After months of working damage control for Avandia, GlaxoSmithKline has released some positive news on the oncology front. The company announced last Monday that it plans to release five new cancer medicines over the next three years, a huge leap for a company whose name is not synonymous with that space. The newcomers, three direct-acting oncologics that treat cancer and two supportive cancer medications, are:

, an oral breast cancer treatment released in the United States in March. This drug has been used to treat nearly 3,000 patients.

, a new vaccine entering Phase III trials in late 2007. The therapeutic vaccine has shown positive effects when used to treat non-small-cell lung cancer. GSK claims that with more than 2,200 patients already signed up, the Phase III trial will be one of the largest ever conducted for the treatment of cancer. "Non-small-cell cancer is very unresponsive to any type of treatment. So if you have a successful compound in that space that is likely to generate very significant sales, it could become a blockbuster," says Graham Lewis, vice president of global pharma strategy at IMS Health.

, an oral multi-kinase inhibitor that prevents the development of new blood vessels, thereby slowing tumor progression. In clinical trials, the drug has seen positive effects in treating renal cell carcinoma, soft tissue sarcoma, and aggressive ovarian cancers, according to GSK.

, a fully human high-affinity antibody for the treatment of follicular non-Hodgkin's Disease and chronic lymphocytic leukemia.

, an oral novel compound used to treat thrombocytopenic sufferers that are at risk for uncontrollable bleeding. In a controlled study, patients treated with the medication saw a drop in bleeding as opposed to those taking the placebo. The drug also is being investigated for people afflicted by idiopathic thrombocytopenic purpura, hepatitis C-associated thrombocytopenia, and chemotherapy-induced thrombocytopenia.

, an enti-emetic medicine that in combination with Zofran can be used to curb nausea and vomiting in cancer patients.

"The science has been moving faster in oncology than in other scientific areas, and we understand so much more now that we are in the phase of translating the knowledge to application," said Paolo Paoletti, senior vice president at GSK. "On the other hand, cancer is still a huge unmet need, and while we are taking a huge step forward, we have not completely cured the disease."

According to Paoletti, the drug manufacturer began researching cancer drugs just before the merger of Glaxo and SmithKline, more than 10 years ago. After the unification, the new company formed small drug-development divisions called Centers of Excellence in areas such as cardiology and oncology, so that researchers could focus solely on individual drug treatments.

"From discovery through development, we are creating a unique group that is working only on oncology," Paoletti said. "We don't have five drugs in discovery, we have five drugs in late-stage development that will be submitted in three years and, hopefully, we will have new drugs for cancer patients."

Oncology is one of the fastest-growing sectors of the pharmaceutical industry and is expected to double in size by 2011 and be worth $75 to $80 billion, according to IMS Health. "This is a vibrant and growing market on a global basis, and we think it is going to continue," Lewis says. IMS expects that 50 new chemical entities will be launched in direct oncology in the next five years. "GSK is not currently a top 10 player in oncology, but it is likely to become a serious player in the space," Lewis said. "It is unlikely that any other major players will launch more than three novel compounds over this period."

One of the challenges in the cancer drug arena is competition. "Once upon a time, you developed a novel compound in oncology and essentially there was no competition," Lewis said. "Quite a number of the compounds that will be launched in the next five years will be competing with drugs that are already on the market." In addition, a number of drugs on the market will be exposed to generic competition, which could well affect some of the new products.

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PricewaterhouseCoopers' recent announcement that the global pharma market will double to $1.3 trillion by 2020 should have been met with corks popping and confetti falling. 

But the blue-chip consulting firm squelched the party mood with its sobering conclusion that the industry's current business model will fall to pieces if companies don't start innovating--and fast. The just-released, much-publicized PwC report, "Pharma 2020: The Vision--Which Path Will You Take?" says the industry needs more than a new pair of glasses to see its way to a profitable future.

"We'not suggesting the blockbuster strategy will die," said Tony Farino, PwC's US pharmaceutical and life sciences advisory services leader. "It just will not suffice to address the global healthcare concerns." Instead, companies need to develop outside-the-box strategies involving mass marketing and consumer services as well as turning generics and OTC medications to their advantage--think of the one-two punch of GlaxoSmithKline's Alli (orlistat) and its tip-packed Web site, myalli.com--to pump up sales lost to patent expirations And big pharmas also need to step up their outside-the-house R&D with more innovative license and partenering deals.

Pipeline renovation is key. But with companies already throwing twice the money they spent in 1996 into drug development with fewer than half the results, leaner and smarter is the way to go. "We're going to see a shift from linear phases to in-life testing and early licensing," Farino said. "In-life testing" means smaller, more focused clinical trials that lead to an early license allowing the company to market the drug to a controlled population while further testing is completed. 

But, he said, such early market introduction can only work if companies' understanding of a drug -- from its molecular structure to potential side effects--is much more thorough than it is now. And with pressure on the FDA to increase its safety monitoring, PwC recommends that companies step up to the plate with their own proactive best-practices for clinical development.

The PwC report calls out several additional pharma opportunities:

Emerging markets: The E7 countries--China, India, Brazil, Russia, Indonesia, Mexico, and Turkey--will also come off the global pharma market bench, yielding one-fifth of the sales pie by 2020. Right now, these countries account for only 8 percent of the market. But as they transition from "developing" to "developed" and their populations grow and age, they'll put more money into combating chronic conditions like diabetes and heart disease. "Focusing on drugs that deal with chronic diseases is the best way to deal with an aging global population," said Farino. 

Patient compliance: One out of every five Americans either don't fill their prescriptions or use someone else's medication. Besides being unsafe, high noncompliance also cuts into profits and hurts companies' reputations. So PwC advocates personalized compliance monitoring. Companies need to take a more active role in supporting consumers--and finding technological solutions. "We're not quite there yet, but with things like implantable chips and wireless, we can already remotely check blood glucose levels," he said. Compliance monitoring will go a long way toward repairing Big Pharma'sbusted image, Farino said, since it demonstrates dedication to patient safety.

Prevention: Eighty percent of heart-related conditions, strokes, and cases of diabetes can be prevented, along with 40 percent of cancer cases. A significant percentage of these preventive measures involve vaccines, which might explain the 245 pure vaccines and 11 combos in the global pipeline. The total prevention market--including vaccines, compliance monitoring, and the like--will be worth $42 billion by 2015.

Farino added, "There's never been a greater opportunity for the pharma industry to grab hold of these changes to decrease healthcare costs and increase quality."

Global market will be twice as big by 2020, but industry needs new vision

Pharma Seeing Double, Says New Report

Abbott Labs has waded deeper into a media quagmire this week, pursuing a risky PR strategy that casts the drug giant as Goliath to the AIDS-activist community's David.

A Paris judge has set October 3 as the start date for the Chicago-based company's lawsuit against ACT UP-Paris. The French AIDS activists are charged with launching a cyberattack--or "zap" in activist lingo--on Abbott's Web site in April on the eve of the company's annual shareholder's meeting. ACT UPers from several countries logged on to the site for several hours, overloading Abbott's server and shutting the site down for at least half an hour.

The group said it was protesting an offer by Abbott in its contentious negotiations with the Thai government to cut the cost of its anti-HIV powerhouse Kaletra (lopinavir/ritonavir) on condition that the nation block generic versions from its market. The group was also demanding that Abbott reverse its decision not to market its newest drugs in Thailand.

The suit is the latest development in a months-long, high-profile battle over patents and prices that Abbott is waging against Thailand and activists--and, increasingly, public opinion. Although the drug maker is standing tall against threats by the Thai ministry of health to issue a compulsory license--or "bust the patent" in pharma parlance--for the company's second-line HIV treatment of choice, the fighting strategy may have hurt it--and Big Pharma's image--in the court of public opinion.

According to a Harris Interactive poll for the Wall Street Journal, 61 percent of Americans think developing nations should be able to break patents on AIDS drugs. A smaller survey on pharmalot.com revealed that 68 percent of that blog's readers thought Abbott was wrong to sue.

The Abbott lawsuit also breaks pharma's tacit rule of steering clear of controversies, especially those involving access to HIV drugs in the developing world. Most HIV drug makers have learned the hard way that working with, rather than against, global advocates for patients with a life-threatening disease is the path to progress.

But Abbott CEO Miles White has frequently bucked this trend. And the prospect of other nations following Thailand's lead in overriding drug patents seems only to have stiffened his spine. "[The Thai] government told us no price that we would offer [for Kaletra] would matter. They told us they already had a supplier lined up," White said. "Why would we...provide the product if a generic company is providing the product?"

Abbott insists that pursuing the case against ACT UP-Paris is no less a matter of principle. "While our organizations can disagree on various matters, it is important to convey those disagreements in a respectful, appropriate, and legal manner," the company said in a statement. The French protestors shouldn't be treated differently from American scofflaws, added Abbott Public Affairs Director Jennifer Smoter. "In the US, cyberattackers face prison time and are sought after by the FBI," she said. ACT UP-Paris could face a fine of $100,000 and disbandment.

Mark Harrington, head of the Treatment Action Group (TAG), a leading AIDS-advocacy-and-policy group widely respected by industry insiders, disagrees. "Every company has its own corporate culture," he said. "Some respect people's right to live, but the only other culture Abbott respects is that of its shareholders." Harrington called the lawsuit "a bullying attempt to distract" from the Thailand controversy.

The current shaky deal between Abbott and Thailand could shatter if the two sides cannot agree on price. The Thai ministry of health insists that Abbott put the price tag no higher than 5 percent more than the generics annual cost per person--about $695. Abbott won't go lower than $1,000; the drug costs $2,200 in the US. Thai officials are expected to make a final decision in the middle of next month.

The media dustup hasn't hurt Abbott financially, according to Morningstar analyst Heather Brilliant. "There won't be any material effect on the company for now," she said. And she doubted that the cyberattack affected the company's sales, though Abbott said online sales of its nutritional products were disrupted.

Yet more strife is likely in store, given that Abbott is still withholding six other drugs, including one for cancer, and the Thai health ministry has announced that it may next target cancer drugs for compulsory licensing."If conflicts like this keep popping up with countries and groups, there could be some damage to every pharma company, especially Abbott," Brilliant said.

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