Sign Up NowThis Month's Tiny Gems - June 2012

Cardium Therapeutics, Inc. (CXM)
Dynavax Technologies Corp. (DVAX)
Idenix Pharmaceuticals, Inc. (IDIX)
InterMune, Inc. (ITMN)

 

 

 

Cardium Therapeutics, Inc. (CXM)

 

Cardium Therapeutics, Inc. (CXM) is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering, and other economic monetizations. Cardium's current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the company's in-house MedPodium Health Sciences healthy lifestyle product platform.

 

The company's lead commercial product, Excellagen® topical gel for wound care, recently received FDA clearance for marketing and sale in the United States. Following Excellagen®'s initial market introduction, CXM will look to strategic commercialization partners with existing sales and marketing forces in the U.S., as well as internationally.

 

In line with this strategy, during first quarter, the company announced an agreement for the sale and distribution of Excellagen® in South Korea, which represents the first of what Cardium plans to be a series of marketing and distribution agreements with commercialization partners in the U.S. and other markets. Initial market introduction includes educating physicians and wound care clinics about Excellagen® through direct mailing, advertising in trade publications, building a network of key opinion leaders, web outreach to both physicians and patients, and exhibiting at medical trade shows.

 

Cardium is dedicated to building on its core products and product candidates to continually create new opportunities for greater success. Leveraging the advantages of its capital-efficient, asset-based business strategy, the company provides a diversified and more balanced portfolio of risk/return opportunities with the chief objective of providing long-term shareholder value.

 

 

 

Dynavax Technologies Corp. (DVAX)

 

Dynavax Technologies Corp. (DVAX), a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and earlier protection with fewer doses than currently licensed vaccines.

 

HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as 1018 ISS to enhance the immune response.

 

DVAX's financial results for the first quarter ended March 31, 2012, included total revenues of $2.4 million, an increase over the $1.7 million reported for the first quarter of 2011. Total operating expenses of $18.2 million for the first quarter 2012 was a decrease from the $19.7 million reported for the first quarter of 2011, resulting primarily from the completion of certain clinical activities for HEPLISAV.

 

The company is currently engaged in preparing to submit its first Biologics License Application (BLA) for the HEPLISAV Hepatitis B Vaccine to the FDA in the second quarter, followed soon by a submission of Marketing Authorization Application for European approval.

 

 

 

Idenix Pharmaceuticals, Inc. (IDIX)

 

Idenix Pharmaceuticals, Inc. (IDIX) is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases with operations in the United States and Europe. The company's research and development focus is on the treatment of hepatitis C virus (HCV).

 

HVC reports from the New England Journal of Medicine say there about 170 million-plus people carrying the virus globally, including 4.1 million Americans. Annual projections for the market value of vaccines range from $3 billion to $20 billion by 2020. A global rush is on to try and find a cure for this disease.

 

In July 2011, IDIX initiated a phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (Peg-IFN/RBV), in treatment- HCV genotype 1-infected patients. The company's drug candidate for its NS5A inhibitor program is IDX719. In December 2011, it filed an investigational new drug application (IND) for IDX719 and in January 2012, it initiated a phase I clinical study.

 

For the first quarter of this year, total revenues totaled $35,645,000 compared to $4,001,000 a year ago. Income from operations was $11,108,000 against loss from operations of $8,543,000 a year ago. Income before income taxes was $11,450,000 compared to $8,235,000 a year ago. Net income was $11,449,000, or $0.10 per diluted share, against net loss of $8,236,000, or $0.11 per basic and diluted share, a year ago.

 

 

 

InterMune, Inc. (ITMN)

 

InterMune, Inc. (ITMN), a biotechnology company, engages in the research, development, and commercialization of therapies in pulmonology and orphan fibrotic diseases. ITMN was founded in 1998 and is headquartered in Brisbane, California.

 

The company focuses on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. It markets pirfenidone, an orally active small molecule drug for the treatment of adults with mild to moderate IPF, under the Esbriet name in the European Union.

 

The company's pirfenidone product is in Phase III clinical trials for the treatment of IPF in the United States. Pirfenidone is also approved for the treatment of IPF in Japan, where it is marketed under the Pirespa trade name. Pirfenex is the trade name for the product used in India. Additionally, the product is sold by Shanghai Genomics in China. The company also has rights to one approved and marketed product, Actimmune, which is approved in the United States and other countries for the treatment of chronic granulomatous disease and severe, malignant osteopetrosis.

 

For the first fiscal quarter ended March 31, 2012, ITMN reported total revenue of $8,936,000 against $6,352,000 a year ago. Total revenue in the first quarter of 2012 included $4.9 million of revenue from sales of Esbriet in Europe.