Impax Pharmaceuticals Initiates Phase IIb Trial of IPX159 in Restless Legs Syndrome
Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. IPXL
+0.11% , announced that it has initiated a Phase IIb trial of
its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).
“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.
The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.
About IPX159
IPX159 is an oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has previously completed a proof of concept study with the molecule in RLS patients.
About Restless Legs Syndrome
Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million RLS sufferers in the US.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, with a full range of capabilities located in its Hayward, Philadelphia and Taiwan facilities.
Ohr Pharmaceutical Announces $1,100,000 Private Placement Led by Existing Investors
Ohr Pharmaceutical Inc. OHRP
0.00%
announced that on December 16, 2011 it sold 1,833,342 shares of its common stock to a group of institutional and accredited investors at a price of $0.60 per share, the closing bid price prior to the closing of the transaction. In addition, the investors will receive 916,678 warrants to purchase common stock exercisable at $0.65 for a five year period. The Company did not engage a placement agent for the transaction.
The estimated net proceeds to the Company from the offering were approximately $1.09 million. The Company intends to use the net proceeds from this offering to further the clinical development of its portfolio compounds, Squalamine eye drops and OHR/AVR118, and general corporate purposes.
“The Company’s ability to raise funds on favorable terms is a testament to the strong progress that has been made over the last year, highlighted by the successful reformulation of Squalamine for topical administration,” said Ira Greenstein, Chairman of the Board of Directors. “It is a very exciting time as the Company continues development on many fronts to address the needs of large patient populations.”
Dr. Irach B. Taraporewala, CEO of Ohr Pharmaceutical, added, “We are expecting an eventful 2012, with the initiation of a clinical trial of Squalamine eye drops for Wet Macular Degeneration and the completion of our Phase II OHR/AVR118 trial in cancer cachexia.”
Somaxon Pharmaceuticals Hires Financial Advisor to Assist in Seeking Strategic Alternatives
Somaxon Pharmaceuticals, Inc. SOMX
-15.17% , a specialty
pharmaceutical company, today announced that it has hired Stifel Nicolaus Weisel as a strategic advisor. Stifel will assist the company in identifying and evaluating various strategies to maximize stockholder value.
“We are committed to working with the Stifel team to evaluate strategies which will allow us to fully leverage our rights in our core asset — Silenor(R) for the treatment of insomnia characterized by difficulty with sleep maintenance,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “This process will focus on strategic alternatives, which may include one or more of a sale of the company or assets relating to Silenor, or partnering or other collaboration transactions relating to U.S. or ex-U.S. prescription or over-the-counter rights to Silenor.”
“While we are conducting this process, we will continue to market Silenor in the U.S. to existing prescribers through our 30-person sales force and non-personal promotion, and to protect the intellectual property position of the product,” continued Pascoe. “We will also undertake measures to minimize our cash burn rate, including through a reduction in force involving approximately 60% of our current non-field-based employees.”
The exploration of strategic alternatives may not result in any agreement or transaction and, if completed, any agreement or transaction may not be successful or on attractive terms. Somaxon does not intend to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or it enters into a definitive agreement for a specific, material transaction.
About Silenor(R)
Silenor is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulties with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep.