Pozen shares up on new drug application submission

NEW YORK -- Shares of Pozen Inc. got a boost Wednesday after the company said it submitted a new drug application to the U.S. Food and Drug Administration for the marketing approval of two potential cardiovascular drugs.

THE SPARK: The move is a major step toward commercializing the drugs and means that the company thinks it has proven that the drugs are safe and effective.

THE BIG PICTURE: Posen's PA32540 and PA8140 are both intended as alternatives to plain aspirin for the prevention of cardiovascular disease. Many people take aspirin to prevent heart problems, but long-term use of aspirin can cause ulcers.

Pozen's drugs contain aspirin and the omeprazole, the active ingredient in heartburn drugs like Prilosec. The omeprazole is released as soon as the drug is taken and the aspirin is released over time.

Pozen is seeking approval for use in patients at risk of aspirin-induced ulcers.

Pozen CEO John Plachetka called the move "an important milestone for the drug" and said the company looks forward to completing a commercial deal with a partner "in the upcoming months."

THE SHARES: Up 15 cents, or 3 percent, to $5.39 in morning trading, after peaking at $5.50 earlier in the day. Over the past 52 weeks, the company's shares have traded between $4.81 and $8.12.

Pozen shares are down about 2 percent so far this year.

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UPDATE 2-Ziopharm cancer drug fails in trial; shares plunge 66 pct

* Company to halt drug development for soft tissue sarcoma

* Says will focus on synthetic biology drugs

(Adds CEO comment from conference call, analyst comment)

By Vrinda Manocha

March 26 (Reuters) - Ziopharm Oncology Inc will stop developing its drug to treat soft tissue sarcoma after it failed to improve patients' survival without the cancer worsening, wiping out nearly two-thirds of its market value.

The drug, palifosfamide, was being tested in a late-stage trial as a treatment for metastatic soft tissue sarcoma - a type of cancer of the bone, cartilage, fat or muscles.

"We know that based on progression-free survival, there is no way the drug will get approval anywhere in the world," Chief Executive Jonathan Lewis said.

The company will now evaluate all its palifosfamide programs and convert its late-stage study of the drug in small cell lung cancer to a mid-stage trial, he said.

Ziopharm said it would now focus on its synthetic biology program, which creates DNA-based drugs that enable controlled delivery of genes that produce proteins to treat cancer.

The palifosfamide sarcoma trial involved 447 patients with metastatic soft tissue sarcoma across 150 centers.

The patients received either palifosfamide along with doxirubicin - an approved cancer drug - or doxirubicin alone.

An independent committee recommended that the patients be followed to test the improvement in their overall survival, but the company said it does not expect to continue the follow-up.

Brinson Patrick Securities analyst Vernon Bernardino said the company's decision to stop the drug's development was "drastic" but noted that the company had "burned" a lot of money on the project.

"They obviously need to restructure expenses to meet the needs of what has the best chances of success and they believe more in the synthetic biologic program," Bernardino said.

Ziopharm is testing its lead drug in this program in two mid-stage trials for the treatment of melanoma and breast cancer.

However, Bernardino said he ascribed a very low value to the synthetic biology program and that it accounted for only 3 percent of his share-price target of $7.

The company's shares fell 66 percent to $1.76 in early trading -- their lowest in more than three years.

(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Maju Samuel)

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Keywords: ZIOPHARM STUDY/CANCER

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Idenix Pharma shares sink on patent decision

CAMBRIDGE, Mass. -- Idenix Pharmaceuticals Inc. shares sank Monday after the U.S. Patent and Trademark Office determined a competitor was the first to request a patent for a hepatitis therapy.

The biopharmaceutical company said an appeals board decided that Idenix's patent application for compounds used to treat hepatitis C was filed after Gilead Pharmasset LLC's application. The U.S. Patent and Trademark Office appeals board will next determine which company invented the product first.

Idenix said that it does not believe that the patent application is relevant to any of the compounds it is currently developing, including two that are expected to begin midstage studies within the next few months, or another compound for which it soon plans to file a new drug application.

The news sent shares of Cambridge, Mass.-based Idenix down more than 15 percent to $3.89 by early afternoon, its lowest level in months. The company's stock is approaching the bottom of its 52-week trading range of $3.35 to $11.30.

Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the U.S. The disease is spread through the blood, which can happen through sharing intravenous drug needles or having sex with an infected person. There are around 3 million Americans with the disease, which can go undetected for many years until the liver is severely damaged.

Shares of Gilead Sciences Inc. fell 65 cents to $44.86.

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Ahead of the Bell: Spectrum shares continue slide

Shares of Spectrum Pharmaceuticals Inc. plunged in premarket trading Wednesday after the pharmaceutical company said sales of its drug Fusilev could fall significantly this year.

The Henderson, Nev., company's stock started to slide Tuesday after it said it expects Fusilev revenue to total between $10 million and $15 million in the first quarter and about $80 million to $90 million for the year.

The estimate for the year would represent a drop of at least 56 percent from Fusilev's 2012 total of $204.3 million, and it is much less than analysts expected.

Fusilev is an injectable treatment for the side effects of a chemotherapy drug called methotrexate.

Roth Capital Partners analyst Joseph Pantginis said Spectrum's announcement shocked Wall Street, and he believes investor confidence in the company will be shaky until its new sales push show results. He had expected Fusilev revenue of $47.2 million in the first quarter and $210 million for 2013.

"We are certainly disappointed by this news and unfortunately we believe that this sends a poor signal to the Street, which has been hanging on everything Fusilev," Pantginis wrote in a Wednesday morning research note.

Pantginis said that while the Fusilev announcement will hurt Spectrum's stock, he still sees value when looking at the company's total revenue stream.

Company shares had climbed 4 percent to close at $12.43 on Tuesday. That put the stock up 11 percent so far in 2013 before shares began sliding after hours.

By Wednesday morning before markets opened, the stock was down about 40 percent, or $4.93, to $7.50. If that price carries over into regular market trading, it would be its lowest price since 2011.

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Impax shares tank as FDA flags fresh concerns on manufacturing plant

March 4 (Reuters) - Impax Laboratories Inc said U.S. health regulators raised fresh concerns related to manufacturing practices at the drugmaker's Hayward, California facility, sending its shares down more than 20 percent after the bell.

The company's hopes of securing an approval for its Parkinson's drug Rytari are tied to its ability to resolve issues at the plant, where the drug is partly manufactured.

The U.S. Food and Drug Administration completed its re-inspection of the Hayward facility and outlined 12 "observations", three of which had already been pointed in earlier communications, Impax said on Monday.

The regulator typically outlines observations from conditions that may constitute violations of standard manufacturing practices.

The FDA had rejected approval to Rytari in January, pending a satisfactory re-inspection of the Hayward facility.

"We have committed significant resources in our efforts to meet FDA requirements and are clearly disappointed by this news," Impax Chief Executive Larry Hsu said.

The FDA first expressed concerns related to the facility in a warning letter in June 2011.

The company said on Monday the FDA did not inform it on the impact the new concerns would have on resolving the warning letter, or if the agency planned to take further regulatory action.

Impax plans to respond to the FDA's new observations within 15 business days.

The company's shares, which were halted pending the release of its statement, fell about 21 percent to $15.80 in after-market trading on Monday afternoon.

(Reporting By Vrinda Manocha in Bangalore; Editing by Saumyadeb Chakrabarty)

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Keywords: IMPAX FDA/

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MARKET EYE-Ranbaxy shares fall on Q4 loss, no update on Dewas

* Shares in Ranbaxy Laboratories Ltd

fall 3.6 percent, down for a second consecutive session, after India's top drugmaker by sales on Tuesday reported a surprise quarterly loss on product recall charges.

* Ranbaxy shares fell 3.95 percent on Tuesday. * Credit Suisse maintained its "neutral" rating on the stock after the results, citing continued regulatory uncertainty, especially from its Dewas plant. * The U.S. Food and Drug Administration blocked some generic drug imports from Ranbaxy, citing procedural violations at the drugmaker's Dewas and Paonta Sahib plants in India. * "Without update on the Dewas facility, we do not see upside to the stock and maintain our NEUTRAL rating," Credit Suisse said in its note. (abhishek.vishnoi@thomsonreuters.com /; abhishek.vishnoi.thomsonreuters.com@reuters.net)

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Zogenix shares rise on delayed FDA drug decision

WASHINGTON -- Shares of drugmaker Zogenix Inc. surged Wednesday, as investors speculated that a delayed decision on the company's lead drug will lead to positive approval in coming weeks.

THE SPARK: Zogenix reported Tuesday that the Food and Drug Administration would take longer than expected to review its drug Zohydro, a long-acting version of the painkiller hydrocodone. The FDA did not provide an explanation for the delay but indicated it "would likely be brief and may last only several weeks." Zogenix said the company has not been asked to submit any additional information.

THE BIG PICTURE: If approved Zohydro would be the first pure hydrocodone medication available in the U.S. Currently available products combine the drug with lower-grade painkillers such as acetaminophen. The company's announcement that FDA is still reviewing the drug may have surprised investors in light of the drug's negative review from federal advisers. In December an FDA panel of specialists voted 11-2 against the drug due to concerns that it could be abused by people addicted to painkillers. Hydrocodone belongs to a family of medicines known as opiates, which includes morphine, oxycodone, codeine and methadone.

The FDA does not have to follow the guidance of its advisers, though it often does.

THE ANALYSIS: Wells Fargo analyst Michael Tong said in a note to investors that the delay may bode well for Zogenix, since the FDA could have rejected the drug outright if it thought it was unapprovable. Tong said the short-term delay suggests the agency is working on measures to make sure the drug is used safely.

"We continue to believe the odds for eventual approval are high. We speculate FDA is dealing with issues of access and potential misuse," Tong said. He rates the company as "outperform" with a price target of $1.21.

SHARE ACTION: Shares of San Diego-based Zogenix Inc. rose 46 cents, or 38 percent, to $1.67 in afternoon trading.

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Threshold Pharma shares rise on analyst upgrade

NEW YORK -- Shares of Threshold Pharmaceuticals Inc. rose Wednesday after a Piper Jaffray analyst upgraded the stock as the company prepares to report more clinical trial data for its experimental cancer drug TH-302.

THE SPARK: Analyst Charles Duncan raised his rating to "Overweight" from "Neutral" and doubled his price target to $10 per share from $5. Threshold is getting ready to report clinical trial data for TH-302 as a treatment for soft tissue sarcoma, but Duncan said investors are overlooking earlier-stage clinical trials of the drug as a treatment for leukemia, multiple myeloma, and gastrointestinal tumors and kidney cancer.

THE BIG PICTURE: TH-302 is designed to become active in parts of the body with abnormally low oxygen levels. Threshold said those conditions exist in many types of solid tumors because of the irregular growth of the blood vessels that feed the tumors. Once the drug becomes active, it stops cancer cells from replicating their DNA and dividing. The company said the drug can also attack oxygenated regions of the tumor.

"We believe that near-term data will enhance conviction on the broad applicability of Threshold's hypoxia-activation platform for targeting a wide range of cancer indications with the potential to substantively add/extend efficacy over standard chemotherapy," said Duncan.

Duncan said he is particularly interested in the possibility that TH-302 could be combined with drugs that block the blood vessel growth in tumors.

The South San Francisco, Calif., company is conducting late-stage trials of TH-302 as a treatment for soft tissue sarcoma and pancreatic cancer and early-stage trials in other cancers. It is developing TH-302 through a partnership with German drugmaker Merck KGaA.

SHARE ACTION: Threshold shares rose 45 cents, or 10 percent, to $4.91 in afternoon trading. The stock has traded between $3.30 and $9.28 in the last year, but has lost about half its value since Sept. 17 when it reported disappointing trial results for TH-302 as a treatment for pancreatic cancer.

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Humana Shares Fall as 2014 Medicare Rates Cloud Outlook

Ty Wright | Bloomberg | Getty Images The Humana Inc. headquarters office stands in Louisville, Kentucky, U.S.

Health insurer Humana said on Tuesday that the government's proposed 2014 payment rates for Medicare Advantage participants were lower than expected and would affect its profit outlook, sending its shares lower.

Medicare Advantage is the Medicare program in which private insurers provide health insurance to seniors and are reimbursed by the government. Humana has around 2 million members enrolled in Medicare Advantage programs.

On Friday, the government's Centers for Medicare and Medicaid Services issued preliminary base payments rates for this business that implied a mid-single-digit decline in those rates for the company, Humana said.

"Humana is closely analyzing all operational avenues available to address those preliminary rates and the related impact upon the company's ability to grow both its Medicare membership and its earnings for 2014," Humana said in a regulatory filing.

Humana shares were down about 10 percent at $70.50 from a close on Friday of $77.99. Shares in UnitedHealth Group, another large provider of Medicare Advantage plans, were down about 6 percent at $54, from $57.32 on Friday.

UnitedHealth was not immediately available to comment.

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Novo Nordisk Shares Plunge on US Blow to Insulin Drug

U.S. regulators refused to approve Novo Nordisk's new long-acting insulin Tresiba until it conducts extra tests for potential heart risks, dealing a major blow to a key product for the Danish drugmaker.

Shares in Novo, the world's leading insulin maker and the most valuable company in the Nordic region, slumped 12.5 percent as it said the decision would make it harder to meet long-term financial targets. Rival insulin producer Sanofi rose 4.5 percent.

At one stage, Novo shares were down as much as 17 percent on Monday, their biggest daily decline since 2002.

As the world suffers from an epidemic of type 2 diabetes tied to over-eating and lack of exercise, demand for treatments has snowballed. Novo has benefited more than any other company because it is so focused on diabetes, lifting its shares to a lofty premium over other European drugmakers.

Novo said the U.S. Food and Drug Administration (FDA) had requested additional data from a trial focused on cardiovascular effects before it would consider approving Tresiba and related product Ryzodeg.

The drugmaker, which is banking on Tresiba to keep it in the lead in diabetes care, said late on Sunday it could not provide the data in 2013 and Chief Scientific Officer Mads Thomsen later told Reuters it would not be ready in 2014 either.

"It is a really bad situation," said Sydbank analyst Soren Hansen, who expects a delay of two or three years.

Tim Anderson of Bernstein said the best that Novo could now hope for was that Tresiba made it to market in 2015, assuming the new trial enrolls patients quickly and the FDA requires only partial data and not full completion.

Waiting for all the data could delay approval to 2017 or 2018, he said, and if the study reveals new risks it may never be approved.

Thomsen said he hoped to start talks with the FDA this week to find out exactly what data it required and how long a new study might take.

The setback for Tresiba, also known as degludec, is good news for rival makers of insulin medicines, notably France's Sanofi, whose Lantus product is threatened by Novo's newer ultra-long-lasting treatment.

Most investors had expected a green light from the U.S. watchdog, following a positive recommendation from an advisory panel to the FDA last November, despite earlier signals that there might be heart issues with the medicine.

Optimism about Tresiba and Ryzodeg - which combines degludec with another formulation of insulin - was further boosted by approval in Europe, where both drugs won a final go-ahead last month. They have also been approved in Japan.

Confounds Expectations

Analysts had been expecting Tresiba and Ryzodeg to sell some $2.8 billion annually by 2017, according to consensus forecasts compiled by Thomson Reuters Pharma. Those numbers look set to fall sharply, since the lucrative U.S. market was seen making up more than half of the total.

Novo Chief Executive Lars Sorensen said the U.S. setback would have no impact on the group's plans for the roll-out or pricing of the drugs in Europe and Japan.

The FDA's decision to issue Novo with a so-called "complete response letter" confounded expectations. Such letters are issued when the U.S. agency determines that an application cannot be approved in its existing form.

"We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review," Sorensen said.

Novo received the letter on Feb. 8 but only made it public on Sunday. In fact, concerns about the cardiovascular safety of Tresiba are not a complete surprise, although Novo and most analysts had thought the issue had been resolved.

The FDA advisers' meeting last year expressed concern about a trend toward higher incidence of adverse heart events with the new insulin than with older ones. However, the differences seen in 16 large clinical trials were not statistically significant.

In addition to calling for new trials on Tresiba's heart safety, the FDA said approval for Tresiba and Ryzodeg could not be granted until violations cited in a Dec. 12 warning letter had been resolved.

The FDA is very cautious about the safety profile of new diabetes treatments, following controversy over GlaxoSmithKline's Avandia pill, which was linked to serious heart problems after being on the market for years.

Novo said the FDA's decision not to grant approval at the present time was not expected to impact its financial forecasts significantly for the current year.

The big concern of investors, though, is that a lengthy delay in getting Tresiba launched in the world's biggest drugs market will seriously undermine Novo's ability to stay ahead of rivals such as Sanofi and Eli Lilly.

Mark Clark of Deutsche Bank said the setback would be seen as "unequivocally good news" for Sanofi's long-acting insulin Lantus, which is the French company's biggest-selling product, with sales this year expected to reach some $6.6 billion, 62 percent of which will come from the United States.

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UPDATE 4-Merck shares fall on worries about osteoporosis drug

* Per-share earnings 83 cts in quarter vs view 81 cts

* Quarterly sales $11.74 bln, vs view $11.48 bln

* Delay in filing for osteoporosis drug worries analysts

(Adds CFO comments, details on osteoporosis drugs, updates shares)

Feb 1 (Reuters) - Merck & Co Inc's quarterly results beat estimates, but the drugmaker issued a cautious 2013 profit forecast and said it will delay seeking approval for a high-profile osteoporosis drug, sending its shares down 3 percent.

Merck will not submit its osteoporosis treatment odanacatib to U.S. regulators until next year. Some analysts had predicted the medicine could generate annual sales of up to $2 billion, if approved.

"We continue to believe in the potential of this drug, and look forward to filing it in 2014," Chief Executive Kenneth Frazier said on a conference call with analysts who expressed concern about the delay.

Merck research chief Peter Kim told analysts he had seen complete data from a large Phase III trial of the drug. But he said the company would delay a marketing application to submit data from an "extension" trial, or a follow-up observation of patients who had completed the study. He did not cite any specific problems with the drug.

An independent monitoring board last July recommended the Phase III study be stopped because its data had already proven odanacatib reduced fracture risk. But the panel flagged certain potential safety concerns.

Merck continued with the extension trial, largely to better examine the safety issues, which have not been publicly identified.

Merck's older Fosamax osteoporosis treatment was the world's top seller, with annual sales of $3 billion until its U.S. patent lapsed in 2008 and generics flooded the market.

The No. 2 U.S. drugmaker earned $1.4 billion, or 46 cents per share, in the fourth quarter. That compared with $1.51 billion, or 49 cents per share, a year earlier, when it took charges for acquisition and restructuring expenses.

Excluding special items, Merck earned 83 cents per share. Analysts, on average, expected 81 cents, according to Thomson Reuters I/B/E/S.

Global company sales fell 5 percent to $11.74 billion, hurt by generic competition for its Singulair asthma drug, but still beat analysts' estimates of $11.48 billion.

The company forecast 2013 earnings of $3.60 to $3.70 per share, excluding special items. The midpoint of that range is below analysts' estimate of $3.68 per share. The company earned $3.82 per share in 2012.

Merck predicted sales in 2013 would be similar to 2012 levels, excluding foreign exchange factors, as Singulair generics continue to take their toll.

"Merck's 2013 (earnings) guidance was a bit conservative, which could point to higher expenses" this year, said Judson Clark, an analyst with Edward Jones. But he said the flat sales forecast was welcome because analysts were expecting somewhat lower sales.

Peter Kellogg, the chief financial officer, said few drugmakers are able to keep sales steady if one of their major medicines faces cheaper generics.

"That means we have a tremendously healthy portfolio of other products to provide compensating growth," Kellogg said in an interview.

Clark predicted Merck's earnings would rebound next year and grow in the high-single-digit range in percentage terms, as experimental drugs are approved and bring in new revenue.

"We think Merck has one of the best drug pipelines in the industry and that it will drive growth," Clark said.

Merck, whose $6 billion-a-year Singulair lost U.S. marketing exclusivity in August, is girding for more pain from cheaper copycats.

Its Maxalt migraine drug, with $600 million in annual sales, goes generic in December, and its near-blockbuster Temodar brain cancer medicine faces generics next year.

Merck said Friday it aims to seek marketing approval this year for five drugs, including suvorexant for insomnia.

It is counting on the new drugs to help cushion plunging sales of Singulair, Maxalt and Temodar.

Merck suffered a major setback in January, when an experimental cholesterol drug called Tredaptive failed to prevent heart problems and raised safety concerns. The drug, which was expected to become a big seller in the United States, was recalled in Europe following the negative study findings.

Singulair sales plunged 67 percent in the quarter to $480 million. Combined sales of diabetes drugs Januvia and Janumet rose 18 percent to $1.6 billion, fueled by growth in the United States and Japan.

Sales of Gardasil, its vaccine to prevent cervical cancer, jumped 61 percent to $442 million, helped by higher public sector purchases and demand in Japan and emerging markets.

Merck shares were down $1.35, or 3.1 percent, to 41.90 in midday trading on the New York Stock Exchange.

(Editing by Gerald E. McCormick, Jeffrey Benkoe and Bernadette Baum)

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Isis Pharma shares rise on Kynamro approval

NEW YORK -- Shares of Isis Pharmaceuticals Inc. soared Wednesday on news that the U.S. Food and Drug Administration approved its new drug application for its Kynamro cholesterol drug.

THE SPARK: The approval clears the way for Kynamro, the company's first drug, to reach market.

Carlsbad, Calif.-based Isis has a deal with Genzyme, a unit of French drugmaker Sanofi SA, to market the drug if it is approved. The FDA approval triggers a $25 million milestone payment to Isis from Genzyme.

THE BIG PICTURE: Kynamro is an injectable drug designed to treat patients who are genetically predisposed to have high levels of LDL cholesterol, known as the "bad" cholesterol. The drug has been approved for use as an adjunct to lipid-lowering medications and diet for patients with homozygous familial hypercholesterolemia.

HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in about one in one million individuals, according to the company.

THE ANALYSIS: BMO Capital markets analyst Dr. Jim Birchenough backed his "Outperform" rating for the stock, estimating the drug's peak sales at about $400 million. He added that the approval also bodes well for Isis' platform of more than 20 drug candidates.

Jefferies analyst Eun Yang backed an "Underperform" rating for Isis, but raised her price target by 50 cents to $7. Yang said that while the approval is a good thing for the company, she still thinks that the drug's commercial potential is low given the numerous side effects identified while it was being tested, including links to both benign and cancerous tumors. As a result, Yang said the drug's peak U.S. sales potential is probably less than $100 million.

THE SHARES: Up $1.51, or 11 percent, to $14.89 in afternoon trading, after peaking at $15.60 and coming within a penny of its 52-week high. Isis shares have risen steadily since November, gaining about 74 percent.

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Keryx shares keep climbing on drug trial results

Shares of Keryx Biopharmaceuticals Inc. extended its gains Tuesday, a day after the drug developer said its potential kidney disease drug, Zerenex, performed much better than a placebo in a late-stage clinical trial.

THE SPARK: The New York company said Monday that Zerenex showed a "highly statistically significant" change in serum phosphorus levels compared with a placebo in patients with advanced kidney failure who were on dialysis.

The drug also improved iron levels in patients, reducing the use of intravenous iron and other agents designed to treat anemia by boosting the oxygen-carrying component of the blood. The company said that should separate Zerenex from similar treatments on the market.

THE BIG PICTURE: Keryx has no products on the market, and Zerenex is its most advanced drug. The company plans to submit an application for approval of the drug to both the U.S. Food and Drug Administration and European regulators in this year's second quarter.

THE ANALYSIS: The magnitude of how much Zerenex decreases the need for the intravenous treatments was much better than expected, Stifel Nicolaus analyst Stephen Willey said in a research note. His estimate for peak, annual sales of the drug more than doubled to a range of $550 million to $600 million.

SHARE ACTION: Up 41 percent, or $2.48, to $8.54 in afternoon trading. The stock rose as high as $8.71 earlier in the session, its highest level since May 2010. It had soared 77 percent on Monday after Keryx announced the study results. The share price has more than tripled since the start of the year.

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Optimer shares rise on Dificid sales growth

NEW YORK -- Shares of Optimer Pharmaceuticals Inc. jumped 10 percent Monday after the drug developer said its fourth-quarter sales of a key drug rose 14 percent from third-quarter levels.

THE SPARK: Optimer said fourth-quarter U.S. and Canadian gross product sales of the antibacterial drug Dificid totaled $21.3 million. For the full year, gross product sales totaled $74.4 million, up from $24.4 million the year before. The drug launched in July 2011.

THE BIG PICTURE: Dificid is a treatment for Clostridium difficile, an infection that usually affects older patients and can cause symptoms ranging from diarrhea to potentially life-threatening inflammation of the colon.

The Food and Drug Administration approved the drug in May 2011. It's also approved in Europe and is sold through a partnership with Japanese drugmaker Astellas Pharma.

In October, the company announced plans to cut the price of Dificid for hospitals by 25 percent. The company said Dificid is effective but hospitals have been deterred from using the drug because of its high cost, and the price cut will help its sales.

Optimer said Monday that increased the wholesale acquisition cost of the drug by about 5.6 percent, effective Jan. 3. But it added that for hospitals, which already receive the 25 percent discount, the price increase will be offset through an additional discount, keeping the net price the same.

The company also said Monday that it will launch a co-pay assistance program for commercially insured patients that will provide up to $200 toward a patient's out of pocket cost for one prescription of up to 20 tablets per calendar year.

THE SHARES: Up 96 cents, or 10 percent, to $10.21 in afternoon trading, after peaking at $10.28 earlier in the day. Over the past 52 weeks, the company's shares have traded between $8.64 and $16.49.

During 2012, Optimer shares lost about 26 percent of their value.

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