Champion Industries Stock (OTC:CHMP), Trade Ideas

CHAMPION INDS INC

Champion Industries Inc is a commercial printer, business form manufacturer, and supplier of office products and office furniture. The company operates principally in two industry segments organized on the basis of product lines: Printing segment and Office Products and Furniture segment. The Printing segment comprises the production, printing and sale, printed materials including brochures, pamphlets, reports, tags, continuous and other forms principally to commercial customers. The Office Product and Furniture segment are engaged in the sale of office products and office furniture including interior design services. Printing segment is the major revenue contributor to the company.

News

CHMP

Abbott Receives Positive Opinion for HUMIRA in Ulcerative Colitis from EMA&#39;s CHMP

AMLN

CHMP Recommends Approval of BYETTA for Use With Basal Insulin

ALXA

Alexza Pharmaceuticals Receives Day 80 Assessment Report for ADASUVE MAA  

CHAMPION INDUSTRIES INC by Champion Industries, Inc.

Champion Industries Inc

Champion Industries /WV (NASD: CHMP) reports third-quarter EPS of $-0.10.

Earnings

Champion Industries /WV Reports Q3 EPS $-0.10

Abbott (NYSE: <a class="ticker" href="/stock/abt#NYSE">ABT</a>) today announced that the European Committee for Medicinal
Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) has issued a positive opinion for HUMIRA
(adalimumab) in adults with moderate to severely active ulcerative colitis
(UC) who have not responded to, cannot tolerate or have medical
contraindications to conventional therapies. Based on the CHMP's positive
opinion, a final decision from the European Commission is anticipated in the
next few weeks. Upon final decision, HUMIRA will be the first and only
self-injectable biologic therapy available for moderate to severe UC patients.

Abbott Receives Positive Opinion for HUMIRA in Ulcerative Colitis from EMA's CHMP

Amylin
Pharmaceuticals, Inc. (Nasdaq: <a class="ticker" href="/stock/amln#Nasdaq">AMLN</a>) and Eli Lilly and Company (NYSE: <a class="ticker" href="/stock/lly#NYSE">LLY</a>)
today announced that the Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>)
of the European Medicines Agency (<a class="ticker" href="/stock/ema#">EMA</a>) has issued a positive opinion in the
European Union (<a class="ticker" href="/stock/eu#">EU</a>) for the expanded use of BYETTA® (exenatide twice-daily) as
an add-on therapy to basal insulin, with or without metformin and/or Actos®
(pioglitazone), for the treatment of type 2 diabetes in adults who have not
achieved adequate glycemic control with these agents. The CHMP's decision is
now referred for final action to the European Commission, which has the
authority to approve medicines for the EU. The Commission usually decides on
CHMP recommendations within two to three months.

Alexza Pharmaceuticals, Inc. (Nasdaq: <a class="ticker" href="/stock/alxa#Nasdaq">ALXA</a>) announced today that it has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency regarding its Marketing Authorization Application for Adasuve™ (Staccato® loxapine). The ADASUVE MAA seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder. 

The Day 80 Assessment Report for ADASUVE outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary safety in patients with active airways disease and recommendations to address this issue via the risk management plan, other aspects of the risk management plan, and the need to obtain an EU GMP certificate for the Alexza manufacturing facility and commercial manufacturing process. The next official EMA communication Alexza expects to receive will be the Day 120 notification and report, where the CHMP finalizes the list of review questions, the overall conclusions of scientific data and a listing of outstanding issues.

The ADASUVE MAA was filed using the Centralized Procedure. The Day 80 assessment report provides initial questions drafted by the Rapporteur and Co-Rapporteur, and is prepared for distribution to the EMA's Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) members. The EMA provides this assessment report to the applicant for information only, as it contains preliminary conclusions and does not represent the position of the CHMP nor does it bind the CHMP in any way.

Allos Therapeutics, Inc. (NASDAQ: <a class="ticker" href="/stock/alth#NASDAQ">ALTH</a>) today announced that it has submitted
a request to the European Medicines Agency (<a class="ticker" href="/stock/ema#">EMA</a>) for a re-examination of the
negative opinion issued in January by the EMA's Committee For Medicinal
Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) for conditional approval of FOLOTYN^ for the treatment of patients with peripheral T-cell
lymphoma whose disease has progressed after at least one prior systemic
therapy. PTCL comprises a biologically diverse group of aggressive, rare blood
cancers that have a worse prognosis than most other types of lymphoma,
including B-cell lymphoma. According to current CHMP guidelines, a final
opinion on the re-examination could be issued by the EMA within four to five
months.

ALTH

Allos Therapeutics Requests Re-Examination of CHMP Opinion on FOLOTYN in PTCL at the European Medicines Agency

Champion Reports Q3 EPS $0.09 vs ($0.07) Prior; Revenue $32M vs 33.17M Est

Piper Jaffray is upgrading shares of Acorda Therapeutics (NASDAQ: <a class="ticker" href="/stock/acor#NASDAQ">ACOR</a>) to Neutral from Underweight, and it has a $30 price target on shares.

In a note to investors, Piper Jaffray writes, "With the European Medicine Agency's (EMEA) Committee for Medicinal Products
for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) reversing itself, now recommending conditional marketing authorization for Fampyra (the ex-U.S. trade name for Ampyra), we are upgrading Acorda to a Neutral from Underweight. The reversal was a surprise to us given that
the CHMP initially cited a "small effect on walking speed" as a basis for its rejection. We are expecting approval in 3Q11, and with the inclusion of royalties from partner Biogen Idec, we are raising our price target to $30 from $21. That said, we remain cautious regarding the U.S. sales trajectory for Ampyra, and would expect similar dynamics in the EU."

Shares of ACOR gained $3.67 on Friday to close at $30.38, a gain of almost 14%.

Analyst Color

Price Target

Analyst Ratings

ACOR

UPDATE: Piper Jaffray Upgrading Acorda Therapeutics  

Cloud Computing Deal with Verizon and Terremark Creates Top Trader for Investors
POINT ROBERTS, Wash., January 28th 2011 - <a href="http://www.InvestorIdeas.com" title="www.InvestorIdeas.com">www.InvestorIdeas.com</a>, a global investor research portal for independent investors, reports on late morning trading on the NASDAQ.com. 
The top gainers include: (NASDAQ: <a class="ticker" href="/stock/chmp#NASDAQ">CHMP</a>), (NASDAQ: <a class="ticker" href="/stock/tmrk#NASDAQ">TMRK</a>), (NASDAQ: <a class="ticker" href="/stock/aray#NASDAQ">ARAY</a>), (NASDAQ: <a class="ticker" href="/stock/oplk#NASDAQ">OPLK</a>). 
Trading Close-Up 
Company Last Sale* Change Net / %
(NASDAQ: <a class="ticker" href="/stock/chmp#NASDAQ">CHMP</a>) Champion Industries, Inc. trading at $ 2.12 0.77, up 57.04%
(NASDAQ: <a class="ticker" href="/stock/tmrk#NASDAQ">TMRK</a>) Terremark Worldwide, Inc. trading at $ 18.96 4.91 34.95%
(NASDAQ: <a class="ticker" href="/stock/aray#NASDAQ">ARAY</a>) Accuray Incorporated trading at $ 8.431 1.57 22.90%
(NASDAQ: <a class="ticker" href="/stock/oplk#NASDAQ">OPLK</a>) Oplink Communications, Inc. trading at $ 23.45, trading up 4.13 21.38%
Market Snapshot (at time of release)
Dow 11,847.51 -142.32 -1.19% 
Nasdaq 2,692.78 -62.50 -2.27% 
S&amp;P 500 1,280.92 -18.62 -1.43% 
10 Yr Bond (%) 3.3330% -0.0520 
Oil 89.42 +3.78 +4.41% 
Gold 1,341.90 +23.50 +1.78%
Company Snapshot: Cloud Computing Stocks
Terremark Worldwide (Nasdaq: <a class="ticker" href="/stock/tmrk#Nasdaq">TMRK</a>) is a leading global provider of IT infrastructure services 
delivered on the industry's most robust and advanced technology platform. Leveraging data 
centers in the United States, Europe and Latin America with access to massive and diverse 
network connectivity, Terremark delivers government and enterprise customers a comprehensive 
suite of managed solutions including managed hosting, colocation, disaster recovery, security, 
data storage and cloud computing services. Terremark's Enterprise Cloud computing architecture 
delivers the agility, scale and economic benefits of cloud computing to mission-critical enterprise 
and Web 2.0 applications and its DigitalOps(R) service platform combines end-to-end systems 
management workflow with a comprehensive customer portal. More information about Terremark 
Worldwide can be found at <a href="http://www.Terremark.com" title="www.Terremark.com">www.Terremark.com</a>.
Recent news: Cloud Computing Stocks; Verizon to Acquire Terremark, Boosting Cloud Strategy 
through Powerful Unified Enterprise IT Delivery Platform 
Acquisition Will Accelerate 'Everything as-a-Service' Strategy by Leveraging the Companies' 
Collective Strengths 
Wholly Owned Subsidiary to Retain Terremark Name, Extend Leadership in Rapidly Evolving 
Global Cloud Services Market
NEW YORK and MIAMI, Jan. 27, 2011 ( <a href="http://www.investorideas.comnewswire" title="www.investorideas.comnewswire">www.investorideas.comnewswire</a> ) In a move that will 
decisively reshape the rapidly evolving global business technology solutions market, Verizon 
Communications Inc. (NYSE, Nasdaq: <a class="ticker" href="/stock/vz#NYSE, Nasdaq">VZ</a>) and Terremark Worldwide Inc. (Nasdaq: <a class="ticker" href="/stock/tmrk#Nasdaq">TMRK</a>) today
announced a definitive agreement under which Verizon will acquire Terremark, a global provider 
of managed IT infrastructure and cloud services, for $19.00 per share in cash, or a total equity 
value of $1.4 billion.
Pursuant to the agreement, Verizon anticipates that it will commence a tender offer between 
Feb. 10, 2011, and Feb. 17, 2011, for all shares of common stock of Terremark. The tender offer 
price constitutes a premium of 35 percent per share over today's closing price. The transaction 
is subject to the valid tender of a majority of the shares of Terremark; the expiration or early 
termination of the Hart-Scott-Rodino antitrust waiting period; and other customary closing 
conditions. The Board of Directors of Terremark has unanimously approved the transaction, 
and the transaction was unanimously approved by the directors of Verizon present and voting. 
Verizon has also entered into agreements with three stockholders of Terremark to tender their 
shares into the offer, representing approximately 27.6 percent of the outstanding voting shares of 
Terremark. Verizon expects to close the tender offer late in the first quarter of 2011.
This transaction will accelerate Verizon's "everything-as-a-service" cloud strategy by delivering 
a powerful portfolio of highly secure, scalable on-demand solutions to business and government 
customers globally through a unified enterprise IT platform and unique business cloud offerings 
that leverage the companies' collective strengths.
Verizon plans to operate the new unit as a wholly owned subsidiary retaining the Terremark name 
and with Terremark's current management team continuing to manage the company.
"Cloud computing continues to fundamentally alter the way enterprises procure, deploy and 
manage IT resources, and this combination helps create a tipping point for 'everything-as-a- 
service,'" said Lowell McAdam, president and chief operating officer of Verizon. "Our collective 
vision will foster innovation, enhance business processes and dynamically deliver business 
intelligence and collaboration services to anyone, anywhere and on any device."
Research more cloud computing stocks at Investorideas.com and its tech 
sector portal <a href="http://www.investorideas.com/TSS/stock_list.asp#Cloud" title="http://www.investorideas.com/TSS/stock_list.asp#Cloud">http://www.investorideas.com/TSS/stock_list.asp#Cloud</a>
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Markets

Trading Ideas

ARAY

OPLK

TMRK

Cloud Computing Deal with Verizon and Terremark Creates Top Trader for Investors

Novartis (<a href="http://www.zacks.com/stock/quote/NVS">NVS</a>) reported earnings per share of $1.14 for the fourth quarter of 2010, much below the Zacks Consensus Estimate of $1.21 and the year-earlier earnings of $1.26 per share. The substantial drop from the base period was due to robust profits booked in 2009 from windfall sales of H1N1 flu vaccines, not repeated in the current year. High spending in the quarter also affected the earnings performance.

	Fourth quarter revenues were up 10% from the prior-year quarter to $14.2 billion. Total revenues edged past the Zacks Consensus Estimate of $14.1 billion. Strong growth in the Pharmaceuticals and Sandoz divisions were offset by disappointing performance in the Vaccines and Diagnostic and Consumer Healthcare divisions.

	For full year 2010, Novartis reported earnings per share of $5.15, up 14% from the year-ago figure of $4.50 owing to revenue growth. The full year 2010 earnings per share were also above the Zacks Consensus Estimate of $5.11. Full year 2010 revenues increased 14% over the prior year to $50.6 billion driven by strong growth across all business units of the Switzerland-based pharma giant. 2010 revenues were, however, a tad below the Zacks Consensus Sales Estimate of $50.7 million.

	The Quarter That Was

	The performance of each of the four segments is discussed below.

	Pharmaceutical division sales were up 3% to $8 billion in the quarter. Growth from volume expansion and new product launches (accounting for 23% of pharmaceutical sales) was offset by slight price erosion. All the franchises performed well in the quarter.

	Oncology sales growth of 9% was led by some established products like Gleevec (up 5% to $1.1 billion), Sandostatin (up 11% to $351 million) and Femara (up 3% to $351 million) as well as new products like Tasigna (up 85% to $126 million), Afinitor (up 150% to $80 million) and Exjade (up 14% to $209 million).

	Galvus (up 88% to $124 million) led the 4% growth in the Cardiovascular and Metabolism franchise. The Neuroscience and Ophthalmics franchise experienced a 3% increase led by Lucentis (up 5% to $394 million) and Extavia (up 74% to $40 million). The franchise also benefited from a solid start to multiple sclerosis drug, Gilenya, which has been launched in the US. Novartis has received positive opinion from the Committee of Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) for approval of Gilenya in the EU. Gilenya has also been approved in Switzerland and Australia.

	Sandoz division sales were up 10% to $2.4 billion, benefiting from new product launches like gemcitabine (generic Gemzar), continued exclusivity of enoxaparin (generic Lovenox) and strong biosimilars growth.

	The Vaccines and Diagnostics division, recording a sales decline of 74% to $361 million, pulled down overall revenues, thereby affecting earnings. Depressed sales of H1N1 pandemic flu vaccine in the quarter (due to the waning of the swine flu disease) as well as shipment delays (due to production issues at a vaccines plant) perpetrated the fall.

	Consumer Health division sales were flat over the prior year at $1.6 billion. We note that the fourth quarter of 2009 reflected the impact of the over-the-counter (OTC) launch of Prevacid24 HR.

	2011 Guidance

	In 2011, Novartis expects double-digit constant currency growth for overall revenues with Pharmaceuticals growing in the low-to-mid single-digit range and Sandoz growing in the mid-single-digit range. Growth in both the divisions is expected to be driven by new product launches, expansion of existing products and also in emerging markets, slightly offset by pricing pressure and generic competition.

	Novartis also aims to increase its operating margins in 2011, despite the pricing pressure, generic competition and decline in H1N1 pandemic flu sales.

	Pipeline Update

	In 2010, Novartis gained 13 product approvals and filed regulatory applications for 16 pipeline drugs. Important product approvals/label expansions in the fourth quarter include Tasigna in first-line chronic myeloid leukemia (in EU and Japan), Lucentis in diabetic macular edema (in EU), and Afinitor in subependymal giant cell astrocytomas associated with tuberous sclerosis (in the US).

	Important regulatory filings in the quarter were for ACZ885 (Ilaris) in gouty arthritis (in EU), Lucentis in retinal vein occlusion (in EU), SOM230 in Cushing's disease (in EU), Afinitor in advanced neuroendocrine tumors (in EU and US) and meningococcal B vaccine, Bexsero (in EU).

	Novartis presented Ilaris data from two phase III trials for the treatment of gouty arthritis, in the quarter which showed the drug met its primary endpoint. Based on this data, the company filed for approval in Europe in December with the US filing expected in the first quarter of 2011.

	Novartis announced that it will not develop QMF149 in either the chronic obstructive pulmonary disease (COPD) or asthma indications for the US market and will only initiate EU filing for asthma and ex-US filing for COPD in 2014.

	Our Recommendation

	Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank. We are impressed by Novartis' wide range of products and its efforts to diversify further as is evident by the recent acquisition of a majority stake in Alcon (<a href="http://www.zacks.com/stock/quote/ACL">ACL</a>). Novartis is looking to acquire the remaining stake in the eye-care company by the first half of 2011.  However, weighing in the risks, we prefer to remain on the sidelines due to the imminent patent cliff faced by Novartis as a number of Novartis drugs are about to come up against generic competition between 2011 and 2015.
   <a href="http://www.zacks.com/registration/pfp?ALERT=ZER_LINK&amp;d_alert=ZER_LINK&amp;t=ACL&amp;ADID=BENZ_CONTENT_ZER">ALCON INC (<a class="ticker" href="/stock/acl#">ACL</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/registration/pfp?ALERT=ZR_LINK&amp;d_alert=rd_final_rank&amp;t=NVS&amp;ADID=BENZ_CONTENT_ZRANK">NOVARTIS AG-ADR (<a class="ticker" href="/stock/nvs#">NVS</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/">Zacks Investment Research</a>

Vaccines Pull Down NVS Q4 Earnings  - Analyst Blog

Novartis (<a href="http://www.zacks.com/stock/quote/NVS">NVS</a>) recently announced that it has entered into a definitive agreement to acquire California based diagnostic laboratory, Genoptix Inc. (<a href="http://www.zacks.com/stock/quote/GXDX">GXDX</a>), for a cash consideration of $470 million. Genoptix is a specialist in providing personalized diagnostic services to community-based hematologists and oncologists.

	Genoptix specializes in the diagnosis of cancers in bone marrow, blood and lymph nodes. The acquisition will be a good strategic fit for Novartis' Molecular Diagnostics business, in particular the companion diagnostic programs, especially oncology.

	Novartis has offered to pay $25 per share for all outstanding shares of common stock of Genoptix, representing a total equity value to $470 million and an enterprise value of $330 million.

	The offer price represents a premium of 27% over Genoptix' closing price of $19.76 on January 21, 2011. The board of directors of Genoptix has approved the deal and will recommend shareholders to accept the $25 per share offer. The transaction is expected to close in the first half of 2011.

	Genoptix generated sales of $184 million in 2009.

	Novartis also recently announced that it gained approval in Switzerland and Australia for Gilenya for the first-line treatment of relapsing-remitting multiple sclerosis (RRMS) patients.

	Gilenya was also recommended for approval in the European Union by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) for the treatment of patients with highly active RRMS despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS. Gilenya is already marketed for the first-line treatment of relapsing forms of multiple sclerosis in the US.

	Our Recommendation

	Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank. We are pleased with Novartis' wide range of products and its efforts to diversify further as is evident by the recent acquisition of a majority stake in Alcon (<a href="http://www.zacks.com/stock/quote/ACL">ACL</a>).

	Novartis is looking to acquire the remaining stake in the eye-care company.  However, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company as a number of Novartis' drugs will face generic competition between 2011 and 2015.
   <a href="http://www.zacks.com/registration/pfp?ALERT=ZER_LINK&amp;d_alert=ZER_LINK&amp;t=ACL&amp;ADID=BENZ_CONTENT_ZER">ALCON INC (<a class="ticker" href="/stock/acl#">ACL</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/registration/pfp?ALERT=ZR_LINK&amp;d_alert=rd_final_rank&amp;t=GXDX&amp;ADID=BENZ_CONTENT_ZRANK">GENOPTIX INC (<a class="ticker" href="/stock/gxdx#">GXDX</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/registration/pfp?ALERT=ZR_LINK&amp;d_alert=rd_final_rank&amp;t=NVS&amp;ADID=BENZ_CONTENT_ZRANK">NOVARTIS AG-ADR (<a class="ticker" href="/stock/nvs#">NVS</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/">Zacks Investment Research</a>

GXDX

Novartis to Buy Genoptix - Analyst Blog

Merck KGaA (<a href="http://www.zacks.com/stock/quote/MKGAF">MKGAF</a>) recently said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) upheld its negative recommendation related to the approval of cladribine for the treatment of relapsing-remitting multiple sclerosis (<a class="ticker" href="/stock/ms#">MS</a>).

	In September last year, the CHMP had first recommended against the approval of cladribine for the treatment of relapsing-remitting MS on its belief that the benefits reaped by MS patients from the drug do not outweigh the risks that come with it. Thereafter, Merck KGaA requested the EMA, in October 2010, for a re-examination of the adverse recommendation issued by the CHMP.

	The CHMP's negative opinion came as a shock for Merck KGaA given the fact that cladribine is approved in Australia and Russia for the treatment of relapsing-remitting MS. The drug is marketed as Movectro in these countries.

	Moreover, the US Food and Drug Administration (FDA) extended the review period of cladribine by three months in November 2010. The prescription drug user free act date, which was earlier set for November 28, 2010, has now been postponed to February 28, 2011. The regulatory body said that it needs more time to fully review the additional information provided by Merck KGaA on cladribine.

	Our Take

	We currently have a Zacks #3 Rank (short-term Hold rating) on Merck KGaA. Though we view the negative stand from the CHMP as a major setback for the company, we believe that Merck KGaA's continuous investment in R&amp;D, marketing and new product launches should help sustain earnings growth for the next few years.

	Meanwhile, we note that the MS market is highly competitive given the presence of players like Teva Pharmaceuticals Industries Ltd. (<a href="http://www.zacks.com/stock/quote/TEVA">TEVA</a>), Biogen Idec Inc. (<a href="http://www.zacks.com/stock/quote/BIIB">BIIB</a>) and Elan Corp. (<a href="http://www.zacks.com/stock/quote/ELN">ELN</a>).
   <a href="http://www.zacks.com/registration/pfp?ALERT=ZER_LINK&amp;d_alert=ZER_LINK&amp;t=BIIB&amp;ADID=BENZ_CONTENT_ZER">BIOGEN IDEC INC (<a class="ticker" href="/stock/biib#">BIIB</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/registration/pfp?ALERT=ZR_LINK&amp;d_alert=rd_final_rank&amp;t=ELN&amp;ADID=BENZ_CONTENT_ZRANK">ELAN CP PLC ADR (<a class="ticker" href="/stock/eln#">ELN</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/registration/pfp?ALERT=ZER_LINK&amp;d_alert=ZER_LINK&amp;t=TEVA&amp;ADID=BENZ_CONTENT_ZER">TEVA PHARM ADR (<a class="ticker" href="/stock/teva#">TEVA</a>): Free Stock Analysis Report</a>   <a href="http://www.zacks.com/">Zacks Investment Research</a>

BIIB

TEVA

CHMP Stands Negative on MKGAF Drug - Analyst Blog

MKGAF

Valeant Pharmaceuticals International (<a href="http://www.zacks.com/stock/quote/VRX">VRX</a>) and GlaxoSmithKline plc (<a href="http://www.zacks.com/stock/quote/GSK">GSK</a>) recently said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) recommended the approval of epilepsy drug, retigabine.

	The companies had submitted the Marketing Authorization Application (<a class="ticker" href="/stock/maa#">MAA</a>) for retigabine to the EMA in November 2009. The companies are looking to get retigabine approved as an adjunctive treatment for adults suffering from partial-onset seizures.

	Retigabine is referred to as ezogabine in the US and will be marketed under the brand name Trobalt in the European Union (<a class="ticker" href="/stock/eu#">EU</a>). The candidate is being developed under a worldwide license and collaboration agreement between Glaxo and Valeant.

	US Status of Ezogabine

	The positive recommendation from the CHMP comes as a boost for the companies, particularly in the wake of a complete response letter (<a class="ticker" href="/stock/crl#">CRL</a>) from the US Food and Drug Administration (FDA), received in December last year, for the new drug application (NDA) of ezogabine.

	The CRL was for non-clinical reasons and Valeant and Glaxo plan to file a response to the FDA in 2011.

	We note that earlier, in August 2010, Glaxo and Valeant had received a positive recommendation from an FDA advisory panel regarding ezogabine. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee had reviewed the safety and efficacy of the drug and voted unanimously in favor of ezogabine's efficacy for the treatment of partial-onset seizures in adults where other treatments failed. However, later during the month, the FDA extended the review date for the candidate by three months.

	Competition

	Currently available epilepsy treatments include drugs like Pfizer Inc.'s (<a href="http://www.zacks.com/stock/quote/PFE">PFE</a>) Neurontin and Lyrica, Glaxo's Lamictal, UCB Pharma's (<a href="http://www.zacks.com/stock/quote/UCBJF">UCBJF</a>) Keppra and Johnson &amp; Johnson's (<a href="http://www.zacks.com/stock/quote/JNJ">JNJ</a>) Topamax. We believe that ezogabine, once approved, should be able to carve a niche for itself due to its differentiated mechanism of action.

	Our Recommendation

	We expect investor attention to be focused on the US and EU approvability status of ezogabine/retigabine.

	We have Neutral recommendations for both Valeant and Glaxo.
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Boost for VRX-GSK Epilepsy Drug - Analyst Blog

UCBJF

Biogen Idec (<a href="http://www.zacks.com/stock/quote/BIIB">BIIB</a>) recently faced a pipeline setback with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) recommending against the approval of oral drug Fampyra (US trade name: Ampyra), aimed at improving walking speed in patients suffering from multiple sclerosis (<a class="ticker" href="/stock/ms#">MS</a>).

	Biogen plans to file a request for re-examination of the decision taken by the CHMP. We note that though the EMA is not bound to follow the CHMP's recommendation, it usually does so.

	Ampyra has been developed by Acorda Therapeutics Inc. (<a href="http://www.zacks.com/stock/quote/ACOR">ACOR</a>), which has a licensing agreement with Biogen for the development and commercialization of the drug outside the US. Further, Acorda has a supply agreement with Elan Corporation (<a href="http://www.zacks.com/stock/quote/ELN">ELN</a>) for manufacturing Ampyra.

	Acorda received the US Food and Drug Administration's (FDA) approval, in late January 2010, for the marketing of Ampyra in the US for improving walking speed in patients suffering from MS.

	The European Union (<a class="ticker" href="/stock/eu#">EU</a>) does not have any approved drug for facilitating walking in patients suffering from MS. Fampyra, if approved in the EU, would therefore be able to establish itself in the market.

	Ampyra is an extended release tablet formulation of dalfampridine. The drug enjoys orphan drug designation in the US, thereby providing it with seven years of market exclusivity.

	Ampyra was found to be effective in patients with all four major MS types (relapsing remitting, secondary progressive, progressive relapsing and primary progressive). The drug can either be used alone or with existing treatments of MS, including immunomodulator drugs.

	However, the FDA stated that Ampyra can cause seizures if patients take higher-than-recommended doses, and is best avoided by those suffering from moderate to severe kidney disease.

	The MS market has big players like Pfizer Inc. (<a href="http://www.zacks.com/stock/quote/PFE">PFE</a>) and Teva Pharmaceutical Industries Ltd. (<a href="http://www.zacks.com/stock/quote/TEVA">TEVA</a>). A chronic and usually progressive disease, MS affects the brain and nervous system, resulting in a loss of balance, muscle spasms and other problems related to movement.

	We currently have Neutral recommendations on both Biogen and Acorda.
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Biogen-Acorda MS Drug Faces Setback - Analyst Blog

Novartis AG (<a href="http://www.zacks.com/stock/quote/NVS">NVS</a>) recently received European approval for Lucentis to treat patients with certain forms of diabetic macular edema (DME). It is an eye condition related to long-standing diabetes that may lead to blindness, particularly in working-age population in most developed countries. Lucentis led to an improvement in vision and vision related quality of life in patients with visual impairment due to DME. Lucentis is currently marketed for the treatment of wet AMD.

	The current standard of care for DME is laser therapy, which can stabilize vision but not improve it. Lucentis showed faster, better and sustained gain in visual activity compared to dummy therapy or laser therapy as demonstrated by pivotal data from RESTORE and RESOLVE trials. Patients treated with Lucentis recovered their vision by the eighth day, on an average, after the first injection. The vision improvement was maintained at one year with some patients regaining the ability to carry out daily activities such as driving.

	Data from the RESTORE study showed that at twelve months, patients treated with Lucentis gained an average of 6.8 letters in visual acuity compared to baseline. Similarly, patients treated with Lucentis plus laser therapy gained an average of 6.4 letters in visual acuity. On the contrary, laser-treated patients gained an average of 0.9 letters as measured on a standard ETDRS eye chart.

	The RESOLVE study showed similar results at twelve months where Lucentis-treated patients gained an average of 10.3 letters in visual acuity compared to baseline. However, patients treated with dummy therapy, some of whom also received laser treatment, lost an average of 1.4 letters.

	Further, an independent US study examining Lucentis for the treatment of DME compared to laser therapy showed that at 12 months patients treated with Lucentis plus laser gained an average of 9 letters in visual acuity compared to baseline. However, patients treated with laser therapy gained an average of 3-4 letters.

	Novartis had received a positive recommendation from the Committee for Medicinal Products for Human Use (<a class="ticker" href="/stock/chmp#">CHMP</a>) for this indication in October 2010.

	Our Recommendation

	Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank. We are pleased with Novartis' wide range of products and its efforts to diversify further as is evident by the recent acquisition of a majority stake in Alcon (<a href="http://www.zacks.com/stock/quote/ACL">ACL</a>). Novartis is looking to acquire the remaining stake in the eye-care company.  However, we prefer to remain on sidelines due to the upcoming patent cliff for the company as a number of Novartis drugs will face generic competition between 2011 and 2015.
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