Medical Device Daily
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Phase Forward (Waltham, Massachusetts), a provider of data management solutions for clinical trials and drug safety, has priced its previously disclosed public offering of 5.5 million shares of common stock at $15 a share, for estimated net proceeds of about $78 million (Medical Device Daily, May 11, 2007). Closing of the offering is expected on May 29.

The underwriters have a 30-day option to purchase another 825,000 shares to cover any over-allotments. If all the over-allotments are exercised, the company could garner up to $90.38 million, before expenses.

The company said it intends to use the net proceeds for working capital, sales and marketing, R&D and capital expenditures.

Phase Forward offers solutions for electronic data capture (InForm), clinical data management (Clintrial), clinical trials signal detection (CTSD), strategic pharmacovigilance (WebVDME and Signal Management), adverse event reporting (Clintrace) and applied data standards (WebSDM). In addition, it provides services in the areas of application implementation, hosting and validation, data integration, business process optimization, safety data management and industry standards.

Thomas Weisel Partners and UBS Investment Bank are acting as the joint bookrunners for the offering. Piper Jaffray & Co., Craig-Hallum Capital Group and Pacific Crest Securities are serving as co-managers.

Genomic Health (Redwood City, California) raised $46.5 million in a public offering to fund development and expansion of its genomics-based clinical diagnostic tests in cancer applications.

The company, which disclosed the offering earlier this month (MDD, May 16, 2007) sold 3 million shares at $15.50 a share. Underwriters have an option to purchase up to another 450,000 shares to cover any over-allotments.

Genomic Health in 2004 launched its first test, Oncotype DX, which is used to predict the likelihood of cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit in early stage breast cancer patients. The company, founded in 2000, went public in September 2005, raising about $60.2 million in an IPO at $12 per share. (MDD, Oct. 3, 2005).

The Oncotype DX test uses quantitative genomic analysis in standard tumor pathology specimens to provide tumor-specific information, or the oncotype, of a tumor, to improve cancer treatment decisions. The clinical laboratory service entails analyzing the expression levels of 21 genes in tumor tissue samples, which generates a recurrence score based on tumor's aggressiveness, a score believed to be correlated with the likelihood of chemotherapy benefit. The test costs $3,460.

Genomic Health is conducting clinical studies in an attempt to expand the clinical utility of Oncotype DX in breast cancer, and is developing the product for similar diagnoses in patients with early stages of colon, prostate, renal cell and lung cancers and melanoma.

One study, to be reported at the upcoming American Society of Clinical Oncology meeting, was completed in node-positive breast cancer. Data support further investigation for prediction of recurrence, Genomic Health said. It also plans a second study focused on identifying patients more likely to benefit from anthracycline-based chemotherapy regimens. If successful, the company said, the studies could support launch for the expanded use in those patients in 2008.

Other studies are testing the utility of gene scores, the use of the product in other patient populations, and use with different chemotherapy classes.

The company said its strategy is to identify treatment decisions that can benefit from, and be guided by, the patient's individual genomic information. A goal is to make its genomic-based tests a standard of care, delivering information after diagnosis but prior to the decision to undergo a specific cancer treatment. It said treatment decisions now are being made with little understanding of the molecular profile of each tumor, resulting in economic inefficiencies.

Genomic Health on March 31 reported cash and equivalents of $35.1 million. Following the offering, it had about 27.6 million shares outstanding, as well as options outstanding on another 3 million shares at an average exercise price of $9.94.

J.P. Morgan Securities is sole book-running manager for the offering, with Lehman Brothers, the co-lead manager. Piper Jaffray & Co. and JMP Securities are co-managers.

In other financing news: Novadaq Technologies (Toronto), a developer of real-time medical imaging systems and image-guided therapies for the operating room, reported closing its previously disclosed private placement of 4 million common shares at a $7.50 a share for gross proceeds of $30 million.

The syndicate of agents was led by RBC Dominion Securities and included Blackmont Capital and Versant Partners.

The company said the net offering proceeds will be used to fund R&D work, sales and marketing expenses and recent acquisitions, including the exclusive distribution rights to PLC Medical System's (Franklin, Massachusetts) Heart Laser System for transmyocardial revascularization in the U.S.; the acquisition of certain business assets of Xillix Technologies (Richmond, British Columbia); and for general corporate purposes.

Novadaq first disclosed the offering earlier this month (MDD, May 15, 2007) and increased the number of shares in the offering from 2 million to 4 million last week (MDD, May 15, 2007).