AP Pharmaceuticals Inc., a Bay Area company that’s developing a migraine treatment with Irvine-base drug maker Allergan Inc., said that it plans to try again for Food and Drug Administration approval in coming months.
Allergan and MAP are working on Levadex, which the FDA declined to approve in March. The two companies will share Levadex’s profits if it’s approved.
The Botox maker bought the rights for co-marketing Levadex to neurologists and pain specialists from MAP in January 2011 for $60 million. Allergan and MAP also are sharing costs evenly, and the drug makers will co-promote Levadex in Canada.
MAP said that it has clinical data that will address all of the regulators’ concerns about the chemistry, manufacturing and controls of Levadex, an inhaled drug. It said that its new data will contain observations from a third-party manufacturing facility as well as more information about the inhaler that delivers Levadex. The company plans to resubmit for approval late in the current quarter or early in the fourth quarter.
The FDA might take some time to review the new Levadex submission. Similar reviews generally take either two or six months.
MAP does not expect to have to run additional clinical trials of Levadex.
An approval would open the potential for Levadex to become part of a migraine franchise Allergan has created in the wake of 2010’s FDA approval of Botox for treating chronic migraine headaches.
Allergan Chief Executive David Pyott has said his company would be able to offer Levadex and Botox with little branded competition because many migraine drugs have now gone off patent.
“We like quiet places, because if you’re the only guy, you’re appreciated,” Pyott said.
Levadex is targeted to the 25% of acute migraine patients who don’t respond to two or three triptan drugs. Triptans include the blockbuster Imitrex and are the most widely used drugs to treat acute migraines.
A Seeking Alpha article said that Allergan and MAP would have an “addressable market” of 2.5 million prescriptions, or 25 million doses, a year for Levadex.
Some patients still suffer around seven or eight acute migraine attacks a year, “so Levadex should complement Botox very well,” the Seeking Alpha article said.
Allergan and MAP also are studying the potential of Levadex to treat pediatric migraines and cluster headaches.
Watson: Court Agrees
Watson Pharmaceuticals Inc., a drug maker founded by Anaheim Hills resident Allen Chao, said that a federal appeals court agreed with its argument that four patents on an overactive-bladder treatment that Allergan holds the U.S. rights to are not valid.
Watson, which is based in Parsippany, N.J., is seeking Food and Drug Administration approval to market a lower-cost generic version of Sanctura XR.
The drug maker said that the U.S. Court of Appeals for the Federal Circuit agreed with its argument that four patents supporting Sanctura XR aren’t valid.
The appeals court’s ruling confirmed an earlier decision by the U.S. District Court for the District of Delaware, Watson said.
Watson said that U.S. sales of the branded Sanctura XR totaled $66 million for the 12-month period ended April 30.
Regulators have not yet approved Watson’s generic.
Quality Systems News
Quality Systems Inc., an Irvine-based healthcare software maker, won 14 awards in the American Business Awards competition. Quality had two gold awards, five silver awards and seven bronze awards.
Chief Executive Steven Plochocki won a gold award for executive of the year in the health products and services category, while the company itself got a gold award for best marketing or sales brochure or kit in the online/electronic category.
Separately, Quality’s NextGen Healthcare Information Systems LLC subsidiary said that a version of its NextGen Electronic Dental Record software was certified by the Certification Commission for Health Information Technology.
Quality also said that it changed the name of its NextGen Practice Solutions division to NextGen RCM Services to reflect the wide range of revenue management cycle services the unit provides.
Bits and Pieces:
National University’s Costa Mesa campus is now offering a bachelor of science degree program in radiation therapy. The university said that students who successfully complete the program will be prepared to work as entry-level radiation therapists and eligible to take examinations and apply to the California Radiation Health Board for licensure. … San Clemente-based nutritional product maker Metagenics Inc. said it is hosting a “lifestyle medicine summit” in Dana Point at the end of September. … Speakers include John Gray, the author of Men are from Mars; Women are from Venus. Aliso Viejo-based healthcare information technology company Enclarity Inc. said that it has donated a subscription to its ProviderLookup software to Give an Hour, a Bethesda, Md.-based nonprofit that is dedicated to meeting the mental health needs of military personnel.
