West Coast Editor
With the way apparently clearing for approval of its low-molecular-weight heparin, Momenta Pharmaceuticals Inc. raised about $130.4 million by selling about 4.8 million shares of stock at $27.02 each.
The company's stock (NASDAQ:MNTA) closed Friday at $25.18, down $1.84.
Momenta's stock has enjoyed a steady run-up this summer, starting with a 62 percent jump in mid-June after a judge invalidated the patent held by Paris-based Sanofi-Aventis Group for its drug Lovenox (enoxaparin sodium) - a development that opened the door for Momenta to file an abbreviated new drug application for its version of the blood thinner, M-Enoxaparin. The drug is partnered with Sandoz Inc., of Princeton, N.J., and the ANDA is expected next month. (See BioWorld Today, July 18, 2005.)
"We believe we have the potential to [make] the only generic heparin," said Alan Crane, chairman and CEO of Cambridge, Mass.-based Momenta, adding that "the investment community understands that, and that's why our stock has benefited." The court decision combined with more visibility in general boosted the company's value, he said.
Heparin is used to treat and prevent deep-vein thrombosis and pulmonary embolisms, as well as peripheral arterial embolism in acute coronary syndromes. Lovenox's sales growth had been slowing. In the second quarter, revenues from the product had grown only 15 percent, though sales in 2004 totaled $1.4 billion in the U.S.
A patent covering Lovenox expired last year, and another Sanofi-Aventis patent met with dispute by Jerusalem-based Teva Pharmaceuticals Industries Ltd. and Amphastar Pharmaceuticals Inc., of Rancho Cucamonga, Calif., both of which had filed ANDAs for their versions of the drug. They won a decision in their favor last month. (See BioWorld Today, June 17, 2005.)
By sequencing sugars for more precise bioequivalence, Momenta has leverage over companies such as Teva and Amphastar, Crane said, noting that his company also has in the works an improved, generic version of Fragmin (dalteparin sodium), another low-molecular-weight heparin, this one from Pfizer Inc., of New York. Momenta plans to file an ANDA for that product in mid-2006.
The company has in preclinical study M118, yet another rationally engineered low-molecular-weight heparin designed for improved efficacy and flexible administration as baseline therapy for patients with acute coronary syndrome.
Almost all patients entering emergency rooms with signs of cardiovascular distress are given some kind of heparin therapy, and a physician's choice depends on the patient's anticipated treatment path and whether invasive treatment such as angioplasty or bypass surgery will be needed.
M118's benefits are believed to include not only better efficacy, but also reversibility plus more predictable response, an ability to be monitored, and diminished risk of adverse reactions.
"There is significant unmet medical need in acute coronary syndrome," Crane told BioWorld Today, and M118 might fill that need. "Generally, there's ongoing extension of the clot [in ACS], and M118 actually shuts down the thrombosis whereas the existing agents do not," he said.
"We're also applying our technology to protein drugs," he said. Most proteins have sugars in them that have not been well characterized, and Momenta is applying its technology to "a number of complex mixture drugs," which it believes it will be able to make generic versions of.
Momenta plans to use its technology in drug discovery, too, exploring the use of complex polysaccharides in such areas as cancer.
"People haven't been able to sequence and understand the sugar-structure changes that are occurring in cancer," Crane said. "We've been able to develop inhibitors based on those mechanisms," and there is promise in such disorders as atherosclerosis, Alzheimer's disease and rheumatoid arthritis, where "sugars have been shown to play a major role, but it's been difficult to understand what molecules are causing which activities."
He likened the company's efforts in sugars to the revolutionizing work done in the 1970s to sequence proteins.
"We can do the same thing with these complex sugars," he said. "Much like proteins, there are specific sequences with specific biological activity."
Momenta went public last June, selling about 5.4 million shares of common stock at $6.50 apiece for $34.7 million, a price down from its estimate of $13 to $15 per share, which would have brought in more than $80 million. On registering for the IPO, the company said it expected to bring in about $86.25 million. After-market performance has been remarkable, with the stock climbing more than 280 percent this year, hitting a 52-week high of $34.60. (See BioWorld Today, March 15, 2004.)
Net proceeds from the latest financing are expected to total about $122 million, and Momenta ended the first quarter with just less than $50 million, Crane said. Underwriters have an option to buy up to 724,095 additional shares of common stock within 30 days of the offering to cover overallotments.
"Assuming we're successful with M-Enoxaparin, we should have plenty of cash to get to profitability," he said. The FDA typically decides on ANDAs in 12 months to 18 months.
A handful of New York-based banks helped make the latest financing happen. Morgan Stanley acted as the sole bookrunner and Deutsche Bank Securities acted as co-lead manager, with co-managers Banc of America Securities LLC and SG Cowen & Co. LLC also taking part.
Adventrx Brings In $20M
San Diego-based Adventrx Pharmaceuticals Inc. entered definitive agreements with institutional investors for a private placement of about 10.8 million shares of stock for $2.26, for proceeds of about $20 million. Investment funds controlled by Carl Icahn, including Icahn Partners LP and Icahn Partners Master Fund LP, were the largest investors in the transaction, along with Viking Global Investors LP, of New York.
The company plans to use proceeds to finance ongoing clinical development of its biomodulator, CoFactor, and for working capital. In June, Adventrx said response data from 48 patients in its Phase II trial of CoFactor, in combination with 5-fluorouracil as a first-line treatment for metastatic colorectal cancer, showed that 65 percent, or 31 patients, achieved clinical benefit. Adventrx's stock (AMEX:ANX) closed Friday at $2.80, up 55 cents, or 24.4 percent.