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have you ever looked at agennix
Does anyone have access to this article
IntelGenx, Valeant Pharmaceuticals neurology news
http://www.biocentury.com/weekinreview/othercompany/2011-02-14/intelgenx-valeant-
Any idea why PRAN is running?
http://www.asx.com.au/asxpdf/20110218/pdf/41ww10m2g9r1mq.pdf
It was close to profitability but cotton prices have made it a loser
dsci was operating at breakeven but because the price of cotton is going up they are now at a loss.
that is how low their margins are.
dsci
I bought in the last financing, I sold the stock and warrants in the run up.
The animal testing said the one percent dose should be good, yet it did worse than the placebo. The 3 percent did fine but we are speaking about only 27 or 29 patients in each arm. So when you ask why did the one percent do worse than placebo the company says that you are dealing with small numbers in each arm. Why can't that be the reason that the 3 percent did well?
I say if you can't trust each arm because the numbers are too small, then you should have done a larger study.
ThinkEquity/VRUS: Earnings Recap
over 200 million dollars in the bank and it doesn't let them run a phase 3 trial, unbelievable.
There were no surprises in Pharmasset's earnings release as the company reported GAAP EPS of ($0.69) per share. Since the end of 2010, the company has already raised ~$123.4 million and announced the first cross-company collaboration combining two DAAVs for Hep C with Bristol-Myers Squibb. Based on the the elimination of a financing overhang and the potential for the BMS-052/PSI-7977 combo, we are raising our price target to $50 but maintaining our Hold rating given what we believe is a reasonable valuation based on the current risk/reward.
Pharmasset Reports Net Loss of ($0.69) Per Share for Quarter Ended December 31, 2010. The loss came in slightly greater than we expected due to higher than expected operating expenditures. We believe this is related to the increasing clinical development activities as Pharmasset is currently running a number of studies for the lead proprietary drug candidate, PSI-7977. Pharmasset ended the calender year with $102 million in cash and equivalents.
Equity Raise Extends Runway, Limits Financing Risk. In January, Pharmasset raised approximately $123 million in a offering of 2,795,000 share of common stock at $46.33 per share. We believe this positions Pharmasset with over $210 million in the bank today and a runway through Phase 2b studies for PSI-7977 as well as a substantial number of additional studies, including PSI-7977 combination studies and development of PSI-938 and PSI-661. However, we would expect an additional financing should Pharmasset decide to move PSI-7977 into Phase 3 development in 2012.
Expect PSI-7977/BMS-052 Combination Study to Initiate in 1H11. We believe that the nucleotide analog, PSI-7977, and the NS5a inhibitor, BMS-052, are two of the most attractive DAAVs in clinical development. Both are administered once daily and have compelling activity against a broad range of HCV genotypes. The study will assess the combination of PSI-7977 and BMS-052 with or without ribavirin in patients with HCV genotypes 1, 2 and 3 and includes a 24-weeks post treatment analysis. We believe the purpose of this study is to find an all-oral combo that can result in sustained viral responses.
Here are the 6-month price percentage moves in some of the things people need to live with:
Cotton = +125.7%
Sugar = +82.6%
Corn = +59.0%
Coffee = +41.4%
Rice = +40.5%
Oats = +36.6%
Copper = +36.1%
Lumber = +33.8%
Oil = +25.1%
It was actually Bentley pharmaceuticals that had the trandermal technology that was licensed to Auxl to market testim.
Ocient was selling factive.
my have the mighty have fallen
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I'm a bit surprised the drug got approved given the issues XNPT ran into with the FDA for its gabapentin formulation (#msg-46816470). I guess PHN is a much bigger issue than RLS?
The preclinical rat data was much different for xnpt than gabapenton. I just do not understand why, if the FDA had an issue with it, they let the company continue trials and didn't put the drug on hold until their questions were resolved. They have put other drugs on hold because of questions about the preclinical data
Clinical Data Could Use More Data
Jan. 30 2011 - 10:12 pm | 487 views | 0 recommendations | 2 comments
By MATTHEW HERPER
http://blogs.forbes.com/matthewherper/2011/01/30/clinical-data-could-use-more-data/
Tiny Clinical Data of Newton, Mass., became one of the hottest companies in the biotechnology sector a week ago after the Food and Drug Administration approved its antidepressant, Viibryd, catapulting the small company’s shares up more than 70%.
Clinical Data says Viibryd could become a $1 billion-a-year seller in a matter of years thanks to less bothersome side effects, particularly sexual ones, than other antidepressants. Bullish investors also say Clinical Data is likely to get bought out at a significant premium by any of a number of desperate big pharmaceutical companies. Bolstering the buyout case is the presence of the company’s founder and largest investor, Randal J. Kirk, who sold his last company, New River Pharmaceuticals, to Shire for $2.6 billion in 2007. That deal made Kirk a billionaire.
It’s hard to argue against Kirk’s savvy, Big Pharma’s need for new products, or the fact that antidepressants can become big sellers based on little more than marketing.
But interviews with three psychiatrists without financial ties to either Clinical Data or other drug companies reveal skepticism about Viibryd’s side effect profile, including the lack of sexual side effects, although doctors were intrigued by the chemical idea behind the drug.
“The drug clearly is an active compound,” says Jeffrey Lieberman, chairman of psychiatry at Columbia University’s College of Physicians and Surgeons. “But to make statements that you can have any degree of confidence in that it has clearly better safety or efficacy based on this data is really stretching it.”
How much better are Viibryd’s side effects? Ever since the introduction of Prozac and Paxil in the 1990s, some patients have had to deal with a deadening of sexual appetite or function. Lexapro from Forest Laboratories, currently the top seller in the category, caused ejaculatory dysfunction in 12% of men in a study included in the drug’s approved labeling. For Paxil, that figure is 13%.
By comparison, the FDA-approved label for Viibryd shows a 2% rate of delayed ejaculation and 5% rate of decreased libido. That certainly sounds better than what has been seen with older drugs. But Dan Iosifescu of Mount Sinai Medical Center notes that patients in the placebo group in the Viibryd studies had no sexual dysfunction at all. He worries that this is because patients and doctors just weren’t reporting these issues – something that happened with many older antidepressants whose sexual side effects looked good on paper but turned out to be a problem in practice.
Cymbalta, a newer type of antidepressant from Eli Lilly, lists only a 3% rate of ejaculatory dysfunction and a 6% rate of decreased libido. But when researchers conducted a clinical trial using a more exacting survey about sexual issues, called the Arizona Sexual Experience Scale (ASEX), they found that Cymbalta does cause increases in sexual side effects.
Clinical Data collected ASEX data on Viibryd, and also measured sexual dysfunction using a second survey. In neither case was there a close to significant difference between Viibryd and placebo. But this data is not in the drug’s FDA-approved label, which means that Clinical Data’s marketers won’t be able to use them in advertisements or in sales calls. Clinical Data says that in its discussions with FDA, “it was determined that these data were not appropriate for the label at this time.”
Viibryd also caused diarrhea in 28% of patients and nausea in 23%, both triple placebo. Iosifescu said that given the small numbers of patients involved they may or might not be a problem. Only 7% of patients on the drug in studies dropped out because of side effects.
Iosifescu wants to see “significantly more data” for Viibryd. “It’s yet another tweak on existing mechanisms,” he said. “It has a place, it’s interesting but it’s not a paradigm shift.”
More impressive: Viibryd’s chemistry. It combines the mechanism of selective serotonin reuptake inhibitors (SSRIs) like Prozac and Lexapro with the mechanism of the anxiety drug Buspar, which hits a brain receptor called 5-HT1A. In a large government trial called STAR*D, the combination of Buspar and an SSRI was better than an SSRI alone in treating depression.
That impressed Alan Manewitz, of Lenox Hill Hospital, who says he sees psychiatrists trying out the drug in patients who are both anxious and depressed. “This isn’t a magic bullet kind of medication,” he said. “It’s going to have to find its place in the market.”
Antidepressants were prescribed 168 million times in 2009, according to market researcher IMS Health. Cymbalta, from Lilly, generated $2.5 billion in U.S. sales on 16.6 million prescriptions; Forest Laboratories’ Lexapro racked up $2.5 billion in sales on 28 million prescriptions. Assuming that Viibryd is sold close to Cymbalta’s higher price, it could bring in $150 million for every million prescriptions, or $250 million for every 1% of the market it grabs.
Clinical Data chief executive Drew Fromkin argues that the nature of the depression market is changing as more and more drugs go generic, with branded drugs being prescribed increasingly by specialists. “If a physician is considering switching drugs, wants solid efficacy, wants a drug that works differently and wants to avoid some of the big side effects,” Fromkin says, “we fit perfectly into that progression.”
Fromkin is also talking pretty openly about the prospect of selling the company. In an interview, he said that there was a real potential for a “change of control” and that just because there hadn’t been a deal yet does not mean there have not been offers.
Pharmaceutical companies often don’t make out that well on biotech acquisitions. Eli Lilly bought ImClone Systems for $6.5 billion two years ago; last year its revenue from flagship drug Erbitux edged down 1%. One of the Randal Kirk’s earlier companies, Scios, was sold to Johnson & Johnson for a big premium but then sales of its main drug, Natrecor, collapsed due to safety worries. The drug from New River, Kirk’s last company, sold $151 million last quarter as part of Shire’s attention deficit disorder franchise; that probably justifies the deal price, but not by a lot. Also worth noting: many drug companies are backing out of antidepressant research, which may make new assets in that area less attractive.
But most of the big pharmaceutical companies are contending with big drugs that are about to go off patent; Viibryd has patent protection at least until 2019.
The argument that Pfizer, Forest, Lilly, AstraZeneca, or somebody eventually buys Clinical Data is pretty strong. But can this small company compete if a buyout doesn’t happen? That’s harder to say.
will teva catch momenta or will their plans blow up in the end
RAY DIRKS Research: PSTI update Jan 24, 2011 by Ray Dirks
Posted on admin on January 23, 2011 // Leave Your Comment
RAY DIRKS Research Update PSTI January 24, 2011
By Ray Dirks
RAY DIRKS Research reiterates Buy recommendation of Pluristem (NASDAQ: PSTI) for significant capital appreciation in the near future.
Valuation Discrepancy Justifies Aggressive Buy Recommendation for PSTI
Updated price target Jan 24, 2011
Pluristem Therapeutics, Inc (NASDAQ: PSTI)
Current Price Per Share: $ 2.76
12 Month Price Target: $10.00
24 Month Price Target: $17.00
On January 3, 2011, I issued a note reiterating a BUY recommendation on Pluristem Therapeutics, Inc. (NASDAQ:PSTI) pointing out the discrepancy in valuation between PSTI and Mesoblast Limited (MSB.AX). On January 3rd PSTI’s and MSB’s market was approximately $35 million and $745 million respectively, due in part to the announcement of a collaboration between MSB and Cephalon (NASDAQ: CEPH) potentially valued at over $1.9 billion The note and details of the transaction can be seen at: http://www.cpreports.com/?p=781
PSTI and MSB are both cell therapy companies and are considered comparables. PSTI, an American company with headquarters in Haifa Israel, uses the Human placenta (afterbirth) as a source of their therapeutic cells while MSB, an Australian company, uses bone marrow as their source of cells. Additionally, PSTI grows their cells in-house in a proprietary bioreactor while it is felt that MSB outsources the expansion of their cells where they are grown in Petri dishes or tissue flasks.
At the time of the January 3rd note, PSTI had completed two Phase I/IIa trials in the US and Germany using their PLX-PAD cell product in peripheral artery disease (PAD) while MSB was entering Phase III trials for the use of their cells as an alternative to bone marrow transplantation in hematological malignancies and in Phase II trials for orthopedic and cardiovascular indications.
On January 18, 2011 PSTI announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company’s planned clinical development program for PLX-PAD. Based on the positive feedback from the EMA and FDA, Pluristem is now advancing towards two clinical studies with PLX-PAD: a joint FDA-EMA Phase II/III study for critical limb ischemia (CLI) and a Phase II study for intermittent claudication (IC), both diseases being subsets of PAD.
From my viewpoint, both PSTI and MSB now have products entering Phase III pivotal trials. However, the discrepancy in valuation between the two companies is still quite large. PSTI and MSB currently have market values of approximately $70 million and $900 million respectively. MSB, therefore, is almost 12.5 times larger than PSTI. Although MSB does have the collaboration in place with CEPH, I believe it is just a matter of time before PSTI also has one or more collaborations in place. Therefore, I am recommending investors take advantage of this valuation discrepancy before it ceases to exist.
PLX Cells May Fill the Void in the Neuropathic Pain Market
I had breakfast with management of Pluristem Therapeutics last week and the discussion turned towards the next indication the Company will focus on using their proprietary PLX cells. PLX cells are placental-derived mesenchymal stromal cells grown via a proprietary three dimensional (3D) technology. Pluristem is actively working on the use of PLX cells for Intermittent Claudication (IC) where a Phase II trial will begin in the spring and Critical Limb Ischemia (CLI) where a Phase II/III trial will begin in the fall.
The Company indicated that their PLX cells are essentially a sophisticated drug delivery vehicle for diseases where there is an “ischemic/inflammatory” element. The Company is considering neuropathic pain as a next indication after PAD because neuropathic pain has a significant “ischemic-inflammatory” element, PLX cells have shown to be extremely effective for neuropathic pain in animal studies, the cells can be easily injected locally for this indication, and the Company can go immediately into Phase II clinical trials.
Neuropathic pain is a chronic condition caused by inflammatory diseases such diabetes, viral infections and chemotherapy. The market for neuropathic pain has been estimated to increase from $6 billion in 2008 to $9.7 billion in 2018 worldwide.
My hypothesis is that Pluristem’s PLX cells may be able to fill the void in the neuropathic pain market created by the failure of anti-nerve growth factors. On December 28, 2010, it was announced that the U.S. Food and Drug Administration (FDA) notified Johnson & Johnson (NYSE:JNJ) that the development program for their drug fulranumab had been put on hold over concerns that this drug and others in the class of compounds categorized as the anti-nerve growth factors (NGF) may be associated with a condition representing either rapidly progressive osteoarthritis or a disease known as osteonecrosis. These conditions may result in the need for total joint replacement. Similar drugs in this class that are under development by AstraZeneca PLC (NYSE:AZN) and Regeneron Pharmaceuticals (NASDAQ: REGN) have also reportedly been put on hold.
Pluristem’s PLX cells treat neuropathic pain via a different mechanism of action than nerve-growth inhibitors, acting by secreting a blend of therapeutic proteins in response to signals sent by inflamed, ischemic tissue. Pluristem, together with its scientific collaborators and experts in the field, have performed preclinical studies in two animal models of inflammatory and neuropathic pain. Inflammation was induced via chemicals in a rat model and PLX cells were injected locally into the inflamed area two days later with pain levels assessed daily. A second model involved a chronic constriction injury (CCI) of the sciatic nerve in the mouse where PLX cells were subsequently injected. The results of these experiments showed that treatment with Pluristem’s PLX cells had a dramatic beneficial effect on pain. In the first model, animals injected with PLX cells achieved a reduction in pain, which was achieved and maintained longer than with standard opiate treatments. In the second model, PLX cells injected at the nerve injury site attenuated both mechanical and thermal sensitivity.
I am raising my price targets based on:
1. I am recommending investors take advantage of the valuation discrepancy between PSTI and MSB.AX before it ceases to exist
2. Studies suggest that Pluristem’s proprietary PLX cells can be a viable new therapy for the treatment of neuropathic and inflammatory pain. PLX cells may fill the void in the development of new products for neuropathic pain and ergo, my recommendation.
3. On January 18, 2011 PSTI announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company’s planned clinical development program for PLX-PAD. Based on the positive feedback from the EMA and FDA, Pluristem is now advancing towards two clinical studies with PLX-PAD: a joint FDA-EMA Phase II/III study for critical limb ischemia (CLI) and a Phase II study for intermittent claudication (IC), both diseases being subsets of PAD.
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Barclays did an expert call on prostate cancer
I thought this would be interesting info for the board
AbirateroneDr. Smith is enthusiastic about abiraterone and expects FDA approval later this year.
Approval will be based on Study 301, which was conducted in castrate-resistant prostate
cancer patients refractory to chemotherapy. The trial showed an improvement in overall
survival in a setting where, prior to Jevtana, none has previously been demonstrated. As
abiraterone is both an oral agent and more tolerable than chemotherapy, Dr. Smith believes
its use could precede chemotherapy in metastatic, castrate-resistant prostate cancer.
However, Dr. Smith will reserve judgement until the results of Study 302 in first-line
castrate-resistant prostate cancer patients are known, though he believes that Study 302 is
also likely to show benefit.
With respect to abiraterone use in the earlier-stage hormone-sensitive patients, Dr. Smith
noted that the use of concurrent prednisone would be an impediment. Prednisone is used
with abiraterone to reduce the incidence of severe hypokalemia and hypertension. Dr.
Smith also opined a theoretical disadvantage to using abiraterone ahead of Provenge
because the prednisone is immunosuppressive.
Barclays Capital | Amgen Inc.
24 January 2011 4
MDV-3100
Medivation's MDV3100 is a potential competitor to abiraterone. With the first Phase 3 trial,
AFFIRM, fully accrued and with patients similar to abiraterone’s Study 301, cross trial
comparison is inevitable. MDV3100 does not require concurrent prednisone but may have
a seizure signal. As Dr. Smith noted, the biggest challenge for MDV3100 is that it trails
abiraterone in development by 12-18 months.
ProvengeDr. Smith considers Provenge’s profile very interesting with no clear signal of anti-tumor
effect, including no effect on tumor progression and PSA levels, but with a survival benefit.
The absence of a PSA benefit presents a challenge in the current context of management of
prostate cancer patients who are well informed about the role of PSA and actively follow
their PSA levels. Thus, if a physician instigates Provenge, the absence of a PSA benefit
causes confusion for the patients. Add to this the logistical challenges Provenge means for
the clinician and patient, despite DNDN's best efforts, Dr. Smith believes new therapies
could pose a threat to Provenge.
XL184XL184, is a receptor tyrosine kinase with a unique profile as it targets VEGF R , c-Met, and
to a lesser extent, Ret and Kit. XL184 has demonstrated responses including some
complete responses of bone metastases as assessed by scan in 19/20 patients. Dr. Smith
pointed out that there is no precedent for this rate of bone scan improvement and that the
commonly used determinant of response in oncology, RECIST, does not include bone scan
improvement as a category. Add to this a 10% ORR for measurable, non-bone disease and
effects on bone turnover markers, XL184 has a unique clinical profile. From ongoing
studies, EXEL will learn more about the durability of benefit, benefit in truly Taxotererefractory
patients, as well as data on more rigorously defined patient-reported outcomes
including pain.
As with all oral TKIs, Dr Smith noted that XL184 has side effects and that ~40% of patients
required a reduction in dose during the randomized discontinuation study. Dr. Smith
opined that given the striking efficacy in prostate cancer that lower, and thus more
tolerable, doses could be tested in future studies.
The must have conductors from the Long Island Railroad on board with a job slowdown because they want a raise
he is saying it wasn't approved in Europe because the walking benefit wasn't an important enough endpoint to justify approval, and they ignored the drug's broad benfits.
That is why I said they should have had endpoints in the broad benefits.
Focus on the walking benefit - which was the study endpoint while good science misses the point that 4AP provides a broad range of benefits to MS patients with MS disabilities.
I guess if they would have actually tested the drug in the endpoints that would show the broad range of benefits they wouldn't have this problem. Then again in a clinical trial it probably would have failed in those endpoints and that is why they weren't tested.
Biogen Idec Receives Negative Opinion from the CHMP on FAMPYRA
The Company intends to appeal the negative CHMP opinion
Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones. Boy that was a lot of money down the drain.
ZUG, Switzerland--(BUSINESS WIRE)-- Biogen Idec (NASDAQ:BIIB - News) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA® (prolonged-release fampridine 10 mg tablets) to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.
“About two-thirds of MS patients report difficulty in walking due to their disease1,2, and currently there is no therapy approved in Europe to address this high unmet medical need,” said Alfred Sandrock, M.D., Ph.D., Head of Neurology Research & Development at Biogen Idec. “Tens of thousands of people with MS have already received the therapy in the United States, where it is approved, and many have reported important benefits. We will work closely with the CHMP during the appeal process to address the Committee’s concerns, with the goal of making this important medication available to MS patients in Europe.”
As a leader in MS with two MS medications on the market and six potential MS therapies in the pipeline, Biogen Idec has significant scientific expertise in MS and is committed to improving the lives of patients living with this disease.
As of the end of September 2010, approximately 6300 prescribers had initiated approximately 31,000 MS patients on prolonged-release fampridine tablets treatment in the United States (U.S.), where the drug is commercialized by its developer, Acorda Therapeutics, Inc., under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. AMPYRA was approved by the U.S. Food and Drug Administration on January 22, 2010.
For further details about the CHMP opinion on FAMPYRA, please visit the EMA website
Both teams played without making too many mistakes and with respect for each other and without cheap shots.
I guess the reason for the high ratings was too huge markets and a good rivalry.
OT I would like to congratulate the Jets in their exellent win over the Pats yesterday. On to the Steelers.
Big pharma gets screwed again
This is the product that we used to discuss on the board, in think the company was called Altus. It had loads of cash and burned it all after the drug was rejected. Then the former management bought this drug from bankrupcy for practically nothing and without doing much said they were ready to refile and Lilly came to their rescue. Some of this may be wrong because I wrote this from memory but I don't think I am far off.
WASHINGTON (Dow Jones)--A Food and Drug Administration panel rejected a new type of pancreatic-enzyme replacement product developed by an Eli Lilly & Co. (LLY) unit on concerns the drug isn't effective.
The panel said clinical data submitted in support of the drug, liprotamase, didn't "constitute substantial evidence of the efficacy," or effectiveness, in a 9-to-3 vote. The panel also said additional studies of liprotamase should be conducted prior to approval and potentially compared to current pancreatic-enzyme replacement products on the market.
The panel also said, in a 7-to-4 vote, that the benefits of liprotamase didn't outweigh the potential risks, which amounts to a recommendation that the FDA not approve the product. One person abstained on that vote.
Liprotamase, which has a proposed brand name of Sollpura, was reviewed Wednesday by outside medical experts on the FDA's gastrointestinal drugs advisory committee.
The product was developed by Alnara Pharmaceuticals to treat exocrine pancreatic insufficiency in children and adults caused by cystic fibrosis and other conditions. EPI is a lack of digestive enzymes made by the pancreas that results in the inability to properly digest food and absorb nutrients. Lilly bought Alnara last year.
In a statement, Lilly said it remained confident in liprotamase's clinical data. The FDA is expected to make a decision in April.
Unlike other pancreatic-enzyme replacement products, such as Abbott Laboratories' (ABT) Creon, liprotamase was developed without using enzymes taken from the pancreas of the pig. The FDA has said there's a very small risk that viruses could be transmitted to patients with porcine-derived enzymes. Liprotamase is also designed to be given with just one pill per meal or snack unlike other drugs which can require multiple pills per meal.
Some parents of children with cystic fibrosis who spoke during the FDA panel meeting said up to 25 pancreatic-enzyme pills are needed each day and urged the panel to vote to approve liprotamase.
But the FDA questioned liprotamase's effectiveness. The agency said the main clinical study endpoint used to evaluate pancreatic-enzyme replacement products is a change in so-called coefficient of fat absorption, a measure of fat absorption.
"FDA reviewers have questioned whether the change in fat absorption observed with liprotamase is comparable to that observed with the porcine-derived [products]," the agency said in a summary document prepared for the meeting. If enough fat isn't absorbed from meals, it can results in weight loss and impaired growth in children.
In one of the main studies of liprotamase, the change in fat absorption was 11% compared to those receiving a placebo. The FDA said the change in the fat-absorption with other pancreatic enzyme products ranged from 26% to 41%.
Officials from Alnara cautioned against comparing studies of liprotamase to studies of other products partly because they had different designs. The patients who stayed on liprotamase for up to a year showed little change in a measure of body mass index, suggesting the product was effective at meeting nutritional goals.
Cystic fibrosis affects about 30,000 children and adults in the U.S. About 90% of cystic fibrosis patients receive pancreatic enzyme replacement therapy.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
We are lowering our rating on Aastrom from Buy to Hold after meeting with management at JP Morgan. We are not lowering our rating because of Aastrom's recent financing. Our rating change is driven by two changes. The first is the communications between the company and the FDA regarding the two SPA's requests. The FDA is un-yielding on AFS as a primary endpoint and is emphatic that all analysis shall be based on intent to treat (ITT) which will begin when patients are enrolled in study (regardless of if they receive ASTM's TRC product). The second reason is based on the competitive landscape and our belief that the autlogous advantage of ASTM's TRC's is actually a hindrance in CLI as an indication. The competitive landscape is heating up and we expect at least one other company (PluriStem-PSTI, Buy rated) to be in a phase II/III CLI trial and Athersys (ATH-Buy rated) may not be far behind. We believe that PLX (PSTI's allogenic cells) or Athersys' Multistem may be a better product for peripheral arterial disease related indications. Aastrom is also close to our $4 target versus when we launched coverage this summer at ~1.50
Highlights
FDA says NO to MALEFS: It is our understanding that the FDA has essentially said no to Aastrom's request for a MALEFS endpoint and instead insists on AFS. We view this as negative as one may recall that in the most recent analysis, ASTM's TRC's failed to show significance on an AFS endpoint in the last (PIIb) interim look. MALEFS was requested for the second pivotal trial in which is designed to focus on slightly less severe patients ("poor options") patients
ITT begins when you start Enrolling Patients: We were also disappointed to learn that the FDA will not accept a modified MITT score. All patients once enrolled in the study will be counted. Recall that in an autologous therapy there are several weeks of processing. This means that severely ill CLI patients may worsen sharply and never receive TRC cells, or by the time they receive them, they have deteriorated substantially and would not meet the original enrollment criteria. There are even a few instances of patients for whom for one reason or another, the company may not be able to produce a TRC treatment. These patients will all count as failures. We view this as a negative skew going into an already complex trial
Is There really an Advantage to Autlogous Therapy ? I'm not as sure as I once was. My recent experiences with Pluristem and Athersys have demonstrated to me that cell source and cell ageing are real factors in the robustness of the final product. I believe that both Multistem (ATHX) and Pluristem (PSTI) PLX cells are more robust products versus Aastrom's TRC's. Since the efficacy in CLI is likely driven by a Paracrine effect (and not the longer term survival of the cells), engraftment is not a factor. The additional penalties associateed with the wait time for autlogous processing and the manufacturing variability and cell source (age) issues indicate to me that an allogenic therapy likely has significant and multiple advantages versus an autlogous one, in this type of indication.
Valuation: We launched coverage in August at $1.43. Aastrom today is at $3.13 with a market capitalization of $119 million versus $41 million when we launched. As such we no longer see the valuation as compelling given the risks ahead.
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Amicus Therapeutics, Inc. [fold] +12.15%
CombiMatrix Corporation [cbmx] +9.65%
Compugen Ltd. [cgen] +9.41%
Curis, Inc. [cris] +9.09%
Neuralstem, Inc. Common Stock [cur] +8.53%
InterMune, Inc. [itmn] +6.21%
Sangamo BioSciences, Inc. [sgmo] +5.01%
Regeneron Pharmaceuticals, Inc. [regn] +4.84%
with income of 200 million in 2009 and 600 million in 2010 they do not need money
what they do need is a way to cash out at the top because the valuation doesn't make sense. Leaving the new shareholders holding the bag.
A number of biosimilar products are already in the market in Europe. Following enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), an abbreviated approval pathway for biosimilars has been created in United States.
What short cut does he see that most other companies can't find.
If everyone that progressed went on the drug how can there be a survival benefit since everyone is on the drug.
probably the only people that didn't go on the drug got too sick so of course they were going to die fast. They were too sick to stay in the trial
Their trials always but for some reason they get approved in China.
do you think they walk around the chinese drug approval offices with bags of cash?
)-- At its first Analyst Day, Neoprobe Corporation (OTCBB:NEOP.ob - News), a diversified developer of innovative oncology surgical and diagnostic products, provided analysts and investors in attendance with an in-depth update on Neoprobe’s corporate and drug pipeline developments as well insights into recent progress in cancer diagnosis and treatment.
I especially love the statement below regarding the Riggs technology as a possible game changer. This is a product they discussed 9 years ago and have not done a thing with it in all of that time
The event featured clinical and scientific presentations on the challenges of treatment in head and neck cancer and melanoma. The session also included a corporate update provided by Neoprobe President and CEO David Bupp and a pipeline science review by Fredrick O. Cope, Ph.D., Neoprobe Senior Vice President, Pharmaceutical Research and Clinical Development. The New York City University Club gathering closed with a Q&A session with analysts on improving cancer care through the development and implementation of innovative technologies in the clinical setting.
Cancer Diagnosis, Treatment Highlighted by Clinical Thought Leaders
Dr. Amit Agrawal, Associate Professor in the College of Medicine, Department of Otolaryngology—Head and Neck Surgery at The Ohio State University Comprehensive Cancer Center, presented data and clinical experiences in the treatment of head and neck cancers. Dr. Vernon Sondak, Chief of the Division of Cutaneous Oncology at the H. Lee Moffitt Cancer Center and Research Institute, provided an overview of melanoma and the medical community’s experience diagnosing and treating the disease.
In his presentation, Dr. Agrawal presented learnings in the evolution of head and neck cancer treatment and benefits including developing novel ways to diagnose and manage this disease. “Although significant progress has been made in non-surgical treatment of head and neck cancers, many cancers still require surgery to treat these cancers successfully,” said Dr. Agrawal. “With this continued need for surgery, it’s imperative that we develop less invasive technologies, like sentinel node biopsy, to help physicians diagnose and treat cancerous tissue effectively with the hope of avoiding more radical procedures and thereby limiting the damage to healthy tissue in these patients.”
Dr. Sondak’s presentation on melanoma provided analysts with a scientific overview of the disease, its surgical diagnosis and targeting agents for treating it. In his review of melanoma surgical diagnosis, Dr. Sondak commented on the critical role of sentinel lymph node biopsy in predicting survival rates in these patients. “As we have seen in multiple clinical studies, sentinel node biopsy is currently the most important predictor of melanoma survival and is critical to helping physicians limit disease recurrence in their patients,” said Dr. Sondak. “Melanoma patients undergoing earlier sentinel node procedures experience less damage to their lymph nodes, and more importantly, improved survival rates following diagnosis and treatment.”
Neoprobe Technology Overview, Pipeline Update Presented
Following the presentations by Drs. Agrawal and Sondak, Dr. Frederick Cope presented a scientific overview of Neoprobe’s GDS line of gamma detection systems, and its drug pipeline products Lymphoseek® and RIGS. “The scientific presentations by Drs. Agrawal and Sondak provided an outstanding look inside the science of cancer diagnosis and treatment, and a better understanding of the value Neoprobe’s technologies bring to treatment and patient care,” said Dr. Cope. “We see the promise of our technologies – from our gamma detection devices to our RIGScan technology – is in helping to address pressing clinical issues faced by surgeons who seek to improve surgical procedures and care for those patients who require surgical cancer treatment.”
Neprobe President and CEO David Bupp also presented an update on the Company’s two pipeline programs, Lymphoseek and RIGScan, highlighting the most recent regulatory and clinical development milestones for these products.
Lymphoseek, Neoprobe’s investigational radioactive tracing agent for use with a gamma detection device in lymph node mapping procedures, recently completed a pre-NDA meeting with the Food and Drug Administration (FDA). In that meeting, FDA requested that data from both the completed NEO3-05 study and the NEO3-09 study currently in progress be included in the Company’s primary New Drug Application (NDA) for Lymphoseek rather than submitting the NEO3-09 study data as a major amendment to the ongoing NDA review. Neoprobe expects this study to be completed in the first quarter of 2011 and the Company plans to submit the primary NDA package for Lymphoseek shortly thereafter.
Last week Neoprobe announced that FDA has granted the Company a Type B pre-IND meeting to review its RIGS technology Biologic License Application (BLA). “We see the RIGS technology as a potential game-changer in the diagnosis of colorectal and other solid-tumor cancers that have long been some of the most difficult to treat and deadly forms of cancer,” said Dr. Mark Pykett, Neoprobe Executive Vice President and Chief Development Officer, who is leading Neoprobe’s RIGS development initiative. “Our upcoming pre-IND meeting with FDA is a key step in rapidly ramping up our development efforts for our RIGS program in 2011. This meeting represents an opportunity for further positive dialogue with FDA and serves as a tangible example of progress in moving this product into the clinic and ultimately to commercialization.”
In closing the session, Mr. Bupp commented, “As we saw in the presentations at Analyst Day, surgeons continue to face multiple challenges in the diagnosis and treatment of deadly cancers. It is with these clinical challenges in mind that we at Neoprobe continue to work aggressively to make progress on the regulatory and development milestones for both Lymphoseek and RIGS, with the belief that these technologies will help medical professionals better treat patients who look forward to healthy and productive lives following their cancer treatment.”
For more detail on Neoprobe’s disclosures from the event, including links to the presenters’ PowerPoint Presentations and audio replays, please visit http://www.neoprobe.com/AnalystDay.asp.
Harry Stylli as restructuring chief and Mark Attarian as interim financial chief.
harry stylli can turn stocks aroound. he recapped sequenom and the stock went from the two to the twenty's based on false data.
How can he be in charge of turning around another company, even if he had nothing to do with the scam at sequenom he was running the company and should have had procedures in place to prevent that scam was taking place.
Acorda Therapeutics, Inc.
ACOR : NNM : US$27.38
Sell | Price Target: US$22.00
Prescription Growth Still Anemic, Side
Effects May Be Catching Up With
Ampyra Based On AERS Database --
Downgrading to Sell from ReduceDavid Moskowitz
david.moskowitz@madisonwilliams.com 212.508.4016
I have always thought this was a awful drug and the reason for the company to exist was to get the stock price up, not to benefit patients.
We recommend that investors sell ACOR shares, as
prescription trends for Ampyra remain uninspiring. Besides
the pent-up demand being exhausted in 3Q, we have also
found a high number of seizures and other neurological
adverse events (AEs) being reported to the FDA that could
be weighing on the drug’s launch curve. We count a total
of 44 unique seizure events reported to the agency from
March 29 through September 27 citing Ampyra as the
primary source. While the FDA warns of seizures in
Ampyra’s label, we calculate a higher rate than is listed by
the agency (despite likely underreporting). Given the data,
we believe that real world experiences could cause
physicians to be more cautious in prescribing the drug. In
addition, the FDA could strengthen Ampyra’s warnings if
our take is correct and the trends keep up. As a result, we
are downgrading ACOR shares from Reduce to Sell.
FOIA report reveals high number of convulsions and other AEs. Based on our analysis of FDA Adverse Events Reporting
System (AERS) data, we count 44 unique seizure events from the launch of Ampyra through the end of 3Q. Additionally, 10 of
the 44 events are classified as Grand Mal seizures, a type of convulsion that is worse than the one focal seizure observed in
clinical trials. We also note several pages of other adverse events, including dizziness and nausea, as anticipated given the
clinical trial experience with the drug. Loss of consciousness with and without seizures is also a notable AE in the database, as
are gait disturbances. Most physicians polled during the launch of Ampyra did not expect the drug to have significant safety and
tolerability issues, and in our view, doctors could become more cautious on Ampyra if the AERS database thus far is a guide.
We calculate a higher rate of seizures than indicated in Ampyra’s label. Pooled data in Ampyra’s label indicate a seizure
rate of 0.41 per 100 patient years. This comes from FDA calculations that include pivotal trial data for Ampyra, as well as data
from open label studies. Based on the AERS data thus far, and using the company’s statement that 31,000 patients had
received an Ampyra prescription by the end of 3Q, we estimate a seizure rate range of 1.7 to 0.49 events per 100 patient years.
The wide range depends on the average months on therapy to calculate “patient years”; we use a range of 1 month to 3.5
months. If we use a 2- to 2.5-month range for average length of use thus far, we estimate a rate of 0.76, significantly higher
than the 0.41 in the label. Such a rate could cause the FDA to strengthen the warnings on Ampyra, in our view (our analysis is
shown on the following page).
Post-Thanksgiving Rx data is disappointing. The week ended November 26 showed a dip in Ampyra prescription trends as
expected, given the holiday, and the rebound off that figure indicates that prescription growth is tracking flat to down. Total
prescriptions were averaging 2,246 in the 8 weeks up to the Thanksgiving holiday. Averaging the week before Thanksgiving,
the week of, and the week after Thanksgiving (reported today), the 2,153 result reveals a negative trend.
Management and directors continue to sell stock?signals bearish sentiment and no near-term take out. On the back of
several healthcare acquisitions this past Friday, ACOR, along with other speculated take-out candidates, rose in sympathy. We
note that company executives and directors continue to sell ACOR stock, based on SEC filings. In our view, this signals that no
take-out deal is in the works, and that insiders believe the stock is priced to sell.
this is proof that qe2 is not working
it isn't helping housing and prices on everything else are going up.
it is time for the fed to stop buying treasuries and to stop taking on the debt. Housing will go up when it has bottomed out. Frankly I do not understand how these commodities prices are going up like this and it isn't hitting the cpi.
something isn't adding up.
HEDGEYE
EARLY LOOK: RICH PRIVILEGES
"One of the privileges of a rich man is that he can afford to be foolish much longer than a poor man."
-Ludwig von Mises
This morning's top global macro headline is 'China raising rates on reserve requirements in order to fight inflation.' This shouldn't be new "news" to anyone who follows Chinese monetary policy closely. China is willing to give-up short-term stock market performance (the Shanghai Composite Index is down -13.3% for the YTD) for long-term price stability. Fancy that.
What is inflation? It's when prices are breaking out to higher-highs over the intermediate-term TREND. In Ludwig von Mises 4th Lecture ("Inflation", page 52 of Economic Policy) he reminds us that "the most important thing to remember is that inflation is not an act of God; inflation is not a catastrophe of the elements or a disease that comes like the plague. Inflation is a policy."
The Ben Ber-nank's inflation policy has been crystal clear. Since his decision to engage in Quantitative Guessing part deux at the Groupthink Inc. meetings in Jackson Hole in August, here are the 3-month percentage moves of real-time market prices:
1. Crude Oil = +18.2%
2. Natural Gas = +20.8%
3. Heating Oil = +18.2%
4. Gold = +10.1%
5. Silver = +41.2%
6. Palladium = +38.3%
7. Copper = +17.3%
8. Cocoa = +12.3%
9. Cotton = +52.4%
10. Lumber = +19.8%
11. Orange Juice = +16.5%
12. Sugar = +35.5%
13. Corn = +24.2%
14. Oats = +27.9%
15. Rice = +20.5%
16. Soybeans = +23.6%
17. Wheat = +10.3%
We are discussing a small company with a unique technology. It is important that they inform investors that there is interest in the technology
Stem Cell Collaboration Perspectives
Cephalon has taken a 19.99% stake in Mesoblast Ltd. and bought the rights to market the
Australian company’s adult stem-cell therapies for heart and nervous system conditions
in a deal potentially worth more than $2 billion. Cephalon will pay $220 million for the
stake, a price that represents a 35% premium to the closing price of Mesoblast shares
prior to the deal announcement. In addition, Cephalon is also slated to give Mesoblast as
much as $1.7 billion in regulatory milestone-based payments. While a tiered royalty on
net sales of the products is also part of the deal, this rate was not disclosed. The
agreement, the largest thus far in stem-cell therapies, is significant in our view because it
signals Cephalon's move into the stem cell space and further demonstrates the company's
commitment to transforming into a biotechnology-based business enterprise. If the stem
cell product candidates make it to the market, we believe they are likely to have lengthy
commercial windows and significantly greater resistance to generic competition than traditional organic small molecules. The funds are also likely to help Melbourne-based
Mesoblast develop new stem-cell treatments for Alzheimer’s and Parkinson’s diseases,
in addition to therapies for heart-failure patients and bone-marrow donors.
Mesoblast is slated to initially receive $130 million from Cephalon for the rights to its
stem cell products in cardiac and CNS indications, with $30 million of it due upon
approval of Mesoblast’s shareholders. In addition, Mesoblast will pay for and conduct
some clinical trials while Cephalon will fund and perform Phase IIb and Phase III trials.
Mesoblast will hold the rights to manufacturing commercial supplies of the stem-cell
products included in the deal, while Cephalon will pay Mesoblast a markup on product
manufactured for sale by Cephalon. The Australian company, which is undertaking at
least six human trials currently, will retain the rights to develop and market stem cell
treatments for diabetes, eye diseases and a number of orthopedic, inflammatory and
immunological conditions.
Compelling Stem Cell Data Reported with Mesoblast Product
Candidates
In our view, the high price tag for the Mesoblast collaboration is justified based on the
data that has thus far been obtained using Mesoblast's candidates. Mesoblast has a
relationship with the privately-held firm Angioblast Systems, Inc., founded in 2001,
which is working on a set of products based on its proprietary platform using
mesenchymal precursor cells (MPCs). Upon raising capital in December 2004 through a
public offering on the Australian stock market, Mesoblast acquired an approximate 33%
interest in Angioblast in view of Angioblast's extensive potential commercialization
rights with respect to the MPC technology. Under a cost-sharing agreement among the
parties, Mesoblast and Angioblast shared costs associated with various development
efforts related to the shared MPC platform technology, including the GMP process
development and certain preclinical and clinical costs. Angioblast is primarily focused
on developing its platform in the domain of cardiovascular indications. Recently,
Mesoblast acquired the remaining Angioblast shares and Angioblast became a fullyowned
subsidiary of Mesoblast.
On the cardiac front, Angioblast announced in November 2009 that the first group of
patients who received the lowest dose of Revascor™, the proprietary “off-the-shelf”
adult stem cell product for heart failure, continued to show sustained improvement in
heart muscle function at six months. Interim results of the ongoing Phase II trial of
Revascor™ were presented at the annual conference of the American Heart Association
(AHA) in Orlando, Florida. The randomized, placebo-controlled Phase II trial was run at
various sites in the US, including California, Arizona, Minnesota and Texas. The trial
aimed to compare one of three increasing doses of Revascor™ against standard of care
in up to 60 patients suffering from moderate-severe congestive heart failure, defined as a
baseline ejection fraction (EF) 40% or lower by echocardiogram. Each dose is tested in a
group of 20 patients, randomized 3:1 treated to control patients.
Patients who received a single injection of Revascor™ into damaged heart muscle and
significantly improved cardiac function at both three and six months compared with baseline. At six months, a single dose of Revascor™ was accompanied by a 22% mean
increase in EF, whereas controls had an 18% mean decrease in EF over the same time
period. There were no cell-related adverse events. The observed improvement between
treated and controlled patients on top of medical standard of care was over two-fold
higher than previously reported with existing device therapies. Revascor™ is delivered
to damaged areas of the heart by a minimally invasive cardiac catheterization procedure
performed under local anesthesia while the patient is awake. Patients undergoing the
procedure were released from the hospital within 24 hours, underscoring the relative ease
with which the administration of this product can be conducted.
We note that the positive data seen with Revascor™ in this initial proof-of-concept study
bode well for the future development of this agent and compare favorably with data
released by Athersys, Inc. (ATHX: not rated) in late July 2010 on its own off-the-shelf
stem cell product, MultiStem. In the Athersys Phase I trial, patients received MultiStem
delivered via a catheter into the damaged region of the heart 2 to 5 days following
percutaneous coronary intervention (PCI), a standard treatment for heart attack. The
study included patients in three treatment cohorts or dose groups (20 million, 50 million
and 100 million cells per patient) and a registry group where patients received only
standard of care. Nineteen treated and six registry subjects participated in the study. The
trial was conducted at cardiovascular treatment centers in the U.S., including the
Cleveland Clinic, Columbia University Medical Center and Henry Ford Health System.
Administration of MultiStem was found to be well tolerated at all dose levels; no
clinically significant changes in vital signs, allergic reactions, or infusion-related
toxicities were associated with MultiStem administration. Each dose group showed
improvement in mean left ventricular ejection fraction (LVEF), a measure of heart
function, compared to baseline and relative to the registry group. Patients in the 50-
million dose group had a statistically significant absolute improvement in mean 4-month
LVEF relative to baseline (9.8 percentage points, representing a 23.4% improvement
over baseline, p<0.02). Among patients with more severe heart attacks, (as measured by
baseline LVEFs less than or equal to 45%) the 50- and 100-million dose groups each
demonstrated better than a 25% improvement in mean LVEF at four months posttreatment
over baseline. In our view, the relative efficacy of MultiStem is comparable to
that seen with Revascor™, but the Revascor™ trial was larger, making the data more
robust at this stage. Accordingly, therefore, we believe that Cephalon has made an astute
investment because the myocardial infarction indication represents a significant unmet
medical need and the competitive landscape beyond Athersys does not appear to be
particularly significant, especially with respect to other stem cell-based therapies. In our
view, given the rapid execution of clinical trials and the short evaluation window
necessary to monitor ejection fraction-based endpoints, we believe that the MPC-based
solution to treat myocardial infarction could complete pivotal development within two
years and be launched in the 2013/2014 time frame.
Also in November 2009, Angioblast announced positive results from a study involving
patients who received a bone marrow transplant using umbilical cord blood expanded by
the patented allogeneic, or “off-the-shelf”, mesenchymal precursor cells (MPCs). The
trial was being conducted at the world-renowned University of Texas M.D. Anderson
Cancer Center's Department of Stem Cell Transplantation and Cellular Therapy. The
U.S. National Institutes of Health (NIH) has funded treatment in up to 30 patients.
Angioblast’s objective was to develop a therapy that results in bone marrow
reconstitution as effectively as unrelated adult bone marrow, but without the potentially
life-threatening complication of graft-versus-host disease, which occurs in as many as
60% of patients. Angioblast's proprietary MPCs expanded hematopoietic stem cells in
umbilical cord blood by approximately 40-fold. In patients receiving MPC-expanded
cord blood, the median time to neutrophil recovery was 16 days and to platelet recovery
38 days, compared with approximately 30 days and over 90 days, respectively, in
published reports of patients transplanted with an unexpanded cord. Only two patients in
the initial 16-patient cohort (roughly 12%) have developed Grade III/IV graft-versus-host
disease, compared with approximately 40% in published reports of patients transplanted
with unexpanded cord blood. The MPC product used in this trial has Orphan Drug
designation from the FDA, which was granted for expanding hematopoietic stem and
progenitor cell numbers in patients with hematologic malignancies. In our view, this
product candidate could be approved via an accelerated development path and may reach
the market in late 2012 if late-stage data demonstrate its efficacy. In our view, following
the late-stage failure of Osiris Therapeutics' Prochymal in graft-vs.-host disease, the
competitive landscape for this product looks quite attractive as well and may yield a
relatively sound return on investment for Cephalon. Overall, we believe that the
Angioblast products in hematology and cardiology represent the highest likelihood for
the Mesoblast collaboration agreement to yield positive returns for Cephalon, as these
product candidates are aimed at significant unmet medical needs and have shown
positive proof-of-concept efficacy in clinical trials. We also note that Mesoblast's
initiatives to develop its stem cell-based therapies in Parkinson's and Alzheimer's
diseases represent higher-risk, higher-reward opportunities at earlier stages of
development.
Current Outlook
Cephalon shares have been unfairly punished, in our view, in the wake of the Mesoblast
deal, with investors contending that this collaboration does not help Cephalon defend
against a future decline in revenues due to the pending introduction of generic
competition for Provigil. While we believe that this is a valid criticism, we also feel that
Cephalon is not done deal-making and that the Mesoblast collaboration agreement
represents an important potential cornerstone for the building of Cephalon's long-term
future, given its two-fold advantages of giving Cephalon a foothold in the stem cell arena
and broadening Cephalon's biotechnology footprint.
What makes you think large pharmas want their name disclosed, especially in a formulation deal like this
Cephalon and Mesoblast Enter Into Strategic Alliance to Develop and Commercialize Novel Therapeutic Products for Regenerative Medicine
did anyone mention this
Agreement Provides Cephalon with Global Rights in Three Treatment Areas to Products Derived from Mesoblast's Innovative Adult Mesenchymal Precursor Stem Cell Technology
Mesoblast to Receive Upfront Payment of US$130 MM (US$30 MM Upon Shareholder Approval), up to $1.7 BN in Milestone Payments, and an Equity Investment by Cephalon of 19.99%
Press Release Source: Cephalon, Inc.; Mesoblast Limited On Tuesday December 7, 2010, 4:38 pm EST
FRAZER, Pa. and MELBOURNE, Australia, Dec. 7, 2010 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:CEPH - News) and Mesoblast Limited (ASX:MSB.ax - News), today announced they have entered into a strategic alliance to develop and commercialize novel adult Mesenchymal Precursor Stem Cell (MPC) therapeutics for degenerative conditions of the cardiovascular and central nervous systems. These conditions include Congestive Heart Failure, Acute Myocardial Infarction, Parkinson's Disease, and Alzheimer's Disease. The alliance also extends to products for augmenting hematopoietic stem cell transplantation in cancer patients.
Under the terms of the Development and Commercialization Agreement between the companies, in exchange for exclusive world-wide rights to commercialize specific products based on Mesoblast's proprietary adult stem cell technology platform, Cephalon will make an upfront payment to Mesoblast totaling US$130 million (US$30 million upon Mesoblast shareholder approval) and regulatory milestone payments of up to US$1.7 billion. Mesoblast will be responsible for the conduct and expenses of certain Phase IIa clinical trials and commercial supply of the products. Cephalon will be responsible for the conduct and expenses of all Phase IIb and III clinical trials and subsequent commercialization of the products. Mesoblast will retain all manufacturing rights and will share significantly in the net product sales.
In addition, under the terms of a Stock Purchase Agreement and a Subscription Deed, Cephalon will make an equity investment to purchase a 19.99% stake in Mesoblast at A$4.35 per share, totaling approximately US$220 million. This price represents a 45% premium to the last 30 days' volume weighted average price for Mesoblast shares. Cephalon has entered into a standstill agreement to limit its investment to 19.99% of Mesoblast common stock for the next 12 months, with a right to maintain its equity stake on a top up basis, subject to the Australian Securities Exchange rules. Cephalon Chief Operating Officer J. Kevin Buchi will join the Mesoblast Board of Directors, effective immediately.
"This global licensing agreement positions Cephalon as a leader in regenerative medicine while further strengthening our late stage pipeline with another innovative biologic platform," said Mr. Buchi. "Mesoblast has done an outstanding job of developing Phase II clinical data in congestive heart failure and hematopoietic stem cell transplants, plus preclinical data in acute myocardial infarction. We are excited to have the opportunity to develop potentially the world's first stem cell therapy for indications that could serve millions of patients globally."
Mesoblast Chief Executive Professor Silviu Itescu said: "Cephalon's demonstrated strength in late-stage product development and commercialization, and proven expertise in developing products for neurological diseases make Cephalon an ideal strategic partner for Mesoblast. We are therefore very pleased to partner with Cephalon in one of the largest biotechnology transactions of the past 12 months, and the largest ever in the regenerative medicine sector. We look forward to working with the Cephalon team to commercialize and deliver these products to physicians and the patients who will ultimately benefit from an arsenal of new innovative approaches for degenerative diseases."
Mesoblast will separately and with its own resources continue to develop, manufacture and commercialize the rest of its suite of adult stem cell products for bone and cartilage applications, diabetes, eye diseases, and inflammatory and immunological conditions.
Deutsche Bank Securities Inc. served as exclusive financial advisor to Cephalon.
Mesoblast will host a conference call today at 5:00 pm ET. To participate in the conference call, please dial 866-524-3160 (domestic), +1 412-317-6760 (international) and 1-800-822-994 (Australia) and reference the access code Mesoblast. The presentation will also be available via a live webcast at: http://www.videonewswire.com/event.asp?id=74943. A replay of the call will be available from 8:00pm ET on Tuesday, December 7, 2010 until 5:00pm ET on Friday, December 17, 2010. To access the replay, please dial 877-344-7529 (domestic) and +1 412-317-0088 (international) and reference the access code 446742.
About Cephalon, Inc.
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 150 products in nearly 100 countries. More information on Cephalon and its products is available at http://www.cephalon.com
About Mesoblast Limited
Mesoblast Limited (ASX:MSB.ax - News) is a world leader in commercializing biologic products for the broad field of regenerative medicine. Having completed its acquisition of United States-based Angioblast Systems Inc., which will remain a wholly-owned subsidiary, Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult MPCs. Upon the closing of this transaction, Mesoblast will have approximately 270 million issued shares. For further information, please visit www.mesoblast.com.
As I said to my broker at credit swuisse, this new analyst came out with coverage on large pharma and I think except for Gilead gave all the companies a neutral.
I think it is moronic for a new analyst to come out with neutral ratings basically telling clients not to buy or sell. If his picks aren't buys he should look for new stocks.
this deal with access is a formulation deal, not a partnersthip.
they are saying that they have about 80 percent bioavailability of oral insulin. The big pharma is not taking their word for it.
So they are being reimbursed for certain costs associated with getting drug and data shipped so that the pharma company can duplicate the results. If and when that happens it can turn into a partnership and the pharma company will be announced with all the other bells and whistles.
announced it has entered into an agreement with a major global pharmaceutical company to test Access' oral insulin formulation based upon its proprietary vitamin B-12-based CobOral™ Drug Delivery Technology. Access will provide CobOral insulin to the pharmaceutical company. Access anticipates completion and delivery of its CobOral insulin formulation to the pharmaceutical company by the end of the month
as you can see the company has not said it is a licensing or partnership agreement. They will be getting reimbursed for doing this and it can turn out to be a big deal. They owe it to their shareholders to announce these deals because it shows interest in their technology and can turn into a big deal.
if you would like more detail click on this link
http://videoupdates.ceolive.co/accp-video-blog-4-jeff-davis/