XenoPort to drop multiple sclerosis drug, shares fall

By robinlee ~ May 20th, 2013 @ 5:56 pm No Comments »


Mon May 20, 2013 12:32pm EDT

(Reuters) – XenoPort Inc said it would stop development of an experimental multiple sclerosis treatment it planned to launch in 2015 after a late-stage trial failed to show significant improvement over a placebo.

Shares of the company fell 26 percent to $ 5.03 in morning trade on the Nasdaq.

“This is disappointing, given (the drug’s) promising mid-stage data,” Wells Fargo analyst Brian Abrahams wrote in a note to clients. “We had modeled sales of $ 77 million by 2017 for the product.”

The drug, arbaclofen placarbil, was XenoPort’s only product in late-stage trial, according to information on the company’s website.

A XenoPort executive said on a conference call that the company’s operating plan had included costs associated with a potential launch, and that it would take several weeks to determine the savings from the termination.

Xenoport spent about $ 13.2 million in 2012 on the development of the drug, according to a March regulatory filing.

The executive said more resources could be allocated to the company’s experimental drug XP23829 to treat relapsing-remitting multiple sclerosis, as well as marketing of its restless legs syndrome drug Horizant, its only drug on the market.

XP23829, currently being tested in an early-stage trial, is a derivative of Biogen Idec’s multiple sclerosis drug Tecfidera. Tecfidera was approved by the U.S. Food and Drug Administration on March 27.

“(Termination of the study) should enable resources to become more focused on XP23829, which we view as the company’s core value driver,” Wells Fargo’s Abrahams wrote in the note.

XenoPort ended its collaboration on Horizant with marketing partner GlaxoSmithKline PLC in November.

XenoPort said net sales of Horizant in the U.S. as recorded by GSK were $ 6.5 million in 2012, according to a regulatory filing. The drug is marketed by Astellas Pharma Inc as Regnite in Japan.

SECOND SETBACK

The company said on Monday that arbaclofen placarbil did not show statistical significance compared to the placebo on two clinical scales – severity of symptoms and response to treatment, and spasticity.

The drug, which was intended to treat spasticity, stiffness and involuntary multiple spasms, was tested on 228 multiple sclerosis patients in the United States.

Dosages of 30 mg and 45 mg were administered twice a day.

XenoPort said seven patients experienced adverse events, none of which were related to the treatment.

Acorda Therapeutics’s Zanaflex, JHP Pharmaceuticals LLC’s Dantrium and CNS Therapeutics’s Gablofen are some of the approved treatments for spasticity — an unusual tightness, stiffness, or “pull” of muscles.

XenoPort had stopped the development of arbaclofen placarbil as a heartburn drug in March 2011, after it failed in a mid-stage trial. (link.reuters.com/hab38t)

The company’s shares were down 11 percent at $ 6 by midday on the Nasdaq.

(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Roshni Menon)


Reuters: Health News

Saudi Arabia has another case of new coronavirus: WHO

By robinlee ~ May 19th, 2013 @ 10:50 am No Comments »


LONDON |
Sat May 18, 2013 5:43pm EDT

(Reuters) – Saudi Arabia has reported another case of infection in a concentrated outbreak of a new strain of a virus that emerged in the Middle East last year and spread into Europe, the World Health Organization (WHO) said on Saturday.

In a disease outbreak update issued from its Geneva headquarters, the WHO said the latest patient is an 81-year-old woman with multiple medical conditions. She became ill on April 28 and is in a critical but stable condition.

Worldwide, there have now been 41 laboratory-confirmed infections, including 20 deaths, since the new coronavirus was identified by scientists in September 2012.

The novel coronavirus, which had been known as by the acronym nCoV but which some scientific journals now refer to as Middle East Respiratory Syndrome coronavirus, or MERS, belongs to the same family as viruses that cause common colds and the one that caused a deadly outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003.

MERS cases have so far been reported in Saudi Arabia, Jordan, Qatar, Britain, Germany and France, but Saudi Arabia has had the vast majority of cases.

The WHO said that latest patient was in the same clinic in eastern Saudi Arabia that has seen 22 cases, nine of them fatal, since April 8.

WHO experts visiting Saudi Arabia to consult with the authorities on the outbreak have said it seemed likely the new virus could be passed between humans, but only after prolonged, close contact.

(Reporting by Kate Kelland; Editing by Robin Pomeroy)


Reuters: Health News

Virus found in Iowa hog population, possibly beyond

By robinlee ~ May 18th, 2013 @ 3:49 am No Comments »


WASHINGTON |
Fri May 17, 2013 7:33pm EDT

(Reuters) – A potentially fatal hog virus, porcine epidemic diarrhea, has been found in the United States for the first time, government and private industry officials said on Friday, posing a new threat for the country’s struggling pork producers.

PEDV, an incurable condition that causes diarrhea, vomiting and dehydration in hogs, has been identified in Iowa, the largest producing state, and possibly beyond. The severity of the outbreak is not yet known.

The virus exists in much of the world but has not previously occurred in the western hemisphere.

The USDA’s National Veterinary Services Laboratories has detected the virus in the Iowa hog population, a Department of Agriculture spokesman said.

Cindy Cunningham, spokeswoman for the National Pork Board in Des Moines, Iowa, said: “It may be a little bit more widespread than just with Iowa at this point … we’re still trying to understand that and determine where it all is.”

Hog futures in Chicago fell sharply on Friday as rumors swirled the disease had been detected in Iowa and Minnesota.

PEDV is not a food safety concern and does not affect humans, the USDA spokesman said.

Officials with USDA’s Animal and Plant Health Inspection Service (APHIS) held a call with livestock industry representatives on Friday to discuss the situation. There are currently no interstate trade restrictions related to PEDV for U.S. hogs and pigs.

PEDV has been seen in England, much of Europe, China, Taiwan and South Korea, according to Iowa State University.

“We don’t know the orientation of this particular disease (PEDV) and how it first got here to the United States,” Cunningham said.

Tom Burger, executive director of the American Association of Swine Veterinarians, said his group was getting “conflicting reports” on how the virus might have arrived.

There is no effective treatment for the virus other than good care and the provision of adequate water to combat dehydration, according to the university. Sanitary and quarantine measures can help to slow the spread of the virus.

“All ages of the swine can be affected. But the most severe clinical signs are seen in the very young and nursing baby pigs, the baby pigs that are still nursing,” said Burger.

The current outbreak could be short lived. Pig herds typically develop a strong immunity to the virus over two to three weeks, at which point the virus disappears spontaneously.

Depending on how widespread the incidence, the virus could tighten U.S. pork supplies in about five to six months by causing the deaths of baby pigs, said Steve Meyer, president of the consulting firm Paragon Economics.

But Meyer said exports of U.S. pork would probably not be effected.

U.S. pork producers have been fighting back from record-high feed costs that followed the historic 2012 drought, which hurt their operating margins. Grain prices are headed down, giving incentives to producers to expand their herds.

(Additional reporting by Theopolis Waters, Tom Polansek and P. J. Huffstutter in Chicago; Editing by Chris Reese and Andre Grenon)


Reuters: Health News

Her vision: Better, clearer sight

By robinlee ~ May 17th, 2013 @ 7:54 pm No Comments »



STORY HIGHLIGHTS

  • Marguerite McDonald performed the world’s first laser vision correction surgery
  • She also conducted the first custom laser surgeries in the United States
  • Several pharmaceutical and medical device companies also use McDonald as a consultant

(CNN) — Dr. Marguerite McDonald has a clear vision for helping people see better.

Throughout her career, McDonald, an ophthalmologist at Ophthalmic Consultants of Long Island (New York), has performed several pioneering eye surgeries.

In 1987, she performed the world’s first excimer laser treatment, a procedure that eliminates or reduces the need for contact lenses. She used this technique in 1993 — for the first time anywhere — to treat farsightedness. An excimer laser is a type of laser used in eye surgeries.

McDonald was also the third physician in the world to perform a procedure called conductive keratoplasty — a noninvasive surgery for farsightedness that involves using radio-frequency energy to heat small spots around the cornea. She served as the medical monitor of clinical trials of the procedure in the United States, which led to Food and Drug Administration approval.

In addition, McDonald conducted the first wavefront-based laser surgeries in the United States. Wavefront technology allows doctors to customize surgeries for individual patients.

You don’t know them, but these innovators may have changed your life

In September 2003, she was the first in North America to perform Epi-LASIK — a relatively new procedure that may avoid some of the risks associated with LASIK — in September 2003.

“Along with being noted for performing the first laser vision correction procedure… (McDonald) takes an active role in advancing women’s careers through mentoring,” Jan Beiting, president of Ophthalmic Women Leaders, said in a statement. “She is a trailblazer in every way.”

Ophthalmic Women Leaders announced in 2012 that she had won the organization’s Visionary Woman Award.

McDonald served as the director of the Southern Vision Institute in New Orleans from 1993 to 2005.

Today, she is a clinical professor of ophthalmology at NYU School of Medicine, and an adjunct clinical professor of ophthalmology at Tulane University Health Sciences Center in New Orleans.

Several pharmaceutical and medical device companies also use McDonald as a consultant.

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CNN’s Edythe McNamee contributed to this report.


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Further Reading

XenoPort to drop multiple sclerosis drug, shares fall

Saudi Arabia has another case of new coronavirus: WHO

Virus found in Iowa hog population, possibly beyond

Her vision: Better, clearer sight

Up to 1 in 5 children suffer from mental disorder: CDC

Erectile Dysfunction Tied to Long-Term Narcotic Use in Men

Bayer starts Phase III trial on regorafenib in liver cancer

French competition body fines Sanofi in Plavix dispute

Agent Orange tied to aggressive prostate cancer risk

Rumors, grief and questions: A virus ravages a Saudi family

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