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Otonomy Introduces Scientific Advisory Board
Date: March 30, 2009
Client: Otonomy
Summary: SAN DIEGO – Otonomy Inc. today introduced its scientific advisory board comprised of physicians and research scientists specializing in diseases and disorders of the ear. The advisory board includes three of the company’s founders: Rick Friedman, M.D., Ph.D.; Jeffrey Harris, M.D., Ph.D.; and Allen Ryan, Ph.D. Joining the founders on the advisory board are Stephan Heller, Ph.D.; Charles Liberman, Ph.D.; Christopher Post, M.D., Ph.D.; and Alec Salt, Ph.D.
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Calixa Pushes Anti-Pseudominal Antibiotic Towards Phase II for UTI - Trista Morrison
Date: March 30, 2009
Client: Calixa
Summary: With $30 million of Series A financing in its offers, Calixa Therapeutics Inc. is gearing up for a Phase II trial of CXA-101, a broad-spectrum cephalosporin antibiotic that has shown potent anti-pseudominal activity. San Diego-based Calixa was founded in late 2007 by antibiotic expert James Ge and serial entrepreneur Eckard Weber. The two have a long history of working together at antibiotic firms funded by Domain Associates, where Weber serves as a partner.
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Results From Study Show Promising Efficacy and Safety Results for Corthera’s Relaxin in Acute Heart Failure
Date: March 29, 2009
Client: Corthera
Summary: SAN MATEO‚ Calif. – Corthera Inc. today announced that results from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, placebo-controlled international study, demonstrated promising efficacy and safety for relaxin, the company’s investigational drug for treatment of acute heart failure (AHF). The report containing the detailed study results is being published on-line in the medical journal, The Lancet.
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Molecular Insight Releases Positive, Detailed Phase 2 Trial Results Demonstrating Ability of Zemiva™ to Rapidly Detect Cardiac Ischemia
Date: March 26, 2009
Client: Molecular Insight
Summary: Cambridge, MA – Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today provided positive detailed data on its Phase 2 clinical trial (BP-23) for Zemiva. In this trial, the combination of Zemiva imaging with initial clinical information resulted in improved sensitivity (85%) compared to the sensitivity of the initial clinical diagnosis alone (52.2%) (p<0.0001), while maintaining specificity (p=NS). Zemiva is a molecular imaging radiopharmaceutical the Company is developing to detect cardiac ischemia, the lack of sufficient blood flow to the heart. Ischemia can lead to heart attacks.
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Cougar Biotechnology to Present at Citi Biotech Day
Date: March 25, 2009
Client: Cougar Biotechnology
Summary: Los Angeles, CA - Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that Alan H. Auerbach, Chief Executive Officer and President of Cougar, will present at Citi’s 4th Annual Biotech Day on Wednesday, April 1, at 10:40 a.m. EDT in New York City. Mr. Auerbach will provide a company overview and update on the status of Cougar’s current clinical development programs.
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Opinion: The value of FAME - Dr. Ascan Warnholtz
Date: March 24, 2009
Client: Radi Medical Systems
Summary: The recently published results of the COURAGE1 trial have questioned the advances and benefits of percutaneous coronary intervention (PCI). Since the publication of this trial the interventional community has responded globally with more defensive strategies and a slight reduction of the number of performed PCI. However, subanalyses have revealed that patients with a significant extent of stress-induced myocardial ischaemia still benefit from the percutaneous coronary intervention of an ischaemia inducing coronary stenosis. Therefore, the results of the COURAGE trial do not argue against the value of percutaneous coronary intervention but emphasise the importance of obtaining evidence of myocardial ischaemia prior to PCI... Taken together, the FAME trial adds valuable prognostic information for patients with multivessel disease. At least, for the selected patient population investigated in the FAME trial, the FFR guided approach is preferable to the angiography guided approach. It may not only save patients’ lives by reducing major adverse cardiac events rates, but also alleviate the health care-related economic burden of the interventional treatment of coronary artery disease.
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Calixa Passes Key Safety Test in Clinical Trial of New Antibiotic - Luke Timmerman
Date: March 24, 2009
Client: Calixa
Summary: MRSA is the headline-grabbing boogeyman of the day when it comes to the type of deadly infections that people can pick up in the hospital. But there are all sorts of other nasty bugs crawling around your healthcare facility, and San Diego-based Calixa Therapeutics says it is on its way to creating a new drug to fight one of them. Calixa, which has remained stealthy for its first couple years in business, is announcing today that it has passed a Phase I clinical trial of 58 healthy volunteers, which shows its antibiotic for pseudomonal infections appears safe. The drug appears to have a good enough profile to move into the next phase during the second quarter, with a study of about 100 patients that will provide a measure of its effectiveness.
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Otonomy Tackles Hearing and Balance Disorders with Delivery - Trista Morrison
Date: March 23, 2008
Client: Otonomy
Summary: While navigating the curves of La Jolla, Caif.'s Coast Boulevard last January, Jay Lichter, managing director of Avalon Ventures, experienced an intense episode of vertigo. After a trip to the emergency room, he found himself in the office of Jeffery Harris, a participating physician and chief of the division of otolaryngology at the University of California, San Diego. Lichter recalled that, a decade before, when he'd worked at Pfizer Inc., the commercial team had clamored for dtugs that could treat hearing loss, but there were simply none available for licensing. Desepite the fact that hearing and balance disorders affect 30 million Americans and represent a significant market opportunity, the field "hasn't had drug hunters look at it." But not for long, if Lichter and Harris have their way. The two teamed up to found Otonomy Inc., a San Diego-based start-up seekig to optimize the delivery and gain FDA approval of genetic drugs used off-label for hearing and balance disorders. Otonomy's lead product is an intratympanic injection of a sustained-release gel formulation of the steroid dexamethasone for Meniere's disease.
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Results From Efficacy and Safety Study of Corthera’s Relaxin in Acute Heart Failure to be Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session
Date: March 23, 2009
Client: Corthera
Summary: SAN MATEO‚ Calif. – Results from the Phase II portion of a Phase II/III clinical trial of Corthera’s investigational drug relaxin for the treatment of acute heart failure will be presented at 10:30 a.m. EDT on Sunday, March 29, at the American College of Cardiology’s (ACC) 58th Annual Scientific Session in Orlando, Fla. John R. Teerlink, M.D., professor of medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center will present the results from the multicenter, international Pre-RELAX-AHF study as part of an ACC special session entitled “Late-Breaking Clinical Trials I: Congestive Heart Failure.”
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The Whole World is Watching - Hope—and anxiety—run high as the first clinical trial of embryonic-stem-cell therapy begins this summer
- Claudia Kalb
Date: March 21, 2009
Client: Geron
Summary: Six weeks before the hoopla over President Barack Obama's executive order lifting restrictions on embryonic-stem-cell research, Hans Keirstead, a scientist at the University of California, Irvine, was already sipping champagne. In 2005 Keirstead had published a study showing that a therapy derived from human embryonic stem cells could make partially paralyzed rats walk. Now he'd gotten word that the FDA had cleared the way for Geron, a small biotech company in California, to launch the first clinical trial of the treatment in human beings with spinal-cord injuries. It was incredible news,not just for Keirstead, who'd been wanting to invent a therapy for brain and spinal-cord disorders since he was 11 years old, but for scientists who believe human embryonic stem cells can teach them about complex diseases and potentially lead to cures. Keirstead, 41, and his team of scientists hailed the news over a case of chilled Veuve Clicquot. "We put the last bottle down about six hours later," Keirstead says. "It was just a really fun time."
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Playing the Field: Rather than relying on any single source of financing, biotechnology companies need to call upon a toolbox of various instruments - Daniel S. Levine
Date: March 18, 2009
Client: Ambrx and GlobeImmune
Summary: The numbers paint a stark reality for capital hungry biotech companies. In 2008, the industry raised only $10.1 billion, less than half of the $21.9 billion raised in the previous year. Just one biotechnology company managed to go public, netting a measly $6 million, compared to the industry’s more than $2 billion in IPO proceeds in 2007. The need for capital hasn’t abated. Far from it. But to raise money today, companies need to think about alternatives to traditional sources of financing. Ambrx CEO Steve Kaldor decided to forgo additional venture capital investment in 2006, even though the company had ready access to it. During its first three years, the La Jolla, California-based company, which genetically engineers proteins with new amino acids to create molecules with new physical, chemical, and pharmacological properties, raised about $90 million through venture financings. But it saw alliances as more attractive, since they would be non-dilutive and would accelerate the development of the company’s pipeline. Since then, Ambrx has raised nearly $70 million through partnering deals that have played an important role in growing the company. Of course the best alternative financing is one that costs nothing. That’s something Louisville, Colorado-based GlobeImmune is proving adept at doing, thanks to researchers’ interest in the company’s so-called Tarmogens—genetically engineered yeast that express proteins that stimulate the immune system against cancer and infectious disease.
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Amira’s Drug Discovery Team, Pioneers of Hit Asthma Treatment, Take Aim at Pulmonary Fibrosis - Luke Timmerman
Date: March 18, 2009
Client: Amira
Summary: People with pulmonary fibrosis have a pretty raw deal. Scientists don’t really know what causes this lung-damaging disease, and there’s no really effective FDA-approved treatment. The disease makes it hard to breathe, and kills an estimated 40,000 people a year. That’s a bigger killer than some far better known culprits like prostate cancer. A few drug companies have tried to fill this void with little to show for it yet. But San Diego-based Amira Pharmaceuticals says it is hot on the trail of creating a new small-molecule drug against a new target that it thinks could represent a big step forward. This program is in very early stages—too early to say anything about potential effectiveness—but I figured I’d listen because this company’s scientific team worked together at Merck’s former San Diego operation and played important roles in developing montelukast sodium (Singulair), the asthma drug that generates $4 billion a year in revenue. |
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S*BIO Receives BioSingapore’s 2009 Award for the Most Successful Bio-Partnership in Asia
Date: March 18, 2009
Client: S*BIO
Summary: Singapore, March 18, 2009 - S*BIO Pte Ltd today announced that it has received BioSingapore’s 2009 award for the “Most Successful Bio-partnership in Asia”. Dr. Jan-Anders Karlsson, CEO of S*BIO, accepted the award on behalf of the company at the 2nd annual BioSingapore Award Gala Dinner during the BioMedical Asia 2009 Conference. BioSingapore annually receives nominations from biotechnology industry associations, industry peers, academics and institutions across Asia-Pacific for the most outstanding companies or individuals in various categories. Adjudged by a panel of distinguished leaders in the field, BioSingapore’s Asia-Pacific Biotechnology Awards recognize the outstanding performance of companies and colleagues in the past year. S*BIO was chosen by its peers for its accomplishments in the life sciences industry, and for the significant contributions the company has made to advancing scientific enterprise in the Asia-Pacific region.
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Using HIV as Model, Anadys Develops Drug Cocktail Ingredient for Hepatitis C - Luke Timmerman
Date: March 17, 2009
Client: Anadys
Summary: HIV was transformed from a terminal illness into a chronic disease in wealthy countries in the late 1990s, once scientists learned to mix anti-viral drugs into a potent cocktail. That was supposed to hold the virus in check by attacking it from many different angles, keeping it from developing resistance to any one drug.
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Briefings help educate reporters on products and topics - Jaimy Lee
Date: March 16, 2009
Client: Radi Medical Systems
Summary: Many Companies provide background and insight to hournalists via meetings in one-on-one and group settings. But for health companies, such sessions are especially useful. Device-provider Radi Medical Systems invited a Wall Street Journal reporter, who was seeking information about inventional cardiology procedures, to a hospital to observe a procedure and speak with cardiologists, acording to David Schull, president of Russo Partners, which works with Radi.
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Helix Biopharma Announces Q2 2009 Financial Results
Date: March 16, 2009
Client: Helix Biopharma
Summary: (Aurora, Ontario) – Helix BioPharma Corp. (TSX, FSE: “HBP”) today announced financial results for the second quarter of fiscal 2009, ended January 31, 2009.
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Cougar Biotechnology Reports 2008 Fourth Quarter and Year-End Financial Results
Date: March 16, 2009
Client: Cougar Biotechnology
Summary: Los Angeles, CA - Cougar Biotechnology, Inc. (NASDAQ: CGRB), a biotechnology company engaged in the in-license and development of clinical stage cancer drug candidates, today reported its financial results for the fourth quarter and year ended December 31, 2008. For the quarter ended December 31, 2008, Cougar reported a net loss applicable to common stock of $21.5 million, or $1.04 per share, compared to a net loss applicable to common stock of $7.7 million, or $0.43 per share, for the quarter ended December 31, 2007. Net loss applicable to common stock for the year ended December 31, 2008, was $59.8 million, or $2.90 per share, compared to a net loss of $32.2 million, or $2.17 per share, for the year ended December 31, 2007.
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Helix Biopharma Receives Approval to Initiate Phase II Pharmacokinetic Clinical Study of Topical Interferon Alpha-2b in Patients with Low-Grade Cervical Lesions
Date: March 16, 2009
Client: Helix Biopharma
Summary: (AURORA, Ontario) – Helix BioPharma Corp. (TSX, FSE: “HBP”) announced that it has received the necessary regulatory approvals in Germany to initiate its planned Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions. The clinical study was designed, as mandated by regulatory authorities, to gather data on the absorption and elimination profile of Topical Interferon Alpha-2b in patients with low-grade cervical lesions, in addition to further data on its safety and efficacy. Depending on the data generated in the study, it is expected that interim results, which Helix anticipates will be received during its fiscal fourth quarter 2009, will allow the company to proceed with its planned regulatory filings in the U.S. and Europe respectively for its future Phase IIb and Phase III pivotal efficacy trials for this indication.
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Automated Sequence Capture for Next-Generation Sequencing Paves the Way for Personalized Medicine
Date: March 16, 2009
Client: febit
Summary: LEXINGTON, MA (USA), and HEIDELBERG – febit today announced the official launch of its new sequence capture technology Hybselect. In several biomedical studies of early access customers over the past months, HybSelect demonstrated superb enrichment factors and deep sequencing coverage for a broad range of human genes and genomic regions. As the first sequence capture technology combining outstanding enrichment and walk-away convenience, HybSelect opens up new opportunities in biomarker discovery and the development of personalized medicine.
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Molecular Insight Pharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2008 Financial and Operational Results
Date: March 16, 2009
Client: Molecular Insight
Summary: Cambridge, MA – Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced the financial results for the fourth quarter and year ended December 31, 2008. In a conference call scheduled for today at 10:00 a.m., Eastern Time, the Company will discuss in detail the financial results as well as the Clinical and Financial Milestones for 2009.
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Helix Biopharma Form 20-F Registration Statement Declared Effective by SEC
Date: March 12, 2009
Client: Helix
Biopharma
ne">Summary: -(AURORA, Ontario) – Helix BioPharma Corp. (TSX, FSE: “HBP”) announced that its registration statement on Form 20-F has been declared effective by the U.S. Securities and Exchange Commission (“SEC”). Accordingly, Helix’s common shares are now registered with the SEC pursuant to Section 12(g) of the Securities Exchange Act of 1934, as amended. Registration of Helix’s shares in the United States allows its shares to be solicited and traded by licensed brokers in the United States in compliance with SEC regulations and blue sky requirements in various states in the United States.
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EntreMed Reports Fourth Quarter and Year-End 2008 Financial Results
Date: March 12, 2009
Client: EntreMed
Summary:ROCKVILLE, MD – EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today reported results for the three months and twelve months ended December 31, 2008. For fiscal year 2008, revenues were $7.5 million versus $7.4 million for 2007. For the year ended December 31, 2008, the Company reported a net loss of ($24.9 million) or ($0.29) per share, versus ($23.4 million), or ($0.28) per share, for fiscal year 2007. As of December 31, 2008, the Company had cash and short-term investments of approximately $24 million.
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Molecular Insight Receives Special Protocol Assessment Approval from FDA for Phase 2 Trial of Azedra™, a Radiotherapeutic to Treat Neuroendocrine Cancer
Date: March 11, 2009
Client: Molecular Insight
Summary: Cambridge, MA – Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced the receipt of a Special Protocol Assessment (SPA) letter stating that the U.S. Food and Drug Administration (FDA) has reached agreement with the Company regarding the design of the pivotal Phase 2 trial for registration of its lead oncology candidate, AzedraTM (UltratraceTM iobenguane I 131, formerly known as Ultratrace MIBG). Molecular Insight is developing Azedra for the treatment of neuroendocrine tumors, such as pheochromocytoma in adults and neuroblastoma in children. This study will be conducted in adults with pheochromocytoma. If successful, Azedra would be the first anti-cancer therapy in the United States indicated for the treatment of pheochromocytoma.
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Cougar Biotechnology to Present at Cowen and Company 29th Annual Health Care Conference
Date: March 11, 2009
Client: Cougar Biotechnology
Summary: LOS ANGELES - Cougar Biotechnology, Inc. (NASDAQ: CGRB - News) today announced that Alan H. Auerbach, Chief Executive Officer and President of Cougar, will present at the Cowen and Company 29th Annual Health Care Conference on Wednesday, March 18, at 11:00 a.m. EDT at The Boston Marriott Copley Place. Mr. Auerbach will provide a company overview and update on the status of Cougar’s current clinical development programs.
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Otonomy Tunes in to Biotech's Sound Opportunity: Diseases of the Ear - Luke Timmerman
Date: March 6, 2009
Client: Otonomy
Summary: Driving down Prospect Street in La Jolla one day in January 2008, Jay Lichter got so dizzy he had to pull over. After a stop in the ER, he ended up in the office of Jeff Harris, the chief of ear, nose, and throat surgery at the UC San Diego. The diagnosis: Meniere’s (Men-yay’s) disease, an inner ear fluid imbalance that leads to episodes of severe dizziness, vertigo, and gradual hearing loss. There wasn’t much the doctor could really do, which got the patient and doctor talking. Since Lichter makes a living as a venture capitalist with San Diego-based Avalon Ventures, their discussion quickly advanced beyond the usual small talk. They kicked around ideas on how to better treat all sorts of hearing loss. A month later, a company was born—San Diego-based Otonomy.
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S*BIO Receives BioSpectrum Editor's Choice, Emerging BioScience Company of Singapore Award
Date: March 6, 2009
Client: S*BIO
Summary: Singapore - S*BIO Pte Ltd today announced that it has received the BioSpectrum Editor's Choice, Emerging BioScience Company of Singapore Award. Dr. Stephen Rhind, Senior Vice President Corporate Development, S*BIO, received the award on behalf of the company, from Mr. S.Iswaran, Singapore’s Senior Minister for Trade and Industry. The Annual BioSpectrum awards recognize outstanding contributions to the growth of the biotechnology and life sciences industry in Asia. S*BIO was chosen for its innovative business model and leading position in Singapore’s biotechnology industry.
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CorNova looks to improve stent devices - Marc Songini
Date: March 6, 2009
Client: CorNova
Summary: Burlington-based medical device startup CorNova Inc. is taking existing stent-related devices and processes and combining them with cutting-edge technologies, such as fiber optics, to get better patient outcomes. The company is at work on a set of balloon catheters designed to help eliminate cases of stent restenosis, or thrombosis, by helping with stent selection and optimizing the process of implanting the stent, explained Eric Ryan, the company CEO. Its FiberHalo catheters carry a hair-thin fiber wire that provides blood vessel measurement from inside the balloon itself to assist in stent procedures, without a corresponding increase in time, risk or cost.
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Regulus Therapeutics Receives $20 Million in a Series A Equity Financing
Date: March 4, 2009
Client: Regulus
Summary: CARLSBAD, Calif., and CAMBRIDGE, Mass., – Regulus Therapeutics Inc., Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq:ISIS) announced today that Regulus has raised $20 million in a Series A preferred equity financing that further strengthens its balance sheet. Alnylam and Isis were the sole and equal investors in the financing. Regulus was established in September of 2007 by Alnylam and Isis to focus on the discovery, development, and commercialization of microRNA-based therapeutics. Regulus also announced that the company has completed a legal reorganization from an LLC to a C-Corporation providing an optimal capital structure for additional future investors.
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Savara Expands Board of Directors, Appoints Three New Members
Date: March 4, 2009
Client: Savara
Summary: Austin, TX, - Savara, Inc., a biopharmaceutical company developing novel respiratory therapeutics utilizing its NanoCluster dry-powder formulation technology, today announced that it has expanded its Board of Directors and appointed three new members. Nevan Elam, former head of the pulmonary business unit at Nektar Therapeutics, has been appointed to fill a seat previously held by Cory Berkland, Ph.D. The board has also been expanded from three members to five, with Curt Bilby, Ph.D., and Matthew Dennis filling the new seats.
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Cougar Biotechnology to Present at Barclays Global Capital Healthcare Conference
Date: March 4, 2009
Client: Cougar Biotechnology
Summary: Los Angeles, CA, - Cougar Biotechnology, Inc. (NASDAQ: CGRB) today announced that Alan H. Auerbach, Chief Executive Officer and President of Cougar, will present at the Barclays Global Capital Healthcare Conference on Wednesday, March 11, at 11:15 a.m. EDT at Loews Miami Beach Hotel in Florida. Mr. Auerbach will provide a company overview and update on the status of Cougar’s current clinical development programs.
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febit joins the READNA consortium with its novel sequence capture technology
Date: March 3, 2009
Client: febit
Summary: HEIDELBERG, Germany – As febit announced today, the company will further advance its HybSelect technology for use in READNA projects. HybSelect enables automated capture of specific DNA regions for high-throughput sequencing and will soon be launched in several markets. Joining a group of 16 European partners from industry and academics, febit will support the READNA consortium (REvolutionary Approaches and Devices for Nucleic Acid analysis). In projects supported by the EU with 12 million Euros of funding, the consortium pursues the development and evaluation of trail-blazing new technologies for DNA sequencing.
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CorNova Announces Addition of Andrew T. Jay, D.M.D., M.B.A.,to its Board of Directors
Date: March 3, 2009
Client: CorNova
Summary: BURLINGTON, Mass., – CorNova Inc. today announced the addition of Andrew T. Jay, D.M.D., to its board of directors. The addition increases board membership to 4. Dr. Jay, 46, is the managing partner of the Medical Solutions Fund of Siemens Venture Capital GmbH, the venture organization for Siemens AG. Prior to joining Siemens Venture Capital, he was an Institutional Investor-ranked medical technology analyst with both Alex. Brown and Wachovia Securities, where his coverage included cardiovascular device companies.
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Aerovance Initiates Phase IIb Clinical Trial with Aerovant™ for the Treatment of Uncontrolled Asthma
Date: March 2, 2009
Client: Aerovance
Summary: BERKELEY, Calif., – Aerovance Inc. today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance’s Phase IIb clinical trial, AeroTrial™, of inhaled dry powder Aerovant in patients with uncontrolled asthma. Study initiation begins today in the United States for AeroTrial, a double-blind, randomized, placebo-controlled, Phase IIb dose-ranging study. Aerovance expects to enroll approximately 500 patients with moderate to severe asthma, in the United States and Europe, who are poorly controlled by the combination of inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).
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