Healthcare Industry News:  mTOR pathway 

Biopharmaceuticals Oncology FDA

 News Release - November 5, 2014

FDA Grants Orphan Drug Designation to Merrimack Pharmaceuticals' MM-141 for the Treatment of Pancreatic Cancer

CAMBRIDGE, Mass., Nov. 5, 2014 -- (Healthcare Sales & Marketing Network) -- Merrimack Pharmaceuticals, Inc. (MACK) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to their investigational drug candidate MM-141 for the treatment of pancreatic cancer. MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). The IGF-1R and HER3 complexes both activate a major cellular signaling pathway that allows tumor cells to grow and develop resistance to therapies.

"Receiving orphan drug designation for MM-141 is an important regulatory advancement in the development of our clinical program," said Ulrik Nielsen, Ph.D., Chief Scientific Officer and Co-Founder of Merrimack. "Pancreatic cancer is an aggressive and devastating disease, with a five year survival rate of 6% and a low early detection rate. Merrimack is dedicated to changing the landscape of this disease for patients across all lines of therapy. We look forward to advancing the clinical development of MM-141 as we believe that it has the potential to significantly inhibit tumor survival signaling and address pathways of therapeutic resistance in this indication."

The FDA's Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. This orphan drug designation will potentially provide Merrimack Pharmaceuticals with seven-year marketing exclusivity for MM-141 and other benefits if the drug is approved by the FDA.

MM-141 is Merrimack's sixth oncology candidate to enter clinical development and is currently being tested in a Phase 1 dose-escalation clinical study. A Phase 2 study testing MM-141 in combination with nab-paclitaxel and gemcitabine in front line pancreatic cancer is expected to start in 2015.

About MM-141

MM-141 is a fully human tetravalent antibody that targets signaling of the PI3K/AKT/mTOR pathway driven through activation of IGF-1R and ErbB3/HER3. The PI3K/AKT/mTOR is a major pro-survival pathway that tumor cells use as a resistance mechanism to anti-cancer therapies. MM-141 is designed to interfere with this pathway by blocking ligand-induced signaling through the IGF-1R and ErbB3 receptors and degrading oncogenic receptor complexes. A Phase 1 clinical study of MM-141 for the treatment of advanced solid tumors is currently underway.

About Pancreatic Cancer 1,2

Pancreatic cancer is rare and deadly, accounting for only three percent of all cancer cases worldwide but is the fourth leading cause of cancer death. An estimated 140,000 new cases are diagnosed every year around the world, two-thirds of which are among people aged 65 or older. In the United States alone, approximately 46,000 people are diagnosed with pancreatic cancer and about 40,000 patients die annually.

Because the signs and symptoms of pancreatic cancer are non-specific and may not appear until the disease has spread to other sites, approximately 80% of patients are diagnosed with late stage disease and are not candidates for surgery, instead receiving chemotherapy as the mainstay of their therapy. As a result, the five year survival rate is less than 6%; fewer than 20% of newly diagnosed patients survive more than two years.

About Merrimack

Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of underlying cancer biology through its systems biology-based approach and develop new insights, therapeutics and diagnostics to improve outcomes for cancer patients. Merrimack currently has six oncology therapeutics in clinical development and three additional candidates in late stage preclinical development. Merrimack's lead program, MM-398, recently completed a Phase 3 trial in post-gemcitabine pancreatic cancer. Based on the results of this trial, Merrimack is currently preparing a New Drug Application for MM-398. For more information, please visit Merrimack's website at or connect with us on Twitter at @MerrimackPharma.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements about Merrimack's strategy, future operations, future financial position and future expectations and plans and prospects for Merrimack, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "hope" and similar expressions. In this press release, Merrimack's forward-looking statements include statements about the potential for MM-141 to provide clinical benefit and the timing of initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimack's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, availability of data from ongoing clinical trials, expectations for regulatory approvals, development progress of Merrimack's companion diagnostics and other matters that could affect the availability or commercial potential of Merrimack's drug candidates or companion diagnostics. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimack's views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimack's business in general, see the "Risk Factors" section of Merrimack's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2014 and other reports Merrimack files with the SEC.

1 American Cancer Society. Cancer Facts and Figures 2014. Atlanta: American Cancer Society; 2014.

2 World Health Organization. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012; Lyon, Fr.: International Agency for Research on Cancer; 2012.

Source: Merrimack Pharmaceuticals

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