The Big Red Biotech Blog

Over 35 Blockbuster Pharmaceuticals to Go Off-Patent in 2011 and 2012

More than $209 B in branded drug sales will go off-patent between 2011 and 2014 including big names - Advair, Viagra, Seroquel, Zyprexa, Symbicort, Singulair and Lexapro.  Projections are that the generic market will reach $135-$150 B by 2015 as a result, representing a 9% CAGR.

PharmaGossip: Over 35 Blockbuster Branded Pharmaceuticals to Go Off-Patent in 2011 and 2012.

GenMed CEO, Erwin Bouwens says, "The coming decade will be a period of agresive growth for companies positioned in the generic pharmaceuticals market. We plan to take full advantage of the opportunities to apply for additional drug licenses as they become available."

Posted by Bruce Lehr Jan 24th 2011.

Genoptix Agrees to $470M Takeover by Novartis

Novartis will acquire Genoptix for $470 M representing a 39% premium over its current stock price of $17.98 per share.  It's a tender offer which means the majority of Genoptix shareholders will need to agree to surrender their shares.

Genoptix Agrees to $470M Takeover by Novartis.

The acquisition of Genoptix, a company specializing in diagnosing cancers in bone marrow, blood and lymph nodes, will help Novartis in its pursuit of personalized cancer treatment programs. Novartis currently is the world's second biggest maker of cancer drugs - with 2009 sales of more than $9 B.  The fact that Genoptix is a profitable company doesn't hurt the deal. Genoptix will become part of Novartis' Molecular Diagnostics unit.

 

Posted by Bruce Lehr Jan 24th 2011.

Waiting On Sanofi's Offer, Poor Opportunity for Genzyme Shareholders

Seeking Alpha's Chad Brand has put a different spin on the protracted Sanofi-Genzyme negotiations.  He simply asks if it is worth it for a Genzyme shareholder to hang onto the stock hoping for higher Sanofi offer versus selling it NOW in the market range of $71-72 per share?

Interesting.  Most shareholders at present seem to be holding the stock waiting for Genzyme's board to ratchet up Sanofi's offer price to the $80 per share range they've been lobbying for since almost July 2010. However, Brand points out that almost certainly any offer from Sanofi touching $80 per share will be for cash in $72 to $75 range plus a CVR at $5 per share.  Here's the rub.  The extra $5 per share (if that's the CVR value) will likely not appear for another 2.5 years - between final amount of time to consumate deal and for performance milestones from sales of Lemtrada to kick in (assuming they do).

Brand says that means a Genzyme shareholder who could sell for $71.50 today would be holding out for 5% more ($75) over another 6 months, and might be waiting on the additional $5 (or 6.6%) over another 2 years.  Is that 3.3% annual average return worth fighting for, or can one find an alternative investment that would be more attractive?

 

Posted by Bruce Lehr Jan 24th 2011.

Francis Collins Moves NIH Into Drug Development

An admittedly "little frustrated" Francis Collins says that he plans to fund the new NIH center for translational medicine with $1 B to help kick start translation of "scientific breakthroughs" into marketed therapeutics.

What Innovation? NIH Moves Into Drug Development // Pharmalot.

Collins plan is for scientists in the new center to get enough proof-of-concept data together to spur pharma industry investment and bringing the products to market, i.e. gain regulatory approval. Many commentators question the skills/experience NIH has for this type of product development -- as generally speaking academic scientists receive little if any training from this perspective. 

Questions Dr. Thomas Inset, director of National Institute for Mental Health (how appropriate), "Would we be foolish -- we being an agency that has never developed drugs and actually doesn't know how to do therapeutics that well -- to get into this space?" 

In a word, LIKELY.  This will either be beginning of a new paradigm of academic and industry collaboration or a tremendous waste of funding that could have gone to more basic research questions that NIH staff are skilled at delineating and answering.

PhRMA responded with a carefully worded statement.  The statement encourages the NIH "in the hope of improving the ultimate success rates in drug development."  But it also finishes with the following,

"The fact remains that biopharmaceutical research companies today and in the future will play a pivotal role: Our companies create the vast majority of new medicines from start to finish [emphasis added] and, for the remainder, in close collaboration with academia and NIH, fulfill the critical final phase that transforms promising molecules into actual medicines for patients."

Maybe we need to spend the extra $1 B on more small biotech tax credits and grants aimed at translational studies?

 

 

Posted by Bruce Lehr Jan 24th 2011.  

$69 per share? Going once, going twice, extended again

Fierce Biotech reports this morning that Sanofi has again extended the deadline on its offer of $69 per share ($18.5 B) for the purchase of Genzyme.  So far, 0.4 percent of Genzyme shareholders have accepted in the previous two offer periods. 

The latest extension is merely a formality to allow Sanofi and Genzyme negotiation teams to contnue the process of trying to reach an agreement on the value of the company.  Both continue to haggle over the value of Genzyme's late stage MS drug, Lemtrada (alemtuzumab MS) in trying to set a value on CVRs to augment the share price bid. 

Sanofi continues to note "there is no guarantee that the parties will come to an agreement."

 

 

Posted by Bruce Lehr Jan 24th 2011

Lilly Alzheimer's Diagnostic Expected to Get FDA Approval

Seeking Alpha says it is only a matter of time before Eli Lilly's newly-acquired Alzheimer’s disease diagnostic, florbetapir, wins FDA approval.  Lilly purchased florbetapir last November for $300 M from Avid Radiopharmaceuticals. 

Florbetapir, also known as AV-45 and which Eli Lilly has branded Amyvid, is an imaging agent which binds to the characteristic beta-amyloid plaques found in the brains of Alzheimer’s patients. This essentially dyes the plaques, which can then be seen on a PET scan.  Amyvid will help doctors rule out the degenerative brain disease if there is an absence of plaques.

Amyvid, and other Alzheimer’s and dementia diagnostics, will really come into their own when therapies become available and early diagnosis becomes more important, although it is possible that simpler tools will be available by then. In the meantime, with a lot of research into therapies that target beta-amyloid, Amyvid could well find an important role in clinical trials. Eli Lilly has one of the most advanced agents pursuing this avenue, solanezumab, which breaks up the beta-amyloid clumps. Amyvid should be able to track this happening.

This will be interesting to watch. The industry seems to strongly believe that companion diagnostic tests will become very important  in the future with these more complex diseases in establishing treatment effectiveness or even identifying which patient classes should receive a given therapy.

 

 

Posted by Bruce Lehr Jan 23rd 2011.

EMA Committee Backs Novartis' Gilenya MS Pill

The WSJ reports that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that oral MS drug, Gilenya, be approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis.

The news should pave the way for EMA approval and give Novartis the chance to launch this purported blockbuster in 2011.  The EMA final announcement is expected in about 3 months.  An approval will give Novartis a further leg up on its competitor Merck KGaA's cladribine which failed to get market approval in Europe. Biogen Idec also failed (coincidentally) on Friday to gain EU approval for its oral MS drug, Fampyra.  Novartis will soon be able to go after its share of the $10 B MS market.

Novartis will present a strong challenge to the others MS drug players including Biogen, Bayer and Teva. Teva's Copaxone had $2.8 B in sales in 2009 and Biogen's Avonex added accounted for another $2 B.  Because Gilenya is a pill and not a daily injection, analysts believe Gilenya can vault to sales of $3.5 B or more.  Patient groups welcomed the news.  There are about a half-million MS patients in Europe.

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

Biogen Reports 6 New PML Cases with Tysabri

As reported in Reuter's on Friday, Biogen acknowledged that 6 new cases of progressive multifocal leukoencephalopathy (or PML) occurred in December bringing the total now to 85 reported cases.  Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.  

Biogen temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.  Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.  Biogen shares were down $2.02 or 2.9 percent on the news. 

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

 

Top 10 Blogs To Make Sense Of The Pharmaceutical Industry

Here is a quick Public Service Announcement from PharmaGossip which reprints an article by the Pharmalot blog's Ed Silverman on blogs.com.  Ed gives us his view of the top ten blogs that help you make sense of the pharma industry - for most of these I'm a regular reader.

PharmaGossip: Top 10 Blogs To Make Sense Of The Pharmaceutical Industry - by Ed Silverman.

I would add Ed's Pharmalot blog to the list as well.  You can access recent Pharmalot blog posts from links in right-hand column of this blog. Enjoy!

Posted by Bruce Lehr Jan 23rd 2011.

 

So You Think Biotech has it Tough? What about VC investors?

Here's a piece from yesterday's Xconomy, by Jens Eckstein a general parner from the TVM Capital venture firm.  He provides his views from the recently concluded JP Morgan conference in San Francisco.

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In summary, negative indicators from the conference participants include:

• Fundamental business model has not been revamped yet to ensure success in drug development - especially with innovators
• IPOs induce a great deal of skepticism by investors in the health care sector - unless near term revenues are evident
• Pharma and biotech need to collaborate to share risk on early stage projects due to high risk profile that is perceived now
• Most new deals will be done under some type of "option" structure based on attaining milestones - no more big upfront payments! No in and out for VC investors.
• Big pharma is beginning to seek innovative or disruptive approaches in early stage pipelines.  They are looking for product platforms.  This may be mismatched to biotech's who have been trying to establish better "clinical proof-of-concept" previously sought by Big Guys

Where does this leave VC investors? Stuck in many cases with legacy portfolios with products in clinical development with a lack of funding -- with no funding in sight.  However, there is potentially breakthrough science aplenty.  Companies and investors just need to work on funding models in concert with business model changes.

Posted by Bruce Lehr Jan 22nd 2011.

 

European Vaccine Market Growth Projected

The Jan 1st issue of GEN (pp 16-17) reports on a Kalorama Information market projection on the prospects for the human vaccine market in Europe from 2010-2014. Kalorama predicts the Euro market for vaccines will hit $7.9 B when 2010 is totalled - up from $4 B in 2006. They are further projecting a 10.6% CAGR from 2010-2014 whereupon the market will reach $11.9 B in size.

Growth is driven by both pediatric vaccines (9.6%) and adult vaccines, like H1N1, (11.6%) to produce the projected combined rate of 10.6%.  As can be seen, the adult vaccine segment is expected to grow somewhat faster and will move from being 42.8% of the total market in 2010 to 44.8% of the total in 2014.

Five main countries account for the vast majority of the $7.9 B vaccine sales in European - that being Germany ($2.7 B), France, UK, Italy and Spain.  The European market is supplied by five main companies: GSK, Sanofi Pasteur MSD, Novartis, Sanofi Pasteur, and Crucell. According to the article, these five account for a combined 82% market share in Europe.

 

Posted by Bruce Lehr Jan 22nd 2011.

More Discussion of Longer Data Exclusivity and Innovation Incentive

On Jan 12th I had a post via the Pharmalot blog that discussed a new academic study that concluded an extension of data exclusivity for 12 years for small molecule drugs would translate into more innovation over a 50 year time span (2060).  A 55yr-old at that time would experience a life-extension of 1.7 months on average -- perhaps in part resulting from the incremental 228 drug approvals that could be expected to result from extended exclusivity and more reinvestment.

Now the Patent Doc blog publishes more of this study conducted by Health Affairs to let you examine it in more detail.  The rub is that a 55 year old today would need to spend more money out of pocket for drugs (i.e. higher prices with more exclusivity) and would not see any life-span extension for him- or herself.  The benefits of such a policy shift would accrue to the future generations. Of course, this is all predicated on certain assumptions.  Assumptions that may not hold up - like no unforeseen changes in 'laws, regulations, science and medicine" or changes in drug manufacturer behaviour (like generics chasing their own independent clinical trial data).  These limits in interpretation are at least recognized.

It's an interesting study to read.  One might consider whether the benefits are great enough to consider a policy change.  One might also consider whether a generation today really is willing to pay for a future generation's benefits - benefits that will never be realized by the generation paying for it.  This type of altruism perhaps at one time was explicit and now may not be even implicit. 

Posted by Bruce Lehr Jan 21st 2011.

 

Protalix Believes Oral Gaucher's Drug on Horizon

Protalix may be gaining on Genzyme in two treatment areas.

Protalix announced this week that it is making strong progress on the development of an oral drug for Gaucher's disease.  This would obviate the need for intravenous administrations (like Genzyme's current therapy Cerezyme).  Patients like oral administration much better which results in higher drug taking compliance and better disease management -- not to mention happier patients.

Similarly, Protalix reports making progress in one of its preclinical drugs - PRX-102 - for Fabry's disease. They tout this new drug as a potential best in class therapy.  Genzyme of course has struggled mightily in the past to years to make enough of its Fabrazyme - due to sever manufacturing issues that have resulted in it being under a FDA consent decree. 

Shire recently introduced a competitive therapy in Europe - Replagel.  And Fabry patients in the US have petitioned the NIH to give patent rights to another manufacturer to make Fabrazyme - and have petitioned the FDA to require Fabrazyme supplies to be sold in the US first before servicing Europe (as Europe has Replagel and the US does not).   The opportunity clearly exists for Protalix if its therapy holds up under clinical trials.  See Fierce Biotech.

"Don't look back [Genzyme], something might be gaining on you"  -- Satchel Paige

 

Posted by Bruce Lehr Jan 21st 2011.

Vertex Still Racing Merck for Hepatitis C Drug Approval

Last month, Merck announced the FDA would give expedited review to boceprevir, its new therapy for hepatitis C.  This week Vertex announced te FDA has agreed to provide expedited review for its similar drug teleprevir for hepatitis C.  The FDA set the date as May 23rd for the Vertex announcement. 

This has set off another round of speculation as to which company is in the lead for approval of its drug candidate.  According to Fierce Biotech, most analysts give teleprevir a nod as being the superior drug for the treatment of hepatitis C - a 3 million patient population.

Vertex CEO, Matthew Emmens said there is room for both therapies.  He expressed supreme confidence that Vertex would be able to compete effectively against the larger Merck sales force and gain a top share position.

 

 

Posted by Bruce Lehr Jan 21st 2011.

Merck Serono Teams with Domain Therapeutics on Parkinson's Drugs

Merck Serono agreed to a $178 M deal with Domain Therapeutics to target new therapies for Parkinson's disease and other neurodegenerative disorders. The deal provides Domain with Eur 2 M upfront for R&D and potential milestones of another Eu 132 M.  Merck will gain access to Domain's G-Protein Coupled Receptor (GPCR) compounds.  See Fierce Biotech.

 

 

Posted by Bruce Lehr Jan 21st 2011.

Can't Tell Big Pharma from Biotech without a Program

This is a post from Seeking Alpha's Jason Chew that makes the observation that the line between Big Pharma and Big Biotech is increasingly non-existent. I think it is basically self-evident that most Big Pharma companies have recognized that the much of the immediate future growth will come with the biological drugs rather than through small molecules.  As such, there has been tremendous acquisition activity in the industry whereby Big Pharma has been swallowing up its biotech bretheren. This has been accelerated not only by the realization that biologics have a better immediate growth future but by the fact that many traditional small molecules have reached the end of their patent life and face generic competition globally.

Similarly, the Big Biotech's, like Amgen and Genetech, are seeing their initial blockbuster drugs coming to the end of their patent lives over the next few years.  These drugs will increasingly face biosimilar competition globally and most of the early patent expirations already have competitive drugs waiting in the wings in clinical development.

My expectation is that a "Big Pharma" player and a "Big Biotech" won't look that different in the near term future - say next 5 years - and you likely can throw in some of the larger generic or biosimilar players like Teva as well. I think these companies will have portfolios of innovative products both large and small molecules, as well as generics and biosimilars.  I think the majority of the industry will have that type of product portfolio breadth.  You can probably sprinkle in some diagnostics and vaccine components as well. And, there will be a move toward personalized medicine.

An exception might be a company, like Roche to its credit, that appears to be willing to go after only innovative small and large molecules -- and in many cases still goes after blockbuster indications.  But, that will be the exception and not the rule.  Also, there may be more niche-type players like a Genzyme that focus their attention toward innovative products for orphan applications that may keep them out of the generics and biosimilar battles -- but of course these companies will be targetted for acquisition by Big Pharma players, like Sanofi, that will be out to build the more complete portfolio described in the paragraph above.

By and large, the industry will be made up of surviving Big Players who originated from the pharma, biotech and generics side of the fence to evolve to companies that blended products from all three models.

 

Posted by Bruce Lehr Jan 21st 2011.

Sanford-Burnham Strikes Deal With J&J for Alzheimer's Drugs

J&J signed a new drug development agreement with Sanford-Burnham Insitute to develop new drugs for Alzheimer's and psychiatric disorders.  The deal could be worth as much as $85 M to Sanford-Burnham. The deal is with the Ortho-McNeil-Janssen division within J&J.

Sanford-Burnham Strikes Deal With J&J, Second Big Pharma Alliance in a Month.

This is just the latest Big Pharma - Academic Insitute deal with several being announced in just the past few months - many between members of Big Pharma and UCSF.  Sanford-Burnham also has a similar deal to the J&J pact with Takeda Pharmaceuticals.

 

 

 

Posted by Bruce Lehr Jan 21st 2011.

 

Theraclone Strikes $632M Deal With Pfizer to Discover Antibodies

As reported in Xconomy, Theraclone was saved by a deal with Pfizer to license its I-STAR antibody discovery platform that could eventually be valued at up to $632 M.  For this money, Pfizer has secured exclusive rights to 4 unnamed targets - two in infectious disease areas and two in cancer.

Theraclone Strikes $632M Deal With Pfizer to Discover Antibodies for Cancer, Infections.

Theraclone's acting president, Steve Gillis, says that Theraclone will realize $189 to $252 M in near to mid-term milestones.  Theraclone lost its president in June and has been increasingly challenged to raise venture funding in a tough economic and biotech investment environment.

A Pfizer vice president says the deal furthers its aims "to be on the leading edge of biotherapeutics and antibody discovery."  I-STAR can quickly test tens of thousands of antibodies to find those with the most biologic activity - thus speeding Pfizer's drug development using the technology.

 

 

Posted by Bruce Lehr Jan 20th 2011.

Patients Petition FDA Over Genzyme Drug Shortage

Fabry patients in need of Genzyme's Fabrazyme are challenging again.  Last month, the challengers lost their attempt to get the NIH to exercise so-called march-in rights to allow another manufacturer to enter the market to make Fabrazyme - for which Genzyme hoolds the license to the patents.  This request was denied due to the NIH's feeling that no alternative manufacturer could start now and bring drug to market before Genzyme could get back into fuller production.

Patients Petition FDA Over Genzyme Drug Shortage // Pharmalot.

Now two of these patients are asking the FDA to regulate how Genzyme allots its drug.  It is asking the agency to make sure drug goes to the US market first before going to Europe -- apparently 62% of the drug is shipped overseas.  The EMEA has licensed an alternative drug, Replagal, made by Shire for the treatment of Fabry's.  The same drug is not licesned in the US and Shire as yet has not applied for one.

The US market is therefore short of Fabrazyme - where current patients subsist on a suboptimal dose in many cases and new patients can't get any drug - and has no access to Replagal.  There have been 3 reported deaths of Fabry's disease patients in the US due to the shortage.  No such deaths have been reported in Europe. Now the FDA is beginning to import Replagal to replace the Fabrazyme which was exported -- but patients must show "critical need" on a case by case basis to receive the US-unapproved drug.

Stay tuned for this one.

 

Posted by Bruce Lehr Jan 20th 2011.

Will the Vise Tighten on Pay-for-Delay Agreements?

This PharmaTech Talk post recaps the recent events with pay-for-delay deals. The FTC and DOJ are both on record as opposing these arrangments as anti-competitive.  Several pharmacies and wholesalers have legally challenged their validity in an antitrust suit, and now 31 AG's from around the US have filed an amicus brief asking the Supreme Court to review these arrangments - specifically in a case involving Bayer and the generic producers Barr Pharmaceuticals and Watson Pharmaceuticals.

PharmTech Talk » Will the Vise Tighten on Pay-for-Delay Agreements?.

Interestingly, the EU has also cracked down on what they term "patent settlements".  The European Commission is reviewing patent settlements from Big Pharma companies in 2009 - indicating that patent settlements are a concern because they may delay the market entry of cheaper generics.

According to the EU, its monitoring is beginning to pay off. It declared that only 10% f patent ssettlements in the period July 2008 to Dec 2009 were problematic as compared to 22% for the period Jan 2000 to June 2008.  See Reuters.

The Pharmalot blog adds some further interest to this topic. It notes that in relation to a pending pay-for-delay suit -- involving Cephalon and the generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharamceuticals over copycat versions of Provigil -- 3 dozen other drug makers are suing to prevent the FTC from disclosing the contents of their pay-for-delay deals in response to a Cephalon petition to force FTC disclosure.  Cephalon want the documents to challenge FTC conclusions that pay-for-delay deals are bad for consumers.  The other drugmakers apparently fear this disclosure despite what Cephalon may think.

We may get to see the Man Behind the Curtain in these pay for delay deals.

 

Posted by Bruce Lehr Jan 20th 2011.

Ariad Pharma Stock Up 25 Percent on Phase III Data

Ariad reported very positive results with its drug, ridaforolimus, in a phase III trial with patients with soft-tissue and bone tumors. The study showed patients' median progression-free survival increased by 21% to 17.7 weeks as compared to a placebo.

Ariad Pharma Stock Up More than 25 Percent on Positive Phase III Data.

Merck, which paid Ariad $50 M upfront plus $19 M in R&D funding in May, plans to file for approval this year.  Merck could pay Ariad an additional $514 M in milestones if the drug is commercially successful. Merck also plans to develop the drug toward other cancers. Ariad's stock rose more than 25% on the basis of the positive phase III news.

 

 

Posted by Bruce Lehr January 20th 2011.

A Sanofi Option: Take Over Genzyme Board

According to a Boston Herald story reported in PharmaGossip, analyst Philip Nadeau of Cowen & Co says that if the Sanofi-Genzyme deal continues to drag out, Sanofi could try to replace the Genzyme board at the next annual shareholders meeting. 

Sanofi-option-take-over-genzyme-board.html - PharmaGossip

Nadeau says that Genzyme is using its time now (and since the initial offer) to figure out exactly what the company is worth.  Genzyme's CEO Henri Termeer declined to comment on a report from a French newspaper last week that Sanofi was prepared to sweeten its offer from $69 per share to $76 per share - split between a raise its cash offer and $5-6 per share in CVRs. 

Senior managers from both organizations are said to be in active negotiations.

 

Posted by Bruce Lehr January 20th 2011.

 

Genzyme CEO says Sanofi deal will take time

In a speech to members of the boston Chamber of Commerce yesterday, Genzyme CEO Henri Termeer shrugged off any notion that there was a need for urgency to conclude a deal with Sanofi before its latest extended tender offer expires at midnight tommorrow. 

Genzyme CEO says Sanofi deal will take time - The Boston Globe.

Termeer told his audience that it took "30 years to get where are. So it will take some time to understand the next step, to understand the dynamics and the value."  Genzyme is still pushing Sanofi to raise its offer from $18.5 B (or $69 per share).  Both companies appear to be in serious negotiation and talking about CVRs as one mechanism to bridge the value gap between the two.

Sanofi spokesmen and its CEO Chris Viehbacher remained silent in response to Termeer's latest public remarks.  Last week, Viehbacher told an investors audience that a Genzyme acquisition would "raise Sanofi's profile in North America, boost its biotechnology franchise, and give it new products at a time when some of its best-selling drugs are losing patent protection."

 

Posted by Bruce Lehr January 20th 2011.

Genzyme Builds new Myozyme/Lumizyme Plant in Belgium

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

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

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

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

 

Posted by Bruce Lehr January 20th 2011.

Boehringer buys Amgen site to expand biologics CMO biz

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

Boehringer buying Amgen site to expand biologics CMO biz.

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

 

 

Posted by Bruce Lehr January 20th 2011.