It has been only four months since Merrimack Pharmaceuticals Inc. (MACK: Quote) went public, pricing its shares at $7 each. The stock has thus far hit a low of $5.66 and a high of $9.20. Given the fact that this biotech company has a number of milestones lined up for the next ten months or so, it may be worth keeping an eye on the stock.
For readers who are new to Merrimack, here's a brief overview of its pipeline and the upcoming events to watch out for...
Merrimack is engaged in developing innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. The company has five therapeutic oncology candidates in clinical development and multiple product candidates in preclinical development.
The most advanced drug candidate in Merrimack's pipeline is MM-398, a nano-encapsulated formulation of the approved chemotherapy drug Irinotecan. Merrimack holds the development and commercialization rights to MM-398 worldwide, with the exception of Taiwan, where it is licensed to PharmaEngine Inc.
A global phase III study of MM-398 in second line metastatic pancreatic cancer - for patients who have failed treatment with Gemcitabine, was initiated last November. The study, which is designed to enroll 270 metastatic pancreatic cancer patients, evaluates MM-398 against 5-Fluorouracil and Leucovorin. The final data collection date for primary outcome measure is expected to be in *December 2013. (Sourced from Clinicaltrials.gov)
Last month, the company expanded the global phase III study of MM-398 to include an additional arm which combines MM-398 with 5-Fluorouracil and Leucovorin. The study is scheduled to begin enrollment on the amended protocol this month.
In addition to pancreatic cancer, MM-398 is also being evaluated for other indications. The investigator sponsored trials with MM-398 that are currently underway include, a phase II clinical trial in colorectal cancer, a phase I clinical trial in colorectal cancer and a phase I clinical trial in glioma.
The compound has orphan drug status for the treatment of pancreatic cancer designated by the FDA and the EMA.
Next in the pipeline is MM-121, which is being developed in partnership with Sanofi under an agreement signed in 2009, and is being tested across a wide spectrum of solid tumors.
A phase II study of MM-121 in combination with Erlotinib in three groups of patients with non-small cell lung cancer; a phase II study of MM-121 with Paclitaxel in HER2-negative breast cancer patients and a phase II trial of MM-121 in combination with Paclitaxel in patients with platinum resistant/ refractory advanced ovarian cancers were initiated in the fourth quarter of 2011.
In addition, one phase I/II clinical trial and four phase I clinical trials of MM-121 in multiple cancer types are underway.
Merrimack's other clinical drug candidates include, MM-111 under two phase I clinical trials in multiple cancer types; MM-302 under one phase I clinical trial in breast cancer and MM-151 under one phase I clinical trial in solid tumors. MM-151 was discovered by Lebanon, New Hampshire-based, privately-held, Adimab LLC and licensed exclusively to Merrimack.
The company also plans to initiate a phase I trial for DX-929, an imaging diagnostic for its nanotherapeutics, in the coming months.
A quick look at the company's balance sheet...
Merrimack, founded in the year 2002, has incurred significant operating losses since inception. The company has no marketed products, and derives revenue from collaboration agreements. The company was included in the Russell 3000 index in June of 2012, following the annual reconstitution of Russell's U.S. indexes.
In the first quarter ended March 31, 2012, Merrimack's net loss widened to $23.4 million or $2.14 per share from $13.5 million or $1.35 per share in the year-ago quarter. The company had an accumulated deficit of $374.1 million at the end of first quarter of 2012.
Collaboration revenues for the first quarter of 2012 increased 77% to $11.3 million as a result of increases in development, milestone and manufacturing revenues recognized under the 2009 agreement with Sanofi for the development of MM-121.
Merrimack had cash of $30.6 million as of March 31, 2012, and net proceeds from the initial public offering, that was closed the following month, were $100.5 million, sufficient to fund operations into the second half of 2013.
As the company works toward pursuing its vision of translating its pipeline of cancer products and diagnostic candidates into therapeutics, stay tuned for the upcoming milestones.
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by RTT Staff Writer
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