July 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Baudette, Minn.-based ANI Pharmaceuticals, Inc. announced today that it bought 22 generic drug products from Israel-based Teva Pharmaceutical Industries Ltd. . The drugs had been previously marketed and the deal was for $25 million in cash and a percentage of future product sales.
The drugs involved in the deal are three oral suspension medications and 19 solid-dose products. ANI has indicated it will start by transferring four of the products that qualify as CBE30 filings into two of its manufacturing plants. According to IMS Health, those four drugs have a combined 12-month market value of $210 million and the entire 22 have a total market value of about $650 million.
In December 2013 ANI bought 31 generic drugs from Teva, which included 20 solid-oral immediate release therapeutics, four extended release products and seven liquid drugs.
“I am excited to add this group of approved products to our generic portfolio and to further leverage our manufacturing capabilities,” said Arthur Brzybyl, president and chief executive of ANI Pharmaceuticals in a statement. “Importantly, we will be manufacturing one of the initial products out of our containment facility for potent compounds. This acquisition meaningfully expands our product pipeline to 68 products with a total market value of $3.9 billion per IMS Health.”
ANI Pharmaceuticals stock has been showing an increase for the last month, after a big drop in April. ANI shares traded for $25.42 on Oct. 14, 2014, rose to $70.75 on Mar. 2, 2015, then to $71.78 on April 23, 2015. Share prices dropped significantly to $49.68 on June 1, 2015, then rose back to $64.58 on June 25, 2015. Shares are currently trading for $62.22.
There is a recommendation consensus of “Buy” according to American Trade Journal. In the last year the company stock rallied 73.12 percent. In addition, James Marken, vice president of ANI operations, reported to the U.S. Securities and Exchange Commission (SEC) that he had sold 15,000 shares at $66.50 each on Mar. 19, 2015, for a total deal $997,500.
On June 2, 2015, ANI announced the U.S. Food and Drug Administration (FDA) had approved its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Oral Solution 5mg/5mL, which is expected to have 12-month sales of about $30 million.
Last week Teva Pharmaceuticals announced the launch of generic Axert (almotriptan malate) tablets in the U.S. Axert is marketed by Janssen Pharmaceuticals, a Johnson & Johnson company, and has sales of the non-generic version of about $31 million in the U.S. Teva is the largest generic drug product in the world. The company’s 2014 net revenues were about $20.3 billion.
Teva has been involved in a complicated legal case over the patent for its multiple sclerosis drug, Copaxone. On June 18, 2015, the U.S. Court of Appeals ruled that the company’s patent is invalid. That drug generated more than $3.1 billion for the company in the U.S. in 2014.
In April 2014 the FDA approved a generic version of the drug, which allowed Momenta Pharmaceuticals, Inc. and Novartis AG ’s Sandoz unit to sell a generic. That version is called Glatopa. Mylan NV has also applied for a generic version of Copaxone. Teva is attempting to acquire Mylan Inc.. Mylan is attempting to acquire Perrigo Company .
Copaxone accounts for about 20 percent of Teva’s total sales. Todd Campbell, writing for The Motley Fool, suggested that Teva’s legal maneuvering “has arguably proven to be a brilliant strategy for keeping Glatopa at bay.”
Although a generic version of Copaxone would definitely be problematic for Teva, in addition to its legal battles and delays, it has been working on a next-generation formulation of Copaxone, which would work longer and require fewer monthly doses. It could, however, lead to a price battle between Novartis’s Glatopa and Copaxone if Novartis prices Glatopa at a price that would convince formularies to favor it over Copaxone.
