The idea that Botox is a civil rights issue is ludicrous -- and yet that is the line being pushed by Allergan AGN in its fight against the 5 percent "Botox tax" proposed in the Senate healthcare reform bill. Instead, Allergan and its rival, Medicis MRX, should embrace this new...
The idea that Botox is a civil rights issue is ludicrous -- and yet that is the line being pushed by Allergan AGN in its fight against the 5 percent "Botox tax" proposed in the Senate healthcare reform bill. Instead, Allergan and its rival, Medicis MRX, should embrace this new...
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Allergan and Medicis Pharmaceutical Corp. lead drug stocks lower in morning activity as shares of the dermatology-products makers fall on news that the health-care reform bill put forth by Senate Democrats would levy a 5% tax on elective cosmetic procedures.
The Orange County California based biotechnology company with a primary focus in oncology, and Nippon Kayaku today announced an exclusive collaboration for the development and commercialization of apaziquone in Asia. Apaziquone is an antineoplastic agent which has been fast tracked by the FDA as a treatment of non-muscle invasive bladder cancer by intravesical instillation. {tiny;sppi;0}Spectrum Pharmaceuticals has previously entered into a strategic collaboration with Allergan, Inc. (NYSE: AGN) for North America, Europe, and other key markets. These two collaborations are representative of the Company’s stated objective of achieving solid strategic partnerships that are aimed at fully exploiting developmental goals for apaziquone on a worldwide basis.
“We are excited to partner apaziquone with a strong Japanese oncology company such as Nippon Kayaku,” said Rajesh C. Shrotriya, MD, Chairman of the Board, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Nippon Kayaku is one of the most established and reputable pharmaceutical companies in Japan and has unparalleled experience in Asia in the field of non-muscle invasive bladder cancer and prostate cancer. We believe that Nippon Kayaku is a terrific strategic partner for apaziquone and for Spectrum.”
“Apaziquone is an ideal candidate to complement our portfolio of 24 anti-cancer products,” said Akira Mandai, Head of Pharmaceuticals Group of Nippon Kayaku. “We look forward to working with Spectrum in developing apaziquone for non-muscle invasive bladder cancer.”
Under the terms of the agreement, Nippon Kayaku will pay Spectrum an upfront payment of $15 million and will make additional payments of up to $136 million based on the achievement of certain regulatory and commercialization milestones.
The stock should continue to climb steadily as Spectrum is currently conducting two Phase 3 clinical trials to investigate apaziquone’s safety and efficacy in non-muscle invasive bladder cancer. Spectrum’s goal is to complete enrollment in both Phase 3 studies by the end of this year.
Last week, said the Centers for Medicare and Medicaid Services (CMS) finalized a policy ruling to allow reimbursement for the company's cancer drug, Zevalin, effective Jan. 1, 2010.
Analysts said they had been expecting CMS to allow reimbursement for Zevalin, but added they do not expect a significant ramp in sales until the first quarter of 2010.
"This is very good news for the company -- long term, it will help generate sales given the ease with which physicians will get reimbursed," Rodman & Renshaw senior biotechnology analyst Reni Benjamin said.
On 7/15/09, the Oncologic Drugs FDA Advisory Committee of cancer drug experts voted 14-1 against approval of Johnson & Johnson's (NYSE:JNJ) Yondelis (trabectedin) NDA, which seeks approval in combination with Doxil (doxorubicin) for the treatment of relapsed ovarian cancer in women. The expected PDUFA action date is 9/20/09 for a possible final FDA decision on this NDA. Final overall survival data for Yondelis is expected within about 18-24 months (early to mid 2011). The FDA Advisory Panel members were willing to reconsider the drug once final data is available and safety concerns were raised for the drug, including pulmonary embolism (blood clots in the lung), cardiac adverse events, and liver toxicity.
On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency. The Company's 505(b)(2) NDA for Acetavance includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surgery and one pivotal clinical trial for the treatment of endotoxin-induced fever.
The NDA is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 pediatric patients, from premature neonates to adolescents, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside of the U.S.
On 7/15/09, Watson Pharma (NYSE:WPI) announced the filing of an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the patent expiration of the drug.Watson's trospium chloride extended-release capsules are the generic version of Allergan's (NYSE:AGN) Sanctura XR product (12-month U.S. sales of about $42 million thru 3/31/09), which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
AGN filed suit against Watson on 7/13/09 seeking to prevent generic competition prior to expiration of U.S. patent number 7,410,978, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson believes it may be first to file an ANDA for generic trospium extended-release capsules.
On 7/15/09, Targacept (NASDAQ:TRGT) announced positive top-line results from a double blind, placebo controlled, flexible dose Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment for major depressive disorder (MDD) in subjects who did not respond adequately to first-line treatment with citalopram (Celexa) alone. The result on the primary outcome measure for the trial, mean change between treatment (TC-5214 + citalopram) and placebo (placebo + citalopram) from baseline on the Hamilton Rating Scale for Depression-17, or HAM-D, was highly statistically significant in favor of TC-5214 on an intent to treat basis.
In addition, TC-5214 exhibited a favorable tolerability profile in the trial. The most frequent adverse events were headache, dizziness and constipation. TRGT plans to present detailed results from the Phase 2b trial of TC-5214 in October 2009 and expects Phase 3 clinical development to be initiated during 2Q10 following planned discussions with FDA and production of clinical trial material.
On 7/21/09, STAAR Surgical (NASDAQ:STAA) announced that it has been informed by the FDA Division of Bioresearch Monitoring that the restrictions of the integrity hold put in place by the Agency on 8/3/07 have been removed. The removal of the integrity hold enables the FDA to resume scientific review of the Company's application for the Toric Implantable Collamer Lens (TICL) for Myopic/Astigmatic patients. This application is a PMA Supplement to the Visian ICL which the FDA approved on 12/22/05. Pursuant to the terms of the integrity hold, between September 2007 and May 2009, STAA initiated and completed the following actions required by the FDA. The Company retained Promedica International (PMI) to perform a comprehensive systems audit and data audit related to the TICL application.
PMI performed the required audits of 100% of data of patient records at all seven clinical sites and a systems audit of the Company from December 2007 to October 2008. PMI prepared a systems audit report dated 10/8/08 and submitted the report to the FDA. In addition, PMI prepared a final field audit report dated 3/13/09 and submitted it to the FDA. Based on these reports, STAA submitted a Corrective Action Plan to the FDA on 5/22/09 to address the findings included in the PMI audit reports and provide assurances that all future studies would be conducted in accordance with applicable laws, regulations and good clinical practices.
On 7/21/09, Spectrum Pharma (NASDAQ:SPPI) and Allergan (NYSE:AGN) announced that the FDA has granted Fast Track Designation for the investigation of apaziquone (EOquin) for the treatment of non-muscle invasive bladder cancer, a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer. Approximately 70% of all newly diagnosed patients with bladder cancer have non-muscle invasive bladder cancer (affecting an estimate of more than 1 million patients in the U.S. and Europe ). EOquin has two Phase 3 trials underway with a primary endpoint of tumor recurrence at Year 2 under defined registration paths for the U.S. and Europe . EOquin is expected to complete enrollment in ongoing Phase 3 pivotal trials by the end of 2009 with more than 1,000 patients enrolled at more than 120 sites. SPPI also expects to initiate trials for EOquin in BCG-Failure bladder cancer patients by the end of 2009.
EOquin is a targeted pro-drug that is bio-activated by enzymes which are over-expressed in bladder tumors to focus the drug activity at the site of the bladder cancer. On 11/6/08 , SPPI announced a licensing deal with AGN for $41.5 million upfront additional milestone payments possible for up to $304 million. SPPI retained exclusive rights in Asia ( Japan , China , India ) while AGN received exclusive rights to apaziquone in the rest of the world ( U.S. , Canada , Europe ). In the U.S. , the two companies will co-promote apaziquone and share in its profits and expenses. AGN will pay royalties to SPPI on EOquin sales outside of U.S. SPPI agreed to conduct EOquin clinical trials with AGN bearing 65% of these expenses.
On 7/21/09, Incyte Corp. (NASDAQ:INCY) announced that it reached agreement with the FDA on a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The SPA provides agreement that the study design and planned analysis of the Phase 3 trial adequately address objectives in support of a regulatory submission.
COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment), is a double-blind, placebo-controlled Phase 3 trial comparing the efficacy and safety of INCB18424 to placebo in approximately 240 patients with PMF, PPV-MF or PET-MF.. COMFORT-I is expected to begin in August while COMFORT-II (a second Phase 3 trial being conducted in Europe ) began patient enrollment in July. INCY expects to file a New Drug Application for INCB18424's use in MF in late 2010 or early 2011, assuming that results from the pivotal study are positive.
On 7/20/09, Ardea Biosciences (NASDAQ:RDEA) announced that it has initiated a Phase 2b clinical trial of RDEA594, its lead product candidate in development for the management of hyperuricemia and gout. The Company also announced the selection of RDEA684, a next-generation URAT1 inhibitor, as a development candidate for the same indication. The randomized, double-blind, placebo-controlled, dose-response study will evaluate the safety and serum urate-lowering effects of 200, 400 and 600 mg of RDEA594 in a total of 140 gout patients with hyperuricemia (uric acid levels of 8 mg/dL or more).
The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (marketed as Uloric by Takeda Pharma and Adenuric by Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
I first reported that Bayer Schering (BYERF.PK) could make an offer to acquire SPPI.
August 2, 2009
Reni J. Benjamin, Rodman and Renshaw biotech analyst, told Jonathan Moreland of RealMoney, “[c]ompany's like Bayer or Bristol-Myers (NYSE: BMY) may also look at the company more seriously if they are able to successfully market Zevalin.”
August 4, 2009
I reported SPPI rose 7.16% on speculation that it may be targeted for acquisition.
August 4, 2009
Adam Feuerstein of TheStreet.com (Nasdaq: TSCM) reported he was skeptical about an SPPI buyout.
August 6, 2009
SPPI announced that it acquired the 100% of the rights to RenaZorb® which is currently being studied in trials for hyperphosphatemia in patients with chronic kidney disease.
SPPI is scheduled to report Q2 earnings via webcast on August 13, 2009 at 12:00 PM ET. Interested investors can access the webcast here.
CONCLUSION
SPPI’s move to acquire all of the rights to RenaZorb® indicates to me that Allergan (NYSE: AGN), who has been working to establish its urological drug division, may now be interested in bidding on SPPI.
While this is merely speculation on my part, the possibilities certainly appear to be growing, rather than shrinking, along with SPPI’s share price.
Shares for the biopharmaceutical company, which focuses on pioneering novel cancer therapies with a focus primarily in the areas of hematology-oncology and urology, are under a heavy accumulation which is related to Spectrum’s dealings with the FDA, seeking approval for ZEVALIN in treating non-Hodgkin´s lymphoma (NHL).
According to many, SPPI's alliance with Allergan Inc. (NYSE: AGN) has added to speculation about a possible buyout of SPPI.
In addition, if approved by the U.S. Food and Drug Administration (FDA), the market for SPPI's drug candidate ZEVALIN could reach more than $1 billion at its market saturation.
SPPI has another FDA decision due next month and they have a fully developed commercial infrastructure that is responsible for the sales and marketing of two drugs in the United States- ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin’s Lymphoma (NHL), and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma.. Its lead developmental drug is apaziquone (formerly EOquin), which is presently being studied in two large phase III clinical trials for non-muscle invasive bladder cancer under that strategic collaboration with Allergan Inc. Another drug, ozarelix is in a phase II clinical trial for benign prostatic hypertrophy (BPH). SPPI operates in the most rapidly growing segment of treatment in the pharmaceutical market.
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