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The DNDN loonies on iVillage (this includes you, S.P.) are disparaging the MDV3100 program because the evil Dr. Scher is involved in the drug’s development. So much for the quaint notion that these posters are concerned with the welfare of cancer patients.
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Not true at all. I hope MDV3100 is a complete success. The more helpful treatments the better. I do believe, however, that Dr. Scher voted his "book" since he was a lead PI in several competing trials at the time. You can call me a loonie, but it is clear that Dr. Scher was actively conflicted.
Iwfal Quote:
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FWIW after reading enough about him (before the Provenge AC) it is clear that his actions and his words are wildly divergent. It was for that reason that I came to the conclusion a while ago that he utter political/vindictive scum - interested in power and not much else.
Probably the most interesting thing about such individuals is that even the most narcistic individual still believes that their motives are pure - he probably tells himself he is fighting the good fight and protecting the good name of the FDA - but that doesn't make it so.
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Wow Clark, tell us what you really think. I could not agree more! Pazdur is exactly the wrong type of person for the job he unfortunately has.
Sutent Significantly Increases Progression Free Survival for Patients with Advanced Pancreatic Islet Cell Tumors, Study Stopped Early
Thursday March 12, 8:29 am ET
NEW YORK--(BUSINESS WIRE)--Pfizer Inc announced today that a phase 3 clinical trial of Sutent (sunitinib malate) has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.
An independent Data Monitoring Committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors.
“We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors — a rare cancer with limited treatment options,” said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit. “These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors.”
Pfizer has notified clinical trial investigators involved in the trial and regulatory agencies of the DMC recommendations. All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent. The full data set from this trial is being analyzed and more details will be presented at an upcoming scientific meeting.
This phase III trial of sunitinib in patients with advanced pancreatic islet cell tumors was initiated based on the results of a earlier phase II trial published in the Journal of Clinical Oncology(July 2008).
In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell tumors are rare, indolent tumors of the endocrine pancreas with an incidence of 5-10 per million worldwide annually. Pancreatic islet cell tumors include insulinomas, glucagonomas and gastrinomas. Current treatment options are limited.
Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sutent has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers. To date, more than 38,000 patients globally have been treated with Sutent in the clinical setting and trials.
This is the second phase III Sutent trial Pfizer has stopped early on the recommendation of an independent data monitoring committee due to benefit. In January 2005, a phase III trial in GIST was unblinded early when a planned interim analysis showed significantly longer time to tumor progression with Sutent compared to placebo.
Sunitinib Clinical Research Program
Pfizer is pursuing a broad development program for sunitinib malate and is studying its role in the potential treatment of various solid tumors including advanced breast cancer, advanced non-small cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma and advanced hormone-refractory prostate cancer in Phase 3 trials.
Healthcare professionals who are interested in learning more about sunitinib trials that are open for enrollment can visit the SUN program web site at www.suntrials.com. Patients with questions should contact their treating physician or obtain additional information through Pfizer, by calling 1-800-TRY-FIRST (1-800-879-4377).
About SUTENT® (sunitinib malate)
SUTENT is an oral multi-kinase inhibitor approved for the treatment of advanced RCC and GIST after disease progression on or intolerance to imatinib mesylate.
SUTENT works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important SUTENT targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. SUTENT also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.
Important SUTENT® (sunitinib malate) Safety Information
Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.
Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure.
Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
The most common adverse reactions in advanced RCC and GIST clinical trials were fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.
Merck and Schering-Plough to Merge
Monday March 9, 6:00 am ET
http://biz.yahoo.com/bw/090309/20090309005463.html?.v=1
Combined Company Positioned for Sustainable Growth Through Scientific Innovation and a Stronger, More Diversified Product Portfolio
Powerful Joint R&D Pipeline with Strong Candidates in All Development Phases Doubles the Number of Late-Stage Compounds to 18
Broader Product Portfolio in Critical Therapeutic Areas
Expanded Global Presence Including High-Growth Emerging Markets
Expected to be Significantly Accretive, Increase Efficiencies and Result in Cost Savings of Approximately $3.5 Billion Annually
Merck Committed to Maintain Current Dividend
WHITEHOUSE STATION, N.J. & KENILWORTH, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. (NYSE: MRK - News) and Schering-Plough Corporation (NYSE: SGP - News) today announced that their Boards of Directors have unanimously approved a definitive merger agreement under which Merck and Schering-Plough will combine, under the name Merck, in a stock and cash transaction. Under the terms of the agreement, Schering-Plough shareholders will receive 0.5767 shares and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Merck Chairman, President and Chief Executive Officer Richard T. Clark will lead the combined company.
Based on the closing price of Merck stock on March 6, 2009, the consideration to be received by Schering-Plough shareholders is valued at $23.61 per share, or $41.1 billion in the aggregate. This price represents a premium to Schering-Plough shareholders of approximately 34 percent based on the closing price of Schering-Plough stock on March 6, 2009. The consideration also represents a premium of approximately 44 percent based on the average closing price of the two stocks over the last 30 trading days.
Upon closing of the transaction, Merck shareholders are expected to own approximately 68 percent of the combined company, and Schering-Plough shareholders are expected to own approximately 32 percent. Merck anticipates that the transaction will be modestly accretive to non-GAAP EPS1 in the first full year following completion and significantly accretive thereafter.
“We are creating a strong, global healthcare leader built for sustainable growth and success,” said Mr. Clark. “The combined company will benefit from a formidable research and development pipeline, a significantly broader portfolio of medicines and an expanded presence in key international markets, particularly in high-growth emerging markets. The efficiencies we gain will allow us to invest in strategic opportunities, while creating meaningful value for shareholders.
“We look forward to joining forces with an outstanding partner we know well and that shares our commitment to patients, employees and the communities where we work and live. Through their talent and dedication, Schering-Plough employees have built an industry leading R&D engine and late-stage pipeline that is complementary to our own. We are confident that, together, Merck and Schering-Plough will make a meaningful difference in the future of global healthcare,” Mr. Clark added.
Fred Hassan, chairman and chief executive officer of Schering-Plough, said, “Over the last six years, Schering-Plough colleagues have transformed our company into a strong competitor in the global pharmaceutical industry. We have built a strong, diverse business and a robust pipeline that offers hope to patients who are waiting for new medicines. I am proud of what we have accomplished. Our success is a testament to the hard work and dedication of our colleagues in every country. We are joining forces with Merck, our long-term partner in our cholesterol joint venture, to create a dynamic new leader in the pharmaceutical industry. By harnessing the strengths of both companies, the combined entity will be well-positioned to further deliver on our shared goal of discovering new therapies for patients to help them live healthier, happier lives.”
“The talent and dedication of Schering-Plough scientists has helped to build an outstanding clinical development pipeline,” said Peter S. Kim, Ph.D., Merck executive vice president, and president of Merck Research Laboratories. “Schering-Plough's considerable biologics expertise will complement Merck's novel proprietary biologics platform and aligns with our commitment to build a powerful biologics presence. The Schering-Plough and Merck pipelines are remarkably complementary and will greatly increase our ability to deliver important new medicines to patients. I believe the combined pipeline will be the best in the industry, by far.”
Strategic Benefits of the Transaction
Complementary Product Portfolios and Pipelines Focused on Key Therapeutic Areas: The combination significantly broadens Merck’s portfolio of medicines – an engine for consistent, sustainable growth – driven in part by the addition of valuable products with long periods of exclusivity. By leveraging the combined company’s expanded product offerings, Merck expects to benefit from additional revenue growth opportunities. For example, the combined company will have expanded opportunities for life-cycle management through the introduction of potential new combinations and formulations of existing products. In addition, Merck and Schering-Plough together have high-potential early-, mid- and late-stage pipeline candidates. The transaction will double the number of potential medicines Merck has in Phase III development, bringing the total to 18.
The combined company will have a more diverse portfolio across important therapeutic areas, including cardiovascular, respiratory, oncology, neuroscience, infectious disease, immunology, women’s health and other areas:
Cardiovascular: This transaction reinforces Merck’s 50-year commitment to the cardiovascular therapeutic area. The consolidation of the cholesterol drugs ZETIA (ezetimibe) and VYTORIN2 (ezetimibe/simvastatin) into Merck's cardiovascular portfolio will simplify the combined company’s approach to the cardiovascular market and create new opportunities to leverage the cholesterol franchise through new medicine combinations. Finally, the addition of Schering-Plough’s Thrombin Receptor Antagonist, a potential first-in-class antiplatelet therapy, among other late-stage development candidates, further complements Merck's Phase III cardiovascular development portfolio and will position the combined company to continue offering meaningful products for patients in this important therapeutic area.
Respiratory: The combination with Schering-Plough expands Merck’s strong respiratory franchise with multiple complementary products, including those for the treatment of asthma and allergic rhinitis.
Oncology: Schering-Plough’s current oncology products will enable Merck to expand its presence in this area and provide the necessary foundation to take advantage of the combined company’s promising pipeline.
Neuroscience: Schering-Plough’s strong R&D capabilities in this area complement Merck’s ongoing neuroscience development efforts, which include both migraine and sleep product candidates. In addition to the two companies’ currently marketed neuroscience products, Schering-Plough brings several promising late-stage candidates, including SAPHRIS (asenapine), an antipsychotic drug for the treatment of schizophrenia and bipolar disorder, and BRIDION (suggamadex), a novel anesthesia reversal agent.
Infectious Disease: Schering-Plough and Merck have complementary efforts in infectious disease. The combined company will leverage the scientific and commercial strengths of both Schering-Plough and Merck in the treatment of Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Schering-Plough's strong portfolio of HCV candidates, including boceprevir, is well-aligned with Merck's programs in this critical disease area.
Immunology: Schering-Plough brings distribution rights outside the United States to REMICADE (infliximab), its well-established biologic product for inflammatory/immunological diseases, and SIMPONI (golimumab), which was filed in Europe in March 2008, as well as a number of other promising products in development.
Women’s Health: Merck expects to benefit from a solid portfolio of women’s health products including GARDASIL [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant], a broad range of contraceptive options and biologic and small molecule fertility drugs, which will allow it to strengthen relationships with women’s healthcare providers.
Other Areas: Schering-Plough brings to the combined company a leading Animal Health business with strength in vaccines and small molecules, as well as many attractive consumer health brands such as CLARITIN, COPPERTONE, DR. SCHOLL’S and MIRALAX.
Robust R&D to Deliver Innovative Medicines for Patients: Merck and Schering-Plough both have proven track records of breakthrough research and scientific discovery. The combined company will have a product pipeline with greater depth and breadth, and numerous promising drug candidates. With greater resources, the combined company will have the financial flexibility to invest in these candidates as well as external R&D opportunities and to build on the strong legacies of both companies.
Stronger Commercial Organization: Both Merck and Schering-Plough have proven teams of talented and experienced employees with strong customer relationships. The progress Merck and Schering-Plough have made in implementing new customer-centric selling models will help ensure the smooth and efficient integration of the two commercial operations. The combined company's broader product portfolio will help its sales force to be more effective, increasing its ability to help physicians and healthcare systems improve patient outcomes. Schering-Plough brings key advantages to Merck through its focus on specialty therapeutic areas and its strength in international markets.
Expanded Global Presence with Geographically Diverse Revenue Base: Schering-Plough generates about 70 percent of its revenue outside of the United States, including more than $2 billion in annual revenue from emerging markets. This will dramatically accelerate Merck's own international growth efforts, including the company's goal of reaching top five market share in targeted emerging markets. The combined company will have an industry-leading global team of marketing and sales professionals. In addition, with a more geographically diverse mix of business, the combined company is expected to generate more than 50 percent of its revenue3 outside the United States.
Increased Manufacturing Capabilities: The combined manufacturing operations of Merck and Schering-Plough will considerably increase manufacturing capabilities, adding more capacity to support anticipated growth in biologics and sterile medicines. Merck will achieve even greater synergies by applying its lean manufacturing and sourcing strategies to the expanded operations.
Financial Benefits of the Transaction
Strong Financial Profile: The combined 2008 revenues3 of the two companies totaled $47 billion. Post-transaction, the combined company will have a strong balance sheet with a cash and investments balance of approximately $8 billion. Merck believes it will maintain its current credit ratings. In addition, the combined company’s broad product portfolio is expected to generate robust cash flow.
Commitment to Maintain Merck Dividend: Merck’s Board of Directors is committed to maintaining the dividend at the current level following the closing of the transaction. Merck currently pays an annual dividend of $1.52 per share, which, on an as-converted basis, represents a three fold increase for Schering-Plough shareholders. In addition, the combined company will continue Merck’s share repurchase program after the closing of the transaction.
Substantial Cost Savings: Merck expects to achieve substantial cost savings of approximately
$3.5 billion annually beyond 2011. These cost savings are expected to come from all areas across the combined company and from the full integration of the Merck/Schering-Plough Pharmaceuticals cholesterol joint venture. These cost savings are in addition to the previously announced ongoing cost reduction initiatives at both companies.
Accretive to Earnings: The transaction is anticipated to be modestly accretive to non-GAAP EPS¹ in the first full year following completion and significantly accretive thereafter.
Ability to Optimize Investments for Maximum Benefit: The substantial cost savings expected to be achieved through this combination will be allocated to the best investment opportunities, including pipeline candidates with the greatest probability of success, as well as licensing opportunities. By optimizing its investments, the combined company will maximize the benefits of strategic growth initiatives and R&D efforts to solidify its position at the forefront of innovation and enhance its scientific and technological leadership.
Leadership and Integration
Following the close of the transaction, the Board of Directors of the combined company will be comprised of the Merck Board and three representatives from Schering-Plough’s Board. Richard T. Clark will serve as chairman, president and chief executive officer of the combined company. Fred Hassan, chairman and chief executive officer of Schering-Plough, is committed to continuing the strong operations at Schering-Plough and intends to participate in the integration planning until the close.
Merck’s integration team will be led by Adam Schechter, president of Global Pharmaceuticals, who will report to Mr. Clark. Schering-Plough’s integration team will be led by Brent Saunders, senior vice president and president, Consumer Health Care, who will report to Mr. Hassan. A key priority is keeping the best talent from both companies. Recognizing that the combination will result in a much larger organization, Merck expects that the substantial majority of Schering-Plough employees will remain with the combined company. In addition, both Merck and Schering-Plough will institute hiring freezes immediately.
The combined company will have its corporate headquarters in Whitehouse Station, NJ.
Financing
The aggregate consideration will be comprised of a combination of approximately 44 percent cash and 56 percent stock. The cash portion will be financed with a combination of $9.8 billion from existing cash balances and $8.5 billion from committed financing to be provided by J.P. Morgan.
Transaction Structure
The transaction will be structured as a "reverse merger" in which Schering-Plough, renamed Merck, will continue as the surviving public corporation. The exchange ratio was calculated based on an agreed price of $26.25, with $10.50 in cash and $15.75 in Merck stock, based on a trailing thirty day volume weighted average price of $27.3109. Effective upon the merger, each Merck share will automatically become a share of the combined company. The receipt of shares by Schering-Plough shareholders and the conversion of Merck shares into combined company shares under the transaction is intended to be tax free for U.S. federal income tax purposes. Schering-Plough shareholders will be subject to tax on the cash received up to the amount of gain realized on the shares exchanged.
Guidance
Merck reaffirmed its expectations for full-year 2009 revenue (as reported by Merck & Co., Inc.) to be in the range of $23.7 billion to $24.2 billion. As previously disclosed, based on current information, revenues are likely to be in the lower half of the range. The company also reiterated its expectations for 2009 non-GAAP EPS to range from $3.15 to $3.30, excluding certain items, and a 2009 GAAP EPS range of $2.95 to $3.17. The 2009 GAAP EPS guidance includes a pretax charge of approximately $400 million to $600 million associated with the company's global restructuring program. This guidance excludes any impact from this transaction, which is expected to close in the fourth quarter.
Merck is targeting a high single digit non-GAAP EPS1 compound annual growth rate from 2009 (2009 base represents Merck's stand alone non-GAAP EPS guidance) to 2013. Additionally, in 2013, Merck is targeting pretax margins¹ to be nearly 40 percent and free cash flow to be approximately $15 billion. In light of the announced transaction, Merck today provided 2013 guidance that supersedes previously provided 2010 stand-alone guidance.
Approvals and Time to Close
The transaction is subject to approval by Merck and Schering-Plough shareholders and the satisfaction of customary closing conditions and regulatory approvals, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, as well as clearance by the European Commission under the EC Merger Regulation and certain other foreign jurisdictions. Merck and Schering-Plough expect to complete the transaction in the fourth quarter of 2009.
Advisors
J.P. Morgan acted as financial advisor and Fried, Frank, Harris, Shriver & Jacobson LLP acted as legal advisor to Merck. Goldman, Sachs & Co. and Morgan Stanley acted as financial advisors and Wachtell, Lipton, Rosen & Katz acted as legal advisor to Schering-Plough.
Conference Call and Webcast
Merck and Schering-Plough will host a conference call today, March 9, 2009, at 8:30 a.m. EDT. To access the call, please dial 800-399-0127 (international: +44 (0) 1452 589 088) and reference conference ID number 89050874. A replay of the conference call will be available as soon as practicable following the end of the call until March 23, 2009 at 11:59 p.m. EDT. To access the rebroadcast, please dial 800-642-1687 (international: 706-645-9291) and reference conference ID number 89050874. In addition, an audio webcast of the call will be available live and will be archived on the investor relations portions of both companies’ Web sites at www.Merck.com and www.Schering-Plough.com, respectively, as well as on the joint Web site launched by the companies this morning, www.ANewMerck.com.
Thanks David. Talk about a complete answer to a question! I do not like the difference in HRs for pain vs. no-pain shown in Slide 18.
What troubles me most about Impact: My calcs. show that approximately 40% of patients will on trial for 26 months or less, and approximately 20% at 22 months or less. In 9901/9902a the curves separate nicely post 24 months. Do you think DNDN management really blew it with the SPA change throwing out those 56 events? What are your thoughts on this?
Thanks
>>That same survival improvement (26%) was enough to get oncologists so hot about Taxotere...<
Actually, Taxotere decreased risk of death by 24%. Great – now I feel like an anally retentive FDA statistician.
"Johns Hopkins Kimmel Cancer Center clinicians were among those at leading institutions that have completed a three-year international study showing that docetaxel, a drug made from yew tree needles, decreases the chance of dying by 24 percent in advanced-stage prostate cancer patients resistant to hormone therapy."
http://www.hopkinsmedicine.org/Press_releases/2004/06_07a_04.html
Question for the Board
Can anyone name an instance where the FDA approved a drug application based on two Phase III near misses on p-value on primary endpoint? Such an application would need to be for a life-threatening disease and the drug was not already approved for another indication.
Thanks
Post # 5632 from the Ihub DNDN before that board was functionally destroyed. Given what has occurred with the Provenge saga since that post - it makes me even more distressed today:
Dew: "If the welfare of cancer patients were the main issue, wouldn’t you want DNDN to wait for another 56 events (360-204) in order to give the trial the best possible chance to succeed?
From a patient-advocacy standpoint, surely the delay in obtaining 56 more events pales in comparison to the nightmare scenario where: a) Provenge really does have good efficacy; b) the new 9902b trial fails; and c) the old 9902b trial would have succeeded."
Me: You describe my nightmare - I wish they would have left the trial alone and waited for those hopefully 56 high HR events. Obtaining financing certainly those not seem to be a problem for them. Waiting another 6 to 12 months would not have been such a big deal since the trial has already been going on for nearly 5 years.
OT - Two open doorways for one - the Hudson was pretty choppy today letting water in - windy and cold today in NYC (as in MA) - likely some damage to the fuselage let water in - and the engines. landing gear, etc. log down with water - plus boats don't have the displacement to weight ratios of boats/ships.
Probably won't be of much help, if any at all - maybe the FDA let's them pick up a few events before unblinding. Throwing out 56 events, well that was plain stupid. Dew, remember your "nightmare" scenario post and my response?
The picture you posted was the plane after it was towed back to a Hudson river dock. It is probably touching river bed there and thus only partially submerged. Where it ditched, the river depth was about 60 feet. When the pilot decided to ditch - he hit a "ditch" switch which helps seal up the bottom of the plane in water. His landing was so smooth that he did not cause any cracks to the fuselage. He cleared the George Washington bridge by about 900 feet. If you look closely at the footage - you can see that the Ferries/NYPD/NYFD had the plane secured with straps to keep it from sinking shortly after the crash. So a beautiful landing and quick response kept the plane afloat after the first few minutes. There was plently of water in the plane during most of the rescue and it would have gone down quickly without quick action.
This FDA to Sponsor memo has an interesting response on post-cut-off data. (Since it is a PDF file I could not cut and paste the text - hope the link works). Take a look at FDA response to question #5 in the top memo.
http://www.fda.gov/cder/foi/nda/2003/20-637S016_Gliadel_admindocs_P2.pdf
Dear Fudoo: I hope it all works out for you (eom).
AKA - Great timing on ZGEN "trainwreck":
Bristol-Myers, ZymoGenetics in $1B hepatitis deal
Monday January 12, 4:03 pm ET
By Linda A. Johnson, AP Business Writer
Bristol-Myers, ZymoGenetics sign hepatitis C drug development deal worth up to $1.1B for Zymo
TRENTON, N.J. (AP) -- Drugmaker Bristol-Myers Squibb Co. and biotech company ZymoGenetics Inc. have signed a deal worth up to $1.12 billion to develop a hepatitis C drug based on a new type of the immune-system stimulant interferon.
New York-based Bristol-Myers will pay ZymoGenetics, of Seattle, Wash., $85 million in cash up front for the rights to develop its PEG-Interferon lambda, which already is in early testing in people. Bristol-Myers also will pay its new partner a license fee of $20 million this year, followed by additional payments that could total just over $1 billion if a series of milestones are reached.
The two companies will test the drug jointly in the United States and Europe and share those costs. The companies said they expect ZymoGenetics will conduct much of the ongoing early human studies, plus some of the midstage testing in people. ZymoGenetics will have an option to jointly sell and share in product profits from U.S. sales, and will receive roylaties from Bristol-Myers on foreign sales.
Interferon is a substance that stimulates the immune system to fight invaders. It has been used to treat hepatitis C, a viral infection of the liver, as well as some forms of cancer.
The two partners will do research on a new, type-3 interferon with a technology, called pegylation, designed to keep the drug active in the body as long as possible, something now standard for advanced hepatitis C treatments. The companies said their compound affects a different cell receptor then existing interferon treatments, and that that could result in more targeted therapy and more effectiveness.
Bristol-Myers Squibb, the world's No. 14 drugmaker by revenue, currently has no hepatitis C drugs on the market. However, it has three other compounds in development, according to a company spokeswoman. Bristol-Myers co-markets blood thinner Plavix, the world's second-best-selling drug.
About 170 million people worldwide are infected with hepatitis C, a virus transmitted by blood that damages the liver and is difficult to treat. Among people with chronic hepatitis C infection, 1 percent to 5 percent develop liver cancer, and others may need a liver transplant.
ZymoGenetics would get up to $430 million if it reaches set milestones for development and approval of PEG-Interferon lambda for treating hepatitis C, up to $287 million for development and regulatory approvals of drugs to treat other conditions, and up to $285 million for meeting certain sales goals.
ZymoGenetics develops drugs based on proteins and currently sells Recothrom, a genetically engineered treatment to stop bleeding.
Endo to buy Indevus for $370 million
Endo Pharma will pay up to $7.50 per share for urology and hormone drug maker Indevus
Monday January 5, 2009, 5:26 pm EST
NEW YORK (AP) -- Endo Pharmaceutical Holdings Inc. said Monday it will buy Indevus Pharmaceuticals Inc. for $370 million upfront, or $4.50 per share, acquiring Invedus' urology and hormone drug candidates in the process.
The upfront price represents a premium of 45.2 percent to Indevus' Monday closing price of $3.08. The boards of both companies approved the deal. Endo plans to launch a tender offer for Invedus shares within the next five days. That offer will remain open for 45 days.
Endo could pay an additional $267 million, or $3 per share, if Indevus' long-acting testosterone drug candidate Nebido and its acromegaly treatment candidate ocreotide reach development and sales milestones in the next few years.
Indevus shares rose $2.28, or 73.6 percent, to $5.38 in aftermarket trading. Endo shares slipped 38 cents to $23.67, from $24.05.
Chadds Ford, Pa.-based Endo said the deal will decrease its profit in 2009 and add to its profit in 2010, although it did not detail the effects.
Invedus' is developing Nebido to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The ocreotide implant is designed to treat acromegaly, a hormone disorder that can make the feet, hands, nose and mouth grow to unusually large sizes.
The Lexington, Mass., company plans to send the Food and Drug Administration new data on Nebido in the first half of 2009, as it seeks approval to market the drug in the U.S.
Endo will pay up to $2 per share if Nebido is approved without restrictions in the next three years, or if its approval is restricted but the drug reaches a sales target within five years. It will pay up to $1 per share if the FDA approves the ocreotide implant to treat acromegaly or carcinoid tumors, which usually occur in the gastrointestinal tract, in the next four years.
Indevus also makes the overactive-bladder treatments Sanctura, which was licensed to Allergan Inc., and Sanctura XR. Other products include the drug Supprelin LA to treat early puberty.
Indevus is also hoping to relaunch its bladder-cancer drug Valstar in 2009. It was withdrawn from the market in 2002 after one of its inactive ingredients was determined to be unstable, and the company is waiting for inspections of the third-party manufacturer of the drug to be completed.
Endo sells pain drugs including the Lidoderm patch, Opana and Opana extended-release. The company reported $913.2 million in revenue through the first three quarters of 2008, while Indevus posted $77.8 million in the fiscal year ended Sept. 30, 2008.
In the last 12 months, Indevus stock has traded between $1.19 and $6.95.
http://finance.yahoo.com/news/Endo-to-buy-Indevus-for-370-apf-13971100.html
ASNV pain drug meets main goal
<<From $.07 to $1.49 in a little over a day. I was never a shareholder, but happened to listen the the CC last month when the announced the failure of the companion trial to this with a p=0.07. They had picked a slighly different time frame for their pain endpoint measurement than in prior trials for that indication. Had they stuck with the original time frame the trial would have been statistically successful. The stock collapsed, they dropped further efforts for that indication, laid off most of their people and became a virtual company. This was a $4 to $5 stock this summer. You could hear the pain in the CEOs voice. This trial below came in successful for another indication and the company may survive.>>
UPDATE 2-Anesiva's pain drug meets main goal; shares zoom
Tue Dec 16, 2008 12:40pm EST
BANGALORE, Dec 16 (Reuters) - Anesiva Inc's (ANSV.O: Quote, Profile, Research, Stock Buzz) experimental pain drug Adlea met the main goal of a late-stage trial, raising hopes that the tiny biopharmaceutical company may find a partner to further develop the drug and prompting a six-fold jump in its market value.
"Anesiva should be able to go out and say that this is a drug that works and they should be able to attract a development partner sometime next year," Zacks Investment analyst Jason Napodano said.
Adlea significantly reduced post-surgical pain in four to 48 hours in patients who underwent total knee-replacement surgery, compared with a dummy drug, in the late-stage trial.
The drug candidate also reduced the intake of opioid medication in patients, the company, whose market capitalization stood at about $2.9 million on Monday, said.
The drug candidate's success provides a break for Anesiva, whose market value has eroded by about $138 million since the start of the year.
In November, the company had withdrawn its pain drug Zingo from U.S. markets, citing manufacturing problems, and cut its workforce by 85 percent to 15 employees to preserve capital.
The latest trial data on Adlea could breathe new life into the struggling company, which has been looking for a partner for the pain drug.
Tuesday's announcement puts Anesiva back in the reckoning to find a partner, or license the drug. A partnership is necessary for the company to conduct an additional late-stage study to prove Adlea's efficacy, Zacks Investment's Napodano and Pacific Growth Equities analyst Liana Moussatos said.
"I would say that before the news today they weren't going to get anything. Today it is at least more likely that there will be a deal," Zacks Investment's Napodano said.
Last month, Anesiva said Adlea failed to reduce pain in four to 32 hours in patients who had surgery to remove bony lumps in the feet, and was looking for a partner to develop Adlea.
But the drug had showed efficacy in reducing pain in four to 48 hours after surgery in an earlier late-stage study.
Anesiva shares shot up to a high of 46 cents, before falling back to trade up 27 cents at 34 cents Tuesday on Nasdaq.
"At this point they don't have the luxury to run the next trial and wait around, and file and wait till 2010 or 2011 to get the drug on the market themselves," Zacks Investment's Napodano said.
I agree, but the stock is up 200% this morning. If you want see another one back from the dead look at ANSV - was up over 2,000% from Monday's close.
GlaxoSmithKline and Dynavax Announce Worldwide Strategic Alliance <<Dynavax Rises From the Dead>>
Developing First-in-Class Endosomal TLR Inhibitors for Autoimmune and Inflammatory Diseases
Wednesday December 17, 2008, 6:45 am EST
LONDON & PHILADELPHIA & BERKELEY, Calif.--(BUSINESS WIRE)--GlaxoSmithKline (LSE:GSK - News) (NYSE:GSK - News) and Dynavax Technologies Corporation (NASDAQ:DVAX - News) today announced a worldwide strategic alliance to discover, develop and commercialize novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.
Under the terms of the alliance, Dynavax will receive an initial payment of $10 million for which GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis.
“Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax,” commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. “Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our stockholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programs.”
Dynavax is to conduct research and early clinical development in up to four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product.
Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its first-in-class oligonucleotide-based endosomal TLR inhibitors, called immunoregulatory sequences (IRS). Dynavax’s lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.
“We are committed to using our expertise, in collaboration with Dynavax, to research and develop new therapeutics that can improve the lives of patients with conditions like systemic lupus erythematosus, psoriasis and rheumatoid arthritis,” commented Jose Carlos Gutierrez-Ramos, Ph.D., Senior Vice President and Head of the Immuno-Inflammation Centre of Excellence for Drug Discovery at GSK. “Dynavax is a recognized pioneer in the scientific community for its innovation of endosomal TLR inhibitors which prevent immune signaling in autoimmune and inflammatory diseases.”
Dynavax Conference Call
Dynavax will webcast a conference call today at 9:00 a.m. ET (6:00 a.m. PT) to discuss this alliance. The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at http://investors.dynavax.com/events.cfm.
About TLR Inhibitors
Dynavax’s endosomal TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax’s TLR inhibitors block IFN-alpha and also reduce symptoms in multiple autoimmune diseases models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates. Based on Dynavax’s proprietary technology platform, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax’s product programs are supported by global partnerships with leading pharmaceutical companies such as Merck & Co., Inc., GlaxoSmithKline, and AstraZeneca AB, as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health. For more information visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.dynavax.com&esheet=5855771&lan=en_US&anchor=www.dynavax.com&index=2.
FDA Approves Genzymes Mozobil
Product provides enhanced mobilization of stem cells for autologous transplantation in Non-Hodgkins Lymphoma and Multiple Myeloma patients
Monday December 15, 2008, 4:59 pm EST
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme Corporation (Nasdaq: GENZ - News) announced today that the U.S. Food and Drug Administration has granted marketing approval for Mozobil™ (plerixafor injection), a drug intended to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM). The product has also been granted orphan drug designation.
“Mozobil is an important advancement in the treatment of patients with certain types of cancer who require a stem cell transplant,” said John F. DiPersio, M.D., Ph.D., professor, Washington University, St. Louis. “This product should become an integral part of the treatment regimen for transplantation because of the benefits it offers to patients, physicians and transplant centers.”
Mozobil is designed to mobilize hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with certain types of cancers to proceed to transplant. Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs called growth factors to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are collected in preparation for a transplant.
In order for the transplant to take place, a minimum number of approximately 2 million stem cells per kilogram of body weight must be collected. For many patients, this process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible.
“For many cancer patients, moving on to a transplant is their only hope for remission or a cure,” added Dr. DiPersio.
In the pivotal studies of Mozobil, 59 percent of patients with NHL who received Mozobil and G-CSF collected the target number of at least 5 million stems cells/kg of body weight in four or fewer apheresis sessions compared with 20 percent of placebo patients. The median number of days to reach the target cell count was three days for the Mozobil group and not evaluable in the placebo group. Seventy-two percent of patients with MM who received Mozobil and G-CSF collected the target number of at least 6 million stem cells/kg of body weight in two or fewer apheresis sessions compared to 34 percent of placebo patients. The median number of days to reach the target cell count was one day for the Mozobil group and four days for the placebo group. The target numbers of stem cells in the pivotal studies were chosen based on literature that suggests that reaching these targets can help to facilitate engraftment. Updated 12-month follow-up findings showed that graft durability rates for patients in the Mozobil plus G-CSF and placebo plus G-CSF arms were comparable.
In addition to its expected benefits for patients with NHL and MM, Mozobil may offer economic benefits for transplant centers. The product has the potential to decrease the number of apheresis days and provide transplant centers with predictable and efficient use of the apheresis center. Mozobil may also reduce the number of patients who require a second mobilization procedure due to a failure to mobilize sufficient numbers of cells with current therapy of G-CSF alone. More than 1,000 patients have already received Mozobil through a compassionate use program in the United States. An additional 250 patients have received the product through similar compassionate use programs in Europe since they began 6 months ago. These patients had failed to mobilize enough cells for transplantation using the current standards of care.
Genzyme will commercialize Mozobil in the United States through a blood and marrow transplant sales force that is part of the company’s Transplant and Oncology business unit. This team of dedicated specialists will receive support from the business unit’s oncology sales force to reach a targeted group of hematologists/oncologists and transplant specialists nationwide. This coordinated approach will support physicians and patients across the complementary customer base for these businesses. Genzyme also markets Clolar® (clofarabine), a product indicated for the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. The company recently filed a supplemental new drug application to expand the indication for Clolar to treat adult patients with acute myeloid leukemia. Genzyme’s drugs Campath® (alemtuzumab) and Thymoglobulin® (Anti-thymocyte Globulin [Rabbit]) are also used in the hematology/oncology setting.
Genzyme has submitted an application in Europe for approval of Mozobil and expects approval of the product in the second half of 2009. Genzyme recently filed applications in Australia and Brazil, and additional global applications in up to 60 countries are planned. Mozobil has received orphan drug designation in Mexico which allows the product to be commercialized in the country upon U.S. approval. Approximately 55,000 hematopoietic stem cell transplants are performed each year globally for multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma, and other conditions. Genzyme expects that over time and with further clinical development, Mozobil will be used in the majority of these procedures. Peak sales of the product in the transplant setting are projected to reach $400 million annually.
Genzyme believes that Mozobil may have broad application outside the current indication. Early preclinical and clinical investigations are already underway to explore additional therapeutic indications for Mozobil, including mobilization of hematopoietic stem cells in allogeneic stem cell transplants and tumor sensitization in oncology/hematology treatments such as adult myeloid leukemia.
“Mozobil is an exciting and innovative new treatment that expands Genzyme’s contribution to the field of Hematology and Oncology,” said Joseph Lobacki, senior vice president and general manager, Genzyme Transplant and Oncology. “We look forward to strengthening our partnership with the blood marrow transplant community to make this product broadly available to patients who are facing transplantation procedures for non-Hodgkin’s lymphoma or multiple myeloma.”
About Mozobil
Mozobil, a novel small molecule CXCR4 chemokine receptor antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood in patients with non-Hodgkin’s lymphoma and multiple myeloma. Once circulating in the blood, stem cells can be collected for use in an autologous stem cell transplant. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006.
Important Safety Information
Mozobil is indicated for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. Prescribing physicians and patients should be aware of the potential for tumor cell mobilization in leukemia patients, increased circulating leukocytes and decreased platelet counts, splenic enlargement, and fetal harm when administered to pregnant women. The most common adverse reactions (≥ 10%) reported in patients who received plerixafor in conjunction with G-CSF that were more frequent than in patients who received placebo were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness and vomiting. For full prescribing information, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.genzyme.com%2Fcorp%2Finvestors%2FMozobil_PI.pdf&esheet=5854256&lan=en_US&anchor=www.genzyme.com&index=2.
Dew - Early on 12/12 When the Madoff Story first Broke (post #69961) I made the following post verbatim and you deleted it. At the time I thought you considered it off topic. Since that time you and several others have posted on the topic. What gives?
Another $50 Billion Hedge Fund Fraud
Bernard Madoff arrested over alleged $50 billion fraud
NEW YORK (Reuters) – Bernard Madoff, a quiet force on Wall Street for decades, was arrested and charged on Thursday with allegedly running a $50 billion "Ponzi scheme" in what may rank among the biggest fraud cases ever.
The former chairman of the Nasdaq Stock Market is best known as the founder of Bernard L. Madoff Investment Securities LLC, the closely-held market-making firm he launched in 1960. But he also ran a hedge fund that U.S. prosecutors said racked up $50 billion of fraudulent losses.
Madoff told senior employees of his firm on Wednesday that "it's all just one big lie" and that it was "basically, a giant Ponzi scheme," with estimated investor losses of about $50 billion, according to the U.S. Attorney's criminal complaint against him.
A Ponzi scheme is a swindle offering unusually high returns, with early investors paid off with money from later investors.
On Thursday, two agents for the U.S. Federal Bureau of Investigation entered Madoff's New York apartment.
"There is no innocent explanation," Madoff said, according to the criminal complaint. He told the agents that it was all his fault, and that he "paid investors with money that wasn't there," according to the complaint.
The $50 billion allegedly lost would make the hedge fund one of the biggest frauds in history. When former energy trading giant Enron filed for bankruptcy in 2001, one of the largest at the time, it had $63.4 billion in assets.
U.S. prosecutors charged Madoff, 70, with a single count of securities fraud. They said he faces up to 20 years in prison and a fine of up to $5 million.
The Securities and Exchange Commission filed separate civil charges against Madoff.
"Our complaint alleges a stunning fraud -- both in terms of scope and duration," said Scott Friestad, the SEC's deputy enforcer. "We are moving quickly and decisively to stop the scheme and protect the remaining assets for investors."
Dan Horwitz, Madoff's lawyer, told reporters outside a downtown Manhattan courtroom where he was charged, "Bernard Madoff is a longstanding leader in the financial services industry. We will fight to get through this unfortunate set of events."
A shaken Madoff stared at the ground as reporters peppered him with questions. He was released after posting a $10 million bond secured by his Manhattan apartment.
Authorities, citing a document filed by Madoff with the U.S. Securities and Exchange Commission on January 7, 2008, said Madoff's investment advisory business served between 11 and 25 clients and had a total of about $17.1 billion in assets under management. Those clients may have included other funds that in turn had many investors.
The SEC said it appeared that virtually all of the assets of his hedge fund business were missing.
CONSISTENT RETURNS
An investor in the hedge fund said it generated consistent returns, which was part of the attraction. Since 2004, annual returns averaged around 8 percent and ranged from 7.3 percent to 9 percent, but last decade returns were typically in the low-double digits, the investor said.
The fund told investors it followed a "split strike conversion" strategy, which entailed owning stock and buying and selling options to limit downside risk, said the investor, who requested anonymity.
Jon Najarian, an acquaintance of Madoff who has traded options for decades, said "Many of us questioned how that strategy could generate those kinds of returns so consistently."
Najarian, co-founder of optionmonster.com, once tried to buy what was then the Cincinnati Stock Exchange when Madoff was a major seatholder on the exchange. Najarian met with Madoff, who rejected his bid.
"He always seemed to be a straight shooter. I was shocked by this news," Najarian said.
'LOCK AND KEY'
Madoff had long kept the financial statements for his hedge fund business under "lock and key," according to prosecutors, and was "cryptic" about the firm. The hedge fund business was located on a separate floor from the market-making business.
Madoff has been conducting a Ponzi scheme since at least 2005, the U.S. said. Around the first week of December, Madoff told a senior employee that hedge fund clients had requested about $7 billion of their money back, and that he was struggling to pay them.
Investors have been pulling money out of hedge funds, even those performing well, in an effort to reduce risk in their portfolios as the global economy weakens.
The fraud alleged here could further encourage investors to pull money from hedge funds.
"This is a major blow to confidence that is already shattered -- anyone on the fence will probably try to take their money out," said Doug Kass, president of hedge fund Seabreeze Partners Management. Kass noted that investors that put in requests to withdraw their money can subsequently decide to leave it in the fund if they wish.
Bernard L. Madoff Investment Securities has more than $700 million in capital, according to its website.
Madoff remains a member of Nasdaq OMX Group Inc's nominating committee, and his firm is a market maker for about 350 Nasdaq stocks, including Apple, EBay and Dell, according to the website.
The website also states that Madoff himself has "a personal interest in maintaining the unblemished record of value, fair-dealing, and high ethical standards that has always been the firm's hallmark."
The company's website may be found here: http://www.madoff.com/
(Additional reporting by Christian Plumb, Phil Wahba, Michelle Nichols and Jennifer Ablan in New York and Rachelle Younglai in Washington; Editing by Andre Grenon, Bernard Orr and Alex Richardson)
Speaking of ELN
Related:Elan Corp. plc
DUBLIN, Ireland & SAN FRANCISCO & NEW YORK--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) announced today that it is realigning some of its functions to direct additional investment towards its innovative pipeline. The realignment will result in the elimination of a number of positions and additional refinement to Elan’s commercial activities in Tysabri for Crohn’s disease. Elan has also decided to close its offices in New York and Tokyo during the first quarter of 2009.
Elan CEO Kelly Martin said that for the past several months the company has been assessing several options to ensure sufficient resources are directed toward its most promising research and development opportunities. “We continually evaluate our pipeline, product portfolio, and company structure with a goal of maintaining our flexibility and ability to invest in the most valuable product opportunities for patients while driving value for our shareholders,” Martin said.
Elan President Carlos V. Paya, MD, PhD, said that Elan will shift its effort from what is a traditional sales commercial model to a model based on clinical support and education. “Going forward,” Dr. Paya said, “we will continue providing the appropriate clinical information and scientific data to support the key gastroenterologist relationships we have established in the United States. Elan continues to believe Tysabri is an important therapeutic option for patients with moderately to severely active Crohn’s disease for whom conventional CD therapies and anti-TNFs are not viable.”
http://finance.yahoo.com/news/Elan-Announces-Resource-bw-13814157.html
Novartis P3 MS Results
http://www.novartis.com/newsroom/media-releases/en/2008/1277020.shtml
December 12, 2008 07:15 CET
First Phase III results for FTY720, a novel oral therapy for MS, show superior efficacy compared to interferon beta-1a FTY720 significantly reduced annualized relapse rates by 52% (0.5 mg dose) and 38% (1.25 mg) vs. interferon beta-1a in one-year TRANSFORMS study[1]
FTY720 generally well-tolerated and safety profile in line with previous experience[1]
Regulatory submissions for FTY720 in US and EU on track for end of 2009; FREEDOMS and FREEDOMS II placebo-controlled Phase III studies continuing
Multiple sclerosis, a devastating disease causing progressive disability, affects up to 2.5 million people worldwide including many young adults[2]
Basel, December 12, 2008 - Initial results from the one-year Phase III TRANSFORMS study show the investigational oral compound FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS). Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex®*)[1].
The study, the first one-year head-to-head Phase III trial against a standard of care in MS, met its primary endpoint for both doses of FTY720.
The annualized relapse rate at one year for patients given FTY720 0.5 mg was 0.16, representing a 52% reduction compared to a relapse rate of 0.33 for interferon beta-1a (p<0.001). The FTY720 1.25 mg dose also showed a significant reduction in relapses with a rate of 0.20 representing a 38% reduction against interferon beta-1a (p<0.001). No statistically significant difference was seen between the two FTY720 doses[1].
Comprehensive analyses of the TRANSFORMS study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. Regulatory submissions remain on track to be completed in the US and EU at the end of 2009.
"We are encouraged by the early results from TRANSFORMS, which represent a major step towards delivering an effective oral treatment for people with relapsing-remitting MS," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "These positive results reinforce the potential for FTY720 to provide a significant advance in the future treatment of this devastating disease."
MS is a chronic autoimmune neurodegenerative disease of the central nervous system associated with irreversible progression of disability[3]. As many as 2.5 million people worldwide are affected by the condition[2] that typically begins in early adulthood between the ages of 20 and 40 years when patients are in the prime of life[4]. TRANSFORMS (TRial Assessing injectable interferoN vS FTY720 Oral in RrMS) is the first of three studies to report results in one of the largest Phase III clinical programs ever conducted in MS, involving more than 3,400 patients around the world.
As a head-to-head trial against interferon beta-1a, TRANSFORMS was designed to assess the efficacy of FTY720 compared to an established disease-modifying therapy in reducing relapse rates in patients with relapsing-remitting MS, the most common form of the disease. Two other studies - FREEDOMS and FREEDOMS II - are two-year placebo-controlled Phase III studies to assess the impact of FTY720 in reducing the frequency of relapses and slowing the progression of disability, and to further characterize the benefit-risk profile. Data from these studies to support regulatory submissions are expected in 2009.
TRANSFORMS was a one-year worldwide double-blind, double-dummy study that enrolled 1,292 patients. The study had three arms: oral FTY720 0.5 mg and 1.25 mg once-daily, and the active comparator interferon beta-1a given once-weekly by intra-muscular injection. The patient population in TRANSFORMS was consistent with the demographics and disease state seen in Phase III clinical trials for other disease-modifying treatments for relapsing-remitting MS[5].
The safety profile of FTY720 seen in TRANSFORMS was in line with previous clinical experience. The compound was generally well-tolerated with 87% of FTY720-treated patients completing the study on treatment. The proportion of patients discontinuing therapy was 10% in the FTY720 0.5 mg group, 15% in the FTY720 1.25 mg group, and 12% in the interferon beta-1a group[1].
The most commonly reported adverse events, seen in more than 10% of patients in all three study arms, were headache, nasopharyngitis and fatigue. Influenza-like symptoms were reported in 37% of patients treated with interferon beta-1a and in 4% of patients treated with FTY720[1].
Adverse effects seen in FTY720-treated patients included transient reductions in heart rate at the start of treatment, minor increases in blood pressure, and elevations in liver enzymes (also seen with interferon beta-1a). Macular edema (swelling of the center of the retina) was detected in less than 1% of FTY720-treated patients[1]. Seven cases of localized skin cancer were diagnosed in FTY720-treated patients (four basal cell carcinoma and three melanoma), while one case of squamous cell carcinoma was seen in the interferon beta-1a group. All of these localized skin lesions were successfully removed[1].
As previously reported, two fatal herpes infections occurred in patients treated with FTY720 1.25 mg. Both cases involved confounding factors impacting the outcome, but a role for FTY720 could not be excluded given its immunosuppressive effect.
In general, the safety profile of the FTY720 0.5 mg dose appeared to be better than that of the 1.25 mg dose, including lower rates of infections and bradycardia. Further analyses of the TRANSFORMS data and results from the ongoing Phase III studies will help to provide a more comprehensive assessment of FTY720's benefit-risk profile.
Alternatively, they could have left the final trigger alone at 360 and moved the interim to say 280 to 300. This would have preserved the final power and given them a reasonable shot at the interim. They have the Azimuth Capital financing in place to fund for a later interim or original final trigger if required. It is a $130 stock line.
At what date are you cutting off your data at? With respect to IDIX, it touched $10/sh on 9/3 - it is touching $6/sh now. Granted it had been an incredible run starting the year at $2.69. JP's recent year end price target of $10/sh may be off now. We are all paying for Washington's incompetence in more ways than one.
With respect to your earlier question about my comment about a "15 minute posting delay" - I just thought Ihub takes 15 minutes to post to board given 15 minute post editing window? Sequence of posts and replies sometimes seems off.
Thanks for the HCV discussion tonight.
These are 2 subsites that I came across with info on the HCV area (as well as HBV and HIV from the parent site):
Hope it is helpful to the BV Board:
HCV experimental:
http://www.hivandhepatitis.com/hep_c/hepc_news_alter.html
HCV approved:
http://www.hivandhepatitis.com/hep_c/hepc_news_comb.html
I guess you did not see my next post because of the 15 min. posting delay. I enjoy the discussion as I am trying to learn more about this area. I think the 2 posted PRs are relevant to the discussion.
InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients with Chronic Hepatitis C
http://www.hivandhepatitis.com/2008icr/ddw/docs/060608_a.html
InterMune Presents Top-line Results from Phase 1b Trial of HCV Protease Inhibitor ITMN-191 Monotherapy
http://www.hivandhepatitis.com/hep_c/news/2008/040408_a.html
Odd - the CC call PR was removed from Yahoo Finance today.
They did sell the land for $11 million for a $7 million gain, however - announced today.
<<<ZGEN just anounced a CC out of the blue,
My guess is a partner for IL-29. But it seems unlikely to be bad news because if it were they would be unlikely to wait until next week.>>>
OT - Yes I still follow ALTH and still have a very very small position. When rsr-13 failed badly I considered myself lucky for getting out at around $5.40 with a basis in the mid $2s. I felt the stock had some townside protection with the PDX PII so I held through the final rsr-13 blow-up. The stock was stable through the blow-up so I guess the market had already discounted failure. PDX is an interesting "new and improved" chemo with the "pivotal" PII for a form of NHL. They have recently started a bunch of new trials for the drug for other indications including, nsc lung, bladder, kidney, so mgt is strong on the drug. The relatively new ceo is from Bone Care so he has brought stuff to market before. The "pivotal" PII is an open label single arm trial measuring response rates. The response dates so far in the trial (2/3rds through) have been good based on independent review at I believe 29%. The stock closed at $9.49 today so I am kicking myself - I just have doubts that a single PII will be enough to get by Pazdur even though they have an SPA - so I have been gun shy. Warburg and Baker Bros. are still heavy investors. If it blows up because Pazdur wants another trial I will probably be buying heavy. But, Pazdur loves chemos the saddist that he is - horrible side effects be damned so long as statistical purity is maintained - so who knows. I find that if you can find biotechs that blow-up with some meat left in their drug development programs and a cheap valuation, as in IDIX for example, ALTH after their 1st blow-up, etc, you can do very well. I don't always have downside protection as I recently reentered DNDN, and their is no downside protection if Impact fails.
I bought in Nov 2007 and I am up 200% since then. Dew provided some very compelling arguments ony why the $2s was way too cheap back then and I have to thank him.
<As I posted to someone here a few months ago:
"name DewD's other biotech success since 2005">
Dew has made a very nice call on IDIX as well.
IDIX Lawsuit Settlement Terms
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5809219
Lawsuit Settlement Terms:
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5809219
Bristol-Myers Squibb Proposes to Acquire ImClone Systems for $60.00 Per Share in Cash
Thursday July 31, 7:59 am ET
Offer Represents Approximately 30% Premium to the Closing Price of ImClone's Stock on July 30, Approximately 40% Premium to the Average Share Price of ImClone Common Stock During the Most Recent One-Month Period and Premium in Excess of 40% for the Average Share Prices of ImClone Stock During the Most Recent Three-Month and 12-Month Periods
Combination Is Natural Development in Companies' Successful, Seven-Year-Long Relationship around ERBITUX(R)
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY - News) today announced that it has proposed to enter into an agreement to acquire ImClone Systems Incorporated (NASDAQ: IMCL - News), a global leader in the development and commercialization of novel antibodies to treat cancer, for $60.00 per share in cash, or a total payment of approximately $4.5 billion, to equity holders of ImClone, other than Bristol-Myers Squibb. Bristol-Myers Squibb currently owns approximately 17 percent of all outstanding shares of ImClone.
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Bristol-Myers Squibb’s all-cash offer, which is not conditioned on the receipt of financing or on the conduct of due diligence, represents a premium of approximately 30 percent over ImClone’s closing stock price on July 30, 2008, the last trading day before Bristol-Myers Squibb sent its proposal to ImClone’s Board of Directors, a premium of approximately 40 percent over the average closing price of ImClone’s stock during the most recent one-month period and a premium in excess of 40 percent for the average closing stock prices of ImClone stock during each of the most recent three-month and 12-month periods.
James M. Cornelius, chairman and chief executive officer, Bristol-Myers Squibb, said, “Our proposed acquisition of ImClone represents an evolutionary development in our companies’ seven-year-long relationship, and is in the best interests of Bristol-Myers Squibb and ImClone shareholders and employees, and the patients we serve together. Bristol-Myers Squibb is the natural partner for ImClone as we possess the knowledge base and resources to advance the company’s growth over the long-term, not only with respect to ERBITUX®, the important cancer therapy we jointly commercialize, but also in terms of developing ImClone’s pipeline assets. Our current contractual relationship with ImClone, in which we hold exclusive, long-term marketing rights to ERBITUX in the U.S., has been very successful, and we believe that, by applying Bristol-Myers Squibb’s financial, R&D and marketing capabilities to support the product, we will be able to reach an even broader patient population.”
“For Bristol-Myers Squibb, the proposed acquisition of ImClone represents a strategically and financially sound add-on to our business, consolidating a relationship we have had for nearly seven years. The acquisition is expected to contribute to our financial performance in the 2012-2013 timeframe as well as drive growth beyond 2013,” continued Mr. Cornelius.
“Bristol-Myers Squibb is prepared to proceed to work with ImClone’s Board of Directors quickly and efficiently to reach a definitive merger agreement regarding our all-cash offer, which delivers full and fair value to ImClone’s shareholders. We look forward to meeting with ImClone’s Board and management to effect this transaction in an expedited manner,” concluded Mr. Cornelius.
ERBITUX (cetuximab) is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. Bristol-Myers Squibb and ImClone have been engaged in the co-development and co-commercialization of ERBITUX in the U.S. and Canada under an agreement entered into in September 2001. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39 percent of net sales in North America. This Agreement was amended in July 2007 to provide for additional development funding for certain indications. The Agreement expires in September 2018 with respect to ERBITUX in the U.S.
Bristol-Myers Squibb and ImClone have also been engaged in the co-development of ERBITUX in Japan with Merck KGaA since December 2004. In October 2007, the three companies amended this agreement to provide for co-commercialization of ERBITUX in Japan. The companies received marketing approval for ERBITUX in Japan on July 16, 2008, for use in combination with irinotecan to treat unresectable advanced or recurrent colorectal cancer.
Bristol-Myers Squibb’s proposal to acquire ImClone for $60.00 per share in cash was conveyed earlier this morning by Mr. Cornelius to Carl C. Icahn, chairman of the Board of Directors of ImClone, and confirmed in a letter sent to the Board of Directors. The full text of the letter follows:
Board of Directors
ImClone Systems Incorporated
180 Varick Street
New York, NY 10014
Care of Mr. Carl C. Icahn, Chairman of the Board
July 31, 2008
Dear Carl:
This confirms that Bristol-Myers Squibb Company is offering to enter into an agreement to acquire ImClone Systems Incorporated for $60 per share in cash. Our all-cash offer represents a premium of approximately 30% over the closing price of ImClone common stock on July 30, 2008, a premium of approximately 40% over the one-month average closing price of ImClone common stock, and a premium in excess of 40% over the three-month and one-year average closing prices of ImClone common stock. A full combination of BMS and ImClone is a natural fit for both our companies, and we are convinced our proposed price represents a full and fair offer for ImClone.
For nearly seven years, BMS and ImClone have worked in concert to bring ERBITUX(R) to patients and build a strong product. We value our commercial agreement with ImClone and believe our respective commercial teams have forged an excellent working relationship. We also value our interactions with your scientists and clinicians. We have high regard for the potential of ImClone's pipeline assets, while recognizing the early stage of their development and the significant investment which is required to further their development.
Our Board of Directors has approved this offer. We and our advisors are prepared to meet with you and your advisors to answer any questions you may have about our offer. We are confident that, with ImClone's cooperation, we can reach a definitive agreement very quickly. We do not foresee any regulatory or other impediment to closing. Our offer is not conditioned on financing or due diligence.
As you know, as a result of our current ownership of ImClone stock, we are subject to U.S. securities laws which require us to disclose any material change in our intentions with respect to ImClone as reflected in our Schedule 13D on file with the U.S. Securities and Exchange Commission. Accordingly, we are filing with the SEC an amendment to our Schedule 13D disclosing our offer and including this letter as an exhibit.
In my view, and in the view of our Board of Directors, this transaction makes compelling business sense for both of our companies and is in the best interests of our respective shareholders and the cancer patients for whom our companies' life saving medicines are so important. The price we are offering represents an extremely attractive opportunity for the shareholders of ImClone to realize today the future value of the company. Our desire is to conclude a transaction which is enthusiastically supported by you and all other members of the ImClone Board. We look forward to your prompt response to our offer.
Sincerely,
/s/ James M. Cornelius
James M. Cornelius
Chairman and
Chief Executive Officer
Bristol-Myers Squibb has filed today an Amended Schedule 13D and a Form 8-K with the Securities and Exchange Commission (SEC). Those filings may be accessed at www.sec.gov or via Bristol-Myers Squibb’s website at www.bms.com/ir.
Morgan Stanley & Company Inc., Citigroup Global Markets Inc. and Credit Suisse Securities (USA) LLC are serving as financial advisors to Bristol-Myers Squibb in connection with the proposed acquisition. Cravath, Swaine & Moore LLP is acting as legal counsel to Bristol-Myers Squibb.
Conference Call Information
There will be a conference call today, July 31, 2008, at 8:30 a.m. (EDT) during which Bristol-Myers Squibb executives will address inquiries from investors and analysts regarding its offer to acquire ImClone. Investors and the general public are invited to listen to a live web cast of the call at www.bms.com/ir or by dialing 347-284-6930, access code 3044806. A replay of the conference call will be available until midnight on August 15, 2008 at 402-280-9013, access code 3044806.
Teva to Acquire Barr
http://biz.yahoo.com/bw/080718/20080718005161.html?.v=1
Friday July 18, 7:00 am ET
Significantly Strengthens Teva's Market Leadership Position in the U.S. and in Key Global Markets
Acquisition Expected to Be Accretive in the Fourth Quarter after Closing
JERUSALEM & MONTVALE, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) and Barr Pharmaceuticals, Inc. (NYSE: BRL - News) announced today that they have signed a definitive agreement under which Teva will acquire Barr, the fourth largest generic drug company worldwide. Under the terms of the agreement, each share of Barr common stock will be converted into $39.90 in cash and 0.6272 Teva ADRs. Based upon the unaffected NASDAQ closing price of Teva’s ADRs on July 16, 2008, the indicated combined per share consideration for each outstanding share of Barr common stock amounts to $66.50, or a total consideration of $7.46 billion plus the assumption of net debt of approximately $1.5 billion.
ADVERTISEMENT
Teva expects the transaction to close in late 2008 and to become accretive to GAAP earnings in the fourth quarter after closing. This purchase price represents a premium of 32% to Barr’s average daily closing price on the New York Stock Exchange for the 52-week period ending on July 16, 2008, and 42% to the closing price on July 16, 2008.
This acquisition will further enhance Teva’s leadership position in the U.S. and will significantly strengthen its position in key European and Central and Eastern European markets. On a pro forma basis, 2007 revenues of the combined company would have been approximately $11.9 billion. The combined company will have an unmatched global platform, operate directly in more than 60 countries and employ approximately 37,000 people worldwide.
The companies’ highly complementary product offerings and development pipelines will extend Teva’s generic and proprietary offerings for customers globally. By adding development resources and breadth to Teva’s product portfolio and pipeline, particularly the Paragraph IV and first to file opportunities, Teva will bring more products to market while increasing access to affordable medicines. The transaction also bolsters Teva’s specialty pharmaceutical platform through the addition of Barr’s substantial women’s health portfolio to Teva’s respiratory franchise, further enhancing Teva's balanced business model.
Shlomo Yanai, President and Chief Executive Officer of Teva, said, “The acquisition of Barr will elevate Teva’s market leadership to a new level. The combination of our two companies provides an outstanding opportunity strategically and economically: It will enhance our market share and leadership position in the U.S. and key global markets, further strengthen our portfolio and pipeline, and provide upside to our strategic plan, by allowing us to exceed our 20/20 goals for 2012.”
Mr. Yanai continued, “We have long admired Barr as a highly-focused company with an excellent management team. This is a transaction in which two great, strong companies are joining forces to capture an even greater share of the growing opportunities in generics and deliver even more value to our stakeholders.”
Bruce Downey, Chairman and Chief Executive Officer of Barr, said, “This transaction will enable Teva to capitalize on Barr's portfolio of unique generic and proprietary products, benefit from our capabilities in biologics, and expand its presence in important Central and Eastern European markets. This agreement has the full support of Barr's Board of Directors and senior management, and will benefit the shareholders, customers and employees of Barr.”
Key benefits of the transaction include:
Exceptional Fit Supporting Teva’s Long-Term Strategy: The transaction combines two industry-leading companies, further enhancing Teva’s lead in the U.S. and delivering increased scale and expanded geographic footprint in key global growth markets.
Expanding the Breadth of the Product Portfolio and Pipeline: Teva and Barr's product offerings are highly complementary, extending Teva's product portfolio and pipeline into new and attractive product categories. The combined company will have over 500 currently marketed products; more than 200 ANDAs pending with the FDA with annual brand sales of greater than $120 billion, including approximately 70 first to file Paragraph IV challenges; and approximately 3,700 product registrations pending with various regulatory authorities worldwide, primarily in Europe.
Strengthening Teva's Balanced Business Model: The transaction also bolsters Teva’s specialty pharmaceutical platform through the addition of Barr’s substantial women’s health portfolio to Teva’s respiratory franchise, further enhancing and diversifying Teva's balanced business model. Additionally, this transaction augments Teva’s biologics capabilities.
Compelling Value Consistent with Stated Acquisition Criteria: The combination is expected to deliver significant revenue and cost synergies based on numerous operational efficiencies, increased scale and geographic scope. Teva anticipates the transaction will generate at least $300 million in annual cost savings within 3 years and will continue to provide additional cost savings well beyond 2011. The transaction is expected to be accretive to GAAP earnings in the fourth quarter after closing. The acquisition offers considerable value with a financial structure that preserves Teva’s strong balance sheet and flexibility.
Enhanced Growth and Profitability Provide Upside to 20/20 Strategic Target: The Barr acquisition will enable us to exceed our 20/20 five-year strategic plan, which was to double revenues by 2012 to $20 billion with net income margins of at least 20 percent.
Transaction Terms:
Under the terms of the agreement, Teva will acquire 100% of the shares of Barr for total cash and stock consideration of $7.46 billion. Each share of Barr’s common stock will be converted into $39.90 in cash and 0.6272 Teva ADRs. In addition, Teva will assume Barr's outstanding net debt of approximately $1.5 billion. Teva intends to fund the cash portion of the consideration by using its cash on hand and marketable securities and by approaching the long-term debt market for the remaining balance.
Approvals and Timing:
The boards of directors of both companies have unanimously approved the transaction. The acquisition is subject to approval by the stockholders of Barr, antitrust notification and clearance statutes in North America and Europe, as well as other customary conditions. The transaction is expected to close in late 2008.
The Merger Agreement may be terminated under certain circumstances, including if Barr's Board of Directors determines to accept an unsolicited superior proposal prior to approval of the merger by Barr's stockholders. If the merger agreement is terminated under certain circumstances, Barr will be required to pay Teva a termination fee of $200 million.
Lehman Brothers acted as financial advisor to Teva in this transaction, and Willkie Farr & Gallagher LLP provided external legal counsel for Teva. Banc of America Securities LLC acted as financial advisor to Barr in this transaction, and Simpson Thacher & Bartlett LLP provided external legal counsel for Barr.
Conference Call
Teva and Barr will host a conference call to discuss the transaction today at 08:30 AM EST. The number to call from within the United States is (800) 573-4752 or (617) 224-4324 Internationally and using the participant code 49487796. The call will also be webcast and can be accessed through the Companies’ websites at www.tevapharm.com and www.barrlabs.com. A replay of the conference call will be available from 10:30AM Eastern time on July 18 through 11:59PM Eastern time on July 25 and can be accessed by dialing (888) 286-8010 in the United States or (617) 801-6888 Internationally and using the passcode 33090437.
The reco royalty payment is capped at $45 million if they use the entire facility. Max 4.5 millions warrants ex. at 25% premium. The deal is designed to minimize dilution.
Seems like you were making some cultist arguments to Andy here:
Author: akasidney86 send pm · add member to favs · ignore · recommend
Recs: 139 My email to Andy
Dr. von Eschenbach:
Your decision regarding Provenge is an unmitigated disaster on so many levels:
1. Biotech funding: this will further reduce funding of biotech, arguably the major component, within a free-market economy, of new solutions to very complex health problems.
2. Status of the FDA within the world medical community: it makes you personally and the office of the Director of the FDA a person/position of zero credibility given your repeated comments about the 'new, bridge-building FDA', and thus hurts patients around the world who look towards the U.S. and the FDA for leadership.
3. New medical thinking and breakthroughs: it encourages the obvious, deliterious and widely commented predatory tactics practiced by the hedge fund community of shorting and pressuring developmental biotechs... with only one outcome... fewer successful drugs on the market.
4. Effect on internal FDA policy; It strengthens those who would serve and who live off of Big Pharma and the money it generates, while weakening those who would, while respecting to the letter the stated policy of the FDA, offer a pathway to approval for drugs in terminal disease applications.
5. The effect on patients suffering terminal diseases: it states that, from the FDA's point of view, there is no difference between a potentially lifesaving treatment and a toe fungus medicine... terrible news for all those who need hope in a desperate struggle.
6. The question of the risk<>benefit relationshipand it's current meaning within the FDA: This treatment was turned down in spite of a panel which unanimously stated that it carries no health risk. Therefore, how possibly can the risk/reward ratio be negative if there is no risk and clear reward.
7. The FDA approval process as a whole: as there was no new information disclosed through the FDA vetting process, that can only mean that the information that the FDA denied the BLA on was exactly the same information that it allowed Dendreon to file under. What is the point of that?
8. The importance and viability of the Advisory Committee process: the BLA was voted by the most prestigious authorities the FDA itself could find safe and eficacious... and then ignored. This can only hurt this vital process, the only part of the process actually open to the people that the FDA is supposed to be serving, the public.
9. The importance of patients and patient advocates within the FDA approval process: All of the recognized Prostate Cancer groups supported the Provenge BLA... and were ignored. The FACT that Dr. Maha Hussain actually fell asleep during the disregarded Advisory Committee meeting speaks volumes.
For these reasons and many, many more, your decision to deny the Provenge BLA is simply unconscionable, and we the people will pay the price for many, many years to come.
signed xxxxx
http://investorvillage.com/smbd.asp?mb=971&mn=107543&pt=msg&mid=2105357
IDIX - Novartis Form 4 - Acq. small number of addl. shares
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=5704766