OTCPicks.com

For Wednesday, November 12th

BSTI, NXPC, PGOG, UBRG, RNNM
NXST, BLUS, ISTA, ARYX, GNVC

Our Stocks to Watch today include Brite-Strike Tactical Illumination Products Inc. (OTC: BSTI), NeXplore Corp. (OTC: NXPC), Perf Go Green Holdings Inc. (OTCBB: PGOG), Universal Bioenergy Inc. (OTC: UBRG), Ronn Motor Co. (OTC: RNNM), Nexstar Broadcasting Group Inc. (Nasdaq: NXST), BELLUS Health Inc. (Nasdaq: BLUS), ISTA Pharmaceuticals Inc. (Nasdaq: ISTA), ARYx Therapeutics Inc. (Nasdaq: ARYX) and GenVec Inc. (Nasdaq: GNVC).

FEATURED COMPANY

IMAGE

BRITE-STRIKE TECHNOLOGIES INCORPORATED (OTC: BSTI)
"Up 50.00% in morning trading"

Detailed Quote: www.otcpicks.com/quotes/BSTI.php

Company Profile: http://www.otcpicks.com/brite-strike/brite-strike.htm

Brite-Strike Tactical Illumination Products, Inc. was started by two police officers to create world-class tactical LED flashlights that had the features that police officers and citizens need to keep them safe. Brite-Strike makes a promise to always use the latest technology, world-class components, highest design and manufacturing standards, so consumers can rely on Brite-Strike products when they are needed.

BSTI News:

November 6 - Brite-Strike Tactical Illumination Products, Inc.'s Personal Protection System to Be Featured in the Prestigious Frontgate Christmas Catalog

Brite-Strike Tactical Illumination Products, Inc. (OTC: BSTI) announced that its "Lightning Strike" Personal Protection System will be featured in Frontgate's national Christmas catalog, and that shipments for the initial order will begin this week. The product is also being carried at 28 BJ's Wholesale Club locations, which can be found at www.brite-strike.com.

"This product, for the money, may be the most effective defensive tool available for women today, particularly in preventing assaults and rapes," said Glenn Bushee, President of Brite-Strike. "The gift set includes a powerful, but compact, tactical flashlight, with the patented tactical touch hi-low-strobe switch, a leather holster, as well as a personal safety alarm, that can emit a shrieking noise of up to 125 db, and can be effective in warding off dogs and assailants. The package includes other accessories, and is packaged in a presentation gift box."

The company also announced that sales of its flagship model, the "Tactical Blue-Dot" flashlight, currently being featured in the Herrington Catalog, remain very strong, and are expected to significantly exceed last year's sales, even in this challenging economic environment. The company has been informed that its product is the top selling product in the catalog at that price-point. "In tough economic times, such as now, the number of robberies and assaults rise dramatically, which increases the demand for all our products," said Mr. Bushee, president of Brite-Strike.

In other news, the company announced that it had shipped its first order to the Pennsylvania Prison System, an area where the company see's significant growth opportunities. The company is also currently in discussions with one major national retailer for the placement of the "Lightning Strike," and is in late-stage testing with one branch of the US Military.

The company recently filed a Form 15 with the SEC. This form is in preparation for the company's financial audit, and intent to file as an SEC reporting company, with application to file for listing on the OTC BB the first half of 2009.

"We are extremely optimistic about the future of Brite-Strike. We feel the current share price dramatically undervalues the company, and its long-term growth prospects. We project dramatic increase in revenues over the next several years, both from our existing product line, as well as new products," said Mr. Bushee. "We appreciate our loyal shareholders, and in acknowledgement of their support, we would like to offer any shareholders ordering product through customer service, at 781-585-5509, a discount on all their purchases, with free gift-wrapping for all our customers for the holiday season."


FEATURED COMPANY

QMCI

NEXPLORE CORPORATION (OTC: NXPC)
"Up 5.56% in morning trading"

Detailed Quote: www.otcpicks.com/quotes/NXPC.php

Company Profile: www.otcpicks.com/nexplore/nexplore.htm

NeXplore Technologies is developing a Web 2.0 search engine and an assortment of social networking portals and tools that will enable users to personalize their Web experience and tailor it to their unique needs, interests, and online pursuits. The Company’s social computing platform, MyCircle.com, offers an enhanced, user-friendly graphical interface search engine, combined with innovative backend technology, which enables users to improve the way they connect with information and other people on the Worldwide Web. MyCircle’s Web 2.0 interface provides users with an online tool for sharing their Blogs, Voice-Over IP, photos and documents, podcasts and videocasts, classified advertising, instant messages, SMS text messages, Chat and personal profiles.

NXPC News:

November 11 - Former Microsoft VP Rowland Hanson Joins NeXplore Advisory Board

Branding Mastermind Behind Microsoft Windows to Guide Business Development and Growth Strategy for NeXplore Search

NeXplore Corporation (OTC: NXPC) announced the appointment of Rowland Hanson to the NeXplore Corporation board of advisors.

Currently CEO of business strategy consulting firm The HMC Company, Mr. Hanson will draw upon his vast experience building brands and growing market share for some of the world's best known, high-growth companies to guide business development and growth initiatives for NeXplore Search (www.NeXplore.com), an innovative Web 2.0 search engine optimized for a superior end-user experience, rich-media display and social network integration.

Prior to founding The HMC Company, Mr. Hanson served as vice president of corporate communications for Microsoft, where he developed and executed the company's highly acclaimed branding strategy which included the market introduction of Microsoft's most popular product -- a graphical interface that Mr. Hanson named "Windows."

"What excites me about NeXplore Search is that the visually rich user interface engages consumers and, at the same time, reinvigorates an advertising medium that, although proven, is losing its luster as text overload leaves more and more consumers with search fatigue," said Hanson. "NeXplore Search is well-positioned to be at the forefront of the next generation of search, and I am pleased to be involved with NeXplore at such a pivotal moment. I look forward to helping the NeXplore executive team take this product and company to the next level."

"Rowland Hanson brings immense business experience, marketing insight and branding wisdom to NeXplore," said Edward Mandel, CEO of NeXplore Corporation. "His proven track record maps out perfectly with NeXplore's aggressive growth goals. Rowland's guidance will be instrumental as we move forward with strategic initiatives to accelerate popularity of NeXplore Search among consumers and drive traction of NeXplore Search among leading brand and direct-response advertisers. We are thrilled to have a professional of Rowland's caliber and distinction serving on the NeXplore advisory board."

Prior to Microsoft, Mr. Hanson served as vice president of worldwide marketing for Neutrogena Corporation, a skin care and cosmetics company that registered phenomenal growth through new product introductions and global partnering before being acquired by Johnson & Johnson.

Over the last several years, Mr. Hanson served as a consultant, CEO, president, and board of director member for several emerging companies.

Mr. Hanson served as president, CEO, and chairman of Amaze Inc., a multi-media software publisher of popular products such as The Far Side, Trivial Pursuit, Bloom County, and Berlitz theme computer calendars and screen savers. Hanson negotiated the sale of Amaze to Delrina Corporation.

Mr. Hanson was founder, CEO, and Chairman of iTravel Corporation, an exclusive developer of multi-media travel guides for United Airlines, United Vacations, and the travel agency network. Hanson negotiated the successful sale of iTravel to StarPress.

Mr. Hanson was business development consultant, branding consultant, and board member of ColdHeat, a company whose proprietary material science led to the successful introduction of several new consumer small appliances.

Mr. Hanson served as a business development consultant, branding consultant, and board member of The Nautilus Group, the developer and marketer of well-known fitness brands such as Bowflex, Nautilus, Schwinn Fitness, and StairMaster.

Mr. Hanson founded The b EQUAL Company with a mission to strengthen the child/parent bond by creating games that make learning a fun, interactive, family event. The b EQUAL Company partners included A&E (The History Channel / Biography), National Geographic, and DreamWorks, Discovery, among others. Hanson negotiated the merging of The b EQUAL Company into Specialty Board Games (SBG) of Toronto, Canada.

Mr. Hanson holds a BBA from Loyola University and an MBA from the Wharton School of Business (University of Pennsylvania).


FEATURED COMPANY

QMCI

PERF GO GREEN HOLDINGS INCORPORATED (OTCBB: PGOG)

Detailed Quote: www.otcpicks.com/quotes/PGOG.php

Company Profile:
http://www.otcpicks.com/perf-go-green/perf-go-green.htm

Perf Go Green Holdings, Inc. is engaged in the creation and global marketing of 100% eco-friendly, non-toxic, food-contact-compliant, biodegradable plastic products. All Perf Go Green products are made from recycled plastics and completely break down in landfill within two years, leaving no toxic or visible residue, as compared to other plastics that take hundreds of years. Perf Go Green’s corporate name reflects its “Go Green” mission to develop, market and distribute biodegradable plastic products as a practical and viable solution to eliminating plastic waste from the world environment.

PGOG News:

November 11 - Perf Go Green Expands Business Development Team

Partners With GEM Business Development to Broaden Retail and Consumer Awareness and Accelerate Go-to-Market Approach

Perf Go Green Holdings, Inc. (OTCBB: PGOG) (“Perf Go Green”), a marketer and distributor of biodegradable plastics, announced the expansion of its business development team through a partnership with GEM Business Development. GEM will assist Perf Go Green in building brand equity with consumers, gaining additional retail distribution and leveraging its partnerships with strategic retailers.

The GEM team will be led by Rebecca Gournay, President, who has more than 15 years of consumer packaged goods experience in Sales Management & Marketing. Prior to co-founding GEM, she served as Franchise Business Director, Marketing & Sales Operations at Johnson & Johnson. While at Johnson & Johnson, she worked on leading brands such as Splenda®, Lactaid®, Band-Aid®, Tylenol® and Aveeno®.

“GEM's deep knowledge of the consumer packaged goods industry will be a great asset to Perf Go Green as we continue to grow,” said Chief Marketing Officer Linda Daniels. “We picked GEM to help us refine our go-to-market strategy in the retail marketplace, enabling shoppers to make better environmental choices when they purchase household products. Our expanded team of seasoned executives will deliver a comprehensive consumer marketing plan, refine our go-to-market structure, and support retailers in their sustainability efforts by focusing on our authentic brand to drive category sales.”

Founded in November 2007, Perf Go Green premiered at the March 2008 International Home and Housewares Show in Chicago, where its products were honored for their design quality and innovation. Perf Go Green is now shipping seven prominent biodegradable plastic products categories, including 13-gallon kitchen trash bags, 30- and 39-gallon lawn & leaf bags, plastic drop cloths, Doggie Duty Bags™ and cat pan liners. Its products are available nationwide at more than 12,000 retail outlets. They are also sold online through Amazon.com and drugstore.com.


FEATURED COMPANY

IMAGE

UNIVERSAL BIOENERGY INCORPORATED (OTC: UBRG)

Detailed Quote: www.otcpicks.com/quotes/UBRG.php

Company Profile: http://www.otcpicks.com/universal-bioenergy.htm

Universal Bioenergy, Inc. is a Mississippi-based company engaged in the production of renewable fuels through its subsidiary Universal Bioenergy North America, Inc. that operates a biodiesel refinery in Mississippi. The refinery intends to produce biodiesel fuel from various virgin vegetable oils, premium greases, and non-edible vegetable oil sources using their unique and economical process.

UBRG News:

November 10 - Universal Bioenergy, Inc. Negotiates for Process Technologies to Lower Biodiesel Production Costs

Universal Bioenergy, Inc. (OTC: UBRG) announced it is in negotiations for two process technologies that could lower costs for biodiesel production.

The first of these technologies will allow the use of lower cost, higher free fatty acid feedstocks while producing other value-added byproducts. These include a furnace oil and a lubricant base oil that can sell for prices 20-25% higher than biodiesel as stated by the technology developers. Another advantage is this process does not produce glycerol, which is quickly becoming more difficult to dispose of or sell.

The second process will allow the lowering of the reaction temperature by up to 35 degrees Fahrenheit while maintaining output. This chemically modified process can save energy and operating costs.


FEATURED COMPANY

QMCI

RONN MOTOR COMPANY (OTC: RNNM)

Detailed Quote: http://www.otcpicks.com/quotes/RNNM.php

Company Profile: http://www.otcpicks.com/ronn-motor-company.htm

Headquartered in Austin, Texas, Ronn Motor Company, Inc. is a design and manufacturing company focused on the leading edge engineering of environmentally friendly, finely built premium automobiles and technology. These technology systems include Hydrogen Fuel, Fuel cells, and Plug in-electrics will be incorporated into our automobiles and made available for aftermarket applications. Our products, coupled with RMC's core values of a strong sense of ethics, environmental sensitivity and premium quality, position the company as one of the new leaders in an automotive industry transitioning toward fuel efficiency.

RNNM News:

November 11 - Ronn Motor Company: 'Speculative Buy' Rating, Target Price $0.84 by Beacon Equity Research

Ronn Motor Company (OTC: RNNM) has received a Speculative Buy rating with a price target of $0.84 by Beacon Analyst, Victor Sula, Ph.D.

The full report is available at www.beaconequity.com/main/Page-data/Adpages/RNNM.

In the report, the analyst writes, “The Company’s H2GOTM system offers an immediate solution to the transportation industry for greenhouse gases emissions reduction. With the long term high oil prices environment a reality, RNNM solution has the potential to rapidly gather market share and report double-to-triple digits growth in sales. … Over the long term, the Company plans to maintain a double-digit growth in revenue due to increased acceptance of its offering and rollout of Hydrogen/Electric Plug-in Hybrid in 2010.”

Comparable companies in the hydrogen or exotic car manufacturing segment include Ballard Power Systems Inc. (Nasdaq: BLDP), FuelCell Energy Inc. (Nasdaq: FCEL), Plug Power Inc. (Nasdaq: PLUG) and Ener1 Inc. (AMEX: HEV).

November 10 - Frigette's Projection of Three-Year Retail Sales of One Million Units of Ronn Motor Company's H2GO™ Real Time Hydrogen Injection System Reinforced After Strong SEMA Response

Ronn Motor Company, Inc. (OTC: RNNM) announced that after strong SEMA response, the Company is reinforcing Frigette's projection of three-year retail sales of Ronn Motor Company's proprietary H2GO(TM) Real-Time Hydrogen Injection system could be potentially one million units globally, producing retail revenues potentially of up to $1 Billion in retail sales globally within the three years.

Ronn Maxwell, CEO of Ronn Motor Company, said, "The H2GO(TM) Real-Time Hydrogen Injection system was recently unveiled by Tommy DuPont, Publisher of the world renowned 'DuPont Registry' and revealed to the world at SEMA, the world's largest and most recognized automotive aftermarket convention show. The H2GO(TM) system is the catalyst behind the world's First Eco-Exotic sports car named the 'SCORPION(TM).' The Scorpion(TM) and the H2GO(TM) system were one of the most talked about features at this year's show and received unprecedented media coverage for its one-of-a-kind Green technologies that increase fuel mileage between 15-35% on any internal combustion engine while reducing noxious emissions to nearly zero.

"We are currently finalizing Global Distribution and manufacturing contracts with Frigette which is the largest aftermarket automotive manufacturer and distributor in the U.S. with nine regional distribution centers and over 5,000 distributors. Frigette products are sold directly or indirectly to over 170,000 locations worldwide. Frigette has distribution presence in the U.S.A., Europe, China, India and Russia."

Ronn Motor Company projections are based on assumptions from Frigette directly. In a prior news release, Mr. Phillip Kreymer, Director of Marketing at Frigette, said sales of one million units over the next three years are easily within Frigette's manufacturing and distribution capabilities and with a suggested retail price of $999.00 that would possibly produce revenues in the one billion dollar range.

Frigette is supplying products to many Original Equipment vehicle manufacturers including General Motors, Ford, Honda, Isuzu, Jaguar, Mazda, Nissan, and Subaru, and has been awarded the coveted "Q1 Supplier Award" by Ford Motor Company and the "First Team Supplier Award" by Nissan Motors of America. We also supply products to thirty-nine (39) OEM Recreational Vehicle manufacturers.

Frigette quality control standards have been approved by Chrysler Motors, Ford Motor Company, General Motors, Honda, Hyundai, Isuzu, Jaguar, Mazda, Nissan, Saturn, Subaru, GAZ, VAZ, Volvo, Winnebago, and others. Frigette's distributor network and key installers number in excess of 500 and have installation capabilities to support the Frigette products to the new car dealers who do not wish to perform installations. This assures the O.E.M. manufacturer that quality products, which they have approved, can be installed on their vehicles even though the car dealer may not wish to make the installation.


STOCKS TO WATCH

NEXSTAR BROADCASTING GROUP INCORPORATED (NASDAQ: NXST)
"Up 33.29% in morning trading"

Detailed Quote: http://www.otcpicks.com/quotes/NXST.php

Nexstar Broadcasting Group, Inc. currently owns, operates, programs or provides sales and other services to 50 television stations in 29 markets in the states of Illinois, Indiana, Maryland, Missouri, Montana, Texas, Pennsylvania, Louisiana, Arkansas, Alabama and New York. Nexstar’s television station group includes affiliates of NBC, CBS, ABC, FOX, My Network and CW, and reaches approximately 8.2% of all U.S. television households.

NXST News:

November 10 - Nexstar Broadcasting Group Third Quarter Net Revenue Increases 9% to $70.3 Million

Nexstar Broadcasting Group, Inc. (Nasdaq: NXST) reported financial results for the third quarter ended September 30, 2008.

Summary 2008 Third Quarter Highlights

Net revenue for the quarter ended September 30, 2008 grew 9.0% to $70.3 million compared to $64.5 million in the third quarter of 2007. Broadcast cash flow totaled $27.3 million in the third quarter of 2008 compared with $22.8 million for the same period in 2007. EBITDA totaled $23.1 million for the third quarter of 2008, compared to $19.7 million in the third quarter of 2007.

CEO Comment

Perry A. Sook, Chairman, President and Chief Executive Officer of Nexstar Broadcasting Group, Inc., commented, “Nexstar’s third quarter net revenue growth of 9.0% demonstrates that we continue to outpace the industry. Revenue growth was driven by strong year-over-year increases in political, retransmission consent and eMedia revenues which offset the softness of traditional television advertising spending in our markets. These results were delivered despite the effects of Hurricane Ike, which disrupted the operations of our Southeast Texas and Louisiana properties for much of the month of September.

“Third quarter 2008 gross revenue of $78.8 million included approximately $7.8 million of political advertising revenue. The Company’s stations captured a significant share of the political advertising spending in our markets, which we believe highlights the strong appeal of our high quality local news programming.

“Third quarter 2008 retransmission consent revenue grew 37.8% from year-ago levels to $6.2 million, eMedia revenue rose 62.6% to $2.7 million, and the Company’s stations captured over $4.0 million of Summer Olympics-related advertising revenue. Our high margin digital revenue streams are expected to continue to grow throughout fourth quarter and 2009 as we renegotiate expiring retransmission consent agreements, enter into agreements with new providers in our markets and benefit from new products and partnerships being added to our eMedia platform.

“Third quarter and year-to-date cap ex spending was approximately $10.0 million and $18.1 million, respectively. Capital expenditures for digital conversions were $13.5 million through September 30, 2008. However, with most of our spending on digital television upgrades being completed in 2008, we expect to be well positioned to generate significant free cash flow in 2009.”

Mr. Sook added, “Given the current environment, we are focused on aggressively controlling our costs, while continuing to grow our eMedia platform, complete our digital build out and reduce our outstanding debt.

“As our recently announced acquisition of KWBF-TV in Little Rock, Arkansas indicates, we are prepared to selectively grow the Company by adding to our station portfolio. This opportunistic and strategic transaction is both accretive to our shareholders and helps de-lever our company.”

Outstanding Debt

The Company’s total net debt at September 30, 2008 was $654.6 million, compared to $665.0 million at December 31, 2007. The total net debt consists of $354.0 million of bank debt, $198.2 million of senior subordinated 7% notes, $36.2 million of senior subordinated 12% PIK notes and $77.8 million of 11.375% senior discount notes, less cash on hand of $11.6 million.

In September 2008, Nexstar repurchased $5.3 million of the 11.375% notes in accordance with the terms of our sale of the senior subordinated PIK notes. This payment was funded with cash generated from operations.

As defined in the Company’s credit agreement, consolidated total net debt was $618.4 million at September 30, 2008. The Company’s total leverage ratio at September 30, 2008 was 6.55x compared to a permitted leverage covenant of 6.75x.

Total interest expense in the third quarter of 2008 was $11.6 million, compared to $13.8 million for the same period in 2007. Cash interest expense for the third quarter of 2008 was $9.9 million, compared to $10.1 million for the same period in 2007.

Impairment of Television Intangible Assets

As required by SFAS 142 “Goodwill and Other Intangible Assets,” in addition to the required annual test, Nexstar Broadcasting tests the impairment of its intangible assets whenever events or changes in circumstances indicate that such assets might be impaired. This testing resulted in a $48.5 million non-cash impairment charge in the third quarter ended September 30, 2008, related to goodwill, broadcast licenses and network affiliation agreements.


BELLUS HEALTH INCORPORATED (NASDAQ: BLUS)
"Up 3.61% in morning trading"

Detailed Quote: http://www.otcpicks.com/quotes/BLUS.php

BELLUS Health is a global health company focused on the development and commercialization of products to provide innovative health solutions to address critical unmet needs. For additional information on BELLUS Health and its drug development programs,call 1-877-680-4500 or visit www.bellushealth.com.

BLUS News:

November 10 - BELLUS Health Reports Results for Third Quarter of Fiscal 2008 and on EMEA Update

BELLUS Health Inc. (Nasdaq: BLUS) (TSX: BLU) reports results for the third quarter ended September 30, 2008. For the three-month period ended September 30, 2008, the net loss amounted to $11,095,000 ($0.22 per share), compared to $13,889,000 ($0.29 per share) for the corresponding period the previous year. For the nine-month period ended September 30, 2008, the net loss amounted to $36,703,000 ($0.74 per share), compared to $65,389,000 ($1.54 per share) for the same period last year.

The net loss for the current third quarter included net sales of $153,000 which represents one month of sales of VIVIMIND(TM), the Company's first natural health brand launched in Canada and on the Internet on September 2, 2008. The net loss for the nine-month period ended September 30, 2007, included a non-cash accretion expense under Canadian GAAP of $10,430,000 relating to the $40 million 5% senior subordinated convertible notes issued in May 2007.

Research and development expenses, before research tax credits and grants, amounted to $5,208,000 for the current quarter ($21,111,000 for the nine-month period), compared to $11,964,000 for the same period the previous year ($43,533,000 for the nine-month period). The decrease in the current periods compared to the same periods the previous year is mainly attributable to a reduction in expenses incurred in relation to the development of tramiprosate (ALZHEMED(TM); homotaurine) for the treatment of Alzheimer's disease, following the Company's decision in November 2007 to terminate the tramiprosate (ALZHEMED(TM)) pharmaceutical drug development program.

As at September 30, 2008, the Company had available cash, cash equivalents and marketable securities of $20,595,000, compared to $58,672,000 at December 31, 2007. The decrease is primarily due to funds used in operating activities.

Eprodisate (KIACTA™) for the Treatment of Amyloid A (AA) Amyloidosis

With respect to eprodisate (KIACTA(TM)), the Company submitted a proposed protocol for the second Phase III clinical trial for consideration by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). EMEA has agreed with the study design including the new primary endpoint focusing on renal events and excluding death. In addition both the FDA and the EMEA have recognized that this second clinical trial will be confirmatory; hence a p-value of less than 0.05, rather than the p-value of less than 0.01 for the previous Phase II/III trial, should be sufficient to gain approval of eprodisate (KIACTA(TM)) for the treatment of AA Amyloidosis,. A follow-up meeting with the FDA to finalize the study details should take place in the very near future.

Consolidated Financial Results Highlights

BELLUS Health Inc., formerly known as Neurochem Inc., (BELLUS Health or the Company) is a global health company focused on the development and commercialization of products to provide innovative health solutions to address critical unmet needs.

The shareholders of Neurochem Inc. approved the change of its name to "BELLUS Health Inc." at the annual and special shareholders' meeting on April 15, 2008. The new stock ticker symbols of the Company are BLUS (NASDAQ) and BLU (TSX).

The Management's Discussion and Analysis (MD&A) provides a review of the Company's operations, performance and financial position for the three- and nine-month periods ended September 30, 2008, compared with the three- and nine-month periods ended September 30, 2007. It should be read in conjunction with the Company's unaudited consolidated financial statements for the periods ended September 30, 2008, as well as the Company's audited consolidated financial statements for the year ended December 31, 2007, which have been prepared in accordance with Canadian Generally Accepted Accounting Principles (GAAP). For discussion regarding related-party transactions, contractual obligations, disclosure controls and procedures, internal control over financial reporting, critical accounting policies and estimates, recent accounting pronouncements, and risks and uncertainties, refer to the Annual Report and the Annual Information Form for the year ended December 31, 2007, as well as registration statements and other public filings, which are available on SEDAR at www.sedar.com or on EDGAR at www.sec.gov. This document contains forward-looking statements, which are qualified by reference to, and should be read together with the "Forward-Looking Statements" cautionary notice which can be found at the end of this MD&A. All currency figures reported in this document, including comparative figures, are reported in US dollars, unless otherwise specified. This MD&A was prepared by Management with information available as at November 10, 2008.

Results of Operations

For the three-month period ended September 30, 2008, the net loss amounted to $11,095,000 ($0.22 per share), compared to $13,889,000 ($0.29 per share) for the corresponding period the previous year. For the nine-month period ended September 30, 2008, the net loss amounted to $36,703,000 ($0.74 per share), compared to $65,389,000 ($1.54 per share) for the same period last year. The net loss for nine-month period ended September 30, 2007, included a non-cash accretion expense under Canadian GAAP of $10,430,000 relating to the $40 million 5% senior subordinated convertible notes issued in May 2007.

Net sales amounted to $153,000 for the current quarter and nine-month period and represent the initial sales of VIVIMIND(TM), the Company's first natural health brand launched in Canada and on the Internet on September 2, 2008. VIVIMIND(TM), to protect memory function, is based on the naturally occurring ingredient, homotaurine, found in certain seaweed. Targeted at healthy baby boomers, this patented natural health brand is expected to address a largely underserved self-care market by providing a scientific, evidence-based health solution. VIVIMIND(TM) is the direct result of over 15 years of significant scientific research, including clinical testing in over 2,000 individuals. Post-hoc analysis of the North American Phase III clinical trial of homotaurine (VIVIMIND(TM)) involving 1,052 Alzheimer's disease (AD) patients showed a positive impact on cognitive function and anatomically it helped to reduce the volume loss of an important area of the brain responsible for memory. VIVIMIND(TM) is commercialized by OVOS Natural Health Inc., a wholly owned subsidiary of BELLUS Health. The Company's strategy includes revenue generation in the short-to-medium-term through the sale of natural health products and in the medium-to-long-term through development of a pipeline of pharmaceutical products.

Revenue from collaboration agreement amounted to nil for the current quarter ($205,000 for the nine-month period), compared to $228,000 for the same period the previous year ($913,000 for the nine-month period). This revenue was earned under the agreement with Centocor, Inc. (Centocor) in respect of eprodisate (KIACTA(TM)), an oral investigational product candidate for the treatment of Amyloid A (AA) amyloidosis. During the first quarter of 2008, the Company announced its decision to continue the drug development program for eprodisate (KIACTA(TM)) and that it will initiate a second Phase III clinical trial for eprodisate (KIACTA(TM)) in close cooperation with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). The Company expects to file the Investigational New Drug application (IND) in the fourth quarter of 2008, with approximately 190 patients to be followed for a period of 24 months. As part of the decision, the Company withdrew its marketing applications for eprodisate (KIACTA(TM)) in the US, the European Union and Switzerland. On April 15, 2008, the Company announced that it had regained full ownership rights and control of eprodisate (KIACTA(TM)) from Centocor. During the second quarter of 2008, the refundable portion ($6,000,000) of the upfront payment received from Centocor in 2005 was refunded to Centocor.

Reimbursable costs revenue amounted to nil for the current quarter ($69,000 for the nine-month period), compared to $73,000 for the same period the previous year ($332,000 for the nine-month period), and, which for the current nine-month period and the comparative periods the previous year, consisted of costs reimbursable by Centocor in respect of eprodisate (KIACTA(TM))-related activities. As the Company regained full ownership of this program from Centocor, these costs are no longer reimbursable by Centocor.

Research and development expenses, before research tax credits and grants, amounted to $5,208,000 for the current quarter ($21,111,000 for the nine-month period), compared to $11,964,000 for the same period the previous year ($43,533,000 for the nine-month period). The decrease in the current periods compared to the same periods the previous year is mainly attributable to a reduction in expenses incurred in relation to the development of tramiprosate (ALZHEMED(TM); homotaurine) for the treatment of AD, following the Company's decision in November 2007 to terminate the tramiprosate (ALZHEMED(TM)) pharmaceutical drug development program.

The Company is also developing NC-503 (eprodisate) for the treatment of Type II diabetes and certain other features of metabolic syndrome. A Phase II clinical trial in diabetic patients was initiated in Canada and patient recruitment and randomization commenced during the second quarter of 2008. The study is a randomized 26-week, double-blind, placebo-controlled study. Interim results are anticipated in early 2009. Results from a validated rat model of diabetes and metabolic syndrome have demonstrated that NC-503 decreases glycemic levels in obese diabetic Zucker rats, when compared to the control group, while preserving 40% more pancreatic islet cells (insulin secreting cells) as compared to the control group, and showed some protective effect on renal function.

Research tax credits and grants amounted to $264,000 for the current quarter ($1,128,000 for the nine-month period), compared to $434,000 for the corresponding period the previous year ($1,434,000 for the nine-month period). Research tax credits represent refundable tax credits earned under the Quebec Scientific Research and Experimental Development Program for expenditures incurred in Quebec. The decrease is mainly attributable to lower research and development expenses incurred in Quebec during the current periods which are eligible for refundable tax credits.

General and administrative expenses totaled $2,987,000 for the current quarter ($8,513,000 for the nine-month period), compared to $2,559,000 for the same quarter the previous year ($9,184,000 for the nine-month period). The increase in the quarter is mainly due to expenses incurred in relation to the Company's natural health product activities.

Selling and marketing expenses amounted to $1,424,000 for the current quarter ($3,459,000 for the nine-month period) and represent expenses incurred in relation to the commercialization of the Company's natural health brand, VIVIMIND(TM), which was launched during the current quarter.

Reimbursable costs amounted to nil for the current quarter ($69,000 for the nine-month period), compared to $73,000 for the same period the previous year ($332,000 for the nine-month period), and, which for the current nine-month period and the comparative periods the previous year, consisted of costs incurred on behalf of Centocor in respect of eprodisate (KIACTA(TM))-related activities and reimbursable by Centocor. As the Company regained full ownership of this program from Centocor, these costs are no longer reimbursable by Centocor.

Stock-based compensation amounted to $439,000 for the current quarter ($2,298,000 for the nine-month period), compared to $998,000 for the corresponding quarter the previous year ($2,854,000 for the nine-month period). This expense relates to stock options and stock-based incentives, whereby compensation cost in relation to stock options is measured at fair value at the date of grant and is expensed over the award's vesting period. The decrease is mainly due to cancellation of stock options as well as adjustments in relation to forfeitures of stock options during the current quarter.

Interest income amounted to $145,000 for the current quarter ($856,000 for the nine-month period), compared to $1,021,000 for the same quarter the previous year ($2,585,000 for the nine-month period). The decrease is mainly attributable to lower average cash balances and lower interest rates during the current periods, compared to the same periods in the previous year.

Accretion expense amounted to $1,243,000 for the current quarter ($3,675,000 for the nine-month period), compared to $1,452,000 for the same quarter the previous year ($14,568,000 for the nine-month period). Accretion expense represents the imputed interest under GAAP on the $42,085,000 aggregate principal amount of 6% convertible senior notes issued in November 2006 (2006 Notes), as well as on the $40,000,000 6% senior convertible notes (Senior Notes) and $40,000,000 5% senior subordinated convertible notes (Junior Notes) issued in May 2007. The Company accretes the carrying values of the convertible notes to their face value through a charge to earnings over their expected life of 60 months, 54 months and 1 month, respectively. The decrease in the current nine-month period, compared to the same period the previous year is mainly due to accretion expenses of $10,430,000 recorded during the second quarter of 2007 on the Junior Notes, which were fully converted during that quarter. As of September 30, 2008, $42,085,000 of the 2006 Notes remains outstanding as well as $4,500,000 of the Senior Notes. Refer to the Liquidity and Capital Resources section for more details on the convertible notes.

Change in fair value of embedded derivatives amounted to a gain of $45,000 for the current quarter (gain of $145,000 for the nine-month period) compared to a gain of $972,000 for the same quarter the previous year (loss of $898,000 for the nine-month period) and represents the variation in the fair value of the embedded derivatives, including the embedded derivative related to the $80,000,000 aggregate principal amount of Senior and Junior Notes issued in May 2007.

Write-down of third party Asset-Backed Commercial Paper amounted to nil for the current quarter ($375,000 for the nine-month period) and represents an additional provision recorded on the valuation of asset-backed commercial paper held by the Company. See Liquidity and Capital Resources section for more details.

Foreign exchange loss amounted to $216,000 for the current quarter (gain of $644,000 for the nine-month period), compared to a gain of $565,000 for the same quarter the previous year (gain of $1,184,000 for the nine-month period). Foreign exchange gains or losses arise on the movement in foreign exchange rates in relation to the Company's net monetary assets denominated in currencies other than US dollars, which is its functional and reporting currency, and consists primarily of monetary assets and liabilities denominated in Canadian dollars. Foreign exchange gains for the current nine-month period include $924,000 of gain recognized on the reclassification, during the first quarter of 2008, from deferred revenue (non-monetary liability) to accrued liability (monetary liability) of the refundable amount ($6,000,000) due to Centocor, following the recovery by the Company of ownership rights and control of eprodisate (KIACTA(TM)).

Other income amounted to $276,000 for the current quarter ($810,000 for the nine-month period), compared to $270,000 for the same quarter the previous year ($987,000 for the nine-month period). Other income consists of non-operating revenue, primarily sub-lease revenue.

Liquidity and Capital Resources

As at September 30, 2008, the Company had available cash, cash equivalents and marketable securities of $20,595,000, compared to $58,672,000 at December 31, 2007. The decrease is primarily due to funds used in operating activities. The Company also has short-term bank indebtedness of $8,466,000, including $5,963,000 incurred in relation to the refund to Centocor. As previously discussed, during the second quarter of 2008, the Company refunded the refundable portion of the upfront payment received from Centocor in 2005. Since this obligation was secured by Asset-Backed Commercial Paper (ABCP), the market for which is currently being restructured as discussed later in this section, the Company entered into a credit facility, with the chartered bank that sold the Company the ABCP, in order to finance the repayment. Bank indebtedness bears interest at the bank's prime rate minus 1%. This bank indebtedness is expected to be refinanced by long term bank facilities upon the successful restructuring of the ABCP discussed below.

On July 17, 2008, the Company acquired 100% of the remainder of the outstanding capital stock that it did not already own of Innodia Inc. (Innodia), a private company engaged in developing compounds for the treatment of diabetes, obesity and related metabolic conditions and diseases. Prior to the acquisition, the Company indirectly held 23% of Innodia's capital stock. The Company acquired all of the business of Innodia including the intellectual property assets related to its diabetes and obesity projects and now holds the exclusive rights to BELLUS Health's diabetes platform and all related compounds. The purchase price, in the amount of $1,278,000, was settled by the issuance from treasury of 1,185,797 common shares. Additional consideration consisting of either treasury shares or, at the option of the Company, cash is conditionally payable on the first anniversary of the closing of the transaction, based upon the determination of the value of certain assets at that time.

On May 2, 2007, the Company issued $80,000,000 aggregate principal amount of convertible notes, consisting of $40,000,000 6% senior convertible notes due in 2027 and $40,000,000 5% senior subordinated convertible notes due in 2012. The 6% senior convertible notes have an initial conversion price equal to the lesser of $12.68 or the 5-day weighted average trading price of the common shares preceding any conversion, subject to adjustments in certain circumstances. The Company will pay interest on the 6% senior convertible notes until maturity on May 2, 2027, subject to earlier repurchase, redemption or conversion. The 5% senior subordinated convertible notes were subject to mandatory conversion into common shares under certain circumstances. In connection with this transaction, the Company issued warrants to purchase an aggregate of 2,250,645 common shares until May 2, 2012, at an initial purchase price of $12.68 per share, subject to adjustments in certain circumstances. During the year ended December 31, 2007, $35,500,000 of the 6% senior convertible notes were converted into 5,619,321 common shares and the totality of the 5% senior subordinated convertible notes were converted into 4,444,449 common shares.

On November 9, 2006, the Company issued $42,085,000 aggregate principal amount of 6% convertible senior notes (the 2006 Notes) due in 2026. The 2006 Notes are convertible into common shares based on an initial conversion rate of 50.7181 shares per $1,000 principal amount of 2006 Notes ($19.72 per share). The 2006 Notes are convertible, at the option of the holder under certain conditions. On October 15, 2009, the conversion rate of the 2006 Notes will be adjusted to an amount equal to a fraction whose numerator is $1,000 and whose denominator is the average of the closing sale prices of the common shares during the 20 trading days immediately preceding, and including, the third business day immediately preceding October 15, 2009. However, no such adjustment will be made if the adjustment will reduce the conversion rate. On and after November 15, 2009, the conversion rate will be readjusted back to the conversion rate that was in effect prior to October 15, 2009. On or after November 15, 2011, the Company may redeem the 2006 Notes, in whole or in part, at a redemption price in cash equal to 100% of the principal amount of the 2006 Notes, plus any accrued and unpaid interest. On November 15, 2011, 2016 and 2021, the holders of the 2006 Notes may require the Company to purchase all or a portion of their 2006 Notes at a purchase price in cash equal to 100% of the principal amount of the 2006 Notes to be purchased, plus any accrued and unpaid interest. The Company, at its discretion, may elect to settle the principal amount owing upon redemption or conversion in cash, shares or a combination thereof. As at September 30, 2008, the totality of the 2006 Notes remained outstanding. The terms of the 2006 Notes require the continued listing of the Company's shares on a recognized American Stock Exchange; failure to meet this requirement may be an event of default which may result in the convertible notes being immediately due and payable. (see subsequent event). For additional information, refer to the Annual report and Annual Information Form for the year ended December 31, 2007, as well as other publicly filed documents.

In August 2006, the Company entered into a securities purchase agreement in respect of an equity line of credit facility (ELOC) with Cityplatz Limited (Cityplatz) that provides the Company up to $60,000,000 of funds in return for the issuance of common shares. The ELOC facility was amended in February 2008 and the term was extended to February 2010. Under the amended ELOC facility, the maximum amount of each drawdown is limited to the lower of $6,000,000 or 12.5% of the volume-weighted price calculation of the common shares at the time of drawdown. The common shares will be issued at a discount of 4.0% to market price if the volume-weighted average price (VWAP) per share is $6 or higher and 7.0% if the VWAP per share is lower than $6 at the time of drawdown. A placement fee equal to 2.4% of gross proceeds will be payable to the placement agent. The ELOC shall terminate if (i) the Company's common shares are de-listed from NASDAQ unless the common shares are listed at such time on another trading market specified in the agreement and such de-listing is in connection with a subsequent listing on another trading market specified in the agreement (see subsequent event), (ii) the Company is subject to a change of control transaction or (iii) the Company suffers a material adverse effect which cannot be cured prior to the next drawdown notice. The Company may terminate the securities purchase agreement (i) if Cityplatz fails to fund a properly notified drawdown within five trading days of the end of the applicable settlement period or (ii) after it has drawn down at least $15,000,000 under the ELOC. As at September 30, 2008, the Company had not drawn any funds under the ELOC. As at September 30, 2008, $3,982,000 of funds were potentially eligible for drawdown.

As at September 30, 2008, the Company held $13,219,000 in principal value of third party ABCP, including $6,606,000 of third party ABCP acquired as part of the Innodia acquisition. These investments were due to mature in August 2007, but, as a result of a disruption in the credit markets, particularly in the ABCP market, they did not settle on maturity and currently remain outstanding. There are currently no market quotations available for these ABCP. On April 25, 2008, the restructuring plan announced by the Pan-Canadian Investors Committee (the Committee) in December 2007 was approved by the ABCP holders and is expected to be completed shortly, resulting in the conversion of the ABCP into longer term financial instruments. As at September 30, 2008, the Company estimated the fair value of these ABCP at approximately $9,716,000, of which $546,000 is presented as part of Restricted Cash, as it is pledged to a bank as collateral for letters of credit issued in connection with lease agreements. In connection with its fair value estimations, the Company recorded a write-down of $1,184,000 for the year ended December 31, 2007, and an additional write-down of $375,000 during the quarter ended March 31, 2008, to recognize impairment losses related to these investments. During the current quarter, no additional write-down was recorded; although there were certain changes in factors and assumptions, the net result did not affect the fair value estimation. The Company estimated the fair value of the ABCP using a probability weighted discounted cash flow approach, based on its best estimates of the period over which the assets are going to generate cash flows ranging from five to 28 years based on the proposed restructuring, the coupon interest rate, the discount rate to apply to the net cash flows anticipated to be received commensurate with the return on comparably rated notes in accordance with the risk factors of the different investments and other qualitative factors. This estimate of the fair value of the ABCP is not supported by observable market prices or rates, therefore is subject to uncertainty, including, but not limited to, the successful implementation of the restructuring plan being considered, the estimated amounts to be recovered, the yield of the substitute financial instruments and the timing of future cash flows. The resolution of these uncertainties could be such that the ultimate fair value of these investments may vary from the Company's current estimate. Changes in the near term could require changes in the recognized amount of these assets.

As at September 30, 2008, the Company's workforce comprised 103 employees compared to 172 employees as at September 30, 2007. During the current period, the Company reduced further its research activities and associated workforce to focus on its key projects.

As at October 31, 2008, the Company had 50,043,892 common shares outstanding, 220,000 common shares issuable to the Chief Executive Officer upon the achievement of specified performance targets, 4,552,856 options granted under the stock option plan, 2,884,471 shares currently issuable under the convertible notes, and 2,250,645 warrants outstanding, for a total of 59,951,864 common shares, on a fully diluted basis.

To date, the Company has financed its operations primarily through public offerings of common shares, private placements, issuance of convertible notes, as well as a sale-leaseback transaction, research tax credits, collaboration and research contracts, interest and other income. The future profitability of the Company is dependent upon such factors as the success of the clinical trials, the approval by regulatory authorities of products developed by the Company, the ability of the Company to successfully market, sell and distribute products, including its natural health products, and the ability of the Company to obtain the necessary financing to complete its projects.

The Company has incurred significant operating losses and negative cash outflows from operations since inception and has an accumulated deficit of $354,957,000. As at September 30, 2008, the Company's committed cash obligations and expected level of expenses for the upcoming twelve months exceed the committed sources of funds and the Company's cash and cash equivalents on hand. The Company received a NASDAQ Staff Deficiency Letter; failure to maintain a listing on a recognized American stock exchange may trigger a default on the convertible notes and the termination of the ELOC. The Company is actively considering various alternatives to secure additional financing. Picchio Pharma and its related parties have expressed their commitment to participate and to purchase at least 30% of the next financing. No definitive agreements with potential investors have been reached yet and there can be no assurance that such agreements will be reached. The ability of the Company to continue as a going concern is dependent upon raising additional financing through borrowings, share issuances, receiving funds through collaborative research contracts or product licensing agreements, and ultimately, from obtaining regulatory approval in various jurisdictions, to market and sell its product candidates and achieving future profitable operations. The outcome of these matters is dependent on a number of items outside of the Company's control. As a result, there is significant uncertainty as to whether the Company will have the ability to continue as a going concern beyond the first quarter of 2009.

The consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue its operations in the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the ordinary course of business. These financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should the Company not be successful in its effort to obtain additional financing or be able to remain listed on a recognized American exchange, to receive significant funds on signing collaborative research contracts or by outlicensing its products or making significant product sales.

Subsequent Events

The Company received a NASDAQ Staff Deficiency Letter dated October 10, 2008, stating that, for 10 consecutive trading days, the market value of the Company's listed securities has been below the minimum $50,000,000 requirement for continued inclusion on The NASDAQ's Global Market. The Company believes that the recent decline in its market value is due to the general pressure on equity markets worldwide. The Company has 30 calendar days, or until November 10, 2008, to regain compliance to which BELLUS Health will strive. If the market value of the Company's common stock is $50,000,000 or more for a minimum of 10 consecutive business days at any time prior to November 10, 2008, NASDAQ may determine that the Company has regained compliance with the applicable listing requirements. If compliance with the Rules cannot be demonstrated by November 10, 2008, NASDAQ will provide written notification that the Company's securities will be delisted, at which time the Company may appeal the determination to a Listing Qualifications Panel, requesting additional time to regain compliance. Pending this appeal, the common stock would continue to trade on NASDAQ. Among the alternatives the Company is considering, is the submission of a transfer application to transfer the Company's listed securities to The NASDAQ Capital Market Tier if it cannot regain compliance with the requirements of NASDAQ's Global Market Tier within the appeals period or any extended time granted by NASDAQ. There can be no assurance that NASDAQ will approve the Company's transfer application. The Company's common stock is also listed on the Toronto Stock Exchange (TSX) and such listing is not affected by the notice received from NASDAQ. The market value of the Company's common stock has not been $50,000,000 or more for a minimum of 10 consecutive business days during the period beginning on October 10 and ending on November 10, 2008. Accordingly, the Company anticipates that it will receive written notification from NASDAQ that its securities will be delisted from its Global Tier Market, and expects to file a notice of appeal in response.

Change in Functional and Reporting Currency

Effective July 1, 2007, the Company adopted the US dollar as its functional and reporting currency, as a significant portion of its revenues, expenses, assets, liabilities and financing are denominated in US dollars. Prior to that date, the Company's operations were measured in Canadian dollars and the consolidated financial statements were expressed in Canadian dollars. The Company followed the recommendations of the Emerging Issues Committee (EIC) of the Canadian Institute of Chartered Accountants (CICA), set out in EIC-130, "Translation method when the reporting currency differs from the measurement currency or there is a change in the reporting currency". In accordance with EIC-130, assets and liabilities as of June 30, 2007 were translated in US dollars using the exchange rate in effect on that date; revenues, expenses and cash flows were translated at the average rate in effect during the six-month period ended June 30, 2007 and equity transactions were translated at historical rates. Any exchange differences resulting from the translation were included in accumulated other comprehensive income presented in shareholders' equity. Financial statements presented after June 30, 2007, are measured and presented in US dollars.


ISTA PHARMACEUTICALS INCORPORATED (NASDAQ: ISTA)
"Up 19.44% in morning trading"

Detailed Quote: http://www.otcpicks.com/quotes/ISTA.php

ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA's products and product candidates addressing the $4.7 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share. The Company's product development and commercialization strategy is to launch a new product every 12 to 18 months, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S.

ISTA News:

October 30 - ISTA Pharmaceuticals Reports Third Quarter 2008 Financial Results

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), an ophthalmic pharmaceutical company, reported financial results for the third quarter ended September 30, 2008. ISTA reported net revenue for the three months ended September 30, 2008, of $21.7 million, a 36% increase over net revenue for the three months ended September 30, 2007. On a quarter-over-quarter basis, net revenue increased 22% over the second quarter of 2008.

"Our growth has moved ISTA up to the fifth largest branded ophthalmic pharmaceutical company position, surpassing Bausch & Lomb. Xibrom and Istalol are leading the way as the two fastest-growing ophthalmic products in the US, both outpacing the growth of their markets," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "During the third quarter, three of our longest-term shareholders provided us with a $65 million credit facility. This financing allowed us to repay our convertible debt, and it gives us the flexibility to continue to grow our business."

"We are making solid progress with our R&D pipeline. This quarter, we expect to report preliminary results from our Xibrom once-daily Phase III studies and, assuming positive results, we expect to file the supplemental NDA in early 2009. We are planning to file the Bepreve NDA before the end of this year. Assuming acceptance and timely review by the FDA, we anticipate receiving approval to market Bepreve in the second half of 2009. With regard to ecabet sodium, our candidate for the treatment of dry eye, we plan to report preliminary Phase II results this quarter. These results will provide the clinical validation we need before making the decision to initiate Phase III trials with ecabet sodium.

"Finally, we are noticing that the FDA is taking longer to review new study protocols and the number of cataract surgeries this fall is lower than anticipated, which may be linked to the economic slow down. We believe that both of these dynamics are lengthening the enrollment times in our studies. As such, we now expect results from our T-Pred studies in early 2009. With three late-stage products, we believe the upcoming months will be an exciting time for us."

Third Quarter Operating Details

Gross margin for the third quarter ended September 30, 2008 was 73%, or $15.9 million, as compared to 74%, or $11.7 million, for the same period in 2007. The change in gross margin as a percentage of revenue is due primarily to an increase in the royalty rate for Xibrom and other costs such as wholesaler distribution agreements. Inventories held by wholesale customers at September 30, 2008 remained relatively unchanged from June 30, 2008.

Research and development expenses were $7.8 million and $8.4 million in the third quarters of 2008 and 2007, respectively. The research and development expenses for the third quarter ended September 30, 2007 included $3.0 million in milestone expenses, of which $2.0 million was associated with an upfront payment paid to Mitsubishi Tanabe for the licensing of the nasal dosage form of bepotastine. The increase in research and development expenses for the third quarter of 2008, excluding the prior year quarter's milestone expenses of $3.0 million, was primarily the result of an increase in clinical development costs, which include clinical investigator fees, study monitoring costs and data management costs, due to the work performed on our key product candidates: Xibrom 0.09% once daily, Bepreve Phase III efficacy, Bepreve safety and T-Pred studies. Research and development expenses during the third quarter of 2008 included $0.2 million in stock-based compensation expense.

Selling, general, and administrative expenses for the third quarter ended September 30, 2008 were $13.2 million, as compared to $11.0 million for the same period in 2007. The $2.2 million increase in selling, general and administrative expenses in 2008 as compared to 2007 primarily results from higher sales and marketing expenses associated with the expansion of our sales force, which occurred in the first quarter of 2008 ($0.6 million), an overall increase in administrative costs, primarily related to legal expenses ($1.3 million) and an increase in our stock-based compensation expense ($0.3 million). Selling, general, and administrative expenses during the third quarter of 2008 include $0.8 million in stock-based compensation expense.

Interest expense for the third quarter ended September 30, 2008 was $2.4 million, as compared to $1.2 million for the same period in 2007. The increase of $1.2 million is primarily attributable to the write off of the unamortized deferred financing costs, the unamortized debt discount and the value of the embedded derivative associated with the senior subordinated convertible notes, which were paid in full as of the quarter ended September 30, 2008.

The net loss for the third quarter of 2008 was $7.4 million, or $0.22 per share, compared with a net loss of $8.2 million, or $0.25 per share, for the same period in 2007. At September 30, 2008, ISTA had cash and cash equivalents of $22.1 million, plus $4.3 million in long-term investments in auction rate securities.

Third Quarter 2008 and Subsequent Financing Information

ISTA entered into an agreement with long-term shareholders, Deerfield Management, Sprout Group and Sanderling Ventures to provide ISTA with up to $65 million in financing through a flexible credit facility at 6.5% interest.

ISTA drew $40 million from the September 2008 facility at closing, issued 12.5 million warrants at $1.41 and subsequently repaid its convertible notes due 2011 for par, or $40 million, plus accrued interest.

During October 2008, ISTA drew the remaining $25 million from the September 2008 credit facility and issued 2.5 million warrants at $1.41. ISTA made this draw in October to strengthen its cash position during this time of uncertainty in the credit and other financial markets.

2008 Financial Outlook

We continue to expect our full-year 2008 net revenue will be approximately $75 to $82 million.

We continue to expect our full-year 2008 gross margin will be approximately 70% to 73%, subject to change based on revenue mix.

Depending upon the progress of our clinical and pre-clinical programs, we continue to expect that our research and development expenses for the full year of 2008 will be approximately $34 to $38 million, including stock-based compensation expense, which we continue to estimate will be approximately $0.5 to $1 million.

We anticipate that our selling, general, and administrative expenses for the full-year 2008 will be approximately $50 to $54 million, including stock-based compensation expense, which we continue to estimate will be approximately $3.5 to $4.5 million. We have been tracking to the high end of our SG&A guidance due to increased legal expenses.

We anticipate that our 2008 interest expense will be approximately $6 to $7 million. Included in those costs is $3.5 to $4 million of interest expense on our debt agreements and $2.5 to $3 million of non-cash amortization costs related to our embedded derivative and debt discount on both our old convertible notes and our new credit facility.

We expect to end 2008 with a cash balance of $25 to $35 million, depending upon fluctuations in working capital.


ARYX THERAPEUTICS INCORPORATED (NASDAQ: ARYX)
"Up 22.27% in morning trading"

Detailed Quote: http://www.otcpicks.com/quotes/ARYX.php

ARYx Therapeutics is a biopharmaceutical company focused on developing a portfolio of internally discovered products designed to eliminate known safety issues associated with well-established, commercially successful drugs. ARYx uses its RetroMetabolic Drug Design technology to design structurally unique molecules that retain the efficacy of these original drugs but are metabolized through a potentially safer pathway to avoid specific adverse side effects associated with these compounds. ARYx currently has four products in clinical trials: an oral anticoagulant agent for patients at risk for the formation of dangerous blood clots, ATI-5923; an oral anti-arrhythmic agent for the treatment of atrial fibrillation, ATI-2042; a prokinetic agent for the treatment of various gastrointestinal disorders, ATI-7505; and, an agent for the treatment of schizophrenia and other psychiatric disorders, ATI-9242.

ARYX News:

November 12 - ARYx Reports Third Quarter 2008 Financial Results

As a Result of Recent Clinical, Strategic and Financial Progress ARYx Is Well Positioned to Achieve Its Corporate Milestones

ARYx Therapeutics, Inc. (Nasdaq: ARYX) reported results of operations and provided an update on its products for the third quarter ended September 30, 2008. An announcement of the completion of an agreement to raise $21.6 million in a private placement is contained in an accompanying press release.
“We continue to make significant progress towards our clinical, strategic and importantly, financial goals and, as a result, we believe ARYx is well positioned to achieve its corporate and product-related milestones. In fact, we are delighted to find ourselves progressing on multiple clinical programs while substantially strengthening our balance sheet,” said Dr. Paul Goddard, chairman and chief executive officer of ARYx. “Presently, we are in active discussions with a number of potential partners related to our leading product candidates, the novel, oral anticoagulant, ATI-5923, and the novel oral anti-arrhythmic agent, ATI-2042. The announced private placement financing gives us increased leverage as we consider potential partnerships so that we can secure the right collaboration partner for these valuable assets.”

Company Highlights

ARYx entered into a definitive agreement to raise $21.6 million in a private placement of approximately 9,649,545 shares of common stock from a group of existing and new top-tier investors. Proceeds from this financing will be used to strengthen ARYx’s balance sheet and provide the necessary capital to execute on its planned clinical programs while enhancing ARYx’s strategic negotiating position with potential collaboration partners.

ARYx completed patient enrollment in the ongoing Phase 2/3 clinical trial of ATI-5923 against the leading anticoagulant agent, warfarin. Based on recent interactions with the FDA, ARYx believes that this Phase 2/3 trial could be positioned as one of the pivotal trials needed for registration. ARYx expects data from this trial to be available by the end of the first half of 2009 as previously forecast and is currently in active discussions with companies interested in potentially partnering on ATI-5923.

ARYx completed enrollment in a Phase 2 clinical trial studying ATI-2042 for the treatment of patients with atrial fibrillation. ARYx is confident it will be able to report top-line data from this trial by the end of this year, as previously forecast and is currently in active discussions with companies interested in potentially partnering on ATI-2042.

ARYx is finalizing its submission to the FDA of the results for a Thorough QT (TQT) study of its oral prokinetic agent, ATI-7505. ARYx will use these results, along with the existing positive clinical and preclinical data, to seek a collaboration partner to continue development of ATI-7505.
Results of Operations

For the third quarter of 2008, ARYx reported net income of $3.2 million, or $0.17 diluted net income per share, compared to a net loss of $7.3 million, or $6.30 net loss per share, in the third quarter of 2007.

Revenues for the third quarter of 2008 were $17.5 million compared to $1.0 million in the same period of 2007. This one-time increase in revenue and net income was primarily due to the recognition of the remaining unrecognized nonrefundable upfront license fee received from Procter & Gamble Pharmaceuticals, Inc. (P&G) as a result of P&G’s termination during the quarter of the collaboration agreement covering our prokinetic agent, ATI-7505.

Research and development expenses for the third quarter of 2008 were $11.8 million compared to $6.6 million in the same period of 2007. The increase in expense is primarily due to costs associated with the ongoing Phase 2/3 clinical trial for ATI-5923 and the ongoing Phase 2 clinical study of ATI-2042.

General and administrative expenses for the third quarter of 2008 were $2.4 million compared to $1.9 million for the third quarter of 2007. The increase in expense is primarily due to higher personnel and related expenses, and other administrative costs associated with enabling ARYx to function as a public company, including efforts towards compliance with the requirements of the Sarbanes-Oxley Act.

As of September 30, 2008, ARYx had cash, cash equivalents and marketable securities totaling approximately $33.8 million. We believe that with the completion of the private placement announced today, the company will have sufficient funds to finance operations through the first quarter of 2010 even in the absence of the completion of any corporate alliances for its programs.

Conference Call and Webcast Information

ARYx will host a conference call and simultaneous Webcast on Wednesday, November 12, 2008 at 8:00 a.m. Pacific Time to review the results for third quarter of 2008 and to provide a general business update on the company. The Webcast will be available live via the Internet by accessing the ARYx Website at www.aryx.com. Alternatively, the call can be accessed by dialing 877-604-9674. Participants outside of the U.S. should dial 719-325-4916. The passcode for the call is 1256451.

Replays of the call will be available until December 15, 2008 at ARYx's Website.


GENVEC INCORPORATED (NASDAQ: GNVC)
"Up 7.19% in morning trading"

Detailed Quote: http://www.otcpicks.com/quotes/GNVC.php

GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec’s lead product candidate, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer and is being evaluated in additional clinical trials in other tumor types. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including foot-and-mouth disease, malaria, HIV, respiratory syncytial virus (RSV), HSV-2, and influenza.

GNVC News:

November 10 - TNFerade™ Receives FDA Fast Track Designation for Treatment of Pancreatic Cancer

Designation Represents a Significant Regulatory Achievement for TNFerade™

GenVec, Inc. (Nasdaq: GNVC) announced that TNFerade™ has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. The designation is based on GenVec having “provided evidence of the potential to improve survival in patients with pancreatic cancer.”

Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast track designation does not apply to a product alone but to a combination of a product and specific indication. This designation provides for expedited regulatory review. Should events warrant, GenVec will be eligible to submit a U.S. biologics license application (BLA) for TNFerade on a rolling basis. Under certain conditions, this permits the FDA to review sections of the BLA prior to receiving the complete submission.

“This Fast Track designation is an important step in the increasing focus on the clinical potential of TNFerade as a treatment for locally advanced pancreatic cancer,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. “As further data emerge regarding TNFerade, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade.”

ABOUT TNFERADE™

TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFα), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.

 
< Prev   Next >
Clicky Web Analytics