Monthly Archives: March 2012

Amid Growing Fears of Antibiotic Resistance, Cempra’s Therapeutics Offer a Promising Solution

Discussing the state of antimicrobial resistance at a recent conference, the director-general of the World Health Organization (WHO), Dr. Margaret Chan, made it clear that there is a significant need for new antimicrobial therapeutics.

Hospitals have now become hotbeds for highly resistant pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA), she said, and diseases that were curable, such as tuberculosis, are now are becoming harder and more complicated to treat. The lack of effective antibiotics can even make surgical procedures and certain cancer treatments too risky, even dangerous to undertake. Common occurrences such as strep throat or a child’s scratched knee could become lethal again, essentially, she said, the “end of modern medicine.”

Recognizing the critical unmet need for new antibacterial therapeutics, Cempra Pharmaceuticals (Nasdaq: CEMP) is pursuing the development of therapeutics targeting drug-resistant bacterial infections. With approximately $54.7 million raised from a recent IPO, including the overallotment option, the company plans to use the funds to advance its two late-stage programs.

A Phase 3 trial of lead therapeutic CEM-101 (solithromycin) for community-acquired bacterial pneumonia (CABP)is planned for later this year, and Cempra is also planning a Phase 2 trial for another antibiotic in development, Taksta™ (CEM-102), for treatment of prosthetic joint infections. The active compound in Taksta, fusidic acid, has a long history of safety and efficacy outside of the United States, with demonstrated activity against gram-positive bacteria, such as MRSA.

Russo Partners looks forward to building awareness of Cempra’s innovative antibacterial programs as they prepare to move into late-stage Phase 3 trials.

Read more about Cempra’s programs in the following article from News & Observer:

News & Observer

Merck Creates the California Institute for Biomedical Research (Calibr), Located in San Diego

Merck announced yesterday the creation of a nonprofit biomedical research institution for translational medicine, focused on the discovery of innovative, new medicines to treat disease. The institute, called the California Institute for Biomedical Research (Calibr), is located in San Diego and will work collaboratively with academic scientists to advance discoveries to preclinical proof of concept, at which point a commercialization partner will be sought. Merck has the option to license any therapeutic candidates that result from research conducted.

Leading the institute is Peter G. Schultz, Ph.D, a renowned chemist at The Scripps Research Institute and serial biotechnology entrepreneur who has founded companies such as Affymax Research Institute, Syrrx, Kalypsys, Phenomix, Symyx Therapeutics, Ilypsa, Wildcat Technologies and Ambrx.

Ambrx is a client of Russo Partners, and we are currently focused on raising awareness of the company’s antibody drug conjugate (ADC) program, which utilizes the company’s protein medicinal chemistry technology to create best-in-class ADCs.

Merck will invest $90 million into the new institute over the next seven years, during which 150 employees will be hired. Key academic institutions in the area include The Scripps Research Institute, The Salk Institute, University of California, San Diego and Sanford-Burnham Medical Research Institute.

Read more about the new institute in the following articles from Xconomy and the San Diego Union-Tribune:

Xconomy

San Diego Union-Tribune

Aragon Pharmaceuticals Secures $42 Million in Series C Financing to Advance Pipeline of Therapies Targeting Hormone-Driven Cancers, Announces Positive Phase 1 Data for Prostate Cancer Program

This week Aragon Pharmaceuticals announced that it secured $42 million in a Series C financing, which will be used to advance its pipeline of therapeutics targeting hormone-driven cancers. These types of cancers are usually treated with anti-hormonal therapies; however patients often become resistant to treatment, making hormone receptors a promising target for therapeutics.

Additionally, the company also reported positive Phase 1 data for its lead therapeutic for the treatment of castration-resistant prostate cancer (CRPC), ARN-509. The data announced are part of an ongoing open-label, dose-escalating Phase 1/2 clinical trial and demonstrated that ARN-509 was safe and well tolerated in patients with progressive metastatic CRPC. The therapeutic also demonstrated promising preliminary antitumor activity, with declines in prostate-specific antigen (PSA) observed in patients treated at all doses of ARN-509.

The financing was led by a new investor, the Topspin Fund, which is an investment group of James Simons, Leo A. Guthart and Steve Winick, and also included the participation of existing investors Aisling Capital, OrbiMed Advisors and The Column Group. With this financing, the amount of capital raised by the company since its founding in 2009 now totals $72 million.

Russo Partners worked to secure coverage of the announcement in the media, resulting in articles from newswires, including Dow Jones VentureWire, as well as trade publications, including Scrip, BioWorld Today, The Pink Sheet and Xconomy. For more information, please visit Xconomy’s coverage of the announcement.

MolecularHealth Forms Collaboration with FDA to Develop Tools for Predicting Drug Safety

Last month, MolecularHealth, a leader in clinico-molecular informatics, formed a five-year collaboration with the U.S. Food and Drug Administration (FDA) to evaluate and refine the company’s Molecular Analysis of Side Effects (MASE) software system. With this tool, users are able to combine current statistical methods of pharmacovigilance with mechanism-based analytics for identifying and validating drug safety signals.

MolecularHealth’s system is intended to help predict adverse drug events before they occur. MASE uses specific molecular information, such as drug mechanism of action and metabolism data as well as genomic factors affecting the behavior of a drug within the body, to more precisely assess and predict safety events. This is also an advantageous tool for pharmaceutical companies, as safety problems can be identified early on.

Through this collaboration, the FDA’s Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate relevant, non-proprietary molecular and clinical endpoints into the system, along with non-proprietary information about patient populations, molecular modes of action and mechanisms of disease.

Russo Partners looks forward to working with MolecularHealth to raise awareness of its solutions that translate medical data into safer and more effective drug choices for patients.

Below is a Pharmaceutical Executive blog entry about the collaboration:

Pharmaceutical Executive