www.bellwetherreport.com Report for REGN today. Positive article.
Regeneron Pharmaceuticals Inc.
Regeneron Pharmaceuticals Inc
(NASDAQ:REGN)
Share price as of Friday¡¯s close: $8.62
Share price as of now: $9.00
Change: 4.41%
Volume: 353,024 shares, daily average 425,641
Last time this high: January 4, 2005
52-week high: $10.28
52-week low: $4.61
Regeneron Pharmaceuticals was founded in 1988 by CEO Leonard S. Schleifer, M.D., to develop and commercialize new therapeutic agents to treat unmet medical needs. The company initially focused on treatments for diseases of the nervous system. However in 1995, when P. Roy Vagelos, M.D., joined Regeneron as its Chairman, he encouraged development of the Company¡¯s strength in science and technology in more diverse disease settings, such as cancer, eye disease, rheumatoid arthritis, allergy, and asthma.
Regeneron is developing a series of ¡°Traps,¡± a new class of product candidate which targets and blocks many of the protein hormones whose over activity seems to contribute to many different diseases. Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, and cancer. The company also has preclinical programs in asthma, allergies, and other diseases and disorders. Regeneron¡¯s scientists continue to be busy in the laboratory bench, producing exciting discoveries that may lead to additional therapeutic product candidates of the future.
During the first quarter of 2005 Regeneron reported revenue of $16.2 million compared to $62.0 million in the same period pf 2004 due primarily to lower revenues related to their collaboration with sanofi-aventis on the VEGF Trap and their prior collaboration with Novartis on the IL-1 Trap. Collaboration revenue earned from sanofi-aventis and Novartis is comprised of contract research and development revenue and research progress payments. Regeneration reported a net loss of $4.1 million, or $0.07 per share for the first quarter of 2005 compared with a net income of $64.5 million, or $1.17 per basic share.
On May 16, 2005 Regeneron announced positive preliminary results from on going phase 1 open-label, dose-escalation study of the VEGF Trap administered intravenously to patients with advanced cancers.
"The preliminary results of this study reinforce our belief that the VEGF Trap has the potential to become an important drug in the treatment of cancer," noted Dr. Jesse Cedarbaum, Regeneron's Vice President Clinical Affairs. "We are looking forward to advancing our clinical program."
The study was designed to examine the safety, pharmacokinetics, biological activity, and preliminary efficacy of the VEGF Trap when administered intravenously every two weeks to patients with advanced solid tumors. The VEGF Trap was generally well tolerated at the dose levels evaluated, with the most common adverse events during treatment including fatigue, pain, and constipation. No anti-VEGF Trap antibodies have been detected, and the maximum tolerated dose has not yet been reached. Preliminary analyses of tumor blood flow and volume by dynamic contrast-enhanced Magnetic Resonance Imaging (MRI) scans have suggested that the VEGF Trap rapidly induces a tumor vascular response. Preliminary efficacy analysis showed evidence of tumor size reduction and prolonged stable disease in some patients after VEGF Trap treatment as a single-agent. One patient achieved a partial response with disappearance of ascites, two patients had minor responses, and one patient has maintained stable disease for over 11 months to date.
On June 10, 2005 Regeneron announced more positive preliminary results from another pilot, this time on weekly dosing of the Interleukin -1 Trap in patients with CIAS1-associated periodic syndrome (CAPS), a family of auto inflammatory diseases. All four patients enrolled in the study to date experienced a positive response to a subcutaneous loading dose regimen of the IL-1 Trap, including a sizable reduction in daily patient diary scores and acute phase reactant levels. In the ongoing chronic dosing phase of the study, these patients continue to demonstrate a positive response to the IL-1 Trap.
Treatment with the IL-1 Trap led to an immediate clinical and laboratory improvement in all patients," the NIAMS investigators reported. "These results will allow us to further investigate the role of IL-1 blockade in treating patients with CAPS and other inflammatory diseases."
The IL-1 Trap is designed to attach to and neutralize IL-1 in the blood stream before it can attach to cell-surface receptors and generate signals that can trigger disease activity in body tissue. Once attached to the Trap, IL-1 cannot bind to the cell surface receptors and, together with the Trap, is flushed from the body. The IL-1 Trap has a long duration in the body, and can be delivered by weekly injection. On July 5, 2005 the company began the initiation of a clinical program to evaluate the VEGF Trap in certain eye diseases utilizing intravitreal injections in the eye. The trial is being conducted on patients with the neovascular AMD, a degenerative condition that is a major cause of severe vision impairment and blindness in adults over 55. "Blocking VEGF is a validated approach in treating wet AMD, and the VEGF Trap blocks all forms of VEGF-A with extremely high affinity," said Jesse M. Cedarbaum, MD, Vice President of Clinical Affairs at Regeneron. "This trial is another significant step forward in further exploring the potential benefit the VEGF Trap can provide to patients suffering from wet AMD and other eye diseases." So far during the second quarter of 2005 the company has enjoyed a lot of success in the trials of the company¡¯s different product candidates. The company will continue to work and conduct trials on these candidates in hopes that they one day enter the market place. If the company can progress any of these treatments into the actual market place, it would be huge. Many of these candidates have high hopes for the treatment of many serious diseases and so far things are looking good. If this success in the trials keeps up the company should enjoy a very positive 2005.
Written By
Kyle Noddin
Kyle Noddin and the Bellwether Report do not have a vested interest in the companies mentioned above
