ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Meta-analysis adds evidence to association between omega-3 supplementation and lower heart rate

Friendly User's Guide for the Timing of Nutritional Supplements

The Health Benefits of Manuka Honey

Increase Your Magnesium Intake

Vitamin D supplementation could ease IBS symptoms

Top Tips to Boost Your Immunity

11 Amazing Health Benefits of Using Baking Soda

Nicotinamide riboside shows promise for treatment of Alzheimer’s disease

Exercise, calcium, vitamin D, and other factors linked with fewer injurious falls

Mediterranean diet associated with lower risk of aggressive prostate cancer

 
Print Page
Email Article

FDA Grants Pharmos Brain-Injury Drug Fast-Track Status

  [ 108 votes ]   [ Discuss This Article ]
www.ProHealth.com • October 2, 2003


By Roger Cheng

NEW YORK -- Shares of Pharmos Corp. (NasdaqSC:PARS - News) surged Tuesday and hit a 52-week high after regulators awarded its traumatic brain-injury drug fast-track status.

Pharmos's dexanabinol, which treats secondary neuroprotective brain damage following injury, won fast-track status from the Food and Drug Administration (News - Websites). The designation is given to drugs that treat serious and life-threatening conditions for which no other approved treatments exist.

Primary brain damage, which stems from something such as a violent impact, precipitates the secondary injury, said Pharmos spokeswoman Gale Smith. The secondary damage involves a neurotoxic cascade which causes molecular deterioration, leading to ailments such as memory loss and ultimately a coma.

Aside from the neurotoxic cascade, the injury includes inflammation, which pressures the brain, she said. Dexanabinol works on three different levels to control the inflammation and neurotoxic cascade, she said.

The company estimates the U.S. market for patients with traumatic brain injury to be more than $500 million. The international market potential may exceed $1 billion.

While dexanabinol's critical Phase III trial began in early 2001, Pharmos is on the cusp of the advanced trials for Phase III, which test efficacy, Ms. Smith said. The company expects Phase III trials to wrap up in the second half of 2004.

Around 12:15 p.m. on the Nasdaq Stock Market (News - Websites), shares of Pharmos were up 67 cents, or 33%, to $2.68 after hitting an intraday high of $2.95. The previous 52-week high of $2.65 was set on June 11.

Along with the FDA news, Pharmos also completed a $21 million convertible debt offering to shore up its cash reserve and prepare itself for potential acquisitions. The offering also cleared up a possible violation of Nasdaq's corporate governance rules.

Nasdaq has a problem with the company's March and May equity offerings, said Chief Financial Officer Bob Cook. The offerings represented more than 20% of existing shares, and the exchange felt the company should have gotten shareholder approval. The current deal is structured so, when grouped together with the prior offerings, it meets Nasdaq's regulations.

"While we didn't agree with (Nasdaq's claim), we worked out a way to drop the issue," Mr. Cook said. "This issue has gone."

He noted the issue never became a formal inquiry, and added the company didn't have to pay any penalties.

A spokesman for Nasdaq couldn't immediately be reached for comment.

The deal followed two prior offerings that have raised enough cash to take the company through 2004, said Mr. Cook. The company's projected 2003 operating expense is about $15 million, and the company hasn't provided guidance for its expense estimate in 2004.

While Pharmos has enough cash to run through the trial and FDA new-drug application for dexanabinol, Mr. Cook wouldn't rule out any future offerings. He also noted the company would be receiving about $10 million in royalty payments from partner Bausch & Lomb Inc. (NYSE:BOL - News) .

As part of the current deal, $16 million of the $21 million raised will be reserved for acquisitions only. Mr. Cook said the company doesn't have any immediate plans on the horizon.

Source: Dow Jones Business News.



Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg Mitochondria Ignite™ with NT Factor® Optimized Curcumin Longvida®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get Energized with Malic Acid & Magnesium
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

Coping When Colds or Flu Catch Up with You Coping When Colds or Flu Catch Up with You
Prepare Yourself for Cold & Flu Season Prepare Yourself for Cold & Flu Season
How I Found My Long-Lost Energy How I Found My Long-Lost Energy
Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker
The Surprising Benefits of Probiotics - What You Didn't Know The Surprising Benefits of Probiotics - What You Didn't Know

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2018 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map