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yep, good call, it seems to be playing out to a script
Teva to Acquire Cephalon in $6.8 Billion Transaction
Enhances and Diversifies Teva’s Branded Portfolio
Pipeline and Marketed Products Broaden Reach into Key Therapeutic Areas Including CNS, Oncology, Respiratory and Pain Management
Attractive Economics with at Least $500 Million in Cost Synergies
Accretive to non-GAAP Earnings Immediately; Accretive to GAAP Earnings Within Fourth Quarter of Closing
Companies to Host Conference Call at 8:30 AM ET
Press Release Source: Teva Pharmaceutical Industries Ltd. On Monday May 2, 2011, 7:00 am
JERUSALEM & FRAZER, Pa.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA - News) and Cephalon, Inc. (NASDAQ:CEPH - News) today announced that their Boards of Directors have unanimously approved a definitive agreement under which Teva will acquire all of the outstanding shares of Cephalon for $81.50 per share in cash, or a total enterprise value of approximately $6.8 billion. The transaction is not conditioned on financing and is expected to be completed in the third quarter of 2011.
The transaction reinforces Teva’s long term strategy of building out its branded and specialty pharmaceuticals business through diversification and expansion of the company’s product portfolio and pipeline. The combined company will utilize its complementary commercial, R&D and operational capabilities. It will capture value by providing customers with a broad spectrum of specialty branded products. The combined company’s sizable branded portfolio represents approximately $7 billion in sales, with a robust pipeline including more than 30 late-stage compounds. The transaction will create immediate and sustainable value in niche therapeutic areas including CNS, oncology, respiratory and pain management. The combined company will become a leader in specialty pharma.
“We are embarking today on a new and exciting future for Teva’s branded business, and we are delighted that we will be working together with the Cephalon team,” said Shlomo Yanai, President and Chief Executive Officer of Teva. “This is transforming for Teva’s branded business, as it will help us to deliver on our strategic goal of creating a diversified, multi-faceted company. We have been following Cephalon for a long time and are very happy with the opportunity to join forces. Our significantly broader portfolio will permit marketing and sales synergies and enhance profitability. We look forward to welcoming our colleagues at Cephalon to the Teva family.”
“Cephalon's merger with Teva is the result of a rigorous process that included a review of a wide-range of strategic options undertaken by Cephalon's Board of Directors and management team to maximize value and deliver significant returns to shareholders,” said Kevin Buchi, Chief Executive Officer of Cephalon. “By joining forces with Teva, we will benefit from their scale, worldwide reach and operational excellence, allowing us to further pursue our shared goals of delivering new, innovative therapies to help patients around the world. Teva shares our strong commitment to R&D, and we believe our pipeline will thrive under their leadership. We look forward to working with the Teva team to ensure a smooth transition and complete the transaction as expeditiously as possible.”
Price and Premiums
The purchase price of $81.50 per share represents a 39% premium to Cephalon’s stock price on March 29, 2011, the last closing price before the unsolicited proposal was announced; a premium of 44% to Cephalon’s average closing stock price over the last 30 trading days prior to the unsolicited proposal; a 12% premium to the unsolicited proposal of $73.00 per share; and a premium of 6% to Cephalon’s closing stock price on April 29, 2011, the last trading day prior to today’s announcement. The transaction is expected to be immediately accretive to Teva’s non-GAAP earnings per share and accretive to Teva’s GAAP earnings within the fourth quarter of closing.
Strategic and Financial Benefits of the Transaction
Diversifies Teva’s Branded Portfolio and Provides Access to New Therapeutic Segments: Together Teva and Cephalon will offer broad market appeal across the pharma spectrum with products that are highly complementary. As a result of the transaction, Teva will expand and diversify its marketed products in CNS, and will add commercial presence in oncology and pain management. The combined company will have more than 20 branded products, with pro forma branded sales of approximately $7 billion.
Provides Attractive and Highly Complementary Pipeline with Significant Value: Cephalon’s attractive pipeline of late-stage products enhances Teva’s pipeline in key therapeutic areas including CNS, oncology, and respiratory, and expands into new areas such as pain management. The combined company will have more than 30 compounds in late-stage development, including three products in filing stage. The pipeline has a long patent life and is well positioned for future growth and success.
Enhances Branded Commercial and R&D Capabilities: Teva will benefit from Cephalon’s brand expertise, infrastructure and talent in specialty pharma. Teva and Cephalon share complementary commercial and R&D capabilities, with proven teams of talented employees with experience in bringing products to market.
Delivers Significant Synergies: By taking advantage of the best of both companies, Teva expects to realize annual cost synergies of at least $500 million in year three following the transaction’s close.
Accretive to Earnings: The transaction is expected to be immediately accretive to Teva’s non-GAAP earnings per share and accretive to Teva’s GAAP earnings within the fourth quarter of closing.
Enhances Global Generic Footprint: With Mepha, Teva will benefit from the #1 generics company in Switzerland with a geographic presence in CEE, Africa and Latin America. Mepha provides Teva with a presence in high growth emerging markets.
Reinforces Teva’s Long Term Strategy: The transaction reinforces Teva’s long term strategy to drive increased diversification across business units, products and geographies. The combined company’s broad product portfolio is expected to support Teva in achieving its stated goal of growing its branded revenues from $4.6 billion in 2010 to over $9 billion in 2015.
Financing and Approvals
The transaction has no financing condition. Teva intends to finance the transaction through cash on hand, lines of credit and the public debt market.
The transaction is subject to the satisfaction of customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and clearance by the European Commission under the EC Merger Regulation, as well as the approval of Cephalon stockholders. The transaction is expected to be completed in the third quarter of 2011.
Advisors
Credit Suisse Securities (USA) LLC is serving as Teva’s financial advisor, and Kirkland & Ellis LLP is serving as its legal counsel. Deutsche Bank Securities Inc. and BofA Merrill Lynch are serving as Cephalon’s financial advisors, and Skadden, Arps, Slate, Meagher & Flom LLP is serving as its legal counsel.
Conference Call and Webcast
Teva and Cephalon will host a conference call to discuss the transaction today at 8:30 AM EDT. The number to call within the United States is 866-713-8566 or 617-597-5325 internationally, using participant code 35520320. The webcast and accompanying slide presentation can be accessed through the companies’ websites at www.tevapharm.com and www.cephalon.com. A replay of the conference call will be available beginning at 11:30 AM EDT on May 2, 2011 through 12:00 AM EDT on May 9, 2011 and can be accessed by dialing 888-286-8010 in the United States or 617-801-6888 internationally, using participant code 91469265.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA - News) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,450 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on neurological, respiratory and women's health therapeutic areas as well as biologics. Teva's leading innovative product, Copaxone®, is the number one prescribed treatment for multiple sclerosis. Teva employs approximately 40,000 people around the world and reached $16.1 billion in net sales in 2010.
About Cephalon
Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas. Cephalon has the distinction of being one of the world's fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 4,000 people worldwide. The company sells numerous branded and generic products around the world. In total, Cephalon sells more than 170 products in nearly 100 countries. More information on Cephalon and its products is available at http://www.cephalon.com.
Additional Information:
This communication may be deemed to be solicitation material in respect of the proposed acquisition of Cephalon, Inc. (the "Company") by Teva Pharmaceutical International Ltd. (“Teva”). In connection with the proposed acquisition, Teva and the Company intend to file relevant materials with the Securities and Exchange Commission (the "SEC"), including the Company’s proxy statement on Schedule 14A relating to the transaction.
INVESTORS OF THE COMPANY ARE URGED TO READ THE COMPANY’S PROXY STATEMENT RELATING TO THE TRANSACTION, AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
Investors and security holders will be able to obtain such documents free of charge through the website maintained by the SEC at www.sec.gov, at the Company's website at http://www.cephalon.com, or by contacting Innisfree M&A Incorporated at (877) 800-5186 (banks and brokers call collect at (212) 750-5833).
The Company and its directors and certain executive officers, may be deemed to be participants in the solicitation of proxies from the holders of the Company’s common stock in respect of the proposed transaction. Information about the directors and executive officers of the Company and their respective interests in the Company by security holdings or otherwise is set forth in its proxy statement relating to the 2011 annual meeting of stockholders, which was filed with the SEC on March 25, 2011. Investors may obtain additional information regarding the interest of the participants by reading the proxy statement relating to the transaction when it becomes available.
Quote: " My predict from 1.5 years ago looks to have been substantially too conservative. At this point it looks like IFN-L gets to market well BEFORE the widespread use of any triple DAA therapy. Excluding the BMY 2DAAs, perhaps it even gets to market before any 2DAAs are approved for use with SOC."
I agree, and the take out price of $735m net of cash was a very bad joke.
I also think your analysis on MNTA has been first rate, and that it is likely they bring something else to market, and if they do it is likely another multi-bagger.
Quote:
"which may say something about what kinds of investors are long DNDN."
----
You mean like me up over 900% and multi-$millions....LMAO
Granted the poster's statement was idiotic.
MNTA- Executive Option and Restricted Stock Grants:
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=7442748
On February 22, 2011, the Compensation Committee of the Board of Directors of Momenta Pharmaceuticals, Inc., a Delaware corporation (the “Company”), approved the following grants of options to purchase shares of the Company’s common stock, $0.0001 par value per share (the “Common Stock”), and awards of restricted Common Stock relating to performance during the fiscal year ended December 31, 2010 for the executive officers of the Company listed below:
Stock Options
Restricted Stock
Craig A. Wheeler
100,000
75,000
Richard P. Shea
23,178
9,271
James Roach
23,178
9,271
John E. Bishop
25,495
10,198
The stock option grants set forth above were made under the Company’s 2004 Stock Incentive Plan, as amended (the “2004 Stock Plan”), under the following terms: (i) an exercise price equal to the last reported sale price of the Common Stock on the date of grant, or $13.26 per share, (ii) a ten year duration and (iii) vesting quarterly over the four-year period following the date of grant, provided that the optionee has a continuous relationship with the Company. The shares of restricted Common Stock set forth above were also awarded under the 2004 Stock Plan. Twenty-five percent of the shares of restricted Common Stock subject to such awards shall vest on February 22, 2012 and an additional 6.25% of the shares of restricted Common Stock shall vest at the end of each three-month period thereafter. The Company’s form of Incentive Stock Option Agreement was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 and is incorporated herein by reference. The Company’s form of Restricted Stock Agreement was filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on February 28, 2008 and is incorporated herein by reference.
Vertex: Stellar Data for Cystic Fibrosis Drug
By Adam Feuerstein 02/23/11 - 08:01 AM EST
CAMBRIDGE, Mass. (TheStreet) --Vertex Pharmaceuticals(VRTX_) released clinical trial results Wednesday demonstrating that an experimental drug VX-770 significantly improved lung function by more than 10% and provided other clinical benefits in adults with a specific form of cystic fibrosis.
The results from the phase III study represent a potential scientific breakthrough because VX-770, if eventually approved, would be the first and only drug to repair the underlying genetic cause of cystic fibrosis rather than merely treating the symptoms of the disease.
Vertex shares were up 20% to $45.90 in Wednesday pre-market trading.
VX-770 corrects a genetic mutation found only in approximately 4% to 7% of the 70,000 cystic fibrosis patients worldwide. The number of cystic fibrosis patients who stand to benefit from VX-770 may be small, but the results from the study are so strong and clinically meaningful that Vertex stands to generate peak annual sales from VX-770 in the range of $400 million to $600 million if the drug is priced comparable to other expensive treatments for rare, genetic disorders.
Vertex said Wednesday that it plans to seek regulatory approval for VX-770 in the second half of the year.
Results from the phase III study known as STRIVE reported by
Vertex showed that treatment with VX-770 through 24 weeks resulted in a mean absolute improvement in lung function of 10.6% compared to placebo. This clinical benefit in favor of VX-770 -- the primary endpoint of the STRIVE study -- was highly statistically significant and was even sustained through 48 weeks of treatment. The STRIVE study enrolled 161 patients aged 12 and older.
To put the 10.6% absolute improvement in lung function in perspective, Vertex designed the phase III study with the intent that a 4.5% improvement would be enough to yield positive results.
Wall Street's professional biotech investors, as a group, were expecting positive results from the VX-770 study but just barely. In a survey of investors conducted by ISI Group biotech analyst Mark Schoenebaum released Tuesday, 87% of respondents believed VX-770 would improve lung function by 5% or less over placebo. Just 6% of the investors in Schoenebaum's poll believed VX-770 could improve lung function by 10% or more.
Vertex shares closed Tuesday at $38.22 but the stock could easily move higher by $3-5 a share Wednesday based on these better-than-expected VX-770 data.
VX-770's robust data in cystic fibrosis is bolstered by positive secondary efficacy endpoints in the study. Patients treated with VX-770 were 55% less likely to suffer from a worsening of their cystic fibrosis symptoms compared to patients treated with a placebo. VX-770 patients gained an average of seven pounds through 48 weeks. VX-770 treatment also resulted in a significant reduction in the amount of salt in the sweat of patients compared to placebo, Vertex announced. So-called sweat chloride is a marker for the underlying cause of cystic fibrosis.
"The results from STRIVE are highly encouraging for the cystic fibrosis community and provide scientific evidence supporting our long-standing belief that targeting the underlying defect of cystic fibrosis may have a profound effect on the disease," said Robert Beall, CEO of the Cystic Fibrosis Foundation, in a statement.
Cystic fibrosis is caused by genetic mutations that result in a malfunctioning or missing protein known as CFTR required for the regulation of sweat production, mucus and certain aspects of digestion. Defective or missing CFTR proteins in lung cells results in the formation of thick, sticky mucus that leads to restricted airflow, chronic infections and lung damage.
Only one working copy of the CFTR gene is needed to prevent cystic fibrosis. Patients with the disease, therefore, inherit two defective genes, one each from their mother and father. Cystic fibrosis is most often diagnosed in childhood and current drugs do not address the underlying causes of the disease. Instead, patients are treated with antibiotics like Novartis'(NVS_) Tobi or Gilead Sciences'(GILD_) Cayston to treat or ward off lung infections. Other drugs and treatments may help loosen or remove the thick, sticky mucus from the lungs. None of the existing cystic fibrosis drugs cure the disease which gets progressively worse as lungs become more damaged over time. The average life span for a cystic fibrosis patient is around 35 years.
VX-770 is designed to be a genetic fix for the 4-7% of cystic fibrosis patients with a genetic mutation known as G551D. Patients with the G551D mutation have sufficient CFTR proteins on the surface of cells but the proteins are damaged and don't work correctly. VX-770 is a "potentiator" designed to improve the function of the damaged CFTR proteins, thereby fixing the root cause of cystic fibrosis in these patients.
A majority of cystic fibrosis patients have a different genetic mutation known as F508del that is not helped by VX-770. Cystic fibrosis patients with the F508del mutation have missing or insufficient CFTR protein on the surface of cells so merely improving the function of these proteins is not enough to reverse the course of the disease.
In a separate phase III study also reported by Vertex Wednesday, treatment over 16 weeks with VX-770 in cystic fibrosis patients with the F508del mutation resulted in a mean absolute improvement of just 1.6% compared to placebo. The result was not statistically significant was not considered clinically meaningful, Vertex said.
Vertex is developing a second cystic fibrosis drug, VX-809, that is designed to "correct" or increase the amount of CFTR protein on the cell surface which therefore may benefit F508del-mutation patients. Vertex is conducting a study investigating multiple combination of VX-770 and VX-809 in cystic fibrosis patients with the F508del mutation. Preliminary results from this mid-stage study are expected in the first half of the year.
Vertex is also running a separate study of VX-770 alone in children with the G551D mutation. Results from this study are expected in the middle of the year.
VX-770 was well tolerated in the phase III studies reported Wednesday. The most commone adverse event reported included pulmonary exacerbation in 13% of VX-770 patients compared to 33% in the placebo patients and bloody cough in 1% of the VX-770 patients compared to 5% in the placebo group.
One percent of VX-770 patients discontinued from the study through 48 weeks compared to 5% for placebo patients.
Most investors identify Vertex with research for new hepatitis C treatments. The company is awaiting an FDA approval decision for an experimental hepatitis C drug telaprevir expected on or before May 23.
--Written by Adam Feuerstein in Boston.
Delcath Systems Receives Refusal to File Letter From FDA
Intends to Resubmit NDA by September 30, 2011
Press Release Source: Delcath Systems, Inc. On Tuesday February 22, 2011, 5:30 am EST
NEW YORK, Feb. 22, 2011 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq:DCTH - News) announced today that the Company has received a "refusal to file" letter from the U.S. Food & Drug Administration (FDA) for the New Drug Application (NDA) for its proprietary chemosaturation system used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride. Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted. Based on management's current understanding of the information in the FDA's letter, the Company intends to resubmit the NDA by September 30, 2011.
In accordance with application regulations, the FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on December 22, 2010. Neither the acceptance nor non-acceptance of the NDA filing is a determination of the approvability of the chemosaturation system.
"The FDA's letter requested information involving manufacturing plant inspection timing, product and sterilization validations and additional safety information that we already planned on filing with our 120 day safety update in April, as well as additional statistical analysis clarification," said Eamonn P. Hobbs, CEO & President of Delcath Systems. "We believe that we will be able to provide the requested information in an updated application and we expect to resubmit the NDA by the end of the third quarter of this year. In the meantime, the CE Mark Technical File review process for marketing approval of the Hepatic ChemoSAT™ Delivery System continues on schedule. Our expectation remains that we will be able to begin addressing the significant European market opportunity by mid-year."
Delcath had a cash position of approximately $47 million as of December 31, 2010. The Company's monthly cash burn rate continues to be approximately $2.2 million per month. As Delcath plans for the anticipated European commercial launch of the Hepatic ChemoSAT Delivery System in the second half of 2011, the Company expects the monthly burn rate will rise in the coming quarters.
Conference Call Information
Delcath will host a conference call today, February 22, 2011 at 8:30 a.m. Eastern Time. Eamonn Hobbs, President and Chief Executive Officer, and David McDonald, Chief Financial Officer, will host the call. The dial-in number for the conference call is 1-877-941-1465 for domestic participants and 1-480-629-9644 for international participants. An audio replay of the call will be available for seven days following the call, and can be accessed by dialing 1-800-406-7325 for domestic callers and 303-590-3030 for international callers, both using passcode 4417144#. The call will also be available on the Internet live and for 7 days thereafter at www.delcath.com.
ASCO - Subsequent treatment with APC8015F and its effect on survival in the control arm of phase III sipuleucel-t studies.
Meeting:
2011 Genitourinary Cancers Symposium
Session Type and Session Title:
General Poster Session B: Prostate Cancer
Citation:
J Clin Oncol 29: 2011 (suppl 7; abstr 139)
Author(s):
D. J. George, C. Nabhan, L. G. Gomella, J. B. Whitmore, M. W. Frohlich; Duke University Medical Center, Durham, NC; Oncology Specialists, SC, Park Ridge, IL; Jefferson Kimmel Cancer Center, Philadelphia, PA; Dendreon Corporation, Seattle, WA
Abstract:
Background: Sipuleucel-T is an autologous cellular immunotherapy approved for metastatic castrate resistant prostate cancer. Methods: After disease progression, subjects in the control arms of 3 randomized controlled sipuleucel-T trials were offered 3 infusions of APC8015F, an autologous immunotherapy made from cells cryopreserved at the time of control generation. Results: Of 249 control subjects, 165 (66.3%) received APC8015F; the median time from randomization to first infusion was 5.2 months (range 1.8 to 33.1), median time from objective disease progression to first APC8015F infusion was 2.2 months (range 0.5 to 14.6), and 145 subjects (87.9%) received all 3 infusions. The frequency of infusional toxicities was increased following APC8015F relative to control infusion, but was slightly lower than following sipuleucel-T. APC8015F-treated subjects (n=155) had improved post-progression survival relative to untreated controls (n=61) (HR=0.52 [95%CI 0.37, 0.73] p=0.0001, log rank test, unadjusted Cox regression); however, APC8015F-treated subjects had more favorable prognostic features than untreated controls. A Cox regression analysis adjusting for baseline PSA and LDH demonstrated that APC8015F therapy remained a predictor of survival in control subjects (HR=0.56 [95%CI 0.40, 0.80]; p=0.001). A Cox regression model adjusting for age, PSA, LDH and post-randomization docetaxel use (yes/no), also showed a significant effect for salvage treatment among control subjects (HR=0.55 [95%CI 0.39, 0.78] p<0.001). Examination of APC8015F product characteristics demonstrated that cumulative CD54 upregulation was associated with survival following first infusion in subjects who progressed and received APC8015F (p=0.03), consistent with previous reports of correlations between sipuleucel-T product parameters and overall survival. Conclusions: Although confounded with measured and unmeasured factors influencing outcome, these analyses suggest that post-progression treatment with APC8015F may have extended the survival of subjects in the control arms of these studies.
http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=104&abstractID=72543
How ZymoGenetics Coulda Been a Contender: The Big Break That Came Too Late
Luke Timmerman 1/25/11
ZymoGenetics, if it had stayed an independent company in Seattle, would be worth tens of millions of dollars more today than what it was in September when it agreed to be acquired by Bristol-Myers Squibb (NYSE: BMY).
Bristol clearly scored a big break with its new ZymoGenetics assets on December 21, about two months after it closed the books on its $885 million acquisition of the venerable Seattle biotech.
If it had still been an independent biotech, the value of ZymoGenetics would have soared that day when Cambridge, MA-based Vertex Pharmaceuticals announced that, essentially, it had failed to make ZymoGenetics’ lead drug candidate obsolete. On that day, Vertex (NASDAQ: VRTX) said it was unable to eradicate one of backbone components of hepatitis C therapy in a high profile clinical trial.
Vertex is blazing a new trail in the field with a potent new oral pill that generates unprecedented cure rates when given in combination with two standard treatments—pegylated interferon alpha and ribavirin. Vertex was hoping to raise the bar even higher, to find out if its lead molecule, telaprevir, could be combined into a new cocktail regimen that Vertex hoped would kick old-school interferon into the dustbin of history. Doctors and patients have been yearning for a way to get rid of interferon, which causes nasty flu-like symptoms that make patients feel awful for months, which discourages most patients from seeking treatment.
ZymoGenetics, knowing this well, had developed a genetically modified version of interferon, which it called pegylated interferon lambda. This new form of interferon was designed to kill the hepatitis C virus just like the older version of interferon, but without the flu-like side effects. Results from early clinical trials were so promising that ZymoGenetics was able to entice Bristol to sign a $1.1 billion partnership to co-develop the drug in January 2009.
Doug Williams
But many on Wall Street weren’t impressed. They had fallen head over heels for Vertex’s new molecule, insisting that ZymoGenetics and Bristol were wasting their time with a new type of interferon. Vertex, they said, was coming along with a cocktail approach of new oral pills that would get rid of interferon, meaning any improvement on old-school interferon would soon be irrelevant. While many doctors, and companies like Vertex still hope it will be possible to do this, the latest clinical trial failure makes it clear that interferon will be part of the standard treatment regimen for years. That means the drug Bristol acquired from ZymoGenetics has a chance to integrate itself into a new standard of care, at a moment when awareness has never been higher among an estimated 6 million U.S. and European patients with this liver-damaging condition.
Former ZymoGenetics CEO Doug Williams, who recently took a new job as head of R&D at Weston, MA-based Biogen Idec, acknowledged in a recent interview that the failure of Vertex’s combination trial would have been a positive event for ZymoGenetics and its pegylated interferon lambda program. He stopped short of saying that Wall Street would have perceived the development in a way that would have boosted ZymoGenetics’ stock price.
“Certainly some people would have come off the fence and perhaps started to believe that interferons will be really hard to get rid of,” Williams says. “I’m certainly of the mind that it will be extremely difficult to get rid of interferon, and achieve [cure rates] currently seen.”
He added: “I gotta believe it would have been viewed as a net positive, but the degree to which it would have been reflected in the stock price, I don’t think anybody can say that.”
David Miller, the president of Biotech Stock Research in Seattle, who criticized ZymoGenetics for selling the company at a bargain price, said he believes investors would have given the company credit. An estimated 6 million patients in the U.S. and Europe have hepatitis C, and many of them are expected to start seeking treatment in 2011, now that a new wave of protease inhibitors like Vertex’s telaprevir and Merck’s boceprevir are being primed to hit the market later this year. The existing interferons from Roche and Merck made up a combined market worth more than $2 billion in 2009, even before the more-effective protease inhibitors came along to spur more interest in hepatitis C therapy.
ZymoGenetics could have seen its stock climb another $2 to $3 a share if it had still been an independent company when the Vertex news hit the wire on December 21, Miller says.
“Smart money was moving toward ZymoGenetics,” Miller says. The latest clinical trial failure of the no-interferon regimen, Miller says, “would have been huge for ZymoGenetics. People were starting to understand that interferons aren’t going anyway anytime soon. This press release (from Vertex) would have cemented that.”
Now that doctors are getting accustomed to seeing hepatitis C cure rates in the neighborhood of 70 to 75 percent of patients who take the combo regimen of the Vertex drug, plus interferon and ribavirin, it’s unlikely they will ever sacrifice even a few percentage points of effectiveness just to get rid of interferon’s side effects, Williams says. That means the bar is high for any oral pill cocktail regimen that aspires to get rid of interferon. It’s certainly possible that the combination of doses, and schedules, could coalesce to make that happen, but it will take years to figure out in clinical trials, Williams says.
Given that was what ZymoGenetics management was betting on with their new interferon, and that its thesis was essentially validated on December 21st, I had to ask Williams if he regrets selling the company for less than a billion dollars. He said no.
“I don’t look back on these sorts of decisions,” Williams says. “You make the decision you have to make at the time with the information you have available to you at the time. I feel we made the right decision at the right time.”
http://www.xconomy.com/seattle/2011/01/25/how-zymogenetics-coulda-been-a-contender-the-big-break-that-came-too-late/?single_page=true
Mylan's Matrix Receives Approval for Generic Version of Protonix®
PITTSBURGH, Jan. 24, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq:MYL -News) today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-release (DR) Tablets USP, 20 mg (base) and 40 mg (base), the generic version of Wyeth's Protonix® DR Tablets, a treatment for the irritation of the esophagus caused by gastroesophageal reflux disease (GERD).
Pantoprazole Sodium DR Tablets had U.S. sales of approximately $1.7 billion for the 12 months ending Sept. 30, 2010, according to IMS Health. Mylan Pharmaceuticals Inc. is shipping this product immediately.
Currently, Mylan has 170 ANDAs pending FDA approval representing $97.8 billion in annual sales, according to IMS Health. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $24.3 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.
http://finance.yahoo.com/news/Mylans-Matrix-Receives-prnews-3432519627.html?x=0&.v=1
Former ZGEN CEO Doug Williams goes bi-coastal:
Biogen Idec’s New R&D Boss, Doug Williams, Spurns Corner Office for a Return to Big Science
Luke Timmerman 1/6/11
Doug Williams spent more than 20 years working his way up from bench scientist to CEO, and long after reaching the top, a realization hit. What he wanted most was to go back to his true passion—getting his hands dirty in a big and strong R&D organization with potential to create new drugs.
“Having done the CEO thing at ZymoGenetics, what I spent an awful lot of time doing was talking to investors and raising money for the company,” Williams says. “Not that I didn’t enjoy it—I did—but for the next chapter in my career what I truly wanted to do is be back in the day-to-day, doing R&D activities all day, every day.”
Williams, 52, will still talk to investors from time to time, but he will certainly get a chance to ply his science and business acumen on a day-to-day basis as the new head of R&D at Weston, MA-based Biogen Idec (NASDAQ: BIIB). The company has grown into the fifth-most valuable organization in the biotech industry, with a $15.9 billion market valuation, ranking it behind Amgen, Gilead Sciences, Celgene, and Genzyme. Much of Biogen Idec’s value is based on its strength as the world’s largest maker of multiple sclerosis drugs. The company runs in the black, generated $4.37 billion in revenue in 2009, and has assembled a talented workforce with 4,275 employees at last count. The R&D budget was about $1.3 billion in 2009.
Despite all that, Biogen hasn’t been able to deliver a new FDA approved product since natalizumab (Tysabri) arrived in 2004. The lack of R&D output has prompted blistering critiques from billionaire investor Carl Icahn, who accused the company in 2009 of suffering from “failed leadership.” Not long after the public attack, R&D chief Cecil Pickett stepped down, and so did CEO James Mullen. Chairman Bill Young, moving on, said the next CEO would likely be a scientist. Sure enough, when CEO George Scangos was introduced, the first thing he said was that R&D had to improve. A few months later, Biogen said it was cutting 650 jobs, closing its San Diego operation, getting rid of cancer and cardiovascular research, and concentrating much of its effort on its core strength of neurology and immunology.
While cuts have already been made, Biogen still needs to start showing more R&D progress if it wants to thrill investors again. Williams, who I have been covering for almost 10 years now dating back to his days as the chief scientist at Seattle-based Immunex, comes to this task with a background that’s clearly relevant to a Biogen that wants to focus on neurology and immunology.
Williams got his Ph.D in physiology, and did a stint on the faculty at Indiana University before he moved to Seattle to join the biotech industry at Immunex in the late ’80s. He carved out his expertise in immunology and autoimmune diseases there, and was the chief scientist at Immunex when it introduced the groundbreaking drug etanercept (Enbrel). That drug is now projected to be the world’s third-best selling pharmaceutical with $8 billion in worldwide sales by 2014, according to Thomson Reuters.
After Immunex got bought by Amgen, Williams moved on to take senior R&D jobs at Seattle Genetics and ZymoGenetics. He was promoted to CEO of ZymoGenetics two years ago.
The experience at the helm of ZymoGenetics was a tumultuous one, where Williams laid off more than one-third of the staff, and made significant cutbacks to a once proud and sprawling ZymoGenetics R&D operation in cancer and autoimmune diseases. To Williams, those were cuts that had to be made, and they represented the kind of ruthless, rational decisions that all R&D organizations must make.
Biogen, he says, “needs to focus on making crisper decisions, and making tough priority calls across the portfolio,” Williams says. “We spent 18 months at ZymoGenetics when I was CEO doing exactly that. It’s something I’m familiar with and comfortable with. It’s something every R&D organization has to get good at.”
The job of chief scientist, Williams says, is essentially about making tough calls on which drug candidates to bet big on, and which ones to kick to the curb. Especially in a weak financing environment like today’s, companies can’t afford much waste if they want to secure more financing.
“You to need to make sure everything you spend money on really provides you the greatest opportunity for success. You can’t go about things half way. You have to bear down on the programs with greatest likelihood of success,” Williams says.
Whatever decisions get made under Williams, he’s not the kind of guy who will work in some kind of imperious fashion. One longtime confidante of Williams, attorney Stephen Graham of Fenwick & West, described him in an Xconomy story in January 2009 as “calm, thoughtful, insightful and unflappable. As a person, he’s low-key, respectful and personable. He’s a leader who seeks and respects the input of others.”
Williams, after leaving ZymoGenetics, certainly had a number of other opportunities to do a startup, or possibly be a CEO again at a development-stage biotech drug company. Instead, he chose an opportunity to sort through a pipeline with 13 drug candidates in clinical trials, including five in the final stage normally required for FDA approval. “It was an opportunity where I could go in with a company with a great history and all the resources necessary to make a big impact,” Williams says. “Not a lot of companies have the profile of Biogen Idec.”
There were some personal attachments, too. Although Williams has made his career and raised his family in Seattle, he grew up in western Massachusetts. He got interested in medical science at a young age, as I noted in a 2002 Seattle Times story. His father had cancer, and he tagged along on hospital trips, intrigued with what the doctors were doing to try to save him. As he mentioned yesterday to the Boston Globe, Williams grew up “a lifelong Red Sox and Bruins fan.”
While Williams has never worked directly with Biogen CEO George Scangos, or the new chief business officer Steve Holtzman, the three executives all got to know each other on the board of San Diego-based Anadys Pharmaceuticals (NASDAQ: ANDS). “For me personally, it’s an opportunity to go to work with a great company, but also with two guys and a management team I respect,” Williams says.
While Williams and his colleagues have a chance to pump new life into Biogen, it’s a loss for Seattle biotech. As I noted in a story back in November when Williams left ZymoGenetics, he’s one of the few nationally prominent biotech executives left in the Northwest. Bob Nelsen, managing director for Arch Venture Partners, said in November that “He can do anything he wants, from CEO, startup, to VC. Hopefully he stays here! I would back him any day.”
Williams intends to commute to Boston during the week, and fly home to Seattle on weekends, at least while his daughter finishes up high school this year, he says. But he will be house-hunting in Massachusetts, and plans to stop the cross-continental commute when his daughter sets off for college.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. You can e-mail him at ltimmerman@xconomy.com, or follow him at twitter.com/ldtimmerman
http://www.xconomy.com/boston/2011/01/06/biogen-idecs-new-rd-boss-doug-williams-spurns-the-corner-office-for-a-return-to-science/?single_page=true
EXEL - Some reading for you:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm182443.htm
There are other documents more specific to HRPC in general, but it would take me a while to find. There was a FDA Prostate Cancer Workshop pre-Impact results (and follow-up publication shortly post Impact results) discussing the suitability of various endpoints in HRPC. It has been a long while since I looked at this stuff. They better have a SPA for the P3 as Pazdur wants survival as the primary.
I have not looked at the EXEL data. My opinion does not matter - the FDA, according to their publicly available guidance documents, much prefers survival data in an HRPC registration trial.
Quote: Provenge, though in fairness it was just short of stat sig in PFS.
--------------------------------------------------------------------------------
IMPACT missed by a wide margin on PFS. HRPC patients typically progress fairly rapidly and a Provenge driven immune response takes time to ramp up. Reading bone scans is a soft subjective endpoint anyway.
Regardless, the FDA much prefers survival as a primary endpoint in oncology registration trials. Despite all the naysayers concerning marginal efficacy - according to DNDN’s MEDCAC presentation – Provenge is one of only four drugs that have demonstrated a 4 month or greater survival benefit in oncology during the past 15 years. This survival benefit would likely have been better without the 70% crossover rate to “Frovenge”. In a sane world, given the treatment's impressive safety profile, it should sell well.
MNTA - Goldman Sachs starts coverage with a Neutral Rating and a 12-Month Price Target of $15
(sorry I do not have a link - appeared on my trading platform news page) Sees the company benefitting from evolving landscape of biosimilars but upside capped by threat of another company entering generic Lovenox market.
UPDATE 1-Barclays raises Novartis on strong Gilenya data
Fri Dec 17, 2010 10:31am EST
* MS drug widely prescribed in first months after launch
* Barclays cites data from ImpactRx
* Novartis shares outperform sector index
(Adds Novartis share price, details, background)
ZURICH, Dec 17 (Reuters) - Barclays analysts raised their Novartis (NOVN.VX) price target on Friday on the back of strong uptake data for the Swiss drugmaker's multiple sclerosis pill Gilenya, adding to upbeat sentiment for Novartis.
The Barclays analysts said Gilenya, recently launched in the United States, had 23 percent of new written prescription starts in November among neurologists, according to data from pharmaceuticals industry research firm ImpactRx.
Gilenya has won market share from rival drugs such as Biogen Idec's (BIIB.O) Tysabri and Teva Pharmaceutical Industries' (TEVA.TA) injectable drug Copaxone, the data showed.
Barclays' new price target for Novartis is 56 Swiss francs, up from 53 francs.
The analysts also said serious adverse affects from Gilenya could still emerge and it could face competition from drugs like Teva's Laquinimod. [ID:nSGE6B805Q]
The Barclays analysts are forecasting Gilenya peak sales of more than $4 billion.
The said Biogen was most exposed to the success of new oral drugs like Gilenya, while Rebif, made by EMD Serono, an affiliate of Germany's Merck KGaA (MRCG.DE) and Pfizer Inc (PFE.N), was least likely to be affected.
At 1447 GMT, Novartis shares were trading near flat at 56.60 francs, outperforming the 1 percent drop in the STOXX Europe 600 Healthcare index .SXDP.
Novartis, which this week wrapped up its buyout of eyecare group Alcon (ACL.N), is banking on specialty medicines, such as Gilenya, as well as a diversification strategy to protect it against patent expiries on big-selling medicines, like blood pressure drug Diovan. [ID:nLDE6BE045]
MS, a disabling neurological condition, can cause dizziness, fatigue, blurred or double vision and cognitive problems. It affects more than 2 million people worldwide.
A decision from the European Medicines Agency on Gilenya is expected to come within the next few weeks.
http://www.reuters.com/article/idUSLDE6BG0RZ20101217
FDA yanks Avastin in breast
http://finance.yahoo.com/news/Genentech-Provides-Update-on-bw-2937117359.html?x=0&.v=1
EU prepares for biosimilar antibody drugs
http://www.reuters.com/article/idUSTRE69047620101001
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON | Fri Oct 1, 2010 1:05pm EDT
LONDON (Reuters) - European regulators will spell out requirements for copies of antibody drugs next month, paving the way for generic competition in a multibillion-dollar market that includes treatments for cancer and immune system disorders.
European Medicines Agency (EMA) Executive Director Thomas Lonngren told Reuters on Friday that guidelines on biosimilar monoclonal antibodies would be published after being reviewed by the agency's expert committee on drug approvals in November.
The keenly awaited guidelines will then be open for three to six months of external consultation before being formally adopted, most likely in the second half of 2011, he said.
Up to now, complex biotech medicines have been generally immune from generic competition, unlike conventional pills and capsules. But the regulatory landscape is starting to change, posing a threat to leading biotech groups such as Roche Holding AG and Amgen Inc.
Europe has already approved 13 biosimilars, including copycat versions of human growth hormone, anemia treatment EPO and G-CSF against low white blood cell levels. Antibodies, however, are a far bigger prize and generic manufacturers are eager to cash in as patents on key products start to expire.
So far, the EMA has received requests for scientific advice on six biosimilar antibodies -- a relatively small number that reflects the difficulties of making such copycat medicines.
"This is much more complicated than the normal generic business, so it will be a lot of work for these companies," said Lonngren, who expects around two or three applications a year.
CLINICAL TRIALS
As with the 13 existing biosimilar drugs approved by the EMA, generic companies will have to conduct clinical trials to prove their antibody is similar to the original product on which it is based. "Clinical trials will be required," he said.
Lonngren declined to detail how extensive trials would have to be but said requirements were likely to be less onerous than in the United States, since the EMA will not give a view on whether biosimilars should be substitutable for the original.
U.S. regulatory preparations for biosimilar are further behind than in Europe, but leading generic drugmakers -- including Teva Pharmaceutical Industries, Novartis AG and Hospira Inc -- are eyeing opportunities in both markets.
Teva already has clinical studies under way comparing its copy of Roche's antibody drug Rituxan to the original in treating both rheumatoid arthritis and non-Hodgkin's lymphoma, a type of blood cancer.
The European patent on Rituxan, also known as MabThera, expires in 2014 and the drug could be the first antibody to face a cut-price biosimilar competitor. Rituxan had sales last year of 6.1 billion Swiss francs ($6.2 billion).
Worldwide sales of all biologic drugs reached some $130 billion in 2009, according IMS Health. With demand growing fast, the potential market for biosimilars could be worth tens of billion of dollars in the second half of the decade as multiple patents expire, industry analysts believe.
(Editing by Dan Lalor and David Holmes)
ZGEN - IL21 Survival Results (not that it matters from an investment perspective, but good for patients):
ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today announced positive survival data from a Phase 2a clinical trial in metastatic melanoma with recombinant Interleukin 21 (IL-21) as a single agent. Median overall survival was 12.4 months, and the percentage of patients surviving at 12 months was 53%.
“The median overall survival of 12.4 months in the Phase 2 study with IL-21 in advanced melanoma patients is very encouraging,” said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “We look forward to further results from an ongoing IL-21 Phase 2b randomized clinical trial in melanoma.”
The open-label, single-arm, multi-center Phase 2 study was conducted by the NCIC Clinical Trials Group in Canada. A total of 40 patients with Stage 4 melanoma were enrolled and treated with IL-21 using 3 dosing regimens. Previous results for the clinical trial were presented at the American Society of Clinical Oncology 2010 meeting. Overall response rate was 23% in 39 evaluable patients, and median progression-free survival was 4.3 months. Common adverse events were fatigue, rash, fever, myalgia, anorexia, chills and nausea. Responses were not dependent on B-Raf status.
About Interleukin 21 (IL-21)
Interleukin 21 (IL-21) is a cytokine that modifies the function of cells in the immune system. IL-21 activates several types of immune cells thought to be critical in eliminating cancerous or virally infected cells from the body. Specifically, IL-21 enhances the activity of natural killer cells and has multiple effects on cytotoxic T cells. This novel immunotherapy has demonstrated antitumor activity in multiple tumor types (metastatic melanoma, renal cell cancer and non-Hodgkin's lymphoma) as a single agent and in combination with other therapies. More than 250 patients have been treated with IL-21 in clinical trials. The lead indication is metastatic melanoma, where IL-21 has shown efficacy.
About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical trials cooperative group that conducts phase I-III trials testing anti-cancer and supportive therapies across Canada and internationally. It is one of the national programmes and networks of the Canadian Cancer Society Research Institute (CCSRI), and is supported by the CCSRI with funds raised by the Canadian Cancer Society (CCS). The NCIC CTG’s Central Office is located at Queen’s University in Kingston, Ontario, Canada.
65% of People Whose Prior Treatment for Hepatitis C Was Unsuccessful Achieved SVR (Viral Cure) with Telaprevir-Based Therapy in Phase 3 REALIZE Study
-17% of people achieved SVR with pegylated-interferon and ribavirin alone in the control arm-
-Safety and tolerability results were consistent with prior Phase 3 studies-
http://finance.yahoo.com/news/65-of-People-Whose-Prior-bw-636554820.html?x=0&.v=1
Press Release Source: Vertex Pharmaceuticals Incorporated On Tuesday September 7, 2010, 4:01 pm EDT
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX - News) today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex’s collaborator, Tibotec.
“The REALIZE data represent a major milestone in the development of new treatments for hepatitis C, as patients who received telaprevir-based therapy had a viral cure rate almost four times greater than the cure rate in those treated with available medicines,” said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany and Principal Investigator of the trial. “These results may provide hope to people who have not been cured and who are in need of new treatment options, including those with advanced liver disease.”
“Along with results from ADVANCE and ILLUMINATE, the REALIZE data provide us with a strong understanding of telaprevir’s potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. “With these data, we look forward to completing our rolling New Drug Application submission for telaprevir later this year.”
Overview of SVR Results
The primary endpoint of the study was SVR in each of the two telaprevir arms compared to the control arm, as well as across the three subgroups of people included in the study. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether there was any further improvement in viral cure rates when delaying the start of telaprevir by four weeks, during which time patients received four weeks of pegylated-interferon and ribavirin alone, compared to a simultaneous start. The SVR rates between these two arms were similar and there was no clinical benefit to the telaprevir delayed start treatment arm in any of the subgroups of patients. The table below combines the two telaprevir arms compared to the control.
Relapsers
(n=354) Partial Responders
(n=124) Null
Responders
(n=184) Overall (ITT)
(n=662)
Telaprevir-
based
Treatment
Arms+ 86%*
(n=245/286) 57%*
(n=55/97) 31%*
(n=46/147) 65%*
(n=346/530)
Pooled Analysis: 78% (n=300/383)**
Control
Arm++ 24%
(n=16/68) 15%
(n=4/27) 5%
(n=2/37) 17%
(n=22/132)
Pooled Analysis: 21% (n = 20/95)**
*Combined endpoint analysis: The SVR rates observed in the overall combined telaprevir-based arms were statistically significant when compared with the control arm (p < 0.0001). Additionally, the SVR rates observed in each of the three groups of patients evaluated were statistically significant when compared with the control arm (relapsers and partial responders (p<0.0001) and null responders (p<0.001)).
+Reflects SVR rates from the combined telaprevir-based treatment groups. There were two telaprevir-based treatment groups:
1. 12 weeks of telaprevir (750 mg, q8h), pegylated-interferon (Peg-IFN) & ribavirin (RBV), followed by 36 weeks of Peg-IFN & RBV alone or
2. 4 weeks of Peg-IFN & RBV alone followed by 12 weeks of telaprevir (750 mg, q8h), Peg-IFN & RBV, followed by 32 weeks of Peg-IFN & RBV alone
++12 weeks of placebo, Peg-IFN & RBV, followed by 36 weeks of Peg-IFN and RBV alone
**Supplemental analysis
Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy.
Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.
Partial Responder: Defined as a person who achieved at least a 2 log10 reduction at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy.
Backgrounders on hepatitis C treatment response and the REALIZE study (including trial design diagram) can be found at http://investors.vrtx.com/press.cfm
SVR rates for the telaprevir simultaneous start arm and the delayed start arm were 64% and 66%, respectively, overall, based on an intent-to-treat (ITT) analysis. For the primary analysis, the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001); 59%, 54% and 15% in partial responders, (p<0.0001); and 29%, 33% and 5% in null responders, (p<0.001).
Safety & Tolerability Results
The safety and tolerability results of the telaprevir-based regimens in the REALIZE study were consistent with results reported from the Phase 3 ADVANCE and ILLUMINATE studies. The most common adverse events, reported in any treatment arm during the telaprevir dosing periods and up to week 16 to account for the telaprevir delayed start arm in order of frequency, were fatigue, pruritis, headache, rash, flu-like symptoms, nausea and anemia, with the majority being mild to moderate. Of these, fatigue, pruritis, rash, flu-like symptoms, nausea and anemia were more common in the telaprevir-based treatment arms compared to control. Adverse events leading to discontinuation of all study drugs during the telaprevir dosing period and up to week 16 occurred in 4% of people in the combined telaprevir arms and 3% in the control arm during the same period. Discontinuation of all drugs due to anemia and rash during the telaprevir dosing period and up to week 16 occurred in 0.6% and 0.4% of patients, respectively, in the combined telaprevir arms, while discontinuation of all three drugs due to rash and anemia did not occur in the control arm during the same period. As in ADVANCE and ILLUMINATE, the use of erythropoiesis-stimulating agents (ESAs) was not allowed in this study.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. With results from the three Phase 3 studies of telaprevir - ADVANCE, ILLUMINATE and REALIZE - Vertex is on track to complete its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010.
Patient Demographics
REALIZE enrolled people with hepatitis C who did not achieve a viral cure after receiving at least one course of prior treatment with pegylated-interferon and ribavirin. Patients in the study were enrolled based on their response to prior treatment: 53% were prior relapsers, 19% were prior partial responders and 28% were prior null responders. In this study, 26% of patients overall had cirrhosis and 89% of patients overall had a high viral load (HCV RNA = 800,000 IU/mL) when entering the study. Specifically in the null responder population, there were an even greater number of people with cirrhosis (33%) and high viral load (95%). Approximately 50% of patients were genotype 1a and 50% were genotype 1b.
About the Study
REALIZE was a pivotal Phase 3, randomized, double-blind, placebo-controlled study conducted in 662 people at more than 100 international clinical trial sites with the majority in Europe and North America. The study was designed to evaluate the efficacy, safety and tolerability of telaprevir-based regimens in people infected with genotype 1 chronic hepatitis C who did not achieve a viral cure after at least one prior treatment with interferon-based therapy. There were two telaprevir-based arms (simultaneous and delayed start) and one control arm. Patients were randomized 2:2:1 to the two telaprevir arms and the control arm, respectively.
The primary endpoint of the REALIZE study was SVR, defined as the proportion of people who had undetectable HCV RNA (<25IU/mL undetectable by Roche COBAS Taqman HCV test) 24 weeks after the end of all treatment. REALIZE was designed to compare the SVR rates for each of the telaprevir-based regimens with the control arm, separately for the prior response subgroups of relapsers and non-responders (null and partial responders), and then for the two subgroups of non-responders. The secondary endpoint was to evaluate the safety and tolerability of telaprevir in combination with pegylated-interferon and ribavirin.
As in all Phase 3 studies of telaprevir, patients received no more than 12 weeks of telaprevir given in combination with pegylated interferon and ribavirin. In REALIZE, the telaprevir arms included 12 weeks of telaprevir in combination with pegylated-interferon and ribavirin with 36 weeks of pegylated-interferon and ribavirin alone for a total of 48 weeks of treatment.
About the Telaprevir Development Program
To date, more than 2,500 people with hepatitis C have received telaprevir-based therapy as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a viral cure.
Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease.2 According to a 2010 report from the Institute of Medicine, up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved treatment regimen, do not achieve SVR, 4,5,6 or viral cure.1
Hepatitis C is spread through direct contact with the blood of infected people.2 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 If treatment is not successful and a person does not achieve a viral cure, they remain at risk for progressive liver disease.7,8,9,10,11 In the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Additional resources for media, including a hepatitis C backgrounder and glossary of common terms, are available at: http://investors.vrtx.com/press.cfm
References:
1Ghany, m.G., Strader, d.B., Thomas, d.L., Seeff, Leondard B. Diagnosis, Management and Treatment of Hepatitis C; An Update. 2009. Hepatology. 2009;49 (4):1-40.
2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
3 Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Available at http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Accessed May 25, 2010.
4 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
5 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
6 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
7 Morgan T.R, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138: 513-521
9 Volk, Michael I., Tocco, Rachel, Saini, Sameer, Lok, Anna S.F. Public Health Impact of Antiviral Therapy for Hepatitis C in the United States. Hepatology.2009;50(6):1750-1755.
10 Veldt, B.J., Heathcote, J., Wedmeyer, H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
11 Pyenson, B., Fitch, K., Iwasaki, K. Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. This report was commissioned by Vertex Pharmaceuticals, Inc. May, 2009.
Investor Conference Call Today at 4:30 p.m. ET
Vertex Pharmaceuticals will host a conference call and webcast today, September 7, at 4:30 p.m. ET. This call and webcast will be broadcast via the Internet at www.vrtx.com/finances. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events & Presentations button. To listen to the call on the telephone, dial (888) 634-7543 (U.S. and Canada) or (719) 457-2573 (International) and use conference ID number ID 5433422. Vertex is also providing a podcast MP3 file available for download on the Vertex website at www.vrtx.com.
The call will be available for replay via telephone commencing September 8, 2010 at 8:00 p.m. ET running through September 22, 2010 at 5:00 p.m. ET. To listen to the replay dial (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International) and use conference ID number 5433422. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. on September 15, 2010.
New York City Investor and Analyst Webcast Tomorrow, September 8, at 8:00 a.m. ET
Vertex Pharmaceuticals will also webcast its investor and analyst meeting from New York City on Wednesday, September 8, 2010 at 8:00 a.m. ET. This webcast will be broadcast via the Internet at www.vrtx.com/finances. The link to the webcast is available on the Events & Presentations button. The New York City webcast will not be available via telephone. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides.
FDA looks into drug marketing campaigns
http://static.reuters.com/resources/media/editorial/20100902/FDAmarketing.pdf
"Unfortunately more often than not this MB's focus misses these."
Why would you think that? :)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=25442338
Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer
South San Francisco, Calif. -- March 11, 2010 -- Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI) investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone. A preliminary assessment of safety performed by CALGB has shown adverse events that have been previously observed in pivotal trials with Avastin. Data from the study will be submitted by CALGB for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints," said Hal Barron, M.D., head, Global Development and chief medical officer at Roche.
These findings do not impact Avastin's approved uses or its broad development program in other tumor types.
About Prostate Cancer
Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate cancer and approximately 27,000 died from the disease in the United States.
About CALGB 90401
CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate Avastin plus docetaxel chemotherapy and prednisone, compared to docetaxel chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the NCI under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB.
The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival, prostate-specific antigen response rate and safety.
Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.
http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12667
More on Novo:
Novo Nordisk Up On Diabetes Drug's Approval
By GUSTAV SANDSTROM
Of DOW JONES NEWSWIRES
STOCKHOLM -- Shares in Novo Nordisk A/S (NOVO-B.KO) traded sharply higher Tuesday after the Danish pharmaceutical company said the U.S. Food and Drug Administration has approved its drug Victoza for treatment of type-2 diabetes.
The Copenhagen-based company said it expects to introduce Victoza in the U.S. market within weeks.
However, it said the U.S. regulator requires that Victoza is labelled with a warning for thyroid cancer.
In previous tests, the drug caused thyroid tumors in rodents although there were no reported cancer cases in humans.
The U.S. marketing authorization also requires that patients and health-care providers are informed about potential risks of pancreatitis, Novo Nordisk said.
FDA approval allows Victoza to be used in the U.S. in monotherapy, as a second-line treatment, and in combination with oral diabetes drugs, the company said.
Victoza, also known as Liraglutide, was launched in European markets in 2009, and gained regulatory approval in Japan last week.
Analysts say the drug has big commercial potential, particularly in the U.S., the world's largest pharmaceuticals market. Compared to diabetes treatment with insulin, it doesn't risk pushing blood sugar too low and it also helps patients lose weight.
Novo Nordisk's Chief Science Officer Mads Krogsgaard Thomsen told Dow Jones Newswires that Victoza will sell at $8 per 1.2 mg dose in the U.S., compared to EUR3 ($4.23) in the E.U, and noted that the market is commercially important due to the high number of diabetics there.
He said there are no indications that Victoza would cause cancer in humans, adding that the required warning label is unlikely to significantly hurt sales of the drug.
Victoza has sold well in the E.U., where Novo Nordisk continues to roll out the drug to more countries, Krogsgaard Thomsen said, adding that his company also has strong hopes for the drug in Japan.
An FDA expert panel in April last year came to a split decision on whether Victoza, a synthetic hormone that stimulates insulin production in the human body, was safe to be marketed after trials showed an increased incidence of tumors in rats and mice.
The drug will face competition from rival treatments such as Byetta LAR, which is expected to reach the market during 2010. Eli Lilly & Co. (LLY) and Amylin Pharmaceuticals Inc. (AMLN) partnered with Alkermes Inc. (ALKS) to develop Byetta LAR.
Analyst Michael Friis Jorgensen at Alm. Brand, who has a buy rating for Novo Nordisk, said the U.S. approval is very positive for the company. Victoza might generate peak sales of 6 billion-7 billion Danish kroner ($1.14 billion-1.33 billion) in the U.S., he said, but added that the estimate is very uncertain.
He noted that Victoza has been approved for most patient groups, and said the cancer warning had been expected by the market.
At 0907 GMT, Novo Nordisk's shares were trading up 6.6% at DKK370.30, outperforming a 0.9% rise in the wider market in Copenhagen.
---By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099; gustav.sandstrom@dowjones.com
http://www.djnewsplus.com/article/SB126449164208621122.html?mod=J1&a=Top+Stories&h=Novo+Nordisk+Up+On+Diabetes+Drug%27s+Approval
Nope, you are double counting some of those shares:
January 15, 2010 4:27 PM EST
In a 13G filing after the close on Dendreon (Nasdaq: DNDN), Steven Cohen's S.A.C. Capital disclosed a 5.5%, or 7,282,030 share, stake in the biotech company. The firm held just 150,000 shares of DNDN at the quarter ended September 30, 2009. A 13G indicates a passive investment above 5%.
Dendreon is expected to be given approval for prostate cancer treatment Provenge which is expected to be blockbuster therapy for this indication and maybe others.
http://www.streetinsider.com/13Gs/Cohens+S.A.C.+Capital+Discloses+5.5%+Stake+In+Dendreon+(DNDN)/5252197.html
UK Watchdog Blocks Bayer Liver Drug
By STEVE MCGRATH
Of DOW JONES NEWSWIRES
LONDON -- In another sign of growing opposition to high cancer-drug prices, a U.K. regulator Thursday said Britain's state health system shouldn't pay for the liver-cancer drug Nexavar, calling its price tag "simply too high."
National Health Service money could be better spent on cancer treatments offering better value for money, the country's healthcare cost watchdog, the National Institute for Health and Clinical Excellence, or NICE, said in a statement.
Nexavar, also known by the generic name sorafenib, is made by Bayer AG (BAYN.XE) and Onyx Pharmaceuticals Inc. (ONXX). It costs about GBP 2,900 per month, according to NICE.
"We were disappointed not to have been able to recommend the use of sorafenib, but after carefully considering all the evidence...sorafenib does not provide enough benefit to patients to justify its high cost," NICE Chief Executive Officer Andrew Dillon said in the statement.
NICE is known as a tough judge of drug costs, having rejected a number of other pricey treatments in the past. Earlier, it rejected Nexavar for kidney cancer, calling it too costly for that condition, as well. Its decisions often draw fire from patient-support groups, which say the watchdog is putting lives at risk.
Insurers and state healthcare systems worldwide are increasingly balking at the high cost of drugs for cancer and other diseases. Some, like NICE, now weigh a drug's clinical benefit against its cost before deciding to pay for it.
Bayer said it will appeal the decision. After NICE rejected Nexavar in a preliminary review earlier this year, Bayer offered to provide every fourth pack for free, but that concession didn't satisfy NICE. Drug companies negotiating with NICE sometimes offer free product instead of lowering their price, because they fear a concession on price would lead other countries to demand lower prices, too.
"We believed we had satisfied NICE's criteria for how Nexavar would be assessed. However, the "goal posts' appeared to have moved," Nicole Farmer, head of Bayer's oncology unit in the U.K., said in a statement Thursday.
Nexavar, which generated global sales of EUR462 million in 2008, has been approved for sale in more than 70 countries for advanced kidney cancer, and in more than 60 countries for liver cancer.
NICE was considering Nexavar to treat advanced hepatocellular carcinoma (HCC) in patients who are unable to have surgery or other treatments. In these patients, Nexavar extends life by at least three months, NICE said, calling the drug "clinically effective" but not "cost-effective."
A large U.K. cancer charity criticized NICE's decision, but also expressed disappointment in the drug companies.
"This drug has an effect in people with advanced liver cancer who are unable to have surgery or any other treatments, so we are disappointed that the manufacturers have been unable to reach an agreement to enable NICE to recommend this drug," Cancer Research U.K. said in a statement.
"It is particularly frustrating that cancer patients in the U.K. are unable to access this drug when it is routinely available elsewhere in the world," the statement said.
http://www.djnewsplus.com/article/SB125862915691663462.html?mod=J1&a=Interview&h=UK+Watchdog+Blocks+Bayer+Liver+Drug
Idenix Pharmaceuticals Presents Data on IDX184 for the Treatment of Hepatitis C Virus (HCV)
http://ir.idenix.com/phoenix.zhtml?c=131556&p=irol-newsArticle&ID=1348947&highlight=
CAMBRIDGE, Mass., Oct. 30 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) currently being held in Boston, Massachusetts.
Data from a three-day, phase I proof-of-concept study evaluating the safety and antiviral activity of IDX184 will be presented. This double-blind, placebo-controlled, monotherapy, dose-escalation study enrolled 41 treatment-naive HCV genotype 1-infected patients into four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg). IDX184 was well tolerated in this study with no serious adverse events reported and no discontinuations from the study. Patterns of adverse events (AEs) were similar between IDX184- and placebo-treated patients with the most frequent AEs being headache, diarrhea and dizziness. Mean viral load declines ranged from 0.47 log10 in the 25 mg group to 0.74 log10 in the 100 mg group after three days of treatment. In the 75 and 100 mg/day cohorts, patients receiving IDX184 experienced improvements in two key markers of liver injury (AST and ALT), with mean levels of these enzymes decreasing to within normal range. Pharmacokinetic data demonstrated that higher plasma levels of 2'MeG were associated with greater reductions in viral load and ALT levels.
"With favorable safety data and good antiviral activity for IDX184 in HCV patients, these early results are encouraging," said Dr. Jacob Lalezari, principal investigator in the study, Director of Quest Clinical Research and an Assistant Clinical Professor of Medicine at UCSF/Mount Zion Hospital. "Nucleotides may become an essential component of future STAT-C combinations for the treatment of hepatitis C. IDX184 has shown a promising early profile and should be evaluated in longer-term, combination trials."
Results will also be presented from in vitro studies evaluating the combination of IDX184 with other direct-acting antivirals or standard-of-care agents, interferon and ribavirin. These in vitro studies suggest that when IDX184 is combined with compounds from different classes, the antiviral activity may be enhanced, and in some combinations, synergistic. Specifically, the triple combination of IDX184, interferon and ribavirin showed strong synergy in vitro. These in vitro studies also suggest that the combination of IDX184 with other compounds from different classes may suppress the emergence of resistance.
"The in vitro combination data for IDX184 are promising," said David Standring, executive vice president of biology for Idenix. "We look forward to assessing this potential synergy in the next clinical study evaluating IDX184 in combination with pegylated interferon and ribavirin in HCV genotype 1-infected patients."
About IDX184
IDX184 is a novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing.
Hospira Learning Valuable Lessons In European Biosimilar Mkt
DOW JONES NEWSWIRES
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Hospira Inc. (HSP) expects the experience of entering the biosimilar market in Europe to benefit its planned entry into the U.S., regardless of whether legislation provides a path for generic biotech drugs.
Hospira, spun off from Abbott Laboratories (ABT) in 2004, sells injectable generic drugs and medical devices, and is developing biosimilars that have $18 billion in current branded sales. Chief Executive Christopher Begley doesn't expect biosimilars to become key to its financial forecasts for at least five years, but he is learning a few tricks about the future market from going head-to-head with biotech marketing veterans Amgen (AMGN) and Johnson & Johnson (JNJ).
"When you have a drug that is $1 billion or $2 billion and very profitable, you don't go away easily," Begley said, noting that the branded companies are using "every possible tactic out there to prevent generic competition from entering the market and establishing themselves."
A J&J spokesman declined to comment, while Amgen officials didn't respond to questions. Biosimilars have hurt sales of branded drugs, reportedly causing prices to drop 25%-30% on certain biologics in Europe.
Biosimilars are as close to a generic version as possible for complex biologic drugs, which are produced through biological processes, but there is currently no regulatory pathway for their approval in the U.S. That could change as their introduction is expected to be part of coming healthcare reform.
Several biosimilars are sold in Europe, including erythropoietin, or EPO, an anemia treatment sold as Epogen by Amgen and used widely in cancer, kidney and HIV patients.
Amgen doesn't sell the drug in Europe because of a licensing agreement with Johnson & Johnson, which sells a similar product called Eprex. Amgen does sell Aranesp, a longer lasting version of Epogen, and has admitted to cutting prices to defend market share in response biosimilar competition in some countries.
Both drugs are costly. In the U.S., they are among Medicare's top medication expenses.
Hospira launched a biosimilar of Epogen in Europe last year, called Retacrit, and plans to launch a biosimilar of Amgen's Neupogen, used in chemotherapy patients, in late 2010. Other copycat versions of both products are already on the market. Hospira plans to enter the U.S. market with a biosimilar of Epogen in 2015.
Begley estimates that biosimilars only make up about 5% of the total EPO market in Europe, but he said Hospira has a 30% market share and is about two-thirds into its launch, already selling in 15 counties.
In the process, Hospira is learning about how the branded companies present data related to the drugs to physicians, including "how medical professionals are used and what those medical professionals say or don't say."
Although Begley doesn't expect the U.S. market to be identical to Europe, he expects many lessons to translate.
"It better prepares us for the U.S., when the hand-to-hand combat takes place between the sales reps," he said.
Although Begley expects biosimilar legislation in the U.S. by year-end, he is prepared to pursue other options to bring biosimilars to the market. That could include filing a biologic license application with the Food and Drug Administration - the current process for introducing a new biologic therapy - and using clinical trials to demonstrate the effectiveness and safety of the drug.
It is unclear if such a tactic would succeed, but Teva Pharmaceutical Industries Ltd. (TEVA) has said it may pursue a similar strategy if timely biosimilar legislation doesn't pass.
-Thomas Gryta; Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
Copyright (c) 2009 Dow Jones & Company, Inc.
http://www.djnewsplus.com/article/DN-CO-20091001-011622.html?mod=J1&a=T+Wire&h=Hospira+Learning+Valuable+Lessons+In+European+Biosimilar+Mkt+
FDA Panel Backs Allos Lymphoma Drug Folotyn >ALTH
Last update: 9/2/2009 4:45:48 PM
(MORE TO FOLLOW) Dow Jones Newswires
September 02, 2009 16:45 ET (20:45 GMT)
10 yes 4 no from what I understand
Fleming was a no vote - what else is new?
Idenix Pharmaceuticals Prices Underwritten Offering of Common Stock
Press Release
Source: Idenix Pharmaceuticals, Inc.
On Wednesday August 5, 2009, 9:15 am EDT
Companies:Idenix Pharmaceuticals Inc.
CAMBRIDGE, Mass., Aug. 5 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the pricing of an underwritten offering of 7,248,936 shares of its common stock at a price of $3.14 per share. After underwriting discounts and commissions and estimated offering expenses, the company expects to receive net proceeds of approximately $21.2 million. All of the shares are being sold by Idenix. The offering is expected to close on August 10, 2009, subject to customary closing conditions.
The shares will be issued pursuant to a shelf registration statement on Form S-3 previously filed with and declared effective by the Securities and Exchange Commission. Idenix also will file with the Securities and Exchange Commission a prospectus supplement with respect to the offering. Leerink Swann LLC is acting as sole book-running manager for the offering.
This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Idenix, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus supplement and accompanying prospectus may be obtained, when available, from Leerink Swann LLC, Attention: Syndicate Department, One Federal Street, 37(th) Floor, Boston, MA 02110 or by calling toll free, at 1-800-808-7525, Ext. 4814.
http://finance.yahoo.com/news/Idenix-Pharmaceuticals-Prices-prnews-350563461.html?x=0&.v=1
Avastin approved in US for the most common type of kidney cancer
Basel, 3 August 2009
Roche today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) plus interferon alpha for people with metastatic renal cell carcinoma, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the United States. In 2009, approximately 13,000 Americans will die from the disease.
Commenting on the approval, William M. Burns, CEO of Roche’s Pharmaceuticals Division said, “Avastin has now been approved for five different types of cancer in the USA. This underscores our belief in the important clinical benefits that Avastin delivers as we push forward with our ongoing research programs in more than 30 tumour types.”
The FDA approval is based on data from the pivotal phase III study (AVOREN) in patients with advanced, previously untreated metastatic renal cell carcinoma. The study showed that patients who received Avastin plus interferon alpha lived nearly twice as long without their disease getting worse compared to those who received interferon alpha alone; 10.2 months versus. 5.4 months respectively.
Avastin is designed to block the vascular endothelial growth factor (VEGF) protein to address a key underlying cause of cancer growth. Avastin works differently than other approved medicines for renal cell carcinoma because it specifically binds to the VEGF protein, which is produced in elevated amounts in most kidney cancers.
“We hope that researchers someday find a cure for kidney cancer,” said William P. Bro, chief executive officer of the Kidney Cancer Association. “Until then, each new medicine, like Avastin, offers patients an opportunity to find a treatment best suited for them.”
In Europe, Avastin has been available since the end of 2007 for the first-line treatment of patients with advanced and/or metastatic renal cell cancer in combination with interferon alpha.
Kidney cancer is the uncontrolled growth of cancerous cells that originate in the kidneys with no known cause. Nine out of ten people with kidney cancer have renal cell carcinoma.
Avastin in Metastatic Kidney Cancer
This FDA approval is based on data from a global, randomised, double-blind, placebo-controlled Phase III study (AVOREN) of 649 patients with previously untreated metastatic renal cell carcinoma. The study showed patients who received Avastin plus interferon alpha had a 67% increase in the time patients lived without their disease worsening (progression-free survival or PFS), compared to those who received interferon alpha alone (hazard ratio=0.60, 95% CI=0.49, 0.72). In AVOREN median PFS was 10.2 months for patients who received Avastin plus interferon alpha compared to 5.4 months for patients who received interferon alpha alone corresponding to an 89% improvement in median PFS.
The study was originally designed to measure an improvement in overall survival (OS). However, in prior consultation with the U.S. FDA and European regulatory authorities, the PFS endpoint was accepted as the basis for regulatory approval.
Secondary analysis endpoints included objective response rate and OS. In this study, tumour size decreased in 30% of patients in the Avastin plus interferon alpha group, compared to 12% of patients who received interferon alpha alone. There was no improvement in overall survival based on the final analysis after 444 deaths, with a median overall survival of 23 months in the Avastin plus interferon alpha arm and 21 months in the interferon alpha plus placebo arm (hazard ratio=0.86, 95% CI=0.72 , 1.04).
Adverse events in this study were consistent with those previously reported for Avastin or interferon alpha.
About Avastin
Avastin is an antibody that specifically binds and blocks VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis – an essential process of development and maintenance of blood vessels which is required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin’s precise mode of action helps control tumour growth and metastases with only a limited impact on side effects of chemotherapy.
Avastin has proven survival benefits across multiple tumour types. Avastin is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause nearly 3 million deaths each year. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, glioblastoma, and renal cell carcinoma.
More than 500,000 patients have been treated with Avastin so far. A comprehensive clinical programme with more than 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, lung, brain, gastric, ovarian, prostate cancers and others) and different settings (advanced or early stage disease).
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80’000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
http://www.roche.com/media/media_releases/med-cor-2009-08-03.htm
Nexavar in Combination with Chemotherapy Shown to Extend Progression-Free Survival in Patients with Advanced Breast Cancer
Statistically Significant Results Reported from a Phase 2 Study Combining Two Oral Cancer Therapies
Press Release
Source: Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
On Wednesday July 22, 2009, 8:00 am EDT
WAYNE, N.J. and EMERYVILLE, Calif., July 22 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that their first cooperative group-sponsored randomized Phase 2 trial in advanced metastatic breast cancer met its primary endpoint of progression-free survival. The study evaluated Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Study findings demonstrated that the median progression-free survival was extended in patients treated with Nexavar and capecitabine compared to patients receiving capecitabine and placebo. These results were statistically significant (p = .0006). In this trial, the safety and tolerability of the combination was as expected and did not show any new or unexpected toxicities. A complete data analysis from this study is expected to be presented at an upcoming scientific meeting.
"Based on these encouraging data, Onyx and Bayer are evaluating various strategies for Nexavar in breast cancer. Nexavar is already benefiting patients worldwide with liver cancer and kidney cancer," said Todd Yancey, M.D., vice president of clinical development at Onyx. "Despite significant treatment advances, breast cancer continues to be the leading cause of cancer death in women.(i) We hope to establish Nexavar as an important new treatment option for patients with this devastating disease."
"This outcome represents a positive signal of the potential benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease," said Jose Baselga, M.D., chairman and professor of medicine at Vall d'Hebron Institute of Oncology in Barcelona and the principal investigator of this study. "One goal of this study was to evaluate the success of an all-oral regimen, which may represent a unique treatment option for patients with breast cancer."
Breast Cancer Trial Design
The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. These patients had locally advanced or metastatic HER-2 negative breast cancer and had received no more than one prior chemotherapy in this setting. The primary endpoint of the study was progression-free survival. There were several secondary endpoints, including overall survival, time to progression, and safety. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to 1000 mg/m(2) of capecitabine twice daily for 14 days followed by a seven day rest from capecitabine.
About the Nexavar Clinical Program in Breast Cancer
Nexavar is being evaluated in collaboration with investigators and cooperative groups in a variety of treatment settings for patients with breast cancer. Among these trials are three ongoing randomized Phase 2 studies, including a trial to evaluate Nexavar plus paclitaxel in the first-line setting, a trial to evaluate Nexavar plus gemcitabine or capecitabine in the first- or second-line setting following progression on bevacizumab, and a trial to evaluate Nexavar plus docetaxel and/or letrozole in the first-line setting.
About Breast Cancer
Breast cancer was the most commonly diagnosed cancer among women worldwide in 2007-2008 (approximately 1.3 million cases), and the leading cause of death among women with cancer (approximately 465,000 deaths). It is the most commonly diagnosed cancer among women in the United States (1 in 4 cancer diagnoses is breast cancer). There are approximately 200,000 new cases of breast cancer in the U.S. and 350,000 in Europe each year. More than 40,000 women in the U.S. die of breast cancer each year.(i)
Nexavar's Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including lung, ovarian and colorectal cancer and as an adjuvant therapy for liver and kidney cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma and advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. In HCC patients, bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. In RCC patients, incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common adverse events greater than or equal to 20% related to Nexavar for both HCC and RCC were fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal pain. Grade 3/4 adverse events in HCC and RCC patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
http://finance.yahoo.com/news/Nexavar-in-Combination-with-prnews-114860600.html?x=0&.v=1
IDIX - Dew any clue why up 20% today? I know there is a CC on Monday, but today was somewhat unusual.
BTW, I came across this month old article on Yahoo (below), in case you have not seen already. After reading your posts on the co., nothing new here, but it is nice to see some institutional interest.
Idenix Pharmaceuticals gets positive 'Overweight' rating by Thomas Weisel analyst
On Friday June 12, 2009, 12:43 pm EDT
Companies:Idenix pharmaceuticals inc.Intermune inc.Novartis ag
NEW YORK (AP) -- Idenix Pharmaceuticals Inc. received a positive rating from a Thomas Weisel Partners analyst Friday, based on the company's hepatitis C treatment program.
Thomas Weisel analyst Stephen Willey gave the stock an "Overweight" rating and expects shares to reach $8 over the next 12 months as it pushes ahead with development of IDX184 for hepatitis C. He said a recent deal for the HIV treatment candidate IDX899 with GlaxoSmithKline, that is worth about $450 million, will give the company some financial flexibility in the coming years.
Both the hepatitis C and HIV drug candidates are part of the same class of new drugs called nucleoside inhibitors, or NI's, which have the potential to become potent antivirals with fewer toxic side effects, Willey said.
"Idenix is the only small cap (company) with access to clinical and preclinical pipeline candidates from all three primary antiviral classes in hepatitis C," he said, in a note to investors. "This makes the company a potential target for one of the many larger players looking to establish a control premium within the hepatitis C space through the consolidation of antiviral assets."
Hepatitis C is caused by a blood-borne virus that can lead to liver scarring or liver cancer. Current treatments on the market include combinations of the drugs peginterferon and ribavirin, but less than half on it are cured. There is currently a large push by several companies to develop treatments that directly target the virus, making the outlook for the hepatitis C market very competitive.
Vertex Pharmaceuticals Inc., Schering-Plough Corp. and InterMune Inc. are all developing Hepatitis C treatments.
Willey said the underlying technology in IDX184 has become the cornerstone of combination therapies for HIV because of a high barrier to genetic resistance. That propensity for viral resistance will likely drive a push to more combination treatments for hepatitis C, benefiting Idenix.
"This high resistance barrier and broad genotypic coverage will translate into a similar outcome for this class of drugs in hepatitis C," he said.
Idenix currently only has one marketed product, the hepatitis B drug Tyzeka, sold overseas as Sebivo. That drug was licensed to Swiss drugmaker Novartis AG, and Idenix receives royalty payments on sales.
Shares of Idenix rose 4 cents to $3.41 in afternoon trading.
http://finance.yahoo.com/news/Thomas-Weisel-analyst-rates-apf-947848572.html?x=0&.v=2
Biotech Stk Fundings Offer Signs Of Hope In Struggling Sector
DOW JONES NEWSWIRES
By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Jazz Pharmaceuticals Inc.'s (JAZZ) raising of $7 million in a private placement is the latest sign of hope for the hundreds of biotech companies struggling to find cash for their survival.
"We have seen early signs of the [biopharma] funding environment coming back," said Annette Grimaldi, managing director of life-sciences investment banking at Jefferies Group Inc.
While equity financing for biotech companies has improved since last year, the pace remains far those of behind previous years. Plus, the market is being picky as to which companies it is giving access.
Overall, corporate financing has eased in general, but the biotechnology sector has a higher need for that cash than other industries because its drug-development model often requires years of losses before a product is approved.
The recession and tight credit environment have left many biotech companies vulnerable. As of the beginning of the year, 40% of the 330 publicly traded biotech companies in the U.S. had less than one year of cash, according to the Biotechnology Industry Organization.
Fortunately for them, equities financing for the current year is on a better road, according to data compiled by Jefferies, with 10 follow-on stock offerings raising $1.2 billion so far, compared to just 13 in all of 2008 raising $1.4 billion.
Those numbers, though, pale to more lucrative times such as 2007 when companies had 44 such offerings that raised more than $5 billion.
In tough markets, Grimaldi noted, issuers have traditionally favored private financings, using registered direct stock offerings or private investment in public equity, called PIPEs, because they don't want exposure to a public marketing process.
There have been 30 registered direct stock offerings in 2009 so far, compared to 28 in all of 2008, but PIPE offerings are less common as investors don't want to be left holding unregistered shares, which are less liquid.
Recent strength in the equities markets has helped the funding increase, as well as pent-up demand from issuers that desperately need cash.
Jazz, for example, had missed three interest payments on $119.5 million in debt due in 2011, and some analysts noted a risk of bankruptcy prior to Tuesday's news.
The improvement in the stock market since the March lows has companies more comfortable with tapping the equities market, said Ben Perkins, managing director of life-sciences investment banking at Pacific Growth Equities.
"Boards are feeling better about not financing at the low," Perkins said. "Folks believe there is some stability."
But there is still uncertainty as to whether the recent funding improvements are part of a trend, or simply a window of opportunity for companies to find buyers for their shares.
Other than Jazz, biopharmaceutical companies including Genta Inc. (GNTA), Immunogen Inc. (IMGN) and Halozyme Therapeutics Inc. (HALO) have raised money in the equities markets in recent weeks. Late Tuesday, Arena Pharmaceuticals Inc. (ARNA) and Xenoport Inc. (XNPT) both disclosed plans for stock offerings.
Despite the apparent improvement, Grimaldi warned that a macroeconomic setback could reverse the trend.
"There is a sense that this could be a fragile recovery," she said, which also increases the enthusiasm for companies to tap the market.
But the funding increase doesn't signal open access to all comers, she warned, as there is a general preference for companies with a market value exceeding $500 million and which have had some recent good news.
Although the difficult funding environment has increased pressure on smaller companies to cut deals, Grimaldi said she doesn't expect any improvement to hurt deal making.
This is because the larger players still need to bolster their product pipelines and tend to focus on attractive science and product development, rather than simply finding a good deal.
Perkins noted that an improved funding market should provide a slight negotiating leverage to the smaller companies, because they won't be forced into a deal to survive.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
Copyright (c) 2009 Dow Jones & Company, Inc.
http://www.djnewsplus.com/article/DN-CO-20090707-014568.html?mod=J1&a=T+Wire&h=Biotech+Stk+Fundings+Offer+Signs+Of+Hope+In+Struggling+Sector+
FDA approves UCB drug for rheumatoid arthritis
Belgian drugmaker highlights easy-to-use injecter with new rheumatoid arthritis drugs
Matthew Perrone, AP Business Writer
On Wednesday May 13, 2009, 7:44 pm EDT
WASHINGTON (AP) -- Belgian drugmaker UCB said Wednesday it received federal approval for an injectable drug to treat arthritis, entering a competitive market dominated by some of the largest U.S. pharmaceutical companies.
The Food and Drug Administration approved the drug Cimzia for patients with moderate to severe rheumatoid arthritis. The injectable medication was previously approved to treat gastrointestinal Crohn's disease last April.
Cimzia is the fourth in a class of drugs known as tumor necrosis factor blockers approved in the U.S. The three other products are each multibillion-dollar blockbusters: Abbott Laboratories' Humira, Johnson & Johnson's Remicade and Wyeth and Amgen's Enbrel. Enbrel was the biggest seller of the group last year with sales of $3.4 billion.
The drugs all work by targeting and neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.
UCB hopes that a syringe specially designed for arthritis patients will give Cimzia an edge over competitors. A collaboration with consumer product maker OXO Products, the prefilled syringe has oversized finger grips and a rounded needle cap, designed to make it easier for patients to uncap and inject the drug. OXO President Alex Lee said the collaboration was natural, since many arthritis patients are already drawn to the company's ergonomically designed kitchenware.
"The idea of universal design is designing products that are easy and comfortable to use for the largest spectrum of users possible," said Lee in an interview. "That means including people with dexterity issues, but not overtly targeting them."
OXO is a division of El Paso, Texas-based Helen of Troy Ltd.
FDA approved Cimzia based on four studies involving more than 2,300 patients that showed Cimzia alongside the immune-system suppressing drug methotrexate significantly reduced arthritis symptoms after six months. The drug combination also slowed progression of joint damage, the company said.
Dr. Roy Fleischmann, who helped conduct trials of Cimzia, said the new drug could be useful for patients who develop resistance to older drugs like Humira. He also noted the drug's flexible dosing schedule, which permits injection every two or four weeks.
"It's the same dose, but you can do it monthly or every two weeks, and from my experience patients respond equally well," said Fleischmann, who is co-medical director of Metroplex Clinical Research Center in Dallas.
Older drugs like Enbrel and Humira are generally injected every one or two weeks. Despite its relative advantage over those medicines, Cimzia will also have to compete with a new drug from J&J called Simponi, the follow-up to Remicade, which is injected monthly. The FDA approved the drug late last month.
Cimzia is critical to UCB's business outlook as the company continues to lose revenue from expiring patents on older medicines. Last fall, generic drug maker Mylan launched a low-cost version of the company's main product, anti-epileptic drug Keppra. Earlier in the year Brussels-based UCB announced plans to cut costs by laying off 2,000 workers worldwide, or nearly a fifth of its work force.
http://finance.yahoo.com/news/FDA-approves-UCB-drug-for-apf-15237885.html?sec=topStories&pos=3&asset=&ccode=
ZGEN - Dewo - They reaffirmed their $25 to $35 million Reco. 2009 guidance. They stated that “demand” for Reco. was up 45% over the prior quarter. Of interest was also a discussion on some of the Lambda topics you, Tony and Clark have communicated about recently. Worth a listen.
DNDN - On the otherhand BMS was partnered with IMCL back in 2001 so profits are split with them. It was a balance back then on accelerating the pipeline vs. exclusive US profits. Hopefully, in the long run, the valuation of the stock is something else you are a bit off on with regards to DNDN.
<<Collaborations with Bristol-Myers Squibb Company
On September 19, 2001, we entered into an acquisition agreement (the "Acquisition Agreement") with BMS and Bristol-Myers Squibb Biologics Company, a Delaware corporation (BMS Biologics), which is a wholly-owned subsidiary of BMS, providing for the tender offer by BMS Biologics to purchase up to 14,392,003 shares of our common stock for $70.00 per share, net to the seller in cash. In connection with the Acquisition Agreement, we entered into a stockholder agreement with BMS and BMS Biologics, dated as of September 19, 2001 (the "Stockholder Agreement"), pursuant to which all parties agreed to various arrangements regarding the respective rights and obligations of each party with respect to, among other things, the ownership of shares of our common stock by BMS and BMS Biologics. Concurrent with the execution of the Acquisition Agreement and the Stockholder Agreement, we entered into a commercial agreement (the "Commercial Agreement") with BMS and E.R. Squibb relating to ERBITUX, pursuant to which, among other things, BMS and E.R. Squibb are co-developing and co-promoting ERBITUX in the U.S. and Canada with us, and are co-developing and co-promoting ERBITUX in Japan with us and either together or co-exclusively with Merck KGaA.
On March 5, 2002, we amended the Commercial Agreement with E.R. Squibb and BMS. The amendment changed certain economics of the Commercial Agreement and expanded the clinical and strategic roles of BMS in the ERBITUX development program. One of the principal economic changes to the Commercial Agreement was that we received payments of $140.0 million on March 7, 2002, and $60.0 million on March 5, 2003. Such payments were in lieu of the $300.0 million milestone payment we would have received upon acceptance by the FDA of the ERBITUX BLA under the original terms of the Commercial Agreement.
On July 27, 2007, the Company and BMS amended the terms of their commercial agreement for the co-development and co-promotion of ERBITUX in the U.S. and Canada (the "BMS Amendment"). Under the BMS Amendment, the companies have jointly agreed to expand the investment in the ongoing clinical development plan for ERBITUX. With this additional funding, the companies will further explore the use of ERBITUX in additional tumor types including brain, breast, bladder, esophageal, gastric, lung, pancreas and prostate.
Under the BMS Amendment, ERBITUX clinical development and other costs, up to threshold amounts, are the sole responsibility of BMS, with costs in excess of the thresholds shared by both companies according to a predetermined ratio effective January 1, 2007. The terms of the Commercial Agreement, as amended on July 27, 2007, are set forth in more detail below. <<
Idenix Pharmaceuticals Reports Data From Three Hepatitis C Development Programs at the 44th Annual Meeting of the European Association for the Study of the Liver
Thursday April 23, 2009, 7:00 am EDT
Idenix Pharmaceuticals Inc.
CAMBRIDGE, Mass., April 23 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported data from its three hepatitis C development programs being presented this week at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. These presentations include data on IDX184, a once-daily, oral nucleotide polymerase inhibitor prodrug currently being evaluated in a phase Ib/IIa clinical trial, and data on two clinical candidates: IDX375, a non-nucleoside polymerase inhibitor and IDX316, a protease inhibitor, both currently undergoing IND-enabling preclinical studies.
"Idenix's primary goal is to discover and develop the leading HCV antiviral platform," said Jean-Pierre Sommadossi, Ph.D., chief executive officer of Idenix. "With drug candidates in each of the three major classes of direct-acting HCV antivirals in our pipeline, we believe that we are well positioned to design an optimal combination therapy."
IDX184 Nucleotide Prodrug Polymerase Inhibitor
IDX184 is a liver-targeted, oral nucleotide prodrug designed to enhance the formation of its active triphosphate in the liver, while minimizing systemic exposure to IDX184 and the resulting nucleoside metabolite (NM). IDX184 is fully active against HCV genotypes 1, 2, 3 and 4 and, preclinically, has demonstrated increased antiviral activity when tested in combination with HCV protease inhibitors, non-nucleoside polymerase inhibitors, interferon or ribavirin.
IDX184 has been evaluated in a seven-day study in HCV-infected chimpanzees, in which six genotype-1 infected chimpanzees received 10 mg/kg of IDX184 daily for four days. Data presented at EASL confirm a pharmacokinetic/pharmacodynamic (PK/PD) relationship between nucleoside metabolite concentrations in serum and viral load reductions in this study. Trough serum nucleoside metabolite levels were low, ranging from 2-8 ng/mL, and there was a direct correlation between levels of NM and HCV RNA, with greater viral load reductions observed as the NM levels increased. Specifically, serum trough NM levels of greater than 2 ng/mL were associated with HCV RNA reductions of 1 log10 or greater.
An additional presentation on IDX184 detailed results of the double-blind, placebo-controlled, single dose-escalation study that evaluated the safety and pharmacokinetics of IDX184 in healthy volunteers. Eight subjects (randomized 6:2, active:placebo) in each dosing cohort were administered a single dose of IDX184, ranging from 5 mg to 100 mg, or placebo. IDX184 was safe and well-tolerated in this study; the most common adverse event reported was dizziness and it was more frequently reported in subjects receiving placebo. In this study, the pharmacokinetics of IDX184 and the nucleoside metabolite were consistent with a liver-targeted drug. Systemic exposures and plasma half-life of the nucleoside metabolite were similar to that of its active triphosphate measured in vitro in human hepatocytes. In this healthy volunteer study, IDX184 doses of 50 mg/day and higher led to serum NM levels greater than 2 ng/mL 24 hours post-dose.
A phase I/II proof-of-concept clinical trial of IDX184 in treatment-naive HCV genotype-1 patients is ongoing.
IDX316 Protease Inhibitor
IDX316 exhibited potent activity against HCV NS3/4A proteases from multiple genotypes (1a, 1b, 2a and 4a) and in HCV replicons. Long-term in vitro treatment (14 days) with IDX316 produced high levels of suppression that was maintained over the treatment period without evidence of rebound or cytotoxicity. IDX316 also demonstrated high selectivity, with tight binding to the HCV protease and no activity observed against eight human cellular proteases. IDX316 retained activity against common mutations in NS3 and exhibited enhanced activity when combined with standard-of-care agents or other Idenix compounds in development (IDX184 and IDX375). Favorable PK profiles in rodent and non-human primate species suggest the potential for once- or twice-daily dosing in humans (half-life of 4.0-5.2 h; bioavailability of ~20%).
IDX375 Non-Nucleoside Polymerase Inhibitor
The preclinical pharmacokinetic and toxicology profile of IDX375 was also presented at EASL. Data support once- or twice-daily dosing in HCV-infected patients based on favorable bioavailability and plasma drug exposure levels in animal studies. IDX375 showed limited metabolism and no cytotoxicity when incubated with mouse, rat, monkey or human hepatocytes. IDX375 demonstrated no adverse effects in monkeys given daily oral doses of 10 or 100 mg/kg for 7 days.
http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-15008332.html?.v=1
PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Tuesday April 14, 2009, 8:30 am EDT
- Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival -
Related Quotes
Symbol Price Change
DNDN 7.30 0.00
{"s" : "dndn","k" : "c10,l10,p20,t10","o" : "","j" : ""} - First Active Immunotherapy for Cancer to Prolong Survival -
- Full Data to be Presented at Plenary Session at Upcoming AUA Annual Meeting -
- Company to Host a Conference Call Today at 9:00 AM ET -
SEATTLE, April 14 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) announced today that the pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.
"Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies."
"The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer," continued Dr. Gold.
Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year to gain licensure of PROVENGE.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
Conference Call Scheduled for Today at 9:00 a.m. ET
Dendreon will host a conference call today at 9:00 a.m. ET. To access the live call, dial 1-877-419-6594 (domestic) or 719-325-4855 (international). The call will also be audio webcast and will be available from the Company's website at http://www.dendreon.com/ under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 (domestic) or 719-457-0820 (international); the conference ID number is 8182435. The replay will be available from 12:00 p.m. ET on April 14, 2009 until midnight April 16, 2009. In addition, the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.