Anacor gets $15M from GSK

GlaxoSmithKline (NYSE: GSK) has obtained an exclusive licence to develop and commercialize an antibiotic derived from Anacor's boron chemistry platform. As a result, Anacor will receive $15 million and is eligible for further milestone payments and royalties on any future product sales. GSK is assuming responsibility for further development of the compound and any resulting commercialization.

In early stage studies, GSK2251052 (GSK '052) has shown robust activity against multi-resistant gram-negative bacteria with no cross resistance to existing classes of antibiotics. GSK '052 is being looked at as a potential treatment for complicated urinary tract infection, complicated intra-abdominal infections and hospital/ventilator-associated pneumonia (HAP/VAP).

"GSK '052 has an entirely novel mechanism of action with the potential to be the first new class antibacterial to treat serious hospital gram-negative infections in 30 years," says David Payne, VP of GSK's anti-bacterial drug discovery unit. "Our collaboration with Anacor has enabled the rapid progression of GSK '052, and we are excited about the opportunity to address the growing need for new treatments for serious hospital acquired infections."

GSK and Anacor entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for viral and bacterial diseases in October 2007. The alliance grants GSK access to Anacor's proprietary boron-based chemistry for use in four target-based project areas. Contingent on achieving certain milestones, Anacor is eligible to receive development and regulatory milestone payments of up to $84 million as well as commercial milestones and tiered double-digit royalties up to the mid-teens, which are dependent on sales achieved.

- read the Anacor release

ALSO: Colgate-Palmolive hasasked a federal court to rule that its new "Triple Action" toothpaste doesn't infringe trademarks of GSK's competing product, Aquafresh. Report

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Hospira plans big study for new Epogen biosimilar

In what's described as an early-stage clinical trial, Hospira (NYSE: HSP) has unveiled plans to take its biosimilar of Amgen's anemia drug Epogen directly into a head-to-head study designed to swiftly pivot into a large, late-stage study.

The Chicago-based company plans to recruit hemodialysis patients at 20 different centers across the U.S. But unlike a typical Phase I study, researchers will immediately study both safety and efficacy of the therapy, Retacrit, in comparison with the market-leading drug. If it's successful, the study will vault into a Phase III trial next year.

"This trial marks a key milestone for Hospira's biosimilars program," says Sumant Ramachandra, a senior vice president at Hospira. "Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."

Retacrit is already available in Europe, where it now has a more than 50 percent share of the "total short-acting EPO biosimilar market." This study illustrates the new approach that developers will take on clinical trials for biosimilars. Jumping past much of the early- and mid-stage research required for new chemical entities, companies can move quickly into Phase III, which requires deep pockets.

- here's the press release
- here's the story from the Chicago Tribune

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Athersys buoyed by upbeat PhI stem cell data

Athersys (ATHX) has benefited from some upbeat buzz about its positive--though small--early-stage results for a prospective new stem cell therapy for victims of a heart attack. Patients who received a medium and high dose of its MultiStem therapy--a stem cell treatment derived from patients' bone marrow cells--demonstrated significantly improved heart function in a Phase I trial. A total of 19 patients were treated with the experimental therapy.

"We are encouraged by the results of this Phase I study, and based on these results, will work with our partner, Angiotech Pharmaceuticals, on plans for a phase II trial to further evaluate safety and assess improvement in cardiac function" said Athersys CEO Gil Van Bokkelen. "This study is an important step and provides additional validation of the clinical potential and therapeutic profile of MultiStem as an off-the-shelf, allogeneic stem cell therapy, and we look forward to building off these results."

That sounded pretty good to investors, who drove the stock up 18 percent on the news. Late last year Pfizer inked a $111 million deal to license rights to develop Athersys' cell therapy for inflammatory bowel disease. But only $6 million of that was paid upfront.

- here's the Athersys release
- read the story from MedCity News
- check out the Dow Jones article

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NEJM spotlights Provenge study

Shares of Dendreon (NASDAQ: DNDN) soared into the stratosphere in the lead-up to Provenge's approval--and then promptly started tumbling fast as all sorts of questions arose about supply issues, cost and efficacy. But the company is likely to benefit enormously from the publication of its biggest study of the innovative prostate cancer vaccine in the prestigious New England Journal of Medicine, which carries biblical weight with providers. Story

With losses rising, Vertex rolls out its telaprevir app

Faced with a rising tide of red ink, Vertex (NASDAQ: VRTX) says it has begun rolling out its NDA for the potential blockbuster telaprevir and expects to wrap the app later this year. Banking on a treasure trove of positive Phase III results already in hand, Vertex is clearly hopeful about its chances with the closely watched hepatitis C drug. And it's laying the groundwork for another FDA campaign next year for its cystic fibrosis program.

Vertex will need to start ginning revenue quickly, assuming it wins an approval for telaprevir. The company projects a $750 million loss for 2010--significantly more than earlier estimates.

"In the first half of this year, we established a seasoned commercial leadership team with broad experience in the area of infectious diseases, and we continue to bolster the internal infrastructure needed to support a field-based sales force for telaprevir and other potential future medicines," says Vertex CEO Matthew Emmens in a statement that lays out the biotech's development strategy.

"Our Phase III registration program in cystic fibrosis is now fully enrolled, positioning us for the planned submission of a New Drug Application for VX-770 in the second half of 2011. There is an urgent need for new and more effective therapies in cystic fibrosis, and we are committed to working toward improving the lives of people affected by this disease."

- here's the press release on Vertex's pipeline strategy
- here's the story from Reuters

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Sanofi-Aventis readies $18.7B bid for Genzyme

Genzyme (GENZ) is in play. After days of fevered speculation over what Genzyme would be worth to a company like Sanofi-Aventis, the big pharma outfit appears to have set its sights on the low side of the spectrum. According to a flurry of news reports, Sanofi CEO Chris Viehbacher and the board think that $70 a share--that's $18.7 billion total--would be a fair price to pay. But any bidding could start under that level. 

Significantly, Sanofi appears ready to move past the discussion stage and lay its cards out on the table in a formally presented letter which spells out its terms, Bloomberg reports, quoting "three people with knowledge of the situation." The New York Times, meanwhile, said that the pharma company would likely issue a "bear hug" letter, indicating it would like to keep the bidding process friendly but would go hostile if necessary - a ploy that could help win over some of the board members who have been on the fence in recent days.

Genzyme, though, isn't likely to leap at any $70 bid that comes its way. Market analysts have been quick to target $80 as a good premium over the current trade, which has soared 30 percent on the back of all the rumors that have been floating around.

"My guess is that Genzyme would turn them down," Cowen & Co's Phil Nadeau told the business news wire, "do some negotiations, and the price would go up a little bit, maybe to $73 or $75."  

True, Genzyme has been damaged by its recent manufacturing snafus, but that's unlikely to intimidate a player like Sanofi, which could use Genzyme's storehouse of biotech knowledge. And a rich M&A deal could be just the way Genzyme CEO Henri Termeer would like to cap his long-running career.

While Sanofi's board has been leaking like an old wooden ship, Viehbacher publicly is keeping a tight lip on the deal. "We are under no pressure to do a deal," Viehbacher told analysts on a call, vowing to stay disciplined on its M&A strategy.

- here's the story from Bloomberg
- here's the report from the New York Times
- here's the report from Reuters

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AZ's blockbuster Brilinta wins landslide FDA panel vote

AstraZeneca scored a big win in front of an FDA advisory panel on Wednesday afternoon, gaining solid support for its blockbuster blood thinner Brilinta in a seven-to-one vote in favor of approval.

AstraZeneca's biggest obstacle was the relatively small contingent of 1,413 American patients in a large international Phase III who failed to benefit from the drug. But the 17,000 patients who participated in the study in 42 other countries demonstrated a sharp drop in deaths and heart attacks, leading the panelists to conclude that the anti-clotting therapy should be effective in a broad patient population.

"The overall results are so striking," said the University of Minnesota's James Neaton, who supported the application. Neaton, though, also reflected some general anxiety about the lack of U.S.-related efficacy data, which AstraZeneca has attempted to blame on a regular use of aspirin among the patients recruited in this country. "We are confident in the [effectiveness] of ticagrelor when used with low-dose aspirin," said AstraZeneca's Jonathan Fox, according to a report by Dow Jones.

The vote puts AstraZeneca on the path to full FDA approval--something that is likely given the lopsided vote in Brilinta's favor. If it does win full approval later this year, analysts project that the drug will quickly rack up more than a billion dollars in sales during its first year and has the potential to hit mega-blockbuster status with $4 billion in peak annual sales. With its patent on Nexium set to expire soon, a big regulatory win here is just what the pharma company needs most.

- here's the story from Reuters
- here's the report from Dow Jones

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Antigenics shares buoyed by early data on genital herpes vax

Shares of Antigenics (AGEN) got some much-needed help after the developer reported that its vaccine/adjuvant combo to guard against genital herpes looked promising in a small, early-stage trial.

The Lexington, MA-based biotech recruited 35 patients for the Phase I study, dividing them into four different groups. One group got the vaccine AG-707 and Antigenics' adjuvant with the other three groups getting either the vaccine alone, the adjuvant alone or a placebo. The biotech noted that all seven patients who were evaluable for immune response and received AG-707 with the QS-21 adjuvant showed a statistically significant CD4+ T cell response.

"I believe these data represent the first finding of their kind in genital herpes treatments-showing a vaccine, AG-707, elicits both CD4+ and CD8+ T-cell responses in humans," said David Koelle, study investigator and professor of Medicine, Laboratory Medicine and Global Health Medicine at the University of Washington. "We are very encouraged by these results. Recent data suggest both of these arms of immunity are needed for successful treatment of genital herpes."

Investors liked the sound of that, pushing Antigenics' shares up about 20 percent to near the $1 mark. Antigenics, though, has had a tough time gaining much market respect, with its cancer vaccine Oncophage experiencing rough treatment at the hands of regulators outside of Russia.

- here's the Antigenics release
- read the story from the Boston Business Journal

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