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Friday, 24 July 2009 06:34 |
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SOUTH SAN FRANCISCO, Calif.-- OXiGENE, Inc. (Nasdaq:OXGN) (Stockholm:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, will report second quarter 2009 results on Thursday, July 30, 2009. A conference call and webcast hosted by OXiGENE management will begin at 10:00 a.m. EDT (7:00 a.m. PDT).
To listen to a live or archived version of the audio webcast, please log on to the Company's website, www.oxigene.com. Under the "Investor" tab, select the link to "Events and Presentations".
OXiGENE's earnings conference call can also be heard live by dialing 888-204-4517 in the United States and Canada, and 913-312-0714 for international callers, five minutes prior to the beginning of the call. A replay will be available starting at 1:00 p.m., EDT (10:00 a.m., PDT) on July 30, 2009 and ending at 12:00 midnight EDT (9:00 p.m., PDT) on Thursday, August 13, 2009. To access the replay, please dial (888) 203-1112 if calling from the United States or Canada, or (719) 457-0820 from international locations. Please refer to replay pass code 6002745.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients. |
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Friday, 24 July 2009 06:23 |
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SEATTLE-- Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) ("CTI" or the "Company") today announced that the underwriter of its previously announced public offering of 29,332,107 shares of its common stock and warrants to purchase up to 7,333,027 shares of its common stock has exercised in full its option to purchase 4,399,816 additional shares of its common stock and warrants to purchase up to 1,099,954 additional shares of its common stock to cover overallotments. The exercise of the underwriter's overallotment option results in the issuance in this offering of an aggregate of 33,731,923 shares of its common stock and warrants to purchase up to 8,432,981 shares of its common stock, for aggregate gross proceeds of approximately $43.9 million. The net proceeds to the Company after deducting underwriting discounts and commissions and estimated offering expenses are expected to be approximately $40.3 million.
Each warrant has an exercise price of $1.70 per warrant share, for total potential additional gross proceeds to the Company of approximately $14.3 million upon exercise of the warrants. The warrants are exercisable immediately upon the date of issuance and will expire nine months thereafter.
As previously announced, the Company expects to close the offering on or about July 28, 2009, subject to customary conditions, at which time the Company will receive the cash proceeds from the offering and deliver the securities.
Rodman & Renshaw, LLC, a wholly-owned subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM), acted as sole book-running manager for the offering. In addition, Trout Capital LLC acted as financial advisor to the Company. The offering was conducted as a public offering pursuant to the Company's shelf registration statement filed with the Securities and Exchange Commission. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained by contacting Rodman & Renshaw, LLC at 1251 Avenue of the Americas, 20th Floor, New York, New York 10020, or by calling (212) 356-0549.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of our shares of common stock or warrants. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com. |
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Friday, 24 July 2009 06:13 |
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MARLBOROUGH, Mass.--Sepracor Inc. (Nasdaq: SEPR) today announced its consolidated financial results for the second quarter and first half of 2009.
For the three months ended June 30, 2009, total revenues increased 11% to approximately $326.2 million compared to $294.1 million for the same period in 2008. The 2009 period includes $16.9 million of previously deferred license revenue accelerated as a result of the termination of the LUNIVIA® (eszopiclone) agreement with GlaxoSmithKline (GSK). GAAP net income for the three months ended June 30, 2009 was approximately $44.9 million, or $0.39 per diluted share, compared to $380.9 million, or $3.28 per diluted share, for the same quarter in 2008. Non-GAAP net income for the second quarter of 2009 was $82.3 million, or $0.72 per diluted share, which excludes a milestone charge and the accelerated GSK license revenue and includes a favorable adjustment to income taxes to reflect Sepracor’s estimated annual effective cash-basis tax rate. These results compare with non-GAAP net income for the second quarter of 2008 of $7.5 million, or $0.06 per diluted share, which excludes an income tax benefit as a result of the release of a valuation allowance on our deferred tax assets and an in-process research and development charge. Non-GAAP net income for these periods excludes certain other items detailed in the attached reconciliation of GAAP to non-GAAP measures.
For the six months ended June 30, 2009, total revenues increased 7% to approximately $656.4 million compared to $614.9 million for the same period in 2008. The 2009 period includes the accelerated license revenue resulting from the termination of the LUNIVIA agreement with GSK. GAAP net income for the six months ended June 30, 2009 was approximately $80.0 million, or $0.70 per diluted share, compared to $388.1 million, or $3.34 per diluted share, for the same period in 2008. Non-GAAP net income for the first half of 2009 was $179.1 million, or $1.57 per diluted share, which excludes a restructuring charge, a milestone charge and the accelerated GSK license revenue and includes a favorable adjustment to income taxes to reflect Sepracor’s estimated annual effective cash-basis tax rate. These results compare with non-GAAP net income of $70.0 million, or $0.60 per diluted share, for the first half of 2008, which excludes an income tax benefit as a result of the release of a valuation allowance on our deferred tax assets, in-process research and development charges and a milestone charge. Non-GAAP net income for these periods excludes certain other items detailed in the attached reconciliation of GAAP to non-GAAP measures.
“We are delighted to have delivered another strong quarter of financial results following the implementation of our strategic corporate restructuring plan and the successful implementation of our new commercial model,” said Adrian Adams, President and Chief Executive Officer. “I am pleased with the post-restructuring prescription performance trends that we have seen across our portfolio, as well as the revenue and earnings momentum we are delivering. As a result of these trends and the success of our cost saving initiatives, we are increasing our financial guidance for 2009, and we are committed to continuing to strive to deliver strong financial performance, EPS momentum and enhanced shareholder value over time.”
Sepracor is increasing its previous 2009 full-year revenue and non-GAAP EPS guidance. The projected 2009 full-year revenue range is now increased to $1,225.0-$1,275.0 million from $1,150.0-$1,250.0 million. The projected non-GAAP EPS range is now increased to $2.55-$2.90 per diluted share, based on 114.5 million fully-diluted shares outstanding, from $2.10-$2.70 per diluted share, based on 116.0 million fully-diluted shares outstanding. The projected revenue guidance excludes the $16.9 million of previously deferred license revenue recognized in the second quarter of 2009 as a result of the termination of the LUNIVIA agreement with GSK. Attached in this press release is a reconciliation of GAAP to non-GAAP calculations.
LUNESTA® brand eszopiclone, for the treatment of insomnia, generated revenues of $151.3 million in the second quarter of 2009 compared to $148.1 million for the same quarter in 2008. First-half 2009 revenues for LUNESTA were $291.7 million compared to $283.7 million for the first half of 2008.
XOPENEX® brand levalbuterol HCl Inhalation Solution, a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD), accounted for $89.9 million of revenues for the second quarter of 2009 compared to $85.4 million for the second quarter of 2008. XOPENEX Inhalation Solution revenues for the first half of 2009 were $208.0 million versus $225.4 million for the first half of 2008.
XOPENEX HFA® brand levalbuterol tartrate Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-dose inhaler (MDI) formulation of levalbuterol, accounted for $14.8 million of revenues during the second quarter of 2009 compared to $14.1 million for the same period in 2008. First-half 2009 revenues for XOPENEX HFA were $34.9 million versus revenues of $34.2 million for the first half of 2008.
BROVANA® brand arformoterol tartrate Inhalation Solution, a long-acting, twice-daily maintenance treatment of bronchoconstriction in patients with COPD, had revenues of $19.1 million for the second quarter of 2009 compared to $13.3 million for the same period in 2008. First-half 2009 revenues for BROVANA were $37.7 million versus $23.2 million for the first half of 2008.
OMNARIS® brand ciclesonide Nasal Spray had revenues of $9.1 million for the second quarter of 2008 versus $7.4 million for the second quarter of 2008. First-half 2009 revenues for OMNARIS Nasal Spray were $15.0 million compared to $7.4 million for the first half of 2008. Sepracor commercially introduced OMNARIS Nasal Spray in April 2008. OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis (SAR) in adults and children 6 years of age and older, and with perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older.
ALVESCO® brand ciclesonide HFA Inhalation Aerosol, an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older, had no revenues for the second quarter of 2009. Sepracor commercially introduced ALVESCO HFA in September 2008 through a staged launch that was initially focused primarily on specialists, with a targeted primary care roll-out during the first quarter of 2009. No revenues were recorded for ALVESCO HFA during the first half of 2009 primarily due to the time necessary to reduce launch-phase inventory.
Revenues from Sepracor Pharmaceuticals, Inc. (SPI), a subsidiary of Sepracor acquired in June 2008 that markets branded prescription pharmaceutical products in Canada, were $5.0 million for the second quarter of 2009 compared to $1.6 million for the second quarter of 2008. First-half 2009 revenues for SPI were $8.8 million compared to revenues of $1.6 million for the first half of 2008.
Sepracor continues to earn royalty revenues on sales of out-licensed antihistamine products, which include Schering-Plough’s CLARINEX® brand desloratadine, sanofi-aventis’ ALLEGRA® brand fexofenadine HCl and UCB’s XYZAL®/XUSAL™ brand levocetirizine. Sepracor's combined royalty revenues were $19.4 million in the second quarter of 2009 compared to $21.8 million for the same quarter in 2008. First-half 2009 royalty revenues totaled $41.5 million versus $37.0 million for the first half of 2008.
Sepracor announced during the second quarter of 2009 the results of a large-scale Phase III study of OMNARIS HFA, a nasal aerosol formulation of ciclesonide, for the treatment of SAR in adult and adolescent patients. In this study, OMNARIS HFA met its primary efficacy endpoint. In addition, OMNARIS HFA met its key secondary endpoints with statistically significant improvement in an ocular symptom score. Sepracor intends to commence a large-scale Phase III trial in patients with PAR in the third quarter of 2009. If developed successfully and approved by the U.S. Food and Drug Administration (FDA), OMNARIS HFA could be the first nasal HFA formulation to be available for patients in the U.S. for the treatment of allergic rhinitis.
In early July, Sepracor announced that it had completed the analysis and validation of the preliminary results of a Phase II study evaluating the efficacy and safety of SEP-225289 for the treatment of major depressive disorder. Sepracor determined that SEP-225289 did not meet the primary efficacy endpoint. In this study, the measured serum concentrations of SEP-225289 were found to be below expected levels of exposure for both doses studied and were well below exposure profiles observed in several Phase I studies. Furthermore, the adverse event profile demonstrated by SEP-225289 was inconsistent with prior clinical experience and was similar to the side effect profile observed when patients were administered placebo. As such, preliminary data have been found to be inconclusive pending further investigation of the dose exposure relationship of SEP-225289.
Also in early July, Sepracor announced that the FDA had notified the company that two studies of LUNESTA underway in pediatric patients were put on clinical hold due to the FDA’s concerns regarding non-clinical data that could be relevant to the administration of eszopiclone in children. The two studies were being conducted in response to a Written Request from the FDA in connection with Sepracor’s efforts to obtain a pediatric exclusivity extension for LUNESTA. The clinical hold does not relate to any findings observed in the pediatric clinical studies nor does it impact any ongoing eszopiclone clinical trials in adults. The non-clinical data resulting in the clinical hold is not related to carcinogenicity or genetic toxicology. In addition, this action does not impact the availability or prescribing information for LUNESTA in the treatment of adults with insomnia. LUNESTA has been proven to be safe and well tolerated in the treatment of adults and elderly patients with insomnia. Sepracor is working with the FDA to address the potential resolution of the FDA’s concerns regarding the non-clinical data with respect to human pediatric subjects.
In 2008, Sepracor submitted a briefing package to the FDA outlining a proposal to conduct an abbreviated Phase III program for SEP-227162, a dual reuptake inhibitor being developed for the treatment of depression. In a recent communication, the FDA agreed with the key elements of Sepracor's proposal, and Sepracor is currently evaluating the possible initiation of a Phase III registration trial for SEP-227162.
SEP-0227018, a new formulation of LUNESTA being studied for potentially improved efficacy, is now in Phase II clinical development. Sepracor is also in the process of completing studies of LUNESTA with a new coating, and subject to FDA approval, anticipates commercially launching LUNESTA with this new, non-functional, but durable, film coating in 2010.
Sepracor submitted a New Drug Application (NDA) to the FDA during the first quarter of 2009 for STEDESA™ eslicarbazepine acetate, a compound licensed from BIAL-Portela & Ca, S.A., as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The NDA was accepted for filing and is now under formal review by the FDA. The Prescription Drug User Fee Act (PDUFA) action date for STEDESA is January 30, 2010. A PDUFA date is the date by which the FDA is expected to review and act on an NDA submission. Sepracor is currently conducting a Phase III program in the U.S. using STEDESA as a monotherapy for the treatment of epilepsy.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward large and growing markets and unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
Use of non-GAAP Financial Measures and Prior Period Adjustments
Effective January 1, 2009, Sepracor adopted FASB Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (FSP APB 14-1) and EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions are Participating Securities) (EITF 03-6-1). As required by these accounting pronouncements, Sepracor adjusted its previously reported financial statements to apply these changes for periods prior to January 1, 2009. While adjusting its prior year financial statements for these new accounting pronouncements, Sepracor also adjusted its financial statements for immaterial corrections. A detailed description of these adjustments and their impact on prior periods is located in Sepracor’s 8-K filed with the SEC on May 14, 2009.
In addition to providing financial measurements based on GAAP, Sepracor is providing additional financial metrics that are not prepared in accordance with GAAP (non-GAAP). The use of, and emphasis on, non-GAAP financial metrics are discouraged by governing regulatory agencies, and companies are required to explain why non-GAAP financial metrics are relevant to management and investors. Sepracor believes that the inclusion of these non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of its past performance and future prospects, consistent with how management measures and forecasts its performance, especially when comparing such results to previous periods or forecasts. Specifically with respect to the exclusion of amortization of intangible assets from GAAP net income, purchased intangible assets relate primarily to core and developed technology of acquired businesses. Sepracor considers these charges non-cash in nature and unrelated to its core operating performance, and use of this non-GAAP measure allows comparisons of operating results that are consistent over time for both Sepracor’s newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies. Sepracor’s management uses all of these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring its core operating performance and comparing such performance to that of prior periods. These measures are also used by management in its financial and operational decision-making. There are limitations associated with reliance on these non-GAAP financial metrics because they are specific to Sepracor’s operations and financial performance, which makes comparisons with other companies’ financial results more challenging. By providing both GAAP and non-GAAP financial measures, Sepracor believes that investors are able to compare its GAAP results to those of other companies while also gaining a better understanding of Sepracor’s operating performance as evaluated by management.
Sepracor estimates its full-year 2009 effective tax rate to be approximately 41%. However, Sepracor is currently utilizing its net operating loss (NOL) carryforwards, subject to certain restrictions, to offset its taxable income, which results in an estimated annual effective cash-basis tax rate of approximately 3%. Sepracor anticipates that this reduced tax rate will be utilized for all of 2009. Therefore, in the attached reconciliation of GAAP to non-GAAP measures, Sepracor has adjusted the GAAP income tax expense for the three and six months ended June 30, 2009 to reflect its estimated annual effective cash-basis tax rate.
Sepracor expects to continue to incur for the foreseeable future significant expenses similar to the non-GAAP adjustment for amortization of intangible assets described in the attached reconciliation of GAAP to non-GAAP measures, as well as imputed interest expense related to discounted future payments under license agreements, which are also excluded from GAAP net income. In addition, second quarter and first-half 2009 and 2008 results and 2009 EPS guidance are adjusted to exclude interest expense associated with Sepracor’s 0% convertible subordinated notes due 2024, or 2024 Notes, as required under FSP APB 14-1. Sepracor also expects to continue to incur this interest expense until the 2024 Notes are repaid in full as well as non-cash income tax expense until all of its NOLs are consumed, however it intends to exclude both of these items from GAAP net income. The exclusion of these items from Sepracor’s non-GAAP financial measures should not be construed as an inference that these costs are unusual, infrequent or non-recurring. Some of the material limitations in relying on these non-GAAP financial measures are that while amortization of intangible assets and GAAP income tax expense do not directly affect Sepracor’s current cash position, such expenses represent the declining value of technology and other intangible assets it has acquired over their respective expected economic lives, or, in the case of GAAP taxes expense, the decrement of its deferred tax assets. The expense associated with these adjustments is excluded from non-GAAP financial measures, and therefore the non-GAAP financial measures do not reflect the costs of acquired intangible assets or the reduction of Sepracor’s deferred tax assets. In addition, while the interest expense on Sepracor’s 2024 Notes and imputed interest expense related to license agreements that are excluded relate to non-cash interest charges and do not directly affect Sepracor’s current cash position, such amounts will eventually be paid by us as principal under the 2024 Notes and relevant license agreements, as the case may be, and are a necessary element of its costs and ability to generate profits. Therefore, any measure that excludes imputed interest expense, interest expense on Sepracor’s 2024 Notes and GAAP income tax expense has material limitations. Sepracor compensates for these limitations by using the non-GAAP measures that exclude associated amortization of intangible assets, GAAP income tax expense, imputed interest expense from discounted future payments under license agreements and interest expense on its 2024 Notes as only one of several comparative tools, together with GAAP measurements, to assist in the evaluation of its profitability and operating results. |
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Friday, 24 July 2009 00:27 |
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DETROIT-- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced that on July 17, 2009 and July 23, 2009, two purported federal securities class action lawsuits were filed in the United States District Court for the Eastern District of Michigan against the Company and certain of its executive officers. The defendants have not yet been served with either suit. Plaintiffs purport to represent the class of persons who purchased or otherwise acquired the common stock of the Company generally between May 29, 2008 and June 25, 2009. Plaintiffs generally allege that during this time period defendants violated federal securities laws, primarily related to public statements on FDA compliance. The Company believes the plaintiffs' allegations are without merit and intends to vigorously contest the actions.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers. |
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Friday, 24 July 2009 00:21 |
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BETHESDA, Md.-- Northwest Biotherapeutics, Inc. (OTC Bulletin Board: NWBO; AIM: NWBT and NWBS) today announces that it will seek shareholder approval for the Company to cancel its listing on the London Stock Exchange's AIM market ("AIM") (the "De-listing"). The Company plans to continue its listing in the U.S., on the NASD Over the Counter Bulletin Board Market ("U.S. listing"), and plans to file an S1 registration statement under which the stock held on AIM may become tradable on the U.S. market.
After much review and evaluation, the Company has concluded that it is in the best interests of the Company and its shareholders to de-list from AIM. The reasons for this include the following:
- The high direct costs of maintaining the Company's AIM listing;
- The operational and legal difficulties of being subject to two different regulatory regimes in two different countries, under which the Company has faced conflicting requirements on an ongoing basis;
- The management time taken up with the Company's AIM listing;
- The lack of significant liquidity or other current benefits from the Company's AIM listing; and
- The ability to continue the Company's U.S. listing, unaffected by the De-listing from AIM.
The annual meeting of the Company's shareholders will be convened shortly and the relevant circular and proxy materials will be mailed to all of the Company' shareholders in advance of this meeting. One of the purposes of the meeting and the circular and proxy materials is to explain the rationale behind the proposed de-listing and consolidation of trading in the Company's shares on a single market in the U.S. Shareholders will be asked to vote at the annual meeting or through proxies on a resolution to approve the de-listing. Further details will be announced in due course.
The Company has sufficient cash at hand to fund operations into August, however the Company will need to raise additional capital to fund its clinical trials and other operating activities, and repay indebtedness in due course. Shareholders should be aware that if the Company's capital raising efforts are unsuccessful, this will have a material adverse effect on the Company's financial position and operations.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products that treat cancers more effectively than current treatments, without toxicity, on a cost-effective basis. The Company has two broad platform technologies: dendritic cell-based vaccines and therapeutic antibodies. The Company is in a large Phase II clinical trial in GBM, with 13 clinical sites across the U.S. The Company has also received clearance from the FDA for a large Phase III trial in prostate cancer, and for Phase I trials in five other cancers. The Company has started, and is currently enrolling patients in, a Phase I/II trial with DCVax(R) for recurrent metastatic ovarian cancer. The Company's second technology platform, involving antibodies to CXCR4, is at the late pre-clinical development stage.
For further information about clinical sites and Company information please visit the company web site at www.nwbio.com. |
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Thursday, 23 July 2009 17:56 |
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SOUTH SAN FRANCISCO, Calif.-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL - News) today announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who had failed to respond to at least one biologic treatment, the group treated with R788 (fostamatinib disodium) did not report significantly higher ACR 20, ACR 50, ACR 70 and DAS28 response rates than the placebo group at three months, and therefore, the trial failed to meet its efficacy endpoints. The objective components (CRP and ESR)* of these ACR scores did show a statistically significant difference; however, the subjective reported response rate components did not as compared to placebo. Although the ACR scores for the R788 group were within the expected range in this patient population, the reported placebo response rates were considerably higher than seen in any other previous study of RA biologic failure patients and rose unaccountably between week 6 (at which point the reported response rates between R788 and placebo were significantly different) and month 3 (when such reported response rates were no longer significantly different).
TASKi3 was the first clinical trial evaluating R788 in which anatomical changes in the patients' wrist and hands were evaluated using Magnetic Resonance Imaging (MRI) and scored using the RAMRIS (Rheumatoid Arthritis Magnetic Resonance Imaging Scoring) system. Those results showed improvements in the treated group versus the placebo group in the Synovitis and Osteitis scores, while the Erosion scores, known to be the slowest to change, showed no significant effect at three months. The most frequent adverse events were as expected from the earlier TASKi trials and appear to be manageable.
Rigel will host a conference call today at 7PM EDT/ 4PM PDT to discuss these results (see conference call details below).
"Our objective with R788 in RA is to position the product after methotrexate and before biological therapies are used. We have shown excellent results in that patient population in our earlier TASKi1 and TASKi2 studies, and we believe that patient population represents the large market opportunity for this product," said James M. Gower, chairman and chief executive officer of Rigel. "In this TASKi3 patient population, biologic failures, we have seen divergent results as sometimes happens in studies with subjective components. However, we are pleased to see excellent results in the objective measures and in the Synovitis and Osteitis MRI scores," he added.
*blood measurements of C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR)
Efficacy Results
Treatment N of Pts ACR 20 ACR 50 ACR 70 DAS28<2.6 --------- -------- ------ ------ ------ --------- Placebo 73 27 (37%) 9 (12%) 4 (6%) 6 (10%) ------- --- ------- ------ ----- ------ 100 mg bid 146 56 (38%) 32 (22%) 13 (9%) 15 (12%) p=0.84 p=0.09 p=0.37 p=0.15 ---------- --- ------------ ------------ ------------ -----------
p=values compared to placebo Note: At 3 months. All patients were on stable doses of methotrexate throughout the clinical trial.
MRI Results
TASKi3 Mean Change from Baseline in RAMRIS* Scores at Month 3
Placebo 100 mg bid p=values ------- ---------- -------- Synovitis** +0.35 -0.52 p=0.038 ---------- ----- ----- ------- Osteitis** Score +1.17 -0.19 p=0.058 ---------- ----- ----- ------- Erosion Score +0.94 +0.78 p=0.62 ------------- ----- ----- ------
* RAMRIS is a rheumatoid arthritis scoring system utilizing magnetic resonance imaging to evaluate abnormalities (synovitis, bone edema and bone erosion) in the hands and wrists. The system was developed by OMERACT, (Outcome Measurements in Rheumatology) in 2002, and has become a global standard measurement of inflammation and destruction in those joints. For these scores a lower value indicates a better clinical condition. ** Synovitis: inflammation of the synovial membrane lining joints Osteitis: inflammation of the bone
Safety Results
Similar to TASKi2, the most common clinically meaningful drug-related adverse events noted in TASKi3 were diarrhea and hypertension. Dose reduction options were pre-specified in the trial protocol and, in cases where doses were reduced, patients generally completed the clinical trial with minimal safety issues. The most common adverse events in the trial overall were related to infections, though these were generally evenly distributed among the placebo and active dose group.
The mean increase in blood pressure from baseline at 3 months, using a last observation carry forward methodology, was 3.2-3.6 mmHg for the 100 mg bid dose group. In TASKi3, approximately 17% of patients in the 100 mg bid dose group had blood pressure medication adjusted or in some cases initiated during the course of the clinical trial, compared to 8% of the placebo patients. For those patients who had their dose of blood pressure medications adjusted or initiated, their blood pressure was successfully reduced and their blood pressure was generally well controlled throughout the trial. The blood pressure medications were standard doses of common blood pressure medications such as ACE inhibitors or diuretics.
"For this patient population, patients who failed biologic therapies, their bones and joints appear to respond to R788, but the objective and subjective components of the ACR and DAS28 scores are incongruent, mainly because the reported subjective placebo response rates were higher than expected," said Elliott Grossbard, M.D., chief medical officer for Rigel. "Nonetheless, R788 is well tolerated and its side effects appear generally manageable, and we look forward to planning our Phase 3 program for R788 with a corporate partner," he added.
Safety Results Tables Placebo 100 mg bid ------- ---------- N 73 146 --- --- --- Dose Reductions N % N % --------------- --- --- --- --- # Had a Dose Reduction 2 3% 21 14% ---------------------- --- --- --- --- Neutropenia (ANC less than 1500) 0 0% 3 2% -------------------------------- --- --- --- --- Diarrhea, nausea, vomiting, dizziness 1 1% 7 5% --------------------------- --- --- --- --- Increase in Blood Pressure (BP) 1 1% 7 5% ------------------------------- --- --- --- --- ALT or Alkphos Elevation 0 0% 4 3% ------------------------ --- --- --- ---
TASKi3 Treatment Emergent Adverse Events
Placebo 100 mg bid ------- ---------- N 73 146 -- --- --- Diarrhea 5 7% 17 12% -------- --- --- --- --- Hypertension 3 4% 19 13% ------------ --- --- --- --- Infections 15 21% 34 23% ---------- --- --- --- ---
Mean Blood Pressure (Systolic/Diastolic in mmHg)
Baseline 128/78 125/77 -------- ------ ------ Month 3 126/77 129/81 ------- ------ ------ Change from Baseline to Month 3 (LOCF) -2.1/-0.5 +3.6/+3.2 -------------------- ---------- -------- N % N % --- --- --- --- # and % Had BP Meds Adjusted/Initiated 6 8% 25 17% ------------------- --- --- --- ---
Trial Design
TASKi3 was a 3 month, multi-center, randomized, double blind, placebo controlled, parallel dose clinical trial involving 219 RA patients in the U.S. who had failed to respond to at least one biologic treatment (such as TNF inhibitors). The patients were randomly assigned to two cohorts and thus received R788 orally in a 100 mg bid (twice daily) dose or placebo for a period of up to 3 months. Patients were assigned on a 2:1 basis to R788 or placebo. Throughout the clinical trial period, all of the patients continued to receive their stable dose of methotrexate.
Efficacy assessments for each participant were based on the American College of Rheumatology criteria, which denotes at least a 20% (ACR 20) improvement, at least a 50% (ACR 50) improvement, or at least a 70% (ACR 70) improvement, from the baseline assessment at the end of the 3 month treatment period. The ACR measurement factors included reported physician and patient global assessment of disease activity, patient reported pain score, and any change in CRP in the patient's blood. The primary efficacy endpoint for the clinical trial was the percent of patients assigned to the R788 100 mg bid dose who were ACR 20 responders at the end of 3 months. Secondary efficacy endpoints included other ACR scores and, a comparison of response rates for the R788 100 mg bid dose versus placebo as determined by MRI using the modified RAMRIS scoring system of wrists and hands at baseline and at month 3.
R788 and RA
RA is a progressive, painful and potentially debilitating disease, that affects more than 2 million people in the U.S. It is a chronic inflammatory disease that puts the body's immune system into overdrive where it ultimately causes inflammation in the joints and destroys soft tissues, cartilage and bone. Rigel's R788 is a novel, orally available syk kinase inhibitor designed to interrupt the cellular signaling at the trigger point of inflammation, thereby stopping the progression of the disease. In July 2009, Rigel announced results from its Phase 2b TASKi2 clinical trial showing significant improvement in RA patients treated with R788 who had failed to respond to methotrexate treatment. |
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Thursday, 23 July 2009 16:42 |
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NEW YORK--DellaCamera Capital Management, LLC (“DellaCamera”) and related entities, which beneficially hold approximately 8.3% of the shares of Enzon Pharmaceuticals, Inc. (“Enzon” or the “Company”) (NASDAQ: ENZN), today announced that it is encouraged by the recent actions taken by the Enzon Board of Directors (the “Board”) and the Company’s announcement that it has formally separated the roles of Chairman and CEO and named Dr. Alexander J. Denner, a representative of affiliated entities of Carl Icahn and previous Chairman of the Executive Committee of ImClone Systems Incorporated, to replace Jeffrey H. Buchalter as Chairman of the Board. DellaCamera is also encouraged by the fact that its efforts have led to the addition of Harold J. Levy, co-CEO of Iridian Asset Management LLC, the Company’s largest shareholder, as a new, independent member to the Board.
As a result of these positive developments, DellaCamera also announced today that it is withdrawing its current consent solicitation to amend Enzon’s By-laws and to remove Enzon CEO and President Jeffrey H. Buchalter in order to better allow the Company’s new Chairman and new independent director to bring positive change to the Board. DellaCamera notes that it has not entered into any standstill agreement with the Company.
Richard Mansouri, Portfolio Manager and Head of Research at DellaCamera, stated: “While it has taken tremendous effort to cause the Company to act, we are encouraged by the recent developments at Enzon and these new signs of improving corporate governance. With the separation of the roles of Chairman and CEO, we believe the vise-like grip that CEO and former Chairman Jeffrey H. Buchalter has had on this Company has been significantly loosened. Furthermore, with three new members joining the Company’s Board within the last two months, including representatives of entities affiliated with Carl Icahn and a representative of Iridian Asset Management LLC that together represent approximately 25% of Enzon’s outstanding shares, we believe that the Board now includes individuals with significant vested interests who can more effectively guide management’s decisions and are better able to represent and protect shareholder interests. DellaCamera has confidence that these members will take timely steps to enhance value and address the Company’s discounted valuation. We will continue to vigilantly monitor the situation at Enzon to help ensure that value is delivered to all shareholders and, to that end, have preserved our ability to take action in the future if necessary to empower shareholders to effect further change.”
Ralph DellaCamera, DellaCamera’s Chief Investment Officer and Managing Member, added: “It has been our long-standing opinion that the intrinsic value of Enzon is significantly in excess of its current stock price. DellaCamera believes that these recent and long-overdue governance enhancements may allow the Company’s shareholders to finally begin to realize this value by bringing additional oversight to the policies and practices of Enzon’s current management. Given that Mr. Buchalter will no longer be Chairman of the Board of the Directors and will now be accountable to a Board that consists of several shareholder representatives, we have decided at this time to withdraw our consent solicitation but have not entered into any standstill agreement with the Company. It is now time for the entire Board, including those longer-serving members of the Board who we believe have been far too deferential to management, to deliver the concrete improvements that are of interest to all the shareholders. We will place great scrutiny on the actions taken by the Company in the near future and whether these actions translate into a higher stock price for the benefit of all shareholders.”
Mr. DellaCamera further stated: “Because DellaCamera has a strong belief in the rights of shareholders as the true owners of a company, we will take active steps, as fiduciaries entrusted to manage the capital of our clients, to add value and protect our client’s interests when necessary. In the case of Enzon, given the value destruction that Mr. Buchalter has presided over, we believe our active involvement was necessary and, in fact, imperative. It is our expectation that Harold J. Levy, as a fiduciary entrusted to protect the interests of all of the shareholders of Enzon as well as the capital of the investors in Iridian Asset Management LLC, will bring a heightened focus to the numerous financial and strategic possibilities facing the Company and will swiftly advocate action to deliver value to the shareholders. Indeed, we will hold every Board member to an exacting standard of accountability, as will presumably the numerous other shareholders who have expressed strong support for our recent efforts.” |
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Thursday, 23 July 2009 16:34 |
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CAMBRIDGE, Mass.-- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, will report its financial results for the second quarter ended June 30, 2009 before the U.S. financial markets open on Thursday, August 6, 2009.
Management will host a conference call on that date at 10:00 am EDT to discuss these results and provide an update on the company. To access the call, please dial (877) 718-5099 (domestic) or (719) 325-4838 (international) prior to the scheduled conference call time and provide the access code 1438216. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through August 20, 2009. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 1438216.
A live audio webcast of the call will be available on the "Investors" section of the Company's website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through Friday, September 4, 2009.
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. |
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Thursday, 23 July 2009 16:32 |
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CAMBRIDGE, Mass.-- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), an innovative cancer drug discovery and development company, today announced that the chemistry and data leading to the discovery of its novel Hedgehog signaling pathway inhibitor, IPI-926, have been published in the Journal of Medicinal Chemistry. The paper, titled "Discovery of a Potent and Orally Active Hedgehog Pathway Antagonist (IPI-926)" and authored by Infinity's Martin R. Tremblay, Ph.D., Alfredo C. Castro, Ph.D., et al., is featured in today's issue of the journal (Volume 52, Issue 14, pages 4400-4418).
The Journal of Medicinal Chemistry publication provides detailed insights into Infinity's medicinal chemistry efforts to develop its Hedgehog signaling pathway inhibitor, IPI-926. The paper discusses how a team of Infinity scientists began with the naturally occurring plant Veratrum californicum, which contains an antagonist of the Hedgehog pathway, and performed a sequence of synthetic transformations leading to the synthesis of a new series of analogs with improved potency and solubility. IPI-926 was selected as Infinity's lead clinical candidate from these semi-synthetic compounds due to its improved pharmaceutical properties and potency and its superior pharmacokinetic profile relative to the naturally occurring compound. The paper highlights data regarding these improvements in potency and solubility, and in vivo and in vitro biological activity demonstrated with IPI-926.
"The discovery of IPI-926 is an example of the fearless chemistry our team is utilizing to identify and develop novel new product candidates," said Julian Adams, Ph.D., Chief Scientific Officer and President of Research and Development. "We are pleased and proud to tell the story of how we took a starting point from nature and then used Infinity's core chemistry expertise to discover, and now advance through clinical development, our novel Hedgehog pathway inhibitor, IPI-926."
Infinity has demonstrated anti-tumor activity of IPI-926 in a number of preclinical models, including those of pancreatic cancer, small cell lung cancer, and medulloblastoma. IPI-926 has also demonstrated excellent pharmaceutical properties, including oral bioavailability, long plasma half-life and duration of action, and dose-dependent inhibition of tumor growth.
A paper featuring IPI-926 further supporting Hedgehog signaling pathway inhibition as a promising new approach to treat cancer was recently published in the May 2009 volume of Science. The data showed that administration of IPI-926 in combination with gemcitabine in a preclinical mouse model of chemo-resistant pancreatic cancer increased tumor cell death, resulting in a reduction of tumor size and increased survival. These data suggest that IPI-926 may enable chemotherapeutic agents to successfully access and kill tumor cells.
Infinity is currently evaluating IPI-926 in a Phase 1 clinical trial in patients with advanced solid tumors.
About the Journal of Medicinal Chemistry
The Journal of Medicinal Chemistry publishes studies that contribute to an understanding of the relationship between molecular structure and biological activity or mode of action. The Journal of Medicinal Chemistry is the most-cited journal in Medicinal Chemistry with 45,190 total citations in 2008.
About the Hedgehog Pathway
The Hedgehog signaling pathway is highly active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway is believed to play a central role in the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers. In addition, recent evidence also suggests a role for the Hedgehog pathway in cancer stem cells, a subpopulation of self-renewing "progenitor-like" cells that are chemo-resistant and Hedgehog-dependent. This subpopulation of cells may be responsible for tumor re-growth and progression, despite treatment with conventional chemotherapeutic agents.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity's two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology drug discovery and development. For more information on Infinity, please refer to the company's website at http://www.infi.com. |
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Thursday, 23 July 2009 16:28 |
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MALVERN, PA-- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, will release results for the second quarter 2009 on Thursday, August 6, 2009 before the opening of the financial markets. The Company will also conduct a conference call that day at 10:00 a.m. EDT to discuss results and highlights of the second quarter 2009.
Mr. Armando Anido, Chief Executive Officer and President, will host the conference call.
Conference call details: Date: Thursday, August 6, 2009 Time: 10:00 a.m. EDT Dial-in (U.S.): 866-730-5763 Dial-in (International): 857-350-1587 Web cast: http://www.auxilium.com Passcode: Auxilium
To access an audio replay of the call: Access number (U.S.): 888-286-8010 Access number (International): 617-801-6888 Replay Passcode #: 57985572
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has five projects in clinical development. XIAFLEX™ (collagenase Clostridium histolyticum), formerly referred to as AA4500, has completed phase III clinical trials for the treatment of Dupuytren's contracture, and the biologics license application is under review at the FDA for the treatment of Dupuytren's contracture. XIAFLEX is in phase IIb of development for the treatment of Peyronie's disease and is in phase II of development for treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) and its fentanyl pain product using its transmucosal delivery system are in phase I of development. The Company is currently seeking a partner to further develop these product candidates. Auxilium has rights to additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com. |
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