The Big Red Biotech Blog

What's In a Name?

They just don't name'em like that anymore.  They just don't name'em like that anymore.

Zytiga. Xgeva. Benlysta. Zactima. What do these have in common? They are 4 of the latest drug approvals on the market -- and they all have catchy names, huh?  What do they treat?

Oops! How coud I forget Zaltrap? Looks like you need to name your product with an "X" or a "Z".

Makes you kinda yearn for the days of Lipitor (lipid metabolism) or Plavix (anti-platelet) or Singulair (asthma).............

Would a rose by any other name really smell as sweet?

 
Posted by Bruce Lehr April 30th 2011.

Synthetic Biology Takes Another Step Forward

Researchers at the University of California earlier this month formed the UC Berkeley Synthetic Biology Institute (SBI) to advance efforts to engineer cells and biological systems. Agilent Technologies is providing infrastructure, expertise, and funding for the new institute. The move signals growing research and commercial interest in the nascent field of synthetic biology.

PharmTech Talk » Synthetic Biology Takes Another Step Forward.

Synthetic biology came to the public ken last year when the J. Craig Venter Institute (JVCI), a genomic-research organization founded and headed by J. Craig Venter, announced the successful construction of the first self-replicating synthetic cell.  This represented a significant step in the still-emerging field of synthetic biology. With that proof of principle, JVCI is working on creating an organism that contains the minimal genome required to sustain itself and its replication to be used as a platform for analyzing the function of every essential gene in a cell. The researchers envision eventual wider use of the technology in the development of a range of therapeutic products, such as pharmaceuticals and vaccines.

SBI is looking to take synthetic biology to the next level. SBI’s ultimate aim is to “create an industrial revolution in biological engineering,” said Matthew Tirrell, chair of Berkeley’s Department of Bioengineering and SBI’s founding director.  “SBI seeks to bridge the gap between the small-scale, biological engineering of the present and industrial-level production by developing design tools and other infrastructure to produce synthetic biological systems reliably on a large scale.”

“Synthetic biology potentially can have as profound an impact in the 21st century as semiconductor technology had in the 20th,” said William P. Sullivan, Agilent’s CEO and president. “To get there, we need to engineer biological solutions that are scalable, reliable, and safe. This is precisely what the UC Berkeley Synthetic Biology Institute is addressing, and why Agilent is enthusiastic about providing infrastructure, expertise, and funding for this new institute.”

This is an interesting new approach to complement or compete with genetic engeering to produce production scale systems.  It's clearly many years away and we'll have to see if it will be competitive to the current systems and their large head start in biotechnology.

Posted by Bruce Lehr April 30th 2011.

Sanofi and Regeneron Get Positive Phase 3 with Aflibercept

Just weeks after Sanofi-Aventis and Regeneron reported poor results with their cancer drug aflibercept in a late-stage study of non-small cell lung cancer, researchers gave a thumbs-up to their top-line results produced in a Phase III study for colon cancer. The two developers said that the drug--to be sold as Zaltrap--will be filed for marketing approval later this year.

"We are pleased with the results of the Zaltrap Phase III study in this group of patients," said Debasish Roychowdhury, senior vice president and head of Sanofi's global oncology division. "We are committed to bringing Zaltrap to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine."

Zaltrap is expected to grab about $200 million per year of the colon cancer market it addresses.  In addition to the stopped lung cancer trial, aflibercept has been discontinued in an ovarian cancer trial but still is being used in an ongoing trial for metastatic prostate cancer. See Fierce Biotech.

J&J Gets Early Prostate Cancer Drug Approval

J&J’s got some very good news when it learned that the FDA approved abiraterone acetate (Zytiga) for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy.  The drug inhibits an enzyme that stimulates androgen production, offering a new approach to fighting the disease.

In clinical trials, those who received Zytiga and prednisone had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone, according to a statement. The decision comes almost two months ahead of the June 20 deadline.

Wells Fargo analyst Larry Biegelson estimates annual sales of $800 million for the therapy by 2015. The treatment is likely to compete with Dendreon's Provenge, which costs $93,000 for a full course of treatment. The approval could also have implications for Medivation, which has been developing MDV-3100 for prostate cancer. See Xconomy and Fierce Biotech.

So we go from having no good treatments for this prostate cancer to two choices within a matter of months.

 

 

 

Posted by Bruce Lehr April 30th 2011.

Hep Hep Hooray! Vertex and Merck Earn C's

Both Merck's boceprevir and Vertex's telaprevir earned thumbs up's from the FDA advisory panel this week for the treatment of hepatitis C.  Both drugs received an unanimous 18-0 vote to approve from the panel. 

In trial data, Vertex's telaprevir improved cure rates of 40% from current standard of care to as high as 80%.  Merck similarly made improvements on the standard cure rate 38% up to 65%.  Telaprevir could shorten the current course of treatment by half as well. 

“Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee’s unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C,” said Peter Mueller, Vertex’s chief scientific officer, in a statement. “We look forward to working with the FDA as it prepares to make its decision next month.”

Debra Birkrant, the director of FDA's antiviral-drugs division, according to a report in the Wall Street Journal, said, boceprevir and telaprevir improve cure rates "to more than 30% above what we have today."

The FDA will make the final approval of both drugs official by May 23rd.  More than 3 billion people in the US are infected with hepatitis C.  Analysts believe both drugs will become blockbusters with annual sales in excess of $2 billion each within a couple of years.  Some estimates have both drugs garnering more than $7 billion in annual sales combined at their peak. See Fierce Biotech and Xconomy.

Posted by Bruce Lehr April 30th 2011.

Caliber opens world’s largest plant-based manufacturing facility

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

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

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

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

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

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

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

 

Posted by Bruce Lehr April 26th 2011.

It's Hepatitis C Week at FDA. Vertex Edges Merck on Approval?

Both drugs Vertex's telaprevir (Thursday) and Merck's boceprevir (Wednesday) will appear for the FDA advisory panel as each tries to get its new drug to treat hepatitis C approved.  Analysts expect both companies to succeed.  Analysts expect both to be able to reach peak sales of greater than $2 billion annually within a few years.

Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week.

Which drug is better?  Well both seem to be significantly better than the current standard of care. Both drugs offer patients increased cure rates, fewer side effects and shorter treeatment regimes.  Treatment specialists can't wait to get both drugs into their repertoir.  Telaprevir offers a slightly better safety profile to boceprevir. 

Most analysts see Vertex’s drug as best-in-class. There will be a clearer answer to that question after hearing what the FDA staff has to say this week about the drugs in its briefing documents, and in the questions that the FDA panel chooses to raise.

Nevertheless, we are poised for a real improvement in the treatment of hepatitis C infection and its sequelae.

 

 

 

Posted by Bruce Lehr April 25th 2011.

Pfizer Walks Tightrope with Potential Blockbuster RA Drug News

Pfizer reported on Friday that it has seen 4 patients die in a phase III trial with its new rheumatoid arthritis (RA) drug, tofacitinib.  Pfizer's shares dropped 3% and Abbott who markets a rival, Humira, went up 2% on the news. Pfizer is managing the news of the trial carefully as a result -- it says trial researchers only attribute one of the four deaths to the drug.

The results from the current trial, which will be presented at the annual meeting of the European League Against Rheumatism in May, are difficult to interpret because the number of patients who received a placebo is much smaller than those who got tofacitinib. Two of the deaths, a brain trauma and a case of rheumatoid arthritis that worsened after treatment was stopped, are clearly not linked to the drug. A third, a case of respiratory failure, was linked to tofacitinib by researchers.

What’s generating the most discussion is a death from acute heart failure. The researchers in the trial did not link this death to tofacitinib, but it according to Wells Fargo analyst Larry Biegelsen it is the fourth death of a patient from heart failure.  The Food and Drug Administration is likely to pool heart failure deaths when it looks at tofacitinib.

The two key questions are whether tofacitinib will be approved, and whether it will compete directly with the existing injections (a bigger market) --  drugs like Humira, Enbrel, and Remicade or Simponi?  Or will be used in patients who failed them (still a big market) as an oral dose alternative?  This could be a multi-billion dollar question over the lifetime of the drug and one worthy of information management. See the Forbes blog.

 

 

Posted by Bruce Lehr April 25th 2011.

 

Next Alzheimer's Hope Step Forward

There is some buzz in the news today about an eagerly awaited Alzheimer's drug, bapineuzumab, as it progresses in a pivotal phase III trial. The drug is being developed by Elan/J&J and Pfizer. The popular press is touting the drug as a potential - 1st drug - to treat Alzheimer's rather than just ameliorate symptoms for relatively short periods.  It may be the first drug approved that can delay or prevent disease progression.  It does this by binding the amyloid beta protein.  We'll see as the trial results become available as to its effectiveness.

I can understand the anxiousness involved with possibly having an actual treatment for Alzheimer's but I think people need to keep perspective until the trial results are available to assess that it actually works -- or on which sub-populations it actually works. Alzheimer's is a tough area.  Just this past summer, Lilly's semagacestat went down and out in a pivotal phase III trial.  This drug too was aimed at preventing amyloid beta plaques --  though it is a gamma secretase inhibitor and worked by blocking an amyloid forming enzyme. 

Bapineuzumab is a mAb that works by binding a soluble form of the amyloid beta protein in the blood.  Thus, has a different mechanism of action from semagacestat.  Lilly does have another direct rival drug to bapineuzumab, called solanezumab, that is also in pivotal phase III trials.  Solanezumab puportedly will work with a wider patient sub-population and has a somewhat better safety profile though that too needs to be proven by the trial data. See Fierce Biotech and The Daily Mail.

Both newer drugs are touted as mega-blockbusters with peak revenue predictions ranging to the $3 billion plus annually.  However, both need to make it through their respective trials and to market through the appropriate regulatory agencies.  Until then, let's keep our enthusiasm tempered. See Investor Village link to Datamonitor report.

 
Posted by Bruce Lehr April 25th 2011.

Pfizer says R&D Should Shrink

This from the In the Pipeline blog quoting Peter Corr, former Pfizer head of global development. "Big Pharma should get smaller."  That's an $8 billion dollar education speaking for the school of hard knocks.

Corr further expands on this, "We needed .....[to] keep smaller R&D sites and let them go on their own. Let them be funded independently.  Let them define how they can work best at their particular site as opposed to manage all of these sites around the world and pretend that we knew what was actually going on."

In other words, Pfizer should have followed this Elizabethan business model for pharma:

 
Big Pharma they say has lost its way.                                                                             And can't tell how to find it.                                                                                     Leave them alone and they'll come home.                                                                       Bringing more drugs to market.

Posted by Bruce Lehr April 25th 2011.

Amgen Admits It's an Old Man in a Young Man's World

Amgen announced its first dividend today.  It was also the first dividend ever paid by a biotech.

Amgen, with several major drugs in the  market, is more like a big pharma company at this point than your classic biotech firm burning through cash while working toward a breakthrough. It's investors have been clamoring for Amgen to pay a dividend.  Now it has announced one.

Paying a dividend is often seen as a signal that a company’s high-growth days are behind it. CEO Kevin Sharer, tried to refute that, insisting that Amgen is determined to “remain an innovation-focused biotechnology company.”

But analysts and investors don’t necessarily want Amgen to be daring. In fact, they started clamoring for the dividend out of fear that Amgen might use its large cash balance for a major acquisition rather than returning money to shareholders.  See WSJ Health blog.

The Biotech King is Dead. Long Live the Pharma King.

 

Posted by Bruce Lehr April 22nd 2011.

 

How Do We Measure Pharma Innovation with Long Timelines?

I like this post from Forbes Science Business blog. The author, David Shaywitz, cites a new book called Little Bets by Peter Sims, that talks about innovation as resulting from a series of small changes.  Shaywitz notes that it is difficult to apply to drug development due to the long time cycles for approval  -- i.e the ultimate measure of "successful innovation" is whether the drug is commercially successful or not. But how do you know if you are making correct changes if the cycles are so damned long.

He notes you can look at intermediary steps like moving from one drug phase to another (1 to 2, 2 to 3, etc) but this doesn't really say the drug will be successful. That's only known if it makes it to commercialization and does well there.  More troublng, if you look to measuring say cost improvements or decreases in cycle times -- you may get gains in these parameters but no more success.  And, you may in fact stifle innovation in the process.

I find the whole discussion interesting as I've long struggled with this problem. I resorted to some of the same things mentioned -- and it's true that you can save money by reducing cost or cutting cycle time but without achieving the commercial results that you want. In those instances, you delude yourself into thinking this is success (it's success in saving money but not in commercialization).

It's missing the forest for the trees or the operation is a success but the patient has died. Bascially, we're measuring what we can but don't have a good surrogate endpoint. 

Shaywith concludes:

We urgently need a better way to figure out how we’re doing, and reliably assess whether our pipeline is generating successful molecules, so we can make the sort of iterative improvements modern drug development desperately requires.  While I doubt anyone is going to stumble upon a magic crystal ball, it’s possible that refinements in the approaches used to select products and identify patients might help.  If not, the industry appears destined to remain where we are now: developing products of uncertain utility — in an increasingly efficient, quantitatively monitored fashion.

Anybody out there got any ideas on this one?

Posted by Bruce Lehr April 22nd 2011.

Biogen Reports Good News on Oral MS Drug

Biogen's sales were up 9% to $1.2 billion for the quarter.  It reiterated that its oral drug for MS, BG-12, met its primary and secondary endpoints in a pivotal phase III trial and gave analysts a peak at some of the data.  The drug reduced relapses by 49% over two years and reduced disease progression by 38% in a study of 1200 MS patients.

Biogen Shares Jump on Good News on Revenue, Oral MS Drug.

Coupling BG-12's performance with sales growth in Biogen's other MS drugs Tysabri and Avonex (interferon beta 1a) resulted in investor happiness and Biogen's stock surging by nearly 22%.  BG-12 looks to extend Biogen's MS franchise lead with the convenience of a pill.

 

 

Posted by Bruce Lehr April 22nd 2011.

Amgen Passes Key Trial With Son of Dmab For Osteoporosis

Amgen along with its partner UCB revealed today that their next generation bone treatment, AMG 785/CDP 7851, had met its phase II primary endpoints by significantly increasing bone density at 12 months in 400 postmenupausal women.

Amgen Passes Key Trial With Son of Dmab; For Osteoporosis.

AMG 785 is unlike Amgen's current bone drug, denosumab, which blocks bone erosion in patients to help prevent osteoporosis and some cancer-related bone fractures.  Denosumab, quite new itself, is expected to generate $3-4 billion.  AMG 785 meanwhile blocks sclerosin action and helps a patient build new bone.  This is a new approach that may aid patients who have already experienced bone loss. 

AMG 785 is now poised to move on to phase III trials.  When approved, it would provide Amgen with two options for treatng osteoporosis patients -- an estimated $9 billion market.  It is estimated that 20% of women over age 50 in the US have osteoporosis.

 

 

Posted by Bruce Lehr April 22nd 2011.

Insitutional Investors Play Tug-o-war with Actelion future

Who will win control of Actelion's board?  Will it be Elliott Advisors and sympathizers or their opponents BB Biotech AG, Rudolph Mag and allies?  Right now it looks like a neck and neck battle. The US consulting group Georgeson is working a straw poll with Actelion investors on Elliott's behalf in preparation for battle at the May 5th annual meeting.  They say a group of International Institutional investors will decide it.

Elliott tells the WSJ it has the upper hand now -- what else would they say?  We've lost?  They say International Shareholder Services will back their candidates.  It will come down to a close vote at the May 5th meeting and will hinge on a group of 18% in the middle who are primarily instituional investors. 

Again, we won't have to wait long -- May 5th hovers in the near future. See Fierce Biotech and warm up the ropes.

 

Posted by Bruce Lehr April 22nd 2011.

 

Valeant CEO Woos Cephalon Shareholders in Letter

J. Michael Pearson, CEO Valeant, writes to Cephalon shareholders that it will be willing to raise its offer  (modestly) from $73 per share if Cephalon management lets them see the books for due diligence.  Sounds similar to Sanofi speaking to Genzyme, No?

He also mentions that if he can't close the deal by May 12th. He'll pick up his $5.7 billion ball and go home.  He notes that he'd still like to acquire Cephalon as a friendly suitor, but needs the Cephalon board to negotiate openly and to remove a poison pill inserted after Valeant made its offer.

Valeant is now taking its case directly to shareholders to elect its new slate of board members (sounds like antics at Actelion among its major shareholders) but says it must gain control by the 12th or it will walk.

We shouldn't have to wait long in this case -- May 12th is only a few short weeks away.  We can always flip a coin for control.  See Fierce Biotech.

 

Posted by Bruce Lehr April 22nd 2011.

 

How much did you shell out for Rx drugs?

From PharmaGossip, the market stats on the top selling drugs in the US in 2010.  More specifically, the top 10 drugs paid for by insurance companies in 2010 according to IMS Health data.

PharmaGossip: Hey, big spender. How much did you shell out for Rx drugs?.

As noted, most were heavily advertised brands for ailments like heartburn, high cholesterol and depression. Also as noted, there are generic products available that will do the job for many if not most patients. Drugs like Lipitor and Plavix will see their patent protection disappearing very soon.

Posted by Bruce Lehr April 21st 2011.

FDA 'Strategic Priorities 2011-2015'

This is straight out of the FDA Transparency blog this morning announcing the agency's release of its strategy for the FDA over the next 4 1/2 years as outlined by Commissioner Hamburg.

Titled “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century,” the 50-page document provides a vision of the FDA that includes:

a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles

an integrated global food safety system focused on prevention and improved nutrition

expanded efforts to meet the needs of special populations.

Senior staff from the FDA’s seven product and research centers and two major offices contributed to the document. A Federal Register notice that invited public input in October 2010 generated more than 200 comments that were considered for the final document.

The field of regulatory science and innovation is among five cross-cutting areas that will serve as strategic priorities at the agency during the next five years.

The FDA must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies. This document sets forth our priorities for achieving that goal.

Thank you,

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs

 

 

 

 

Posted by Bruce Lehr April 20th 2011.

Will Academia-Pharma R&D Deals Threaten VCs?

This headline comes from the very good Life Sci VC blog.  It asks whether the large uptick in Big Pharma and Academia broad R&D pacts (see Sanofi-Harvard, Pfizer-Washington U, Bayer-UCSF, UCB-Harvard, Sanofi-Stanford, Gilead-Yale, Pfizer-UCSF, etc.) will exhaust VC opportunities for startup deals?

In a word, No!  In two words, Hell No! 

Life Sci concludes that this type of deal making still only impacts a very small proportion of the total academic projects out there.  For example, the Sanofi-Stanford deal announced this week is for a maximum of 5 programs per year in an institution with literally more than 100 with 50 departments and 100's of falculty. The pool is not exactly dry as a result of Sanofi's commitment.

Life Sci also argues that this new association of academia and pharma will help academia better understand the requirements for translational activities and what it really means to run a lead optimization program to industrial standards. Moreover, big pharma can help with academia funding gaps by covering more overhead in these deals and also fill a role in providing more early stage funding that VCs are shying away from in today's more risk-averse environment. VCs can jump in later on projects that may lose funding from their initial partners for a variety of "non-program" reasons.

Also while Big Pharma offers another alternative for academia partnerships and early funding, it may not be for everyone as there will be varying tolerances of academic groups for big pharma bureacracy as projects move inside the pharma R&D organization in later stages. Some good academic groups may choose not to engage with such a model.

The post concludes:

At the end of the day, I think there's a (mostly) healthy vetting process conducted by early stage VCs in evaluating, co-creating, funding and helping govern new startups out of academic labs. When done well, Pharma benefits from this,  as does academia.  I don't see these broader partnerships as threatening or significantly reshaping this important role of VC and their startups in the process of translating discoveries into clinical innovations. 

I would agree.  I think big pharma is adding not subtracting by entering these relatinships.  It's broadening the model.  It brings more commercial knowledge to earlier stages toward discovery. It has more of an evolutionary feel to big pharma R&D model than revolutionary feel to me. It may help create a more collaborative and open environment in the process -- that will hopefully result in more translational successes - that I think emboldens and actually helps everyone involved.  Success breeds success.

Posted by Bruce Lehr April 20th 2011.

Strategic deals to drive market share gains for big CROs

This article from Outsourcing Pharma states that Big Pharma will increasingly look to outsource to CROs as it tries to reduce R&D expense.  In doing so, it will consolidate and form strategic partnerships with a limited set of global CRO players. 

Strategic deals to drive market share gains for big CROs.

The top seven CROs (includes Covance, PPD, Parexel, Charles River, Icon, Kendle and Quintiles) will have captured half the market by 2015 as big pharma, especially Pfizer, enters into these strategic deals.  Pfizer will streamline its supplier network into functional service providers (FSP) and niche players. Pfizer terms this new model "performance partnerships" and will likely emerge with a short-list of 5 (or less) strategic vendor relationships.

Analysts say that "Within 5 years, and potentially much sooner, we could see over 80 percent of sponsors engaged in some sort of strategic relationship." In light of this, the CRO industry is expected to split into two groups -- large, global providers working in strategic relationships, and niche providers focused on one or two therapeutic areas.

Time to cement that partnership now if you want to be on the strategic short-list.

 

 

 

Posted by Bruce Lehr April 20th 2011.

 

US Drug Spending - How Low Can You Go?

Reuters reports on IMS Health data that says US spending on drugs grew by only 2.3% in 2010 -- or the second lowest level in 55 years.  This confirms the fears, no doubt, of Big Pharma executives as they look at heightened generic competition, increasing patent expirations and slackening product development pipelines. 

The good news, if any, was that the US market remains the largest for drugs at $307.4 billion.  The subsidence of flu in 2010, more generics, and less spending on newer therapies were cited as reasons the growth rate dived from 5.1% in 2009 to the 2.3% in 2010. Though the 2010 rate was second lowest in the past 55 years, you only have to harken back to 2008 at 1.8% to find the lowest rate in that time span. OUCH!  And the impact of Lipitor's patent expiration this year hasn't even been felt yet.

Other factoids include:

• Patient visits to doc offices down 4.2%
• Patients starting treatments for chronic disorders fell by 3.4 million (unemployment and health insurance or lack thereof blamed)
• Medicare Part D and Medicaid prescriptions up to 30% of total (compared to only 22% in 2006)
• Spending on generics rose 21.7% and account for 78% of all retail prescriptions

 

Posted by Bruce Lehr April 19th 2011.

Biotech Take Over Targets Nominated

Fierce Biotech published today some analyst opinions (for what they're worth) as to which companies may be the next on the list of take over targets as Big Pharma companies go shopping to fill their bare pipelines with approved drugs. The nominees are:

• Human Genome Sciences.  Hardly a surprise with its newly approved Benlysta hitting the market and projections that it will become profitable for the first time next year after 20 years of red ink.  Its partner in Benlysta, GSK, is widely expected to be the likely acquirer.
• Acorda.  Also the ownwer of a newly (2010) licensed drug, the oral MS drug Amyra.  Amyra also may get a patent extension which makes it and Acorda more valuable.  Many players may be suitors in this situation.
• Forrest Labs.  The company is said to be attractive for its portfolio of specialty pharmaceuticals that faces somewhat less generic competition.  It's been on the acquisition list for 3 years now.

That's the Fierce reported list from today.  Of course, Celgene and Actelion have also been mentioned as possible candidates in many circles.  And Cephalon is under hot pursuit by Valeant right now. Get ready shoppers.

 

 

 

Posted by Bruce Lehr April 19th 2011.

Organogenesis Facility Signals Regenerative Medicine Progress

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

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

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

Posted by Bruce Lehr April 19th 2011.  

Alnylam Inks Deal with Precision NanoSystems

Xconomy reports this morning that Alnylam Pharmaceuticals has signed a deal with Precision Nanosystems to use the latter's small lipid nanoparticle drug delivery system to help Alnylam get its RNAi drugs to their cell targets -- specifically in the liver.

Alnylam Inks Deal with Precision NanoSystems.

Thus Alnylam has found an alternative partner to work with on nanoparticle delivery -- given that its last partner, Tekmira, is now suing them for $1 billion.  Tekmira claims that Alnylam "misappropriated" their technology which the latter emphatically denies.  

Posted by Bruce Lehr April 19th 2011.

 

Amgen Investors Clamor for Dividends and R&D Results

 
Amgen will be holding its shareholder meeting soon.  Supposedly they will announce their first ever dividend for its investors.  Analysts say they and investors will be looking for news of pipeline projects.  Acerbicly one comments, "They have been talking about Phase II's for 5 years and nothing has come of it."  AMG479, a new drug for pancreatic cancer, is the top pipeline candidate. It's been dubbed a blockbuster contender. We await the news. See Fierce Biotech.

Posted by Bruce Lehr April 18th 2011.