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Merrimack and Baxalta Announce Enrollment of First Patient in Phase 2 Study of ONIVYDE™ (irinotecan liposome injection) in Previously Untreated Front-line Metastatic Pancreatic Cancer

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Study to evaluate the combination of ONIVYDE plus fluorouracil and leucovorin with or without oxaliplatin

Milestone triggers $62.5M payment from Baxalta

CAMBRIDGE, Mass. and BANNOCKBURN, Ill., Oct. 27, 2015 /PRNewswire/ -- Merrimack (Nasdaq: MACK) and Baxalta Incorporated (NYSE: BXLT) today jointly announced the enrollment of the first patient in an exploratory Phase 2 clinical study of ONIVYDE™ (irinotecan liposome injection), also known as MM-398 or "nal-IRI," in previously untreated, metastatic pancreatic adenocarcinoma.

The Phase 2 clinical study of ONIVYDE in patients with previously untreated, metastatic pancreatic adenocarcinoma will assess the safety and efficacy of the combination of ONIVYDE plus fluorouracil (5-FU) and leucovorin (LV), with or without the addition of oxaliplatin, versus nab-paclitaxel and gemcitabine.  The start-up of this study resulted in $62.5M of milestone payments to Merrimack from Baxalta.

"The initiation of this Phase 2 study is an important step in evaluating ONIVYDE's effectiveness as a front-line treatment option for patients diagnosed with metastatic pancreatic cancer.  This design allows us to quickly and efficiently learn about the safety and efficacy of these potential new regimens prior to entering into a large, confirmatory Phase 3 study," said Eliel Bayever, M.D., Vice President at Merrimack and medical director for ONIVYDE.

"Our team is extremely excited to be the first center in the world to open this trial of ONIVYDE in front-line metastatic pancreatic cancer given the results of the NAPOLI trial in the post-gemcitabine setting," said Dr. Andrew Dean, one of the principal investigators on the study and an Oncologist at St John of God Hospital Subiaco in Australia.

In addition to pancreatic cancer, there are ongoing Phase 1 studies of ONIVYDE in glioma, breast cancer, gastric cancer and pediatric solid tumors.

"This trial is part of our broad development plan for ONIVYDE in solid tumors that have high unmet medical need," said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. "By expanding our research of ONIVYDE into patients who have not been previously treated for metastatic pancreatic cancer, our hope is that we learn more about its potential to meet the needs of people who currently have few approved treatment options."

Merrimack and Baxalta have entered into an exclusive licensing agreement to develop and commercialize ONIVYDE outside of the United States.A Marketing Authorization Application is under review in the European Union for the treatment of adult patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize ONIVYDE in Taiwan.

Clinical Study of ONIVYDE in Previously Untreated, Metastatic Pancreatic Adenocarcinoma

The study will be conducted in two parts, first assessing the safety of ONIVYDE in combination with 5-FU/LV and oxaliplatin, and then expanding into a three arm randomized study assessing the safety and efficacy of the combination of ONIVYDE  and 5-FU/LV with or without oxaliplatin versus nab-paclitaxel and gemcitabine. Eligible patients for the study must have received no prior systemic treatment.

In the first part of the study, approximately 6-18 patients will be enrolled. The primary outcome for Part 1 of the study is to evaluate the safety and tolerability of ONIVYDE in combination with 5-FU/LV and oxaliplatin. In the second part of the study, an additional 150 patients (50 patients per arm) with previously untreated, metastatic pancreatic adenocarcinoma will be enrolled and randomized to receive either ONIVYDE in combination with 5-FU/LV and oxaliplatin, ONIVYDE in combination with 5-FU/LV, or nab-paclitaxel and gemcitabine. In Part 2, efficacy of the ONIVYDE containing regimens will be compared to the nab-paclitaxel and gemcitabine regimen, evaluating progression free survival (PFS) rate at 24 weeks, as well as overall survival, PFS, objective response rate, tumor marker CA19-9 response, safety and tolerability.

Merrimack and Baxalta plan to conduct the study at sites in the United States, Canada, Europe, Australia, New Zealand, Taiwan and South Korea. The first patient in the study was dosed at St. John of God Subiaco Hospital in Subiaco, Western Australia. For more information, please visit www.clinicaltrials.gov (Identifier: NCT02551991). Based on the current design of this study, data are expected in the first half of 2017.  Guidance will be updated as recruitment continues.

About Pancreatic Cancer

Pancreatic cancer is rare and deadly. It accounts for only 3% of all cancer cases1, but is the fourth leading cause of cancer-related death2, leading to a five year survival rate of only 7%3. Each year an estimated 49,000 new cases are diagnosed in the United States3, two-thirds of which are among people aged 65 or older4. There are an estimated 338,000 new cases diagnosed each year worldwide5.

The pancreas is composed of two main cell types: exocrine and endocrine. Exocrine tumors are the most common type of pancreatic cancer, accounting for 96% of all cases3. Adenocarcinoma, a sub-type of exocrine tumors, comprises of 95% of all exocrine tumors1.

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 not candidates for surgery2, instead receiving chemotherapy as the mainstay of their therapy. The majority of these patients receive gemcitabine-based therapy during either adjuvant/neoadjuvant treatment or during first- or second-line therapy for metastatic disease 6.

About ONIVYDE™ [pronounced \ 'on - ih – vide \]

ONIVYDE™ (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation.  The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. ONIVYDE was recently approved by the U.S. Food and Drug Administration in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.  For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.

About Merrimack

Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDETM (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.

About Baxalta Incorporated

Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients' lives, Baxalta's broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International Inc., Baxalta's heritage in biopharmaceuticals spans decades. Baxalta's therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.

Forward-Looking Statements

This release includes forward-looking statements concerning ONIVYDE and the related collaboration between Baxalta Incorporated and Merrimack, including expectations with respect to clinical studies, the timing of related data, regulatory filings and potential impact to patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; additional clinical trial results; changes in laws and regulations; issues with product quality, manufacturing or supply; patient safety issues; and other risks identified in Baxter International Inc.'s and Merrimack's most recent filings on Form 10-K and other SEC filings as well as the Form 10 filed by Baxalta Incorporated. Neither Baxter nor Merrimack undertakes to update their forward-looking statements.

1 American Cancer Society. Pancreatic Cancer Overview. Atlanta: American Cancer Society; 2015.

2 National Cancer Institute. Pancreatic Cancer Treatment –for health professionals (PDQ®). National Cancer Institute at the National Institutes of Health; 2015.

3 American Cancer Society. Cancer Facts and Figures 2015. Atlanta: American Cancer Society; 2015.

4 Surveillance, Epidemiology, and End Results Program. SEER Stat Fact Sheets: Pancreas Cancer; 2015. National Cancer Institute.

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

6 Data presented at ASCO 2014 (Abrams et al.)

CONTACTS:
Merrimack Media Contact:
Dana Robie
617-441-7408
drobie@merrimack.com

Merrimack Investor Contact:
Geoffrey Grande, CFA
617-441-7602
ggrande@merrimack.com

Baxalta Media Contact:
Kellie Hotz
224-940-2202

Baxalta Investor Contact:
Mary Kay Ladone
224-948-3371

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/merrimack-and-baxalta-announce-enrollment-of-first-patient-in-phase-2-study-of-onivyde-irinotecan-liposome-injection-in-previously-untreated-front-line-metastatic-pancreatic-cancer-300166612.html

SOURCE Merrimack Pharmaceuticals, Inc.

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