Pharmaceutical News: FDA Approves Merck’s New Drug Victrelis For Treatment Of Hepatitis C

FDA Approves Merck’s New Drug Victrelis For Treatment Of Hepatitis C

The U.S. Food and Drug Administration (FDA) announced late yesterday that it has approved Victrelis for the treatment of hepatitis C.

Victrelis (boceprevir), which will be marketed by the U.S. pharmaceutical company Merck, is approved for use in combination with the current standard of treatment for hepatitis C, peginterferon alfa (Pegasys or PegIntron) plus ribavirin (Copegus, Rebetol).

“This is an exciting day for physicians and patients because Victrelis is the first major advancement for the treatment of chronic hepatitis C approved in a decade,” said Dr. Bruce Bacon, professor of internal medicine at Saint Louis University School of Medicine and one of the Victrelis clinical trial leaders, in a Merck press release.

“Compared to current standard therapy, Victrelis can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR [sustained virologic response]. For many patients, Victrelis may allow for a shorter total duration of treatment,” he added.

The approval is based on clinical trial results showing that Victrelis increased cure rates for hepatitis C – called a sustained virologic response, or SVR – from around 40 percent to about 65 percent (see related AIDS Beacon news).

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). If untreated, infection with HCV can cause damage and scarring to the liver, liver cancer, and eventually liver failure. Once the liver fails, a liver transplant is necessary for a patient to survive. Some people who are infected can spontaneously clear the virus themselves; the rest need treatment with antiviral drugs.

Victrelis has been approved for use in adults with hepatitis C who have never been treated or who have previously failed treatment. It may be taken even by patients who have cirrhosis (scarring and poor liver function caused by advanced liver disease).

Victrelis has not yet been approved for people with HIV-HCV co-infection. Merck is currently conducting clinical trials to evaluate the drug’s safety and efficacy in people who are infected with both HIV and HCV (see related AIDS Beacon news).

The approved dosing schedule for Victrelis, as anticipated, is somewhat complicated. Most patients taking Victrelis will undergo response-guided therapy. Under this model, the length of treatment varies depending on how well a patient responds to the drugs.

Treatment-naïve patients will receive four weeks of standard treatment (ribavirin plus peginterferon alfa), then 24 weeks of standard treatment plus Victrelis (for a 28 week total treatment length). However, if patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional eight weeks of Victrelis, then 12 weeks of just peginterferon alfa plus ribavirin (for a total treatment length of 48 weeks).

Patients who have been treated previously for hepatitis C will receive four weeks of standard treatment, then 32 weeks of standard treatment plus Victrelis (for a 36 week total treatment length). If patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional 12 weeks of peginterferon alfa plus ribavirin after finishing Victrelis (for a total treatment length of 48 weeks).

Patients who have cirrhosis will take peginterferon alfa and ribavirin for four weeks, followed by 44 weeks of Victrelis, peginterferon alfa, and ribavirin.

If HCV is still detectable after 24 weeks, Merck recommends discontinuing treatment with all three drugs.

Victrelis is taken three times daily with food, every seven to nine hours, in the form of four 200 mg pills.

Merck stated in its press release that it will start shipping Victrelis to pharmacies within a week. The company will also add Victrelis to its patient assistance program, which provides free medications to people who are uninsured and who meet income requirements (annual income of no more than $43,320 for an individual). Victrelis will cost $1,100 per week, or between about $26,000 and $48,000 for an entire course of therapy.

Victrelis is one of two new hepatitis C drugs currently being evaluated by the FDA. Victrelis and telaprevir, which will be marketed by Vertex Pharmaceuticals and Johnson & Johnson, are both HCV protease inhibitors, which work by inhibiting HCV replication in the body. The FDA is expected to announce its decision on telaprevir’s potential approval within the next two weeks.

Pfizer to settle remaining hormone therapy lawsuits for $300 million minimum

Thousands of women who say they developed breast cancer and other diseases after hormone-replacement therapy are poised for victory after Pfizer Inc. announced it expects to settle for at least $300 million this last round of lawsuits in the public-health controversy.

The New York-based pharmaceutical giant, which has research-and-development sites in Groton and New London, expects to pay at least $772 million to settle the more than 10,000 lawsuits that alleged that Wyeth Pharmaceutical’s hormone-replacement therapy drug Prempro caused their health problems, according to a regulatory filing.

This includes the $300 million the company paid out in a previous round of settlements, according to the documents, and $172 million in reported settlements last quarter.

“Additional charges may be required in the future,” Pfizer said.

Critics allege that Wyeth, bought by Pfizer two years ago for $67 billion, never properly studied the effects of hormone replacement before starting to market the treatment in 1995. The therapy is prescribed to ease menopausal symptoms.

It wasn’t until 2002 – after the release of a Women’s Health Initiative study that suggested a connection between hormone replacement and cancer, heart attacks and stroke – that the medical community started to revise its thinking about the by-then standard therapy.

The National Institutes of Health, which sponsored the study, said on its website that hormone therapy – also known as HRT – can still have benefits, including reducing the risk of bone breaks in older women.

“If you do decide to take HRT, it should be the lowest dose that helps and for the shortest time needed,” the health organization said.

Pfizer said it stands by its hormone therapy medicines.

“The FDA has said that hormone therapy ‘is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness,'” a company statement said.

Pfizer didn’t reveal in its filing late Thursday with the U.S. Securities and Exchange Commission how many cases were being put to rest in the latest round of Prempro settlements. Bloomberg News Service estimated the number at more than 3,000, but Pfizer said only that the $300 million set-aside is expected to be the minimal amount required to cover a third of the pending cases.

“The decision to settle cases reflects a business decision by the company to avoid the cost and distraction of prolonged litigation,” Pfizer spokesman Christopher Loder said in a statement Friday.

Analysts saw the settlements as good news for the company’s stock price over the long haul, since it releases another cloud of doubt over Pfizer. The stock hit near its one-year high Friday, closing at $20.92 a share.

Pfizer’s stock, under the leadership of new chief executive Ian Read, has been booming – up 25 percent since his December ascension – even as the company faces concerns over the loss of patent exclusivity for Lipitor, its blockbuster cholesterol pill.

Prempro is a combination of Wyeth’s estrogen replacement Premarin and Pfizer’s progestin hormone Provera. It is still on the market, bringing in only $161 million in annual sales two years ago, compared with more than $2 billion at its height when 6 million Americans were on hormone therapy.

Pfizer no longer pulls out Prempro sales separately, now referring to the “Premarin family” of medicines, whose $235 million in sales in the first quarter were an 8 percent decrease from the same period last year.

The most recent round of cases that Pfizer is settling was consolidated in U.S. District Court in Little Rock, Ark.

Last year, the U.S. Supreme Court refused to hear a Pfizer appeal that sought to have the hormone therapy cases heard in federal courts rather than in state jurisdictions.

AcelRx Pharmaceuticals Reports First Quarter 2011 Financial Results

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (“AcelRx”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported financial results today for the first quarter ended March 31, 2011.

Net loss for the first quarter of 2011 was $3.2 million, or $0.30 per share, compared with a net loss of $3.7 million, or $5.85 per share, for the first quarter of 2010. Common shares used in calculating earnings per share were 10,742,182 in the first quarter of 2011 compared to 629,006 common shares in the first quarter of 2010. Research and development expenses for the three months ended March 31, 2011 totaled $1.9 million, compared with $2.8 million for the three months ended March 31, 2010. General and administrative expenses were $1.6 million for the quarter ended March 31, 2011, compared with $0.7 million for the quarter ended March 31, 2010. The increase in General and Administrative expenses results primarily from incremental public company expenses and non-cash stock compensation.

As of March 31, 2011, AcelRx had cash, cash equivalents and short-term investments of $36.2 million, compared with $3.7 million as of December 31, 2010. In February 2011, AcelRx completed its initial public offering, or IPO, resulting in net proceeds to AcelRx of $35.2 million. In connection with the IPO, $8.0 million in outstanding convertible notes as of December 31, 2010 converted to common stock. On March 31, 2011, AcelRx had $4.0 million in debt outstanding.

“Progress continues towards initiating the Phase 3 program for our lead product candidate, ARX-01, in acute post-operative pain,” said Richard King, President and Chief Executive Officer of AcelRx. “We have manufactured NanoTabs for all Phase 3 clinical trials, and are in the process of manufacturing components for the ARX-01 device. We have selected the CRO to conduct the Phase 3 studies for ARX-01, and anticipate initiating enrollment in our first Phase 3 study, an efficacy study in major abdominal surgery, in the second half of 2011. We anticipate initiating enrollment for our second Phase 3 study, a head-to-head comparison of ARX-01 to the standard of care, IV PCA morphine, in early 2012.”

“We continue to believe that ARX-01 could become the treatment of choice for patient-controlled management of moderate-to-severe post-operative pain,” said Mr. King.

Financial Outlook

AcelRx anticipates that research and development expenses will increase over the next several years as it seeks to complete Phase 3 development of ARX-01. AcelRx does not intend to initiate the third ARX-01 Phase 3 study, an efficacy study in orthopedic hip and knee replacement surgeries until additional funding is obtained. The development of ARX-02,a product candidate for the treatment of cancer breakthrough pain, and ARX-03, a product candidate for mild sedation and pain relief in procedures conducted in a physician’s office, will not advance until additional funding or the identification of a partner to support this effort is secured. Additionally, AcelRx anticipates increases in general and administrative expenses due to costs associated with operating as a public company and expansion of its corporate infrastructure to support ongoing development of its product candidates.

AcelRx believes its current cash and cash equivalents, and the interest earned thereon, are sufficient to fund operations through the second quarter of 2012.

About AcelRx Pharmaceuticals, Inc.

Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, the ARX-01 Sufentanil NanoTab(R) PCA System, which has completed Phase 2 clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia (IV PCA) which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps. AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for providing mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician’s office.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to AcelRx Pharmaceuticals’ financial performance, clinical trial update and future financial performance, including 2011 financial outlook, and statements relating to the timing of the clinical trials and product candidate development. These forward-looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of AcelRx Pharmaceutical’s product development activities and clinical trials; its ability to obtain and maintain regulatory approval of its product candidates; its ability to obtain funding for its operations; its plans to research, develop and commercialize its product candidates; its ability to attract collaborators with development, regulatory and commercialization expertise; the accuracy of AcelRx Pharmaceutical’s estimates regarding expenses, capital requirements and needs for financing; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx Pharmaceuticals’ Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2010. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

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