Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

The Los Angeles Times (9/4, Maugh) reports, "After nearly two decades of futile searching for a vaccine against the AIDS virus," scientists at the Scripps Research Institute "are reporting the tantalizing discovery of antibodies that can prevent the virus from multiplying in the body and producing severe disease." Interestingly, the broadly neutralizing antibodies, or bNAbs, "target a portion of HIV that researchers had not considered" during prior experiments, according to the paper published online in Science. What's more, the target "is a relatively stable portion of the virus that does not participate in the extensive mutations that have made HIV able to escape from antiviral drugs and previous experimental vaccines."

The scientific community has been diligent in its vaccine quest, according to the Wall Street Journal (9/4, Naik, subscription required). Since 1987, researchers throughout the world have had a hand in nearly 100 trials, but they were thwarted in every single one. The biggest setback came in 2007 when a Merck trial yielded an experimental vaccine that actually seemed to increase the risk of infection. Accordingly, funding began drying up, as evidenced by a 10 percent decrease in annual investments in 2008.

One New York-based nonprofit remained undeterred, however. In 2006, Bloomberg News (9/4, Waters) reports, the International AIDS Vaccine Initiative "kicked off an effort dubbed Protocol G, aimed at searching for antibodies that can neutralize the strains of HIV that circulate in the developing world, where the majority of new infections are taking place." Working alongside "doctors and clinics in Thailand, Australia, the US, the UK, and especially Africa, where two-thirds of the world's infected people live, the group collected blood samples from 1,800 people who had been infected with HIV for at least three years without developing symptoms."

Using the "latest biological and computational screening techniques, which emerged from genome-sequencing technologies," investigators screened the "virus-laden samples against B cells to see how many of the HIV strains the immune cells would recognize," Time (9/3, Park) reported. "To their surprise, the B cells were able to neutralize a fair number of the viruses, but two of the antibodies produced by the cells clearly stood out as more potent than the rest" -- PG9 and PG16.

The "two new bNAbs...seem to be different for" a few reasons, the San Diego Tribune (9/3, LaFee) pointed out. Most notably, they "were isolated from...donors in developing countries where HIV is most active." They also "appear to attack a part of the HIV virus that doesn't mutate much, if at all." Lead investigator Dennis Burton said, "It looks like (they) target a particular region on the tops of these surface spikes that stud the viral surface." And, "these spikes are important to the virus because it uses them to interact with or bind to target cells." Simply put, these "antibody-vulnerable areas of the spikes may be the virus' Achilles heel." HealthDay (9/3, Mundell) and Reuters (9/4, Fox) also covered the story.

Drug Approvals

FDA approves guanfacine for AD/HD in children, adolescents.

The Philadelphia Business Journal (9/3, George) reported, "The Food and Drug Administration granted marketing approval Thursday to Shire for Intuniv [guanfacine], a nonstimulant treatment for attention-deficit hyperactivity disorder in children and adolescents aged six to 17." Shire "already has three other ADHD treatments in the United States and two AD/HD medicines outside the United States."

HealthDay (9/3, Roberts) reported that Shire said its "once-daily drug, to be available in 1-to-4 mg. strengths, is expected on pharmacy shelves in November." Reuters (9/4) also covered the story.

Quality and Safety

Single-dose swine flu vaccines raise efficacy questions.

Bloomberg News (9/4, Randall) reports, "Americans may need two vaccine doses instead of one to be immunized against swine flu because officials plan to exclude ingredients used to boost immune responses in shots made by Novartis AG and GlaxoSmithKline Plc." Novartis yesterday said "a single dose of its vaccine, which relies on a shot-boosting ingredient known as an adjuvant, safely provoked a strong immune response in a trial of 100 healthy volunteers." However, Frieden said the "formulation favored by the US doesn't use an adjuvant, and a second vaccine dose is more likely to be required." Bloomberg adds that "adjuvants are controversial because some studies show they cause immune disorders in mice."

According to the AP (9/3), it's unclear what the Novartis trial "would mean for the global swine flu supply," since the Novartis "vaccine was made using cell culture, while about 90 percent of the world's flu vaccines are made using chicken eggs." But the Wall Street Journal (9/4, Bart, subscription required) notes that the cell-based production method that Novartis uses is faster than the egg-based method.

Regulatory

Judge rules Elan-J&J deal breaches Tysabri contract with Biogen.

The Wall Street Journal (9/4, B4, Gryta, subscription required) reports that a US judge ruled that a deal between Elan PLC and Johnson & Johnson breaches a contract with Biogen Idec Inc. over the multiple sclerosis treatment Tysabri [natalizumab]. At issue is J&J's July agreement to purchase 18.4 percent of Elan.

"Biogen and Elan have an agreement that if one is acquired, the other has an option to buy its rights to Tysabri," the Boston Globe/Bloomberg News (9/4, Weidlich) reports. Under the J&J deal, therefore, "Elan assigned its right to J&J in the event that Biogen were ever acquired," Biogen argued. The judge said that "it appears to the court that Elan has designated an obligation it has to [J&J] by taking direction from [J&J] on the purchase-price negotiations." Although "no assignment of rights took place, 'it would seem there has been a breach of the Biogen-Elan collaboration agreement,'" the judge ruled. Elan was given "23 days to fix the breach." Reuters (9/4) also covers the story.

Report indicates most drugmakers meeting federal requirements for post-marketing studies.

The Dow Jones Newswire (9/4, Favole) reports, "Drug and biologics makers are generally keeping up with federal requirements to conduct studies after the Food and Drug Administration approves a medicine," according to a report from consulting firm Booz Allen Hamilton. The "review of more than 1,500 open post-marketing reviews" showed that over "89 percent of the studies are either meeting established deadlines, have been submitted to FDA for review, or have already been completed." In 2007, "Congress gave the FDA new authority...to require companies to continue studying and testing a medicine after it has been approved when health officials have lingering questions about the product's effectiveness or safety."

MedPage Today (9/3, Gever) reported that the review found "more than 750 studies -- nearly half of the 1,531 in the agency's backlog as of 2007 -- were erroneously listed as 'pending,' meaning they had not begun." But, "the agency has since acted on more than 200 post-marketing studies submitted by drug firms that had languished at the agency," of which "the overwhelming majority satisfied the agency's requirements." In fact, "only 211 remained" pending "after the audit." Reuters (9/4) also covers the story.

Technology

Grants allocated for technology-based programs to reduce medication nonadherence.

Healthcare IT News (9/3, Monegain) reported, "The Center for Technology and Aging has released guidelines for a $500,000 grants program aimed at using technology to help reduce patients' failure to adhere to prescribed medication regimens." The Medication Optimization Diffusion Grants Program "provides up to six one-year grants to organizations successfully proposing programs that directly benefit older adults," and four "or five grants will focus on Californians, while one or two may be awarded to other regions of the country." The center said that drug-related hospitalizations "cost $47 billion annually."

Obama plans detailed healthcare address as White House seeks Sen. Snowe's backing.

The Washington Post (9/4, A4, Kornblut) reports that "administration officials promised" that the President will next week "deliver a detailed prescription for reform despite the risks of spelling out exactly where he stands." Vice President Biden said the speech "will map out 'in understandable, clear terms what our administration wants to happen with regard to healthcare, and what we are going to push for specifically.'" Senior administration officials said the speech "will satisfy demands" that Obama "clarify which provisions he supports and which he could jettison. The contents of the speech are largely decided, officials said." The Post also reports the White House is focusing on winning the support of Sen. Olympia Snowe (R-ME), "who they view as the Republican most willing to reach an agreement with the White House. On Thursday, aides to Snowe confirmed that the senator is talking with administration officials, particularly with regard to her 'safety-net fallback option.'" That plan would have the government "sponsor a nonprofit insurance plan but it would become available only in states or regions where private insurance firms had failed to offer a reasonably priced product that would be affordable to 95 percent of the population."

Health Business

Dainippon seeks to tap US drug market with Sepracor purchase.

The New York Times (9/4, B4, Nicholson) reports, "Dainippon Sumitomo Pharma of Japan said Thursday that it would buy the American drugmaker Sepracor for $2.6 billion, as it seeks to tap sales in the United States and increase the products in its pipeline." Sepracor's board unanimously approved the acquisition, and will "be made with a cash tender offer for Sepracor common shares valued at $23 each, or more than 25 percent above their closing price Monday." The Times notes, "Japan's pharmaceutical industry has been especially ambitious in the United States."

The AP (9/4) also reports, "The Japanese drugmaker said the deal will give it access to Sepracor's established sales network of about 1,325 people in the US, which will help it establish a sales platform for lurasidone, a potential treatment for schizophrenia that is now in late-stage trials." Dainippon pointed out "that the acquisition of Sepracor will also increase its overseas revenue to 40 percent of its total."

The Boston Globe (9/4, Wallack) also notes that Sepracor "vowed to maintain" its Massachusetts operations. The Wall Street Journal (9/4, M12, Simms, subscription required), the Boston Business Journal (9/3, Donnelly), Modern Healthcare (9/3, Evans, subscription required), and the Chicago Tribune (9/4) also covered the story.

Bayer to pay Algeta as much as $800 million for Alpharadin.

Bloomberg News (9/4, Von Schaper) reports, "Bayer AG agreed to pay Algeta ASA as much as $800 million for the rights to an experimental cancer medicine known as Alpharadin [radium-223]." The companies will "jointly develop the medicine," and Algeta "will get $61 million in cash, as well as development and sales payments tied to the drug's success." Bayer also said the drug, which is in a Phase III clinical trial, is being tested on patients whose prostate cancer has spread to the bone and "may also battle several forms of cancer that have spread to the bone."

Forest Laboratories paid Minnesota physicians more than $750,000, analysis indicates.

The AP (9/3) reported that "an analysis by a nonprofit group shows a drug company paid Minnesota doctors more than $750,000 in 2008." In fact, "Forest Laboratories Inc. paid 62 Minnesota doctors at least $1,000 each in speakers' fees, with 28 physicians receiving payments of more than $10,000," the Minneapolis Star Tribune (9/3, Moore) reported." The Star Tribune pointed out that "Minnesota was the first among a handful of states requiring drug companies to disclose payments to doctors, and the annual disclosure reports have repeatedly revealed potential conflicts of interest in the way physicians prescribe drugs or conduct clinical research, while adding fuel to a national debate about greater disclosure of the financial ties between industry and" physicians. Nearly one-third "of Forest's payments went to psychiatrists and neurologists, frequent prescribers of antidepressants."

Also in the News

Florida to use portion of Pfizer settlement funds to reward those reporting Medicaid fraud.

The Miami Herald (9/4, Shah) reports, "Florida will use part of its $58 million share of a federal settlement from pharmaceutical giant Pfizer as reward money for tipsters who report Medicaid fraud." The state will use "about $1 million" of the $58 million it received in the settlement to "reward informants whose tips lead to fines, civil or criminal charges or forfeitures of property." Some of the remaining funds "will reimburse the federal Medicaid program for Florida and the state Medicaid program, and nearly $10 million will go into the state's general fund."