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Thursday, 23 July 2009 16:12 |
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SOUTH SAN FRANCISCO, CA-- Theravance, Inc. (NASDAQ: THRX) reported today its financial results for the quarter ended June 30, 2009. Net loss for the second quarter of 2009 was $21.7 million compared with $27.0 million for the same period of 2008, a decrease of $5.3 million. Net loss per share was $0.35 for the second quarter of 2009 compared with a net loss per share of $0.44 for the same period of 2008.
"In the second quarter, we have made significant regulatory progress in our key programs, Horizon and telavancin," said Rick E Winningham, Chief Executive Officer. "I am very pleased that GSK recently announced plans to progress Horizon into a Phase 3 program in COPD in October 2009. We expect a decision from the FDA on our telavancin NDA for complicated skin and skin structure infections by September 16, 2009. We look forward to the initiation of the Horizon Phase 3 program and we continue to work closely with the FDA on our two telavancin applications."
Key Program Highlights
Respiratory Programs
Horizon
GlaxoSmithKline (GSK) has engaged with European and U.S. regulatory agencies to discuss study designs for the Horizon Phase 3 programs to evaluate a combination of a long-acting beta agonist (LABA) and an inhaled corticosteroid (ICS) for the treatment of COPD and asthma. GSK currently expects to initiate the Phase 3 program in COPD in October 2009. This program will include active comparators to evaluate the potential for superiority. GSK is waiting for feedback from the U.S. Food and Drug Administration (FDA) on the development of LABAs in asthma before finalizing the asthma Phase 3 program.
Bacterial Infections
Telavancin
In late April 2009, the FDA accepted for review our response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 16, 2009.
In early April 2009, the FDA accepted the filing of our New Drug Application (NDA) for telavancin for the treatment of nosocomial pneumonia (also known as hospital-acquired pneumonia, or HAP) caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA has established a standard 10-month review for this NDA, with a PDUFA goal date of November 26, 2009. In conjunction with the filing of our NDA, in April 2009 we received a milestone payment of $10.0 million from our partner, Astellas.
Financial Results
Revenue
Revenue was $5.5 million for the second quarters of 2009 and 2008. Milestone payments received to date under our agreements with GSK and Astellas are being amortized over the relevant performance periods.
Research and Development
Research and development expense was $20.0 million for the second quarters of 2009 and 2008. During the second quarter of 2009, salaries and facilities related costs were lower compared to the same period last year due to the reduction in force announced in April 2008 and were offset by higher stock compensation expense. Total external research and development expense for the second quarter of 2009 was $4.0 million compared with $4.9 million for the same period in 2008. Total research and development stock-based compensation expense for the second quarter of 2009 was $3.1 million compared with $1.9 million in the same period in 2008.
General and Administrative
General and administrative expense for the second quarter of 2009 decreased to $6.8 million from $7.3 million for the same period in 2008. The lower expense in the second quarter of 2009 was primarily due to reduced external expenses. Total general and administrative stock-based compensation expense for the second quarter of 2009 was $2.2 million compared with $1.9 million for the same period in 2008.
Restructuring Charges
The company incurred restructuring charges totaling $1.3 million for the six months ended June 30, 2009. The charges resulted primarily from a loss recognized on the sublease of excess space in one of the company's South San Francisco, CA buildings as well as employee severance and benefits resulting from the reduction in force announced in April 2008.
Cash and Cash Equivalents
Cash, cash equivalents and marketable securities totaled $175.7 million as of June 30, 2009, a decrease of $3.2 million during the quarter. The decrease was primarily due to cash used in operations that was partially offset by $13.6 million in milestone and reimbursement payments received from Astellas related to our telavancin license agreement.
Conference Call and Webcast Information
As previously announced, the company has scheduled a conference call to discuss this announcement beginning at 5:00 p.m. Eastern Daylight Time today. To participate in the live call by telephone, please dial 877-440-5788 from the U.S., or 719-325-4937 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company's web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.
A replay of the conference call will be available on the company's web site for 30 days through August 22, 2009. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on August 6, 2009 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 7640818.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company's key programs include: telavancin for the treatment of serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Horizon program and Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program with GlaxoSmithKline plc. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com. |
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Thursday, 23 July 2009 15:43 |
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INDIANAPOLIS-- Today, Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug FORTEO((R)) [teriparatide (rDNA origin) injection] to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture. Glucocorticoid therapy is the most common cause of secondary osteoporosis, leading to bone loss and an increased risk for fracture.(1)
"Patients who take long-term glucocorticoid therapy are already dealing with a serious health condition, and, on top of that, they may be at a significantly higher risk for fracture," said Vladimir Kopernicky, medical director for Eli Lilly and Company. "The FDA's decision provides these patients with a valuable treatment option for osteoporosis, which they may develop as a result of their sustained glucocorticoid use."
Glucocorticoid-induced osteoporosis, or GIO, is associated with chronic use of glucocorticoid medications, which are often prescribed for inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease. Data indicate that glucocorticoid medications are used by up to three out of every 100 adults over age 50. (2) Approximately 50 percent of individuals who are prescribed chronic glucocorticoid therapy will eventually have an osteoporotic fracture.(3) The use of glucocorticoid medications can lead to a reduction in bone formation.(4) FORTEO has been shown to counter this effect by stimulating bone formation.(5)
In the course of the FDA's review of the new indication, Lilly provided data from a clinical study which showed that in patients with glucocorticoid-induced osteoporosis, FORTEO increased bone mineral density (BMD) from baseline to 18 months of treatment by 7.2 percent at the lumbar spine, 3.6 percent at the total hip, and 3.7 percent at the femoral neck.(5)
"Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis," said Kenneth G. Saag, M.D., MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. "The approval of teriparatide for this new indication offers healthcare providers and patients a new treatment option that effectively increases bone mineral density in a different way than anti-resorptives."
Label Updates
Since this new indication extends the use of FORTEO to patients with GIO who may be younger than those currently receiving the medication, Lilly has updated the language in the existing boxed warning section of the label regarding the risk of osteosarcoma to reinforce that FORTEO should not be used in pediatric and young adult patients whose bones are still growing.
In addition, due to the increased patient population, Lilly established a voluntary FORTEO Patient Registry to further evaluate the long-term safety of FORTEO. Osteosarcoma is a serious but rare cancer which occurs at a rate of about four cases per million people, per year. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.
About FORTEO
FORTEO is also indicated for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(6) FORTEO is the first osteoporosis therapy approved by the U.S. Food and Drug Administration (FDA) that actually rebuilds bone.(7) Since receiving FDA approval in November 2002, more than 3.1 million prescriptions for FORTEO have been filled in the United States.(8)
Important Safety Information about FORTEO
During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.
You should not take FORTEO for more than 2 years over your lifetime.
There is a voluntary Patient Registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.rti.org.
Do not use FORTEO if you are allergic to any of the ingredients in FORTEO.
Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease or other bone disease; have cancer in your bones; have trouble injecting yourself and do not have someone who can help you; are a child or young adult whose bones are still growing or have or have had kidney stones; if you have had radiation therapy; have or had too much calcium in your blood; have any other medical conditions; or take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin).
Please consult your healthcare provider if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breast-feeding or plan to breast-feed, it is not known if FORTEO passes into your breast milk. You and your doctor should decide if you will take FORTEO or breast feed. You should not do both.
FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider.
Serious side effects also include increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions such as redness, swelling, pain, itching, a few drops of blood, and bruising. These are not all the possible side effects of FORTEO.
The FORTEO delivery device has enough medicine for 28 days. It is set to give a 20 microgram dose of medicine each day. Do not inject all the medicine in the FORTEO delivery device at any one time. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Talk to a healthcare provider about how to rotate injection sites. Do not transfer the medicine from the FORTEO delivery device to a syringe. This can result in taking the wrong dose of FORTEO. If you do not have pen needles to use with your FORTEO delivery device, talk with your healthcare provider.
If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness or dizziness.
Keep your FORTEO delivery device in the refrigerator between 36 degrees to 46 degrees F (2 degrees to 8 degrees C). Do not freeze the FORTEO delivery device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO delivery device after 28 days even if it has medicine in it (see the User Manual).
For more information about FORTEO, including full prescribing information, visit www.Forteo.com.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. |
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Thursday, 23 July 2009 15:37 |
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LAS VEGAS-- American Pacific Corporation (Nasdaq: APFC) announced today that its wholly-owned subsidiary Ampac Fine Chemicals LLC (AFC) has received from the office of Alyson Huber of the California Legislature Assembly a certificate of recognition for "Voluntarily Reducing Pollution." The award was presented to Jill Dapremont, Martha Murray, Director, EH&S Compliance and Jeff Robinson of AFC, at the Department of Toxic Substance of California (DTSC) and Chemical Industry Council of California (CICC) Pollution Prevention Award ceremony in Sacramento.
"We are proud to receive this certificate from the California Legislature Assembly. This recognition from the state shows that our efforts are mutually beneficial to the community and our operations," said Jeff Robinson, Vice President of Quality Operations and Regulatory Affairs.
Jill Dapremont, Environmental Manager at AFC added, "California is at the forefront of the effort to reduce global warming and obtaining this award is a great achievement for AFC."
ABOUT AMPAC FINE CHEMICALS LLC
AFC is a U.S. based company with demonstrated capabilities in process development, scale-up, and cGMP-compliant commercial production of active pharmaceutical ingredients (API's) and registered intermediates for pharmaceutical and biotechnology customers. Its specially engineered facilities and experienced staff allow AFC to safely produce highly energetic compounds at commercial scale. In addition, AFC's other technology platforms include production of highly potent compounds, continuous processes and industrial-scale chromatographic separation using simulated moving bed chromatography (SMB).
ABOUT AMERICAN PACIFIC CORPORATION
American Pacific Corporation (AMPAC) is a leading custom manufacturer of fine chemicals, specialty chemicals and propulsion products within its focused markets. We supply active pharmaceutical ingredients and advanced intermediates to the pharmaceutical industry. For the aerospace and defense industry we provide specialty chemicals used in solid rocket motors for space launch and military missiles. AMPAC also designs and manufactures liquid propulsion systems, valves and structures for space and missile defense applications. We produce clean agent chemicals for the fire protection industry, as well as electro-chemical equipment for the water treatment industry. Our products are designed to meet customer specifications and often must meet certain governmental and regulatory approvals. Additional information about us can be obtained by visiting our web site at www.apfc.com. |
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Thursday, 23 July 2009 15:33 |
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ALISO VIEJO, Calif.--AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it will release unaudited financial results for the three and nine months ended June 30, 2009 before market open on Wednesday, July 29, 2009. Keith Katkin, President and Chief Executive Officer, Randall Kaye, M.D., Senior Vice President and Chief Medical Officer, and Christine Ocampo, Vice President, Finance, will host an investment community conference call that same day at 8:00 a.m. Pacific time / 11:00 a.m. Eastern time to discuss those results and answer questions.
Investors are invited to listen to the live webcast by visiting AVANIR’s corporate website at www.avanir.com. To listen to the live call, please go to AVANIR’s website prior to the start of the call to register, download and install the necessary audio software.
An archived copy of the webcast will be available on AVANIR’s website for 30 days, and a telephone replay will be available through August 3, 2009, by dialing (800) 642-1687 (domestic) or (706) 645-9291 (international) and entering the conference ID number 21923090.
About AVANIR
AVANIR Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. AVANIR's lead product candidate, Zenvia™, is being developed for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed its MIF inhibitor program to Novartis International Pharmaceuticals Ltd. and has sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Company's first commercialized product, Abreva® (docosanol), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com and further information about pseudobulbar affect can be found at www.PBAinfo.org. |
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Thursday, 23 July 2009 15:31 |
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BRIDGEWATER, N.J.--Enzon Pharmaceuticals, Inc. (Nasdaq:ENZN) announced that in an effort to enhance corporate governance, it has added a new position of non-executive Chairman of the Board. The Company has also expanded the board with one new independent Director.
The Board of Directors has appointed Dr. Alexander J. Denner as non-executive Chairman of the Board, effective immediately. Dr. Denner was recently elected as a Director at the Company’s annual meeting in May 2009. Jeffrey H. Buchalter, who served as executive Chairman will continue to serve as a Director as well as President and Chief Executive Officer. This change separates the role of CEO and Chairman and is in line with current governance best practices.
Also today, Harold J. Levy, senior executive of Iridian Asset Management LLC, has joined the Company’s Board of Directors. Iridian is Enzon’s largest shareholder with beneficial ownership of approximately 18 percent.
“I look forward to Alex Denner’s and Harold Levy’s contributions in their new roles and appreciate their ongoing confidence in our strategy. Enzon is well positioned today thanks to the efforts of our management team, employees and Board of Directors,” said Jeffrey Buchalter, Chief Executive Officer and President of Enzon. “I remain committed to leading Enzon through the next steps of its development.”
“Enzon has demonstrated its commitment to good governance and constructive collaboration with shareholders,” said Dr. Denner. “The Board, whose members now represent more than 25% of the Company’s total ownership, supports Jeff as the chief executive officer of Enzon. His leadership is an important part of realizing Enzon’s strategic plan and value potential.”
“Iridian believes strongly in Enzon,” said Mr. Levy. “I look forward to serving on the Enzon Board.”
Dr. Denner further stated: “I would like to thank the DellaCamera Group for their suggestions about enhancing shareholder value at Enzon and look forward to continuing the communication with all shareholders.”
Further, the Company amended its shareholder rights plan to allow up to a 19% ownership threshold for any shareholder or group of shareholders, removing the previous distinction between schedule 13D and 13G filers.
Additional Information and Where to Find It
Enzon Pharmaceuticals, Inc. (“the Company”) and its directors, and certain executive officers may be deemed to be participants in the solicitation of consent revocations from stockholders in connection with a consent solicitation (the “Consent Solicitation”) that DellaCamera Capital Management, LLC and certain affiliates have stated that they intend to conduct. The Company has filed a revised preliminary consent revocation statement (the “Consent Revocation Statement”) with the Securities and Exchange Commission (the “SEC”) with respect to the solicitation of the consent revocations in connection with the Consent Solicitation. Information regarding the names of the Company’s directors, and executive officers and their respective interests in the Company’s security holdings or otherwise is set forth in the Company’s proxy statement for the 2009 annual meeting of stockholders (the “2009 Annual Meeting”), which was filed with the SEC on April 13, 2009 and may be obtained free of charge from the SEC’s website at http://www.sec.gov and the Company’s website at http://www.enzon.com
On July 23, 2009, Harold J. Levy joined the Company’s Board of Directors. Mr. Levy owns 50,000 shares of the Company’s common stock and, through the Harold J. Levy Revocable Trust, 4.0% Convertible Senior Notes due 2013 convertible into 104,712 shares of the Company’s common stock. Mr. Levy is the Co-President, Co-Chief Executive and Co-Chief Investment Officer of Iridian Asset Management LLC (“Iridian”). Iridian and its affiliates beneficially own approximately 18% of the Company’s common stock. Mr. Levy has shared investment and dispositive power over the shares of the Company’s common stock held by Iridian. Mr. Levy disclaims beneficial ownership of such shares.
Promptly after filing its definitive Consent Revocation Statement with the SEC, the Company will mail the definitive Consent Revocation Statement and a form of consent revocation card to each stockholder entitled to deliver written consent in connection with the Consent Solicitation. STOCKHOLDERS ARE URGED TO READ THE CONSENT REVOCATION STATEMENT (INCLUDING ANY SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY WILL FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain, free of charge, copies of the Consent Revocation Statement and any other documents filed by the Company with the SEC in connection with the Consent Revocation from the SEC’s website at http://www.sec.gov, the Company’s website at http://www.enzon.com, or by contacting Craig Tooman of the Company, c/o Enzon Pharmaceuticals, Inc., 685 Route 202/206, Bridgewater, New Jersey 08807.
About Enzon
Enzon Pharmaceuticals, Inc is a biopharmaceutical company dedicated to the development, manufacturing, commercialization of important medicines for patients with cancer and other life-threatening conditions. Enzon has a portfolio of four marketed products, Oncaspar®, DepoCyt®, Abelcet® and Adagen®. The Company's drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform used to create product candidates with benefits such as reduced dosing frequency and less toxicity. Enzon's PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology. Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden the Company's revenue base. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com. |
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Thursday, 23 July 2009 15:17 |
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BOTHELL, Wash.--Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the second quarter and six months ended June 30, 2009. The company also highlighted recent product development progress.
“The second quarter featured strong clinical data presentations with SGN-35, now named brentuximab vedotin, that continue to demonstrate a compelling objective response rate and tolerability profile in patients with Hodgkin lymphoma or systemic anaplastic large cell lymphoma (ALCL),” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “In both of our phase I clinical trials, brentuximab vedotin achieved complete or partial responses in greater than 50 percent of patients treated at the higher dose levels. These data reinforce the potential of brentuximab vedotin and are supportive of our aggressive development plans. We expect to complete accrual to the ongoing pivotal trial for Hodgkin lymphoma in the third quarter of 2009, and we also recently initiated a phase II trial in systemic ALCL. We ended the second quarter financially strong, with $190 million in cash and investments, including a $4 million upfront payment received under our new antibody-drug conjugate (ADC) collaboration with Millennium: The Takeda Oncology Company. We anticipate continued milestone momentum across our product pipeline and by our ADC collaborators over the remainder of 2009.”
Recent and Planned Pipeline and ADC Collaborator Highlights
Brentuximab vedotin (SGN-35)
- Given robust enrollment to the Hodgkin lymphoma pivotal trial, expect to complete accrual in the third quarter of 2009
- Reported a median duration of response of at least 7.3 months from an every three week dosing phase I trial (European Hematology Association (EHA) 14th Congress)
- Reported that the objective response rate for patients treated at doses of 1.2 milligrams per kilogram (mg/kg) and higher every three weeks was 54 percent based on investigator assessment, compared to 57 percent based on independent review, demonstrating high concordance between the two assessments (EHA 14th Congress)
- Presented data from an ongoing phase I weekly-dosing clinical trial demonstrating that, among 20 evaluable patients treated at doses of 0.8 mg/kg and higher, 60 percent achieved an objective response, including 50 percent with complete responses (American Society of Clinical Oncology (ASCO) 2009 Annual Meeting)
- In both phase I clinical trials, brentuximab vedotin has been generally well tolerated. The majority of adverse events have been Grade 1 and 2, with the most common being fatigue, fever, peripheral neuropathy, neutropenia, diarrhea and nausea
- Initiated a phase II clinical trial for patients with relapsed or refractory systemic ALCL
- Obtained brentuximab vedotin as the SGN-35 U.S. Adopted Name (USAN), a nonproprietary designation for the product candidate
- Preparing to initiate a clinical trial to assess retreatment of patients who previously received brentuximab vedotin therapy
- Planning to present additional phase I data in the second half of 2009
- Evaluating and planning multiple trials of brentuximab vedotin both as a single agent and in combination with chemotherapy for additional relapsed and refractory therapeutic settings, front-line therapy and other CD30-positive malignancies
Dacetuzumab (SGN-40)
- Presented data showing a correlation between a diagnostic gene signature and sensitivity to treatment with dacetuzumab in patients with diffuse large B-cell lymphoma (ASCO 2009 Annual Meeting)
- Expect to report clinical data from multiple ongoing clinical trials of dacetuzumab for non-Hodgkin lymphoma and multiple myeloma later in 2009
Lintuzumab (SGN-33)
- Reported data from a single-agent dose-escalation phase I clinical trial demonstrating multiple objective responses at well-tolerated doses in patients with acute myeloid leukemia (AML) and that 47 percent of AML patients treated across all dose levels experienced reductions in tumor blasts compared to baseline (EHA 14th Congress)
- Continued patient treatment in a randomized phase IIb trial of lintuzumab plus low-dose chemotherapy for patients 60 years and older with AML to determine if the combination extends overall survival. The trial, which is event driven, is expected to yield data in the first half of 2010.
SGN-70
- Initiated treatment of patients with autoimmune disease in a phase I trial, following completion of the healthy volunteer portion of the study
SGN-75
- Advanced investigational new drug (IND)-enabling activities towards a planned IND submission in the second half of 2009 for CD70-positive hematologic malignancies and solid tumors
ASG-5ME (formerly AGS-5 ADC)
- In collaboration with Agensys, a wholly-owned subsidiary of Astellas Pharma, advanced a novel ADC for solid tumors towards a planned IND submission in the first half of 2010
ADC Collaborations
- Entered into a new ADC collaboration with Millennium: The Takeda Oncology Company, under which Seattle Genetics received a $4 million upfront payment and is entitled to receive progress-dependent milestone payments and mid-single digit royalties on any resulting ADC products
Second Quarter and Six Month 2009 Financial Results
Revenues in the second quarter of 2009 were $9.4 million, compared to $10.0 million in the second quarter of 2008. For the first six months of 2009, revenues were $18.6 million, up from $17.1 million in the first six months of 2008. Revenues are primarily driven by the earned portion of the upfront fee, reimbursements and milestone payments received under the company’s dacetuzumab collaboration with Genentech. Revenues also reflect amounts earned under the company’s ADC collaborations.
Total operating expenses for the second quarter of 2009 were $32.7 million, compared to $27.6 million for the second quarter of 2008. For the first six months of 2009, total operating expenses were $70.1 million, compared to $53.7 million in the first six months of 2008. The planned increases in 2009 were primarily driven by clinical development and manufacturing activities for brentuximab vedotin. Non-cash, share-based compensation expense for the first six months of 2009 was $5.4 million, compared to $5.0 million for the same period in 2008.
Net loss for the second quarter of 2009 was $22.5 million, or $0.26 per share, compared to $16.0 million, or $0.20 per share, for the second quarter of 2008. For the six months ended June 30, 2009, net loss was $49.7 million, or $0.59 per share, compared to $33.1 million, or $0.43 per share, for the same period in 2008.
As of June 30, 2009, Seattle Genetics had $189.9 million in cash and investments, compared to $192.4 million as of March 31, 2009. Cash and investments as of June 30, 2009 reflect net proceeds of approximately $11.5 million from the company’s sale of 1,178,163 shares of common stock in a private placement to Baker Brothers Life Sciences, L.P., which was approved at the company’s annual stockholders meeting on May 15, 2009.
Conference Call Details
Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 2:00 p.m. Pacific Time (PT); 5:00 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at www.seattlegenetics.com, under the News and Investor Information section, or by calling (877) 941-8610 (domestic) or (480) 629-9818 (international). The access code is 4114066. A replay of the discussion will be available beginning at approximately 4:00 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4114066. The telephone replay will be available until 4:00 p.m. PT on July 27, 2009.
About Seattle Genetics
Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company’s lead product candidate, brentuximab vedotin (SGN-35), is in a pivotal trial under a special protocol assessment with the FDA. Brentuximab vedotin is empowered by Seattle Genetics’ proprietary ADC technology comprising highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. In addition, Seattle Genetics has three other product candidates in ongoing clinical trials: dacetuzumab (SGN-40), lintuzumab (SGN-33) and SGN-70. Dacetuzumab is being developed under a worldwide collaboration with Genentech (a wholly-owned member of the Roche Group). Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, Daiichi Sankyo, MedImmune, a subsidiary of AstraZeneca, and Millennium: The Takeda Oncology Company, as well as an ADC co-development agreement with Agensys, a subsidiary of Astellas Pharma. More information can be found at www.seattlegenetics.com. |
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Thursday, 23 July 2009 15:14 |
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NEW YORK--Fitch Ratings does not expect Bristol-Myers Squibb's (Bristol-Myers Squibb) ratings and Outlook to change following the company's announcement of its intention to acquire Medarex, Inc. (Medarex) for approximately $2.4 billion, or $2.1 billion net of $300 million of Medarex cash.
Bristol-Myers Squibb's ratings are:
--Issuer Default Rating (IDR) of 'A+';
--Senior unsecured debt rating of 'A+';
--Bank loan rating of 'A+';
--Short-term IDR of 'F1';
--Commercial paper rating of 'F1'.
The ratings apply to $6.36 billion of outstanding debt. The Rating Outlook is Stable.
Today, Bristol-Myers Squibb announced its proposed acquisition of Medarex for approximately $2.4 billion, representing a premium of greater than 90% over yesterday's closing price. The companies already collaborate on the development of ipilimumab (MDX-010) which is in Phase III clinical studies investigating the drug candidate for the treatment of metastatic melanoma. Fitch anticipates that no incremental debt will be issued to complete the transaction, expected in the third quarter.
The acquisition is aligned with Bristol-Myers Squibb's continuing effort to focus its operating model toward biologics primarily focused on the physician specialist. The transformation of the business strategy has included the divestment of non-core businesses, including the sale of its Medical Imaging and ConvaTec businesses in 2008 which yielded proceeds of $4.63 billion. This year, the company publicly sold a 17% equity interest in the Mead Johnson nutritionals business in February, generating incremental cash of $782 million. By the end of the second quarter of 2009, cash and short-term investments totaled $8.12 billion.
Bristol-Myers Squibb has minimal exposure to intellectual property losses in the U.S. until late 2011 when the company's pharmaceutical portfolio faces patent losses. Fitch estimates the negative effect of the company's patent cliff will primarily occur in 2012-2013 concomitant with the market exclusivity losses of Plavix in November 2011 and Avapro in March 2012 (including a six-month market exclusivity extension for conducting pediatric studies). The overall revenue impact was lessened in April with the extension of the co-promotion contract with Otsuka for Abilify until April 2015 from November 2012. Operational performance until this time will be determined by revenue gains of Bristol-Myers Squibb's five top-selling products: Plavix, Avapro, Abilify, Reyataz and Sustiva.
Leverage had fallen to 1.3 times (x) for the latest 12-month (LTM) period at the end of the first quarter of 2009 from 2.0x at the end of 2006 following the unexpected limited market introduction of a generic version of Plavix. Fitch expects leverage to decrease annually from operational improvement until significant drug patent losses starting in late 2011. The long-term debt schedule does not include significant maturities around the time of the Plavix patent expiration. Free cash flow was modest for the LTM period ending March 31, 2009 at $24 million. However, Fitch believes that free cash flow will improve annually given the company's solid intellectual property position over the next two years.
Fitch's rating definitions and the terms of use of such ratings are available on the agency's public site, www.fitchratings.com. Published ratings, criteria and methodologies are available from this site, at all times. Fitch's code of conduct, confidentiality, conflicts of interest, affiliate firewall, compliance and other relevant policies and procedures are also available from the 'Code of Conduct' section of this site. |
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Thursday, 23 July 2009 15:12 |
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SANTA CLARA, Calif.--XenoPort, Inc. (Nasdaq: XNPT) announced today that it will release its second quarter financial results on August 5, 2009 at approximately 4:30 p.m. Eastern Time. The company will host a conference call at 5:00 p.m. Eastern Time that same day. A replay of the call will be available for one week following the event.
To access the conference call via the Internet, go to www.XenoPort.com. Please join the call at least 15 minutes prior to the start to ensure time for any software downloads that may be required.
To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 706-679-1417. The reference number to enter the call is 13770917.
The replay of the conference call may be accessed that same day after 8:00 p.m. Eastern Time, via the Internet, at www.XenoPort.com, or via phone at 1-800-642-1687 for domestic callers, or 706-645-9291 for international callers. The reference number to enter the replay of the call is 13770917.
About XenoPort
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate, XP13512, in collaboration with Astellas Pharma Inc. and GlaxoSmithKline (GSK). The Food and Drug Administration is currently reviewing GSK’s NDA for XP13512 as a potential treatment for moderate-to-severe primary restless legs syndrome in the United States. XenoPort’s product candidates are also being studied for the potential treatment of gastroesophageal reflux disease, migraine headaches, neuropathic pain, spasticity related to spinal cord injury, acute back spasms and Parkinson’s disease.
To learn more about XenoPort, please visit the Web site at www.XenoPort.com. |
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Thursday, 23 July 2009 14:49 |
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SOUTH SAN FRANCISCO, Calif.-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL - News) today announced that the Company plans to host a conference call on Thursday, July 23, 2009 at 7:00 pm EDT (4:00 pm PDT). Members of Rigel's senior management team and the principal investigator of the trial will discuss results of the Company's Phase 2b TASKi3 clinical trial of R788 in rheumatoid arthritis, the Company's plans for further development and related matters.
Conference Call and Webcast Information
To access the live call, please dial 866-700-6293 (domestic) or 1-617-213-8835 (international) 10 minutes prior to the start time and use the passcode 13318888. A replay of the call will be available at approximately 10:00 pm EDT/7:00 pm PDT on July 23, 2009 until July 30, 2009. To access the replay, please dial 888-286-8010 (domestic) or 1-617-801-6888 (international) and use the passcode 14211103. The conference call will also be webcast live and can be accessed from Rigel's website at http://www.rigel.com. Please connect to Rigel's website several minutes prior to the start of the live webcast to ensure adequate time for any software downloads that may be necessary.
About Rigel (www.rigel.com)
Rigel is a clinical-stage drug development company that discovers and develops novel, small molecule drugs for the treatment of inflammatory/autoimmune diseases and metabolic diseases. Our pioneering research focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. Rigel's productivity has resulted in strategic collaborations with large pharmaceutical partners to develop and market our product candidates. Rigel has product development programs in inflammatory/autoimmune diseases such as rheumatoid arthritis, thrombocytopenia and asthma, as well as in cancer. |
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Thursday, 23 July 2009 10:31 |
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SAN DIEGO-- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that it has priced an underwritten public offering of 10,000,000 shares of its common stock at a price of $7.50 per share. Net proceeds, after estimated underwriting discounts and commissions and estimated expenses, will be approximately $70.9 million. Orexigen has granted the underwriter a 30-day option to purchase up to an additional 1,500,000 shares of common stock to cover overallotments, if any. The offering is expected to close on or about July 28, 2009, subject to satisfaction of customary closing conditions. Leerink Swann LLC is acting as sole book-running manager for the offering. Lazard Capital Markets LLC, Canaccord Adams Inc., JMP Securities LLC and Natixis Bleichroeder Inc. are acting as co-managers for the offering.
The securities described above are being offered by Orexigen pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The offering may be made only by means of a prospectus supplement and the accompanying prospectus, copies of which may be obtained, when available, from Leerink Swann LLC , Attention: Syndicate Department, One Federal Street, 37th Fl., Boston, MA 02110 or by calling Leerink Swann LLC, toll free, at 1-800-808-7525, Ext. 4814.
About Orexigen(R) Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead investigational product, Contrave(R), has completed Phase 3 clinical trials and is on track for a regulatory submission with the FDA in the first half of 2010. The Company's second product, Empatic(TM), is in the later stages of Phase 2 clinical development, with results expected in the second half of 2009. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found athttp://www.orexigen.com. |
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