Chelsea Therapeutics soars as FDA panel backs key drug

Chelsea Therapeutics soars as FDA panel backs key drug

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(Global Markets) - Shares of Chelsea Therapeutics International Ltd (CHTP.O) rose as much as 76 percent on Friday after a committee of independent experts recommended the approval of its hypotension drug in the United States.

The FDA panel voted 7 to 4 in favor of the drug's approval on Thursday. Its recommendation will now be taken into consideration by the FDA, which is expected to make a decision on the drug by March 28.

Wedbush Securities analyst Liana Moussatos said she sees more than an even chance of the drug being approved by the action date, and the company's stock price at least doubling if the approval comes through.

Last week, the company received briefing documents from the U.S. Food and Drug Administration raising questions related to the short duration of clinical studies and the limited size of the study population given the orphan status that the drug, Northera, has.

Orphan status is granted by the U.S. health regulator to drugs that treat a rare condition affecting less than 200,000 Americans and guarantees a marketing exclusivity of seven years.

But analyst Moussatos cautioned that there was still a risk that the FDA may seek additional trials on the drug.

Northera, which has been in use in Japan since 1989, has shown some post-marketing safety issues, and is being tested in an ongoing trial -- Study 306b. Results from the study are expected in the third quarter of 2012.

Leerink Swann analysts said despite the potential utility of the 306b study, additional trials would be required.

"Nearly all panelists noted the desire for additional clinical trials, preferably in longer durations, to be required in the post-marketing setting," they said.

Northera is being studied to treat neurogenic orthostatic hypotension -- a disorder resulting from the deficient release of a neurotransmitter used by autonomic nerves to send signals to regulate blood pressure.

Needham analyst Alan Carr said approval by the FDA action date would prove a challenge.

"The agency may discount the (advisory panel) advice and insist on additional pre-approval trials anyway."

Even if the FDA follows the panel's recommendation, there is little time to agree on label and post-approval trial requirements ahead of the action date, Carr said.

Shares of Charlotte, North Carolina-based Chelsea, which have fallen 52 percent since the company received the briefing documents last week, were trading up 52 percent at $3.67 on Friday on the Nasdaq.

(Reporting by Kavyanjali Kaushik in Bangalore; Editing by Roshni Menon)

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FDA lifts hold on Insmed's lung disease drug

FDA lifts hold on Insmed's lung disease drug

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(Global Markets) - Insmed Inc (INSM.O) said U.S. health regulators lifted a clinical hold on its lead drug to treat a form of lung disease that currently has no approved cure, sending the biopharmaceutical company's shares soaring 45 percent.

The U.S. Food and Drug Administration lifted a clinical hold on the drug Arikace for treating non-tuberculous mycobacteria (NTM) lung disease, paving the way for the company to continue a mid-stage study.

The regulator had put the drug on clinical hold for treating NTM lung disease and cystic fibrosis (CF) based on an initial review of results from a long-term rat carcinogenicity study.

The FDA, however, retained the hold on the drug for the treatment of CF.

Wedbush Securities analyst Gregory Wade expects health regulators to lift the hold on cystic fibrosis as well in the next 2-3 months.

Wade said NTM lung disease could represent a $400 million market, a $100 million larger opportunity than CF.

The analyst expects Insmed to restart mid-stage trials for NTM lung disease in the first half of the year, and post results from the study in 2013.

The company said it would move ahead with the drug's 9-month dog inhalation toxicity study as previously requested by FDA, to determine if the findings of the rat inhalation carcinogenicity study are also observed in a non-rodent.

NTM are mycrobacteria widely found in the environment, particularly in wet regions, and its most common manifestation is lung disease.

CF is an inherited disease that affects about 30,000 people in the United States and about 70,000 worldwide. The drug would compete against Novartis' (NOVN.VX) Tobi and Gilead's (GILD.O) Cayston for the indication.

Insmed shares, which have lost about 55 percent of their value since the hold in August, were up 34 percent at $5.09 in midday trade, making them the top percentage gainers on the Nasdaq.

(Reporting by Balaji Sridharan in Bangalore; Editing by Sriraj Kalluvila, Viraj Nair)

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FDA says no need to recall Enfamil formula

FDA says no need to recall Enfamil formula

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(Global Markets) - U.S. health officials said they found no trace of potentially deadly bacteria that killed two infants in recent weeks in sealed cans of Enfamil baby formula, and that a recall was unnecessary, providing relief for the product's manufacturer, Mead Johnson Nutrition Co.

The death of one baby, 10-day-old Avery Cornett in Missouri on December 18, is what led chains including Wal-Mart Stores Inc, Walgreen Co and Kroger to pull some cans of Enfamil Newborn from shelves in an effort to protect consumers from Cronobacter, which can cause severe illness in newborns and has been found in powdered milk-based formula.

The death of a second baby, in Florida, was not known until an update from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention late on Friday following the testing of samples taken from the infected babies' homes and company facilities.

"Parents may continue to use powdered infant formula, following the manufacturer's directions on the printed label," the agencies said in a joint statement.

"We're pleased with the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products," Tim Brown, Mead Johnson's general manager for North America, said in a statement.

Two other babies, one in Illinois and one in Oklahoma, were also reported with infections in recent weeks, but they both recovered.

The agencies said they found Cronobacter in an open container of infant formula, an open bottle of nursery water and prepared infant formula.

They said it was unclear how the contamination occurred, which suggests that it could have happened after the packages were opened. The agencies also said there was no evidence indicating that the infections were related.

"There is currently no evidence to conclude that the infant formula or nursery water was contaminated during manufacturing or shipping," said an FDA spokesman.

These findings basically clear Mead Johnson, whose shares have fallen 10 percent since the issue surfaced, said personal injury and product liability lawyer William Marler of the firm Marler Clark.

"It would be difficult to prove that this formula caused this child's death," said Marler, who has years of experience handling foodborne illness cases, including one in 2009 against Mead Johnson involving Cronobacter. That case was dismissed after no sealed cans tested positive, robbing the prosecution of the proverbial "smoking gun."

Officials for the CDC, Mead Johnson and Wal-Mart could not immediately be reached for comment.

MOVING FORWARD

Mead Johnson's name may be cleared, but the company will likely take some time to fully heal, experts say, given how serious the situation is and how sensitive people are about what they feed their babies.

"Bad news is bad news," said Robert Passikoff, president of research firm Brand Keys Inc. He said the negative publicity has already damaged Enfamil's brand equity and could have cost the company one cycle of new parents, who might feed their children formula for about a year.

Goldman Sachs lowered its earnings estimates for Mead Johnson last week for 2012 through 2014 by 3 percent on average, citing the risk of damage to consumers' trust in the Enfamil brand. It lowered its price target to $74 from $80.

Despite the costs of retesting its formula and the likely hit to earnings from something that is not its fault, Mead Johnson has little legal recourse against either the public health department, the victims' families or Wal-Mart, which pulled its product in the absence of a definite link.

"Could a lawyer cook up legal theories to sue? They can. Would that be a very wise move? I think it would be really, really stupid," Marler said, for two reasons.

"'We didn't know for sure and we wanted to protect our customers' is a pretty good defense," he said, adding that "Suing somebody isn't really the likely way you're going to get your product in their store."

Enfamil is the leading milk-based formula in the United States, controlling nearly 44 percent of the $4.29 billion market, according to Euromonitor International. No. 2 is Abbott Laboratories Inc's Similac, with a 24-percent share, followed by Nestle's Good Start with 10 percent and private label, or store brands, with 9 percent.

Still, the United States makes up less than 30 percent of Mead Johnson's sales, and is not what had been driving the company's shares, said RBC Capital Markets analyst Edward Aaron.

Until its latest troubles, the stock had more than tripled since its February 2009 spin-off from Bristol Myers Squibb, fueled by growth from emerging markets.

In the latest quarter, the company's sales rose 15 percent to $933.9 million, driven by a 30 percent jump in Asia and Latin America.

But Mead Johnson has done many things well in this crisis and should be forgiven quickly, said Mike Rozembajgier, vice president of recalls for Stericycle ExpertRECALL, a consulting and logistics firm.

"There's an understanding by the public that recalls are going to happen," Rozembajgier said. "How forgiving they might be with regard to a particular brand ... comes down to how the company manages the recall."

Mead Johnson has not had a recall, but has gone through many of the same steps, he said, such as working with the government,

being transparent and communicating with retailers and the press.

(Reporting By Martinne Geller in New York and Anna Yukhananov in Boston; Editing by Bob Burgdorfer, Steve Orlofsky, Gary Hill)

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Bayer gains as U.S. hopes revive for stroke drug

Bayer gains as U.S. hopes revive for stroke drug

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FRANKFURT/LONDON (Global Markets) - Bayer (BAYGn.DE) shares rose 2.5 percent on Friday after its stroke-prevention drug Xarelto was recommended by a U.S. panel, moving it a step closer to approval in the world's biggest market.

But analysts said the drug, being developed with Johnson & Johnson (J&J) (JNJ.N), was only likely to carry a claim of non-inferiority, rather than superiority, over the established product warfarin and there may be a need for further studies.

"(The vote) should aid recovery in the stock although investors should be aware that Xarelto could still be delayed in the United States for stroke prevention," JP Morgan analysts said in a note.

Xarelto's place in the global stroke-fighting market, which could top $10 billion annually, had looked in serious jeopardy just three days ago.

On Tuesday, Food and Drug Administration (FDA) reviewers called for the agency to delay approval in an initial assessment, sending Bayer shares on a one-day slump of 7.5 percent.

They recovered on Friday to be up 2.2 percent at 1114 GMT.

Now, with the backing of the advisory panel, the medicine seems likely to get to the U.S. market, though it could face delays and may well end up with labeling that puts it at a disadvantage to rivals.

WestLB analyst Norbert Barth said Xarelto's commercial potential appeared limited, even if it was approved in the U.S. by the target date of early November.

Other analysts were not convinced approval would come so quickly.

Jeffrey Holford of Jefferies said it seemed likely the FDA would require a further small clinical study to assess risks for patients when they come off the drug, delaying its launch by around 12 months.

A delay for Xarelto could give a further edge to a rival treatment, Eliquis, being developed by Bristol-Myers Squibb (BMY.N) and Pfizer Inc (PFE.N), which is considered to have the strongest profile among the new rivals to warfarin.

Another blood clot preventer, Boehringer Ingelheim's Pradaxa, was approved last year and is already available in the U.S. as an alternative to decades-old warfarin.

All three drugs are designed for patients with atrial fibrillation, an irregular heartbeat mainly affecting the elderly that can cause blood to pool, increasing their risk of blood clots and strokes.

Tim Race of Deutsche Bank said it seemed likely Xarelto's label would disadvantage the drug relative to Pradaxa and Eliquis, denting commercial expectations.

That could cut Deutsche's 2015 U.S. Xarelto sales forecasts to 300-400 million euros from a current assumption of 900 million, he added.

Bayer said in a statement it continued to see worldwide peak sales of Xarelto at more than 2 billion euros ($2.8 billion), "irrespective of the decision by the FDA in early November."

The German chemicals-and-drugs group sold exclusive U.S. rights for Xarelto to J&J in 2005. As part of that pact, Bayer stands to receive royalty payments of up to 30 percent on U.S. sales, while retaining exclusive rights outside the U.S.

In Europe, Bayer expects approval of Xarelto in the third or fourth quarter of this year.

($1 = 0.714 Euros)

(Editing by Hans-Juergen Peters, Sophie Walker and David Hulmes)

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FDA rejects Alimera eye drug again, seeks more trials

FDA rejects Alimera eye drug again, seeks more trials

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(Global Markets) - U.S. health regulators declined to approve Alimera Sciences Inc's (ALIM.O) experimental drug to treat retinal swelling for the second time citing safety issues, and asked the biopharmaceutical company to conduct two more trials.

The regulatory decision signaled a setback for the cash-strapped company and wiped out about three-fourths of the company's market value.

"We view this as the worst-case scenario for Alimera, since this news translates into a multi-year delay, and a very significant investment of capital that the company does not currently have at hand," Cowen & Co analyst Simos Simeonidis said.

Alimera, which focuses on diseases affecting the back of the eye, or retina, had about $38.6 million in cash as of September 30.

The company was relying on the drug Iluvien to start bringing in revenue from early 2012.

Alimera, which is pursuing approval for the drug in Europe, said it had necessary funds.

In a complete response letter to the company, the U.S. Food and Drug Administration said Iluvien's benefits did not offset the risks of adverse reactions.

Iluvien, which Alimera is co-developing with pSivida Corp (PSDV.O), is an intravitreal insert designed to provide a therapeutic effect of up to 36 months by delivering sustained release of a drug.

Shares of pSivida lost over half of their value, and fell as much as 65 percent to $1.40 -- their lowest in more than two years.

In the event of Iluvien's commercialization, pSivida gets 20 percent of net profits from the product's sales.

Alimera said it would request a meeting with the FDA to clarify the next steps.

The drug aims to treat diabetic macular edema -- the most prevalent cause of moderate vision loss in patients with diabetes.

In December, the health regulator had rejected Iluvien, citing deficiencies in current good manufacturing practices (cGMP) during facility inspections of two of Alimera's third-party manufacturers.

Shares of the Alpharetta, Georgia-based company were down 73 percent at $1.99 in afternoon trading. They touched a lifetime low of $1.71 earlier in the session.

(Reporting by Esha Dey and Shailesh Kuber in Bangalore; Editing by Maju Samuel and Sriraj Kalluvila)

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Momenta shares rise on biosimilars deal with Baxter

Momenta shares rise on biosimilars deal with Baxter

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(Global Markets) - Shares of Momenta Pharmaceuticals (MNTA.O) rose as much as 7 percent early Friday, a day after it inked a deal with Baxter International Inc (BAX.N), marking the third partnership on generic versions of biotechnology drugs this month.

Momenta will receive an upfront payment of $33 million from Baxter for developing up to six biosimilars, and is entitled to additional milestone payments.

The deal also includes Momenta receiving royalties with a profit-share option on four drugs, for which Baxter will cover clinical trials, manufacturing and commercialization, according to Canaccord Genuity analyst Ritu Baral.

The analyst, who has a price target of $23 on Momenta stock, reiterated her "buy" rating.

Momenta and Baxter's deal comes just days after Amgen Inc (AMGN.O) and generic drugmaker Watson Pharmaceuticals Inc (WPI.N) announced a partnership to develop and sell biosimilars of cancer drugs.

Earlier in the month, Samsung announced an agreement with biotechnology company Biogen Idec (BIIB.O) to set up a joint venture for developing, manufacturing and marketing biosimilars.

Biosimilars are copies of existing biotechnology products developed from organic compounds. However, due to the complex nature of these compounds, biosimilars have come under the regulatory scanner.

Companies hoping to cash in on a potential multi-billion dollar market for biosimilars have long awaited guidelines from the U.S. Food and Drug Administration on the development of such drugs.

Analyst Baral said the slew of deals on biosimilars follows increased FDA clarity on the regulatory path.

Shares of Cambridge, Massachusetts-based Momenta were up 4 percent at $17.63 on Friday morning on Nasdaq.

(Reporting by Zeba Siddiqui in Bangalore; Editing by Roshni Menon)

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FDA okays Boston Scientific stent despite concerns

FDA okays Boston Scientific stent despite concerns

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(Global Markets) - The U.S. Food and Drug Administration has approved a Boston Scientific Corp heart stent, despite concerns about a rare but potentially serious problem, because its benefits still outweigh the possible risks.

The agency approved the Promus Element Plus drug-eluting heart stent late on Tuesday, seven months sooner than expected. Boston Scientific shares rose as much as 5.3 percent on Wednesday.

The decision followed a disclosure by the agency on Friday that it was investigating instances in which the stents - tiny tubular devices made of wire mesh - were found to shrink or lengthen after implantation.

The Promus Element is designed to be thinner and more flexible to make its delivery to the artery easier. Complaint reports about the device show it can become deformed in cases where there is calcification of the artery, a twisted blood vessel or faulty placement by the surgeon.

"While additional data collection is ongoing and will continue into the postmarket, the totality of the information available and considering the addition of appropriate information in the labeling led to the conclusion that the Promus Element provides a reasonable assurance of safety and effectiveness," an FDA spokeswoman said in an email response to Global Markets on Wednesday.

The FDA said the problem, known as longitudinal deformation, has occurred most frequently with Boston Scientific's Ion stent, approved in the United States earlier this year, and the Promus Element, which had been available outside the United States.

The FDA said it viewed both devices as safe when used for authorized indications, but added it was working with the manufacturers to understand the problem.

The approval for the Promus Element Plus stent is an important step that will allow Boston Scientific to replace the Promus stent it co-markets with Abbott Laboratories.

Boston Scientific plans to market the U.S. stent immediately and awaits approval in Japan by mid-2012. It expects the combined launches will add $200 million to its gross margin after 2012.

In response to a Global Markets query, Boston Scientific said an evaluation of worldwide complaints concerning the Promus Element, as of October 31, showed 136 longitudinal stent deformation events per 829,372 units sold.

Of a total of 133 patients in whom longitudinal stent deformation was reported, new stents were implanted in 76 patients and 4 patients underwent surgery.

The FDA action quelled concerns on Wall Street that regulatory approval of the Promus Element would be delayed due to concerns about the deformation cases.

Michael Matson, an analyst with Mizuho Securities, said the approval is key to the company's margin expansion efforts.

"While we continue to watch this issue closely, we think that the Promus Element approval may indicate that FDA is not overly concerned about longitudinal compression," Matson wrote in a research note. "We continue to believe that Boston Scientific is in the early stages of a turnaround in terms of both revenue growth and margins. The Promus Element approval should help on both fronts."

Boston Scientific shares were up 4 cents to $5.35 on the New York Stock Exchange after trading as high as $5.59 earlier in the session.

(Reporting by Debra Sherman; editing by Michele Gershberg, Dave Zimmerman and Andre Grenon)

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Mannkind up on FDA nod for diabetes device trials

Mannkind up on FDA nod for diabetes device trials

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(Global Markets) - Shares of MannKind Corp (MNKD.O) rose as much as 33 percent on Friday, a day after the company said U.S. regulators cleared the design of two clinical studies to test the efficacy and safety of its experimental device, Afrezza, to treat diabetes.

In January, the U.S. Food and Drug Administration rejected the inhaler and asked the company for two more trials to prove that a second-generation version of the device, known as the Dreamboat, is equivalent to a first-generation inhaler known as MedTone.

The FDA confirmed protocols for two studies in which the device will be tested on patients with type 1 and type 2 diabetes.

"We are especially encouraged by the regulatory progress of the Type 2 trial, which we believe now enables approval with a label to address a broader, earlier stage disease, patient population than we had previously anticipated," JMP Securities analysts said in a note to client.

JMP upgraded Mannkind's stock to "market outperform" and set a price target of $7.

Afrezza is administered at the start of a meal and dissolves immediately upon inhalation to deliver insulin to the blood stream.

The trials, called Study 171 and Study 174, will assess the effectiveness of Afrezza in bringing down glucose level in blood compared with MedTone. Mannkind had earlier said that they do not expect the trials to be completed by 2012.

"Ultimately this could be an excess of a billion dollar drug, but how quickly it gets to the market is a real question. It is not going to be in the market for two years," CRT Capital Group analyst Liah Hartman told Global Markets.

The company might be able to complete trials by the late fourth quarter of 2012 or first quarter of 2013, analyst Hartman added.

However, there are concerns over the company raising enough capital to fund the trials.

"It is very possible that they could partner globally for these trials ... Chief Executive Alfred Mann could personally increase the size of unsecured credit which he has been providing the company lately," Hartman said.

Shares of the Valencia, California-based company were up 23 percent at $2.91 on Friday on Nasdaq. They closed at $2.37 on Thursday on Nasdaq.

(Reporting by Kavyanjali Kaushik in Bangalore; Editing by Saumyadeb Chakrabarty, Roshni Menon)

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Nanosphere says bacterial infection test gets FDA nod

Nanosphere says bacterial infection test gets FDA nod

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(Global Markets) - Nanosphere Inc (NSPH.O) said health regulators approved its diagnostic test to detect and differentiate two infection-causing bacteria, sending the company's shares up as much as 34 percent.

Nanosphere, which makes diagnostic devices, said the Verigene BC-S test detects Staphylococcus aureus, Staphylococcus epidermidis, and determines antibiotic resistance from the mecA gene within two-and-a-half hours.

Shares of the company were up 20 percent at $1.52 in late afternoon trade on Tuesday on Nasdaq. They earlier touched a high of $1.70.

(Reporting by Shailesh Kuber in Bangalore; Editing by Joyjeet Das)

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FDA chides Novartis on meningitis vaccine promotion

FDA chides Novartis on meningitis vaccine promotion

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WASHINGTON (Global Markets) - Novartis AG falsely implied that its Menveo meningitis vaccine was approved in a manner consistent with guidelines from an influential U.S. advisory group, health regulators said in a letter to the Swiss drugmaker.

The U.S. Food and Drug Administration in the letter dated June 24 and released on Friday said some statements in a recorded phone call and professional slides from March were "false and misleading."

The FDA also said the promotional materials falsely imply that FDA-approved use of Menveo is consistent with published recommendations by the U.S. Advisory Committee on Immunization Practices, a panel of federal vaccine experts that advises the U.S. Centers for Disease Control and Prevention.

The FDA requested that Novartis immediately stop using such promotional material and the company's spokeswoman said the vaccine unit has already done that.

"(The unit) takes this communication very seriously and has immediately ceased the dissemination of the material in question," said spokeswoman Brandi Robinson. "We are committed to addressing the FDA's concerns adequately and expeditiously."

Earlier this month, the FDA accepted Novartis's application to broaden the use of Menveo in infants and toddlers from 2 months of age. The vaccine, which protects against strains of the meningococcal disease that causes potentially deadly meningitis, is approved in the United States for people aged between 2 and 55.

Novartis has three types of meningitis vaccines, and it is optimistic that its meningitis franchise will be a blockbuster. The company is also hoping its meningitis franchise will help the unit reduce its dependency on sales from pandemic vaccines.

The FDA posted the warning letter here: here

(Reporting by Alina Selyukh. Editing by Robert MacMillan, Bernard Orr)

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FDA clears new Merck drug for hepatitis C

FDA clears new Merck drug for hepatitis C

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WASHINGTON/NEW YORK (Global Markets) - Merck & Co (MRK.N) won U.S. approval on Friday to sell a new drug considered a major advance against the liver-destroying hepatitis C virus.

Victrelis is expected to help transform treatment of the potentially fatal disease with higher cure rates and shorter courses of therapy for some patients.

A similar medicine from Vertex Pharmaceuticals Inc (VRTX.O) is poised to win FDA clearance later this month. Industry analysts predict sales of more than $1 billion annually for each drug with the Vertex product dominating the market.

Merck shares rose 0.6 percent in after-hours trading to $37.33, up from their $37.08 close on the New York Stock Exchange. Approval of Victrelis was widely expected after a Food and Drug Administration advisory panel recommended the drug in an 18-0 vote in April.

Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new medicines, which still must be taken in combination with older hepatitis drugs. About 170 million people around the world are infected with hepatitis C.

"There are so many patients who are just waiting for a new treatment option. There hasn't been anything new in 10 years," said Dr. Eliav Barr, Merck's head of infectious diseases research.

"We're just thrilled and can't wait to get the medicine out the door to patients," Barr said, adding that Merck was ready to begin shipping the drug within the week.

The cure rate for Victrelis reached 66 percent in Merck's studies, an improvement over the 35 to 40 percent seen with current drugs, but less than the 79 percent reported for newly treated patients given the Vertex drug, telaprevir.

"Victrelis is an important new advance for patients with hepatitis C," Dr. Edward Cox, head of the FDA office of antimicrobial products, said in a statement.

The FDA approved Victrelis for adults with hepatitis C who were never treated or who failed previous treatments.

In the United States, 3.2 million people have hepatitis C, a blood-borne disease that can lead to chronic liver problems, liver cancer, cirrhosis and death. The disease is the leading cause of liver transplants in the U.S.

Both the Merck and Vertex medicines in combination with standard drugs cured some patients in half the time of the current therapy of the injectable drug interferon and a pill called ribavirin. The older drugs require almost a year of treatment and often cause flu-like symptoms that are tough to tolerate.

Prescribing instructions for Victrelis suggest that some patients with early responses to the drug can stop treatment after 28 weeks, while some others can stop at 36 weeks.

The most common side effects reported with Victrelis were fatigue, anemia, nausea, headache and taste distortion, the FDA said.

The drug label recommends monitoring for anemia.

Hepatitis C is spread mainly through sharing needles such as those used for illegal drugs and tattoos, or through blood transfusions before 1992 when screening began. Many people who are infected do not know they have the virus and show no symptoms.

The new medicines work by blocking a protein called protease that the virus needs to replicate. The generic name for the Merck drug is boceprevir. It must be taken three times a day with food.

(Reporting by Lisa Richwine and Bill Berkrot; Editing by Carol Bishopric)

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