In one of the biggest single drug codevelopment agreements to date, GlaxoSmithKline and Synta announced last week that they would produce a new melanoma treatment that they say works better than chemotherapy.

GSK is hedging its bets that the drug, STA-4783, will succeed, dropping $80 million in cash and agreeing to more than $1 billion in potential milestones for the drug, now in Phase III trials. The two companies will split the profits in the United States and will get royalties internationally.

"This may be an entirely new way of treating cancer that?s very different from your typical chemotherapy approach," Safi Bahcall, CEO of Synta Pharmaceutical, said in an interview with 

. According to Synta, "STA-4783 boosts the level of reactive oxygen species in cancer cells, causing the cell to exceed a critical breaking point and undergo programmed cell death, or apoptosis." The drug, however, has little to no effect on healthy cells.

"Traditional chemotherapies block cell division," Bahcall said. "They go inside and kill anything that divides rapidly, including non-cancer cells. One of the reasons this drug works in melanoma where other drugs have failed is because melanoma is quite resistant to chemotherapy."

Synta was founded by scientists from Harvard and MIT to develop small molecule drugs for cancer and inflammation. It has three cancer drugs in development. STA-4783 has shown positive data in metastatic melanoma, and the company expects to try the drug in other cancer types, such as breast, prostate, and ovarian cancers. Bahcall said, "We ran a trial that compared patients who received the drug versus a control group, and the patients who received our drug lived twice as long without the disease getting worse."

STA-4783 just entered Phase III trials. Synta estimates that the results will be available by later next year and ready for presentation to FDA by early 2009.

Synta said it has received a large amount of unsolicited interest from big pharmaceutical companies that are interested in working with it on different drugs. "One of the reasons we selected GSK was we saw such consistent enthusiasm and commitment from the company across all of its groups internally," Bahcall said. "That was an important factor, because one of the things you want as a small company is a sense that the larger company is going to be very committed to advancing your program—we got that sense on a personal and economic level. This deal will allow us to realize the full potential of our product."

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In a blockbuster codevelopment deal, GlaxoSmithKline gains rights to an innovative Phase III melanoma drug.

GSK to Pay $1 Billion for Synta Melanoma Drug

AstraZeneca is celebrating Breast Cancer Awareness Month with a viral online campaign designed as a tribute to breast cancer survivors and a way to generate cash for a worthy cause.

Launched October 1, in conjunction with agency Digitas Health, the interactive Web site titled 

 invites people to create paper dolls in the likeness of breast cancer survivors. The site features an intuitive interface that is easy-to-use and rather versatile (think create-a-Simpson, but with pink skin instead of yellow).

"We wanted to address survivorship, and that's really what Celebration Chain is all about," said Meryl Weinreb, consumer brand director of oncology at AstraZeneca. According to the National Cancer Institute, there are more than 2 million women who are breast cancer survivors in the United States, with unique issues and concerns."

The paper dolls serve more as a representation of the person rather than a spitting image. According to AZ, the company wanted to capture the essence of the person—their characteristics, attributes, what's inside—rather than the physical part. For every doll made, AstraZeneca donates $1 to Living Beyond Breast Cancer, an organization that helps women with life after breast cancer.

"One of the wonderful things about the Web is having the ability to make a site interactive," Weinreb said. "This was a way to involve a group of people who are already deeply involved in this community?and do it in a way that allows them to create an expression of how they feel about themselves and how their loved ones feel about them."

Rather than keep the site as a health information portal, AZ decided to make it an obvious branded campaign for Arimidex (anastrozole). The drug is typically prescribed to postmenopausal women with early stage breast cancer who have estrogen-receptor positive disease.

"We wanted to let people know what our brand felt about survivors and survivorship, and this is a medication that helps reduce a risk of a breast cancer occurrence," Weinreb said. "This drug helps assure that breast cancer survivors stay survivors."

The company did a soft launch of the site with little promotion in the beginning of the summer, which helped AZ net 4,749 paper dolls as of press time. In the near future, the company plans to increase promotion and enhance the site with additional character animation and attributes, as well as with a search engine to find dolls.

"The fact that we have had this kind of response with very little promotion really speaks to the viral nature of the Web and the involvement of the people who come to a site like this," Weinreb said.

New Web site allows users to create tribute dolls for breast cancer survivors. For every doll made, AZ will donate $1 to charity.

AstraZeneca Spurs Breast Cancer Awareness with Paper Dolls

Novartis is hoping to make a big splash with its newest hypertension drug, shaking up a sluggish market that has seen little innovation over the past decade. Tekturna (aliskiren), which boasts a novel mechanism of action, is one of two major launches coming out of the company's cardiovascular franchise this year. Debut number two is Exforge--which combines its best seller, Diovan (valsartan), with the generic version of Pfizer's Norvasc (amlodipine)--with a multifaceted third-quarter blitz including community outreach, disease awareness, and a celebrity spokesperson.

The Swiss giant is also pulling out all the stops for Tekturna. "Everyone should expect we'll have a competitive launch," said Mark Iwicki, vice president of the cardiovascular brand team. Without giving too much away, he noted that Novartis is contacting 85,000 physicians and preparing a comprehensive med-ed program. The company has added 1,000 sales reps in the US to support new-product launches, including Exforge and Tekturna, according to the company's annual report.

Tekturna is the first in a class of drugs called direct renin inhibitors, which have been 30 years in the making. While other drugs try to control the effects of renin, Tekturna blocks its production from the get-go. "It's been a hard mechanism to master and bring to market," Iwicki said. The promise, however, is a drug that could have better efficacy than those already available.

Yet Novartis will be introducing its newcomer into a field that is crowded with good generics. And it will also need to guard against the ever-present frustration of patient noncompliance, especially tricky for a silent killer like hypertension.

The firm is currently funding a number of "outcome" mega-studies that could one day allow it to market the drug for additional indications. In the meantime, it expects Diovan to remain its first-line therapy for hypertension, with Tekturna prescribed when patients need additional therapy--as most do. "This product can absolutely be used first line, [but] managed-care plans are really pushing generics right now," Iwicki said about Tekturna. "A large piece of the business will be in combination with other drugs."

Diovan, one of four hypertension drugs in Novartis' portfolio, grew 15 percent last year to $4.2 billion.

On the consumer front, patients who take Tekturna will be able to sign up for the company's BP Success Zone, a program that uses a number of tools to drive home the message of why it's important to stick to therapy. Doctors also get help--like 3-D images of the havoc high blood pressure wreaks inside the body--communicating the point.

Swiss drug maker gears up to launch first in class Tekturna.

Putting the Pressure On

A federal judge has ordered FDA to make a decision on whether to approve a generic version of human growth hormone.

In 2003 Sandoz, the generics manufacturing arm of Novartis AG, filed for approval of omnitrope, a generic version of Pfizer´s human growth hormone product Genotropin, which was approved in 1995. In 2004, the agency said that, though there was nothing wrong with the application, it could not take action on it. Sandoz filed suit in US District Court for the District of Columbia, arguing that FDA had a statutory obligation to act, pointing to the 180-day deadline imposed by the Prescription Drug Users Fee Act (PDUFA).

"This is the first time courts have held FDA to statutory deadlines," explains William Schultz of the law firm Zuckerman Spaeder. Schultz goes on to say that the decision doesn´t mean that any company that fails to get a decision within a PDUFA deadline will have a valid lawsuit. The courts have declined lawsuits of this sort when FDA shows that the delay was a matter of insufficient resources. What makes this case different is that resources weren´t the issue. It was that FDA did not have a policy for a category of drugs.

"The issue of designing some mechanism to facilitate the entry of generic biologics is quite important," says James Love, director of the public-interest Consumer Project on Technology, which tracks issues related to intellectual property. "It´s bad enough that FDA is really slow on processing some of the data on regular generics, where there´s a very well-defined procedure. But biologics are becoming much more important and incredibly aggressively priced."

Sandoz´s omnitrope was approved for marketing in the European Union on April 20. It willl be marketed first in Germany and Austria. The European Medicine´s Agency´s (EMEA) Committee on Medicinal Products for Human Use has already given a positive recommendation for another human growth hormone, Valtropin (somatropin) by Biopartners GmbH, based on Lilly´s Humatrope.

The EMEA has also released guidance for the approval of generic recombinant insulin, somatropin, erythropoietin, and recombinant granulocytic colony stimulating factor (rG-CSF).

To Zuckerman, the decision may empower people at FDA who want to move ahead on generic biologics. "Once FDA starts down this road [of having to make a decision], they will not be able to do just nothing." Andrea Hofelich of the Generic Pharmaceutical Association added, "We´ve been calling for FDA to move forward with guidelines and certainly think FDA has the ability to approve them currently. We would like to see things move forward."

A federal district court ruled that FDA cannot fail to rule on a Sandoz's application for approval of omnitrope, a human growth hormone, just because it has no policy for generic biologics. Court watchers say the decision may help other generic biologics move forward in the approvals process.

Court Says Agency Must Decide on Generic HGH

Consult your doctor? Make that: Consult your fellow patients. On a growing number of Weblogs-interactive Web sites better known as blogs-patients are advising one another about which medications to take and which to avoid. These self-styled experts may not have medical degrees, but they do wield growing influence among pharma’s end customers, not least because they talk frankly about the experience of using medications.

    “Anecdotal evidence is underappreciated by the medical community, but patients really value it,” says Jerod Poore, who calls himself the “Chief Spazz” of CrazyMeds.org, a quirky blog dedicated to patients with neurological disorders. Poore, who says he is bipolar, epileptic, and autistic, created the site when he became frustrated with the information otherwise available. 

    “Product information sheets are incomprehensible,” he says. “Drug [company] Web sites are full of propaganda, and online support groups do little more than give you a gentle hug and tell you everything is going to be okay.”

    CrazyMeds draws 5,000 to 6,000 visitors a day. It chronicles the pros and cons of drugs from a user perspective and, in Poore’s words, shares with fellow patients the “interesting stuff your doctor probably won’t tell you” about hundreds of drugs. 

    While patients use blogs for many purposes- to connect with other patients and trade information about treatments-most use the site to get information on a particular medication. Consequently, the drug guides get the most hits. In November, the top five most widely discussed medications were Topamax (topiramate), Lamictal (lamotrigine), Cymbalta (duloxetine), Seroquel (quetiapine) and Wellbutrin (bupropion). Holly Russell, a spokesperson from GlaxoSmithKline, says that her company has yet to form an opinion on blogs because they are still so new. Other companies manufacturing these medications declined to comment on how blogs impact their marketing strategies. 

    Some industry observers suggest that pharma should monitor blogs like CrazyMeds, since they reveal how consumers perceive their brands. “We are just beginning to understand how to tap into these blogs since they are a new phenomenon,” says Cathy Clift, chief planning officer for Rapp Collins Worldwide, a direct marketing agency. 

    “By understanding the psychological aspects of a disease, pharma can work towards making a better product,” says Debrianna Obara, vice president and director of media for Avenue A| Razorfish, an interactive marketing firm.

    But Poore’s intention is to help patients, not pharma. “I see CrazyMeds as another form of DTC,” he says. “The difference is that I try to provide patients with the good, the bad, and the funny of meds. Then, I let them make their own decisions.”

Log on to CrazyMeds.org. Find out what patients say about your drugs, and what they think doctors and pharma don’t tell them.

Pharmaceutical Executive-10-17-2007

GSK to Pay $1 Billion for Synta Melanoma Drug

AstraZeneca Spurs Breast Cancer Awareness with Paper Dolls

Putting the Pressure On

Court Says Agency Must Decide on Generic HGH

Patients Are Playing Doctor on the Web. It is a Whole New Game for Pharma.