11.25.2008 Williams Mullen Successfully Lobbies for Release of a Drug Used by ALS Patients in U.S. VIRGINIA BEACH, VA – Williams Mullen, advocating on behalf of an ALS patient group, announces that it has successfully lobbied Tercica/Ipsen to allow a new ALS drug to become available in the United States. Until now the availability of this new drug has been limited due to a patent infringement suit that resulted in a Court-Ordered Settlement Agreement.
Against all apparent odds, Thomas R. Frantz and Dr. Kelly J. Hollowell led the pro bono effort which resulted in a signed a letter of intent whereby Ipsen/Tercica have consented to amend the Court-Ordered Settlement Agreement to permit the distribution and use of the new drug in connection with named-patient ALS programs worldwide on a royalty-free basis. Of course, the true effect of the letter of intent is subject to the negotiation and execution of a definitive agreement by the parties for which the ALS community now anxiously awaits.
Insmed, a Richmond-based company, is the producer of the new drug called IPLEX which has been shown to help patients with ALS. ALS, also known as Lou Gehrig’s disease, is a progressive, usually fatal, neurodegenerative disease caused by the degeneration of the nerve cells that control voluntary muscle movement. For the past several years, IPLEX was not available in this country due to a series of blocking patents licensed to Tercica/Ipsen. After a law suit, Insmed was only permitted to distribute the drug for ALS in Italy because of a request from the Italian Ministry of Health and because the initiation of the program pre-dated the settlement.
Over the past two months, Mr. Frantz and Dr. Hollowell have been actively investigating the situation, identifying the key players, and ultimately negotiating with the Richard King, President and CEO of Tercica/Ipsen to see if IPLEX could be distributed in this country. Their efforts resulted in a breakthrough on November 8, 2008 when Tercica/Ipsen and Insmed signed a letter of intent that, when finalized in a formal agreement, will give Insmed approval to distribute the drug after FDA approval.
“This is truly a breakthrough for the ALS community,” said Thomas R. Frantz, President and COO of Williams Mullen. “ALS patients all over the U.S. and the world will finally have access to this very important therapy.” Dr. Hollowell adds that “the actions of Tercica/Ipsen should be commended; as they represent a real commitment to finding a solution to the needs of ALS patients and their families.”
Bruce Thompson, Virginia Beach native and CEO of Gold Key / PHR Hotels and Resorts, also commented on the new developments. Mr. Thompson’s son Josh was diagnosed with ALS; “We are fighting this battle on many fronts; we are fighting for Josh and the entire ALS community. Thanks to Tom Frantz, Kelly Hollowell and the entire Williams Mullen community for giving new hope to all of us.”