August 8, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Massachusetts-based Momenta Pharmaceuticals has been a good news/bad news company recently. On Aug. 4, the company announced that it was halting its Phase II trial of necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer. The decision was based on a recommendation from the independent Data Safety Monitoring Board (DSMB) after evaluations of progress indicated the drug wouldn’t meet the trial’s goals. This resulted in a 6 percent drop in company stock on Aug. 4.
On the same day, however, Momenta reported its second quarter financial results, which were fairly positive. Momenta reported total revenues of $26.4 million for the quarter, including $20.7 million in product revenues from sales of Sandoz’s Glatopa.
“We are pleased with the growth in product revenues from Glatopa this quarter and look forward to the potential launch of our Glatopa 40 mg product next year,” said Craig Wheeler, president and chief executive officer of Momenta, in a statement. “During the remainder of 2016 we plan to announce several key milestones including announcing top-line data from a pivotal trial for M923, a biosimilar candidate of Humira developed in collaboration with Baxalta , the initiation of a clinical trial for M834, a biosimilar candidate of Orencia being developed in collaboration with Mylan , and completing enrollment of the single ascending dose portion of our Phase I trial for M281, a novel anti-FcRn antibody candidate.”
Glatopa is a generic version of multiple sclerosis drug, Copaxone, marketed by Teva Neuroscience . Sandoz is a division of Novartis . Writing for the Boston Business Journal, Don Seiffert says, “CEO Craig Wheeler outlined key dates in a patent challenge for a higher dosage of Glatopa that would compete with a correspondingly more-potent version of Copaxone. Over the next couple of months, the company expects decisions both in the U.S. Patent and Trademark Office and in civil courts that could help clear the way for the launch of the higher-dose versions, which could dramatically increase the company’s revenues next year.”
There has also been speculation that Momenta might be an acquisition target. Although there are rumored to be more than one interested company, the speculation focused on Mylan (MYL), which has a partnership to develop biosimilars with Momenta.
“Based on the past few months, I am more convinced than ever that we made the right choice in our biosimilar collaboration,” Wheeler said in a second-quarter conference call. “At the executive level, our two companies are aligned and are working to help shake the evolving biosimilar field. At the working team level, the two companies’ employees are working as one team, rapidly advancing the programs and cooperatively working to any issues that arise with no duplication of efforts. … I think there are great things ahead for this collaboration.”
Momenta is currently trading for $12.32. Shares traded on Aug. 19, 2015 for $22.53, and dropped to $8.21 on Mar. 16, 2016. Enterprise Leader wrote on Aug. 6, “Momenta Pharmaceuticals has received a high momentum style score by Zacks. The score is arrived, taking into account some aspects, which signal that the stock has attained a favorable position after its movement in either upward or downward directions. … As per the market consensus opinion of sell-side analysts, Momenta Pharmaceuticals is expected to move to $17.57. … The bullish price estimate for the equity stands at $26 while the most conservative price estimate has been kept at $13.”
