THRX gets a second complete response letter for telavancin in complicated skin infections indication. The FDA wants additional data, no new trials. Probably 6 months to go now.

http://www.reuters.com/article/marketsNews/idINBNG44977220090226?rpc=44

Don't think anyone expects this tender offer to succeed.

I think that the line of therapy might be more important than expected but another trouble in the ongoing phase III is the primary endpoint which is overall survival.

Neurogenetics: Predicting antidepressant response

http://www.nature.com/nrn/journal/v9/n3/full/nrn2346.html

By Monica Hoyos Flight

A growing number of single nucleotide polymorphism (SNP)-mapping and genome-wide association (GWA) studies are identifying common genetic variants that are associated with complex diseases such as diabetes, cancer and mood disorders. Such studies can also be used to understand the variability in medication response. In Neuron, Florian Holsboer and colleagues report an important example: genetic variation in the ABCB1 gene can account for some of the differences in antidepressant efficacy.

Overall, only a third of patients on antidepressant medication achieve full remission. A possible reason might be that insufficient drug concentrations reach the nervous system owing to an inadequate ability to cross the blood–brain barrier. Transport molecules on the endothelial cells that line cerebral capillaries, such as P-glycoprotein (P-gp; encoded by ABCB1), determine the intracerebral concentration of certain drugs and thus, could be critical for the clinical response to CNS-targeted drugs.

Using mice in which the homologue of the human ABCB1 gene had been deleted, the authors showed that, after administration for 11 days, the brain concentrations of two structurally distinct antidepressants — citalopram (a selective serotonin re-uptake inhibitor) and venlafaxine (a selective serotonin and noradrenaline re-uptake inhibitor) — were up to four-times higher than in wild-type mice. No differences were found for mirtazapine, indicating that citalopram and venlafaxine are P-gp substrates.

Next, they investigated whether functionally relevant genetic variants in ABCB1 in humans could also affect antidepressant concentrations in the brain. From a group of 443 patients receiving antidepressants, they found a highly significant association between 11 SNPs of ABCB1 and remission in patients taking antidepressants that are substrates of P-gp. No such association was found in patients taking mirtazapine (a non-P-gp substrate).

The occurrence of these SNPs varies considerably between ethnic groups, which could explain the differences in therapeutic outcome that are often observed between African Americans and Caucasians receiving antidepressant medication.

Taking a patient's P-gp genetic status into consideration is likely to be important not only for predicting the response to certain antidepressants, but also to many other clinically important drugs (and steroid hormones) that rely on P-gp to penetrate the brain. Moreover, consideration of ABCB1 polymorphisms in the design of clinical trials of P-gp substrates might help stratify patient populations and therefore reduce the cost of developing ineffective treatments.


ORIGINAL RESEARCH PAPER

1. Uhr, M. et al. Polymorphisms in the drug transporter gene ABCB1 predict antidepressant response in depression. Neuron 57, 203–209 (2008)

Gearing up for follow-on biologics

http://www.nature.com/nrd/journal/v8/n3/full/nrd2847.html#top

By Bethan Hughes

Abstract

Biopharmaceutical and generic companies alike are investing in the follow-on biologics space in advance of patent expirations of major therapeutic protein products from 2013 onwards.

Since the end of 2008, there has been a spurt of investment and interest in the development of follow-on biologics, or biosimilars, by both biopharmaceutical and generic-drug companies. Merck, for example, announced in December that it has created Merck BioVentures to develop follow-on biologics. And in January 2009, leading generic manufacturer Teva Pharmaceuticals announced a strategic partnership with Lonza — a company that provides custom manufacturing of biopharmaceuticals — with the aim of becoming a global provider.

Merck further consolidated its investment on 12 February 2009 by acquiring Insmed, a US biotech company that aimed to be the first company to develop a comprehensive portfolio of follow-on biologics. Through the US$130 million acquisition, Merck will gain Insmed's pipeline of follow-on products, as well as its commercial manufacturing facilities.

A competitive advantage that Merck may have in this arena is the technology that it gained from its 2006 acquisition of GlycoFi, a company that developed a yeast (Pichia pastoris) platform for the commercial production of antibodies. A key aspect of this platform is the ability to control glycosylation of therapeutic proteins (see page 226). "Being able to control glycosylation will allow us to produce proteins with desired therapeutic potency, solubility, half-life and tissue distribution," says Barry Buckland, Vice President of Bioprocess Research and Development at Merck.

The company plans to demonstrate that the glycoforms made by P. pastoris work as well in the clinic, if not better, than the originator product. "Clearly our main focus in the beginning is to match the innovator's product profile, but we will come across opportunities to improve characteristics such as potency and we will pursue those when it makes sense," says Buckland.

Driving investment in follow-on biologics in general is the fact that a number of commercially successful therapeutic proteins will go off patent between 2013 and 2017, says Buckland. One such product is Amgen's drug filgrastim (Neupogen), approved for the treatment of neutropaenia, which Insmed claimed to have replicated last year (Nature Biotech. 26, 962–963; 2008) and whose patent is expected to expire in 2013. Other products with patents that are anticipated to expire during that timeframe include the monoclonal antibodies (mAbs) infliximab (Remicade) and adalimumab (Humira) (Nature Rev. Drug Discov. 7, 733–737; 2008).

However keen companies are to pursue follow-on biologics, a major challenge remains the lack of a pathway for regulating such products in the United States, and the consequent uncertainty over the extent of any potential abbreviation of the development programme. There has been considerable speculation that such a pathway will be created early in President Obama's administration, but while it remains absent, Merck is planning to undertake full clinical development programmes for its follow-on biologics. Buckland explains, "They will be abbreviated in the sense that we have a good idea of key parameters like the dose and we know the target, so these factors make it simpler to design the clinical trials. But we are going to do Phase III studies and, until the regulatory path forward is clearer, that is going to be our approach."

The lack of an FDA pathway is one factor that has deterred other companies from pursuing follow-on biologics. "MedImmune evaluated and explored the opportunities in both biosimilars and me-betters [MedImmune's preferred term for follow-on biologics that offer improved properties over originator products, such as better dose frequency, tolerability, safety and efficacy] and we think that the best opportunities will be in me-betters, particularly given the current regulatory climate where no-one really knows what is going to be required of a biosimilar, both for approval and, I think, for long-term patient safety. Ultimately, we need to consider what provides the most long-term advantage to patients," says Peter Kiener, Executive Vice President, Research and Development at MedImmune, the World Biologics unit of AstraZeneca.

One of the main reasons why there is no regulatory pathway in the United States, despite considerable debate, is that there are many scientific challenges to prove that a follow-on is similar to a reference biologic (Nature Rev. Drug Discov. 6, 437–442; 2007). Even in the European Union (EU), where a biosimilar regulatory framework has existed since 2005 (DIRECTIVE 2004/27/EC), experience with the licensing of follow-on versions of somatropin and erythropoietin has prompted discussions as to whether the current EU framework could be applied to more complex biologics such as mAbs (Nature Biotech. 9, 985–990; 2008).

"There were many questions from companies with respect to how similar products have to be in order to follow the EU biosimilar approach," says Ulrich Kalinke, Director and Division Head at the Twincore Centre for Experimental and Clinical Infection Research, Hanover, Germany. Kalinke suggests that, in certain circumstances, it may be easier to submit a conventional stand-alone marketing authorization application (MAA) rather than use the biosimilar framework. "To prove similarity, you would have to show that your product is as similar as possible to the reference, which for statistical reasons may result in needing to conduct a very large clinical trial. However, if you're sure that your new product is better than the old one, then it may be easier to show superiority in your MAA," he says.

Such issues will be discussed in an upcoming workshop on biosimilar mAbs, expected to be held at the European Medicines Agency (EMEA) in London in July 2009, says Christian Schneider, Chairman of the Working Party on Similar Biological Medicinal Products. "The EMEA is currently inviting trade organizations to send representatives of the generic and innovator industries to the workshop," he says. "The agenda is not finalized, but my vision is that we will openly exchange ideas, for example about analytical methods to characterize biosimilar mAbs and on the clinical development programmes needed." Hopefully, these discussions will help clarify the path ahead both in the EU and the United States.

ONNX - Nexavar in melanoma

The failed phase III melanoma trial was in refractory patients and the ongoing one is in patients who have not received prior cytotoxic chemotherapy or an inhibitor of Ras, Raf, or MEK. In a randomized, double blind, placebo controlled, multicenter, phase II study in chemotherapy-naive melanoma patients, Nexavar improved time to progression, increased PFS, and doubled the response rate (all stst-sig), when compared to the DTIC arm. However, overall survival only showed a positive trend (not stat-sig). It is a long shot but chances are better for the drug to work in chemotherapy-naive patients.

Clearly, the pool of HIV patients continues to grow as HIV turned into a chronic disease requiring lifelong viral suppressing therapy. Also, early diagnosis of HIV becomes notably more common, leading to earlier treatment, which will likely result in larger numbers of patients on treatment.

CEPH - After getting an option to buy Ception Therapeutics for its humanized IL-5 Mab - reslizumab and acquiring rights to Lupuzor from ImmunPharma, CEPH makes another move, this time in the anti-TNF antibody arena.

Genzyme gets FDA approval for Synvisc-One

http://finance.yahoo.com/news/Genzyme-gets-FDA-approval-for-apf-14478854.html

CAMBRIDGE, Mass. (AP) -- Genzyme Corp. said Thursday the Food and Drug Administration approved the biotechnology company's ostheoarthritis of the knee treatment Synvisc-One.

The drug is a single injection treatment aimed at treating knee pain associated with the condition. It can provide relief for up to six months, the company said. Synvisc-One is also approved in Europe and in several Asian and Latin American companies.

Genzyme said the drug is an alternative treatment to its already approved Synvisc, which is a three-injection treatment.

The EMEA has approved the production of Myozyme® at the 4000L bioreactor scale at its manufacturing facility in Geel, Belgium. Sales are expected to accelerate starting in the second quarter and continue to increase throughout the second half of the year. Genzyme expects Myozyme sales for the first quarter of 2009 to be similar to the fourth quarter of 2008.

http://finance.yahoo.com/news/European-Authorities-Approve-bw-14477646.html

Derek Lowe on the Felix Salmon's article:

Single, Simple Numbers: Use At Your Own Risk

http://pipeline.corante.com/archives/2009/02/25/single_simple_numbers_use_at_your_own_risk.php

I wanted to link to this excellent article by Felix Salmon over at Wired. He's talking about the mathematical formula that convinced many people on Wall Street that they'd figured out how to price out correlated risks in debt securities. As we all now know, they'd done no such thing, even though trillions of dollars ended up riding on the whole idea.

The article's well worth reading just on those terms. But it's also worth thinking about for what it says about other fields where the risks - and the correlations between different risks - can't be well measured. Such as drug discovery and development! Many examples in Salmon's article can be extended directly to our own industry: what are the risks of each compound in Company X's pipeline failing? If a compound with a similar mechanism wipes out over at Company Y, how have the odds now changed? What about patent risks - if a Supreme Court decision makes everyone rethink issues of infringement or obviousness, how correlated are the patent-busting exposure around the industry? And so on. . .

The difference is that we haven't (quite) convinced ourselves over here that we've got it all figured out, and we haven't issued billions of dollars in derivative securities on top of our individual drug development programs. Not yet, anyway. But if you come away from a study of the current situation with a mistrust of any formula that people try to use to quantify complex systems down to one easy-to-use number, well, you've come out ahead.

DYAX said in its Q4 CC that the focus of their discussions with FDA is a "safe use program" for DX-88 and gave the impression that this is the last step before approval.

Call Transcript:

http://seekingalpha.com/article/122649-dyax-corp-q4-2008-earnings-call-transcript?source=yahoo

Seroquel Case: Must AstraZeneca Tell All?

http://www.businessweek.com/bwdaily/dnflash/content/feb2009/db20090224_413959.htm?chan=top+news_top+news+index+-+temp_news+%2B+analysis

In more lawsuits, companies are being forced to reveal internal information during the pretrial discovery phase that otherwise would be kept private

By Michael Orey

A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?

In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.

The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.
Cards on the Table

Plenty of companies have found their inner workings on public display through material they have disclosed in lawsuits. Details about Philip Morris' (PM) nicotine research, Firestone's tire designs, Merck's (MRK) Vioxx studies, and Wal-Mart's (WMT) employment practices have all come to light this way. In some instances the companies failed to get confidential treatment for the documents. In other instances, the information has been leaked, despite confidentiality decrees. That's what happened to Eli Lilly (LLY) in litigation involving its antipsychotic Zyprexa. In a February 2007 ruling, a federal judge found that David S. Egilman, an expert witness for the plaintiffs, helped funnel sealed documents to The New York Times. In 2007, Egilman, a community health professor at Brown University, paid $100,000 to Lilly, which donated the amount to charity. Egilman says he thought the documents offered evidence of wrongdoing and he felt he had an obligation to release them.

Companies generally accept that evidence presented during a trial enters the public domain. Most lawsuits, though, never get that far, and even when they do, only a limited amount of material ends up being used at trial. But, as with the Seroquel litigation, confidentiality concerns often arise before that stage, in connection with the truckloads of information businesses often must disclose to their adversaries during the pretrial phase of a lawsuit known as discovery. A big fear is that this information can be used in a selective or distorted fashion to tarnish a company's reputation in the press, or to fuel additional lawsuits and government investigations. "The mere threat of that often coerces companies into settlement of cases that they would otherwise never settle because they feel they have no liability," says Susan Hackett, general counsel of the Association of Corporate Counsel, a trade group of in-house attorneys.

The stakes are high in the Seroquel litigation for London-based AstraZeneca. Nationwide it faces roughly 9,000 lawsuits on behalf of 15,000 consumers. The drug, approved for treating schizophrenia and bipolar disorder, is the company's second-biggest seller, ringing up global revenue of $4.4 billion in 2008. So far, things are off to a good start for the company. The first two cases selected for trial in Orlando were tossed out by the judge in January, who concluded that the plaintiffs wouldn't be able to prove that Seroquel caused the harm they allege.

But there are many more cases to go. AstraZeneca says it has turned 50 million pages of material over to plaintiffs' attorneys. In an e-mail, AstraZeneca spokesman Tony Jewell says the company is willing to discuss lifting its confidentiality claims for "large portions" of the documents. But some should remain under seal, the company argues in a court filing, because they contain trade secrets or because disclosure of incomplete information about Seroquel might "mislead the public" and "create a potential public health risk."
Strange Bedfellows

Bloomberg argues that concerns about Seroquel's health risks are precisely why the material filed in court should be accessible. It also points to the recent litigation involving Lilly's Zyprexa, which similarly raised concerns about diabetes risk. While many Lilly documents were filed under seal, courts ultimately ordered them disclosed. Lilly has paid $1.2 billion to settle Zyprexa claims. A Lilly spokeswoman says the company "stands by the safety and efficacy of Zyprexa."

While the battle over the AstraZeneca and Lilly documents are in many respects similar, the Seroquel litigation contains a twist that is unusual for a drug product-liability case. The plaintiffs have stated in a court filing that Wayne MacFadden, AstraZeneca's former U.S. medical director for Seroquel, had sexual relationships with an outside Seroquel researcher and with another woman who prepared Seroquel medical literature. This, says the filing, calls into question the integrity of information the company has disclosed about Seroquel. AstraZeneca "does not condone the conduct at issue," spokesman Jewell says in an e-mail, noting that MacFadden is no longer employed by the drugmaker. MacFadden did not respond to messages seeking comment.

The company and the plaintiffs are currently arguing about whether this information should be admitted as evidence at a trial, but some documents relating to the debate, including MacFadden's e-mail exchanges with the two women, are under seal. Proclaiming itself to be the "eyes and ears of the public," Bloomberg is seeking this material, too.

Genzyme on the hunt for new products

http://www.boston.com/business/healthcare/articles/2009/02/24/genzyme_on_the_hunt_for_new_products/

By Bloomberg News | February 24, 2009

NEW YORK - Genzyme Corp. may spend about $600 million this year to acquire products that treat chronic diseases, said chief executive Henri Termeer.

Genzyme, the world's largest maker of drugs for rare genetic disorders, will seek opportunities to purchase "personalized drugs, highly specialized medicines where you can easily explain their value," Termeer said yesterday.

Acquisitions made by the Cambridge-based biotechnology company will focus on individual products already tested in humans, Termeer said. He prefers buying products rather than entire companies because he wants to invest in "the value of maintaining the team" that got the new therapies started, he said.

"When you buy a program, the heart of the company is still there," Termeer said.

Roche Holding AG's $86.50-a-share hostile takeover bid for Genentech Inc. risks "losing very, very good individuals," Termeer said. Roche, the 56 percent owner of Genentech, has made a tender offer for the remaining 44 percent of the shares.

Genzyme isn't an acquisition target, Termeer said.

Relative to 3Q08, 4Q08 US systems sold were down 23% (from 71 to 55). Mgmt guided for a flat system sales but for sales growth of 15% in 09, assuming procedure growth of 35-40%. Makes sense to me that system sales will keep dropping in 09, and that puts ISRG's guidance at risk.

looks like Teva won't launch generic Evista at-risk this year:

Lilly Wins Ruling Delaying Teva Bid To Market Generic Evista

http://money.cnn.com/news/newsfeeds/articles/djf500/200902241217DOWJONESDJONLINE000509_FORTUNE5.htm

February 24, 2009: 12:17 PM ET

WASHINGTON -(Dow Jones)- A federal appeals court on Tuesday upheld a trial judge's decision to delay Teva Pharmaceutical Industries Ltd.'s (TEVA) bid to market a generic version of Eli Lilly & Co.'s (LLY) blockbuster osteoporosis drug Evista.

The U.S. Court of Appeals for the Federal Circuit said a federal trial judge in Indiana didn't abuse his power when he ruled that Teva couldn't market a generic version of Evista until March.

The generic-drug maker was supposed to be able to start marketing the drug in mid-November 2008.

The trial judge said the delay was warranted because Teva had amended the information about the generic formulation of Evista that it was planning to offer.

The ruling is part of a bigger patent-infringement lawsuit Eli Lilly has brought against Teva over the company's plan to market a generic version of Evista.

Evista, which brought in sales of more than $1 billion in 2007, is used to treat osteoporosis in postmenopausal women.

Lilly Wins Ruling Delaying Teva Bid To Market Generic Evista

http://money.cnn.com/news/newsfeeds/articles/djf500/200902241217DOWJONESDJONLINE000509_FORTUNE5.htm

February 24, 2009: 12:17 PM ET

WASHINGTON -(Dow Jones)- A federal appeals court on Tuesday upheld a trial judge's decision to delay Teva Pharmaceutical Industries Ltd.'s (TEVA) bid to market a generic version of Eli Lilly & Co.'s (LLY) blockbuster osteoporosis drug Evista.

The U.S. Court of Appeals for the Federal Circuit said a federal trial judge in Indiana didn't abuse his power when he ruled that Teva couldn't market a generic version of Evista until March.

The generic-drug maker was supposed to be able to start marketing the drug in mid-November 2008.

The trial judge said the delay was warranted because Teva had amended the information about the generic formulation of Evista that it was planning to offer.

The ruling is part of a bigger patent-infringement lawsuit Eli Lilly has brought against Teva over the company's plan to market a generic version of Evista.

Evista, which brought in sales of more than $1 billion in 2007, is used to treat osteoporosis in postmenopausal women.

The USPTO uphold DNA's Cabilly patent. Genentech said the decision is final and unappealable.

http://www.reuters.com/article/marketsNews/idINN2443678220090224?rpc=44

PANC will close its Gaithersburg facility and reduce its workforce from eleven to four employees, effective February 27, 2009. Panacos has hired Oppenheimer & Co to help explore options, which includes selling its preclinical HIV program or the entire company.

http://www.genengnews.com/news/bnitem.aspx?name=50135024

Ambrx and Merck Serono Expand Collaboration Through ARX424 Multiple Sclerosis Drug Development Alliance

http://finance.yahoo.com/news/Ambrx-and-Merck-Serono-Expand-prnews-14450556.html

Meaning esreboxetine wasn't as good as Lyrica in fibromyalgia.

Indeed FTY720’s side effects appear very concerning. However, bear in mind that many of the side effects were seen in the discontinued transplant program and at higher doses than currently tested. The more troubling part is the HSV infection rate but this seems to be dose related and the lower dose (0.5 mg) appeared to be associated with less infectious risk. We'll have to wait for the data from ongoing studies to confirm the drug's profile and of course there will be demands for extensive monitoring (screening for previous infections, liver function tests and dermatology visits), since patients will be on chronic therapy, but so far, I don't believe any of the AEs prohibit approval.

On Cladribine - safety profile as a broadly myelosuppressive chemotherapy drug with a warning for bone marrow suppression, is not a good start. Merck KGaA noted an increase in lymphopenia in the CLARITY study, which is expected due to the drugs MoA, but no data on frequency and degree were provided. One more question - although the drug is already approved for oncology use, will one phase III trial in MS be sufficient for approval, as mentioned by Dew, former MS therapies have required two successful pivotal trials for approval. Depending on these issues, Cladribine could still be the 1st oral drug in the MS market.

I think that the Tysabri experience made the FDA more careful but on the other hand, it made physicians and patients more comfortable with side effects especially when monitored carefully like with the TOUCH and TYGRIS programs.

I think you're right. No idea why they keep providing extra work to their legal department and anyway FRX defended the Lexapro patent when challenged by TEVA, so I think it will probably hold against Caraco as well.

...In another case, the court refused to consider an appeal by Forest Laboratories Inc. that sought to overturn a lower court ruling in favor of a generic drug maker that wants to market a generic version of Forest's depression drug Lexapro.

Without comment, the high court left in place an appeals court ruling that generic drug maker Caraco Pharmaceutical Laboratories Ltd. could sue to challenge the validity of one of Forest's Lexapro patents.

Forest argued that Caraco could not bring a lawsuit because there was no legal controversy that would give the courts jurisdiction over the case. Forest said there was no legal dispute between the companies because it had agreed not to sue the generic drug maker for patent infringement.

Caraco's lawsuit now goes back to the lower courts for additional proceedings. The two companies are also engaged in another lawsuit involving a different Lexapro patent.

http://online.wsj.com/article/SB123539083862347389.html?mod=yahoo_hs&ru=yahoo

In general, I feel that the safety issue with Tysabri does and will make things more difficult for newer drugs with the FDA. As for FTY-720, I think that the data from the phase II extension, TRANSFORMS, FREEDOMS 1, and about 300 patients requested by the FDA for safety from FREEDOMS 2, will likely satisfy the FDA.
Safety signals identified thus far in the FTY-720 trial(s) did of course influence changes in the protocol of the trials. For example, after the two fatal infections on the higher dose of the TRANSFORMS, patients with previous herpes exposure are excluded from the FREEDOMS trials and those lacking antibodies require vaccination.

MDT is munching another, and even a bigger fish from the same field:

http://www.marketwatch.com/news/story/corevalve-acquired-medtronic-700-million/story.aspx?guid=%7B32483D52-E6E5-4874-B5E4-7DBD6B1144BA%7D&dist=msr_1

Another Drug Makes It to Europe First: Lilly’s Blood Thinner Prasugrel

http://blogs.wsj.com/health/2009/02/23/another-drug-makes-it-to-europe-first-lillys-blood-thinner-prasugrel/

Posted By Jacob Goldstein On February 23, 2009 @ 8:47 am In

Once again, a drug has won approval in Europe before the U.S. This time, it’s the anticlotting drug prasugrel from Eli Lilly and Daiichi Sankyo. The companies said today that the drug has been greenlighted in Europe for certain patients who have stents put in to clear the arteries around the heart.

The drug, marketed under the name Efient, will compete with the blockbuster Plavix, which is co-marketed by Bristol-Myers Squibb and Sanofi-Aventis.

As we noted a few weeks back when J&J’s Stelara for psoriasis was approved in Europe, it’s become pretty common for drugs to make it to market in Europe before the U.S.

The FDA typically comes to the same conclusions as its European counterparts, but not always. Galvus, Novartis’s diabetes drug, was approved in Europe but has stalled here. And Sanofi’s weight-loss drug Acomplia, which never made it to the U.S. market, was approved in Europe but later suspended over concerns connected to psychiatric side effects.

Still, the U.S. prospects for prasugrel look good. A committee of FDA advisers recently voted unanimously in favor of approving the drug.

Rejected. Will Astellas raise? Cowen and Co analyst Eric Schmidt, thinks so and sees a deal coming through if the offer price is $18 to $20 a share.

http://www.reuters.com/article/rbssHealthcareNews/idUSBNG43514620090220

Zevasca is a very poor drug. Mechanism is similar but GENZ-112638 suppose to be a lot more potent, more specific, and it inhibits the production of fatty acid whereas Zevasca inhibits the production of the sugar part of glucocerebroside.

Regarding the 2 times fold price: I was making a point that Tysabri's introduction at such a premium, ignited aggressive price hikes from other MS drugs. I believe we agree on that.

Not a wonder but in fact the clinical trials done by its rivals which proved its non-inferiority to high dose Rebif (REGARD trial) and Betaseron (BEYOND trial) do impact Copaxone utilization.

On competition - agree that there is no direct competition between Tysabri and Copaxone being used in different lines of therapy. Patients will keep failing interferons and Copacxone and there will be need for Tysabri. Question as you noted before is how will the number of patients on Tysabri grow? we also agree it depends much on future incidents of PML. Hopefully, the rate of PML will remain well below the 1 per 1000 patients, which is considered acceptable by the FDA.

Sorry I'm still talking about this, we live in different time zones and I was asleep while you and Dew posted your last arguments.

Thank you, woofer. Glad you enjoyed it. I thought it's a must-view for anyone who is interested in human organizations, and how to make them not only viable - but worthwhile. Barry Schwartz's pearls of wisdom are indeed a lesson for anyone who lives in the world.

I would like to recommend a twenty minutes and forty-five seconds, Barry Schwartz talk on practical wisdom:

http://www.ted.com/talks/barry_schwartz_on_our_loss_of_wisdom.html

This is the scary part - docs with spreadsheet and program?

A few antidepressants (Prozac, Paxil, Zoloft) are approved by the FDA for the treatment of OCD. It's a very big market, over $4B in size and there's a need for better and more effective treatments. Our local Brainsway also have OCD on its list.

Biopartners failed to bring its recombinant standard interferon alpha called alpheon, a biosimilar version of Roche's Roferon-A, but they did get EU approval for Valtropin, its version of hGH. Think they have EPO in early clinical trials too.

Just noticed that GENZ is calling the Myozyme produced at the 2000L scale - 'Lumizyme', perhaps to distinguish between infantile and adult onset Pompe disease.

BIIB will try fighting back with peg-Avonex and its better dosing advantage.

The ex-US market is expanding in a higher pace relatively to the US, particularly in Europe where I think Copaxone will continue to grow in the number of patients and take market share from Avonex, its main competitor.

Meanwhile, CHMP issued a positive opinion on Myozyme's 4000L production facility.

MS market - Estimations are that it will reach $10B in 2012. The worldwide market is expected to grow by about 10% annually.