surf1944
15 years ago
LabCorp Enters Definitive Agreement to Acquire Monogram Biosciences, Inc.
Acquisition Price of $4.55 per Share in All Cash Transaction
more good news for the sector
LabCorp to Strengthen Leadership in Infectious Disease and Oncology and Advance Personalized Medicine Strategy
Press Release
Source: Laboratory Corporation of America® Holdings
On Tuesday June 23, 2009, 9:05 am EDT
Companies:Laboratory corp. of america holdingsMonogram biosciences, inc.
BURLINGTON, N.C., SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH - News) and Monogram Biosciences, Inc. (NASDAQ: MGRM - News) today announced that they have entered into a definitive agreement and plan of merger under which LabCorp will acquire all of the outstanding shares of Monogram in a cash tender offer for $4.55 per share for an implied total equity value of approximately $106.7 million, or a total enterprise value of approximately $155 million at March 31, 2009, including net indebtedness.
“The transaction announced today is a significant step in the execution of LabCorp’s strategy of leadership in personalized medicine,” said David P. King, Chairman and Chief Executive Officer of LabCorp. “Monogram Biosciences, Inc. has an excellent clinical reputation, a market leading infectious disease test, a market leading companion diagnostic, an exciting technology platform for oncology and offers LabCorp a substantial growth opportunity. By utilizing LabCorp’s national infrastructure to build on Monogram’s already strong sales, we will advance our leadership in infectious disease and cancer testing, companion diagnostics and personalized medicine. We look forward to providing improved offerings to both our and Monogram’s current customers.”
Monogram Biosciences, Inc. is a leading provider of companion diagnostics - molecular diagnostic products that help guide and target appropriate treatments. Monogram’s proprietary, clinically validated Trofile® assay identifies patients who are eligible for the CCR5 class of HIV drugs and is the widely adopted companion diagnostic for the HIV drug Selzentry®. Monogram’s PhenoSense® and PhenoSense GT ® HIV tests measure individual patient viral drug resistance, thereby enabling physicians to design optimal, individualized treatment plans for each patient. PhenoSense® and PhenoSense GT® are among the most widely used HIV resistance tests in the market today. Monogram’s HIV tests are used routinely by physicians for managing patient therapy and are an integral component of anti-HIV drug development and clinical evaluations for the pharmaceutical industry.
Monogram’s proprietary VeraTag™ technology has been used to develop a sensitive means to assess HER-2 status in tissue samples and has significant potential as a tool to help guide therapy decisions in breast cancer patients. Based on the VeraTag platform, Monogram has multiple tests in development for measuring a variety of protein markers that may have clinical utility to help guide treatment decisions across a broad range of cancer drugs. The potential oncology pipeline associated with this technology is a natural extension of LabCorp’s existing oncology offerings for both clinical trials and commercial clients.
“The transaction underscores the fundamental value of the Monogram business, the talent and expertise of our global team and the quality of our offerings,” said William D. Young, Chief Executive Officer and Chairman of Monogram Biosciences, Inc. “LabCorp has an exciting vision of the role of molecular diagnostics in personalized medicine, and we are excited to see Monogram’s technology and employees become a part of that vision. We expect the transaction will significantly accelerate the development of products that will improve treatment outcomes for patients with infectious diseases and cancer.”
The acquisition is expected to be approximately $0.12 dilutive to LabCorp’s 2009 earnings per share (EPS), including approximately $0.04 of transaction related costs, and slightly accretive to 2010 EPS.
Under the terms of the agreement and plan of merger, LabCorp’s acquisition subsidiary, Mastiff Acquisition Corp., will commence a tender offer to purchase all outstanding shares of Monogram Biosciences, Inc. for $4.55 per share in cash, without interest. Following the completion of the tender offer, LabCorp expects to merge Mastiff Acquisition Corp. and Monogram resulting in any shares not purchased in the tender offer being converted into the right to receive the same cash price per share as paid in the tender offer. The tender offer and the merger are subject to customary closing conditions set forth in the agreement and plan of merger, including the acquisition in the tender offer of a majority of Monogram’s outstanding shares on a fully diluted basis (excluding out of the money options) and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The closing of the acquisition is expected in the third quarter of 2009.
The Board of Directors of Monogram Biosciences, Inc. has unanimously determined that the offer and the merger are advisable, fair to, and in the best interests of Monogram and its stockholders, approved the agreement and plan of merger and the other transactions contemplated thereby, including the tender offer, and recommended that the Monogram stockholders accept the offer and tender their shares in the offer when it is made.
The total $155 million estimated enterprise value of the transaction is based on Monogram's approximately 23.5 million fully diluted shares outstanding less net cash and cash equivalents on hand as of March 31, 2009, plus outstanding indebtedness as of that date.
wave
17 years ago
Monogram Announces 2007 Year-End Financial Results
Thursday February 7, 4:00 pm ET
34% Year to Year Growth drives Fourth Quarter Revenue to Record Level
- Conference call today at 4:30 p.m. ET -
SOUTH SAN FRANCISCO, Calif., Feb. 7 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today reported financial results for the quarter and year ended December 31, 2007.
The Company had revenue of $13.7 million for the fourth quarter of 2007, 34% higher than $10.2 million in the fourth quarter of 2006. This growth in revenue was driven primarily by revenue from Trofile(TM), Monogram's proprietary tropism assay. Trofile is the only clinically validated assay for selecting the appropriate HIV patients to be treated with Selzentry(TM), Pfizer's recently FDA-approved CCR5 antagonist. For U.S. patients, Monogram has performed over 3,800 Trofile tests to date, of which over 2,600 tests were performed in the quarter ended December 31, 2007. Reflecting the portion of these tests for which reimbursement has been established, revenue from Trofile in the quarter ended December 31, 2007 was $2.6 million.
"Fourth quarter revenues were at a record level," said Alfred Merriweather, Monogram chief financial officer. "With this strong revenue growth, the leverage provided by our existing laboratory infrastructure and our established sales organization is clearly reflected in significantly improved gross margin, operating loss and cash flow in the fourth quarter."
Gross margin on product revenues was 52% in the quarter ended December 31, 2007, substantially higher than the levels recorded in the first three quarters of 2007. Operating loss was $4.7 million for the quarter ended December 31, 2007, an improvement of 39% compared to $7.6 million in the immediately preceding third quarter of 2007 and an improvement of 33% compared to $7.0 million in the prior year's fourth quarter.
The Company had full year revenue of $43.2 million for 2007, compared to revenue of $48.0 million for 2006. Prior year revenues, especially during the first two quarters of 2006, included substantial revenues from the use of the Company's assays in Pfizer's phase III trial of Selzentry(TM), testing for which was largely completed in mid 2006, prior to FDA review and approval of Selzentry in 2007.
The Company had approximately $30.6 million in cash resources (comprised of cash, cash equivalents and short-term investments) at December 31, 2007.
Monogram's Trofile Assay and Pfizer's maraviroc
"The first full quarter of Trofile commercialization has seen good progress in testing volumes," said William Young, Monogram chief executive officer. "Over 3,800 tests have been performed to date for U.S. patients and weekly levels are now over 200. Coverage and reimbursement level are established with Medicare and with most state ADAP programs. Fifteen state Medicaid programs and Blue Cross have established coverage for Trofile and we continue our discussions with these groups as well as many other public and private payers to establish the level of reimbursement."
Trofile's role in clinical use of Selzentry was reaffirmed recently with the issuance of treatment guidelines by the Department of Health and Human Services. These guidelines recommend that a co-receptor tropism test should be performed whenever the use of a CCR5 antagonist is being considered and might also be considered for patients who fail therapy while on a CCR5 antagonist. The guidelines acknowledged Trofile's role in the clinical studies that formed the basis for approval of Selzentry, the only approved CCR5 antagonist. "Monogram tests, particularly our Trofile Assay, have been pivotal to CCR5 drug development programs," added Young. "Trofile has been used in all phase II and phase III trials of CCR5 antagonists to date, including those of Pfizer, Schering Plough and Incyte. We are continuing our leadership in tropism testing with our enhanced tropism assay, which sets an even higher standard of sensitivity for CCR5 positive patients and which we expect to be commercially available soon."
Trofile is also now available outside of the U.S. where Pfizer is taking the lead in commercializing Trofile. Arrangements are now in place for processing samples from 12 countries, including Germany, the U.K. and Canada. Monogram expects that access to Trofile will be established in countries representing over 95% of the European market potential by the end of June and in approximately 40 countries worldwide by the end of the year.
HERmark(TM) Breast Cancer Assay
"We have continued to advance our HERmark clinical development programs," commented Young. "Less than 50% of metastatic breast cancer patients selected for treatment with Herceptin by currently available tests actually respond and there is growing concern that currently available IHC and FISH tests may not be adequate and may miss some patients who can benefit from Herceptin. The HERmark Assay provides quantitative and more precise measurements of HER2 expression than current tests and also provides a unique and quantitative measure of HER2's activated form -- the HER2:HER2 homodimer. HERmark has the potential to enhance physicians' ability to accurately select patients for Herceptin therapy and to subdivide them into groups with different clinical outcomes following treatment with the drug. Our separate programs are directed at clinical validation of HERmark as a tool to identify the appropriate patients for Herceptin® in the metastatic and adjuvant settings, respectively."
Data presented at the San Antonio Breast Cancer Symposium in December 2007, from a third cohort of metastatic breast cancer patients, confirmed prior observations that HERmark is capable of identifying subpopulations of Herceptin-treated metastatic breast cancer patients with different clinical outcomes based on the measured levels of HER2 expression and homodimers. More extensive analyses of clinical data from this latest test cohort of metastatic breast cancer patients will be presented at a future scientific forum. Programs to confirm and validate these results in additional cohorts are ongoing.
In parallel with these programs in metastatic breast cancer, HERmark measurements are also being correlated with clinical outcomes in two large cohorts of patients treated with Herceptin in the adjuvant setting, involving as many as 2,600 patients. The first of these studies, in up to 1,600 patient samples, was initiated in late 2007 and is ongoing. A second study, involving a large European study of up to 1,000 patients in the adjuvant setting, has recently been initiated.
In December 2007, Monogram received confirmation from the College of American Pathologists (CAP) that the HERmark assays are approved for routine patient testing in Monogram's CLIA certified clinical reference laboratory. "Commercialization of HERmark will be based on the clinical utility established by our ongoing studies in metastatic and adjuvant use of Herceptin," commented Young. "We believe that the unique measurements available from HERmark will represent new and valuable information for physicians, especially when supplemented with specific clinical utility expected to be derived from our ongoing studies."
VeraTag(TM) Oncology Platform
Monogram's first product based on the VeraTag technology platform is the HERmark Breast Cancer Assay, which measures the expression of the HER2 protein and the HER2:HER2 homodimer. Looking beyond this, the Company is continuing its programs to develop assays that measure the HER1 and HER3 proteins as well as dimers involving HER1 and HER3. These additional assays, which are still in development, are intended to broaden the applications for the VeraTag technology to the identification of resistance pathways for Herceptin in breast cancer as well as the identification of signaling pathways relevant to drug response and resistance in other cancer types.
GAAP and Non-GAAP Proforma Results
Net Loss and Net Loss Per Share is shown below in accordance with GAAP and also on a Non-GAAP Proforma Basis. The Company is reporting Non-GAAP Proforma results which exclude certain items to provide a clearer view of ongoing results without the impact of non-cash valuation adjustments related to our convertible debt in 2007 and to our CVRs in 2006. A reconciliation of these Non-GAAP Proforma results to GAAP results is included with the Statement of Operations data attached to this release.
Twelve Months
Three Months Ended Ended
December 31, December 31,
2007 2006 2007 2006
Net Loss ($ Millions)
GAAP Net Loss $(5.0) $(7.0) $(23.5) $(38.7)
Non-GAAP Proforma Net Loss $(4.6) $(7.0) $(30.2) $(22.3)
Net Loss Per Share ($)
GAAP Net Loss Per Share $(0.04) $(0.05) $(0.18) $(0.30)
Non-GAAP Proforma Net Loss Per Share $(0.03) $(0.05) $(0.23) $(0.17)
The following non-cash items that were reflected in non-operating income and expense for the periods ended December 31, 2007 and 2006 are excluded from proforma net loss:
-- "Mark-to-market" adjustments to the 3% Senior Secured Convertible Note
and the 0% Convertible Senior Unsecured Debt. An unfavorable adjustment
of $0.4 million and a favorable adjustment of $4.2 million were
recorded in the three and twelve months ending December 31, 2007,
respectively. There were no such adjustments in the prior year,
although a favorable adjustment of $2.2 million was recorded at January
1, 2007 for the cumulative effect of the change in accounting principle
at that date. Such adjustments could be significant and unpredictable
in future quarters depending on several factors, including the level of
the Company's common stock price.
-- "Mark-to-market" adjustments in 2006 to the liability established for
the payment on the CVRs issued as part of the merger consideration for
ACLARA. As the outstanding CVR's were settled in the second quarter of
2006, adjustments are not significant for third and fourth quarters of
2006 or for 2007. An unfavorable adjustment of $16.5 million was
recorded in the twelve months ended December 31, 2006.
Stock-based compensation in accordance with SFAS123® is recorded as expense for purposes of both GAAP and our Non-GAAP Proforma results. Such costs were $1.2 million in the fourth quarter of 2007, compared to $1.4 million in the prior year's fourth quarter.
Capital Structure
At December 31, 2007, a total of 134 million shares of common stock were outstanding. Stock options and warrants were outstanding on 20.3 million shares and 0.1 million shares of common stock, respectively. The principal amount of Pfizer's $25 million convertible note, issued in May 2006, is convertible into approximately 9.2 million shares of common stock. The $30 million principal amount of our 0% Convertible Senior Unsecured Notes, issued in January 2007, is convertible into approximately 11.9 million shares of common stock.
Conference Call Details
Monogram will host a conference call today at 4:30 p.m. Eastern Time. To participate in the live teleconference please call (877) 548-7912, or (719) 325-4878 for international callers, fifteen minutes before the conference begins. Live audio of the call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. Access to live and archived audio of the conference call will be available by following the appropriate links at www.monogrambio.com and clicking on the Investor Relations link. Following the live broadcast, a replay of the call will also be available at (888) 203-1112, or (719) 457-0820 for international callers. The replay passcode is 4277521.
The information provided on the teleconference is only accurate at the time of the conference call, and Monogram assumes no obligation to provide updated information except as required by law.
About Monogram
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the demand for our Trofile Assay, the outlook for Selzentry and our Trofile Assay, reimbursement that may be available for Trofile, guidelines regarding the use of co-receptor tropism tests, the anticipated availability of Trofile internationally, the ability of VeraTag technology, including HERmark, to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of our VeraTag technology and HERmark products and anticipated clinical and laboratory validation of these products in a CLIA setting and activities expected to occur in connection with the Pfizer collaboration. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that physicians may not use a molecular diagnostic for patient selection for maraviroc or other HIV drugs; risks related to the implementation of the collaboration with Pfizer; risks related to our ability to recognize revenue from activities under the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the risk that our Trofile Assay may not be utilized for patient use with maraviroc and other CCR5 inhibitors; the risk that our VeraTag assays may not predict response to particular therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional VeraTag studies, our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
PhenoSense, PhenoSenseGT, Trofile, HERmark and VeraTag are trademarks of
Monogram Biosciences, Inc. Heceptin is a registered trademark of Genentech,
Inc. Selzentry is a trademark and Celsentri is a registered trademark of
Pfizer Inc.
MONOGRAM BIOSCIENCES, INC.
SELECTED STATEMENT OF OPERATIONS DATA
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
2007 2006 2007 2006
Revenue:
Product revenue $12,731 $9,732 $39,482 $45,150
Contract revenue 798 498 2,064 2,808
License revenue 197 -- 1,683 --
Total revenue 13,726 10,230 43,229 47,958
Operating costs and expenses:
Cost of product revenue 6,120 5,396 22,926 22,703
Research and development 5,090 4,560 19,385 18,981
Sales and marketing 3,647 3,471 15,927 14,735
General and administrative 3,537 3,802 15,686 15,042
Total operating costs and expenses 18,394 17,229 73,924 71,461
Operating loss (4,668) (6,999) (30,695) (23,503)
Convertible debt valuation adjustment
and interest income/(expense), net (370) 17 4,687 1,250
CVR valuation adjustment -- -- 218 (16,450)
Net loss before cumulative effect of
change in accounting principle (5,038) (6,982) (25,790) (38,703)
Cumulative effect of change in
accounting principle -- -- 2,242 --
Net loss after cumulative effect of
change in accounting principle $(5,038) $(6,982) $(23,548) $(38,703)
Basic and diluted net loss per common
share before cumulative effect of
change in accounting principle $(0.04) $(0.05) $(0.19) $(0.30)
Cumulative effect per share of
change in accounting principle $ -- $ -- $0.01 $ --
Basic and diluted net loss per common
share after cumulative effect of
change in accounting principle $(0.04) $(0.05) $(0.18) $(0.30)
Weighted-average shares used in
computing basic net loss per
common share 133,110 130,694 132,282 130,447
Reconciliation of Non-GAAP Proforma
Results to GAAP
Net loss after cumulative effect of
change in accounting principle $(5,038) $(6,982) $(23,548) $(38,703)
Adjustments for certain non-cash
items:
Cumulative effect of change in
accounting principle -- -- (2,242) --
CVR valuation adjustment -- -- (218) 16,450
Convertible debt valuation adjustment 447 -- (4,205) --
Non-GAAP Proforma net loss (4,591) (6,982) (30,213) (22,253)
Non-GAAP Proforma net loss per
common share, basic $(0.03) $(0.05) $(0.23) $(0.17)
Management believes that this non-GAAP proforma financial data supplements the Company's GAAP financial statements by providing investors with additional information which allows them to have a clearer picture of the Company's operations, financial performance and the comparability of the Company's operating results from period to period as they exclude the effects in 2007 of revaluation of the Company's convertible debt and the effects in 2006 of revaluation of the contingent value rights issued in connection with the Company's merger with ACLARA that management believes are not indicative of the Company's ongoing operations. The presentation of this additional information is not meant to be considered in isolation or as a substitute for results prepared in accordance with GAAP. Above, management has provided a reconciliation of the non-GAAP proforma financial information with the comparable financial information reported in accordance with GAAP.
MONOGRAM BIOSCIENCES, INC.
SELECTED BALANCE SHEET DATA
(In thousands)
(Unaudited)
December 31, December 31,
2007 2006
ASSETS (Note 1)
Current assets:
Cash and cash equivalents $18,762 $8,263
Short-term investments 11,828 22,867
Accounts receivable, net 9,100 6,849
Prepaid expenses 1,279 1,234
Inventory 1,250 961
Other current assets 917 378
Total current assets 43,136 40,552
Property and equipment, net 7,665 7,463
Goodwill 9,927 9,927
Deferred costs 7,906 1,783
Other assets 677 1,120
Total assets $69,311 $60,845
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $2,116 $1,271
Accrued compensation 3,324 2,258
Accrued liabilities 3,818 4,720
Current portion of restructuring costs 610 1,128
Deferred revenue, current portion 605 404
Current portion of loans payable and
capital lease obligations 4,469 6,355
Contingent value rights 2,119 2,813
Total current liabilities 17,061 18,949
Long-term 3% convertible promissory note 20,786 25,000
Long-term 0% convertible promissory note 18,511 --
Long-term portion of restructuring costs 289 868
Long-term deferred revenue 13,622 1,783
Other long-term liabilities 282 337
Total liabilities 70,551 46,937
Stockholders' equity:
Common stock 134 131
Additional paid-in capital 286,196 277,892
Accumulated other comprehensive loss (31) (124)
Accumulated deficit (287,539) (263,991)
Total stockholders' equity (1,240) 13,908
Total liabilities and stockholders'
equity $69,311 $60,845
(1) The balance sheet data at December 31, 2006 is derived from audited
financial statements included in the Company's Annual Report on Form
10-K for the year ended December 31, 2006 filed with the Securities
and Exchange Commission.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624 4576 Tel: 415 677 2700
amerriweather@monogrambio.com jeremiah.hall@fkhealth.com
--------------------------------------------------------------------------------
Source: Monogram Biosciences, Inc.
wave
17 years ago
HERmark(TM) Assay Results in Metastatic Breast Cancer Presented at the San Antonio Breast Cancer Symposium
Press Release: Friday December 14, 8:00 am ET
HER2 Homodimer and HER2 Total Protein Assays Validated in CLIA Laboratory
SOUTH SAN FRANCISCO, Dec. 14 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today presented the results of a study detailing the HERmark(TM) Assay's ability to identify metastatic breast cancer patients who are most likely to respond to Herceptin®. The study results were presented this week at the San Antonio Breast Cancer Symposium. Also this week, Monogram received confirmation from the College of Pathologists (CAP) that the HERmark assays are approved for routine patient testing in Monogram's CLIA certified clinical reference laboratory.
"The results presented today are an important step along the way to clinical validation of HERmark, the first product based on the VeraTag technology platform," said William Young, Monogram chief executive officer. "In addition to the presentation of important clinical data, I am pleased to report today that the HERmark assays have completed their validation process in Monogram's CLIA-certified clinical reference laboratory. The establishment of solid technical validation data and the ability to perform the assays under high-throughput, well controlled conditions will provide a strong basis for commercialization of HERmark after completion of our ongoing clinical studies."
In the study reported today, Monogram analyzed tissue samples from patients with metastatic breast cancer who were treated with Herceptin, having been selected for such treatment by centralized IHC testing. While current testing methods identified all these patients as being appropriate for Herceptin treatment, Monogram's HERmark Assay was able to distinguish separate sub-populations of patients with different clinical outcomes.
Study details: Those patients with higher HER2 expression levels (i.e. in the upper half of the distribution for the study cohort) experienced a 59% objective response rate while those with lower levels of HER2 expression (i.e. in the lower half of the distribution) had a response rate of only 18%. Additional analyses revealed that patients with higher HER2 expression values had a median time-to-progression of 12.8 months while those in the lower half of the distribution had a median time-to-progression of only 4 months. This result was statistically significant (p = 0.01). Finally, multivariate Cox proportional hazards models identified HER2 expression (HR = 0.16, p < 0.001) and HER2:HER2 dimer levels (HR = 0.32, p < 0.001) as measured by HERmark as being statistically significant predictors of time-to-progression.
"Current testing technologies do not provide an accurate or precise view of HER2 biology in breast cancer, classifying patients as either HER2 'positive' or HER2 'negative'," continued Young. "At best, conventional technologies provide a semi-quantitative analysis. However, only about half of metastatic patients selected by current technologies for Herceptin treatment respond to the drug. Data are now emerging to suggest that patients who could benefit from Herceptin may be missed by currently used assays. Our HERmark studies have provided data which consistently indicate that HERmark can precisely measure HER2 expression and HER2:HER2 dimer levels in clinical FFPE samples, and that those patients with higher levels of expression have significantly better clinical outcomes than those with lower levels. These data strongly suggest that HERmark can identify patients who are likely to respond to Herceptin better than the assays currently in use."
HERmark Assay in Metastatic Breast Cancer
At ASCO in June 2007, Monogram reported results of studies of HERmark in two patient cohorts. In the first of these studies, it was demonstrated that within a population of patients that were stringently selected by FISH testing, the HERmark assay was able to measure a gradient of HER2 expression and HER2 homodimer levels that was significantly correlated with time-to- progression and overall survival on Herceptin. In the second metastatic patient cohort presented at ASCO, selected by IHC in a clinic-based setting, the HERmark assay was also able to demonstrate that patients who were confirmed HER2 positive by IHC on repeat testing showed a gradient of response, and that those with higher levels of HER2 expression and HER2 homodimer levels as measured by HERmark lived longer than those who had lower levels. The results of these two previously reported cohorts, along with the third cohort presented today, provide the basis for Monogram's ongoing work in metastatic breast cancer. There are approximately 60,000 women annually in the U.S. who are newly diagnosed with Stage IV breast cancer or who have progressed from earlier stages of disease. These are patients for whom the cancer has spread beyond the breast, and in many cases multiple treatments may have already been provided.
HERmark Assay in the Adjuvant Setting
Monogram has initiated a study with one of the leading oncology clinical trial cooperative groups in the country. In this ongoing study, we are performing HERmark assays on tissue samples from up to 1,600 breast cancer patients treated with Herceptin in the adjuvant setting. The goal of the study is to clinically validate the ability of HERmark to predict clinical outcome in these Herceptin-treated patients. These patients are generally newly diagnosed with breast cancer, have had surgery and are now on a first course of treatment to supplement the surgical procedure. In the U.S., there are approximately 200,000 new cases of breast cancer each year, most of whom are candidates for adjuvant treatment and therefore would be candidates for the HERmark adjuvant breast cancer assay.
About HERmark
HERmark is a proprietary diagnostic that accurately quantifies HER2 expression and dimerization in patients with breast cancer. Preliminary data from three cohorts of Herceptin-treated patients with metastatic breast cancer who were identified as "HER2 positive" by conventional assays suggest that HERmark can identify patients who are likely to respond to Herceptin with greater precision than currently available tests, permitting stratification of patients according to their degree of clinical benefit from the drug. Additional studies of HERmark for breast cancer in both the metastatic and adjuvant settings are in progress.
About VeraTag
VeraTag is a proximity-based assay technology platform that accurately quantifies proteins and functional protein complexes. This platform provides a researcher or clinician a more thorough understanding of protein-protein interactions or signaling pathway activity allowing for disease characterization at the molecular level. VeraTag is designed to run on standard formalin-fixed paraffin embedded (FFPE) patient samples.
About Monogram
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to, the ability of VeraTag technology to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of our VeraTag technology and products and anticipated clinical and laboratory validation of VeraTag in a CLIA setting, future commercialization of the HERmark assay based on the VeraTag technology, expected protection provided by patents, and possible regulation of our products by the FDA. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties relating to the performance of our products; the growth in revenues; the risk that our VeraTag assays may not predict response to particular therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional VeraTag studies, our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
VeraTag and HERmark are trademarks of Monogram Biosciences, Inc. Herceptin is a registered trademark of Genentech, Inc.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com
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Source: Monogram Biosciences, Inc.
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