posted by Bruce Lehr September 28th 2010.

Judges Keep Poker-face in Stem Cell Research Ban Appeal

The Federal appeal court of Judges Thomas Griffith, Brett Kavanaugh, and Judith Rogers heard oral arguments from the government lawyer, Beth Brinkmann and plaintiff lawyer, Thomas Hungar, representing the two adult stem cell researchers who brought suit.

Judges Ask Tough Questions of Both Sides in Appeal of Stem Cell Research Ban - ScienceInsider.

The Judges drilled government lawyers on questions as to what real harm hESC researchers would experience if they had to hold research while case decided, and why derivation of stem cells was 'not ok' to be funded by NIH but hESC research using these cells was 'ok'. 

Conversely, the Judges also pointed out to Hungar that the Dickey-Wicker amendment was passed with embryo research in mind and not hESC work. They also noted that the NIH had consistently made the distinction that it would NOT fund stem cell derivation work.

Observers indicated that the Judges seemed well informed on the issues.  They were unsure which way the panel was leaning.  A decision is expected this week as to whether a stay of Judge Lambert's original ruling will remain in place or be lifted - continued research while case is being litigated further or stoppage.

Posted by Bruce Lehr September 28th 2010.

 

Medicare To Grill Dendreon's Provenge?

The Centers for Medicare and Medicaid Services is about to conduct its previously announced National Coverage Analysis for Dendreon's newly approved (June 2010) Provenge.

Here's What Medicare Will Ask About Provenge // Pharmalot.

NCA reviews are considered unusual for newly licensed products.  And to make it more so, CMS apparently plans to ask questions about the drug's efficacy for on label uses! Part of its charter?  See prior blog post on Senate queries into why Medicare was conducting an NCA review in the first place.

Writes ISI Group biotech analyst Marc Schoenebaum. “This is the first time we’ve seen Medicare analyze the efficacy of a drug.”  There apparently is a first for everything.

Posted by Bruce Lehr September 27th 2010.

AZ's Zibotentan Fails

As reported in WSJ and Fierce Biotech this morning another cancer drug has failed to meet its endpoint in a phase III trial. This time it is AZ's zibotentan for the treatment of prostate cancer. The drug is currently in two additional late stage trials but this result will dealy its planned filing date for approval.  a few more bad results may stop it in its tracks.

AZ's drug was seen as a potential competitor to Dendreon's Provenge - which has come under some scrutiny regarding its pricing and its availability. In general, the AZ news should be good news for Dendreon.  For AZ, this result complete the trifecta of disappointing news in late stage cancer trials as its Recentin (colon cancer) and Vandetanib (non-small cell lung cancer) also failed to meet key endpoints.

 

 

Posted by Bruce Lehr September 27th 2010.

Can't Anybody Here Play this Game?

With sincere apologies to Casey Stengel, recent manufacturing failures in pharma industry make this question every bit as pertinent as when it was formulated about the 1962 Mets.

Genzyme. J&J's McNeil. Abbott. Amgen. Not exactly neophytes to the manufacturing and quality control of critical products serving the healthcare market.  Yet all have experienced problems in their manufacturing resulting in recalls, and in some cases shortages, and illness.

What's more? Many of these instances have been marked by a seemingly leisurely attitude in senior management toward getting to the bottom of the issues.  Or worse, lack of transparency in dealing with the problem with the patient base - lack of availability information, dealyed or phantom recalls, and stonewalling regulators.

Results? Loss of consumer confidence or anger among patients who are without their needed medications.  Plant closings and job losses for those employees. Senior management resignations (albeit too little too late).  Proxy fights. Consent Decrees.  And even an acquisition attempt (which could go hostile) in play.

Like most things. It would appear that this would come down to fundamentals.  Companies need to go back to spring training and work on basics of attention to detail, institution and adherence to strong quality systems - but even more importantly a return to responsibility, forthrightness and a commitment to ethics at the top.  These are ethical businesses correct?

Posted by Bruce Lehr September 27th 2010.

Cell Culture Market Trends

Here's a link to an interview of yours truly that appears in BioPharm International.  In it, I respond to several questions about current trends:  with cell culture media formulation, with the use of feeds and chemically-defined media, and emphasis on ACF formulations and traceability.

Enjoy!

Posted by Bruce Lehr September 27th 2010.

Empower to the People! SeaGen Antibody for Hodgkin's

As trumpeted in Xconomy and Fierce Biotech this morning, Seattle Genetics "empowered antibody" therapy for Hodgkin's disease sailed through its last pivotal trial with flying colors.  Brentuximab vedotin (aka SGN-35) was able to partially or completely shrink tumors for 75 percent of the 102 patients with Hodgkin's disease.  As a point of reference, most cancer drugs succeed in shrinking tumors in about 30% of the participants receiving the drug.

Seattle Genetics (and its partner Millenium) is now in position to seek approval from the FDA.  SGN-35 would be the first licensed antibody drug conjugate or empowered antibody to be approved. Empowered antibodies are seen as a new and growing area in the treatment of various types of cancer.  Genetech's T-DM1 is another such therapy that is deep into clinical trials for breast cancer.  

"We are positioned for a Biologics License Application submission to the U.S. Food and Drug Administration in the first half of 2011," said CEO Clay Siegall.  “I’ve been doing cancer research and making cancer drugs for 25 years, and these are the kind of data you dream of. We are going to have an amazing impact on patients.”

Here. Here.

Posted by Bruce Lehr September 27th 2010.

Sanofi Looking to Up Ante to Bring Genzyme to Table

The WSJ reports that Sanofi is looking to arrange more financing to enable it to up its bid for Genzyme and thereby bring Genzyme principals to the negotiating table.  In playing thi styp eof high stakes poker, it is uncertain what Sanofi's raise must be to gain Genzyme's interest.

Nevertheless, Sanofi is reportedly talking to Sanofi big lenders, such as Citigroup Inc. and Bank of America Corp. about funding an offer that already has backing from J.P. Morgan Chase & Co., BNP Paribas SA and Société Générale SA, according to the Journal report.

The pressure may be building on Sanofi with its recent pipeline failures, see Tamaris last week. Until Sanofi gets their opening ante correct (from Termeer's viewpoint), CEO Chris Viehbacher is going to be lonely at the table.

Posted by Bruce Lehr September 26th 2010.

Mapping Innovation Clusters

In the previous post, I talked about innovation clusters and their perceived importance in spurring innovation and economic growth. I also referred to the Cluster Mapping Project being done by Harvard Business School on behalf of the US government to aid in cluster identification to enable future economic policy and support.

Here's a depiction of an global cluster innovation map from Juan Alacer, Harvard Business School and New York University, McKinsey analysis.  In this analysis, 4 types of clusters were identified:

• 'Hot-springs' are small, fast-growing hubs on track to become world players
• 'Dynamic-oceans' consist of large and vibrant ecosystems with continuous creation and destruction of new businesses
• 'Silent-lakes' are older, slower-growing hubs with a narrow range of large established companies
• 'Shrinking-pools' have been unable, so far, to expand beyond their start-up coreand so find themselves slowly migrating down the value chain

In the map provided, clusters are identified by virtually every major city in the US and around the globe. I think it is intriguing to find your city and areas you do business in. 

Hot Spring cities in the US include: Fort Collins, CO, Eugene, OR, Vancouver, WA, Nampa, ID and Des Moines, IA

Dynamic Oceans in the US include: Silicon Valley, CA, San Francisco, San Diego, Anaheim, Minneapolis, MN, Portland, OR and Boise, ID

By contrast, I find I was born in a Shrinking Pool and live in a Shrinking Pool - maybe destined to be Big Fish in Shrinking Pool.  Otherwise, all the cities I've lived in professionally or attended school in are Silent Lakes.  By the way, I also noted that John Lechleiter, one subject of my last post, also lives in a Shrinking Pool.

With apologies to John Mellencamp:

• I was born in a shrinking pool
• And I live in a shrinking pool 
• Prob'ly die in a shrinking pool
• Oh, those shrinking communities         

 

 

Posted by Bruce Lehr September 25th 2010.            

Lilly's Leichleiter Promotes Innovation

The Indy Star reported comments by Lilly CEO John Leichleiter speaking at a conference in Washington DC sponsored by The Brookings Institute. He praised Federal efforts to support regional innovation clusters in the life sciences arena.  He said such policies "can unleash America's true capacity for innovation".

Clusters are geographic concentrations of interconnected firms, and supporting or coordinating organizations. Silicon Valley is the most famous example in the US. The Brookings Institution, a nonprofit think tank, contends that clusters produce lasting value in economies.   According to the Insitute, the US has lagged in supporting clusters as compared to other nations but is catching up.

"We know that when you get businesses, government, academia and nonprofits together in one place, pulling toward similar goals, good things happen," Commerce Secretary Gary Locke told the forum.

Michael Porter has published extensively on clusters. According to him, clusters arise because they increase the productivity with which companies can compete. The development and upgrading of clusters is an important agenda for governments, companies, and other institutions. Cluster development initiatives are an important new direction in economic policy.  The Cluster Mapping project at Harvard will identify and map all US clusters for the government to aid policy formulation and support.

Porter explains how clusters affect competition in three broad ways: first, by increasing the productivity of companies based in the area; second, by driving the direction and pace of innovation; and third, by stimulating the formation of new businesses within the cluster.

Geographic, cultural, and institutional proximity provides companies with special access, closer relationships, better information, powerful incentives, and other advantages that are difficult to tap from a distance. The more complex, knowledge-based, and dynamic the world economy becomes, the more this is true.

Clusters represent a new way of thinking about national, state, and local economies, and they necessitate new roles for companies, government, and other institutions in enhancing competitiveness.

Posted by Bruce Lehr September 24th 2010.

Mass Drug Recalls: End of an Era?

This from the Forbes blog by Matthew Herper. He writes that handling of the Avandia situation by the US FDA may signal their desire to avoid mass market drug recalls ala Baycol, Vioxx and Zelnorm (that one hit my family) for a more surgical approach.

The FDAAA legislation gave the FDA the new risk evaluation and mitigation system (REMS).  Using REMS, the FDA can really really really restrict the use of a drug without killing it altogether.  That way, if a medication is a last resort for a proportion of the population, they potentially can use it after satisfying criteria that all other medications  won't do the job for them. And, these patients will be fully informed and/or supervised in proper use of the medicine. Big Brother to some. But, not as draconian as complete removal of the medication.

Avandia will now be sold in the US under these type of severe restrictions.  GSK says that after the restrictions are implemented, Avandia's annual sales will be "minimal".   Minimal > nothing.  And, only those patients in dire need of this specific drug will be able to use it. Seems like a reasonable balance between safety and true need.  And, this helps explain why Avandia is still on US market while it has been withdrawn from Europe.

Currently, 146 products have approved REMS. Of these, 96 include only a medication guide, 33 include a communications plan requiring additional steps to get a patient approved to use, and 15 have "elements to assure safe use".  Avandia falls into the latter class - which explains its extremely limited expected use in the future.  The FDA now has more precise tools to protect safety.  REMS can be expected to be more commonplace in the future and mass withdrawls are likely extinct.

Posted by Bruce Lehr September 24th 2010.

 

Who Will Have 1st Biosimilar Approved? Place Your Bets

The Patent Doc blog did a nice summary of recent articles speculating on which companies will have the greatest chance to be the first to successfully bring a biosimilar to market.  Most observers think that some big players, who have the wherewithal to navigate IP and regulatory hurdles, as well as the financial strength, will be the first to prevail. 

Companies mentioned from this category include Novartis' Sandoz unit, Pfizer, Merck, Teva, Hospira, and Stada. 

Recent market studies by Global Industry Analysts and PharmaLive peg the biosimilar market to be worth $10 B by 2015 or 2017 respectively. Although, there is further acknowledgement that legislation regarding regulatory pathways and patent infringement could slow things down - and certainly introduce uncertainty which may affect investment.

Posted by Bruce Lehr September 24th 2010.