Does Merrimack Pharmaceuticals Have A Blockbuster Drug With MM-398?

Does Merrimack Pharmaceuticals (NASDAQ:MACK) have a blockbuster pancreatic cancer drug with MM-398?

MM-398 has been tested in four Phase 1 studies and two Phase 2 clinical trials looking at its safety and effectiveness in treating gastric and pancreatic cancers. Merrimack's MM-398 is currently being evaluated in the pivotal Phase 3 trial (NAPOLI-1) as a treatment for 2nd line pancreatic cancer and is in earlier stage development for other tumor types.

Pancreatic cancer incidence is increasing worldwide with almost 220,000 cases per year, and there is a significant need for effective therapies.

Pancreatic Cancer

Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and the world. The one-year relative survival rate is 26% and the five-year survival rate is only about 6%. If the cancer is detected at an early stage and can be removed surgically, the five-year survival rate is about 22%. Since pancreatic cancer patients seldom exhibit disease-specific symptoms until later stages, more than 85% of patients with pancreatic cancer are diagnosed at advanced tumor stages leaving them without any surgical therapy options. The treatment options for pancreatic cancer are limited and generally ineffective.

The American Cancer Society estimates that:

  • About 43,920 people (22,090 men and 21,830 women) in the United States will be diagnosed with pancreatic cancer in 2012.
  • About 37,390 people (18,850 men and 18,540 women) in the United States will die of pancreatic cancer in 2012.

Since 2004, rates of pancreatic cancer have increased about 1.5% per year. The lifetime risk of developing pancreatic cancer is about 1 in 71 (1.41%). The risk is about the same for men and women.

According to Transparency Market Research, the global pancreatic cancer drug market is projected to reach $1.2 billion by 2015. The research firm found that Eli Lilly's (NYSE:LLY) Gemzar (gemcitabine) has an approximate 55% share of the market. Genentech/Roche (OTCQX:RHHBY) and Astellas/OSI Pharmaceuticals (OTCPK:ALPMY) Tarceva (erlotinib) have captured the whole of the market since these are the only U.S. Food and Drug Administration (FDA) approved therapies available.

According to GlobalData, the pancreatic cancer market is forecast to exhibit a 4.1% negative compound annual growth rate (CAGR) between 2009 and 2016. This revenue decrease is primarily due to the estimated patent expiry of Eli Lilly's Gemzar (gemcitabine) and Roche/Genentech's Xeloda (capecitabine). Although new products that are currently in Phase 3 trials could enter the market soon, it will take some time for physicians to use new products rather than Gemzar. While Lilly's Gemzar patent will expire and generics will influence market revenue, GlobalData believes there will be no substantial improvement in the unmet need. Newer entrants might exhibit promising results but they have yet to prove their efficacy. Global Data predicts that the overall pancreatic cancer market, which showed growth between 2001 and 2009, will experience a decline in revenue between 2009 and 2014.

In 2011, the FDA approved Pfifer's (NYSE:PFE) Sutent (sunitinib malate) and Novartis' (NYSE:NVS) Afinitor (everolimus) for the treatment of unresectable pancreatic neuroendocrine tumors, a rare type of pancreatic cancer. Patients with advanced pancreatic neuroendocrine tumors (pNET) have few treatment options. Prior to these approvals, no new drug was approved by the FDA in three decades.

This year, several pharmaceutical companies announced good news about the progress of their investigational pancreatic drugs:

In June 2012, Momenta Pharmaceuticals (NASDAQ:MNTA), announced that preclinical data showed that M402 in combination with gemcitabine prolonged survival and substantially lowered the incidence of metastasis in two pancreatic cancer models.

In June, Edward J. Kim, MD, PhD, of the University of Michigan, announced results from a small study that found one-half of all patients with advanced pancreatic cancer had objective responses or stable disease when they received vismodegib (GDC-449, Erivedge) and gemcitabine. The data was reported at the American Association for Cancer Research Pancreatic Cancer Conference in Lake Tahoe, Nevada. Vismodegib is being developed by Roche/Genentech, under a collaboration agreement between Curis (NASDAQ:CRIS) and Genentech. Vismodegib targets smoothened protein, a key mediator of hedgehog signaling. The drug recently received FDA approval for treatment of basal cell carcinoma.

In July, the Journal of Clinical Oncology published the results of a Phase 2 study that found patients with locally advanced or metastatic pancreatic neuroendocrine tumors (NETs) appear to benefit from the combination of temozolomide [Merck's (MRK) Temodar, generics] and bevacizumab (Roche/Genentech's Avastin). The study found response rates to be 33% among those with NETs compared with no response among patients with carcinoid tumors, consistent with prior studies.

In November 2012, Oncolytics Biotech (ONCY) announced two poster presentations covering expanded results from a Phase 2 clinical trial using intravenous administration of REOLYSIN (Respiratory Enteric Orphan Virus) with gemcitabine. in patients with advanced pancreatic cancer (REO 017), as well as preclinical research in Ras-activated pancreatic cancer. The study found that 33 of a planned 36 patients had received Reovirus (REOLYSIN) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response evaluation to date among 30 evaluable patients showed 27 patients had stable disease or better for a 90% clinical benefit rate [nine partial response (PR) (30%) and 18 stable disease ((NYSE:SD)) (60%)]. Three patients had progressive disease ((PD)) as their best response.

The best news came on November 9, 2012. Celgene (NASDAQ:CELG) said a late-stage study comprised of 861 patients found that a combination of the company's drug, Abraxane (paclitaxel protein-bound) and gemcitabine was more effective than gemcitabine alone in treating pancreatic cancer. Abraxane has been approved by the FDA to treat breast and lung cancer. Celgene will apply for approval to market the drug to treat pancreatic cancer. Celgene acquired Abraxane with the acquisition of Abraxis BioScience in 2010 for $2.9 billion. The drug combines the cancer chemotherapy paclitaxel with the protein, albumin, which Celgene contends helps deliver a greater amount of chemotherapy to cancer cells with fewer side effects. The company expects to release detailed data from the trial in January 2013 and plans to file an application with the FDA to market the drug to treat pancreatic cancer.

Several other companies are developing promising pancreatic cancer vaccines:

South Korea-based KAEL-GemVax's vaccine called GV1001, is in a Stage 3 clinical trial. The vaccine targets telomerase, an enzyme overexpressed in around 90% of all cancer types that helps maintain telomere length in dividing cells and is required for tumor growth. KAEL-GemVax notes that its vaccine differs from NewLink Genetics' vaccine in particular, as "HyperAcute-Pancreas" is a personalized cell vaccine, which involves the harvesting and processing of pancreatic cell lines from patients, whereas GV1001 is a standardized peptide vaccine."

Ames, Iowa-based NewLink Genetics (NASDAQ:NLNK) is conducting a Phase 3 trial to evaluate its HyperAcute Pancreas cancer immunotherapy vaccine. NewLink has received FDA Fast Track and Orphan Drug designations for adjuvant treatment of pancreatic cancer after surgeries to remove tumor tissue. At the American Society of Clinical Oncologists (ASCO) meeting in June 2012, NewLink presented data from the Phase 2 study with 69 patients showing a 37% in one-year survival, 59% in two-year survival and 121% improvement in three-year survival as compared with standard-of-care.

Louisville, Colorado-based GlobeImmune is developing a vaccine that targets pancreatic cancer caused by mutated versions in the Ras protein. Ras mutations are found in approximately 90 percent of pancreas cancers and result in uncontrolled proliferation of malignant cells. In June 2012, GlobeImmune presented data from a Phase 2b trial at the European Society for Medical Oncology (ESMO) 14th World Congress on Gastrointestinal Cancer. Pancreas cancer is rarely curable, with a median survival of 9 to 12 months and an overall five-year survival rate of 3 percent for all stages of the disease. A 2.6 month improvement in median overall survival was observed in R1 subjects treated with GI-4000 in combination with gemcitabine versus subjects treated with gemcitabine and placebo, representing an 18 percent relative improvement. A 5.0 month improvement in median overall survival was observed for treated R1 subjects characterized as immune responders to mutated Ras in comparison with the placebo group. For the R1 subjects treated with GI-4000 plus gemcitabine, a one-month improvement in median recurrence free survival was observed compared to the R1 subjects who received placebo plus gemcitabine. An R1 resection is defined by the presence of microscopic residual disease at the surgical margin.

There has been a significant amount of recent bad news too.

In January 2012, Infinity Pharmaceuticals (NASDAQ:INFI) halted a Phase 2 trial of Saridegib (IPI-926) plus gemcitabine when it was discovered that patients were living longer in the placebo group than the Saridegib group

In August 2012, Amgen Inc. (NASDAQ:AMGN) stopped a Phase 3 clinical trial that added Amgen's drug, ganitumab to gemcitabine to treat pancreatic cancer that has spread. The company's review of the data found ganitumab, also known as AG479, did not improve patient survival, compared with the use of gemcitabine alone. Amgen also discontinued a Phase 2 trial of ganitumab for the treatment of locally advanced pancreatic cancer.

On September 17, 2012, Threshold Pharmaceuticals (NASDAQ:THLD) shares plummeted after the company reported mixed data on survival rates from a Phase 2 clinical trial of its drug TH-302. Threshold shares had skyrocketed over 400% from January 2012. In February 2012, Merck signed a global agreement with Threshold to co-develop and commercialize TH-302, to treat pancreatic cancer. Under the terms of the deal, Merck agreed to pay Threshold an upfront payment of $25 million plus potential milestones and royalties in the future.

In November 2012, Clovis Oncology (NASDAQ:CLVS) announced that patients who were treated with the company's investigational pancreatic cancer drug, CO-101, did not live any longer than patients who were only treated with gemcitabine. Both groups of patients lived for about six months after the start of treatment. The company said it will suspend all development of CO-101 while it reviews results from the study. CO-101 was the company's most advanced drug candidate.


MM-398 is Merrimack's lead drug currently in Phase 3 trials to determine if the drug is effective in the treatment of patients with metastatic pancreatic cancer who fail treatment with the chemotherapeutic drug, gemcitabine. There are no approved therapies for patients with metastatic pancreatic cancer who fail treatment with gemcitabine, which is marketed by Eli Lilly as Gemzar. Gemzar is the standard of care drug for pancreatic cancer.

MM-398 is a novel, stable nanoliposomal encapsulation of the conventional chemotherapy irinotecan. MM-398 is designed to optimize the delivery of irinotecan by extending the duration of circulation in the body and preferentially activating the drug within the tumor to achieve higher levels of the active drug, SN-38.

MM-398 is a new version of irenotecan, a chemotherapeutic drug marketed as Camptosar by Pfizer . Irenotectan is used for the treatment of colon and rectal cancers. MM-398 encases irenotectan in a liposome to allow for longer circulation time, greater efficacy and fewer side effects. Irinotecan hydrochloride was originally marketed by Pfizer under the brand name, Camptosar. Camptosar was introduced in the United States in 1996 and received full FDA approval in 1998 as a second-line treatment for metastatic colorectal cancer. In April 2000, the FDA approved Camptosar, as first-line therapy for the treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil/leucovorin (5-FU/LV). Since Camptosar has dose limiting toxicities that often result in serious side effects, such as late onset diarrhea and myelosuppression, that prevent it from being explored for anti-tumor efficacy

MM-398 has been tested in several clinical trials including a Phase 2 single agent study of MM-398 in metastatic pancreatic cancer and an ongoing Phase 2 study of MM-398 in combination with 5-FU and leucovorin in patients with metastatic colorectal cancer. Merrimack holds the development and commercialization rights to MM-398 worldwide, with the exception of Taiwan. Merrimack has licensed the Taiwanese commercialization rights to PharmaEngine, Inc. (Taipei), which conducted previous studies of MM-398 under the designation PEP02.

PharmaEngine tested PEP02 in several human clinical studies, including four Phase 1 studies and two Phase 2 studies in gastric and pancreatic cancers. Both Phase 2 studies met their of response rate and three-month survival primary endpoints.

In January 2011, Taiwan-based PharmaEngine, Inc. announced the results of a Phase 2 pancreatic cancer study that was presented at the 2011 ASCO meeting in San Francisco.

Andrew Ko, MD, of the University of California, San Francisco, led the study that evaluated PEP02, also known as MM-398, as a second line therapy in 40 metastatic pancreatic cancer patients in Taiwan and the United States who were refractory to the gemcitabine-containing regimen. In the study, 75% of patients achieved the primary endpoint of 3-month survival rate, exceeding the targeted statistical threshold, with acceptable safety. The study found some patients had survived six months or longer. Researchers also found that 20% of the patients survived for more than one year.

In May 2011, Merrimack agreed to pay PharmaEngine $10 million upfront and up to $210 million in milestone payments for the rights to develop, manufacture, and commercialize PEP02 (MM-398) in Asia and Europe. Merrimack obtained U.S. rights for MM398 when it acquired Hermes Biosciences in 2009.

On August 1, 2011, the FDA granted MM-398 orphan drug designation for the treatment of pancreatic cancer. Orphan drug designation was also granted by the European Medicines Agency in December 2011.

In January 2012, Merrimack initiated a pivotal Phase 3 clinical trial of MM-398 for the treatment of patients with metastatic pancreatic cancer who have previously failed treatment with gemcitabine. The trial, called NAPOLI-1 (NAnoliPOsomaL Irinotecan), is a global, randomized, open label Phase 3 study. NAPOLI-1 calls for a total enrollment of 405 patients equally randomized across the three arms: MM-398 as a monotherapy and MM-398 in combination with 5-fluorouracil (NYSEMKT:FU)-leucovorin (LV) (5-FU/LV) compared with the shared control arm of 5-FU/LV.

MM-398 Phase 3 data is expected in mid-2013. Several analysts expect MM-398 to launch in 2015, with global peak sales in pancreatic cancer alone exceeding $900M given the unmet medical need. Why do some analysts believe that MM-398 could be a blockbuster? There is little competition. MM-398's market is for patients with metastatic pancreatic cancer who fail treatment with gemcitabine. There are no approved therapies for patients with metastatic pancreatic cancer who fail treatment with gemcitabine. Gemcitabine continues to be the standard of care for locally advanced and metastatic disease, despite a median survival of less than six months and rate of one-year survival of around 18%. Most clinical trials have studied combinations with gemcitabine and none have been able to provide significantly superior outcomes than gemcitabine monotherapy.

Merrimack believes that MM-398 has potential uses in a number of other indications, including colorectal cancer, lung cancer, gastric cancer and glioma. In addition to NAPOLI-1, there are ongoing Phase 1 and Phase 2 clinical trials of MM-398 in glioma and colorectal cancer. MM-398 has been tested in several clinical trials including a Phase 2 single agent study of MM-398 in metastatic pancreatic cancer and an ongoing Phase 2 study of MM-398 in combination with 5-FU and leucovorin in patients with metastatic colorectal cancer.

Strong Pipeline, Sophisticated Platform

Merrimack Pharmaceuticals Inc. was founded in 2000. The Cambridge, Massachusetts, company went public on March 29, 2012. Merrimack is focused on cancer therapeutics and diagnostics, and has five potential therapies in its pipeline. The company has a partnership with French drug maker Sanofi (NYSE:SNY).

Merrimack has five novel therapeutic candidates progressing through clinical development, including one Phase 3 trial in second line pancreatic cancer and four Phase 2 trials in multiple cancer indications.

Merrimack's research and development platform is based on Network Biology, which applies computational modeling to high-throughput quantitative biology. Merrimack combines the disciplines of biology, engineering, and computational modeling to understand and design therapies.

A significant amount of cancer research has focused on tumors characterized by a single overexpressed receptor or a mutated regulatory gene, also known as "oncogene-induced cancers." Merrimack believes these types of cancers, such as HER2 and EGFR, are somewhat rare. Network Biology enables scientists to move beyond one dimensional measures of molecular activity. Merrimack research suggests that identifying the signaling networks that a patient's tumor cell is utilizing will enable a more precise, mechanistic diagnosis.

MM-398 is only one of five clinical-stage drug candidates Merrimack is currently developing. Some analysts believe MM-121, an ErbB3 antibody, is Merrimack's most promising candidate.


MM-121 is a fully human monoclonal antibody that targets ErbB3, a cell surface receptor, or protein attached to the cell membrane that mediates communication inside and outside the cell, that Merrimack's Network Biology approach identified as a potentially important target in a range of cancers.

MM-121 is designed to inhibit cancer growth directly by restoring sensitivity to drugs to which a tumor has become resistant. MMM-121 is also designed to delay the development of resistance of a tumor to other agents. In partnership with Sanofi, MM-121 is being evaluated in Phase 2 studies in advanced ovarian cancer, hormone sensitive breast cancer, non-small cell lung cancer (NSCLC) and HER2 negative neoadjuvant breast cancer.

In October 2011, Merrimack initiated a Phase 2 study to evaluate whether the combination of MM-121 with paclitaxel is more effective than treatment with paclitaxel (Onxol, Taxol, generics) alone when administered as part of a neoadjuvant treatment regimen in HER2-negative, locally advanced breast cancer patients. Following treatment with MM-121 and paclitaxel, or paclitaxel alone, patients will receive standard treatment with doxorubicin and cyclophosphamide and monitored until surgical resection.

On October 2, 2012, Merrimack presented data from a Phase 1 trial that evaluated MM-121 in combination with weekly paclitaxel, a standard regimen for patients with advanced gynecological and metastatic breast cancers. This combination regimen is also being evaluated in two Phase 2 studies, one in advanced ovarian cancer and one in neoadjuvant breast cancer.

This small trial composed of 28 patients with certain platinum resistant gynecological cancers or HER2 non-overexpressing breast cancer received a combination of MM-121 and weekly paclitaxel until disease progression or intolerable toxicity.. Researchers assessed response every eight weeks.

The study found that the observed safety profile of MM-121 combination with weekly paclitaxel suggested a similar toxicity profile to that of weekly paclitaxel alone.

Researchers found that the overall clinical benefit rate was 70% across all dosing cohorts. The study found 48% achieved a partial response (PR) and of those, 39% achieved a confirmed PR with a median duration of 2.7 months (range 1.7 - 15.1 months). Researchers found 22% experienced stable disease (SD) > 4 months with a median duration of 5.3 months, 9% of patients had progressive disease (PD) at first assessment and 26 \% percent remain on study with a median on-study time of 13.5 months in 23 evaluable patients.

JP Morgan noted "…MM-121, partnered with Sanofi, is currently in phase 2 trials for NSCLC, breast and ovarian cancer (data 2013-14) with peak sales potential of $1.3B in the US alone (driving royalties of ~$320M)."


MM-111 is a bispecific antibody designed to target cancer cells that are characterized by overexpression of the ErbB2 cell surface receptor, also referred to as HER2. Merrimack's Network Biology approach identified that ligand-induced signaling through the complex of ErbB2 (HER2) and ErbB3 is a more powerful and widespread promoter of tumor growth and survival than previously appreciated. Merrimack believes that MM-111 is potentially applicable across a broad range of solid tumors. Merrimack is conducting multiple Phase 1 clinical trials of MM-111 in monotherapy and combination therapy settings. In addition to these trials, Merrimack is planning to initiate Phase 2 studies, which will further examine the role of MM-111 in the treatment of a variety of tumors.

On October 2, 2012, Merrimack announced the results of a Phase 1 study comprised of patients with breast, gastric, esophageal and bladder cancers. Researchers examined the safety, pharmacokinetics and anti-tumor activity of MM-111, combined with the standard of care HER2-targeting regimens of capecitabine, cisplatin and trastuzumab ; lapatinib +/- trastuzumab; and paclitaxel with trastuzumab.

In this Phase 1 study, comprised of 46 patients with documented advanced HER2+ cancer were studied., researchers found that MM-111 was tolerable and could be safely combined at full dose with lapatinib / trastuzumab and paclitaxel / trastuzumab regimens. The capecitabine containing arm required dose reduction of capecitabine. The toxicity profile of the MM-111 combinations was consistent with that generally observed in patients receiving the underlying HER2 therapy.

The study found that across all dosing regimens, the overall clinical benefit rate, defined as complete response (NYSE:CR), partial response (PR) and stable disease for at least 4 months, was 52 percent in 29 evaluable patients. Responses were observed across various tumor types including, breast, bladder, esophageal, colorectal and ovarian cancers.

Merrimack will conduct Phase 2 studies to further examine the role of MM-111 in the treatment of a variety of tumors, the first of which is expected to be initiated later this year.


MM-151 is an oligoclonal therapeutic consisting of a mixture of three fully human monoclonal antibodies designed to bind to non-overlapping epitopes of the epidermal growth factor receptor, or EGFR. EGFR is also known as ErbB1. An oligoclonal therapeutic is a mixture of two or more distinct monoclonal antibodies. Merrimack has designed MM-151 to block signal amplification that occurs within the ErbB cell signaling network, which Merrimack believes may result in greater efficacy than currently marketed EGFR (ErbB1) inhibitors. In January 2012, Merrimack initiated a Phase 1 study to assess the safety of MM-151 and to determine the recommended Phase 2 dose.


MM-302 is a nanotherapeutic encapsulation of doxorubicin with attached antibodies that are designed to target MM-302 to cells that overexpress the ErbB2 (HER2) receptor. Merrimack believes that MM-302 has the potential to retain the safety profile of liposomal doxorubicin, in particular with respect to cardiac safety, and achieve better efficacy than either free doxorubicin or liposomal doxorubicin in ErbB2 (HER2) positive tumors. Merrimack is conducting a Phase 1 clinical trial of MM-302 in patients with advanced ErbB2 (HER2) positive breast cancer.


Merrimack reported a net loss of $23.3 million for the third quarter of 2012, compared to $18.7 million for the third quarter of 2011. Net loss per share available to common stockholders for the third quarter of 2012, both basic and diluted, was $0.25 per share, compared to a loss of $1.81 per share for the third quarter of 2011.

This decrease in net loss per share available to common stockholders was primarily attributable to an increase in the number of weighted-average common shares used in computing net loss per share available to common stockholders as a result of Merrimack's April 2012 initial public offering in which all outstanding shares of Merrimack's convertible preferred stock were converted into 66,255,529 shares of common stock and in which Merrimack issued 15,042,459 new shares of common stock.

Collaboration revenue for the third quarter of 2012 were $11.3 million, compared to $8.6 million for the third quarter of 2011, an increase of $2.7 million, or 31%. This increase was a result of increases in development, milestone and manufacturing revenues recognized under the 2009 license and collaboration agreement with Sanofi for the development and commercialization of MM-121.

Research and development expenses for the third quarter of 2012 were $30.9 million, compared to $23.9 million for the third quarter of 2011, an increase of $7.0 million, or 29%. This increase was primarily attributable to $3.9 million of increased overall spending on the MM-398 program related to Merrimack's ongoing Phase 3 clinical trial coupled with $2.8 million of increased spending on preclinical programs, general research and discovery due to an increase in the number of preclinical programs in the pipeline, and increased costs associated with each preclinical program as they approach clinical development, including increased costs of $0.8 million due to IND-enabling activities related to MM-141.

General and administrative expenses for the third quarter of 2012 were $4.3 million, compared to $3.3 million for the third quarter of 2011, an increase of $1.0 million, or 30%. This increase was primarily attributable to an increase in labor and labor-related costs, including increased stock compensation expense of $0.3 million, and increased rent, insurance and pre-commercialization costs.

On November 8, 2012, Merrimack entered into a Loan and Security Agreement with Hercules Technology Growth Capital, Inc. (NASDAQ:HTGC) pursuant to which a term loan of up to an aggregate principal amount of $40.0 million is available to Merrimack. The Loan and Security Agreement provides for an initial term loan advance of $25.0 million, which closed on November 8, 2012, and an additional term loan advance of up to $15.0 million, which is available at any time through December 15, 2012 upon Merrimack's request.

The term loan bears interest at an annual rate equal to the greater of 10.55% and 10.55% plus the prime rate of interest minus 5.25%, but may not exceed 12.55%. The Loan and Security Agreement provides for interest-only payments for 12 months and repayment of the aggregate outstanding principal balance of the loan in monthly installments starting on December 1, 2013 and continuing through May 1, 2016.

Merrimack expects its existing unrestricted cash and cash equivalents and investments on hand as of September 30, 2012 of $86.7 million, plus the $40.0 million term loan made available under the Loan and Security Agreement with Hercules, to be sufficient to fund operations into 2014.

Conclusion: Buy

In May 2012, J.P. Morgan has initiated coverage of Merrimack with an "Overweight" rating and a $10 price target.

In May, Oppenheimer also started coverage of Merrimack. It placed an "Outperform" rating on the stock and set a $12 price target. In May, Cowen initiated coverage with an "outperform rating."

In August, Bank of America-Merrill Lynch began coverage of Merrimack, B of A analysts put a "Buy" rating on the stock with a $13 target.

In September, Brean Murray Carret and Company initiated coverage of Merrimack with a "Buy" rating and a price target of $12.

In November, Guggenheim started coverage on shares of Merrimack and set a "Buy" rating on the stock.

Is now a good time to invest in Merrimack? The company's initial public offering (NYSEARCA:IPO) was on March 29, 2012. On that day, the stock closed at $6.04 a share. Since then, the stock has ranged from $5.66 to $11.11. The median analyst target on the stock is $13. I believe the stock is a good buy, trading in the $7.00 range.

Over the next 12 months, Merrimack anticipates the these milestones:

  • Completion of enrollment and announcement of top line data on the NAPOLI-1 study, MM-398's global Phase 3 clinical trial in gemcitabine-resistant pancreatic cancer;
  • Completion of enrollment in several Phase 2 clinical trials;
  • Announcement of top line data from several MM-121 Phase 2 clinical trials;
  • Presentation on a Phase 1 monotherapy study of MM-302;
  • Initiation of a Phase 2 clinical trial for MM-111 in second line gastric cancer;
  • Initiation of a Phase 1 clinical trial for MM-141, an IGF signaling inhibitor that will represent Merrimack's sixth novel therapeutic to enter clinical development.

Merrimack has a robust pipeline with five clinical and three pre-clinical candidates based on the company's sophisticated Network Biology-based drug development technology. While most investors and analysts are focused on the near-term progress of MM-398 and the NAPOLI-1 trial, Merrimack's other candidates, particularly MM-121, which is partnered with Sanofi, show great promise for the treatment of ovarian, breast, and lung cancers, making this progressive company worthy of a speculative, long-term investment.


Disclosure: I am long MRK, MNTA, CELG. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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