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Current biotech holdings in order of size: OXGN, EMIS, NKTR, MNTA and JAV.
Great call by wallstarb last week on the OXGN spike. I was in meetings until mid-afternoon on Friday and was only able to sell 5,000 out of the 20,000 share order I placed at $2.50. Sale of all 20,000 shares would have still left OXGN as my largest position, one that I plan to continue to reduce if the price gets back to the $2.30.
I look to increase my positions in NKTR and MNTA. I will sell out JAV in all likelihood when it releases its latest PIII results in the next few weeks.
Thanks for last week's recap over at biotech values on the sad state of GTC's finances. I have a tendency to hold on to a losing position that shows signs of life in response to a PR event (the ATryn launch was clearly such an event) when the right move is to sell. Your post inspired me to sell most of my GTC position that day, and the sale looks good in retrospect.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=37598998
MNTA -- new M118 abstract -- better than UFH, at least in mice
M118, a novel low-molecular weight heparin with decreased polydispersity leads to enhanced anticoagulant activity and thrombotic occlusion in ApoE knockout mice.
Chakrabarti S, Beaulieu LM, Reyelt LA, Iafrati MD, Freedman JE. Whitaker Cardiovascular Institute and Evans Department of Medicine, Boston University School of Medicine, 715 Albany Street, W507, Boston, MA, 02118, USA, subrata@bu.edu.
Heparin and low-molecular weight heparin (LMWH) are complex, heterogeneous polysaccharides used in the treatment of arterial and venous thrombosis. M118 is a novel LMWH with low polydispersity and pronounced anti-Xa and anti-thrombin (IIa) activity as compared to current LMWHs. To determine if M118 is effective in preventing thrombosis in the setting of a vascular plaque, apolipoprotein E knockout mice fed a high fat diet were injected with M118, enoxaparin, unfractionated heparin, or saline control and examined for arterial thrombosis using a rose bengal laser induced carotid artery injury model. M118 significantly increased the time to occlusion as compared to control and unfractionated heparin but not compared to enoxaparin although fewer M118 treated animals had any vascular occlusion present at the time of protocol completion. Platelet-neutrophil aggregates were studied by flow cytometry and were found to be decreased with M118 as compared to enoxaparin. This is the first published report examining M118, a novel LMWH designed to have low polydispersity and enhanced anticoagulant activity. In an animal model of vascular plaque, M118 is a potent inhibitor of arterial thrombosis and, despite lower in vivo anti-Xa and anti-IIa activity levels, M118 was superior to UFH in the prevention of arterial thrombosis.
http://www.ncbi.nlm.nih.gov/pubmed/19399370?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
>> Mentioning "swine flu" in today's PR would get more attention.<<
It's probably just a matter of time before they dust off this 2007 press release, substituting "swine" for "avian":
CEL-SCI'S CEL-1000 Shown to Significantly Enhance Immune Response Against Avian Flu Antigen in Animals
VIENNA, Va., May 23 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION
(Amex: CVM) announces that CEL-1000 increased the immune response against H5 avian influenza antigen in combination with MAS-1, a water-in-oil adjuvant delivery system. These findings were presented on May 23, 2007 by Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular
Immunology at CEL-SCI at the American Society of Microbiologists 107th annual general meeting in Toronto, Canada.
************************
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/05-23-2007/0004594586&EDATE=
OSTEOLOGIX (OLGX)-- It is over 60 percent owned by Nordic Biosciences
Interesting, Nordic Biosciences is NVS's development partner for the NVS/Emisphere oral calcitonin phase 3 trials for the treatment of osteoporosis and O/A. Over 6,000 patients are currently enrolled in the trials. According to NVS's pipeline charts, the oral calcitonin filings are expected to occur in 2011.
Over a year ago, I came across a Danish news article (translated by Google) indicating that that N/B, which is predominantly owned by Dr. Claus Christiansen, was considering an IPO to fund its osteoporosis and O/A drug development efforts. I thought at the time that IPO funds were needed to cover its share (which has not been disclosed) of the calcitonin trial costs. However, perhaps N/B was also considering using some of the funds for the development of strontium malonate through an additional investment in OLGX. I have not seen anything further about an N/B IPO. In this market an IPO seems unlikely.
The Efficacy of Oral Everolimus in Patients With Neovascular Age-Related Macular Degeneration
I have not seen any publicity from NVS on the use of afinitor for AMD. The side effects must be relatively mild or NVS would not risk trying it in a non-life threatening indication. It appears that results will be available by year end.
http://clinicaltrials.gov/ct2/show/NCT00857259
The Efficacy of Oral Everolimus in Patients With Neovascular Age-Related Macular Degeneration
This study is currently recruiting participants.
Verified by Novartis, March 2009
First Received: March 4, 2009 Last Updated: March 5, 2009 History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00857259
Purpose
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration
Condition Intervention Phase
Choroidal Neo-Vascular Age-Onset Macular Degeneration
Age-Related Macular Degeneration
Drug: RAD001
Drug: Lucentis
Drug: RAD001 in combination with Lucentis
Phase II
******************************
I hope you are right.
I did read the documents carefully. The only reference to the potential anti-takeover effective of the increased authorization is here in the discussion of the reverse split:
>>Potential Anti-Takeover Effect
Although the increased proportion of unissued authorized shares to issued shares could, under certain circumstances, have an anti-takeover effect (for example, by permitting issuances that would dilute the stock ownership of a person seeking to effect a change in the composition of the Board of Directors or contemplating a tender offer or other transaction for the combination of the Company with another company), the reverse stock split proposal is not being proposed in response to any effort of which we are aware to accumulate shares of our common stock or obtain control of the Company, nor is it part of a plan by management to recommend a series of similar amendments to the Board of Directors and stockholders. Other than the reverse stock split proposal, the Board of Directors does not currently contemplate recommending the adoption of any other actions that could be construed to affect the ability of third parties to take over or change control of the Company.<<
It seems to me that companies seeking to protect current shareholders from cheap takeovers will propose specific poison-pill type share authority. The measures being proposed here will enable management to dilute us for reasons other than a takeover. So I remain suspicious.
The preliminary proxy materials also disclose that they are seeking approval for a reverse split at an up-to-1/10 exchange ratio. Plus authority to issue up to 50,000,000 new common shares (in addition to the 50,000,000 of previously authorized, unissued common shares) and 15,000,000 new preferred shares.
I can see voting for a reverse split to maintain the NASDAQ listing. But the authority to issue the new preferred and common shares, together with the existing unissued shares, indicates to me that massive dilution is coming in the not too distant future.
http://www.sec.gov/Archives/edgar/data/908259/000095013509002042/b74779prpre14a.htm
Symphogen and Origen Collaborate to Produce Transgenic Chicken for Generation of Fully Human Antibody Therapeutics
Last update: 6:00 a.m. EST March 6, 2009
COPENHAGEN & EMERYVILLE, Calif., Mar 06, 2009 (BUSINESS WIRE) -- Symphogen A/S and Origen Therapeutics today announced a strategic collaboration to develop a transgenic chicken capable of producing human antibodies against a wide variety of disease targets. Origen will use its avian transgenic technology to develop transgenic chickens, which can be immunized with any disease target of interest, including diseases such as cancer and autoimmunity. Symphogen will apply its antibody discovery and expression platforms to create novel, recombinant fully human monoclonal and polyclonal antibody therapeutics against such targets. Both companies plan to employ the jointly developed transgenic technology to produce novel antibody therapeutics.
"Symphogen's Symplex(TM) technology is an extremely powerful platform for direct isolation of potent, fully human antibody drug lead candidates against exogenous targets, for example such as those for infectious diseases," said Kirsten Drejer, Ph.D., CEO of Symphogen. "The transgenic chicken to be developed by Origen will complement our existing discovery platform and provide us with the strategic freedom to develop recombinant fully human antibodies against any disease of interest, including cancer and autoimmune diseases, for our own product pipeline or together with our partners."
"We are very pleased to form this collaboration with Symphogen, a company with outstanding technical capabilities and a similar vision to our own about the direction of next generation of antibody therapeutics," said Robert Kay, Ph.D., President and CEO of Origen Therapeutics. "We both believe the future lies in the use of multiple antibodies against a disease target, rather than the single monoclonal antibody approach, to achieve a more potent therapeutic effect with fewer side effects. Origen's avian transgenic technology provides the means to reach that goal. Together, we will develop transgenic chickens capable of producing a repertoire of human sequence antibodies in response to immunization with specific disease antigens, and create complex antibody-based therapeutics against a wide range of diseases."
Under the terms of the agreement, both companies will provide funding for the development of transgenic, human antibody-expressing chickens using Origen's avian transgenic technology. Origen will receive upfront license payments and further payments upon reaching defined research and development goals. In addition, Symphogen and Origen will pay each other royalties on products arising from the technology. Once human antibody-producing chickens are developed, both companies will hold rights to develop products from those birds. Furthermore, Symphogen will have the right to purchase exclusive access to the collaboration technology for use to generate human recombinant antibody products. The two companies plan to address targets in the areas of infectious disease, cancer and autoimmune diseases.
About Origen Therapeutics
Origen Therapeutics, headquartered in Emeryville, CA, is a privately held biotechnology company developing product opportunities from their avian transgenic platform. The company's mission is to become a leading developer and producer of complex recombinant protein therapeutics, including next-generation human antibody therapeutics. Origen is establishing global corporate alliances with biotechnology and pharmaceutical companies for the commercialization of its technology.
About Symphogen
Symphogen is the leader in developing recombinant polyclonal antibodies (pAb), a new class of biopharmaceuticals for the treatment of serious human diseases. By employing its pioneering antibody discovery and manufacturing technologies, Symphogen generates recombinant antibody compositions that capture the diversity and effectiveness of the natural immune system. Symphogen is building a proprietary product pipeline within several disease areas, including infectious diseases and cancer. Symphogen is a private biopharmaceutical company with more than 70 employees, based in Copenhagen, Denmark.
SOURCE: Symphogen A/S
http://www.marketwatch.com/news/story/symphogen-origen-collaborate-produce-transgenic/story.aspx?guid=%7B1A4FDFD6-AFF4-4EDF-B710-F9F7AB68564B%7D&dist=msr_1
NKTR-118
Thanks for the reference to the Entereg trials. Your recollection is correct. One of the 2 PIII trials met its endpoints but the second failed. Here is a link to the PIII press release.
http://phx.corporate-ir.net/phoenix.zhtml?c=120919&p=irol-newsArticle&ID=901612&highlight
Safety issues also cropped up in the trials, which has caused Adolor to cease further development in OBD. FWIW, NKTR's CEO Howard Robin, stated that there is strong partnering interest in NKTR-118. GSK paid Adolor a $50 million upfront fee in 2002 to partner Entereg for OBD and the other indications.
>>we don't know yet what price Ovation will set for rATIII<<
This is one item that I do not recall has been commented on recently, but it concerns me. Ovation has set outlandish prices for existing limited-market drugs immediately after it bought those drugs. Its pricing has been the subject of Congressional hearings (there is a 4 or 5 month-old thread that I am too lazy to go back and find on this), and I believe it may now be the subject of an FTC investigation. Ovation may have had the LEO pricing in mind when it inked the ATIII deal with GTCB. I hope that Ovation restrains itself and keeps the price in line with the plasma product. Both Ovation and GTCB would fare better, IMO, from a public relations standpoint if the initial ATIII pricing is reasonable.
Grifols: New trial for AT in cardiac surgery
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
This study is not yet open for participant recruitment.
Verified by Grifols Biologicals Inc., January 2009
http://clinicaltrials.gov/ct2/show/NCT00823082?rcv_s=01%2F14%2F2009&rank=310
>>1:30 p.m. Topic II: GTC Biotherapeutics Inc. Biologics License Application <<
Some have speculated that trading in GTCB would be halted this afternoon during the FDA hearing. I have not seen any announcement to this effect, and the proceedings will continue after the market's close. Does anyone know if there will be a suspension? TIA
Drug Manufacturing in Bioengineered Goats: FDA Says It Looks Safe
Luke Timmerman 1/7/09
Would you take a drug made from the milk of a genetically modified goat? A committee of expert advisers to the FDA will take a swing at that question, weighing the safety and effectiveness of such a treatment on Friday. The U.S. drug regulator is seeking advice on whether to approve an application from Framingham, MA-based GTC Biotherapeutics, a company aiming to prove that the drug it makes in goats, an anti-clotting agent, should be the first transgenic- animal-derived drug cleared for sale in the U.S.
Given the ultra-cautious tone the FDA is often accused by companies of taking toward new medicines, GTC’s recombinant antithrombin, a protein drug marketed as ATryn in Europe, sounds like a non-starter here, right? Nope. “The safety profile appears to be acceptable,” FDA staff said, and “ATryn at the recommended dose is effective” in patients with a hereditary deficiency of the anti-clotting protein, according to briefing materials posted online this morning, in preparation for Friday’s meeting of the Blood Products Advisory Committee in Rockville, MD.
Driving home these points in a persuasive way to the advisory panel will be critical for GTC (NASDAQ: GTCB) as a company. It is holding on by the thinnest of threads, with its stock closing yesterday at 57 cents. ATryn, approved in Europe in 2006, is sold there for a rare hereditary disorder that causes clotting. But the drug hasn’t generated nearly enough sales to sustain GTC, so its hopes are riding on U.S. approval. If GTC can get this drug through the FDA, it would also clear the path for other companies that hope to use transgenic farm animals as drug factories, a process sometimes referred to as “pharming.” (In fact Pharming is the name of one such company, a Dutch firm.)
So why on earth would anybody want to make drugs this way? Don’t scientists already know how to make genetically engineered protein drugs through fermentation-style techniques using standard lab organisms like E. coli, yeast, or hamster cells?
As David Stipp described it for us in a feature back in February, pharming’s appeal comes from its ability to churn out large quantities of protein drugs in a cheap way. And GTC makes the point that all protein drugs have to go through a rigorous purification process to separate the drug from all the gunk it brews with. As long as GTC can prove its end product is pure and consistent, who cares if it came from a goat udder?
We’ll see if the FDA panel agrees when it hands down a recommendation on Friday afternoon. The FDA isn’t required to follow the recommendations of its panels, although it usually does. The agency’s deadline for deciding whether or not to apporve the GTC drug is Feb. 7.
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can email him at ltimmerman@xconomy.com or call 206-624-2374.
Informative new website for patent and other IP-related litigation. You need to register, but registration is free:
http://lexmachina.stanford.edu/patents
Just voted my 100,000 + shares against the 3 proposals. Not that I expect that they will be rejected, although I did receive a telephone solicitation yesterday morning urging me to vote. Perhaps it's not a completely lost cause.
I would like to see GTC shopped by an investment broker, or even its IP sold in an auction process. IMO, there should be at least 2 big pharma companies that would have an interest in its trangenic technology. Roche, for example, licensed a trangenic technology this summer.
http://www.labtechnologist.com/Products/Roche-licenses-zinc-finger-tech-to-aid-its-discovery-programmes
More significantly, NVO has this to say about trangenic production in its corporate "sustainability" statement:
"Complicated human proteins can often not be produced efficiently and in their correct form by microorganisms or mammalian cell cultures. Some human proteins, however, can be secreted in large amounts and in their correct form in the milk or blood of mammals such as cows, goats, sheep, rabbits or mice. In certain cases, transgenic animals represent the only means to produce important new human drugs."
http://www.novonordisk.com/sustainability/positions/transgenic_animals.asp
And NVO is noted for its coagulant factor products and pipeline; e.g.,
http://www.novonordisk.com/science/pipeline/rd_pipeline.asp?sort=6&phase=000.All&indication=Haemostasis
It seems to me that NVO, Roche and perhaps other pharmas would consider buying GTC or its IP on the cheap if given the opportunity but at a better price than we will ever see from LFB.
The cash portion of Cox's compensation was about $525,000 for 2007. 85,000 shares at $.17 per share is an investment of less than $15,000. I view this as an investment to induce shareholders to continue his salary, and it will not change my planned vote against the financing.
FWIW, pricing info on a new Ovation deal embedded in press release:
http://www.fiercebiotech.com/press-releases/biovail-corporation-acquires-prestwick-pharmaceuticals?utm_medium=nl&utm_source=internal&cmp-id=EMC-NL-FB&dest=FB
Biovail Corporation Acquires Prestwick Pharmaceuticals
September 17, 2008
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Biovail Corporation Acquires Prestwick Pharmaceuticals
TORONTO -- Biovail Corporation today announced it has acquired Prestwick Pharmaceuticals, Inc., a privately held, U.S.-based pharmaceutical company that holds the Canadian and U.S. licensing rights to Xenazine® (tetrabenazine tablets). Xenazine® was recently approved by the United States Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's disease. Xenazine® was granted Orphan Drug designation by the FDA, which provides the product with seven years of market exclusivity in the United States.
Prestwick recently entered into an exclusive agreement with Ovation Pharmaceuticals, Inc., a leading U.S.-based specialty biopharmaceutical company, to commercialize Xenazine® in the U.S. The product's commercial launch is anticipated late-2008.
"We are delighted to have acquired Prestwick, and with it, an interest in Xenazine® - the first and only FDA-approved treatment for any symptom of Huntington's disease," said Biovail Chief Executive Officer Bill Wells. "The transaction meets all of our acquisition criteria, and represents Biovail's first commercial exposure to specialty markets in central nervous system, or CNS disorders. The acquisition is another important step in the implementation of our New Strategic Focus."
Under the terms of the agreement, Biovail has paid $100 million to acquire 100% of Prestwick Pharmaceuticals, Inc. and related license rights. Beyond Xenazine®, the acquisition also provides Biovail with other early-stage products, including Lisuride Sub Q (advanced Parkinson's disease), Lisuride Patch (Parkinson's disease) and D-Serine (Schizophrenia).
Biovail will commercialize tetrabenazine tablets in Canada (marketed under the Nitoman® brand name) through the Biovail Pharmaceuticals Canada sales force. Biovail will pay a variable supply price that ranges from 50% to 67% of net sales to Cambridge Laboratories (Ireland) Ltd., the worldwide license holder of tetrabenazine. In addition, Biovail holds an option to develop future related products with Ovation for the U.S. market in conjunction with Cambridge.
The transaction is expected to be accretive to both earnings per share and cash flows in 2009.
Transfer of U.S. Commercialization Rights to Ovation Pharmaceuticals, Inc.
Prestwick recently entered into an exclusive supply and marketing agreement with Ovation Pharmaceuticals, Inc. for Xenazine® in the U.S. Following Biovail's acquisition of Prestwick, Biovail will supply the product to Ovation for a variable percentage of the product's annual net sales. For net sales up to $125 million, Biovail's supply price will be 72% of net sales. Beyond $125 million, Biovail's supply price will be 65% of net sales. At both tiers, Biovail will pay a supply price of 50% of net sales to Cambridge.
Ovation will market Xenazine® to U.S. specialists through a 48-person sales force, which already markets a number of other products targeting CNS disorders, including epilepsy and Attention Deficit Disorder. As part of the agreement, Biovail holds an option to co-promote Xenazine® in the United States. Should this option be exercised, Biovail has the right to utilize Ovation's existing infrastructure to assist in the recruitment, training and operational management of a sales force.
Approval of Xenazine®
Xenazine® was approved by the FDA on August 15, 2008 for the treatment of chorea associated with Huntington's disease, based on the results of a double-blind, placebo-controlled, Phase 3 study that found that Xenazine® significantly reduced patients' chorea burden, improved global outcome scores, and was generally safe and well tolerated. Additional post-marketing preclinical studies further elucidating the safety profile of the product will be conducted. Xenazine® has been available in Europe for more than 30 years and in Canada since 1996.
About Huntington's Disease
Affecting an estimated 25,000 Americans, Huntington's disease is a devastating neurodegenerative disease that causes progressive movement disorders, cognitive dysfunction and behavioral changes and is ultimately a fatal condition. Chorea is the most common symptom, affecting approximately 90% of Huntington's disease patients, and is characterized by excessive, involuntary and repetitive movements, which are the most visible and dangerous manifestations of Huntington's disease and interfere with patients' abilities to perform activities of daily living, including dressing, bathing and caring for themselves. For more information about Huntington's disease, please visit http://www.hdfoundation.org or http://www.hdsa.org.
About Xenazine® (tetrabenazine)
Xenazine® is indicated for the treatment of chorea associated with Huntington's disease. Xenazine® is a highly selective and reversible centrally-acting dopamine depleting drug that works by inhibiting a molecule known as vesicular monoamine transporter 2 (VMAT2). Full prescribing information is available on the Investor Relations page of Biovail's website at www.biovail.com.
>>Denosumab, especially if priced lower than Reclast can compete well in 2nd line<<
Cost aside, it seems to me that the mortality risk reduction benefit of reclast should be a huge selling point. The follow-up study reported in the abstract below indicates that the benefit may not be attrubutable solely to a reduction in secondary fractures.
http://www.asbmr.org/Secure/FINAL_Abstract_Book.pdf
1030
Potential Mediators of the Reduction in Mortality with Zoledronic Acid after Hip Fracture. C. Colón-Emeric1, P. Mesenbrink*2, K. Lyles3, C. Pieper*1, S. Boonen4, P. Delmas5, E. Eriksen6, J. Magaziner7. 1Duke University Medical Center, Durham, NC, USA, 2Novartis Pharmaceuticals Corporation, New Jersey, NJ, USA, 3VA Medical Center, Durham, NC, USA, 4Leuven University Center, Leuven, Belgium, 5Hôpital Edouard Herriot, Lyon, France, 6Novartis Pharma AG, Basel, Switzerland, 7University of Maryland, Baltimore, MD, USA.
Zoledronic acid reduces the risk of death by 28% in patients with recent hip fracture, but the mediators of this effect are not completely known. We performed a retrospective
analysis of the HORIZON-RFT clinical trial database using stepwise Cox-proportional Hazards modeling to characterize the causes of death, and explore potential mechanisms
for the reduction in mortality. The analysis included 2111 patients with recent hip fracture randomized and treated with zoledronic acid or placebo infusion yearly. Causes of
mortality were reported by the investigator and adjudicated by a blinded, central review committee. Models included baseline covariates associated with greater risk of death, and
time-dependent covariates occurring during the study period including subsequent fracture, change in bone mineral density, infections, cardiac arrhythmias, and falls. In a model adjusted for baseline risk factors, zoledronic acid reduced the risk of death by 25% (95% CI 3-42%). Males experienced a greater mortality benefit (6.4% absolute risk reduction) than females (2.8%), with a particularly marked reduction in cardiac-related deaths (incidence 2.9% vs. 7.7%). Subjects living in a nursing facility at baseline, and subjects with greater levels of cognitive impairment did not experience a major reduction in deaths. Adding subsequent fractures to the model, we found that they were significantly associated with higher risk of death (HR 1.72, 95% CI 1.17-2.51), but explained only approximately 2% more of the zoledronic acid effect. Adjusting for other time-dependent risk factors decreased the death risk reduction by zoledronic acid; however, no treatment-by-factor interactions suggested treatment with zoledronic acid combined with the presence of any risk factors influenced the risk of death in any cohort. Compared to the placebo arm, there was a similar incidence of, but decreased death from pneumonia, neoplasms, and
cardiovascular disease in subjects treated with zoledronic acid, suggesting that the drug may influence physiologic reserve. We conclude that zoledronic acid’s death benefit is not fully mediated through a reduction in secondary fractures, but may also have an impact on physiologic reserve and ability to recover from acute illnesses.
Disclosures: C. Colón-Emeric, Novartis, Research Support from the Alliance for Better Bone Health 2, 3.
This study received funding from: Novartis Pharma AG, Basel, Switzerland.
>Takeover by Ovation.<
I doubt that Ovation at this point would want to subject itself to the additional disclosures and scrutiny that a public company must deal with. The adverse publicity about its drug pricing coninues; there was a USA Today article on Thursday. Of course, Ovation could keept the GTCB name after the reverse merger, but the likely result of doing so would be to drag our goats and ATryn pricing into the Ovation controversy, rather than deflect attention from Ovation's past pricing.
http://www.usatoday.com/money/industries/health/drugs/2008-08-07-costlydrugs_N.htm
>>What you cited hardly constitutes a contractual MAC under any interpretation I’ve ever seen<<
I did not intend to suggest that the hearings could derail the GTCB deal. However, they might have been a reason for some of the delay in finalizing it. I see that no Ovation exec testified at the hearings, which would have consumed an enormous amount of exec time. But I also suspect that Ovation was given a heads-up that it was going to get skewered, and there was probably more than one meeting last week with PR and legal advisors to consider a response.
Probably saying nothing was their best course of action at this point. But I doubt the issue will go away for Ovation.
>>Given that Ovation has experience selling acute-care drugs to hospitals<<
At what are perceived to be ultra high prices. It seems doubtful that the hearings have held up the GTCB closing, but they must have been a huge distraction for Ovation's execs last week.
Congressional Hearing Attacks Price Gouging
19 Comments
By Ed Silverman // July 25th, 2008 // 7:52 am
http://www.pharmalot.com/2008/07/congressional-hearing-attacks-price-gouging/
Why has the cost of some drugs skyrocketed? That’s the question the Joint Economic Committee explored at a hearing yesterday in which some specialty pharma companies were skewered for raising prices dramatically after buying meds from larger drugmakers.
Among those cited were Ovation Pharmaceuticals, whose ceo, Jeff Aronin, is a PhRMA board member. In her opening remarks, US Senator Amy Klobuchar, a Democrat from Minnesota, indicated she asked the Federal Trade Commission to investigate Ovation for allegedly exploiting a lack of competition to one of its products. Another company cited was Questcor Pharmaceuticals.
“When we have pharmaceutical companies like Ovation or Questcor increasing prices to astronomical levels because of the lack of competition in the market, their actions are able to exploit an extremely vulnerable and captive market,” she said. “These staggeringly high prices, in turn, threaten the financial stability of middle class families relying on these drugs.”
Alan Goldbloom, ceo of Minnesota Children’s Hospital, testified that Ovation’s Indocin is an example. The drug is used to treat patent ductus arteriosus, or PDA, a condition that can interfere with breathing in newborn and premature babies. Until January 2006, the drug cost about $108 per unit. A few months earlier, though, Ovation bought the med from Merck, gaining exclusive rights, and the price jumped to $1,500 – a 1,278 percent increase.
“Indocin is not the only drug Ovation has marked up in such a dramatic fashion,” he continued. “Three other drugs that were purchased from Merck – Cosmegen, Diuril Sodium, and Mustargen have seen price increases of 3,437 percent, 864 percent, and 979 percent, respectively. Cosmegen is an agent used to treat a variety of pediatric cancers, Diuril Sodium is a diuretic used to reduce fluid overload in infants and neonates, and mustargen is used to treat brain tumors and certain lymphomas.”
Pharming signs Commercialization Agreement for Lactoferrin with Aslan Group A.S.
http://www.marketwatch.com/news/story/pharming-signs-commercialization-agreement-lactoferrin/story.aspx?guid=%7B3D0B9602-8138-4CE9-9D4C-F93851272A97%7D&dist=hppr
Last update: 2:05 a.m. EDT July 15, 2008
LEIDEN, NETHERLANDS, Jul 15, 2008 (MARKET WIRE via COMTEX) -- Leiden, The Netherlands, July 15, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has signed a commercialization and supply agreement with Aslan Group A.S. in Turkey ("Aslan") for the marketing and distribution of food or food supplements containing Pharming's human lactoferrin product (hLF).
Under the agreement, Pharming will supply to Aslan milk powder containing specified amounts of hLF. Aslan will be responsible for the production and the design of the finished products. The final products will be used as food or as a food supplement targeted at people who will benefit from the use of hLF. Aslan acquired the exclusive distribution rights for Turkey, Middle East, Ukraine and Russia. Under the terms of the agreement Aslan will pay a transfer price for the bulk product which is dependent on the specified concentration of hLF. Further financial details were not disclosed. The agreement has a lifetime of five years with an option to further extension. During the initial period of the agreement Pharming's production capacity will be increased to be able to satisfy the growing market's demand.
Lactoferrin is a protein naturally present in different mammalian secretions especially in human breast milk, saliva and tears. The protein has several properties related to the human immune system, including anti-infective and anti-inflammatory protection. Several scientific studies have shown that the product is safe. Pharming is producing hLF in milk of transgenic cattle in its facilities in Wisconsin (USA) for use as an ingredient in advanced nutritional products.
Dr. Bruno Giannetti, Chief Operations Officer at Pharming, commented: "The agreement with Aslan on recombinant human lactoferrin is a hallmark for Pharming's transgenic technology platform. It is our first product to become available on the market and it is the first human product from this technology in advanced food products. People are more and more focussing on health and healthy food and markets for nutritional applications are only growing."
Aslan Group is one of the leading family owned companies in Turkey, with a successful track record in several business areas, which has been established in 1978. Nutrition is the newest focus of the Aslan Group in the fast growing market of Turkey. Ibrahim Aslan, owner and Chairman of the Aslan Group commented: "The agreement with Pharming can be considered for the Aslan Group as a first step in the important high-tech nutritional market."
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin(R) for Hereditary Angioedema and human lactoferrin for use in food products. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
Contact:
Carina Hamaker, Investor Voice, T: +31 (0)6 537 499 59 or T: +31
(0)71 52 47 400
Samir Singh (US), Pharming Group NV, T: +1 908 720 6224
Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400
Copyright Copyright Hugin AS 2008. All rights reserved.
SOURCE: Pharming Group N.V.
Copyright 2008 Market Wire, All rights reserved.
Avastin(R) Shows Unprecedented Benefits in Colorectal Cancer Patients, Irrespective of K-Ras Gene Mutation
BASEL, Switzerland, June 26 /CNW/ -
- For Non-US Media Only
- Avastin is the Only Biologic Proven to Extend Life in Patients With
Normal K-Ras Gene
Data presented today at the 10th World Congress on Gastrointestinal
Cancer (WCGC) in Barcelona confirm that Avastin (bevacizumab) significantly
improves survival in patients with metastatic colorectal cancer regardless of
whether they have mutation in a gene known as K-Ras. This outcome is important
because other biologic combinations have been found to be ineffective in
patients with a mutation in the K-Ras gene, which is found in up to half of
patients with colorectal cancer.
Analyses of the randomized, controlled phase III AVF2107 study, showed
Avastin-based treatment resulted in:
Unprecedented efficacy in patients with normal K-Ras gene (wild type)
- a 82% increase in the time patients live without their disease getting
worse (7.4 vs 13.5 months) vs chemotherapy alone
- a 57% increase in overall survival (17.6 vs. 27.7 months) vs
chemotherapy alone confirming that Avastin is the only biologic with
proven survival benefit in this patient group
- a significant increase in response rate; 60% compared to 37% in
patients receiving chemotherapy alone
Significantly enhanced efficacy in patients with K-Ras mutation
- a 69% increase in the time patients live without their disease getting
worse (5.5 vs 9.4 months) vs chemotherapy alone
- these results show that Avastin-based therapy is the only biologic
option with proven benefits for patients with K-Ras mutation
"These data demonstrate that the addition of Avastin to standard
chemotherapy is active for patients with metastatic colorectal cancer with
both K-ras wild type and mutant tumours," commented Dr. Herbert Hurwitz, Duke
University in Durham, North Carolina, and principal investigator of AVF2107.
"The high response rate, PFS, and OS in the K-Ras wild type group are
impressive and confirm that Avastin should be part of the first line
management of patients irrespective of K-Ras status. On a practical level,
K-ras testing is not needed to initiate treatment with Avastin."
In January 2008, Avastin received a broad label in the EU allowing it to
be used in combination with fluoropyrimidine-based chemotherapy for first and
later treatment lines in patients with metastatic colorectal cancer. This
means that virtually all patients with metastatic colorectal cancer have
access to Avastin's benefits.
About AVF2107
AVF2107 investigated the efficacy of Avastin in more than 800 previously
untreated metastatic colorectal cancer patients. In the study Avastin was
combined with a standard chemotherapy called irinotecan, fluorouracil and
leucovorin (IFL).
The addition of Avastin to chemotherapy gave the most significant
improvement in survival time ever observed in a trial of advanced colorectal
cancer, significantly extending the duration of patient's life by 30%. The
results of AVF2107 formed the basis of Avastin's first approval in February
2004 (USA) and January 2005 (EU).
In the AVF2107 analysis reported in Barcelona today, tumour tissue
samples were collected in a prospective manner to analyze the efficacy of
Avastin according to K-Ras status. Samples were available from 230 patients
(about one third of all patients treated in the study).
About Avastin
Roche is pursuing a comprehensive clinical trial program investigating
the use of Avastin in over 20 tumour types and different settings (advanced,
post surgical). The total development program is expected to include over
40,000 patients world-wide and has already resulted in approvals in advanced
colorectal, breast, lung, and kidney cancer.
- February 2004 (US) and January 2005 (EU) - first line treatment in
patients with metastatic colorectal cancer (CRC)
- June 2006 (US) - second-line treatment in patients with metastatic CRC
- October 2006 (US) and August 2007 (EU) - first line treatment in
patients with advanced non-small cell lung cancer
- March 2007 (EU) - first line treatment in patients with metastatic
breast cancer (BC)
- April 2007 (Japan) - treatment in patients with recurrent or advanced
CRC
- December 2007 (EU) - first line treatment in patients with advanced
renal cell cancer
- January 2008 (EU) - first and later line treatment in patients with
metastatic CRC in combination with any chemotherapy
- February 2008 (US) - first line treatment in patients with HER-2
negative metastatic BC
Additional information
To access video clips about Avastin in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com.
http://www.newswire.ca/en/releases/archive/June2008/26/c8010.html
GTCB presenting at AAPS Nat. Biotech Conference on 6/23
http://www.aapspharmaceutica.com/meetings/biotec/bt08/programinfo/PRELIM/2c-nbc08.html
3:30 pm - 5:00 pm
Molecular Pharming: Therapeutic Antibodies from Plants and Animals
Roundtable
This roundtable will aim to present the current state of development as well as challenges in the area of molecular "pharming" by comparing and contrasting the platforms of plants and animals. This session will complement the symposium on plant-based biologicals. Discussion will focus on illuminating issues of production and purification of proteins from these platforms, and the regulatory hurdles to commercialize them.
Moderators
Satish K. Singh, Ph.D.
Pfizer Inc.
Raja B. Velagapudi, Ph.D.
Barr Laboratories, Inc.
Production of Recombinant Proteins in the Milk of Transgenic Animals
Yann Echelard, Ph.D.
GTC Biotherapeutics
Plant-based Biologics
Ajaz S. Hussain, Ph.D.
Philip Morris International
>>They’re working on something really exciting… they promise!<<
Sounds like a press release that NSTK, now known as MRNA, might have issued.
>couldn't Pfizer use their foreign cash to fund stock buybacks on foreign exchanges, leaving the US cash to cover the dividend?<
Also, the use of their foreign subs' cash to buy Phizer stock or the stock of any other US company will likely trigger US income tax liability.
<<phase-2b cancer trial that is restricted to patients with the KRAS mutation?>>
Nektar for its Pegged version of irinotecan, NKTR-102. I listened to its ASCO webcast last night and found it interesting -- several PRs in the P1 trial.
Here is the link to the slides: http://library.corporate-ir.net/library/72/721/72130/items/296478/Nektar_Presentation_FINAL.pdf
FWIW, while most of the analysis in this January post is beyond me, my takeaway from it was that the longer half life and increased exposure produced by NKTR-102 might have a significant therapeutic benefit.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=26304316
OT -- more on LLCs vs S corps
FWIW, I form about 15- 20 new business entities per year for clients, and probably 9 out of 10 will be formed as LLCs, preferably under Delaware law (which provides for the application of its well-developed corporate case law to resolving LLC limited liability issues). It's not that difficult to inadvertently bust a corporation's Sub S election, and an LLC has far greater ownership and structuring flexibility. Needless to say, I strongly disaree with the comment below that S corps should be favored over LLCs.
http://askfsb.blogs.fsb.cnn.com/2008/05/21/taking-over-a-dormant-llc/
Taking over a dormant LLC
Forming your own new entity is a better idea, the experts say.
Thomas
Dear FSB: I am looking to form an LLC on a new business with a group of partners. The S-Corp. is less expensive and less complicated and has deductions on personal taxes, but I was informed that an S-Corp must have all the corporate officers drawing a salary - and this is not applicable for a startup company. So, I recently found a colleague that has a dormant LLC that has never been used (he formed it and let it sit dormant because his business partners split up.) I am considering buying it for a greatly reduced price so he could recoup some of his costs, but wonder whether there are potential liabilities to be concerned about - even for a dormant NYC LLC. Am I correct in assuming that there could be potential hazards and liabilities involved - even if my colleague (who owns the dormant LLC) assures me it’s been sitting idle since inception?
By Lenora Chu, Fortune Small Business contributor
Dear Thomas: On the whole, the experts recommend forming a new LLC rather than acquiring a dormant one.
Why? For starters, it’s possible that even an inactive LLC might have incurred tax or other liabilities that are unknown, despite the assurances of your colleague.
“My reluctance would increase with the amount of time the LLC has been dormant,” says attorney and partner Edward T. Savage of the international law firm Reed Smith, LLP.
For example, some states impose a type of franchise tax payable on an annual basis simply to keep an entity in good standing with the state, according to Washington, D.C.-based attorney Bob Reif of Epstein, Becker & Green.
If the LLC in question did not pay these fees, the state could revoke its charter, in which case there would be costs to “re-start” the LLC, Reif says.
Realize also that any cost savings you anticipate by acquiring a dormant LLC - rather than forming a new one - may be immaterial, Savage says.
The “publication costs” associated with forming an LLC can be as little as $225 in some counties, or as much as $2,000 in New York State.
Even if your colleague gives you the dormant LLC free of charge, the amount you might save by taking this route is at most the publication cost.
“I would question whether such savings justify the potential risks of liabilities that might be inherited,” Savage says.
Savage adds that he generally favors the use of S-Corporations over LLCs because S-Corporations are less complicated and are subject to a well-established framework.
The legal fees needed to prepare a limited liability company agreement for the LLC may also be substantial, and you’re also more likely to incur additional legal costs when new investors join.
Consider using an LLC in those circumstances where you’ll need a tiered capitalization structure, or varying types of equity to provide different measures of return to investors, Savage says. Indeed, as Reif says, an LLC is often more flexible than an S-Corporation because the principals have greater opportunity to address unique economic arrangements for sharing profits and losses.
Furthermore, other entities, such as corporations, can also be owners of the LLC, yet with a few exceptions only individuals can be owners of the stock of an S-Corporation.
Thanks, at some point I expect to buy MNTA. I am just not sure how soon.
I went back and reviewed relatively recent abstracts, several of which assert that the incidence of HIT is greater with UFH than with LMWH. However, a metaanalysis of trials appears to confirm the Lovenox label info, FWIW.
1: Thromb Res. 2008 Feb 7. [Epub ahead of print] Links
Heparin-induced thrombocytopenia: A stoichiometry-based model to explain the differing immunogenicities of unfractionated heparin, low-molecular-weight heparin, and fondaparinux in different clinical settings.Greinacher A, Alban S, Omer-Adam MA, Weitschies W, Warkentin TE.
Institut für Immunologie und Transfusionsmedizin, Ernst-Moritz-Arndt-Universität Greifswald, Germany.
INTRODUCTION: Heparin-induced thrombocytopenia (HIT) is caused by platelet-activating antibodies that recognize platelet factor 4 (PF4)/heparin complexes. The frequency of HIT is highly variable in different clinical settings, and is more frequent with unfractionated heparin (UFH) than with low-molecular-weight heparin (LMWH), despite the in vitro observation that HIT antibodies activate platelets similarly well with LMWH as with UFH. An important difference between UFH, LMWH, and fondaparinux is their widely differing plasma concentrations. We aimed to provide a model that included anticoagulant concentrations and PF4 availability as risk factors influencing the anti-PF4/heparin immune response. MATERIALS AND METHODS: By photon correlation spectroscopy we determined the concentrations at which UFH, LMWH, and fondaparinux form complexes optimally with PF4. Plasma concentrations of UFH and LMWH were calculated based on ex vivo pharmacokinetic data, with information on fondaparinux and PF4 concentrations taken from the literature. RESULTS AND CONCLUSIONS: The main features of our model are: optimal complex formation occurs at prophylactic-dose UFH and high PF4 levels, whereas therapeutic-dose LMWH concentrations are too high for optimal complex formation; in contrast, concentrations of fondaparinux are usually below the optimal stoichiometric range. Thus, immunization should occur more often in situations with major rather than minor platelet activation, and-for a given degree of platelet activation (PF4 availability)-as: prophylactic-dose UFH>therapeutic-dose UFH>prophylactic-dose LMWH, fondaparinux>therapeutic-dose LMWH. Our model provides a framework for explaining empirical observations that LMWH induces less anti-PF4/heparin antibodies than does UFH, and that anti-PF4/heparin antibodies are more often found in patients undergoing major surgery than in medical patients.
PMID: 18262226 [PubMed - as supplied by publisher]
1: Chest. 2007 Oct;132(4):1131-9. Epub 2007 Jul 23. Links
Comment in:
Chest. 2007 Oct;132(4):1108-10.
No difference in risk for thrombocytopenia during treatment of pulmonary embolism and deep venous thrombosis with either low-molecular-weight heparin or unfractionated heparin: a metaanalysis.Morris TA, Castrejon S, Devendra G, Gamst AC.
Division of Pulmonary and Critical Care Medicine, Department of Family and Preventative Medicine, University of San Diego, CA, USA. t1morris@ucsd.edu
BACKGROUND: Low-molecular-weight heparin (LMWH) is a popular alternative to unfractionated heparin (UH) for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT), in part based on the perception of a lower risk for heparin-induced thrombocytopenia (HIT). To investigate the evidence supporting this perception, we performed a metaanalysis to compare the incidence of thrombocytopenia between LMWH and UH during PE and/or DVT treatment. METHODS: Randomized trials comparing LMWH with UH for PE and/or DVT treatment were searched for in the MEDLINE database, bibliographies, and by correspondence with published investigators. Two reviewers independently selected high-quality studies and extracted data regarding heparin-associated thrombocytopenia (HAT), HIT confirmed by laboratory testing, and heparin-induced thrombocytopenia with thrombosis (HITT). Outcome rates between LMWH and UH were compared using a binomial, generalized linear mixed model with a logit link and Gaussian random effects for study. RESULTS: Thirteen studies involving 5,275 patients met inclusion criteria. There were no statistically significant differences in HAT rates between the two treatments (LMWH, 1.2%; UH, 1.5%; p = 0.246). The incidence of documented HIT and HITT was too low to make an adequate comparison between groups. CONCLUSIONS: Our review disclosed no statistically significant difference in HAT between LMWH and UH and insufficient evidence to conclude that HIT and HITT rates were different between them. There was no evidence from randomized comparative trials to support the contention that patients receiving treatment for PE or DVT with UH are more prone to these complications than those receiving LMWH.
PMID: 17646239 [PubMed - indexed for MEDLINE]
>>side effects associated with heparin therapy, including heparin-induced thrombocytopenia<<
Has M118 been designed to reduce or eliminate the risk of HIT? From what I've read about HIT, there is still a risk of developing HIT from the administration of LMWH, but not as great as with unfractionated heparin. E.g., --
1: Surgery. 2008 Mar;143(3):305-12. Epub 2007 Dec 21.
Contemporary standards for the diagnosis and treatment of heparin-induced thrombocytopenia (HIT).Baldwin ZK, Spitzer AL, Ng VL, Harken AH.
Division of Vascular Surgery, Department of Surgery, School of Medicine, University of California, San Francisco, Calif.
BACKGROUND: Heparin binding to platelet factor 4 (PF4) generates a new antigenic epitope. In an unpredictable fashion, as many as approximately 17% of patients treated with unfractionated heparin (UFH) and approximately 8% treated with low-molecular-weight heparin (LMWH) subsequently develop the anti-heparin-PF4 antibodies that mediate heparin-induced thrombocytopenia and thrombosis (HIT). Very few of those patients with circulating anti-heparin-PF4 antibodies, however, progress to develop clinical HIT (referred to previously as Type II HIT). Only 20% of those who harbor antibodies ( approximately 3% of those exposed to heparin) will manifest the thrombocytopenia subsequently. Even fewer patients (0.03% to 0.09% of those exposed to heparin) experience the marked platelet activation and morbid thromboses characteristic of the HIT syndrome. The pathogenesis of heparin-induced thrombocytopenia (HIT) remains elusive. The pathophysiologic understanding to date has revolved around pathogenic anti-heparin-PF4 antibodies that trigger platelet activation, release of platelet procoagulant microparticles, and resultant thrombosis. The clinical diagnosis of HIT is confusing because current assays to detect anti-heparin-PF4 antibodies do not correlate well with the disease. Currently available assays lack either adequate sensitivity and interlaboratory reproducibility (ie, functional serotonin release assays) or specificity (ie, enzyme-linked immunosorbent assays or ELISAs). CONCLUSIONS: Fortunately, the treatment for HIT is not confusing. The purposes of this review are as follows: (1) to examine the relevant clinical definition of HIT, (2) to explore our current understanding as to the pathogenesis of HIT, and (3) to present an algorithm for the identification and treatment of the HIT syndrome.
PMID: 18291250 [PubMed - in process]
FWIW, yesterday ENMD's BOD backed away from seeking reverse split authorization. The stock had traded as low as .51/share. Today it closed up almost .11 to .90/share. The only news was the press release below. Apparently investors were impressed by the BOD's vote of confidence in the future share price.
http://www.entremed.com/news/entremed-will-not-seek-shareholder-approval-for-reverse-stock-split-at-annual-meeting
EntreMed Will Not Seek Shareholder Approval for Reverse Stock Split at Annual Meeting
ROCKVILLE, Md., April 22, 2008 — EntreMed, Inc.
(Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that the Company’s Board of Directors has decided against seeking stockholder approval for a reverse stock split at the Annual Meeting of Stockholders to be held on June 5, 2008. In light of recent gains in the Company’s stock price, management’s confidence in the Company’s product candidate pipeline and the Company’s current cash position, the Board of Directors concluded that it is not necessary to seek stockholder approval of a reverse stock split at this time.
On April 4, 2008, the Company issued a press release disclosing that it had received a Deficiency Notice from the Listing Qualifications Department of the NASDAQ Stock Market, LLC, and had announced its intention to seek stockholder approval for a reverse stock split. The Company remains committed to becoming compliant with all Nasdaq listing requirements.
About EntreMed
EntreMed, Inc. is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. MKC-1 is currently in multiple Phase 2 clinical trials for cancer. MKC-1 is an oral cell-cycle regulator with activity against the mTOR pathway. ENMD-1198, a novel antimitotic agent, and ENMD-2076, a selective kinase inhibitor, are in Phase 1 studies in advanced cancers. The Company also has an approved IND application for Panzem(R) in rheumatoid arthritis. EntreMed’s goal is to develop and commercialize new compounds based on the Company’s expertise in angiogenesis, cell-cycle regulation and inflammation — processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company’s web site at http://www.entremed.com and in various filings with the Securities and Exchange Commission.
CEO's statements that a deal was in the offing were fairly accurate -- from 4Q conference call:
http://seekingalpha.com/article/69533-cell-genesys-inc-q4-2007-earnings-call-transcript?source=yahoo&page=4
Now with respect to business goals for the year ahead, I want to take a moment to just comment again on our efforts to secure commercial partnership for GVAX prostate. What I have to say today is basically to repeat what I have said on several occasions recently, namely that we remain in very active discussions with multiple parties.
And while I can appreciate that this process may seem prolonged and deliberate to some of you, from our standpoint, this is without question, one of the most important transactions in our history, and we are absolutely committed to doing the best possible deal with the best possible partner.
And what that means, as I have said before, is to make sure that we have a deal where the company can participate in the downstream success of this product in a significant way, and that we have a partner that would prioritize GVAX prostate as much as we would, if we were able to commercialize it on our own.
We have continued to progress in these discussions, even since the last time that I commented on our partnering efforts, and we look forward to keeping you posted.
Good issue with other articles I found of interest as well, thanks.
FWIW, in the insulin article, Biocon does not yet have an oral insulin on the market in India or elsewhere. "Insugen" referred to in the article is its version of injected insulin. Its oral insulin is in phase I and II studies. And EMIS has suspended development of its oral insulin.
Interesting piece on impact of recent biotech deals on PPS of small biotech. Hopefully, the upcoming deals in the works (at least according to management) at various small biotechs -- in my case, OXGN, EMIS and GTCB -- will result in better share price outcomes than seen here:
Wednesday, March 26, 2008
Why Investors Don’t Like Biotech Alliances
We all know that the public markets are not funding biotech. Add up all the dollars invested in biotech IPOs and follow-ons over the last three years ($16.2 billion) and it doesn’t equal even half of what VCs and other private-equity players have put into the industry ($33.3 billion).
But alliance dollars continue to climb.
And yet investors don’t seem to like them very much.
Since November 2007, there have been nine deals by public biotech companies with upfront payments (equity and cash) of greater than $20 million – to us a reasonable proxy for a biggish deal. Among them: Isis Pharmaceuticals’ mipomersen deal with Genzyme ($325 million upfront); Merck’s with GTx on its Phase II SARM and two backups ($70 million upfront); and Sanofi Aventis’ multi-antibody arrangement with Regeneron ($85 million upfront). **********
http://invivoblog.blogspot.com/2008/03/why-investors-dont-like-biotech.html
In Zimbabwe, our shares are now worth Z$17.5 million each.
And the goats have value:
She recently exchanged a goat for 100kg of maizemeal, Zimbabwe’s staple food. "It would not make sense for me to accept our local cash and then start struggling to find the scarce maize, whose price would have increased by the time I buy it."
Thanks, I was proceeding under the assumption that severe sepsis and sepsis with DIC would be essentially the same conditions but, as mentioned, my science background is minimal. I appreciate all info being posted on this board and the Biotech Values board.
Agennix is about to start a P2 trial for talactoferrin in sepsis. From what I've read on this board and my review of the Agennix website, it would seem to complement A Tryn as a treatment for sepsis (but with my limited scientific background, this is essentially a guess).
http://clinicaltrials.gov/ct2/show/NCT00630656?term=talactoferrin&rank=1